Market Size & Trends
The global live biotherapeutic products and microbe CDMO market size was estimated at USD 52.37 million in 2024 and is projected to grow at a CAGR of 38.5% from 2025 to 2030. The prime factor propelling market growth is the rising importance of the potential advantages of live biotherapeutic products and microbiome-based therapeutics in treating various diseases, including inflammatory bowel disease, cancer, and neurological disorders, among patients and healthcare providers.
Key Highlights
- The North American live biotherapeutic products and microbiome CDMO market accounted for the largest share of 76.84% in 2024 of the global live biotherapeutic products and microbiome market.
- The live biotherapeutic products and microbiome CDMO market in the U.S. held the largest share in 2024
- By application, the C. Difficile segment held a market share of 86.93% in 2024.
Furthermore, the live biotherapeutic products and microbiome-based therapeutics market expands due to the increasing prevalence of chronic diseases and the growing demand for personalized medicine. CDMOs specializing in these fields have the expertise and infrastructure to support the development and manufacturing of these complex therapies, which require specialized equipment and facilities. As a result, pharmaceutical and biotech companies can outsource their production to CDMOs, allowing them to focus on research and development. Moreover, a growing interest in LBPs and microbiomes as potential therapeutic agents leads to increased research and development activities in these areas. Such activity has resulted in a greater demand for CDMOs with expertise in these fields. Advances in sequencing technologies and bioinformatics have allowed for a more profound understanding of the microbiome and its role in health and disease. Such knowledge has enabled the development of more targeted and effective live biotherapeutic products and microbiome-based therapies.
Furthermore, regulatory bodies, such as the FDA, have recognized the potential of live biotherapeutic products and microbiomes and have guided the development and approval of these products. This has increased investor confidence and encouraged companies to invest in developing these products. Overall, the LBPs and microbiome CDMO market is expected to experience significant growth in the coming years due to these drivers and the increasing interest in these innovative therapies.
Report Coverage & Deliverables
The PDF report & online dashboard will help you understand
- Competitive benchmarking
- Historical data & forecasts
- Company revenue shares
- Regional opportunities
- Latest trends & dynamics
Opportunity Analysis
The live biotherapeutic products and microbiome CDMO market is projected to witness significant innovation, such as innovative microbiome science and personalized medicine, thereby accelerating market demand. The growing understanding of how the microbiome affects human health is increasing the need for tailored live microbial therapies, which in turn requires specialized and scalable manufacturing solutions. CDMOs that are skilled in advanced bioprocessing can help biotech companies effectively turn complicated microbial mixtures into safe, reliable, and compliant products. As rules change and clinical testing advances, CDMOs that provide flexible manufacturing systems along with strict quality checks will take advantage of new chances to create innovative treatments for long-term and immune-related health issues, helping to grow the market for microbiome-based therapies.
Technology Landscape
The technology landscape in the live biotherapeutic products and microbiome CDMO market includes modern methods for growing microbes, precise fermentation systems, and advanced ways to create products specifically for living organisms. Unlike traditional biologics, LBPs require special bioprocessing technologies that keep conditions very low in oxygen and use real-time monitoring tools to ensure the living products stay alive and effective during production. Additionally, companies are adapting innovations in lyophilization, encapsulation, and cryopreservation to enhance shelf stability and target delivery of live microbes. CDMOs are also using flexible cleanroom setups, automated systems for filling and finishing sterile products, and digital tools for quality management to address the specific needs of microbiome-based treatments regarding growth, tracking, and regulations.
Pricing Analysis
Pricing models in the live biotherapeutic products and microbiome CDMO market are changing to take into account the complicated, customized, and regulation-sensitive nature of making live microbes. Traditional pricing based on the number of batches or the amount produced often doesn't work well because developing live biotherapeutic products is very specialized and needs custom fermentation, careful handling of sensitive microbes, and processes that keep the products viable. As a result, CDMOs are increasingly adopting hybrid models that combine milestone-based pricing for early-stage development with premium service tiers for GMP manufacturing, stability testing, and long-term storage. Pricing is also influenced by the need for rapid scale-up, integration of quality-by-design (QbD) principles, and the incorporation of advanced analytics, making cost structures more value-driven and collaborative in nature.
Market Concentration & Characteristics
The live biotherapeutic products and microbiome CDMO market's growth stage is stable and expected to accelerate over the estimated period. The market is characterized by various factors, including technologies, regulatory considerations, globalization, and the outsourcing of product processes, which contribute to its advantages and specialized capabilities.
Live biotherapeutic products and microbiome CDMO innovations are continuously evolving to meet the industry’s demands due to the increased burden of infectious and rare diseases. Several advancements have shaped the live biotherapeutic products and microbiome CDMO market, enhancing drug development, manufacturing processes, and productivity.
Compliance with stringent regulatory requirements, particularly in the pharmaceutical industry, is critical. CDMOs in this market emphasize robust quality assurance practices and adherence to regulatory standards, thereby witnessing lucrative growth opportunities.
Live biotherapeutic products and microbiome CDMO players in the market leverage strategies such as collaborations, partnerships, and acquisitions to promote the reach of their offerings and increase their product capabilities globally.
Increasing R&D activities, a rising number of mergers & acquisitions, & a growing disease burden can influence market dynamics positively.
The local presence of several established pharmaceuticals, the rising burden of infectious and rare diseases, and the growing demand for CDMOs fuel market growth.
Application Insights
The C. Difficile segment held a market share of 86.93% in 2024. The market for live biotherapeutic products and microbiome segmentation includes applications such as C. Difficile, Crohn's disease, IBS, Diabetes, and Others. C. difficile is a bacterium found in the human gut microbiome and can cause severe diarrhea and colitis, particularly in people who have recently taken antibiotics.
Recently, there has been growing interest in using live biotherapeutic products to treat various diseases, including those related to the gut microbiome. Live biotherapeutic products are living organisms, such as bacteria or viruses, used to prevent or treat diseases. C. difficile is a potential LBP for treating C. difficile infections. As research into the human microbiome and the potential applications of LBPs continues to grow, the market will likely show more interest in using C. difficile and other organisms for therapeutic purposes.
Regional Insights
The North America live biotherapeutic products and microbiome CDMO market accounted for the largest share of 76.84% of the global live biotherapeutic products and microbiome market in 2024. The presence of key players and increasing investments in research and development activities in this region primarily drive the market. The growing demand for effective treatments for various diseases, such as C. difficile, Crohn's disease, and IBS, has also contributed to market growth in North America.
Moreover, the region has many established pharmaceutical and biotech companies with expertise in developing and commercializing biologic products, including live biotherapeutic products and microbiome-based therapies. Furthermore, the region has a well-established regulatory framework for biopharmaceuticals, which provides a stable environment for companies to develop and manufacture these products.
U.S. Live Biotherapeutic Products And Microbiome CDMO Market Trends
The live biotherapeutic products and microbiome CDMO market in the U.S. held the largest share in 2024, owing to the presence of several pharmaceutical and life sciences companies. Growing interest in clinical trials and the benefits of live biotherapeutics for rare diseases drives the development of new and novel drugs. Moreover, a well-established regulatory framework provides new opportunities for companies to develop and manufacture products with a wide range of applications and target populations with improved knowledge of microbiota's importance in health and disease.
Europe Live Biotherapeutic Products And Microbiome CDMO Market Trends
The market for live biotherapeutic products and microbiome CDMO in Europe is expected to grow a lot because there are many cases of CDI and established companies like 4D Pharma, Microbiotica, EnteroBiotix, Prokarium, and Eagle Genomics are already operating there. Moreover, increasing funding, acquisitions, and high R&D spending in European countries contribute to market growth. For instance, in April 2023, Seres Therapeutics, Inc. & Nestle Health Science announced the U.S. FDA approval for VOWST (fecal microbiota spores, live-brpk), known as SER-109.
The live biotherapeutic products and microbiome CDMO market in Germany held the largest share in 2024. The rapidly aging population, growing demand for biotherapeutics, and emerging chronic diseases have increased the pressure on pharmaceutical companies to innovate new drugs for patients. These factors have led pharmaceutical and biotechnology companies to shift their focus on R&D to produce niche live biotherapeutic products and microbiomes.
The UK live biotherapeutic products and microbiome CDMO market is anticipated to grow over the forecast period. The UK is one of the key countries in microbiome science and innovation in both the public and private sectors. The country has growing IMT and IMMP opportunities with unique clinical research and genomic and digital capabilities. Moreover, it is the key destination for microbiome investment and innovation.
Asia Pacific Live Biotherapeutic Products And Microbiome CDMO Market Trends
Asia Pacific is expected to grow at a CAGR of 44.82% during the forecast period. The market in the Asia Pacific has witnessed significant growth and promising developments in recent years. Some key factors contributing to this growth are the prevalence of IBD and Crohn's disease as well as rising R&D investment and funding. Moreover, growing outsourcing and an increasing number of clinical trials are among the major factors responsible for the fastest market growth in Asia Pacific.
Over the forecast period, we expect the live biotherapeutic products and microbiome CDMO market in China to grow due to its increasing growth potential. Global leadership in the industry has led companies to innovate niche products, such as live biotherapeutic products and microbiomes, with increasing collaboration, acquisitions, funding, and FDA approvals.
The Japan live biotherapeutic products and microbiome CDMO market held the largest share in 2024 due to a significant increase in the overall number of clinical trials on emerging live biotherapeutics and microbiomes. The government is undertaking steps to offer regulatory support and promote clinical trials in the country.
The live biotherapeutic products and microbiome CDMO market in India is anticipated to grow over the forecast period, owing to rapidly increasing private healthcare services and academic research, which have led to growing interest and rising awareness of live biotherapeutics. Moreover, rising infectious diseases, hospital-acquired infections, and the emerging IBD burden nationwide are driving the market demand.
Latin America Live Biotherapeutic Products And Microbiome CDMO Market Trends
The Latin America Live Biotherapeutic Products and microbiome CDMO market is gaining momentum due to increasing research interest in microbiome-based health solutions and growing demand for localized, GMP-compliant manufacturing infrastructure. As local biotech companies and universities work harder to understand how gut and skin bacteria can help with long-term health issues, metabolic problems, and antibiotic resistance, they need specialized CDMO partners more than ever.
Brazil's live biotherapeutic products and microbiome CDMO market is witnessing emerging trends driven by a maturing biotech ecosystem, increased government focus on innovation, and a rising demand for alternative therapies targeting chronic and lifestyle-related diseases. Local startups and research institutes are looking more and more into using local microbial strains for developing treatments, which is creating a demand for CDMOs that can work with these specific strains in strict anaerobic and GMP-compliant conditions.
Key Live Biotherapeutic Products And Microbiome CDMO Company Insights
The major players operating across the market focus on adopting inorganic growth strategic initiatives such as mergers, partnerships, acquisitions, etc. The prominent strategies that companies adopt include service launches, mergers and acquisitions or joint ventures, partnerships and agreements, expansions, and other initiatives aimed at increasing market presence and revenue while gaining a competitive edge to drive market growth.
Key Live Biotherapeutic Products And Microbiome CDMO Companies
The following are the leading companies in the live biotherapeutic products and microbiome CDMO market. These companies collectively hold the largest market share and dictate industry trends.
- Arrant Bio
- 4D Pharma
- Cerberus
- Biose Industrie
- Assembly Biosciences, Inc.
- Wacker Chemie AG
- Quay Pharmaceuticals
- NIZO
- Lonza
- Inpac Probiotics
Recent Developments
-
In February 2025, Assembly Biosciences, Inc. announced the positive Phase 1a results for ABI-1179. These results highlight Assembly Biosciences’ capabilities in advancing novel microbiome-derived therapeutics and reinforce the company’s strategic positioning within the live biotherapeutics market.
-
In February 2025, Cerbios-Pharma SA said it would grow its Lugano facility to produce Highly Potent Active Pharmaceutical Ingredients (HPAPIs), which include toxic materials used in antibody-drug conjugates (ADCs).
-
In March 2023, Cedars-Sinai established a new Human Microbiome Research Institute that supports investigators studying microbiomes, the diverse collection of fungi, bacteria, and viruses.
Live Biotherapeutic Products And Microbiome CDMO Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 78.05 million |
|
Revenue forecast in 2030 |
USD 397.49 million |
|
Growth rate |
CAGR of 38.5% from 2025 to 2030 |
|
Actual data |
2018-2024 |
|
Forecast period |
2025-2030 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2030 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Application, region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; Mexico; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; South Korea; Thailand; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
Arrant Bio; 4D Pharma; Cerbios; Biose Industrie; Assembly Bioscience Inc.; Wacker Chemie AG; Quay Pharmaceuticals; NIZO; Lonza; Inpac Probiotics. |
|
Customization scope |
We offer free report customization, equivalent to up to 8 analysts' working days, when you make a purchase. Changes or additions to the scope of the country, region, and segment are possible. |
|
Pricing and purchase options |
Avail yourself of customized purchase options to meet your exact research needs. Explore purchase options |
Global Live Biotherapeutic Products And Microbiome CDMO Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, MIR has segmented the global live biotherapeutic products and microbiome CDMO market report based on application and region
-
Application Outlook (Revenue, USD Million, 2018-2030)
-
C. Difficile
-
Crohn’s Disease
-
IBS
-
Diabetes
-
Others
-
-
Regional Outlook (Revenue, USD Million, 2018 - 2030)
-
North America
-
U.S.
-
Canada
-
Mexico
-
-
Europe
-
UK
-
Germany
-
France
-
Italy
-
Spain
-
Denmark
-
Sweden
-
Norway
-
-
Asia Pacific
-
Japan
-
China
-
India
-
Australia
-
South Korea
-
Thailand
-
-
Latin America
-
Brazil
-
Mexico
-
Argentina
-
-
Middle East and Africa (MEA)
-
South Africa
-
Saudi Arabia
-
UAE
-
Kuwait
-
-
Related Reports
FAQ'S
For a single, multi and corporate client license, the report will be available in PDF format. Sample report would be given you in excel format. For more questions please contact:
Within 24 to 48 hrs.
You can contact Sales team (sales@marketinsightsresearch.com) and they will direct you on email
You can order a report by selecting payment methods, which is bank wire or online payment through any Debit/Credit card, Razor pay or PayPal.
Discounts are available.
Hard Copy