세계의 생균 치료제 및 마이크로바이옴 CDMO 시장

Global Live Biotherapeutic Products and Microbiome CDMO Market to Reach US$627.7 Million by 2030

The global market for Live Biotherapeutic Products and Microbiome CDMO estimated at US$94.6 Million in the year 2024, is expected to reach US$627.7 Million by 2030, growing at a CAGR of 37.1% over the analysis period 2024-2030. C.difficle, one of the segments analyzed in the report, is expected to record a 37.7% CAGR and reach US$276.8 Million by the end of the analysis period. Growth in the Crohn's Disease segment is estimated at 37.6% CAGR over the analysis period.

The U.S. Market is Estimated at US$24.9 Million While China is Forecast to Grow at 35.1% CAGR

The Live Biotherapeutic Products and Microbiome CDMO market in the U.S. is estimated at US$24.9 Million in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$93.4 Million by the year 2030 trailing a CAGR of 35.1% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 33.9% and 32.1% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 25.8% CAGR.

Global Live Biotherapeutic Products and Microbiome CDMO Market - Key Trends & Drivers Summarized

Why Is the Market for Live Biotherapeutic Products and Microbiome CDMO Expanding Rapidly?

The increasing understanding of the human microbiome’s role in health and disease has fueled significant growth in live biotherapeutic products (LBPs) and microbiome contract development and manufacturing organizations (CDMOs). LBPs, which consist of living microorganisms offering therapeutic benefits, are gaining traction in treating gastrointestinal, metabolic, immunological, and neurological disorders. As microbiome research advances, pharmaceutical companies are heavily investing in LBP development, necessitating the support of specialized CDMOs to ensure regulatory compliance and scalable manufacturing. The shift toward precision medicine and the demand for personalized microbiome-based therapies are also driving the expansion of the sector. Additionally, regulatory agencies such as the FDA and EMA are providing clearer guidelines for LBPs, accelerating their commercialization. The growing prevalence of chronic diseases and the rise in antibiotic-resistant infections have further solidified the need for microbiome-based interventions. As awareness of microbiome-targeted treatments rises among consumers and healthcare providers, the LBP market is expected to witness exponential growth.

What Innovations Are Driving Growth in Live Biotherapeutics and Microbiome CDMO Services?

Technological advancements are significantly enhancing the development and scalability of live biotherapeutic products. One of the key breakthroughs is the application of artificial intelligence (AI) and machine learning in microbiome analysis, enabling researchers to identify beneficial bacterial strains more efficiently. Next-generation sequencing (NGS) and metagenomics are providing deeper insights into microbial diversity, allowing for the design of targeted LBP formulations. Innovations in fermentation technology and bioprocessing are improving large-scale production, ensuring consistent quality and viability of live microbial therapeutics. Freeze-drying and encapsulation techniques are also improving stability and shelf-life, addressing challenges associated with microbial viability. Additionally, microbiome CDMOs are integrating automated manufacturing systems and real-time quality control analytics to optimize production processes. The use of synthetic biology to engineer probiotics with enhanced functionalities is further expanding the potential applications of LBPs. With continued research and innovation, live biotherapeutic products are becoming safer, more effective, and commercially viable at scale.

How Are Consumer Trends and Industry Collaborations Shaping the Market?

The rising consumer demand for microbiome-based therapies and probiotic-driven health solutions is reshaping the live biotherapeutic products market. Consumers are increasingly prioritizing gut health and its connection to immunity, mental health, and metabolic balance, leading to heightened interest in microbiome-based interventions. Direct-to-consumer (DTC) microbiome solutions, such as personalized probiotic regimens and microbiome testing kits, are also gaining popularity, fueling market expansion. Industry collaborations between pharmaceutical companies, biotech firms, and CDMOs are accelerating research and development efforts, leading to faster commercialization of microbiome-based therapies. Regulatory agencies are streamlining approval processes for LBPs, facilitating quicker market entry and greater consumer access. Additionally, increased venture capital and private equity investments in microbiome research startups are providing funding for further innovations. As consumers continue to seek science-backed microbiome solutions, and industry stakeholders forge strategic partnerships, the live biotherapeutic products market is expected to experience sustained growth.

What Are the Key Growth Drivers Fueling the Live Biotherapeutic Products and Microbiome CDMO Market?

The growth in the live biotherapeutic products and microbiome CDMO market is driven by multiple factors, including the rising prevalence of chronic diseases, increasing investments in microbiome research, and evolving regulatory frameworks. One of the primary drivers is the expanding role of LBPs in addressing conditions such as inflammatory bowel disease (IBD), obesity, and metabolic disorders. The growing body of clinical evidence supporting the efficacy of microbiome-based interventions is prompting pharmaceutical companies to accelerate product development. The involvement of microbiome CDMOs is crucial in ensuring scalable, high-quality production of LBPs, enabling their broader adoption. Additionally, advancements in synthetic biology and bioengineering are optimizing microbial strain selection, enhancing therapeutic efficacy. The emergence of microbiome-based precision medicine is also contributing to market growth, as researchers develop targeted therapies based on individual microbiota compositions. Increasing consumer awareness of gut health, coupled with government initiatives to promote probiotic-based treatments, is further supporting the expansion of the market. With ongoing innovation and investment, the live biotherapeutic products and microbiome CDMO industry is poised for significant growth, transforming modern healthcare and therapeutic approaches.

SCOPE OF STUDY:

The report analyzes the Live Biotherapeutic Products and Microbiome CDMO market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:

Application (C.difficle, Crohn's Disease, IBS, Diabetes, Others)

Geographic Regions/Countries:

World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 36 Featured) -

• 4D Pharma plc
• Arrant Bio
• Assembly Biosciences, Inc.
• Bacthera
• Biose Industrie
• Cerbios-Pharma SA
• Freya Biosciences
• Genetic Analysis
• Genome & Company
• Inpac Probiotics
• Lallemand Health Solutions
• List Biological Laboratories, Inc.
• Lonza Group
• Microbiotica
• NIZO Food Research
• Quay Pharmaceuticals
• Rebiotix Inc. (A Ferring Company)
• Seres Therapeutics
• Siolta Therapeutics
• Wacker Biotech

AI INTEGRATIONS

We're transforming market and competitive intelligence with validated expert content and AI tools.

Instead of following the general norm of querying LLMs and Industry-specific SLMs, we built repositories of content curated from domain experts worldwide including video transcripts, blogs, search engines research, and massive amounts of enterprise, product/service, and market data.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by increasing the Cost of Goods Sold (COGS), reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

• 1. MARKET OVERVIEW
  • Influencer Market Insights
  • Tariff Impact on Global Supply Chain Patterns
  • Live Biotherapeutic Products and Microbiome CDMO - Global Key Competitors Percentage Market Share in 2025 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)
• 2. FOCUS ON SELECT PLAYERS
• 3. MARKET TRENDS & DRIVERS
  • Rising Clinical Validation of Microbiome-Based Therapies Throws the Spotlight on Live Biotherapeutic Product Development
  • Surge in Investment Across Microbiome Startups Drives Demand for End-to-End CDMO Services
  • OEM Focus on cGMP-Compliant Manufacturing of Anaerobic Organisms Strengthens Scale-Up Capabilities
  • Expansion of IND-Focused Microbial Therapeutics Spurs Growth in Clinical-Grade Microbiome CDMO Pipelines
  • Regulatory Recognition of Live Biotherapeutics as a Distinct Drug Class Propels CDMO Specialization
  • OEM Development of Freeze-Drying, Spray-Drying, and Encapsulation Technologies Enhances Strain Viability and Shelf Life
  • Growth in Fecal Microbiota Transplant (FMT) Alternatives Accelerates Innovation in Defined Microbial Consortia
  • OEM Emphasis on Controlled Fermentation and Cell Banking Enhances Batch Consistency and Regulatory Compliance
  • Rising Incidence of Chronic Inflammatory and GI Disorders Strengthens Demand for Live Microbial Drug Candidates
  • OEM Integration of Genomic and Metabolomic Tools in CDMO Workflows Enhances Product Characterization
  • Growth in Oncology and Immunotherapy Co-Therapies Drives Expansion of Microbiome-Based Adjuvant Therapies
  • OEM Investment in Targeted Delivery Mechanisms Expands Application in Non-GI Therapeutic Areas
  • Expansion of CDMO Services to Include Regulatory Filing and Stability Testing Strengthens Strategic Partnerships
  • OEM Collaboration With Academic Spin-Offs and Platform Companies Fuels Early-Stage Development Pipelines
  • Emerging Interest in Vaginal, Skin, and Nasal Microbiome Therapeutics Broadens CDMO Capabilities
  • Rising Demand for Personalized Microbial Therapeutics Supports N-of-1 and Modular GMP Production Models
  • OEM Emphasis on Cryopreservation and Room-Temperature Stability Drives Formulation Innovation
  • Growth in Companion Animal Microbiome Health Products Opens Veterinary CDMO Service Channels
  • Regulatory Alignment Across US and EU for Live Biotherapeutic Clinical Trials Encourages Global Development Programs
  • Focus on Process Development and Tech Transfer Efficiency Strengthens CDMO Differentiation
• 4. GLOBAL MARKET PERSPECTIVE
  • TABLE 1: World Live Biotherapeutic Products and Microbiome CDMO Market Analysis of Annual Sales in US$ for Years 2015 through 2030
  • TABLE 2: World Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 3: World 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets for Years 2025 & 2030
  • TABLE 4: World Recent Past, Current & Future Analysis for C.difficle by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 5: World 6-Year Perspective for C.difficle by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
  • TABLE 6: World Recent Past, Current & Future Analysis for Crohn's Disease by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 7: World 6-Year Perspective for Crohn's Disease by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
  • TABLE 8: World Recent Past, Current & Future Analysis for IBS by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 9: World 6-Year Perspective for IBS by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
  • TABLE 10: World Recent Past, Current & Future Analysis for Diabetes by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 11: World 6-Year Perspective for Diabetes by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
  • TABLE 12: World Recent Past, Current & Future Analysis for Others by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 13: World 6-Year Perspective for Others by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030

III. MARKET ANALYSIS

• UNITED STATES
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
  • TABLE 14: USA Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 15: USA 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• CANADA
  • TABLE 16: Canada Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 17: Canada 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• JAPAN
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
  • TABLE 18: Japan Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 19: Japan 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• CHINA
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
  • TABLE 20: China Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 21: China 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• EUROPE
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
  • TABLE 22: Europe Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
  • TABLE 23: Europe 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2025 & 2030
  • TABLE 24: Europe Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 25: Europe 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• FRANCE
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
  • TABLE 26: France Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 27: France 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• GERMANY
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
  • TABLE 28: Germany Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 29: Germany 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• ITALY
  • TABLE 30: Italy Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 31: Italy 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• UNITED KINGDOM
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
  • TABLE 32: UK Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 33: UK 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• REST OF EUROPE
  • TABLE 34: Rest of Europe Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 35: Rest of Europe 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• ASIA-PACIFIC
  • Live Biotherapeutic Products and Microbiome CDMO Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
  • TABLE 36: Asia-Pacific Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 37: Asia-Pacific 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030
• REST OF WORLD
  • TABLE 38: Rest of World Recent Past, Current & Future Analysis for Live Biotherapeutic Products and Microbiome CDMO by Application - C.difficle, Crohn's Disease, IBS, Diabetes and Others - Independent Analysis of Annual Sales in US$ for the Years 2024 through 2030 and % CAGR
  • TABLE 39: Rest of World 6-Year Perspective for Live Biotherapeutic Products and Microbiome CDMO by Application - Percentage Breakdown of Value Sales for C.difficle, Crohn's Disease, IBS, Diabetes and Others for the Years 2025 & 2030

IV. COMPETITION