Human Microbiome Market Size, Share & Trends

The human microbiome market is projected to reach USD 4,206.0 million by 2030 from USD 814.6 million in 2024. This market is projected to grow at a CAGR of 31.5% over the forecast period. The primary drivers behind the expansion of this industry are the technological advancement in microbiome sequencing, the collaborative efforts between the microbiome industry, organizations, and academia for microbiome research, and the increase in the number of startups and SMEs exploring the microbiome niche, and further opportunities such as the increase in demand for personalized medicine and the emergence of synbiotics may help drive the human microbiome market. However, complex regulatory policies and high investments to commercialize human microbiome products present a challenge to this industry. This is further amplified by the slow patient adoption rate and the complexity of the development of human microbiome-based therapy.

AI-driven technologies are revolutionizing microbiome-based therapies by enabling personalized healthcare by precisely analyzing individual microbiome data and its correlation with specific health conditions. Machine learning and deep learning techniques enhance the accuracy of disease diagnosis and treatment efficacy by managing complex datasets, which include host data, lifestyle factors, and genetic information, allowing for tailor-made medical interventions. This integration of AI in microbiome research has accelerated the development of customized treatments, revolutionizing the precision healthcare industry. This is exemplified by major investments in AI-driven microbiome therapeutics companies. For instance, Biomica (Israel), which utilizes a computational predictive biology platform (CPB), is composed of MicroBoost AI, ChemPass AI, and GeneRator AI, leveraging big data and AI to develop efficient human microbiome therapies.

Global Forecast for the Human Microbiome Market Through 2030

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Promising Opportunities in the Human Microbiome Market

Global Human Microbiome Market Dynamics

DRIVER: Increasing number of startups and SMEs

The human microbiome market is experiencing significant growth driven largely by startups and small to medium-sized enterprises (SMEs). As of August 2023, over 100 companies are actively engaged in developing 243 microbiome modulator candidates, with startups and biotech companies focusing on technological innovations. Improving funding opportunities encourages startups and SMEs to enter the human microbiome market. The industry growth is fueled by startups leveraging cutting-edge technologies to develop human microbiome therapeutics. For instance, BioMed Technology Holdings (China) is engaged in developing probiotics formulated to solve problems pertaining to allergies, detoxification, emotional stress, and weight loss. Beo Therapeutics AG (Switzerland) offers a microbiome pill that requires a small amount of human gut bacteria to treat hyperuricemia.

RESTRAINT: High investments for commercializing microbiome drugs

The high commercialization costs associated with human microbiome drugs present significant barriers to market growth. Developing live biotherapeutic products (LBPs), which are classified as biological products by the US FDA and intended for disease prevention, treatment, or cure, involves complex and costly processes. LBPs require meticulous sourcing, handling, and processing of microbiome components to meet good manufacturing practice (GMP) standards. This includes maintaining the viability of live organisms under specific conditions and ensuring batch consistency and potency through lyophilization and encapsulation. The initial investment in establishing a cGMP facility is substantial, further compounded by the need for anaerobic handling environments for many microbial candidates.

Despite significant R&D investments, success in commercializing microbiome-based therapies is not guaranteed. For instance, fecal microbiota transplant in rCDI by Finch Therapeutics, Inc. (US) was discontinued in its phase 3 trial for CP101. The complexity of microbiome-disease interactions, especially in non-gastrointestinal conditions, necessitates causal links and standardized data collection. AI and machine learning may help elucidate these interactions, but high failure rates and complexities drive up costs, posing significant challenges to the field.

OPPORTUNITY: Growing demand for personalized medicine

The growing demand for personalized medicine is driving the growth of the global human microbiome market. Personalized medicine involves customizing medical treatments for each patient, considering their unique genetic, environmental, and lifestyle factors. The human microbiome plays a critical role in many aspects of human health, and researchers are increasingly exploring the potential of the microbiome in personalized medicine. For instance, a study conducted by BMC Health Services Research and IC2PerMed consortium in May 2023 surveyed 47 experts across Europe and China and reported that big data and digital solutions, citizen and patient literacy, and translational research were majorly responsible for the demand for personalized medicine moreover, efforts such as standardization of practices and services are being implemented to apply personalized medicines strategies internationally.

Data collected from electronic health records, wearable devices, diagnostic tests, genomics, and microbiomics are major types for the development of personalized medicines. Data from microbiome diagnostic tests coupled with microbiome libraries are being utilized to develop personalized treatment options such as personalized probiotics and personalized microbiome drugs. For instance, Microbiome Bank Ltd. (UK) offers personalized FMT capsules. A survey conducted in March 2024 by Università Cattolica del Sacro Cuore and Amsterdam UMC's APH Research Institute revealed increasing awareness of personalized medicine, with 57.3% of 7,215 respondents knowledgeable about it. These studies and initiatives by academic institutes, organizations, and industry emphasize the rising demand for personalized medicine in the forecast period, providing an opportunity for the microbiome industry to capitalize on this trend.

CHALLENGES: Slow adoption of microbiome-based therapies

Despite the potential benefits of microbiome-based therapies, expected patient adoption rates have been slow. One of the primary reasons for the slow adoption of microbiome-based therapies is the lack of awareness and education among patients and healthcare providers. Several patients are unaware of the potential benefits of microbiome-based therapies, and healthcare providers may not be familiar with the latest developments in microbiome research. This can make it difficult for patients to access microbiome-based therapies and for healthcare providers to recommend them.

The cost of microbiome-based therapies can hinder their adoption by patients. However, the costs of these therapies are expected to decrease as the market matures and competition increases, the high cost of developing and producing microbiome-based therapies can make them unaffordable for many patients.

Global Analysis of the Human Microbiome Market Ecosystem

The human microbiome market ecosystem comprises raw material suppliers, microbiome product manufacturers, and end users such as hospitals and clinics, long-term care facilities, and specialized treatment facilities such as fecal microbiota transplant centers. Regulatory authorities and standardization bodies also play pivotal roles in influencing market trends, innovations, and the ethical use of genomic data.

The probiotics segment accounted for the largest share by product segment in the human microbiome market in 2023.

The market segmentation, by product, includes drugs, probiotics, prebiotics, and synbiotics. The probiotics segment had the largest share of the human microbiome market in 2023. Probiotics have proven effective as adjuvant therapy with antibiotics. The major adverse effects of antibiotics include dysbiosis. Prescribing probiotics with antibiotics has become a common clinical practice in many regions. A Factsheet for Health Professionals published by the National Institute for Health (NIH) advises health professionals across the US to prescribe probiotics as adjuvant therapy for diarrhea, inflammatory bowel syndrome, and obesity. According to the European Centre for Disease Prevention and Control (ECDC), antibiotics consumed across Europe were 17 doses per 1000 people daily. The rising consumption of antibiotics is expected to propel the probiotics industry. Another driver for this market is the continuous research that is propelling the field and exploring potential applications of probiotics. Advanced cultivation methods and enhanced complete genome sequencing have allowed for isolating and characterizing a new range of microbes from the human microbiome, which presents an opportunity to develop next-generation probiotics. Still, the prebiotics segment held the second-largest market share.

The gastrointestinal diseases segment accounted for the largest share by disease segment in the human microbiome market in 2023.

By disease, infectious diseases, gastrointestinal diseases, endocrine and metabolic disorders, and other diseases constitute the human microbiome market. The gastrointestinal diseases segment held the largest share of the human microbiome market in 2023. The gastrointestinal disease segment within the human microbiome market is propelled by increasing demand for personalized therapies and supported by regulatory approvals and a large clinical pipeline. The infectious diseases segment accounted for the second largest market share.

The live biotherapeutic products segment is expected to emerge as an attractive segment in the human microbiome market in 2023.

By type, bacterial Consortia transplantation (BCT)/ fecal microbiota transplantation (FMT), live biotherapeutic products, and others segment the human microbiome market. The section with the biggest proportion of the human microbiome market in 2023 is the live biotherapeutic products segment. This can be attributed to the rising research, infrastructure, growing demand, and need for effective and personalized treatment options. Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Guidance for Industry document by the US FDA provides detailed guidelines for the conduct of clinical trials surrounding LBPs, which has allowed the design of robust clinical trials for LBPs. Many CDMOs such as Wacker Chemie AG (Germany), Vermicon AG (Germany), ReciPharm AB (Sweden), and List Biological Laboratories (US) offer LBPs manufactured in cGMP-certified facilities based on proprietary platform technologies such as Wacker Chemie AG (Germany) offers LIBATEC Platform which is a specialized technology for developing LBPs. This rise in infrastructure is expected to drive growth in LBPs. However, bacterial consortia transplantation (BCT)/ fecal microbiota transplantation (FMT) accounted for the second largest market share. This can be attributed to growing approvals in FMT products such as REBYOTA by Ferring Pharmaceuticals (Switzerland), VOWST by Nestle S.A. (Switzerland), and BIOMICTRA by Biome Bank (Australia). The approvals exemplify the rising trust of regulatory bodies in these therapies. FMT and BCT products are also being offered as personalized treatment options by initiatives such as Microbiome Bank Ltd. (UK) and FMT Capsule G3 by Openbiome (US). These rising regulations and personalized treatment options are expected to drive the growth of the bacterial consortia transplantation (BCT)/ fecal microbiota transplantation (FMT) segment.

The hospitals and clinics segment accounted for the largest share by end-user segment in the human microbiome market in 2023.

By end users, hospitals and clinics, long-term care facilities, and other end users segment the Human Microbiome market. In 2023, the hospitals and clinics segment accounted for the largest share of the human microbiome market. Hospitals are settings where rigorous clinical protocols and regulatory standards are upheld, ensuring these treatments are administered in a controlled and sterile environment. This enhances the efficacy and safety of the therapies, making hospitals integral to their application in clinical practice.

The North American region accounted for the largest share of the human microbiome market in 2023.

The human microbiome market is segmented into six major regions, namely, North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. North America accounted for the largest market share in in 2023, while Europe became the second-largest market. The large share of North America can be attributed to factors such as the established research infrastructure, technological advancements, demand for precision medicine, supportive regulatory environment, robust biotechnology and healthcare industry, and availability of funding and investment. However, the Asia Pacific is estimated to be the fastest-growing region, primarily due to the increasing awareness of microbiome health, emerging healthcare and biotechnology industries, government support, and funding potential for personalized medicine.

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Key players in the human microbiome market are Seres Therapeutics, Ferring Pharmaceuticals (Switzerland), BiomeBank (Australia), Seed Health, Inc. (US), International Flavors & Fragrances Inc (US), Pendulum (US), BioHM Health Inc. (US), Actial Farmaceutica SRL (Italy), Optibiotix Health plc (UK), Resbiotic (US), Infinant Health Inc (US), Biogaia AB (Sweden), Exegi Pharma Llc (US), and Vedanta Biosciences Inc (US).

Scope of the Human Microbiome Market Study

This report categorizes the Human Microbiome market into the following segments:

By Product

• Drugs
• Probiotics
• Prebiotics
• Synbiotics

By Disease

• Infectious Diseases
• Gastrointestinal Diseases
• Endocrine and Metabolic Disorders
• Other Diseases

By Type

• Bacterial Consortia Transplantation (BCT)/ Fecal Microbiota Transplantation (FMT)
• Live Biotherapeutic Products
• Other Types

By End Users

• Hospitals and Clinics
• Long-Term Care Facilities
• Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific (RoAPAC)
• Latin America
• Brazil
• Rest of Latin America (RoLATAM)

• Middle East & Africa

• Middle East
  • GCC Countries
    • Saudi Arabia (KSA)
    • United Arab Emirates (UAE)
    • Rest of GCC Countries
  • Rest of Middle East (RoME)
• Africa

Latest Advances in the Human Microbiome Market

• In July 2024, Nestlé S.A. (Switzerland) obtained full ownership of VOWST (live-brpk), the oral microbiome therapy, from Seres Therapeutics, Inc. (US). Nestlé S.A. (Switzerland) has been the lead commercialization party for the product since its launch in June 2023 in the US. This transaction has allowed Nestlé S.A. (Switzerland) full control over the further development, commercialization, and manufacturing of VOWST in the US and worldwide.
• In December 2023, Ferring Pharmaceuticals (Switzerland) and PharmaBiome (Switzerland) announced a research & development collaboration to drive new microbiome-based biotherapeutics in gastroenterology. The deal provided Ferring with exclusive rights to develop, manufacture, and commercialize next-generation microbiome-based therapeutics within the field of gastroenterology.
• In November 2023, BiomeBank (Australia) announced the opening of its new GMP manufacturing facility designed to increase the global supply of approved donor-derived microbiome-based therapy and further develop its second-generation therapies.
• In January 2023, Seed Health, Inc. (US) and the Swiss Institute of Allergy and Asthma Research (SIAF) announced the launch of a new platform to develop the next generation of non-toxic, non-inflammatory, microbiome-safe home and personal care products.
• n April 2023, ExeGi Pharma LLC announced a partnership with TannerLAC, Inc. to distribute Visbiome in Mexico. Under the license agreement, Tanner will register, commercialize, and promote Visbiome initially in Mexico with plans to expand to other Latin American countries.

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