The global human microbiome therapeutics market was valued at USD 284.5 million in 2019 and is expected to grow at a CAGR of 23.8% from 2020-2027. The growth in human microbiome therapeutics is driven by increasing funding from the government towards microbiome research, unmet needs in different therapeutic areas such as women health and rare diseases, the sudden spike in infectious diseases, and side effects of current drugs currently being in use. The increased participation of venture capitalists also played pivotal in live biotherapeutics innovation. According to the statistics published by Springer, as of 2019, more than USD 3.0 billion have been used in live biotherapeutics research companies, with the U.S. being the biggest participant with around USD 2.4 billion investment.
The gut microbiome plays an important role in digestion, immune system, endocrine system, defense against pathogens, and mental health. Disruption in the normal equilibrium of the body might induce brain related and metabolic disorders such as lactose intolerance and coeliac disease. They also play an important role in the digestion of residual substrates, which are involved in development of essential amino acids, thiamine, folate, riboflavin, and vitamin K and B12. Moreover, fermentation of carbohydrates and dietary fibers result in the synthesis of short chain fatty acids, propionate, and butyrate, which strengthens the intestinal mucosal layer.
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Global microbiome therapeutics market is primarily driven by rapidly changing research, innovation, and its application into personalized medicine and nutrition, high therapeutic potential medicines. Baylor College of Medicine (BCM) showcased its research study in Microbiota’s 2019 conference to demonstrate the power of microbiome in personalized nutrition and therapeutic cure. It did microbiome analysis for the onset of diabetes in young people. The study showed how fat diet constitute different microbiomes linking it with a decline in the level of oxytocin.
Switzerland based start-up SpheroBiotics, developed a screening tool known as nanoFleming, composed of nano-spheres allowing test on millions of bacteria to find new antibiotics. The significance of the platform could be enumerated from the fact that more than 70 percent of antibiotics derived from micro-organisms and 99 percent microbiome profile is still to be validated. AsiaBiome, Hong Kong based, Asia’s first Microbiota bank in the conference illustrated the fact that despite the region’s 60 percent representation of global population, its contribution in microbiome profiling building is very less.
Azitra, the U.S. based live bio-therapeutics based dermatology company showcased its product through engineered Staphylococcus epidermidisto delivered for psoriasis, Netherton syndrome, EGFR-inhibitor associated rash, eczema skin treatments. The company’s product AZT-01, which addresses skin barrier deficiency through filaggrin, to regulate immunity and regulating dysbiosis by inhibiting S. aureus. The above mentioned research and innovation expected to contribute to the development of the concerned market.
The scientific knowledge regarding live biotherapeutics is progressing at a rapid pace. However, microbiome complexity and microbial interactions with the current drugs in use and side ill effects caused due to them it is still to be ascertained. To understand the basic mechanism of action and positive clinical evidence data require good scientific literature.
The market is primarily segmented on the basis of Product, By Therapeutic Area, By Indication, By Approach, and geographic region.
By Therapeutic Areas
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Based upon the product, the global market is categorized into probiotics, prebiotics, medical foods, and prescription drugs. In 2019, probiotics segment accounted for the largest share. This high share is attributed to high nutritional benefits associated with it, research and development in microbiome based probiotics, and the ban on antibiotic growth promoters in the human foods in the EU.
The research on microbiome has resulted in the development of next generation probiotics, which includes Akkermansia muciniphila, Bacteroides uniformis, Clostridium clusters IV, XIVa and XVIII, and F. prausnitzii. These new age probiotics expected to drive the market in the next few years with better clinical outcomes.
On the basis of the therapeutic area, the global market is categorized into autoimmune disorders, metabolic disorders, digestive and gastrointestinal disorders, dermatological disorders, dental disorders, infectious disease, oncology, and others. In 2019, gastrointestinal disorder segment accounted for the largest share. This high share is attributed to the high prevalence of C-difficile infections and intestinal bowel problems.
Infectious disease segment is anticipated to garner highest growth rate over the study period. The rising cases of microbial dysbiosis based infections with extensive use of antibiotics, and the rising clinical trials in microbiome based therapies are the major prominent factors driving the segment’s future growth.
On the basis of indication, the global market is categorized into acne vulgaris, clostridium difficile infection, atopic dermatitis, colorectal cancer, lactose intolerance, lung cancer, diabetes, inflammatory bowel disease (IBD), non-alcoholic steatohepatitis (NASH), obesity, and coeliac disease. In 2019, clostridium difficile infection segment garnered the largest share, owing to its increasing incidence with cross-reactions with antibiotics and the current life style and bad food habits.
Diabetes segment is projected to register the highest growth rate over the study time frame. The segment growth is attributed to positive clinical evidence towards the treatment of diabetes with live biotherapeutics, and the current pipeline of products to be launched. In June 2020, the U.S. based microbiome company introduced Pendulum Glucose Control. This is the medical probiotic expected to lower A1C levels and blood sugar rise. This oral medication is expected to manage 30 million U.S. people suffering with type 2 diabetes.
On the basis of approach, the global market is categorized into small molecule therapies, single strain whole bacteria, microbial consortia, genetically modified single strain bacteria, phage cocktail, and microbial ecosystems. In 2019, the small molecule therapies segment accounted for the largest share and projected to register the highest growth rate over the study time frame. The high share is attributed to its extensive use and number of drugs in the pipeline.
Geographically, the global human microbiome therapeutics market is bifurcated into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa (MEA). North America region is the largest revenue contributor followed by Europe and the Asia Pacific regions. In 2019, the North America region accounted for more than 45% of the global market. The factors responsible for the market growth include the presence of industry-academia collaboration, government funded microbiome projects, and the presence of dedicated microbiome based small start-ups.
In line with this, in November 2019, National Institute of Health (NIH) announced funding of more than USD 12 million to the researchers of Cleveland Clinic to ascertain the association between gut microbiota and onset of cardio-metabolic diseases metabolic pathways. The primary aim of the project is to identify microbiota pathways impacting thrombosis and atherosclerosis. Secondly, to determine the mode of action how microbial metabolites behave in the fat environment to induce any disease, and thirdly, deciphering different new microbial genes responsible for cardiac ailments.
Asia Pacific is projected to be fastest growing regional market over the study timeframe. The factors responsible for the market in this region are a sudden spike in the COVID-19 cases in Asian countries such as China, South Korea, Japan, India, and Australia. India and China are the countries with the highest population density, so the proportion of people suffering with target diseases is maximum.
In line with high income countries, the government of India (GOI) also announced funding of INR 150 crores for the microbiome project in the country, comprising all strata of Indian population from heavily meat eating state like Telangana to vegetarian population of Rajasthan. The objective of the human microbiome project is to have country based microbiome database, to determine impact of genetics, life style and diet on the microbial composition and its associated disease risks, and to ascertain impact of antibiotics usage on Indian human gut. This three-year project would be collaborative effort of All India Institute of Medical Sciences, National Centre for Microbial Resource (NCMR) including other state universities.
The global human microbiome therapeutics market is flooded with small and big players. Some of the key players operating in the market are Enterome Bioscience, Biotagenics, Seres Therapeutics, Oxidien Pharmaceuticals, LLC, BoobyBiome, 4D Pharma PLC, UBiome, Carbiotix, E.I. du Pont de Nemours and Company, Finch Therapeutics, GNUbiotics Sciences, ClearB Therapeutics, GoodBelly, GoodGut, Synlogic, Second Genome, 16S Technologies, 5QBD-Biotech, Vedanta Biosciences, Holobiome, Commense, Ferring Pharmaceuticals, Evelo Biosciences, CoreBiome, Igen Biolab Group, ViThera Pharmaceuticals, DermBiont, Hyggut, Embion Technologies, Lactobio, BiomX, Exeliom Biosciences, and LNC Therapeutics.