#United States Biosimilar Market

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Biosimilars Unleashed: The Future of Healthcare in the US

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What is the Size of US Biosimilar Industry?

US Biosimilar Market is expected to grow at a CAGR of ~ % between 2017-2022 and is expected to reach ~USD Bn by 2028. Biosimilars enhance patient access to essential treatments, especially in therapies with high demand, like oncology, by providing more affordable options. Additionally, Growing evidence of biosimilars' comparable efficacy and safety fosters trust among healthcare professionals, driving adoption.

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Biosimilars offer cost savings compared to originator biologics, addressing the need for affordable healthcare solutions in the face of rising medical costs. Favorable regulatory frameworks, like the BPCIA, streamline biosimilar approval processes, encouraging manufacturers to invest in development.

Furthermore, The expiration of patents for numerous reference biologics creates opportunities for biosimilar entry, leading to increased competition and market expansion. Pharmaceutical companies are investing in biosimilar R&D and production, expanding the pipeline and market availability. Supportive healthcare policies and reimbursement models incentivize biosimilar adoption, creating a favorable environment for market growth.

US Biosimilar Market by drug class

The US Biosimilar market is segmented by Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-inflammatory agents and Others. Based on drug class, Monoclonal Antibodies segment dominates the bio similar market in 2022.

Monoclonal antibodies have diverse applications across various therapeutic areas. From cancer treatment to autoimmune diseases, biosimilar Mabs addressed a wide range of medical needs, leading to a broad and growing market. Biosimilars, with their potential for cost savings while maintaining comparable efficacy and safety, gained significant attention as viable alternatives.

US Biosimilar Market by application

In US Biosimilar market, they are segmented by application into Oncology, Blood disorders, Chronic diseases and autoimmune conditions and Others. On the basis of application, Oncology segment was the dominant in 2022.

The increasing prevalence of cancer and the high cost of traditional biologics used in oncology treatment have created a strong incentive for the adoption of biosimilars. Biosimilars offer the potential to provide similar therapeutic outcomes at a lower cost, making them an attractive option for both healthcare providers and patients.

Additionally, the rigorous clinical trials and regulatory processes that biosimilars undergo to gain approval provide reassurance to healthcare professionals and patients regarding their safety and efficacy. This has led to increased acceptance and adoption of biosimilars in oncology.

US Biosimilar by Region

The US Biosimilar market is segmented by Region into North, East, West and South. In 2022, the dominance region is North region in US Biosimilar market.

The North region benefits from a concentration of healthcare providers and academic institutions that are at the forefront of adopting and integrating biosimilars into their treatment protocols. These institutions are more likely to have the expertise to evaluate and incorporate biosimilars effectively, driving their adoption among healthcare professionals and patients.

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Competition Scenario in US Biosimilar Market

The US biosimilar market has witnessed an evolving competitive landscape, with several key players competing for market share. Prominent pharmaceutical companies such as Amgen, Pfizer, Sandoz (Novartis), and Boehringer Ingelheim have been actively involved in developing and marketing biosimilar products. These established players have utilized their expertise in biologics and significant resources to navigate the regulatory landscape and compete effectively.

The competition in the US biosimilar market is characterized by a balance between established pharmaceutical giants and emerging biotech companies. While the major players possess the advantage of resources and experience, smaller biotech firms are also contributing to the market with innovative approaches and niche biosimilar offerings.

What is the Expected Future Outlook for the Overall US Biosimilar Market?

The US Biosimilar market was valued at USD ~Million in 2022 and is anticipated to reach USD ~ Billion by the end of 2028, witnessing a CAGR of ~% during the forecast period 2022- 2028. The US biosimilar market is likely to experience significant growth in the coming years, driven by several factors. Biosimilars are biologic drugs that are highly similar to already approved reference biologics. They offer potential cost savings, increased competition, and improved patient access to crucial treatments.

Firstly, the regulatory environment is becoming more favorable for biosimilars. The Biologics Price Competition and Innovation Act (BPCIA) established a pathway for biosimilar approval in the US, allowing for a smoother regulatory process. As more biosimilars receive approval, competition in the market is expected to intensify.

Secondly, patents for several blockbuster biologics are expiring or have already expired. This creates opportunities for biosimilar manufacturers to enter the market with more affordable alternatives, offering healthcare systems and patients a choice in treatment options.

Thirdly, as healthcare costs continue to rise, biosimilars present an attractive solution for reducing expenses. Their potential to offer cost savings without compromising therapeutic efficacy could lead to increased adoption by healthcare providers, insurers, and patients alike.

Physician and patient education are crucial, as misconceptions about biosimilars' safety and effectiveness might hinder their adoption. Additionally, legal and market access barriers, including patent litigation and complex distribution systems, could slow down the growth of the biosimilar market.

The biosimilar market witness consolidation as larger pharmaceutical companies acquire or partner with smaller biotech firms to bolster their biosimilar portfolios. This will lead to more resources being devoted to biosimilar development and marketing. Changes in healthcare policies, such as reimbursement models and value-based care initiatives, can influence the biosimilar market's growth. Favourable policies that incentivize biosimilar adoption drives their market growth.

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The Generic Sterile Injectables Market poised for strong growth driven by increasing demand for affordable healthcare

The generic sterile injectables market encompasses pharmaceutical formulations such as vials, ampoules, bottles, syringes and bags, which are administered parenterally into the body for treatments. They offer effective and affordable alternatives to branded sterile injectable drugs across therapeutic areas including oncology, cardiovascular diseases, infectious diseases and autoimmune diseases. The growing prevalence of chronic diseases and increasing healthcare expenditure have boosted the demand for generic sterile injectables globally.

The global generic sterile injectables market is estimated to be valued at US$ 46.33 Bn in 2024 and is expected to exhibit a CAGR of 10% over the forecast period 2024 to 2031. Key Takeaways Key players operating in the generic sterile injectables market are Baxter International Inc., AstraZeneca plc, Merck and Co., Inc., Pfizer Inc., Fresenius Kabi, Novartis International AG, Teva Pharmaceuticals, Hikma Pharmaceuticals, Dr. Reddy's Laboratory, Mylan N.V., Sun Pharmaceutical Industries Ltd. The key players dominate the market with their wide array of products in various dosages. The increasing prevalence of chronic diseases and aging population has amplified the demand for affordable healthcare solutions. The rising healthcare costs have prompted patients and providers to shift towards cost-effective generic injectable drugs from branded equivalents. This has accelerated the growth of the global generic sterile injectables market. With rising healthcare expenditures, healthcare providers are boosting investments in emerging markets of Asia Pacific, Latin America, Middle East and Africa for expansion of their generic sterile injectables portfolio. Generic Sterile Injectables Market Trends is expected to drive during the forecast period. Market Key Trends Increased Research & Development and manufacturing capabilities of emerging players: With growing demand for affordable and effective biologics, emerging players are investing significantly in R&D and expanding their sterile injectables manufacturing infrastructure. This has led to increased competition and entry of more affordable biologics in the market.

Porter’s Analysis Threat of new entrants: Low barriers to entry make it easy for new companies to enter the market. However, regulations and requirement of high capital to set-up sterile facilities pose challenges. Bargaining power of buyers: Large group purchasing organizations and hospital networks have significant influence on prices. However, need for essential medicines keeps bargaining power in check. Bargaining power of suppliers: Few major global players supply key starting materials and APIs. However, potential for forward integration limits suppliers' bargaining power. Threat of new substitutes: Limited threat as generics have few major therapeutic substitutes. Biosimilars pose a potential long-term threat in certain disease segments. Competitive rivalry: Intense competition on pricing and new product development. Major players compete by improving quality, reliability of supply and enhancing portfolios. Frequent litigation and regulatory issues also impact competition. The United States dominates the Generic Sterile Injectables Market Regional Analysis accounting for over 40% revenue share in 2024. Strong payer system, sizable healthcare spending and increasing generic adoption to contain costs drive high growth. China sterile injectables market is projected to grow at over 12% till 2031, making it the fastest growing regional market. This can be attributed to rising living standards, healthcare reforms focusing on essential medicines and initiatives to expand domestic sterile manufacturing capabilities.

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Biosimilars Market Size, Trends, Growth Analysis 2032

Biosimilars Market Overview

An integral component of the Biosimilars Market is the emergence of follow-on biologics. These biologics, which closely resemble existing biologic drugs, offer additional options for patients and healthcare providers. Follow-on biologics undergo rigorous testing to demonstrate similarity to the reference product, ensuring interchangeability and therapeutic equivalence. With their introduction, follow-on biologics stimulate competition in the biopharmaceutical industry, driving down prices and promoting innovation. As the demand for cost-effective biologic therapies continues to grow, the Biosimilars Market stands to benefit from the availability and acceptance of follow-on biologics, expanding treatment options and improving patient outcomes.

According to Market Research Future (MRFR), the biosimilars market insights was valued at USD 29.7 billion in 2023 and is projected to grow from USD 36.79 Billion in 2024 to USD 161.95 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 20.35% during the forecast period (2024 - 2032).

Biosimilars Market: Latest News and Developments

The FDA has approved the first Humira biosimilar. Adalimumab-bwwd (Cyltezo), a Humira biosimilar, received FDA approval in January 2023 for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Rising use of biosimilars in the treatment of cancer. A growing number of biosimilars are being used to treat cancer. The FDA authorised filgrastim-sndz (Zarxio), pegfilgrastim-jmdb (Onpro), and trastuzumab-dkst (Herzuma) as three biosimilars for the treatment of cancer in 2022.

Market Segmentation

Biosimilars industry can be considered with respect to product, applications, and end users.

The products based on which the market has been split into are recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant non-glycosylated proteins are the biggest segment in the global market, thanks to the soaring cases of chronic disorders ranging from growth hormone deficiency to diabetes. As a result, recombinant non-glycosylated proteins are therapeutically used as they are readily available and are cost-effective.

Application-wise, the biosimilars market caters to chronic diseases, oncology, blood disorders, autoimmune diseases, infectious diseases, growth hormone deficiency, and more. Blood disorders have emerged as the top segment, as a result of the rising burden of the condition worldwide and the increased use of biosimilars by virtue of their low cost and the overall reduction in the treatment cost.

Major end users in the global market are hospitals and clinics as well as research institutes. Hospital and clinics are healthcare settings where treatment options and skilled professionals are easily available, and therefore, have emerged as the leading segment in the global industry.

Regional Status

Europe, MEA or Middle East & Africa along with the Americas, APAC or Asia Pacific are the primary markets for biosimilars.

Europe has taken the lead in the global market, as the region houses a vast elderly pool, with close to one fifth of the overall EU population aged more than 65 years. This has given way to several lifestyle-related disorders such as oncology, autoimmune diseases, diabetes, to name a few. Presumably, the scenario has raised the demand for biosimilars and can mean higher market growth over the next few years. In addition to this, numerous blockbuster biologics are on track to lose patent in the coming years, which should present lucrative opportunities to the biosimilar manufacturers.

The North American market displays a bright outlook and can emerge quite lucrative in the coming years, in view of the surging burden of chronic ailments in Canada and the United States. The rising spending on research activities by the healthcare agencies also fuels the market expansion in the region. Favorable reimbursement landscape in the region, especially in the US, encourages healthy competition as it results in lower incentives for the players to compete based on price.

The APAC market is slated to witness considerable growth, with China, South Korea and India offering a host of lucrative opportunities for drug development as well as commercialization. These are generics-driven countries and are known for frequently launching new and advanced manufacturing platforms, which has brought down the costs associated with biosimilar production. In the coming few years, majority of the patent expiries is touted to be in biosimilars, which is deemed as a profitable aspect by leading manufacturers and can translate into substantial market growth.

Eminent Vendors

Top global key players listed by biosimilars market outlook report include Stada Arzneimittel AG (Germany), Teva Pharmaceuticals (Israel), Biocon (India), Pfizer (US), Sandoz International (Germany), Eli Lily & Company (US), Actavis, Inc. (US), Dr. Reddy’s Laboratories (India), Cipla Ltd (India), Amgen, Inc. (US), Samsung Biologics (South Korea), Hospira Inc.(US), Mylan, Inc.(US), Celltrion (South Korea), to mention a few.

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Why India’s Pharma Exports Boom: US and UK Demand Rises

India has emerged as a global powerhouse in pharmaceutical exports, witnessing a significant boom in recent years. The country has become a preferred source of high-quality and affordable medicines for countries worldwide, including the United States and the United Kingdom. This surge in demand can be attributed to several factors, including India's robust manufacturing capabilities, a well-established supply chain, and a reputation for producing cost-effective and high-quality pharmaceuticals.

The Rising Demand from the US and UK

The United States and the United Kingdom have been at the forefront of increasing their imports of Indian pharmaceuticals. Several reasons explain this rising demand:

Cost-Effectiveness: Indian pharmaceutical companies are known for their ability to produce high-quality drugs at a fraction of the cost compared to other countries. This cost advantage is primarily due to lower manufacturing and labor costs in India, which enables these companies to offer competitive prices without compromising on quality. The cost-effectiveness of Indian drugs has made them an attractive option for healthcare providers and insurance companies in the US and UK, especially amidst rising healthcare costs.

Stringent Quality Standards: Indian pharmaceutical manufacturers adhere to stringent quality standards set by international regulatory bodies such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Over the years, Indian companies have invested heavily in quality control, research and development, and infrastructure to ensure compliance with global standards. This commitment to quality has enhanced India's reputation as a reliable supplier of safe and effective medications.

Diverse Product Portfolio: India's pharmaceutical industry boasts a diverse product portfolio, ranging from generic drugs and over-the-counter (OTC) medications to complex formulations and vaccines. This diversity allows Indian exporters to cater to a wide range of therapeutic needs, from chronic diseases like diabetes and hypertension to life-saving drugs and vaccines. The ability to supply a broad spectrum of medicines has made India a preferred partner for countries like the US and UK, which require a steady and diverse supply of pharmaceuticals.

Supply Chain Resilience: The COVID-19 pandemic highlighted the importance of a resilient supply chain in the pharmaceutical industry. India's well-established and robust supply chain network, coupled with its ability to quickly ramp up production, played a crucial role in meeting global demand during the pandemic. This resilience has continued to make India an attractive partner for countries seeking reliable suppliers in times of crisis.

Focus on Innovation and Research: India has also made significant strides in pharmaceutical research and development. Indian companies are increasingly focusing on developing new drugs, complex generics, and biosimilars, which has positioned them as key players in the global pharmaceutical market. The rise in patent expirations in the US and UK has also opened new opportunities for Indian companies to introduce cost-effective alternatives to expensive branded drugs.

India's Strategic Position in Global Pharma

India's strategic position in the global pharmaceutical industry is further strengthened by its commitment to innovation, regulatory compliance, and strong government support. The Indian government has introduced several initiatives to boost pharmaceutical exports, including production-linked incentive (PLI) schemes and streamlined regulatory processes. These measures have encouraged more investments in the sector and enhanced India's competitiveness in the global market.

Furthermore, the country's skilled workforce, advanced technological capabilities, and increasing focus on digital healthcare solutions are expected to drive further growth in pharmaceutical exports. With the growing emphasis on affordable healthcare and the demand for high-quality medicines, India's pharmaceutical industry is poised for continued expansion, particularly in key markets like the US and UK.

Conclusion: How Mcare Exports is Supporting the Healthcare Industry Globally

In this booming landscape, Mcare Exports stands out as a leading player, helping shape the future of global healthcare by providing high-quality pharmaceutical products worldwide. As a trusted partner, Mcare Exports leverages India's competitive advantages to supply a wide range of medicines, ensuring they meet the stringent quality standards required by international markets. By focusing on customer satisfaction, innovative solutions, and a commitment to quality, Mcare Exports has established itself as one of the best pharma exporters around the globe.

Mcare Exports not only meets the growing demand from markets like the US and UK but also supports healthcare systems worldwide by providing access to affordable and effective medications. As India's pharmaceutical exports continue to rise, Mcare Exports is well-positioned to contribute significantly to the healthcare industry's evolving needs, helping improve patient outcomes and advancing global health.

In a world where quality, affordability, and reliability are paramount, Mcare Exports continues to deliver, making a substantial impact in the global healthcare sector.

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Chromatography Resin market is expected to display a steady growth by 2028

According to a new report published by UnivDatos Markets Insights the Chromatography Resin Market is expected to grow at a CAGR of around 8% from 2022-2028. The analysis has been segmented into Type (Inorganic, Natural and Synthetic); Application (Affinity, Ion Exchange, Size Exclusion, Hydrophobic Interaction and Others); Region/Country.

The Chromatography Resin market report has been aggregated by collecting informative data on various dynamics such as market drivers, restraints, and opportunities. This innovative report makes use of several analyses to get a closer outlook on the Chromatography Resin market. The Chromatography Resin market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth. Furthermore, this statistical market research repository examines and estimates the Chromatography Resin market at the global and regional levels.

Market Overview

The chromatography resin market is expected to witness CAGR of 8% during the forecast period owing to the advent of biosimilars and growing pharmaceutical & biopharmaceutical R&D activities for drug delivery applications. Further, chromatographic resins are used to purify and separate proteins and other bio-molecules in biotechnological, pharmaceutical, food industries.

In addition, Chromatography resins also have applications in commercial processes like water purification and environmental analysis. A rise in R&D investment is anticipated to enhance the need for chromatography, which is a crucial component of R&D operations in the pharmaceutical sector. According to Congressional Budget Office USA, the pharmaceutical industry spent USD 83 billion dollars on R&D in 2019.

Moreover, strategic measures like mergers and acquisitions, partnerships, etc. is further expected to drive the market. For instance, in April 2020, Bio-Rad Laboratories Inc. announced the acquisition of Celsee Inc., a company that offers instruments and consumables for the isolation, detection, and analysis of single cells

COVID-19 Impact

The recent covid-19 pandemic has disrupted the world and has brought a state of shock to the global economy. The global pandemic has impacted the healthcare industry and has transformed the way healthcare is delivered. The COVID-19 pandemic, on the other hand, has bolstered the Chromatography Resin business by boosting the use of vaccinations and medications, resulting in increased demand for Chromatography Resin.

The global Chromatography Resin market report is studied thoroughly with several aspects that would help stakeholders in making their decisions more curated.

Based on technique, the market is classified into Affinity, Ion Exchange, Size Exclusion, Hydrophobic Interaction and Others. Affinity resin has a sizable portion of the market and is frequently used for protein purification due to its characteristics including high binding efficiency, low ligand leaking, and selectivity for a variety of antibody segments. Comparing affinity chromatography to other techniques, it has the benefit of using a protein structure for purifying. This makes affinity chromatography more easy and time-effective.

Based on type, the market is classified into Inorganic, Natural and Synthetic. A sizeable portion of the market is accounted for by the natural sector, which can be attributed to rising natural product consumption as well as widespread use of size exclusion chromatography and paper chromatography in various industrial applications. Key market drivers include the growing demand from the food and beverage industry as well as the pharmaceutical and medical sectors, which are expanding due to the increase in healthcare spending.

Chromatography Resin Market Geographical Segmentation Includes:

North America (United States, Canada, and Rest of North America)

Europe (Germany, United Kingdom, Italy, France, Spain, and the Rest of Europe)

Asia-Pacific (China, India, Japan, and the Rest of Asia-Pacific)

Rest of the World

For a better understanding of the market dynamics of the Chromatography Resin market, a detailed analysis was conducted for different regions across the globe including North America (U.S, Canada, and the Rest of North America), Europe (Germany, France, Spain, United Kingdom, Italy, and Rest of Europe), Asia-Pacific (China, India, Australia, Japan, and Rest of APAC), Rest of World has been conducted. Geographically, the North America region dominated the Chromatography Resin market owing to the growing investment in healthcare sector in the region.

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The major players targeting the market include

Cytiva Lifesciences

Bio-Rad Laboratories Inc.

Sartorius AG

Generon

Tosoh Bioscience

Bio-Works

Repligen Corporation

LAF-Biotechnology

JNC Corporation

Anatrace Products LLC.

Competitive Landscape

The degree of competition among prominent global companies has been elaborated by analyzing several leading key players operating worldwide. The specialist team of research analysts sheds light on various traits such as global market competition, market share, most recent industry advancements, innovative product launches, partnerships, mergers, or acquisitions by leading companies in the Chromatography Resin market. The major players have been analyzed by using research methodologies for getting insight views on global competition.

Key questions resolved through this analytical market research report include:

• What are the latest trends, new patterns, and technological advancements in the Chromatography Resin market?

• Which factors are influencing the Chromatography Resin market over the forecast period?

• What are the global challenges, threats, and risks in the Chromatography Resin market?

• Which factors are propelling and restraining the Chromatography Resin market?

• What are the demanding global regions of the Chromatography Resin market?

• What will be the global market size in the upcoming years?

• What are the crucial market acquisition strategies and policies applied by global companies?

We understand the requirement of different businesses, regions, and countries, we offer customized reports as per your requirements of business nature and geography. Please let us know If you have any custom needs.

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Cardiovascular Drugs Market Size & Share to Surpass USD 195.6 billion By 2031

The global cardiovascular drugs market was valued at US$ 142.8 billion in 2022. The market is expected to expand at a CAGR of 3.8% from 2023 to 2031, reaching US$ 195.6 billion. Cardiovascular treatments may become more targeted and effective with genomics and personalized medicine advances. By identifying a patient's genetic profile and specific risks, tailored treatment can help improve outcomes and reduce side effects.

Researchers are working on new drug classes and therapies to treat cardiovascular disease, like gene therapies, RNA-based therapeutics, and stem cell therapies. By using these innovations, traditional medications could be rendered less effective and less durable. With digital health technologies like wearables and remote monitoring, cardio conditions could be better managed. Monitoring in real-time, coupled with data analytics, could lead to more proactive and personalized interventions.

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Research may continue into combinations of drugs with complementary mechanisms. The use of combination therapies may lead to better patient compliance and efficacy for cardiovascular diseases. Biosimilar versions may become more competitive as some cardiovascular drugs' patents expire. As a result, essential medications may be more affordable and easier to access.

Key Findings of the Market Report

Based on drug class, the anti-clotting agents (anti-coagulants and platelet aggregation inhibitors) will drive the cardiovascular drugs market.

North America accounts for the majority of market share as cardiovascular disease incidence rises.

Based on indication, the hypertension segment is anticipated to drive demand for cardiovascular drugs.

In terms of distribution channels, hospital pharmacy is expected to drive the market for cardiovascular drugs.

Global Cardiovascular Drugs Market: Regional Landscape

Cardiovascular drugs are expected to be in high demand in North America. North America continues to experience a significant burden of cardiovascular diseases (CVDs), accounting for a significant share of the overall burden of disease. Several cardiovascular diseases, including hypertension and coronary artery disease, are prevalent, resulting in a high demand for cardiovascular drugs.

Healthcare expenditures in North America are relatively high in the United States and Canada. This financial commitment to healthcare infrastructure and services enhances access to and utilization of cardiovascular drugs.

Pharmaceutics research and development are centered in North America, especially in the United States. Technological advances and drug discovery have introduced innovative cardiovascular drugs with improved efficacy and safety. In general, cardiovascular health is becoming more widely known among the public, which has led to a greater emphasis on prevention and early intervention.

Government regulatory agencies, such as Health Canada and the U.S. Food and Drug Administration (FDA), ensure cardiovascular medication safety and efficacy by overseeing drug approvals. Regulatory frameworks and government policies influence market dynamics.

Global Cardiovascular Drugs Market: Key Players

Leading companies follow market trends and launch generic heart failure drugs after patents on well-known drugs expire, per the latest cardiovascular drugs market analysis. In addition, the major drug manufacturers have established partnerships with academic institutions to develop innovative treatments and retain their competitive edge.

● ICU Medical Inc.

● Tandem Diabetes Care Inc.

● Medtronic plc

● Terumo Corporation

● F. Hoffmann-La Roche AG

● Baxter International

● BD

● Fresenius Kabi AG

● B. Braun SE

● Insulet Corporation

Key Developments

In January 2023, Lupin launched an India-based generic version of a Novartis drug for heart failure following the expiration of the patents on Valsartan and Sacubitril. In addition, it is available under the brand names Arnipin and Valentas, both of which are used for treating heart failure.

In January 2023, Glenmark Pharmaceuticals launched sacubitril + valsartan tablets for treating heart failure in India. The products are marketed as 'Sacu V'.

Global Cardiovascular Drugs Market: Segmentation

By Drug Class

Renin-Angiotensin System Blockers (ACE Inhibitors and Angiotensin Receptor Blockers)

Beta Blockers

Diuretics

Anti-Clotting Agents (Anti-Coagulants and Platelet Aggregation Inhibitors)

Antihyperlipidemics

Other Antihypertensive

Calcium Channel Blockers

Others

By Indication

Hypertension

Hyperlipidemia

Coronary Artery Disease

Peripheral Artery Disease

Arrhythmia

Others

By Distribution Channel

Hospital Pharmacy

Retail Pharmacy

Online Pharmacy

By Region

North America

Europe

Asia Pacific

Latin America

MEA

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Biosimilars Market Projections: Future Growth and Trends

Biosimilars Market Outlook, Scope & Overview:

Industry reports indicate that the global biosimilars market was valued at USD 29.51 billion in 2023 and is projected to reach USD 108.8 billion by 2031, growing at a CAGR of 17.7% over the forecast period 2024-2031.

Regulatory Approvals and Patent Expirations to Drive Growth of Global Biosimilars Market

The increasing adoption of biosimilars will continue to influence global market revenues. Healthcare systems are turning to biosimilars as a cost-effective alternative to biologics, with the potential to significantly reduce healthcare expenditures and improve patient access to essential therapies.

As a product segment, monoclonal antibodies (mAbs) currently hold a significant share of the global biosimilars market. This segment is anticipated to grow at a year-over-year rate of 17.7% in 2024 over 2023 and reach USD 108.8 billion in revenues by 2031. The upcoming patent expirations of major biologic drugs and the increasing number of biosimilar approvals are expected to drive market growth.

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Biosimilars Market – Market Dynamics

Drivers:

The biosimilars market is experiencing significant growth due to the rising prevalence of chronic diseases, the increasing demand for cost-effective biologic therapies, and the expanding number of biosimilar products entering the market. Regulatory bodies in major regions, such as the FDA in the United States and the EMA in Europe, are actively supporting the development and approval of biosimilars, further driving their adoption. Additionally, the growing acceptance of biosimilars by healthcare providers and patients, along with initiatives to promote biosimilar usage, is contributing to market expansion.

Restraints:

Despite the strong growth potential, challenges such as stringent regulatory requirements, high development costs, and the complexity of manufacturing biosimilars are hindering their widespread adoption. Additionally, patent litigations, brand loyalty towards original biologics, and the need for extensive clinical trials to demonstrate biosimilarity pose additional challenges to market growth. Furthermore, the lack of awareness and education about biosimilars among healthcare professionals and patients can also limit market expansion.

Biosimilars Market – Market Outlook

The proven benefits of biosimilars in reducing healthcare costs, increasing access to biologic treatments, and improving patient outcomes have contributed to the market's growth. Biosimilars are expected to witness increased adoption across major markets, including North America, Europe, and Asia Pacific, driven by favorable regulatory frameworks, growing healthcare expenditures, and the rising focus on biologic treatments for chronic diseases.

Global Biosimilars Market

The rise in demand for biosimilars in developed and emerging markets is expected to drive market growth over the forecast period. North America currently holds a significant market share in the global biosimilars market, with the US being a key contributor to market revenues. Europe and Asia Pacific regions are also experiencing rapid adoption of biosimilars, supported by increasing biosimilar approvals, patent expirations, and initiatives to enhance biosimilar uptake.

Key Players in the Biosimilars Market

Leading companies in the biosimilars market include Pfizer Inc., Novartis AG (Sandoz), Amgen Inc., and Biocon Limited. These companies are at the forefront of developing and commercializing biosimilar products for various therapeutic areas, including oncology, immunology, and endocrinology.

In conclusion, the global biosimilars market is poised for substantial growth over the forecast period, driven by increasing regulatory support, patent expirations of major biologics, and the expanding adoption of biosimilars across diverse therapeutic areas.

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Understanding the Dynamics of Medicine Export from India

India's pharmaceutical industry has emerged as a global powerhouse in medicine exports, significantly impacting global healthcare with its cost-effective, high-quality solutions. This article provides a comprehensive overview of India's medicine export landscape, covering the factors driving its success, including government initiatives, skilled labour, and robust manufacturing capabilities. It delves into the leading Indian pharmaceutical companies that dominate the market, the extensive range of medicines exported, and India's competitive standing among the top medicine-exporting nations. Additionally, the article explores the vital role of medicine export from India in strengthening healthcare in Africa and the mutual benefits of this trade relationship.

Prominent Medicine Exporters in India: Industry Leaders

In the vast and competitive pharmaceutical sector in India, several companies have established themselves as key players, driving the nation's exports to new heights. These leaders not only contribute significantly to India's economy but also ensure the supply of high-quality medicines across the globe. This section highlights the major medicine exporter in India, detailing their contributions and the strategic practices that have positioned them at the forefront of the market.

Dr. Reddy’s Laboratories

Cipla

Sun Pharmaceutical Industries

Lupin

Aurobindo Pharma 

Above these are among the most prominent names in the Indian pharmaceutical export market. These companies have consistently demonstrated excellence in producing a wide range of medicines, from generics to complex formulations. They have invested heavily in research and development, enabling them to introduce new and effective treatments to the market regularly.

Additionally, these companies have expanded their global presence through strategic partnerships, acquisitions, and the establishment of manufacturing facilities abroad. Their commitment to quality, regulatory compliance, and competitive pricing has not only boosted their reputation but also propelled India’s status as a top medicine exporter.

Comprehensive List of Medicines Exported from India

India's pharmaceutical export portfolio is extensive, encompassing a diverse range of medicines that cater to various therapeutic needs. From essential drugs to highly specialized pharmaceuticals, India's export list is both vast and varied. This section provides a comprehensive list of medicine export from India, showcasing the country's capability to meet the diverse medical needs of the global population.

India’s exports include a wide array of generic medicines, over-the-counter drugs, active pharmaceutical ingredients (APIs), and speciality medicines. Some of the most commonly exported medicine categories include antibiotics, antiretrovirals, anti-inflammatories, cardiovascular drugs, and vaccines. These medicines are manufactured in compliance with stringent international standards, ensuring their safety and efficacy.

Moreover, India has a strong presence in the generic drug market, supplying affordable alternatives to brand-name pharmaceuticals. The country also exports a significant volume of biopharmaceuticals, including biosimilars and health supplements. With its robust manufacturing infrastructure, India is well-equipped to continue expanding its medicine export portfolio.

Top 10 Medicine Exporting Countries: Global Competition

To understand India's position in the global market, it is crucial to examine the other leading medicine exporting countries. This not only puts India's achievements into perspective but also highlights the competitive landscape of pharmaceutical exports. This section presents an overview of the top 10 medicine exporting countries, including their export values, major markets, and the unique advantages they possess.

The top 10 medicine exporting countries, in addition to India, include 

The United States

Germany

Switzerland

Belgium

India

France

Italy

Netherlands

Ireland

China

Each of these countries has established a robust pharmaceutical industry, driven by innovation, advanced research and development, and strong regulatory frameworks.

The United States stands out as a leading exporter due to its cutting-edge drug development and high R&D investment. Germany and Switzerland are known for their high-quality pharmaceutical products and advanced manufacturing technologies. Belgium and the Netherlands benefit from their strategic locations and strong logistics networks, facilitating efficient distribution of medicines.

France and Italy have a long history in the pharmaceutical sector, with well-established companies and a focus on both innovation and quality control. Ireland has become a significant player due to its favorable business environment and investment in pharmaceutical manufacturing. China, with its massive production capacity and ongoing improvements in quality standards, has also emerged as a major exporter.

Medicine Exports from India to Africa: Strengthening Healthcare

A significant portion of medicine export from India to Africa, addressing the continent's healthcare challenges and contributing to improved public health outcomes. This section explores the dynamics of medicine exports from India to Africa, examining the types of medicines exported, the impact on healthcare in African countries, and the mutual benefits that arise from this trade relationship.

India's exports to Africa include essential medicines that are crucial for addressing widespread health issues such as malaria, tuberculosis, and HIV/AIDS. The affordability and availability of these medicines have had a profound impact on healthcare systems across the continent, providing life-saving treatments to millions of people.

The Indian government, along with various pharmaceutical companies, has actively engaged in partnerships and initiatives aimed at improving healthcare infrastructure in African countries. These efforts have resulted in the development of local manufacturing facilities, skill enhancement programs, and increased access to affordable healthcare solutions.

The mutual benefits of this trade relationship are significant. For African countries, the import of affordable and high-quality medicines from India enhances their healthcare capabilities and patient outcomes. For India, the growing market in Africa presents an opportunity to further expand its pharmaceutical export footprint and foster long-term trade relationships.

Conclusion

India's role as a leading exporter of medicines has far-reaching implications, affecting not just the country's economy but also the global healthcare landscape. In conclusion, this section sums up the key points discussed in the article, emphasizing the significance of India's contributions to the global medicine supply and the continuous growth and potential of the industry. This concluding section reinforces the importance of India's position in the global pharmaceutical market and its positive impact on global health.

India's pharmaceutical industry has proven to be a critical player in meeting global healthcare needs, especially in providing cost-effective solutions for various medical conditions. The country's strategic initiatives, commitment to quality, and innovative practices have ensured its place as a reliable and essential source of medicines worldwide. As the industry continues to evolve and grow, India's presence in the global pharmaceutical market is expected to strengthen further, bringing countless benefits to healthcare systems and patients around the world. However, if you want to know about export of medicines from India, medicine HS codes, or global trade data, connect with Seair Exim Solutions.

Frequently Asked Questions (FAQs)

Q1. What factors contribute to India's success in medicine exports?

India's medicine export success is driven by its cost-effective production, high-quality standards, skilled labor, government initiatives, and robust manufacturing capabilities.

Q2. Who are the leading medicine exporters in India?

Prominent medicine exporters in India include Dr. Reddy’s Laboratories, Cipla, Sun Pharmaceutical Industries, Lupin, and Aurobindo Pharma.

Q3. What types of medicines are included in India's export portfolio?

India exports a wide range of medicines, including generic drugs, over-the-counter medications, active pharmaceutical ingredients (APIs), and specialized medicines such as antibiotics, antiretrovirals, and vaccines.

Q4. Which countries are the top 10 medicine exporters globally?

The top 10 medicine-exporting countries include the United States, Germany, Switzerland, Belgium, France, Italy, Netherlands, Ireland, China, and India.

Q5. What impact do medicine exports from India have on healthcare in Africa?

Medicine exports from India to Africa play a crucial role in addressing healthcare challenges by providing affordable, high-quality medicines for diseases like malaria, tuberculosis, and HIV/AIDS.

Q6. How do Indian pharmaceutical companies maintain their global competitiveness?

Indian pharmaceutical companies maintain competitiveness through strategic partnerships, global expansion, investment in research and development, and adherence to international quality standards.

Also Read:

The Rising Significance of the Export of Steel from India

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Biotechnology Contract Manufacturing Market Projections: Global Industry Analysis and Forecast (2023-2032)

The Biotechnology Contract Manufacturing Market is projected to witness significant growth, with its value expected to surge from USD 19,149.43 million in 2024 to USD 36,105.98 million by 2032, reflecting a robust compound annual growth rate of 8.25%.

The biotechnology contract manufacturing market is experiencing robust growth, driven by the increasing outsourcing trends in the biopharmaceutical industry, where companies seek to leverage external expertise and infrastructure to streamline production processes and reduce costs. Contract manufacturing organizations (CMOs) offer a range of services, from cell line development and process optimization to large-scale production and regulatory support. This market expansion is fueled by the rising demand for biopharmaceuticals, including monoclonal antibodies, vaccines, recombinant proteins, and gene therapies, which require sophisticated manufacturing capabilities and stringent regulatory compliance. As the complexity of biologic drugs increases, biopharmaceutical companies increasingly rely on CMOs to provide the necessary technological expertise, advanced facilities, and scalability.

North America dominates the biotechnology contract manufacturing market due to its well-established biopharmaceutical industry, robust research and development activities, and the presence of leading CMOs. The United States, in particular, benefits from a strong focus on innovation and substantial investment in biotechnology, which drives the demand for contract manufacturing services. Europe also holds a significant share of the market, supported by a strong regulatory framework, advanced healthcare infrastructure, and increasing investment in biotech research. The region's focus on personalized medicine and biosimilars further propels the demand for contract manufacturing services.

The study on the biotechnology contract manufacturing market reveals several key findings that underscore the market's dynamics, growth drivers, challenges, and future prospects.

1. Robust Market Growth

The biotechnology contract manufacturing market is experiencing substantial growth, driven by the increasing trend of outsourcing manufacturing processes in the biopharmaceutical industry. This growth is attributed to the rising demand for biopharmaceuticals, including monoclonal antibodies, vaccines, recombinant proteins, and gene therapies, which require sophisticated manufacturing capabilities and stringent regulatory compliance.

2. North America Leads the Market

North America dominates the biotechnology contract manufacturing market, primarily due to its well-established biopharmaceutical industry, robust research and development activities, and the presence of leading CMOs. The United States is at the forefront, benefiting from substantial investments in biotechnology and a strong focus on innovation.

3. Significant Market Share in Europe

Europe holds a significant share of the market, supported by a strong regulatory framework, advanced healthcare infrastructure, and increasing investment in biotech research. The region's focus on personalized medicine and biosimilars further propels the demand for contract manufacturing services.

4. Rapid Growth in Asia-Pacific

The Asia-Pacific region is witnessing rapid growth in the biotechnology contract manufacturing market. Countries like China, India, and South Korea are emerging as key players, offering cost advantages and large-scale manufacturing capabilities. Government initiatives to develop biotechnological infrastructure and improve regulatory standards support market growth.

5. Increasing Demand for Biopharmaceuticals

The rising incidence of chronic diseases and the increasing adoption of biologics in treatment protocols are driving the demand for contract manufacturing services. Biopharmaceutical companies are increasingly outsourcing manufacturing to CMOs to leverage their expertise and advanced facilities, ensuring high-quality and scalable production.

6. Technological Advancements

Ongoing advancements in biotechnology and manufacturing technologies are critical drivers of market growth. CMOs are investing in state-of-the-art facilities and adopting innovative technologies such as single-use systems and continuous manufacturing to enhance efficiency and meet the evolving demands of their clients.

7. Operational Challenges

The market faces several challenges, including high operational costs, stringent regulatory requirements, and complex manufacturing processes. Ensuring consistent product quality and managing supply chain complexities are critical issues that CMOs must address to maintain their competitive edge.

8. Strategic Collaborations and Partnerships

Strategic collaborations and partnerships are becoming increasingly important in the biotechnology contract manufacturing market. These alliances help CMOs expand their service offerings, enhance their technological capabilities, and meet the growing demands of biopharmaceutical clients.

9. Focus on Personalized Medicine

The growing focus on personalized medicine is driving the demand for specialized manufacturing services. CMOs are adapting to this trend by developing capabilities to produce small batches of personalized therapies, which require highly specialized and flexible manufacturing processes.

Key Player:

Lonza (Switzerland)

Samsung Biologics (South Korea)

Thermo Fisher Scientific, Inc. (US)

Catalent, Inc. (US)

JSR Corporation (Japan)

WuXi Biologics (China)

AbbVie, Inc. (US)

Boehringer Ingelheim International GmbH (Germany)

Eurofins Scientific (Luxembourg)

GenScript Biotech Corporation (US)

More About Report- https://www.credenceresearch.com/report/biotechnology-contract-manufacturing-market

The biotechnology contract manufacturing market is influenced by several trending factors that shape its growth trajectory and operational dynamics. These factors highlight the evolving landscape of biopharmaceutical production and the strategic adjustments being made by Contract Manufacturing Organizations (CMOs) to stay competitive and meet industry demands.

1. Increasing Demand for Biologics

The demand for biologics, including monoclonal antibodies, vaccines, recombinant proteins, and cell and gene therapies, is on the rise. Biologics are becoming integral to modern therapeutic regimens due to their specificity and efficacy in treating complex diseases such as cancer, autoimmune disorders, and genetic conditions. This surge drives the need for specialized manufacturing capabilities offered by CMOs.

2. Advancements in Biomanufacturing Technologies

Technological innovations are transforming biomanufacturing processes. The adoption of single-use systems, continuous manufacturing, and automation enhances production efficiency, reduces contamination risks, and allows for greater flexibility in manufacturing operations. CMOs are increasingly investing in these advanced technologies to offer cutting-edge services and maintain a competitive edge.

3. Outsourcing Trends

Biopharmaceutical companies are increasingly outsourcing manufacturing to CMOs to focus on core competencies such as research and development, and to reduce capital expenditure on manufacturing infrastructure. Outsourcing also provides access to specialized expertise and advanced facilities, which are crucial for the production of complex biologics.

4. Regulatory Stringency and Compliance

The regulatory landscape for biopharmaceutical manufacturing is becoming more stringent, with regulatory bodies like the FDA and EMA enforcing rigorous quality standards. CMOs are responding by enhancing their compliance frameworks, investing in quality assurance, and adopting Good Manufacturing Practices (GMP) to ensure product safety and efficacy.

5. Personalized Medicine

The shift towards personalized medicine, where treatments are tailored to individual patient profiles, is driving demand for flexible and scalable manufacturing solutions. CMOs are developing capabilities to produce small, customized batches of therapies, which requires highly specialized manufacturing processes and sophisticated quality control measures.

6. Collaborations and Partnerships

Strategic collaborations between biopharmaceutical companies and CMOs are becoming more common. These partnerships enable the sharing of knowledge, resources, and technology, fostering innovation and expanding service offerings. Collaborations also help in risk-sharing and accelerating the time-to-market for new therapies.

7. Emerging Markets

The biotechnology contract manufacturing market is expanding rapidly in emerging markets, particularly in Asia-Pacific. Countries like China, India, and South Korea are investing heavily in biotechnology infrastructure and capabilities. These regions offer cost advantages and large-scale manufacturing capacities, attracting biopharmaceutical companies looking to optimize production costs.

8. Focus on Sustainable Manufacturing

Sustainability is gaining prominence in the biopharmaceutical industry. CMOs are adopting eco-friendly manufacturing practices, reducing waste, and improving energy efficiency. Sustainable manufacturing not only meets regulatory requirements but also aligns with the growing emphasis on corporate social responsibility and environmental stewardship.

9. Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions, driven by the need for consolidation and expansion of service portfolios. Larger CMOs are acquiring smaller, specialized companies to enhance their capabilities and enter new markets. This trend is leading to the creation of integrated service providers that can offer end-to-end solutions.

10. Innovation in Cell and Gene Therapy Manufacturing

The rapid development of cell and gene therapies is creating new opportunities for CMOs. Manufacturing these advanced therapies requires specialized expertise and infrastructure. CMOs are investing in the necessary technologies and processes to support the production of these innovative treatments, which are expected to play a significant role in future therapeutics.

Segments:

Based on Service:

Manufacturing

Formulation and Fill-Finish

Packaging and Labeling

Other services

Based on Type:

Biologic Drug Substance Manufacturing

Biologic Drug Product Manufacturing

Based on Source:

Mammalian Expression Systems

Non-Mammalian Expression Systems

Based on Molecule:

Monoclonal Antibodies

Cell Therapy & Gene Therapy

Antibody-Drug Conjugates (ADCs)

Vaccines

Therapeutic Peptides & Proteins

Other Molecule Types

Browse the full report –  https://www.credenceresearch.com/report/biotechnology-contract-manufacturing-market

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Phone: +91 6232 49 3207

Email: sales@credenceresearch.com

Website: https://www.credenceresearch.com

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Ankylosing Spondylitis Market Projected to Show Strong Growth

The Latest research coverage on Ankylosing Spondylitis Market provides a detailed overview and accurate market size. The study is designed considering current and historical trends, market development and business strategies taken up by leaders and new industry players entering the market. Furthermore, study includes an in-depth analysis of global and regional markets along with country level market size breakdown to identify potential gaps and opportunities to better investigate market status, development activity, value and growth patterns. Access Sample Report + All Related Graphs & Charts @: https://www.advancemarketanalytics.com/sample-report/35094-global-ankylosing-spondylitis-market

Major & Emerging Players in Ankylosing Spondylitis Market:- AbbVie Inc. (United States), Janssen Pharmaceuticals Inc. (Belgium), Pfizer Inc. (United States), Sandoz International GmbH (Germany), Amgen Inc. (United States), Protalix BioTherapeutics, Inc. (Israel), Reliance Life Sciences Pvt. Ltd. (India), Momenta Pharmaceuticals Inc. (United States), Celgene Corporation (United States), Regeneron Pharmaceuticals (United States), Merck & Co. Inc. (United States) The Ankylosing Spondylitis Market Study by AMA Research gives an essential tool and source to Industry stakeholders to figure out the market and other fundamental technicalities, covering growth, opportunities, competitive scenarios, and key trends in the Ankylosing Spondylitis market. Ankylosing spondylitis (AS) is a type of arthritis that mostly affects the back. It causes infection in the joints of the spine, leading to pain and stiffness. Ankylosing spondylitis affects people in diverse ways some people can almost forget they have the condition, while for others it can have a big effect on their quality of life and sometimes joints other than those in the spine can be affected too. Sometimes, other parts of the body may also be affected. Ankylosing spondylitis is a type of spondyloarthritis is a group of conditions that share many of the same symptoms.

The titled segments and sub-section of the market are illuminated below: by Application (Hospitals, Clinics, Ambulatory Surgical Centers), Route of Administration (Oral, Parenteral), Treatment Type (Nonsteroidal Anti-Inflammatory Drugs (Ibuprofen and Naproxen), Disease-Modifying Antirheumatic Drugs (Methotrexate), Biologics (Secukinumab, Certolizumab Pegol, and Infliximab)), Molecule Type (Small Molecules, Biologics, Biosimilars) Market Trends: Increasing Number of Treatment Seeking Population

Opportunities: Rising Research and Development Expenditure

Market Drivers: Increasing Prevalence of Ankylosing Spondylitis

Rising Awareness about Diagnostics and Treatments

Enquire for customization in Report @: https://www.advancemarketanalytics.com/enquiry-before-buy/35094-global-ankylosing-spondylitis-market Some Point of Table of Content: Chapter One: Report Overview Chapter Two: Global Market Growth Trends Chapter Three: Value Chain of Ankylosing Spondylitis Market Chapter Four: Players Profiles Chapter Five: Global Ankylosing Spondylitis Market Analysis by Regions Chapter Six: North America Ankylosing Spondylitis Market Analysis by Countries Chapter Seven: Europe Ankylosing Spondylitis Market Analysis by Countries Chapter Eight: Asia-Pacific Ankylosing Spondylitis Market Analysis by Countries Chapter Nine: Middle East and Africa Ankylosing Spondylitis Market Analysis by Countries Chapter Ten: South America Ankylosing Spondylitis Market Analysis by Countries Chapter Eleven: Global Ankylosing Spondylitis Market Segment by Types Chapter Twelve: Global Ankylosing Spondylitis Market Segment by Applications What are the market factors that are explained in the Ankylosing Spondylitis Market report?

– Key Strategic Developments: Strategic developments of the market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors.

– Key Market Features: Including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin.– Analytical Tools: The analytical tools such as Porter’s five forces analysis, SWOT analysis, feasibility study, and investment return analysis have been used to analyze the growth of the key players operating in the market. Buy This Exclusive Research Here: https://www.advancemarketanalytics.com/buy-now?format=1&report=35094 Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market. Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia. Contact US : Craig Francis (PR & Marketing Manager) AMA Research & Media LLP Unit No. 429, Parsonage Road Edison, NJ New Jersey USA – 08837 Phone: +1 201 565 3262, +44 161 818 8166 sales@advancemarketanalytics.com

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Top 5 players in US Biosimilar Market

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STORY OUTLINE

Pfizer: Excelling in the line of Biosimilar drugs with an experience of more than 10 years with presence in over 180 countries.

Amgen: Making pharmaceutical products with an experience of over 40 years and presence in over 100 countries.

Viartis: Presence in over 165 countries, and making Biosimilar drugs in over 75 markets, this pharmaceutical company is another leading contributor of US Biosimilar market.

Coherus Biosciences: Increasing patient access to cost effective medicines with a Biosimilar drugs experience of 13 years.

Biogen: serving humanity through science with a experiences of more than 40 years in the field of biologics.

According to Ken Research, the US Biosimilar market is anticipated to grow at a CAGR of ~40% in the next five years which currently has a market size of ~USD 9.4 Bn.

The US Biosimilar market is rapidly growing and will be witnessing a significant growth in the next five years.

There are various reasons behind the rapid growth of US Biosimilar market. Some of the major reasons behind the growth of US Biosimilar market include the cost effective nature of Biosimilar drugs, rising geriatric population, rising prevalence of chronic diseases, and growing partnerships between companies to develop Biosimilar drugs.

Various companies and players are contributing to their best efforts in the growth of the US Biosimilar market.

This article aims to put light on the contributions done by the major players towards the growth of the US Biosimilar market.

1.Pfizer

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Pfizer is a leading American pharmaceutical company which is operating in the field of generics or original drugs for more than 30 years. But did you know that this pharma not only manufactures biologics but also biosimilar drugs?

Pfizer has been in the business of biosimilar drugs for more than 10 years and have been quite successful as well. With more than 83,000 employees and presence in over 180 countries, this leading pharmaceutical company made almost USD 2 Bn. revenue only from its Biosimilar drugs sale in 2021.

Recently, this pharmaceutical company also collaborated with Samsung in two deals to produce various biosimilar drugs in South Korea. The deal size between these two companies happens to be approximately USD 900 Bn.

The major Biosimilar drugs of this pharmaceutical giant are primarily

ZIRABEV (a Biosimilar of Avastin)

TRAZIMERA (a Biosimilar of Herceptin)

RUXIENCE (a Biosimilar of Rituxan)

RITACRIT (a Biosimilar of Epogen)

NVYEPRIA (a Biosimilar of Neulasta)

NIVESTYM (a Biosimilar of Neupogen)

FILGRASTIM (a Biosimilar of Neupogen).

2.Amgen

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Amgen is another leading American pharmaceutical company which not only makes Biologics or generic drugs but also Biosimilar drugs. This pharmaceutical company has more than 40 years of experience when it comes to pharmaceutical line.

With over 25000 employees and presence in over 100 countries, this pharmaceutical company earned about USD 2 Bn. from their three biosimilar drugs which are reportedly MVASI, KANJITNTI, and AMJEVITA.

This pharma giant has also invested about USD 2 Bn. in the development of Biosimilar drugs.

This pharmaceutical company has made Biosimilar drugs primarily in 4 fields which are General Medicine, Oncology, and Hematology along with, Inflammation.

EPOTEIN ALFA

AMJEVITA

AVSOLA

KANJINTI

MVASI

RIABNI

are the various Biosimilar drugs of Amgen. And, STELARA, EYLEA, SOLIRIS are in their pipeline.

Recently Amgen revealed their Biosimilar report’s 8 version. It revealed a major information which said that the pharmaceutical company saved about USD 10 Bn. through their Biosimilar drugs in the past five years.

3.Viartis

Headquartered in Canonsburg, Pennsylvania, this American pharmaceutical company was founded only in 2020 yet they have achieved massive success in the pharmaceutical products with their revenue being USD 16 ~Bn. in 2022.

With presence in 165 countries and with over 45,000 employees worldwide, this pharmaceutical company makes pharmaceutical products in 10 areas which primarily are Cardiovascular, Dermatology, ophthalmology, Oncology, Gastroenterology, Women’s health, Infectious diseases, Diabetes & Metabolism, Immunology, CNS & Anesthesiology, Respiratory diseases and allergy.

Speaking of their first Biosimilar products, their first ever Biosimilar drug was launched in 2014. They have a variety of Biosimilar drugs which are primarily

TRASTUZUMAB

INSULIN ASPART

PEGFILGRASTIM

INSULIN GLARGINE-YFGN

ADALIMUMAB

BEVACIZUMAB

Their Biosimilar drug Insulin Glargine which is known as SEMGLEE was the first ever interchangeable Biosimilar drug in the United States which was FDA approved.

Their PEGFILGRASTIM also was the first ever FDA approved drug in the United States. They have launched their Biosimilar drugs in over 75 markets worldwide.

4.Coherus Biosciences:

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Headquartered in Redwood city, California this American pharmaceutical company earned a revenue of almost USD 211 Mn. In 2022.

With presence in over 55 countries and 300+ employees worldwide, this pharmaceutical company makes products in various areas such as solid tumors, non-small lung cancers, nasopharyngeal carcinoma, small cell lung cancer and hepatocellular carcinoma.

Speaking of their Biosimilar drugs, this pharma has been in the field of creating Biosimilar drugs since 2010 which has given them almost 13 years of experience.

This pharmaceutical company also disclosed that it plans to spend at least USD 1 Tn. on medicines worldwide, out of which at least 40% will be spent on Biosimilar drugs.

Their three major Biosimilar drugs which are also FDA approved include UDENCYA, YUSIMRY, and CIMERLI.

Udencya is a Biosimilar drug of Pegfilgrastim, Yusimry is a Biosimilar drug of Ranibizumab, and Cimerli is a Biosimilar drug of Adalimumab.

5.Biogen

Headquartered in Cambridge, Massachusetts, this American pharmaceutical company earned a revenue of around USD 10 Bn. in 2022.

This company happens to have an experience of more than 40 years when it comes to making pharmaceutical products.

With presence in over 80 countries and more than 9000 employees worldwide, this pharmaceutical company primarily deals in Neurology, Specialized Immunology, Neuropsychiatry, Ophthalmology, and Rare Diseases.

ADUCANUMAB

LECANEMAB

TOFERSEN

ZURANOLONE

LITIFILIMAB

BENAPALI

FLIXABI

IMRALDI

are some of their Biosimilar drugs.

With their Biosimilar drugs, more than 250,000 people have gone on Anti-Tumor Necrosis Factor therapy.

Recently, this pharmaceutical company also made an agreement with Bio-Thera solutions to develop a Biosimilar drug for the treatment of Rheumatoid Arthritis.

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Pen Needle Market Statistics and Global Analysis Report 2030

The growth of the pen needles market is primarily fueled by increased awareness among consumers. Favorable reimbursement policies and the widespread adoption of pen needles have led to a rise in self-administered insulin usage through insulin pens. The market is also influenced by the trend towards minimally invasive procedures, driven by shorter hospital stays, reduced trauma, and the higher prevalence of chronic conditions like diabetes and obesity. Additionally, factors such as the growing elderly population, improvements in healthcare systems, increased health awareness among consumers, and technological innovations are all contributing to the positive trajectory of the pen needles market. Market players are positioned to capitalize on favorable opportunities during the projected period from 2022 to 2030, driven by the rising demand for biosimilar medications.

Make The Smart Decision. Download A Free Sample Of Our Report @ https://cognizancemarketresearch.com/request/pen-needle-market/

The market for safety pen needles has seen an increase in diabetes cases worldwide due to lifestyle changes and a rise in genetic factors among the global population. According to data from the Centers for Disease Control and Prevention (CDC), around 10.5% of the American population (equivalent to 34.2 million individuals) had diabetes, with 26.9 million diagnosed cases and 7.3 million undiagnosed cases. This substantial diabetic population is expected to propel sales growth in the safety pen needles throughout the forecast period.

Global Pen Needle Market Amid COVID-19 Pandemic

The impact of COVID-19 hit various industries hard, and one of those affected was the safety pen needle market, especially as the number of global COVID-19 cases increased. In recent times, there’s been a shortage of important medical supplies and basic medical equipment. The necessity to control the spread of diseases has caused a surge in the demand for specific medical supplies and equipment. We’ve also seen an increase in the overall number of cases, infectious diseases, and mortality rates. More people are requiring critical care, ventilator support, and medical assistance, which means there’s a need for more medical staff and specialists.

The COVID-19 pandemic made a significant impact on over 100 countries, leading the World Health Organization (WHO) to declare it a public health emergency. According to WHO’s estimates, the coronavirus (COVID-19) has infected around 166 million individuals globally.

COVID-19 has influenced the economy in several ways, disrupting supply and demand, causing issues in distribution chains, and affecting businesses and stock markets. Moreover, the healthcare system in the United States saw a noticeable decrease in surgical procedures between March 2022 and June 2022 compared to the same period the prior year. The pandemic had widespread effects on major economies like the US, China, Japan, and various European nations. In response to the growing presence of COVID-19, key players in the US pen needles market are concentrating on creating innovative solutions to lessen the impact of the disease. Both the US and the global economies have felt profound consequences due to the COVID-19 pandemic.

Increasing Prevalence of Chronic Diseases, and Adoption of Novel Drug Delivery Systems, Consumer Awareness & Technological Trends to Boost Global Pen Needle Market

The growth of the pen needles market is being pushed by several factors. These include increased awareness among consumers, favorable reimbursement options, and the wider use of pen needles for self-administering insulin. The market is also being shaped by the trend toward less invasive procedures, shorter hospital stays, the growing occurrence of chronic conditions like diabetes and obesity, the aging population, investments in healthcare systems, people’s heightened awareness of their health, and advancements in technology. The period projected from 2022 to 2030 is anticipated to offer profitable opportunities for market players due to the rising demand for biosimilar medications.

In the pen needles market, a significant factor is the rise in global diabetes cases due to changes in lifestyle and genetic mutations. The CDC’s data shows a substantial number of Americans dealing with diabetes, which is expected to contribute to increased sales in the global pen needles market throughout the forecast period.

Devices for self-injection, particularly pens used for giving biopharmaceuticals subcutaneously, are gaining prominence in the drug delivery device market. The demand for these devices is on the rise because of the introduction of new injectables, the preference for at-home treatments, and the desire for improved patient comfort. The market is witnessing the introduction of next-generation pen needles with enhanced features that benefit both healthcare professionals and patients.

North America to Spearhead the Global Pen Needle Market

The world’s population is aging quickly, particularly in advanced economies like the United States. The World Health Organization (WHO) estimates that the number of elderly people worldwide will increase from 900 million in 2022 to around 2000 million (22% of the world’s population) by 2030. Due to substantial alterations in lifestyle, an increase in malnutrition cases, and genetic abnormalities in the area, it is anticipated that the prevalence of diabetes in North America will climb tremendously in the upcoming years.

Increasing occurrence of chronic disorders: One of the main potential growth elements thought to be responsible for the increased prevalence of chronic diseases in this area is the clinical urgency to use these items.

Favorable Regulatory Environment: The regulatory climate in North America is improving. Pharmaceutical businesses are finding it simpler to launch new drugs since regulatory agencies are creating clearer policies and procedures for the clearance of these therapies.

Adoption of new technology: Adoption of new technologies by the major industries to develop effective medical equipment.

New product development: Intensive new product development activities are carried out to meet the needs demanded by the people for the treatment.

Increased investment in Health care infrastructure: Due to the increase in investment in the healthcare segment North America is leading the drug-device combination products market.

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Some of the key players operating in the global pen needles market are Becton Dickinson and Company (U.S.), Novo Nordisk A/S (Denmark), Ypsomed Holding AG (Switzerland), UltiMed, Inc. (U.S.), Allison Medical, Inc. (U.S.), Owen Mumford, Ltd. (U.K.), B. Braun Melsungen (Germany), Artsana S.p.a. (Italy), HTL-STREFA S.A. (Poland),  Terumo Corporation (Japan), Links Medical Products Inc., Arkray Inc., McKesson Medical-Surgical Inc.

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United States Biosimilars Business and Investment Opportunities Databook

According to BioIntel360, the United States biosimilar market size is expected to record a CAGR of 23.7% during 2023-2027 to reach US$11,429.1 million by 2027, increasing from US$3,918.4 million in 2023. Over the last five years, the sector has recorded a CAGR of 29.3% to reach US$3,031.6 million in 2022.

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Globalization of Pharmaceutical Supply Chains: Implications for Testing Services

Introduction

The pharmaceutical industry plays a pivotal role in the healthcare sector by developing and manufacturing life-saving drugs and therapies. However, ensuring the safety, efficacy, and quality of pharmaceutical products is paramount, leading to the growth of the Pharmaceutical Testing Services Market. This market segment has been steadily expanding to meet the rigorous regulatory requirements, technological advancements, and the ever-increasing demand for pharmaceutical products. In this article, we will delve into the dynamics of the Pharmaceutical Testing Services Market, its key drivers, challenges, and future prospects.

Market Overview

Pharmaceutical testing services encompass a wide range of activities aimed at ensuring the quality, safety, and efficacy of drugs and pharmaceutical products. These services include raw material testing, stability testing, method validation, bioanalytical testing, and microbial testing, among others. The market for pharmaceutical testing services has witnessed significant growth in recent years due to several key factors.

Key Drivers

1. Regulatory Compliance: Regulatory bodies, such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe, have stringent requirements for drug approval. Pharmaceutical companies must adhere to these regulations, making testing services essential for compliance.

2. Increasing Complexity of Drug Formulations: The pharmaceutical industry is evolving rapidly with the development of complex drug formulations, including biologics, biosimilars, and personalized medicines. These innovations require sophisticated testing methodologies and expertise.

3. Globalization of Pharmaceutical Supply Chains: The globalization of pharmaceutical supply chains has led to the need for standardized testing procedures and quality control measures to ensure product consistency across borders.

4. Rising Healthcare Expenditure: Growing healthcare expenditure, particularly in emerging markets, has increased the demand for pharmaceutical products and subsequently, pharmaceutical testing services.

5. Technological Advancements: Advances in analytical technologies, such as mass spectrometry, chromatography, and genetic testing, have improved the precision and efficiency of pharmaceutical testing services.

Challenges

While the Pharmaceutical Testing Services Market has experienced substantial growth, it also faces several challenges:

1. Cost Constraints: Pharmaceutical companies are under pressure to reduce costs, which can affect their willingness to invest in testing services.

2. Data Security and Compliance: Handling sensitive patient data and complying with data protection regulations, such as GDPR, adds complexity to pharmaceutical testing.

3. Competition: The market is highly competitive, with numerous specialized and contract testing laboratories vying for contracts.

4. Evolving Regulatory Landscape: Constantly changing regulations require testing facilities to stay updated and adapt their processes accordingly.

5. COVID-19 Pandemic: The pandemic disrupted supply chains and affected the availability of essential testing supplies and resources, impacting the market.

Future Prospects

The Pharmaceutical Testing Services Market is poised for continued growth and innovation. Some key trends and opportunities for the future include:

1. Outsourcing Trends: Pharmaceutical companies are increasingly outsourcing their testing needs to specialized laboratories, leading to the expansion of the contract research organization (CRO) sector.

2. Biopharmaceuticals and Biosimilars: The market for biopharmaceuticals and biosimilars is growing rapidly, driving the demand for specialized testing services in this segment.

3. Advanced Analytical Techniques: Continued advancements in analytical techniques, including artificial intelligence and machine learning, will enhance the efficiency and accuracy of pharmaceutical testing.

4. Regulatory Harmonization: Efforts to harmonize global pharmaceutical regulations may streamline testing requirements, making it easier for companies to navigate international markets.

5. Personalized Medicine: The rise of personalized medicine will require tailored testing solutions to ensure the safety and efficacy of patient-specific treatments.

Conclusion

The Pharmaceutical Testing Services Market is an essential component of the pharmaceutical industry, ensuring the safety and quality of drugs and pharmaceutical products. With evolving regulatory requirements, technological advancements, and the demand for innovative healthcare solutions, this market is expected to continue its growth trajectory. Pharmaceutical companies, testing laboratories, and regulatory bodies must collaborate to address the challenges and seize the opportunities presented by this dynamic market, ultimately benefiting patients worldwide.