Human microbiome plays a major role in modern healthcare as they have multiple functions such as, enabling easy digestion of food, regulation of immune system, and production of vitamins such as Vitamin K, Vitamin B, and Vitamin B12. Human microbiome boosts immunity, provides necessary nutrition, and others. According to the article published in the International Journal of Microbiology: May 22, 2020, in recent times, the human microbiome has become an important area of interest because of its association with several respiratory diseases and immunity. The gut microbiome has been associated with the immunity of a person. Researchers have reported that variation in the number of microorganisms, such as actinobacteria, firmicute, and bacteroidetes, leads to the development of lung and respiratory, diabetes, arthritis, gastrointestinal disorders, and other neurological disorders. Thus, increasing research studies in the field of human microbiome are the key drivers boosting the growth of this market.
Global Human Microbiome Market - Impact of the Coronavirus (COVID-19) Pandemic
The COVID-19 pandemic is expected to drive the growth of the global human microbiome market. According to the study published in the American Society of Microbiology: January 12, 2021, people infected with COVID-19 experience a range of symptoms and severities. According to the article published in the International Journal of Microbiology: May 22, 2020, it has been reported that the COVID-19 infection affects the liver, spleen, kidney, heart, and even the gastrointestinal tract. According to the same source, the people with the poor gastrointestinal health are affected the most as such patients are hospitalized and have breathing problems.
Thus, due to increasing importance as well as demand for medical foods during the COVID-19 pandemic, many market players are increasing the research and development activities for probiotics during the pandemic. For instance, on April 24, 2020, Biosearch Life initiated clinical trials examining the effect of its product, Hereditum Immunactiv K8, for measuring its effectiveness in reducing the incidence or severity of COVID-19 infection. The product consists of the probiotic strain Lactobacillus coryniformis CECT5711 K8. The company gained clinical evidence reporting that the probiotic strain Lactobacillus coryniformis CECT5711 K8 can reduce virally transmitted respiratory infections in elderly populations.
Moreover, according to the article published in the National Center for Biotechnology Information (NCBI): March 17, 2020, fecal microbiota transplantation (FMT) was found to be effective in the treatment of recurrent Clostridioides difficile infection because of its advantages over antibiotics and could be used as an effective measure for the management of COVID-19 symptoms in patients.
Furthermore, according to the review article published in the Diseases Journal: November 17, 2020, the U.S Food and Drug Administration (U.S. FDA), on March 23, 2020, warned clinicians that the SARS-CoV-2 virus can be transmitted in fecal samples during FMT procedures, thus the FDA has recommended to use stool samples donated before December 1, 2019. Moreover, the European Society for Blood and Bone Marrow Transplantation has recommended to exclude potential donor who tested positive for COVID-19. Thus, these guidelines are expected to affect the growth of the global human microbiome market over the forecast period.
|Base Year:||2020||Market Size in 2021:||US$ 91,075.4 Mn|
|Historical Data for:||2018 to 2020||Forecast Period:||2020 to 2027|
|Forecast Period 2021 to 2028 CAGR:||18.9%||2028 Value Projection:||US$ 306,351.2 Mn|
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.
|Restraints & Challenges:||
The global human microbiome market is estimated to be valued at US$ 91,075.4 Mn in 2021 and is expected to exhibit a CAGR of 18.9% over the forecast period (2021-2028).
Figure 1: Global Human Microbiome Market Share (%) Analysis, By Drug, 2021
Rising investment for the research and development activities and robust pipeline of products for the treatment of Clostridium Difficile Infection (CDI), inflammatory bowel disease (IBD), metabolic disorders, and others, act as the major factors driving the global human microbiome market growth.
Market players are indulged in increasing research and development activities, which is expected to increase the growth of the market over the forecast period. For instance, in January 2021, Vedanta Biosciences, a clinical-stage company developing therapies with human microbiome-derived bacteria, received US$ 25 million investment from Pfizer, as part of its Breakthrough Growth Initiative. Vedanta will use the investment to fund a Phase II study of VE202 in inflammatory bowel disease (IBD).
Various investment firms and multinational pharmaceutical companies are financially supporting companies such as small biotech startups. Venture financing and state funding for microbiome companies and research institutes is expected to accelerate drug development platform.
On December 1, 2020, MaaT Pharma announced that the company received an additional funding of US$ 8.7 million in an extension of its Series B financing round, bringing the total raised amount (for this round) to US$ 30.33 million. The additional funding was on behalf of the French state. This funding will help MaaT Pharma to develop microbiome drugs in order to improve overall survival in patients with blood cancer and Graft-versus-Host Disease (GvHD). Moreover, on September 17, Finch Therapeutics Inc. closed a US$ 90 million series D financing round to take its oral microbiome therapy, CP-101, into late-stage clinical development and also for its registration in the treatment of chronic Clostridioides difficile infection.
Market players are involved in inorganic activities such as acquisition, in order to expand their product portfolio. This is expected to increase the growth of the market over the forecast period.
Increasing acquisition by the key players, is expected to increase the growth of the market over the forecast period. For instance, in 2018, Ferring Pharmaceuticals acquired Rebiotix, Inc. in order to acquire its microbiome based drug RBX2660, for the prevention of recurrent Clostridium difficile infection.
Global Human Microbiome Market – Restraints
Increasing regulatory concerns regarding the microbiome based therapeutics is expected to hamper the growth of the global human microbiome market. Microbiome-based therapeutics is a relatively new concept, which thus creates safety concerns. At present, there is an inadequate standard regulatory framework for microbiome based drugs. Strong evidence-based studies are required with respect to the safety of administering live bacteria or bacterial products in the human body. There are some concerns about efficacy of microbiome-based platform as well. The establishment of link between dysbiosis of microbiome and disease is critical to establish clinical potential of the human microbiome market. There is a unique set of challenges for designing clinical trials, as the lack of uniformity in microbiome in target patient pool may affect clinical trial outcomes and reproducibility. Moreover, the cost of therapy may prove to be a barrier for penetration of the product into the market. Considering methods by which microbiome are produced, it may be difficult to scale up the production in a natural way, which may impact cost and availability.
In addition to this, reimbursement scenario is still unclear for microbiome-based drug therapies. Considering principle on which the therapy works, microbiome drugs may produce variation in pharmacological effects depending upon the microbial gut flora characteristics. The payer organization may place stringent clinical endpoint to provide full reimbursement, which may lead to denial of payment in case of insufficient clinical enhancement in patient’s disease condition. The above factors are expected to hamper the growth of the global human microbiome market over the forecast period.
Global Human Microbiome Market – Regional Analysis
On the basis of region, the global human microbiome market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America is expected to hold a dominant position in the global human microbiome market during the forecast period, owing to the increasing incidence rate of various gut disorders (IBD, Crohn’s disease etc.) and increased awareness about probiotics for their role in preventive health and in balancing gut microbiome. According to article published by the Centers for Disease Control and Prevention (CDC), 2019, in 2015, Clostridium difficile infection (CDI) is one of the most common healthcare-associated infections in the U.S., affecting over 500,000 people, causing around 29,000 deaths annually.
Moreover, market players in North America are indulged in applying for patents for their new products, this is expected to drive growth of the market in the region. For instance, on February 25, 2021, OxThera AB, a privately-held biopharmaceutical company, which is dedicated in improving the lives of people with Primary Hyperoxaluria (PH), announced that a new U.S. patent has been granted for its product candidate Oxabact, a natural, non-pathogenic, gut bacteria, and for a method used for the treatment or prevention of an oxalate-related disorder such as hyperoxaluria.
Furthermore, Europe is expected to witness significant growth in the human microbiome market, owing to the increasing research and development activities by the market players. For instance, on March 24, 2021, ENTEROME, a clinical stage biopharmaceutical company, which develops novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2 clinical trial of EO2463, a potential treatment for indolent non-Hodgkin B-cell lymphomas (iNHL).
Figure 2: Global Human Microbiome Market (US$ Mn), by Region, 2021
Global Human Microbiome Market – Competitive Landscape
Major players operating in the global human microbiome market include 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.
According to the National Center for Biotechnology (NCBI), the human microbiota consists of 10-100 trillion symbiotic microbial cells, which is harbored by each person, this primarily includes bacteria in the gut. The human microbiome consists of the genes these microbial cells harbor. Microbiome projects worldwide have been launched with the goal of understanding the roles that these microbes play and their impacts on human health. They are being studied for the treatment of diseases such as obesity, diabetes, autoimmune disorders, cancer, gastrointestinal disorders, central nervous system disorders, and others.
Increasing incidence rate of various gut disorders (inflammatory bowel disease (IBD), Crohn’s disease etc.) is expected to increase the growth of the global human microbiome market over the forecast period. For instance, according to a study published in Lancet in October 2019, around 319 (U.S.) cases and around 322 (Europe) cases of Crohn’s disease were reported per 100,000 people. As per the Centers for Disease Control and Prevention’s (CDC) 2018 statistics, an estimated 1.3% of the U.S. adults (accounting for 3 million individuals) were diagnosed with IBD (either Crohn’s disease or ulcerative colitis) in 2015. This showcased a major increase in the incidence rate of IBD from 1999, when 0.9% of the U.S. adults (2 million) were diagnosed with IBD.
Market players are involved in inorganic activities such as collaborations for research and development activities. This is expected to increase the growth of the market over the forecast period. For instance, in 2017, Second Genome, Inc., collaborated with the research institutes i.e., Stanford Cancer Institute, Ruprecht-Karl's-University Heidelberg, Roswell Park Comprehensive Cancer Center, and John Theurer Cancer Center in order to evaluate the effect of gut microbiota on individual response to cancer immunotherapies.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.