Global Live Biotherapeutic Products and Microbiome CDMO Market Share Grows at a Staggering CAGR of 39.10%

Introduction

The global market for live biotherapeutic products and microbiome contract development and manufacturing organisations (CDMO) is undergoing swift expansion, propelled by heightened awareness of the therapeutic potential of microbiome-based interventions for chronic conditions such as inflammatory bowel disease, cancer, and neurological disorders. The market, dedicated to developing and producing live biotherapeutic products (LBPs), is driven by increasing investments in research and development.

Moreover, significant themes encompass progress in microbial engineering and AI-enhanced manufacturing, improving accuracy and scalability. Regulatory endorsement from organisations such as the FDA and the increasing incidence of C. difficile infections drive the demand for specialised Contract Development and Manufacturing Organisations (CDMOs). Collaborations between biopharmaceutical companies, Contract Development and Manufacturing Organisations, and a transition towards personalised treatment significantly enhance growth.

Market Dynamics

Increasing incidence of chronic illnesses and regulatory endorsement drive market growth

The increasing incidence of chronic diseases and favourable regulatory environments are primary catalysts for the live biotherapeutic products and microbiome CDMO industry. Conditions such as C. difficile infections, inflammatory bowel disease (IBD), and diabetes, with worldwide cases surpassing 1 billion, heighten the demand for microbiome-based therapeutics. The market expansion is propelled by these health issues.

• In August 2024, little capsules of gut microbiota, referred to as “crapsules,” are undergoing trials in NHS and private clinics in the UK to address serious conditions such as liver ailments, Parkinson’s disease, and malignancies. FMT is authorised in the UK for recurrent C. difficile, with ongoing research broadening its use, underscoring regulatory acknowledgement and a rising demand for microbiome medicines targeting chronic ailments.

Furthermore, regulatory clarity and increasing healthcare expenditures motivate biopharmaceutical companies to outsource to Contract Development and Manufacturing Organisations (CDMOs), improving scalability and fostering innovation in medicines for chronic and infectious diseases.

Advancement of personalised medicine and strategic alliances creates tremendous opportunities

The growing focus on personalised medicine presents a promising opportunity for the LBP and microbiome CDMO market. As treatments increasingly aim to match individual gut profiles and genetic data, microbiome-based therapies are gaining momentum. CDMOs are critical in helping biotech firms scale these personalised therapies, especially during clinical trials. Strategic collaborations are rising as companies seek partners to manage complex microbial production processes.

• For example, WuXi Biologics’ launch of a new microbial manufacturing facility in Chengdu with large-scale fermenters in 2025 highlights how infrastructure is expanding to support this trend.

Research institutions and government agencies also invest heavily in microbiome research, enhancing opportunities for CDMOs to offer precision manufacturing services. These partnerships not only accelerate innovation but also reduce time-to-market for new therapies.

Regional Analysis

North America leads the global LBP and microbiome CDMO market owing to a robust biotech ecosystem, substantial R&D investment, and well-defined regulatory frameworks. The U.S. FDA's articulated LBP approval requirements considerably facilitate the development-to-market process. Finch Therapeutics and Seres Therapeutics spearhead innovation in oncology and recurrent C. difficile infections. Significant financing from the NIH, in conjunction with partnerships with CDMOs like Bacthera, facilitates manufacturing scaling. Canada contributes via governmental innovation subsidies and facility expansions, particularly in neurological and gastrointestinal applications. The region enjoys regulatory clarity, access to cutting-edge technology, and a developed outsourcing culture, establishing it as a global leader in personalised microbiome-based medicines.

Key Highlights

• The global live biotherapeutic products and microbiome CDMO market size was valued at USD 55.19 million in 2024 and is projected to grow from USD 76.77 million in 2025 to USD 1,075.98 million in 2033, exhibiting a CAGR of 39.10% during the forecast period (2025–2033).
• By Component, the market is segmented into solutions. The solution segment, encompassing manufacturing equipment like fermenters, bioreactors, and analytical tools, dominates the market due to its critical role in scaling LBP production.
• By Type, the market is segmented into bacterial LBPs, viral LBPs, fungal LBPs, and others. Bacterial LBPs lead the type segment, holding an 80% share in 2024, due to their versatility in treating gastrointestinal disorders and infectious diseases.
• By Application, the market is segmented into gastrointestinal disorders, oncology, neurological disorders, infectious diseases, and others. The gastrointestinal disorders segment commands the largest market share, at 87.11% in 2024, driven by the high prevalence of C. difficile infections and IBD, affecting over 1 million patients annually in the U.S.
• Based on region, the global market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East, and Africa. North America dominates the global market.

Competitive Players

Lonza Group, WuXi Biologics, Thermo Fisher Scientific, Catalent, Bacthera, Seres Therapeutics, Ferring Pharmaceuticals, Exeliom Biosciences, 4D Pharma, Finch Therapeutics, Vedanta Biosciences, Chr. Hansen Holding, Recipharm, Evonik Industries, Biocon, and others.

Recent Developments

• In June 2025, WuXi Biologics launched a microbial manufacturing campus in Chengdu, China, featuring a 15,000L fermenter for LBP production. This facility supports gastrointestinal and oncology applications therapies, strengthening China’s position as a global CDMO hub and addressing Asia-Pacific’s growing demand.
• In November 2024, Lonza expanded its microbial manufacturing capacity in Cologne, Germany, to scale LBP production for oncology and neurological disorders. The upgrade incorporates AI-driven analytics, enhancing batch consistency and supporting therapies like Exeliom’s EXL01, aligning with Europe’s regulatory demands.

Segmentation

1. By Component
   1. Solution
   2. Services
2. By Type
   1. Bacterial LBPs
   2. Viral LBPs
   3. Fungal LBPs
   4. Others
3. By Application
   1. Gastrointestinal Disorders
   2. Oncology
   3. Neurological Disorders
   4. Infectious Diseases
   5. Others
4. By Region
   1. North America
   2. Europe
   3. Asia-Pacific
   4. Latin America
   5. The Middle East and Africa