Live Biotherapeutics Products and Microbe CDMO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (C.difficle, Crohns disease, IBS, Diabetes, Others), By Product (APIs, FDFs), By Type of Formulation (Solid Formulations, Oral Liquids, Injectables, Others), By Scale of Operation (Preclinical Scale Operations, Clinical Scale Operations, Commercial Scale Operations), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 33.22 Billion
CAGR (2026-2031)	37.71%
Fastest Growing Segment	Clinical Scale Operations
Largest Market	North America
Market Size (2031)	USD 226.56 Billion

Market Overview

The Global Live Biotherapeutics Products and Microbe CDMO Market will grow from USD 33.22 Billion in 2025 to USD 226.56 Billion by 2031 at a 37.71% CAGR. Live Biotherapeutic Products (LBPs) are medicinal treatments containing live microorganisms designed to prevent or cure disease, necessitating specialized Microbe Contract Development and Manufacturing Organizations (CDMOs) to manage the complex anaerobic fermentation and formulation processes. The market is propelled by a robust clinical pipeline and the increasing reliance of biopharmaceutical companies on external partners to overcome technical manufacturing hurdles without heavy capital investment. This growth is further catalyzed by significant public sector commitment to advancing the field. According to Human Microbiome Action, in 2025, the European Commission mobilized close to €100 million under Horizon Europe funding to support the development and deployment of microbiome-based solutions.

However, a major impediment to market expansion is the lack of harmonized global regulatory standards for these novel therapies. This regulatory uncertainty creates challenges in establishing standardized manufacturing protocols and quality control measures, which can delay the transition from clinical trials to commercial-scale production and ultimately slow the approval rate of new products.

Key Market Drivers

The rapid expansion of the global live biotherapeutic clinical pipeline serves as a primary engine for market growth, necessitating specialized CDMO partners capable of scaling complex anaerobic manufacturing processes. As therapeutic candidates progress from early-stage discovery to late-stage pivotal trials, the demand for high-quality, GMP-compliant clinical trial material surges, compelling developers to secure external manufacturing capacity. This pipeline maturation is exemplified by companies moving into advanced testing phases, which creates immediate revenue opportunities for service providers handling live bacterial strains. According to Vedanta Biosciences, May 2024, in the 'Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3 RESTORATiVE303 Study' announcement, the company initiated dosing for a global Phase 3 trial of its orally administered bacterial consortium candidate. Such advancements underscore the critical need for CDMOs to support the technical transition from pilot to commercial-scale production.

Increasing capital investment and funding for microbiome-based therapeutics further propels the sector, providing the financial liquidity required to construct specialized facilities and refine stability-enhancing formulation technologies. This influx of capital not only supports biotech innovation but also validates the commercial viability of the wider market, allowing companies to outsource manufacturing without incurring prohibitive infrastructure costs. According to EnteroBiotix, April 2024, in the 'EnteroBiotix Completes £27m Financing Round' press release, the company secured £27 million to advance its clinical pipeline and enhance its manufacturing capabilities. The eventual commercial success of such investments stimulates further market activity and strategic acquisitions. According to Seres Therapeutics, in 2024, the company completed the sale of its VOWST business assets to Nestlé Health Science for an upfront payment of $155 million, highlighting the substantial value realized upon achieving commercialization.

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Key Market Challenges

The lack of harmonized global regulatory standards represents a significant barrier to the expansion of the Global Live Biotherapeutics Products and Microbe CDMO Market. This regulatory fragmentation creates profound uncertainty for developers and contract manufacturers, who must navigate disparate compliance requirements across different jurisdictions. Because live biotherapeutic products involve complex biological organisms, the absence of a unified framework complicates the validation of manufacturing processes and analytical methods. Consequently, Contract Development and Manufacturing Organizations encounter difficulties in establishing standardized protocols, leading to increased operational costs and extended timelines for technology transfer and commercial scale-up.

This uncertain regulatory environment directly stifles the progression of the robust clinical pipeline into marketable therapies. Companies face heightened risk when transitioning from clinical trials to mass production, as inconsistent guidelines often necessitate expensive process re-engineering to meet varying regional criteria. The impact of these bottlenecks is evident in the struggle to convert innovation into approved, revenue-generating treatments. According to the Alliance for Regenerative Medicine, in 2025, the organization reported that approximately 75 percent of global revenue in the advanced therapy sector was generated by fewer than ten commercialized products. Without clear international alignment, this pattern of restricted commercial success risks stalling the broader development of microbiome-based solutions.

Key Market Trends

The expansion of integrated end-to-end one-stop-shop service models is reshaping the market as CDMOs consolidate capabilities to support the entire product lifecycle, from strain isolation to commercial fill-finish. This shift is driven by the need to streamline complex supply chains and mitigate the risks associated with transferring sensitive anaerobic biologicals between multiple vendors. By offering unified development and manufacturing solutions, service providers can accelerate timelines and ensure consistency for microbiome-based therapies. According to Biose Industrie, December 2024, in the 'Microbiome Wrapped 2024 – A Year in Review & What's Next' report, the company highlighted the scale of this integrated approach by reporting the manufacturing of over 600 bacterial strains and the delivery of 10 million finished products globally.

The rise of genetically engineered live biotherapeutics (eLBPs) is driving demand for highly specialized manufacturing technologies capable of handling modified organisms with precise therapeutic payloads. Unlike traditional consortia, these next-generation therapies require advanced genetic editing tools and containment protocols, pushing CDMOs to adopt novel processing techniques. This technical evolution allows for the direct modification of the microbiome to target specific disease pathways with unprecedented precision. According to Eligo Bioscience, July 2024, in the 'Eligo Publishes Landmark Study in Nature that Unlocks Genome Editing of Bacteria in the Gut' announcement, the company demonstrated a breakthrough capability to genetically modify bacteria with nearly 100% efficiency directly within the gut environment, validating the potential of these sophisticated modalities.

Segmental Insights

Clinical Scale Operations represents the fastest-growing segment within the Global Live Biotherapeutics Products and Microbe CDMO Market. This rapid expansion is driven by the maturation of the therapeutic pipeline, with a significant volume of candidates advancing from preclinical research into human clinical trials. The FDA’s Center for Biologics Evaluation and Research (CBER) has established clearer regulatory frameworks for Live Biotherapeutic Products, thereby facilitating Investigational New Drug applications. As a result, developers are increasingly outsourcing to contract organizations to secure the specialized, Good Manufacturing Practice compliant anaerobic production capacity necessary to support these critical clinical studies.

Regional Insights

North America maintains a dominant position in the global live biotherapeutics products and microbe CDMO market due to a high concentration of biopharmaceutical developers and extensive clinical trial activity. The region benefits from a mature pharmaceutical infrastructure and significant capital investment in microbiome research. A critical driver is the established regulatory framework provided by the US Food and Drug Administration, which offers specific guidelines for the development and manufacturing of live biotherapeutic products. This clarity encourages innovation and allows contract organizations to effectively expand their production capabilities to meet industry needs.

Recent Developments

• In June 2025, CJ Bioscience presented interim clinical data for its lead immune-oncology microbiome candidate, CJRB-101, at the American Society of Clinical Oncology Annual Meeting. The company shared results from a Phase 1/2 study evaluating the live biotherapeutic product in combination with an immune checkpoint inhibitor. The data demonstrated a favorable safety profile with no severe adverse events reported, overcoming common manufacturing and stability challenges often faced in the sector. Additionally, the presentation highlighted that the therapy successfully modulated the immune system by increasing the expression of genes related to T-cell activation.
• In January 2025, MaaT Pharma announced positive topline results from its pivotal Phase 3 ARES clinical trial evaluating MaaT013, a pooled allogeneic microbiome ecosystem therapy. The study, which treated patients with acute Graft-versus-Host Disease who were refractory to standard treatments, met its primary endpoint with a significant Gastrointestinal Overall Response Rate of 62% at Day 28. The data also highlighted a 12-month overall survival rate of 54% in the treated population. These breakthrough results positioned the therapy as a potential first-in-class microbiome treatment for this severe hemato-oncology indication.
• In January 2025, Vedanta Biosciences published detailed results from its Phase 2 study of VE303 in the journal Nature Medicine. The research demonstrated that the defined bacterial consortium candidate significantly reduced the recurrence of Clostridioides difficile infection compared to placebo. The study data confirmed that the therapeutic strains successfully colonized the gut in a dose-dependent manner, restoring a healthy microbial community and suppressing the pathogen. This publication validated the company's approach of using defined bacterial consortia to treat infectious diseases and supported the ongoing progression of its pivotal Phase 3 registrational trial.
• In September 2024, Seres Therapeutics completed the strategic sale of its VOWST business to Nestlé Health Science. The transaction provided the company with approximately $175 million in upfront capital, which was utilized to retire existing debt obligations and strengthen its financial position. Under the terms of the agreement, the developer committed to providing transition services and manufacturing support for the FDA-approved fecal microbiota spore formulation through 2025. This divestiture allowed the organization to streamline its operations and concentrate resources on advancing its pipeline of cultivated microbiome candidates for medically vulnerable patient populations.

Key Market Players

• Lonza Group Ltd.
• Catalent, Inc.
• Thermo Fisher Scientific Inc.
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Samsung Biologics Co., Ltd.
• Recipharm AB
• Eurofins Scientific SE
• AGC Biologics A/S
• Boehringer Ingelheim International GmbH
• Piramal Pharma Limited

By Application	By Product	By Type of Formulation	By Scale of Operation	By Region
C.difficle Crohns disease IBS Diabetes Others	APIs FDFs	Solid Formulations Oral Liquids Injectables Others	Preclinical Scale Operations Clinical Scale Operations Commercial Scale Operations	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Live Biotherapeutics Products and Microbe CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Live Biotherapeutics Products and Microbe CDMO Market, By Application:

• C.difficle
• Crohns disease
• IBS
• Diabetes
• Others

• Live Biotherapeutics Products and Microbe CDMO Market, By Product:

• APIs
• FDFs

• Live Biotherapeutics Products and Microbe CDMO Market, By Type of Formulation:

• Solid Formulations
• Oral Liquids
• Injectables
• Others

• Live Biotherapeutics Products and Microbe CDMO Market, By Scale of Operation:

• Preclinical Scale Operations
• Clinical Scale Operations
• Commercial Scale Operations

• Live Biotherapeutics Products and Microbe CDMO Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE