Global Human Microbiome Manufacturing Service Market Size, Share, and COVID-19 Impact Analysis, By Type (Strain Development & Optimization, Fermentation & Downstream Processing, Formulation & Fill/Finish, and Others), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, and Others), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035.

Global Human Microbiome Manufacturing Service Market Insights Forecasts to 2035

• The Global Human Microbiome Manufacturing Service Market Size Was Estimated at USD 0.10 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 16.76% from 2025 to 2035
• The Worldwide Human Microbiome Manufacturing Service Market Size is Expected to Reach USD 0.55 Billion by 2035  
• Asia Pacific is expected to grow the fastest during the forecast period.

According to a research report published by Spherical Insights and Consulting, The Global Human Microbiome Manufacturing Service Market Size was valued at USD 0.10 Billion in 2024 and is Predicted to Grow to around USD 0.55 Billion by 2035 with a compound annual Growth rate (CAGR) of 16.76% from 2025 to 2035. Growing personalized medicine, biotherapeutic development, advanced fermentation technologies, regulatory support, increased research investments, pharmaceutical partnerships, and growing demand for microbiome-based therapeutics are some of the opportunities in the human microbiome manufacturing services market.

Market Overview

The human microbiome manufacturing service market refers to the specialized industry of contract manufacturing organizations (CMOs) and service providers that allow the large-scale production of probiotics, nutraceuticals, diagnostics, and therapeutics from microbiomes with GMP compliance. This ecosystem used microbial consortia from human-associated sites like skin, oral cavity, and gut for developing targeted therapies for metabolic disorders, inflammatory bowel disease, and immune system-enhancing treatments, among others. Metabolon, Inc. introduced an advanced human microbiome manufacturing service solution that integrates metagenomic sequencing, bioinformatics tools, and a specialized microbiome metabolite panel. In March 2025, the U.S. National Institute of Standards and Technology (NIST) introduced a standardized human gut microbiome reference material to aid in the quality assurance of the industry. The sector of the human microbiome manufacturing services is booming mainly because of the swift development of live biotherapeutic products (LBPs), increasing outsourcing of GMP-compliant microbiome production, along with heavy investments in next-generation microbial therapies.

Report Coverage

This research report categorizes the human microbiome manufacturing service market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the human microbiome manufacturing service market. Recent market developments and competitive strategies, such as expansion, product launch, development, partnership, merger, and acquisition, have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyzes their core competencies in each sub-segment of the human microbiome manufacturing service market. 

Driving Factors  

The market for human microbiome products is significantly driven by the expanding pipeline of live biotherapeutic products (LBPs). A number of interconnected scientific, therapeutic, and industrial variables are driving the growth of the human microbiome manufacturing services market. In order to expedite scale-up, guarantee regulatory compliance, and assist in the commercialization of next-generation microbiome-based treatments, service providers are also working with innovators. The requirement for production capabilities that adhere to Good Manufacturing Practice (GMP) has grown as clinical trials for live biotherapeutic items and medications generated from microbiomes have expanded.  

Restraining Factors  

Complex regulatory restrictions, high production costs, technical difficulties in microbial standardization, a lack of long-term clinical data, scaling limitations, and the demand for specialized infrastructure and knowledge are all factors restricting the human microbiome manufacturing services market. 

Market Segmentation      

The human microbiome manufacturing service market share is classified into type and end user.

The fermentation & downstream processingsegment accounted for the largest share in 2024 and is anticipated to grow at a significant CAGR during the forecast period.        

Based on the type, the human microbiome manufacturing service market is divided into strain development & optimization, fermentation & downstream processing, formulation & fill/finish, and others. Among these, the fermentation & downstream processingsegment accounted for the largest share in 2024 and is anticipated to grow at a significant CAGR during the forecast period. Its crucial importance in large-scale microbial cultivation, purification, and stabilization operations is seen in the fermentation and downstream processing market. The generation of premium microbial strains and metabolites necessary for probiotics, live biotherapeutic products, and other microbiome-based treatments is included in the fermentation and downstream processing section.

• The pharmaceutical & biotechnology companies segment accounted for the highest market revenue in 2024 and is anticipated to grow at a significant CAGR during the forecast period.     

Based on the end user, the human microbiome manufacturing service market is divided into pharmaceutical & biotechnology companies, academic & research institutes, and others. Among these, the pharmaceutical & biotechnology companies segment accounted for the highest market revenue in 2024 and is anticipated to grow at a significant CAGR during the forecast period. The firms' considerable research, development, and commercialization efforts in microbiome-based medicines and live biotherapeutic products are responsible for the pharmaceutical and biotechnology companies’ category. Additionally, the need for scalable, legally compliant manufacturing solutions has increased due to the growing focus on microbiome-driven therapies and precision medicine.   

Regional Segment Analysis of the Human Microbiome Manufacturing Service Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the human microbiome manufacturing service market over the predicted timeframe.       

North America is anticipated to hold the largest share of the human microbiome manufacturing service market over the predicted timeframe. Strong research and development capabilities, bolstered by substantial public and private investment in precision medicine and microbiome science, are advantageous to the North America region. Market leadership is further reinforced by a significant concentration of top pharmaceutical firms, contract manufacturing companies, and academic research institutions. The FDA's fast-track designations, which speed up GMP-compliant strain engineering and downstream processing by specialized contract development and manufacturing organizations (CDMOs), and significant R&D investments exceeding USD 500 million per year from organizations like the National Institutes of Health (NIH) are the sources of the leadership. The NIH's FY2021-2025 Strategic Plan extension, which emphasizes the integration of microbiome therapies into precision medicine, is one of the latest government initiatives.

Asia Pacific is expected to grow at a rapid CAGR in the human microbiome manufacturing service market during the forecast period. Growth is fueled by rising investments in pharmaceutical manufacturing, biotechnology research, and healthcare infrastructure in emerging nations. The region's governments are aggressively promoting innovation in the bio sciences through international partnerships, favorable regulations, and financial programs. The Asia-Pacific Microbiota Consortium's April 2025 policy statement on LBP development standards, which standardizes regulatory frameworks among member states, is one example of a government launch. The June 2025 probiotic line from BGI Group is highlighted by new advancements that use gut microbiome databases to provide customized treatments.  

Competitive Analysis:  

The report offers the appropriate analysis of the key organizations/companies involved within the human microbiome manufacturing service market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.   

List of Key Companies

• Charles River Laboratories
• Cerbios-Pharma SA
• Elise Biopharma
• Eurofins Scientific
• Evonik
• Lallemand Inc.
• List Biological Labs, Inc.
• Lonza
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs) 

Recent Development

• In September 2024, Lonza launched an expanded Human Microbiome Manufacturing Service in Germany, scaling microbial production for live biotherapeutic products, enhancing capacity to meet growing clinical- and commercial-scale microbiome and biologics manufacturing demand.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the human microbiome manufacturing service market based on the below-mentioned segments: 

Global Human Microbiome Manufacturing Service Market, By Type  

• Strain Development & Optimization
• Fermentation & Downstream Processing
• Formulation & Fill/Finish
• Others

Global Human Microbiome Manufacturing Service Market, By End User

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes
• Others

Global Human Microbiome Manufacturing Service Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa