PUBLISHER: The Business Research Company | PRODUCT CODE: 2106442
PUBLISHER: The Business Research Company | PRODUCT CODE: 2106442
Live biotherapeutics are pharmaceutical biological products composed of living microorganisms, including bacteria and yeasts, that are intended to prevent, manage, or treat human diseases. These therapies exert their effects by interacting with the body's microbiome or physiological processes to deliver therapeutic benefits and are manufactured under stringent pharmaceutical standards to ensure their safety, effectiveness, and quality.
The primary product types of live biotherapeutics include single-strain live biotherapeutics, multi-strain live biotherapeutics, genetically engineered live biotherapeutics, fecal microbiota-based therapeutics, and bacterial consortia therapeutics. Single-strain live biotherapeutics refer to therapeutic products containing a single live microorganism strain intended to prevent, manage, or treat specific diseases. These products are developed using microorganism types including bacteria-based therapeutics, yeast-based therapeutics, viral or bacteriophage-based therapeutics, and mixed microbial therapeutics, and are administered through oral, rectal, and other routes of administration. They are distributed through hospital pharmacies, retail pharmacies, and online pharmacies, and the key applications include gastrointestinal disorders, infectious diseases, oncology supportive care, metabolic disorders, autoimmune and inflammatory diseases, neurological disorders, dermatological conditions, and respiratory disorders.
Tariffs are influencing the live biotherapeutics market by increasing the cost of imported fermentation systems, bioprocessing equipment, and temperature-controlled logistics components required for manufacturing and distribution. This is creating supply chain bottlenecks and raising production costs, particularly affecting fecal microbiota-based therapies and genetically engineered live biotherapeutics that rely on specialized infrastructure. Regions such as North America and Europe, which depend on Asia-Pacific manufacturing hubs for key raw materials and equipment, are experiencing slower commercialization and delayed scaling of advanced therapies. However, tariffs are also encouraging domestic production capabilities, regional supply chain diversification, and increased investment in localized biomanufacturing ecosystems, which may strengthen long-term resilience and reduce dependency on global suppliers.
The live biotherapeutics market size has grown rapidly in recent years. It will grow from $92.31 billion in 2025 to $105.62 billion in 2026 at a compound annual growth rate (CAGR) of 14.4%. The growth in the historic period can be attributed to increasing prevalence of gastrointestinal and metabolic disorders, rising utilization of probiotics in clinical nutrition practices, early expansion of microbiome research initiatives, growing awareness of gut health benefits among consumers, and limited availability of targeted biological treatment options.
The live biotherapeutics market size is expected to see rapid growth in the next few years. It will grow to $182.52 billion in 2030 at a compound annual growth rate (CAGR) of 14.7%. The growth in the forecast period is driven by rapid progress in precision microbiome engineering technologies, rising regulatory approvals for live biotherapeutic products, increasing investments in microbiome-focused drug development pipelines, broader adoption of personalized medicine approaches, and growing demand for targeted therapies that avoid antibiotic use. Key trends in the forecast period include greater integration of microbiome-based treatments into hospital protocols, rising adoption of patient-specific microbiome modulation therapies, increasing regulatory standardization and harmonization for live biotherapeutic products, expansion of clinical trials focused on next-generation engineered microbial therapies, and growing demand for non-antibiotic therapeutic alternatives in chronic disease treatment.
The rising prevalence of gastrointestinal disorders and inflammatory bowel diseases (IBD) is expected to propel the growth of the live biotherapeutics market going forward. Gastrointestinal disorders and inflammatory bowel diseases are chronic digestive system conditions that cause inflammation, immune dysfunction, abdominal pain, diarrhea, and damage to the gastrointestinal tract. The increasing prevalence of gastrointestinal disorders and inflammatory bowel diseases is primarily driven by unhealthy dietary habits and increased consumption of processed foods, which disrupt gut microbiota and contribute to chronic intestinal inflammation. Live biotherapeutics assist in the management of gastrointestinal diseases by restoring microbial balance, improving gut health, reducing intestinal inflammation, and offering targeted microbiome-based therapeutic solutions for chronic digestive disorders. For instance, in February 2025, according to Crohn's & Colitis Australia, an Australia-based national organization, the projected prevalence of inflammatory bowel disease (IBD) in Australia is expected to increase from 20,511,881 cases in 2023 to 23,067,771 cases by 2030. Therefore, the rising prevalence of gastrointestinal disorders and inflammatory bowel diseases is driving the growth of the live biotherapeutics market.
Leading companies operating in the live biotherapeutics market are focusing on developing advanced solutions, such as integrated multi-omics microbiome platforms, to enhance microbiome research, improve therapeutic discovery, and accelerate the development of next-generation live biotherapeutic products. Integrated multi-omics microbiome platforms refer to advanced scientific systems that combine microbiome, metabolomics, bioinformatics, and AI-driven analytics to generate comprehensive biological insights for therapeutic development. For example, in November 2024, Cmbio, a Denmark-based microbiome and metabolomics science company, launched a unified global brand integrating Clinical Microbiomics, CosmosID, MS-Omics, DNASense, and Microba's Research Services Unit under one platform. The new platform combines GxP-certified laboratory services, AI-powered bioinformatics, and scalable multi-omics technologies to support microbiome innovation across pharmaceutical, biotechnology, and healthcare sectors, enabling faster and more standardized microbiome-based therapeutic research and development.
In October 2023, Kanvas Biosciences, a US-based microbiome therapeutics company, acquired key assets from Federation Bio for an undisclosed amount. This acquisition enhances Kanvas Biosciences' capabilities in developing and manufacturing microbiome-based therapeutics and live biotherapeutic products by expanding its bioprocessing infrastructure and strengthening its microbiome platform technologies. Federation Bio is a US-based company specializing in the development of microbiome therapeutics and live biotherapeutic products.
Major companies operating in the live biotherapeutics market are Ferring Pharmaceuticals SA, Rebiotix Inc., Seres Therapeutics Inc., MaaT Pharma SA, Vedanta Biosciences Inc., Infant Bacterial Therapeutics AB, EnteroBiotix Limited, AOB Pharma Inc., BiomX Inc., Microbiotica Limited, Azitra Inc., MRM Health NV, BiomeBank Pty Ltd, Siolta Therapeutics Inc., Servatus Biopharmaceuticals Pty Ltd, Scioto Biosciences Inc.
North America was the dominant region in the live biotherapeutics market in 2025. Asia-Pacific is expected to be the rapidly expanding region in the forecast period. The regions covered in live biotherapeutics report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the live biotherapeutics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The live biotherapeutics market consists of sales of spore-forming microbial therapeutics, yeast-derived live biotherapeutics, probiotic therapeutics, microbiome restoration therapies, and synthetic microbial therapeutics. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
The live biotherapeutics market research report is one of a series of new reports from The Business Research Company that provides live biotherapeutics market statistics, including live biotherapeutics industry global market size, regional shares, competitors with a live biotherapeutics market share, detailed live biotherapeutics market segments, market trends and opportunities, and any further data you may need to thrive in the live biotherapeutics industry. This live biotherapeutics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Live Biotherapeutics Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses live biotherapeutics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for live biotherapeutics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The live biotherapeutics market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
Added Benefits available all on all list-price licence purchases, to be claimed at time of purchase. Customisations within report scope and limited to 20% of content and consultant support time limited to 8 hours.