#CDI and recurrence

[industrynewsupdates]

What’s Driving the Global Growth of the Microbiome Therapeutics Market?

The global microbiome therapeutics market is projected to reach USD 1,066.8 million by 2030, growing at a compound annual growth rate (CAGR) of 35.32% from 2023 to 2030, as per a new report by Grand View Research, Inc. The growth in the market is primarily driven by the increasing prevalence of diseases that target the gastrointestinal system, diabetes, and immunological conditions. One of the major advancements is the adoption of fecal microbiota transplant (FMT), with FMT now available in capsule form. This has enhanced the acceptance of microbiome therapeutics, particularly among patients suffering from C. difficile infections. In addition, rising research and development (R&D) investments, as well as government support, are expected to propel market growth further.

FMT has shown significant success in treating patients with recurrent C. difficile infection. The growing prevalence of this condition is likely to increase the demand for microbiome therapies. For example, according to the Therapeutic Advancements in Gastroenterology Journal, between 25% and 65% of patients in the U.S. who experience an initial occurrence of C. difficile infection (CDI) face recurrent infections, making treatment more complex and underscoring the need for effective therapies.

There is also a growing emphasis on understanding the human microbiome in order to harness its therapeutic potential. This has led to a surge in R&D efforts, resulting in a stronger product pipeline in the market. For instance, candidates such as CH-0601 and M-008 are currently under development for treating diabetes. Additionally, companies in the sector are receiving increased funding from investors, as interest in microbiome-based therapies continues to rise. A notable example of this is Vedanta Biosciences, which received USD 68 million in funding in July 2021 for the phase III development of its product, VE303, for treating high-risk CDI.

Get a preview of the latest developments in the Microbiome Therapeutics Market? Download your FREE sample PDF copy today and explore key data and trends. 

FAQ for the Global Microbiome Therapeutics Market

1. What is the global microbiome therapeutics market size?

The global microbiome therapeutics market is expected to reach USD 1,066.8 million by 2030, growing at a CAGR of 35.32% from 2023 to 2030.

2. What are the key drivers of growth in the microbiome therapeutics market?

The market growth is driven by the increasing prevalence of gastrointestinal diseases, diabetes, and immunological disorders. Additionally, the rise in the adoption of fecal microbiota transplants (FMT) and advancements in drug delivery systems have significantly enhanced the acceptance of microbiome therapeutics, particularly for conditions like C. difficile infections.

3. How has fecal microbiota transplant (FMT) contributed to the market?

FMT has demonstrated considerable success in treating patients with recurrent C. difficile infections. The growing prevalence of C. difficile infection is expected to further drive the demand for microbiome therapies. The availability of FMT in capsule form has also increased patient acceptance and made treatment more accessible.

4. What is the impact of research and development (R&D) on the microbiome therapeutics market?

Increasing investments in R&D and growing interest in the therapeutic potential of the human microbiome are key factors driving market growth. This has led to the development of a stronger pipeline of microbiome-based therapeutic products. Several new candidates, such as CH-0601 and M-008, are under development for treating diabetes and other chronic diseases.

5. What are some notable developments in the microbiome therapeutics market?

In 2021, Ferring Pharmaceuticals and Rebiotix announced Phase III trial data for their candidate, RBX2660, aimed at reducing recurrent C. difficile infections. The product has received fast track, orphan, and breakthrough therapy designations from the FDA, accelerating its path to market.

6. What is the significance of microbiome research in therapeutic applications?

Research into the human microbiome is essential for understanding its role in health and disease. This understanding opens up new avenues for treating a variety of conditions by harnessing the microbiome's potential to restore balance and improve patient outcomes.

Order a free sample PDF of the Microbiome Therapeutics Market Intelligence Study, published by Grand View Research.

[nursingwriter]

Practicum Project According to Ho et al. (2015), statistics indicate that approximately 20% to 40% of health care associated infections have been linked to cross-infection through the hands of health care workers. Efficacious hand hygiene is imperative to prevent communication of healthcare associated pathogens. A great deal of hand hygiene programs in healthcare settings lay emphasis on compliance of healthcare personnel, for the reason that transitory contamination of their hands is deemed to be the key basis for transmission of pathogens (Kundrapu et al., 2014). The use of alcohol-founded hand sanitizers in health units has become prevalent since their recommendation by the Centers for Disease Control and Prevention (CDC) during 2002. This was acclaimed due to patient interaction especially in case hands are soiled, physically. However, alcohol-based hand sanitizers are not efficacious against some classifications of pathogens (Carter, 2013). The problem identified is in healthcare settings; are the use of alcohol base hand rubs more effective or less effective in reducing hospital rate infection statistics (HRIS) in comparison to water and soap techniques? Problem My mentored practicum experience took place in an Acute Rehabilitation/ Brain Center. Nursing care can be undertaken via a mixture of organizational approaches. The model of nursing care utilized differs largely from one healthcare facility to another and from one set of patient situations to another. The model of care delivery applied in my practicum experience is progressive patient care. This is a system of nursing care in which the patients are set in units based on their necessities for healthcare as ascertained by magnitude of illness (Current Nursing, 2012). Our unit was made up of 10 nurse assistants and 8 registered nurses. The main way in which my nurse manager proposes to solve this problem is the use of alcohol-based hand sanitizers five times before washing hands with soap and water. With the manager employing a dictatorial style of leadership, the decision-making process employed is one that fails to take into consideration the thoughts and ideas of external sources or internal sources such as employees. This particular problem has an adverse impact on patient outcome. Taking into account the fact that alcohol-based hand sanitizers are not fully effective in eradicating bacteria, particularly C. difficile bacteria, this solution leads to poor patient health care (Carter, 2013). In the end, this can give rise to patient dissatisfaction. In addition, it can lead to lack of employee motivation as they have no sense of input in activity and their opinions are not taken into account. Intervention I believe that this problem could be resolved in a different way from the manager's proposal. In particular, my proposal entails employing soap and water in washing hands. Moreover, if there is a low level of hospital rate infection statistics for a period of 6 months, the personnel ought to receive financial bonuses and also have a written note in their personal file. Kundrapu et al. (2014) ascertained that the hand of patients with Clostridium difficile infection (CDI) and asymptomatic carriers were repeatedly contaminated with C. difficile bacteria. This sort of contamination could prospectively lead to transmission or recurrence of CDI when bacteria on hands are consumed. The research indicated that soap and water washing was efficacious for diminishing the rate of recurrence of constructive cultures and the problem of bacteria on hands, while alcohol hand rub was not. Results of the study recommend that patient hand washing could be a beneficial and simple way to execute aide to standard control measures for C. Difficile. Carter (2013) assesses the ideal balance between hand washing and hand sanitizers. The articles consider the question whether over dependency on alcohol-based hand sanitizers has played a part in causing disease outbreaks or generating more infectious strains of pathogens. The author obtains insight from experts such as Aron Hall, who happens to be an epidemiologist and an expert at the CDC's Viral Diseases Division, along with Clifford Mcdonald, who is an authority of C. difficile as well as high-ranking adviser intended for science and integrity at the CDC's Health Quality Promotion Division. It is noted that overreliance was not a case as noroviruses mutate quite repeatedly. Both experts agree that there is no evidence that alcohol-based hand sanitizers played a part in strain or outbreaks selection. The recommendation is going against additional modifications in CDC guiding principles so that the substantial advancement in ABHS use, leading to decreasing health-linked infections, will not be misplaced. In overall, the proper equilibrium for hygiene of hand encompasses increased devotion to appropriate hygiene of hands via education and constantly prompting staff to at least scrub all hand surfaces for at least forty to sixty seconds with water and soap or twenty to thirty seconds with 3 to 5 mL involving alcohol. The research study by Edmonds et al. (2013) sought to determine whether surrogate organisms are able to envisage activity against C. Difficile bacteria and made the comparison of the effectiveness of hygiene processes against C. difficile. The outcomes of the study delineate that C. difficile bacteria were much harder to remove through hand washing in comparison to bacteria of surrogate species. These outcomes are in line with preceding research studies and point out that surrogate organisms ought not to be employed to predict effectiveness of hand hygiene against C. difficile bacteria. Moreover, the results of the study show that prevailing hand hygiene interventions have restricted effectiveness against C. difficile spores. As a result, healthcare workers ought to continue adhering to the recommendations for hand washing with soap and water and lay emphasis on contact safety measures for providing healthcare to patients with CDI. According to Ho et al. (2015), the use of alcohol hand rub is acknowledged as the gold standard for hand hygiene of non-soiled hands and is deemed to decrease the time needed for hand hygiene. On one hand, recommendation from the World Health Organization (WHO) is to employ alcohol hand rub adhering to the similar 7-step procedure as for handwashing with antimicrobial soap and water. On the other hand, the recommendation from the Centers for Disease Control and Prevention (CDC) is the application of alcohol for covering all surfaces of both hands and fingers to the point when hands are dry. The authors attempt to assess the efficacy of 3 hand hygiene procedures in decreasing hand carriage of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (MSSA) amongst health care workers. The research study demonstrates that use of alcohol hand rub, either covering all hand surfaces in no precise directive or by means of the 7-step procedure, and chlorhexidine handwashing, were similarly efficacious for the elimination of hand carriage of MRSA and MSSA. According to Tuladhar et al. (2015), human norovirus is the principal origin of acute gastroenteritis, which affects individuals of all age brackets. The spread of the virus takes place either directly through person-to-person contact or indirectly through soiled food, water, and environmental fomites. A great deal of norovirus epidemics are linked to person-to- person spread and hands are considered to be a primary means for spreading viruses, directly or indirectly. In addition, human norovirus, and other pathogenic infections can continue being communicable on human hands for hours. The research study by Tuladhar et al. (2015) tested the effectiveness of alcohol hand antiseptic against human enteric and respiratory infections. It also compared the effectiveness of an alcohol-based hand antiseptic and handwashing with soap and water against norovirus. Therefore, the authors concluded that washing hands with soap and water is more effective compared to using alcohol-based hand antiseptics in eradicating noroviruses from hands. For this reason, it is the favored intervention method to preclude communication through hands in healthcare environments and food preparation amenities. Other facilities deal with this problem differently. A different approach utilized is that of smearing alcohol to cover all surfaces of both hands and fingers until the hands are dry. I believe the good solution to this problem is utilizing the 7-step technique as for handwashing with antimicrobial soap and water. In addition, I also consider staff education and training to be a longstanding solution to this particular problem. Personnel enlightenment enables them to have a better understanding as to why using soap and water in hand washing is the most efficacious approach for eradicating bacteria and precluding hospital infections (Ho et al., 2015). Comparison In the contemporary, the manner in which the issue, whether alcohol-based hand rub is more effective or less effective in reducing HRIS than soap and water techniques, is taken care of subsequent to using alcohol-based hand sanitizers five times, is washing hands with soap and water. However, this particular approach is ineffective. This is due to increase in hospital rate infection statistics. There is a great need for more education of employees. It is imperative to note that personnel are adherent to the commands and directions given. A great deal of employees are uninformed that alcohol is ineffectual in killing pathogens, and this suggests the great need for education of employees in dealing with infections and the significance of hand washing (Kundrapu et al., 2014). The manager within the unit employs a dictatorial style of leadership. In essence, being an autocratic leader, the manager tells the employees what she wants them to do. In a dictatorial leadership style, the individual giving the orders has complete authority and control over decision-making. By virtue of their position and job duties, they not only control the determinations of the team, but also constantly observe them under close examination to ensure they accomplish their duties. The decision-making process encompasses handing down instructions to the members within the unit devoid of any discussion or vote. The leader does not enquire for any recommendations or thoughts from external sources and chooses from his or her own inherent information and discernment of the state of affairs (Leadership Management Development Center, 1997). For instance, in this case, the manager of the unit hands out instructions for the employees to wash their hands using soap and water subsequent to using alcohol-based hand sanitizers five times, without taking into account the thoughts, perspectives and experiences of personnel working under her. This problem does have an impact on patient outcome. In particular, owing to the decision made and the issue at hand, staff within the unit still walk around with dirty gloves outside patients' room. In turn, this has had an adverse impact on patient case as it recently gave rise to two patients developing Clostridium difficile infection (CDI). As initially pointed out, alcohol hand rub is not efficacious in diminishing the rate of recurrence of constructive cultures and the problem of bacteria on hands (Kundrapu et al., 2014; Tuladhar et al., 2015). Therefore, in general, this gives rise to lack of patient satisfaction, which is the core of the healthcare unit. In addition, this has an impact on staff. One of the immediate effects is that personnel are obligated to adhere to the autocratic decisions made by the manager devoid of any of their input taken into consideration for improving team effort. In this case, regardless of whether the staff consider the need to undertake hand washing with soap and water as more effective, they still have to adhere to the rule of using alcohol-based sanitizers five times first. A key adverse impact is on the morale of the personnel. According to Leadership Management Development Center (1997), it is quite challenging to obtain a balance between the use of authority and the morale of personnel. A great deal of direct scrutiny through the dictatorial leadership style causes the subordinates to be unhappy, and being too heavy handed ends up crushing all group participation. Motivation is an intricate element that is influenced by acuities and reinforced by manifold factors. A largely autocratic style of leadership ends up demotivating the staff, which as a result leads to poor delivery of health care to patients. The lack of employee input in the decision-making process gives a sense of lack of ownership, which in turn, gives rise to employee dissatisfaction (Bhatti et al., 2012). Outcome The outcome of my PICOT question that I hope to achieve through the new intervention I am proposing is lower infection rate. Taking into account that the proposal will address the main issue that alcohol-based hand sanitizers are not completely effective in eradicating the transmission of hand bacteria, the result ought to be decreased rate of infection. In particular, this will enable the capacity to ensure that C. difficile infections are not prevalent in the healthcare setting. Improved staff morale and higher patient satisfaction are other expected outcomes. Time Frame The timeframe for measuring outcomes of this PICOT question will be 6 to 12 months. References Bhatti, N., Maitlo, G. M., Shaikh, N., Hashmi, M. A., & Shaikh, F. M. (2012). The impact of autocratic and democratic leadership style on job satisfaction. International Business Research, 5(2), 192. Carter, D. (2013). The Right Balance Between Hand Sanitizers and Handwashing. AJN The American Journal of Nursing, 113(7), 13. Current Nursing. (2012). Models of Nursing Care Delivery. Retrieved from: http://currentnursing.com/nursing_theory/models_of_nursing_care_delivery.html Edmonds, S. L., Zapka, C., Kasper, D., Gerber, R., Mccormack, R., Macinga, D.,...& Gerding, D. N. (2013). Effectiveness of hand hygiene for removal of Clostridium difficile spores from hands. Infection Control & Hospital Epidemiology, 34(03), 302-305. Ho, H. J., Poh, B. F., Choudhury, S., Krishnan, P., Ang, B., & Chow, A. (2015). Alcohol hand rubbing and chlorhexidine handwashing are equally effective in removing methicillin-resistant Staphylococcus aureus from health care workers' hands: A randomized controlled trial. American journal of infection control, 43(11), 1246-1248. Kundrapu, S., Sunkesula, V., Jury, I., Deshpande, A., & Donskey, C. J. (2014). A randomized trial of soap and water hand wash versus alcohol hand rub for removal of Clostridium difficile spores from hands of patients. Infection control and hospital epidemiology, 35(2), 204-206. Leadership Management Development Center. (1997). Decision-Making Styles. Retrieved from: http://www.leadershipmanagement.com/html-files/decision.htm Tuladhar, E., Hazeleger, W. C., Koopmans, M., Zwietering, M. H., Duizer, E., & Beumer, R. R. (2015). Reducing viral contamination from finger pads: handwashing is more effective than alcohol-based hand disinfectants. Journal of Hospital Infection, 90(3), 226-234. Read the full article

[factmrblogs]

Clostridium Difficile Infection Treatment Market Size, Trends, Growth Scenario and Analysis by 2034

The global Clostridium difficile infection treatment market (クロストリジウム・ディフィシル感染症治療市場) is projected to achieve a size of US$ 1.24 billion by the conclusion of 2024, surging further to US$ 2.28 billion by the conclusion of 2034. This growth trajectory reflects a robust Compound Annual Growth Rate (CAGR) of 6.3% spanning the period from 2024 to 2034.

Several factors are propelling this market expansion. These include the escalating prevalence of Clostridium difficile infection (CDI), intensified research and development endeavors, enhancements in available treatment modalities, and an increasing recognition of the importance of early detection and intervention.

𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐚 𝐒𝐚𝐦𝐩𝐥𝐞 𝐂𝐨𝐩𝐲 𝐨𝐟 𝐓𝐡𝐢𝐬 𝐑𝐞𝐩𝐨𝐫𝐭: https://www.factmr.com/connectus/sample?flag=S&rep_id=9742

Clostridium difficile infection (CDI) remains a significant healthcare concern worldwide, presenting challenges in patient management and infection control. As the incidence of CDI continues to rise, the demand for effective treatment options is escalating, creating both challenges and opportunities within the Clostridium difficile infection treatment market.

Challenges in CDI Treatment:

 One of the foremost challenges in treating CDI is the growing prevalence of antibiotic resistance among C. difficile strains. Traditional antibiotic therapies, such as metronidazole and vancomycin, have been the cornerstone of CDI treatment for decades. However, the emergence of resistant strains has diminished their efficacy, necessitating the exploration of alternative treatment modalities.

Moreover, recurrent CDI poses a persistent challenge, with a substantial proportion of patients experiencing multiple episodes of infection. Recurrence not only contributes to patient morbidity but also imposes a considerable economic burden on healthcare systems due to prolonged hospital stays and additional treatment costs.

Opportunities for Innovation:

 Amidst these challenges, there are notable opportunities for innovation within the Clostridium difficile infection treatment market. One promising avenue is the development of novel therapeutics targeting C. difficile virulence factors, such as toxins and spore formation mechanisms. By disrupting key pathogenic processes, these next-generation therapies aim to achieve superior efficacy while minimizing the risk of resistance development.

Furthermore, the advent of fecal microbiota transplantation (FMT) has revolutionized the management of recurrent CDI. FMT involves the transfer of healthy donor fecal matter into the gastrointestinal tract of CDI patients, restoring microbial diversity and functionality. This approach has demonstrated remarkable success rates in resolving recurrent CDI, paving the way for its integration into mainstream clinical practice.

Additionally, advancements in diagnostic technologies are facilitating early detection and intervention in CDI cases. Rapid molecular assays and point-of-care testing enable timely identification of C. difficile infection, enabling prompt initiation of appropriate treatment and containment measures to prevent transmission within healthcare settings.

𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬:

Novartis AG

Baxter

ANI Pharmaceuticals, Inc.

Mylan N.V.

Akorn

Sun Pharmaceutical Industries Ltd.

Merck & Co., Inc.

B. Braun Medical Inc.

Teva Pharmaceutical Industries Ltd.

Hikma Pharmaceutical PLC

Perrigo Pharmaceutical.

Apotex Inc.

AbbVie Inc.

Ferring Pharmaceuticals

Fresenius Kabi USA

Pfizer Inc.

Strides Pharma Science Limited

Sanofi

AstraZeneca

Eli Lilly and Company

Actelion Pharmaceuticals Ltd.

Astellas Pharma

𝐂𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞:

The competitive landscape within the Clostridium difficile infection treatment market is marked by the presence of established pharmaceutical giants, burgeoning biotech startups, and strategic alliances aimed at navigating the intricacies of this infectious ailment while vying for a significant share of the market.

At the forefront of this landscape are industry leaders such as Pfizer, Merck & Co., and Astellas Pharma. These key players leverage a combination of research and development initiatives, strategic partnerships, and a diverse array of treatment options to drive sustained growth and propel advancements in therapeutic interventions for Clostridium difficile infection.

Pfizer, a renowned multinational pharmaceutical corporation, holds a prominent position in the Clostridium difficile infection treatment market. With its extensive portfolio spanning pharmaceuticals, vaccines, and consumer healthcare products, Pfizer stands as a formidable contender in combating infectious diseases.

Astellas Pharma, on the other hand, offers a range of immunotherapeutic products, including antibiotics, for the treatment of CDI. The company's steadfast commitment to addressing infectious ailments aligns with the evolving needs of the consumer base, positioning it as a pivotal player in the battle against Clostridium difficile infection.

𝐒𝐞𝐠𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐂𝐥𝐨𝐬𝐭𝐫𝐢𝐝𝐢𝐮𝐦 𝐃𝐢𝐟𝐟𝐢𝐜𝐢𝐥𝐞 𝐈𝐧𝐟𝐞𝐜𝐭𝐢𝐨𝐧 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡

By Drug Type :

Metronidazole

Vancomycin

Fidaxomicin

By Route of Administration :

Oral

Injectables

By Distribution Channel :

Hospital Pharmacies

Retail Pharmacies

Mail Order Pharmacies

By Region :

North America

Europe

Latin America

East Asia

South Asia & Oceania

Middle East & Africa

The Clostridium difficile infection treatment market is poised for dynamic growth, driven by the increasing prevalence of CDI, shifting treatment paradigms, and ongoing efforts to address therapeutic challenges. By harnessing the collective expertise of the scientific community and leveraging innovative technologies, stakeholders can navigate the complexities of CDI management and usher in a new era of effective and sustainable treatment options.

𝐂𝐨𝐧𝐭𝐚𝐜𝐭:

US Sales Office

11140 Rockville Pike

Suite 400

Rockville, MD 20852

United States

Tel: +1 (628) 251-1583, +353-1-4434-232

Email: sales@factmr.com

[cdifffoundation]

Seres Therapeutics Announced Data From Its Phase 3 ECOSPOR III Study Evaluating SER-109, An Investigational Oral Microbiome Therapy For Recurrent C. diff. (C. difficile) Infection

Seres Therapeutics Announced Data From Its Phase 3 ECOSPOR III Study Evaluating SER-109, An Investigational Oral Microbiome Therapy For Recurrent C. diff. (C. difficile) Infection

Seres Therapeutics, Inc.  a leading microbiome therapeutics company, today announced data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapy for recurrent C. difficile infection (rCDI), will be presented at the IDWeek 2021 Virtual Conference (Sept. 29-Oct. 3). The Company will be presenting seven posters and oral presentations related to SER-109 and…

[myfeeds]

New live bacterial product for stubborn superbug improves quality of life

SER-109 is a pill with live, purified Firmicutes bacterial spores designed to compete metabolically with C. diff and restore colonization resistance to C. diff. In the world of superbugs (bacteria that have grown resistant to antibiotics), C. diff is among the most stubborn. Symptoms of C. diff infection are not only life-threatening but can persist for long periods, especially in persons with recurrent disease. “In this exploratory analysis patients treated with SER-109 had significantly greater improvements in health-related quality of life (HRQOL) scores compared to placebo-treated patients as early as Week 1, with continued steady and durable improvements by Week 8,” reports Garey in the Journal of the American Medical Association (JAMA) Network Open. He developed the disease-specific Quality of Life Survey (Cdiff32) measurement. “These findings suggest that an investigational microbiome therapeutic may improve HRQOL, an important patient-related outcome.” A new medicine to fight C. diff is highly in demand: C. diff is the most common health care-associated infectious agent in the U.S. and is estimated to cause more than 460,000 infections and 20,000 deaths annually. C. difficile infection (CDI) is a debilitating disease causing up to 10 to 20 watery bowel movements daily leading to poor HRQOL, loss of productivity, anxiety and depression. “Currently approved antibiotics generally lead to symptom resolution through reduction of toxin-producing bacteria. However, sustained efficacy rates remain modest since antibiotics do not kill dormant C. difficile spores nor address the disrupted microbiome, the underlying cause of recurrent disease,” said Garey. The effectiveness of SER-109 to improve quality of life was tested in 182 adults with C. diff infections using a quality-of-life questionnaire originally developed by Garey and his colleagues. Another positive finding was the observed improvements in the mental domain and subdomain scores in the eighth week of the study in patients taking SER-109 regardless of clinical outcome. “Several interesting hypotheses arise from this novel observation, which may be related to the potential role of the microbiome in disorders related to the gut-brain axis. CDI is associated with a disrupted microbiome which has been associated with mood disorders, including anxiety and depression,” said Garey.

[rootsanalysis-blog]

The human microbiome market is anticipated to grow at a CAGR of 24% till 2035

With the increasing concept of precision medicine, several scientists have demonstrated interest in the therapeutic manipulation of human microbiome (commonly gut bacteria) for the treatment of a wide range of disease indications.

  Roots Analysis has announced the addition of “The Human Microbiome Market, (4th Edition) 2022-2035” report to its list of offerings.

 The microbiome-based therapies pipeline features six drugs in phase III clinical development, over 200 candidates in other clinical and preclinical stages of development along with more than 60 diagnostics and screening / profiling tests that are commercialized for the detection of various diseases. However, the current microbiome market is driven by the fecal microbiota therapies approved by the FDA, particularly for the recurrent CDI and the commercialized diagnostic tests available to the patients. The human microbiome remained a largely unexplored area until 2007 when the Human Microbiome Project (HMP) was initiated. Given the role of microbiota in disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine. 

 Key Market Insights

 Over 230 drug candidates are currently being developed by more than 70 drug developers

Nearly 30% of the pipeline drugs are in clinical phase of development, while more than 150 drugs are in preclinical and discovery stages. Clinical stage drugs are primarily being developed for infectious diseases and digestive disorders, while candidates in preclinical and discovery stages are focused on oncological disorders.

 More than 75 diagnostics and screening / profiling test are available / under development

Of these, around 80% of the tests are available in the market, while rest are under development. More than 40 companies are engaged in providing these tests; these are primarily based in North America (45%) and Europe (39%). It is worth highlighting that majority (68%) of the players are small companies.

 FMTs are the only commercially available microbiome therapies approved by the FDA

These therapies are primarily used for the treatment of recurrent Clostridium difficile infection (rCDIs). It is worth mentioning that more than 400 trials have been registered for evaluating these therapies for a wide range of indications.

 Partnership activity in this domain has increased at a CAGR of 26%, between 2017 and 2021

Maximum number of partnerships were established in 2021, indicating a recent rise in the interest of players engaged in this domain. It is worth highlighting that majority of the deals were R&D agreements, representing over 35% of the total number of partnerships signed in the given time period.

 More than USD 1 billion has been invested by both private and public investors, since 2017

Of the total amount invested, over USD 563 million was raised through venture capital financing, representing over 56% of the overall funding activity in this domain. Further, 36 instances of grants / awards were also reported, wherein players collectively raised more than USD 137 million.

 Outsourcing has become an integral part of the microbiome and live biotherapeutics development process

Presently, over 25 service providers claim to offer a multitude of contract manufacturing services for microbiome and live biotherapeutic products. It is worth noting that close to 10 firms were established post 2010 and around 45% of the players are located in Europe.

 Microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035

As late-stage therapeutics will get approved by the FDA in the foreseen future, the microbiome therapeutics market is likely to grow at an annualized rate of 37% till 2035. It is worth mentioning that microbiome diagnostics is likely to capture 20% of the total microbiome market share by 2035.

 To request a sample copy / brochure of this report, please visit

https://www.rootsanalysis.com/reports/281/request-sample.html

 Key Questions Answered

§  Who are the leading players engaged in the development of microbiome therapeutics?

§  Which are the key microbiome based drugs being developed across various stages of development?

§  Which companies are actively involved in conducting clinical trials for microbiome therapeutics and FMTs?

§  Who are the leading players engaged in the development of microbiome diagnostics and screening / profiling tests?

§  Which types of partnership models are commonly adopted by industry stakeholders?

§  Who are the key investors in the field of human microbiome therapeutics and diagnostics?

§  What are the different initiatives undertaken by big pharma players for the development of human microbiome therapeutics in the recent past?

§  What is the role of various start-ups engaged in developing human microbiome therapeutics?

§  Which are the most commonly targeted therapeutic indications for which microbiome therapeutics are being developed?

§  What are the various steps involved in the manufacturing of microbiome therapeutics?

§  What are the key considerations for selecting a CMO / CRO for manufacturing of microbiome therapeutics?

§  What are the various algorithms / tools used to analyze data generated from microbiome research?

§  How is the current and future opportunity, related to microbiome therapeutics, diagnostics and FMT likely to be distributed across key market segments?

§  What are the various non-pharma applications of microbiome products?            

 The financial opportunity within the human microbiome therapeutics market has been analyzed across the following segments:

§  Type of Product

§  Probiotic Drugs

§  Other Drugs

 §  Target Indication

§  Recurrent C. difficile Infection

§  Necrotizing Enterocolitis

§  Primary Hyperoxaluria

§  Graft versus Host Disease

 §  Therapeutic Area

§  Infectious Diseases

§  Digestive and GI Disorders

§  Rare Disorders

 §  Route of Administration

§  Oral Route

§  Rectal Route

 §  Type of Formulation

§  Capsules

§  Suspensions

§  Enemas

 §  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

  The financial opportunity within the human microbiome diagnostics and screening / profiling tests market has been analyzed across the following segments:

§  Target Indication

§  Irritable Bowel Syndrome

§  Inflammatory Bowel Disease

§  Colorectal Cancer

§  Diabetes Mellitus

 §  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

 The financial opportunity within the fecal microbiota therapies market has been analyzed across the following segments:

§  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

 The report features inputs from eminent industry stakeholder(s), who were very optimistic concerning the growth of the human microbiome market. It includes detailed transcripts of the discussions held with the senior representatives of the stakeholder firms, including:

§  Charlie Badham (Senior Manager, Corporate Development, 4D Pharma)

§  Nicholas Monsul (Co-founder and Chairman, Quorum Innovations)

§  Alicia Scheffer (Chief Executive Officer, Floragraph)

§  Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)

§  Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

§  Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)

§  Assaf Oron (Chief Business Officer, BiomX)

§  Debbie Pinkston (Former Vice President, Sales and Business Development, List Biological Laboratories)

§  Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)

§  Colleen Cutcliffe (Co-founder and Chief Executive Officer, Pendulum Therapeutics)

§  Nikole Kimes (Co-founder and Chief Executive Officer, Siolta Therapeutics)

§  James Burges (Ex-Co-founder and Vice President of Innovation, OpenBiome)

§  Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)

§  JP Benya (Ex-Vice President, Operations, Assembly Biosciences)

§  Lee Jones (President and Chief Executive Officer, Rebiotix)

§  Mark Heiman (Ex-Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)

§  Pierre-Alain Bandinelli (Chief Strategy Officer, Da Volterra)

   The report also includes detailed profiles of the companies (listed below) engaged in developing microbiome therapeutics, diagnostics and screening / profiling test; each profile features an overview of the company, its financial information (if available), details on its product portfolio, recent developments, and an informed future outlook.

§  4D Pharma

§  Biosotia Microbiomics

§  DNA Genotek

§  Finch Therapeutics

§  GoodGut

§  Infant Bacterial Therapeutics

§  Invivo Healthcare

§  MaaT Pharma

§  OxThera

§  Qu Biologics

§  Rebiotix

§  Seres Therapeutics

§  Servatus

§  Shoreline Biome

 For additional details, please visit https://www.rootsanalysis.com/reports/view_document/human-microbiome-market/281.html or email sales@rootsanalysis.com

 You may also be interested in the following titles:

1.       Targeted protein degradation market, 2022-2035

2.       Cell Therapy Manufacturing Market, 2021-2030

3.       Single-Use Upstream Bioprocessing Technology / Equipment Market, 2022-2035

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

 Contact:

Ben Johnson

+1 (415) 800 3415

+44 (122) 391 1091

Ben.johnson@rootsanalysis.com

[juniperpublishers-crdoj]

Therapeutic Potential of Gut Microbiome Manipulation: Concepts in Fecal Microbiota Transplantation

Abstract

Microbial Alterations and Dysbiosis: The composition and diversity of gut microbiota is an indicator of health and various groups of commensal bacteria provide health advantages as they enhance metabolism, the immune system, cancer resistance, endocrine signaling and brain function. In general, the gut microbiome remains relatively resilient over time, however, antibiotic use, erratic diet, illness and other factors can lead to alterations and dysbiosis, which weaken various elements of the barrier, causing collapse of the mucus layer that separates epithelial cells and microbiota and reduced expression of antimicrobial peptides which control bacteria including C. difficile.

FMT- Invasive Gut Microbial Manipulation: FMT is administration of a form of fecal material from the donor into the intestinal tract of the recipient in order to directly modify the recipient’s gut microbial composition suitably to confer health benefits. FMT has been used to successfully treat recurrent Clostridium difficile infection (DCI). There are preliminary indications to suggest that it may also carry therapeutic potential for other conditions such as inflammatory bowel disease, obesity, metabolic syndrome and functional gastrointestinal disorders.

Mechanisms and Effects of FMT: FMT involves administration of the whole microbiota from healthy donor stool into the recipient’s intestinal tract to normalize or modify intestinal microbiota composition and function. FMT has restorative potential for both composition and functionality of gut microbiota and results in normalization of microbial diversity and community profile in patients by multiple mechanisms including competition for nutrients among C. difficile and other microbiota, direct suppression by antimicrobial peptides, bile-acid-mediated inhibition of spore germination and vegetative growth; and activation of immune-mediated colonization resistance.

Mechanisms and Effects of FMT: M. FMT involves administration of the whole microbiota from healthy donor stool into the recipient’s intestinal tract to normalize or modify intestinal microbiota composition and function. FMT has restorative potential for both composition and functionality of gut microbiota and results in normalization of microbial diversity and community profile in patients by multiple mechanisms including competition for nutrients among C. difficile and other microbiota, direct suppression by antimicrobial peptides, bile-acid-mediated inhibition of spore germination and vegetative growth; and activation of immune-mediated colonization resistance.

Possible Scope of FMT Interventions: FMT is be considered for recurrent or relapsing CDI when there is failure to respond to conventional antibiotic therapy. For a moderate CDI, FMT is indicated when there is no response to standard therapy for at least 1 week. For severe CDI, it is indicated when there is no treatment response after appropriate maximal therapy for 48 h. FMT leads to a significant change in microbial diversity in patients with recurrent CDI and complete resolution of symptoms. However, the trials to treat ulcerative colitis (UC) with FMT have shown conflicting results. Further, the patients with Crohn’s disease (CD) and ulcerative colitis (UC) have increased incidence of CDI, and presence of CDI commonly complicates the course of these underlying diseases.

Limitations, Regulations and Complications: The occasional adverse effects of FMT are diarrhoea, abdominal cramping, belching and nausea, which are self-limiting and resolve in a variable period. An increased risk of IBD flare, fever and elevation in inflammatory markers following FMT may occur. Some serious adverse effects are upper GI bleeding, enteritis and peritonitis, which vary with the administration method and may be related to complications of the method itself rather than FMT. FMT is regulated in Canada as a ‘new biologic drug’, specifying the indications, patient’s consent, preparing the FMT from a known solitary donor and screening for potential pathogens prior to administration. The US Food and Drug Administration (FDA) considers stool as a biological product and drug, and mandates physicians to maintain similar precautions to administer FMT. FMT, so far is not regulated in West by the European Medicines Agency, or elsewhere in Asia, Africa or Australia.

Future Directions and Developments: There is increasing acceptance for the therapeutic use of FMT. However, the range of risks and benefits remains poorly defined because the published FMT experience remains limited. In future, FMT can be a pauci-strain type or multi-strain type depending on the fecal microbiota analysis of the recipient. The suitable strains can be picked-up from donor fecal sample, grown in cultures and transplanted through an appropriate route. Depending on the recipients’ microbiota diagnostic analysis, the FMT using suitable pauci-strains may be a promising development in near future

Read More About This Article:https://juniperpublishers.com/crdoj/CRDOJ.MS.ID.555803.php

Read More Juniper Publishers Google Scholar Articles:  https://scholar.google.com/citations?view_op=view_citation&hl=en&user=KKJjfyEAAAAJ&citation_for_view=KKJjfyEAAAAJ:VnuxuLaQPLMC

[cdifffoundation]

Dale Gerding, MD, FACP, FIDSA, FSHEA To Chair the July 16, 2021 C. diff. Patient, Family, and Caregiver Live-Online Symposium

Dale Gerding, MD, FACP, FIDSA, FSHEA To Chair the July 16, 2021 C. diff. Patient, Family, and Caregiver Live-Online Symposium

Scientific Advisor Prof Dale Gerding to chair C. diff. Foundation C. diff. Patient, Family, and Caregiver Symposium July 16th  – Live-Online beginning at 1:00 p.m. – 3:00 p.m. EDT  Register Today!         Brighton, United Kingdom – 02 July 2021 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines to prevent…

[pusware]

ID Factoid

Treatment with antibiotics, use of PPIs, and underlying comorbidities are important predictors of mortality in recurrent CDI.

PPIs keep coming up in the literature.  Acid is good.  Or PPIs are bad.

https://doi.org/10.1093/ofid/ofy175

[pinoywhealth]

Could number two be number one when it comes to combating recurrent Clostridium difficile (CDI) infections? Using genetic material analysis and machine learning, researchers have pinpointed several key factors to ensure successful fecal microbiota transplants (FMT), which have...

[healthcare00897]

Clostridium Vaccine Market Surge in Demand from Healthcare Industry to Boost Growth Forecast to 2026

Clostridium difficile infections are the most widely recognized cause of hospital acquired infectious diarrhea. There is a critical need for development of prevention vaccine for this disease. Clostridium difficile, is a gram-positive bacterium, which produces an anaerobic toxin that is transmitted through fecal-oral route. Clostridium difficile infection occurs during antibiotic treatment or can be caused due to healthcare associated infection with clinical manifestation ranging from asymptomatic infection to watery diarrhea or serious intestinal condition such as colitis and colonic perforation.

Get Exclusive Sample Report at: https://www.coherentmarketinsights.com/insight/request-sample/2359

Growing C. difficile infections at healthcare facilities and antibiotic resistance to treatment drugs are propelling demand for development of prophylactic options to reduce the risk of infection in vulnerable patients. A 2013 bulletin published from the Centers for Disease Control and Prevention (CDC) outlined Clostridium difficile as urgent antibiotic-resistance threats in the U.S.  

Clostridium Vaccine Market Drivers

Rising incidence and high prevalence of clostridium difficile infection is expected to boost growth of the market over the forecast period. Incidence of clostridium difficile infection has been witnessing an increase since the recent past, due to its infection recurrence and antibiotic resistance. According to Centers for Disease Control and Prevention (CDC), in 2015 around half a million people in the U.S. suffer from clostridium difficile infection in a year.

Moreover, according to National Center for Biotechnology Information (NCBI), an estimated 37,900 patients were suffering from clostridium difficile infection in Canada in 2012. A review and meta-analysis of studies published in National Center for Biotechnology Information (NCBI), 2016, conducted in China between 2010 and 2016, reported significant incidence of clostridium difficile infection in China.

Currently, there is no alternative therapies apart from antibiotics available for the treatment of clostridium difficile infection and only option available is surgery (in severe cases), fecal microbiota transplant, and probiotics in case of recurrent clostridium difficile infection.

Moreover, key pharmaceutical players are engaged in conducting clinical trials for development of clostridium vaccine that can offer preventive measure in the clostridium difficile infection in near future.

For instance, in January 2017; Pfizer announced phase II study of investigational clostridium difficile vaccine candidate: PF-06425090; for the prevention of C. difficile infection. This randomized phase II study was conducted to examine the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer initiated a phase III study in March 2017, with around 16,000 participants.  

In July 2016, Valneva SE announced the successful completion of its phase II clinical study for its prophylactic vaccine candidate VLA84 targeting on primary prevention of C. difficile infection (CDI).

Clostridium Vaccine Market Regional Analysis

North America is expected to hold a dominant position in the global clostridium vaccine market and it is expected to account for largest market share over the forecast period, owing to increased prevalence of Clostridium difficile in the U.S. and growing awareness regarding the adoption of preventive measurement in Clostridium difficile infection in this region.

For instance, according to CDC, in 2011; healthcare-associated infections (HAIs) caused by C. difficile was estimated to cause around half a million infections in the U.S. and 29,000 died within 30 days of the initial diagnosis.

Clostridium Vaccine Market Restraint

Increased risk associated with the failure of vaccine candidate during the clinical trial studies and high cost associated with late stage testing is expected to slow down commercialization of clostridium vaccine and restrain the clostridium vaccine market growth over the forecast period.

For instance, in December 2017, Sanofi terminated its phase III C. difficile clinical trial studies, due to the results of an interim trial analysis, which stated low probability of success with its C. difficile candidate. Moreover, discontinuation of Sanofi’s C. difficile vaccine program is expected to offer great future opportunity for Pfizer and Valneva to offer its vaccine to patients after getting the satisfactory regulatory approval in the future.      

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Clostridium Vaccine Market Key Players

Key players operating in global clostridium vaccine market include Valneva SE and Pfizer, Inc.

Clostridium Vaccine Market Taxonomy:

The global clostridium vaccine market is segmented on the basis of vaccine and region

By Vaccine

  PF-06425090

  VLA84

By Region

  North America

  Latin America

  Europe

  Asia Pacific

  Middle East

  Africa

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[cdifffoundation]

Microbiota Restoration Therapy (MRT) (Drug Platform) Reduces Antibiotic-resistant Bacteria Gut Colonization In Patients with Recurrent C. difficile Infection (rCDI)

Microbiota Restoration Therapy (MRT) (Drug Platform) Reduces Antibiotic-resistant Bacteria Gut Colonization In Patients with Recurrent C. difficile Infection (rCDI)

Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study Amy Langdon, Drew J. Schwartz, Christopher Bulow, Xiaoqing Sun, Tiffany Hink, Kimberly A. Reske, Courtney Jones, Carey-Ann D. Burnham, Erik R. Dubberke & Gautam Dantas for the CDC Prevention Epicenter…

[krishnatwinkle-blog]

Analysis of depression levels in children.

In this examination, it was expected to decide the wretchedness levels, suicide musings and suicide endeavors of explicitly mishandled kids and young people.

Medical records of 218 explicitly mishandled youngsters and teenagers matured 8– 17 years who were alluded to the Kahramanmaras Sutcu Imam University School of Medicine, Department of Child and Adolescent Psychiatry for orchestrating legal reports or potentially were conceded by their families for treatment were reflectively researched. In all cases, age, sexual orientation, instruction, insight level, type and recurrence of maltreatment, partiality of the abuser with the person in question, mental analysis as indicated by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) characterization, despondency levels, and self-destructive contemplations and suicide endeavors of the cases were assessed. Discouragement dimensions of the cases were dictated by the Children’s Depression Inventory (CDI).

[miamibreast-blog]

Center For Diagnostic Imaging

How's CDI Miami Becoming One Of The Most Advisable Diagnostic Center For Women Miami?

Center for Diagnostic Imaging Miami is committed towards delivering one of the most advanced patient care with their updated technology and gear. Together with the introduction of 3D mammogram as well as other diagnostic mechanisms, CDI Miami has turn into one of the most advisable diagnostic center for women Miami.

With 1 in 8 vulnerable to breast cancer, diagnostic services and standard inspections have turn into a mandate. Center For Diagnostic Imaging Miami implements a variety of diagnostic services employing one of the most advanced technologies and equipment generating them the top diagnostic center for women Miami. With 3D mammogram and also other tools like breast MRI, this Miami Breast Center is functioning towards alleviating breast cancer in the state of Miami. Center for Diagnostic Imaging Miami is proving to become a extensive Women's Diagnostic Center Miami with imaging and diagnostic tools as well as standard consultations and risk assessments offered. Together with the early screening and detection, Center for Diagnostic Imaging Miami is becoming one of the most advisable diagnostic center for women Miami.

Center for Diagnostic Imaging Miami is amongst the only facilities in south Florida to offer you 3D mammogram, also called tomosynthesis. Tomosynthesis can be a 3D mammogram that aids in early detection of breast cancer by allowing medical doctors to analyze thin slices of tissue individually. By inspecting the tissues independently, medical doctors are able to keep away from any confusion that may possibly arise from overlapping on the tissues and result in false readings. Additionally, 3D mammogram can be a advisable mammography tool for girls with denser breasts. In case of 3D mammogram, a number of images on the breasts are captured from a variety of angles, which are then utilised to reconstruct the breasts that the radiologists can view employing 1mm thick slices. Tomosynthesis is 40% far more sensitive and 30% far more effective than digital mammograms. With tomosynthesis, early detection of modest masses is attainable with enhanced accuracy in identifying size, shape and place even though obtaining greater odds of detecting a number of abnormalities giving a clear picture on the dense tissue.

The group at Women's Center Miami is comprised of board certified radiologists and technicians. The team properly customizes the exams as per the distinct specifications on the individuals. They make sure that all therapies and diagnosis take place even though keeping the sufferers at comfort. A non-invasive breast MRI is also conducted by Center for Diagnostic Imaging Miami, that is utilised to evaluate the scar tissue to take away the recurrent illness and aids in gauging the selection and good quality of implants in case of patients diagnosed with breast cancer. With breast MRI Miami and 3D mammogram solutions, radiologists at Center for Diagnostic Imaging Miami are in a position to appropriately establish the effects of chemotherapy and assess the tissue to offer one of the most comprehensive treatment, thereby, becoming the top Women's Diagnostic Center Miami.