Live Biotherapeutics Products and Microbe CDMO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Live Biotherapeutics Products and Microbe CDMO Market is projected to surge from USD 33.22 Billion in 2025 to USD 226.56 Billion by 2031, expanding at a CAGR of 37.71%. Because Live Biotherapeutic Products (LBPs) utilize live microorganisms to treat or prevent diseases, they require specialized Contract Development and Manufacturing Organizations (CDMOs) equipped to handle intricate anaerobic fermentation and formulation tasks. Market acceleration is fueled by a strengthening clinical pipeline and the tendency of biopharmaceutical firms to utilize external partners to navigate manufacturing complexities without significant capital expenditure. Furthermore, public sector initiatives are actively promoting this sector; for instance, Human Microbiome Action noted in 2025 that the European Commission allocated nearly €100 million through Horizon Europe to foster development and deployment of microbiome-based solutions.

However, the absence of harmonized global regulatory standards serves as a significant obstacle to market progress. This regulatory ambiguity complicates the creation of standardized manufacturing protocols and quality control systems, which hinders the smooth transition from clinical trials to commercial-scale production. Ultimately, these uncertainties can decelerate the approval process for new products, limiting the speed at which novel therapies reach the market.

Market Drivers

A primary catalyst for market growth is the swift broadening of the global live biotherapeutic clinical pipeline, creating a critical need for CDMOs that can scale complex anaerobic manufacturing operations. As candidates advance from early discovery phases to late-stage pivotal trials, the requirement for high-quality, GMP-compliant clinical trial materials increases substantially, prompting developers to engage external manufacturing resources. This maturation is highlighted by companies entering advanced testing stages, such as Vedanta Biosciences, which announced in May 2024 that it had enrolled the first patient in its pivotal Phase 3 RESTORATiVE303 study for an orally administered bacterial consortium.

Additionally, rising capital investments and funding for microbiome-based therapies are driving the sector forward by providing necessary liquidity for building specialized facilities and improving stability-enhancing formulation technologies. This financial support not only fuels biotech innovation but also confirms the commercial viability of the market, enabling firms to outsource production without bearing prohibitive infrastructure costs. For example, EnteroBiotix announced in April 2024 that it had secured £27 million to further its clinical pipeline and manufacturing capabilities. Furthermore, commercial success drives strategic activity, as seen in 2024 when Seres Therapeutics sold its VOWST assets to Nestlé Health Science for an upfront payment of $155 million, highlighting the value realized upon commercialization.

Market Challenges

The lack of harmonized global regulatory standards constitutes a major hurdle for the Global Live Biotherapeutics Products and Microbe CDMO Market. This regulatory fragmentation fosters deep uncertainty for both developers and contract manufacturers, who are forced to manage differing compliance mandates across various regions. Since live biotherapeutic products rely on complex biological organisms, the lack of a unified framework makes validating manufacturing processes and analytical methods increasingly difficult, causing CDMOs to struggle with establishing standard protocols, which raises operational costs and prolongs timelines for technology transfer and scaling.

Consequently, this uncertain regulatory landscape hampers the movement of a robust clinical pipeline toward becoming marketable therapies. Companies encounter significant risks when scaling from clinical trials to mass production, as inconsistent guidelines often demand costly process re-engineering to satisfy divergent regional requirements. The severity of these bottlenecks is illustrated by the difficulty in transforming innovation into approved treatments; according to the Alliance for Regenerative Medicine in 2025, roughly 75 percent of global revenue in the advanced therapy sector came from fewer than ten commercialized products, highlighting how a lack of international alignment restricts broader commercial success.

Market Trends

The market is currently being reshaped by the proliferation of integrated end-to-end service models, where CDMOs consolidate their capabilities to manage the full product lifecycle, spanning from strain isolation to commercial fill-finish. This evolution is motivated by the necessity to simplify complex supply chains and minimize risks involved in transferring sensitive anaerobic biological materials between different vendors. By providing unified development and manufacturing services, providers can hasten timelines and ensure consistency; for instance, Biose Industrie noted in its December 2024 report that it had manufactured over 600 bacterial strains and delivered 10 million finished products worldwide, showcasing the scale of this integrated strategy.

Concurrently, the emergence of genetically engineered live biotherapeutics (eLBPs) is stimulating demand for highly specialized manufacturing technologies designed to manage modified organisms with specific therapeutic payloads. Unlike traditional consortia, these next-generation treatments necessitate advanced genetic editing tools and strict containment protocols, compelling CDMOs to implement novel processing techniques. This technical progression enables precise microbiome modification to target specific disease pathways, a potential validated by Eligo Bioscience in July 2024 when they announced a landmark study in Nature demonstrating the ability to genetically modify bacteria directly within the gut environment with near-perfect efficiency.

Key Players Profiled in the Live Biotherapeutics Products and Microbe CDMO Market

• 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

Report Scope

In this report, the Global Live Biotherapeutics Products and Microbe CDMO Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Live Biotherapeutics Products and Microbe CDMO Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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