Dublin, June 12, 2023 (GLOBE NEWSWIRE) -- The "Human Microbiome Market Report 2023-2033" report has been added to ResearchAndMarkets.com's offering.
Overall world revenue will surpass US$224 million in 2023 with strong revenue growth through to 2032.
This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
Big Pharma Players Striving To Gain Market Entry Through Collaboration with Microbiome Players
There has been a growing interest from the big pharma players in microbiome research. Many of the big pharma players have been supporting the start-up microbiome players for their clinical drug candidate through funding and collaborations. For instance, in July 2022, Enterome a clinical stage microbiome company signed a strategic R&D collaboration with Nestle Health Science.
This license agreement primarily targeted food allergy and Inflammatory Bowel Disease (IBD) under this agreement Enterome will receive an upfront payment of €40 million (US$46.9 million) in cash and equity. In return, Nestle Health Science will be eligible to receive the royalties and sales milestone payments on commercialization of the drug candidates.
In February 2021, 4D Pharma Inc. has collaborated with Merck Co Ltd. and Pfizer for its oncology and vaccines to evaluate its MRx5018 in combination with BAVENCIO for treatment of locally advanced or metastatic urothelial carcinoma. Both Merck KGaA and Pfizer Inc. will co-develop and also commercialize it in collaboration.
Similarly, in January 2021, Vedanta Biosciences has received US$25 million investment fund from Pfizer as a part of breakthrough growth initiative. Vedanta will use these funds for Phase II study of VE202 indicated for treatment of Inflammatory Bowel Disease. In July 2021, Seres announced its collaboration with Nestle Health Science to co-commercialize SER-109 therapeutic drug for treatment of Clostridioides difficile infection (CDI) in U.S. and Canada.
In 2019, Seres had collaborated with AstraZeneca and received US$20 million as a financial support to conduct its research activity for immuno-oncology therapies. With more pharma players are entering this market, the overall market for human microbiome is expected to foresee a staggering growth during the forecast period.
Regulatory Approvals to Challenge Market Growth
The human microbiome has a huge potential in curing and treating diseases that have been difficult to treat through conventional methods. Moreover, the use of Live Biotherapeutic Products (LBPs) has been studied to be of great potential, however lack of defined regulatory approvals for human microbiomes is hampering the growth of this market.
There has not been any clearly defined segregation for LBPs and their use, especially when classifying prebiotics, probiotics, and pharmaceutical products. The U.S. FDA in 2010, first time presented draft guidance for microorganisms intended to prevent and treat diseases which got updated in 2016 to officially make a category for LBPs. Similarly, the European Pharmacopeia Commission issued a draft in 2019 with a mention of LBPs to comply with the legislation of biological medicinal products with additional specific guidelines for LBPs.
There has been a clear demand from the regulatory authorities regarding the benefits against the risks of LBPs. Conventional GMP practices emphasize the removal of microbes in the final product however, human microbiome products need to be in the final product. Hence, drafting new guidelines for regulatory approvals needs detailed documentation and justification as these products differ from non-therapeutic products.
Risk assessment through genomic profiling is crucial as the LBPs have the potential to transfer genes to other microbes or may metabolize other drugs or hormones in the body. To avoid this, in vitro and ex-vivo studies, and animal models studies are essential. Detailed documentation of the origin of the strain, isolation procedure, and cell banking is required. In addition, the difficulty in having consistent batches of LBPs is also a major GMP regulatory hurdle.
Market Dynamics
Market Driving Factors
- Wide Array of Therapeutic Applications to Boost Industry Growth
- Rise in Funding from Private Ventures and Government Institutes to Trigger Industry Growth
- Big Pharma Players Striving to Gain Market Entry Through Collaboration with Microbiome Players
- High Throughput Sequencing, Machine Learning (AI & Deep Learning) to Reinforce the Market Growth
- Microbiome Biomarker Discovery Supporting the Growth of Companion Diagnostics
Market Restraining Factors
- Regulatory Approvals to Challenge Market Growth
- Formulation and Translational Manufacturing Obstacles Restraining the Market Growth
- Lack of Clarity on Pricing and Reimbursement Likely to Hamper Market Growth
Market Opportunities
- Contract Research Manufacturing Services
- Nanotechnology to Support Microbiome Diagnostics
Leading companies and the potential for market growth
- 4D Pharma Plc.
- Axial Therapeutics
- BiomX
- Enterobiome
- Enterome
- Finch Therapeutics Group Inc.
- MaaT Pharma
- Rebiotix Inc.,( a Ferring Pharmaceutical Company)
- Second Genome
- Seres Therapeutics
- Synlogic
- Theriva Biologics (ex-Synthetic Biologics)
- Vedanta Biosciences Inc.
Segments Covered in the Report
By Therapeutics
- Gastrointestinal Disorders
- Infectious Diseases
- Metabolic Disorders
- Cancers
- Gut-Brain Axis
- Others
By Type
- Fecal Microbiota Transplant (FMT)
- Live Biotherapeutic Product (LBP)
- Prebiotics
- Post-Biotics
- Precision Antibiotics
By Product
- Prebiotics & Probiotics
- Medicinal Drugs
- Diagnostic Tests
- Skin Microbiome
By Technology
- Genomics
- 16SrRNA Amplicon Sequencing
- Shotgun Metagenomic Sequencing
- Longread Metagenomic Sequencing
- Proteomics
- Metabolomics
For more information about this report visit https://www.researchandmarkets.com/r/ta7kb1
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