In addition to aiding in digestion, regulating the immune system, and vitamin production (including K, B, and B12), the human microbiome plays a significant role in contemporary medical practice. The human microbiome has many beneficial effects, including improved immunity and the provision of essential nutrients. The human microbiome has recently attracted a lot of attention due to its link with several respiratory diseases and immunity, as stated in an article that appeared in the International Journal of Microbiology on May 22, 2020. Human immunity has been linked to the microbiome in the digestive tract. Variation in the number of microorganisms, including actinobacteria, firmicute, and bacteroidetes, has been linked by scientists to the onset of lung and respiratory, diabetes, arthritis, gastrointestinal, and other neurological disorders. As a result, expanding academic investigation into the human microbiome is a major factor propelling the development of this market.
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Global Human Microbiome Market – Impact of the Coronavirus (COVID-19) Pandemic_MI
The global human microbiome market should expand because of the COVID-19 epidemic. A variety of symptoms and degrees of severity have been reported by those infected with COVID-19, as detailed in a study published in the journal American Society for Microbiology on January 12, 2021. The COVID-19 infection is reported to affect the liver, spleen, kidney, heart, and even the gastrointestinal tract, as stated in an article published in the International Journal of Microbiology on May 22, 2020. Those with compromised respiratory systems and poor gastro – intestinal health are disproportionately impacted, as reported by the same source.
So, many market participants are increasing their R&D activities for probiotics during the COVID-19 pandemic as a result of the rising importance and demand for medical foods. On April 24, 2020, for instance, Biosearch Life launched a clinical trial of its product, Hereditum Immunactiv K8, to determine whether or not it could reduce the prevalence or severity of COVID-19 infection. Product components include Lactobacillus coryniformis CECT5711 K8, a probiotic strain. Clinical data were obtained showing that the probiotic strain Lactobacillus coryniformis CECT5711 K8 can lessen the frequency of respiratory infections caused by viruses in the elderly.
Furthermore, faecal microbiota transplantation (FMT) was evaluated for its efficacy in the treatment of recurrent Clostridioides difficile infection due to its advantages over antibiotics and may serve as an effective measure for the management of COVID-19 symptoms in patients, as reported in an article posted in the National Center for Biotechnology Information (NCBI): March 17, 2020.
In addition, the U.S. Food and Drug Administration (FDA) advised against using stool samples donated after December 1, 2019, in a review article posted in the Diseases Journal on November 17, 2020. This is because the SARS-CoV-2 virus can be communicated in faecal samples during FMT procedures. Further, potential donors who tested positive for COVID-19 have been advised to be disregarded by the European Society for Blood and Bone Marrow Transplantation. Accordingly, the expansion of the worldwide human microbiome market is anticipated to be impacted by these regulations during the predicted time period.
In 2021, the value of the global human microbiome market is projected to reach US$ 91,075.4 Mn, expanding at a CAGR of 18.9% from 2016 to 2021. (2021-2028).
The global human microbiome market is expanding due to a number of factors, the most important of which is the increasing funding of R&D activities and the strong pipeline of products for the treatment of conditions such as Clostridium Difficile Infection (CDI), inflammatory bowel disease (IBD), metabolic disorders, and others.
Researchers and developers are ramping up their efforts, which bode well for the market’s expansion in the coming years. Pfizer, as part of its Breakthrough Growth Initiative, invested US$ 25 million in clinical-stage company Vedanta Biosciences in January 2021 to help advance the development of therapies utilizing bacteria isolated from the human microbiome. The money will be used to conduct a Phase II study of VE202 in IBD (IBD).
Small biotech startups have the financial backing of a wide range of investors and multinational pharmaceutical conglomerates. Drug development is anticipated to be hastened by the availability of venture capital and government funding for microbiome companies and research institutions.
After receiving an additional US$ 8.7 Mn in an extension of its Series B financing round, MaaT Pharma announced the news on December 1, 2020, bringing the total amount raised (for this round) to US$ 30.33 million. The French government contributed the extra money. With this money, MaaT Pharma will be able to further research and develop microbiome drugs with the goal of enhancing the overall survival of patients suffering from blood cancer and Graft-versus-Host Disease (GvHD). In addition, Finch Therapeutics Inc. closed a US$ 90 Mn series D financing round on September 17 to advance CP-101, an oral microbiome therapy, into late-stage clinical development and to seek registration for the therapy for ongoing Clostridioides difficile infection.
In order to broaden their offerings, major players in the market engage in inorganic activities like mergers and acquisitions. As a result, this factor is viewed as a driver of the market’s expansion during the forecast horizon.
Over the next few years, the market is projected to expand thanks to the increasing number of mergers and acquisitions carried out by major players. In 2018, Ferring Pharmaceuticals, for instance, purchased Rebiotix, Inc. to obtain its microbiome-based drug RBX2660, used to treat and prevent recurrent Clostridium difficile infection.
Global Human Microbiome Market – Restraints_MI
The global human microbiome market is expected to be slowed by rising regulatory concerns about therapeutics based on the microbiome. Because of the novelty of the idea, there is concern about the safety of therapeutics based on the microbiome. There is a lack of a universally accepted regulatory system for drugs based on the microbiome. The safety of introducing live bacteria or bacterial products into the human body needs to be thoroughly investigated. The effectiveness of a microbiome-based platform is also a source of some concern. For the human microbiome market to reach its clinical potential, it is essential that a connection be made between microbiome dysbiosis and disease. Because of the potential impact of heterogeneity in the microbiome of the target patient pool on the results and reproducibility of clinical trials, designing these studies presents a unique set of challenges. In addition, the high price of therapy may prevent it from being widely adopted. It may be challenging to naturally scale up production of microbiome, which may have implications for price and availability given the methods by which they are produced.
Furthermore, the future of financial support for drug therapies based on the microbiome is unknown. Drugs targeting the microbiome may have different pharmacological effects depending on the composition of the microbes that make up the gut microbiota, the underlying principle upon which the therapy relies. There is a risk of non-payment if the patient’s disease does not improve sufficiently beyond the established clinical endpoint set by the payer organization. Those aforementioned restraints on growth are likely to be felt by the global human microbiome market in the years ahead.
Global Human Microbiome Market – Regional Analysis_MI
The global human microbiome market is broken down into sections based on geography: the Americas, Europe, Asia-Pacific, the MENA region, and Africa.
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Due to rising rates of gastrointestinal disease (IBD, Crohn’s disease, etc.) and rising awareness about probiotics for their role in preventative health and in balancing gut microbiome, North America is expected to maintain a commanding share of the global human microbiome market over the forecast period. Over half a million Americans contract Clostridium difficile infection (CDI) every year, leading to about 29,000 deaths, as reported in a 2015 article posted by the Centers for Disease Control and Prevention (CDC), 2019.
To add fuel to the fire, major market participants in North America are actively seeking patents for their innovative new products. For example, on February 25, 2021, OxThera AB, a privately held biopharmaceutical company focused on helping people with Primary Hyperoxaluria (PH), announced that it had received a patent from the United States covering both its product candidate Oxabact, a strain of naturally occurring, non-pathogenic gut bacteria, and a method for treating or preventing an oxalate-related disorder.
In addition, rising investment in R&D by key industry participants is forecast to drive expansion in Europe’s human microbiome market. For example, on March 24, 2021, ENTEROME, a clinical stage biopharmaceutical company, developed IND clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2 clinical trial of EO2463, a potential treatment for indolent non-Hodgkin B-cell lymphomas, based on its ability to de-code molecular interactions in the gut microbiome impacting human health (iNHL).
Global Human Microbiome Market – Competitive Landscape_MI
The main companies participating in the market for human microbiome worldwide are ENTEROME SA, Embion Technologies S.A, IGEN BIOLAB GROUP, Evelo Biosciences Inc., Ferring Pharmaceuticals, 4D Pharma Plc., Gnubiotics Sciences, YSOPIA Bioscience, ViThera Pharmaceuticals Inc., SECOND GENOME THERAPEUTICS, Osel Inc., OxThera AB, Immuron Ltd., AOBiome, Vedanta Biosciences, Inc., Rebiotix Inc., Seres Therapeutics, Inc., Assembly Biosciences, Inc., and Finch Therapeutics Group, Inc.
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The Human Microbiome Market is displayed in 13 Chapters:
Chapter 1: Market Overview, Drivers, Restraints and Opportunities
Chapter 2: Market Competition by Manufacturers
Chapter 3: Production by Regions
Chapter 4: Consumption by Regions
Chapter 5: Production, By Types, Revenue and Market share by Types
Chapter 6: Consumption, By Applications, Market share (%) and Growth Rate by Applications
Chapter 7: Complete profiling and analysis of Manufacturers
Chapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expenses
Chapter 9: Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10: Marketing Strategy Analysis, Distributors/Traders
Chapter 11: Market Effect Factors Analysis
Chapter 12: Market Forecast
Chapter 13: Human Microbiome Research Findings and Conclusion, Appendix, methodology and data source
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