India, Jan 02, 2026 - Quintile Reports, a leading provider of strategic healthcare market intelligence, has unveiled its latest research report on the Innovations Boost Live Biotherapeutic & Microbiome CDMO Market.The study highlights the rapid evolution of microbiome-based therapeutics and the expanding role of CDMOs in supporting advanced drug development and commercialization globally.
The report examines how live biotherapeutic products, including next-generation probiotics and microbiome-derived treatments, are emerging as a transformative approach in managing chronic diseases, gastrointestinal disorders, and immune-related conditions. It outlines how CDMOs are playing a critical role in offering specialized development capabilities, large-scale GMP manufacturing, formulation optimization, and regulatory support for these innovative therapies.
The global live biotherapeutic products and microbiome contract development and manufacturing organization (CDMO) market is projected to grow at a compound annual growth rate (CAGR) of 38.66% between 2025 and 2035. Key growth drivers include rising incidence of chronic diseases linked to gut microbial imbalance, increasing investments by pharma and biotech companies in microbiome-based drug development, streamlined regulatory pathways accelerating clinical progress, growing private funding and collaborations between large pharma and microbiome startups, and rising demand for targeted live biotherapeutic products offering localized treatment with fewer side effects.
Market Size: The global live biotherapeutic products and microbiome contract development and manufacturing organization market was valued at USD 78.05 million in 2025 and is expected to reach USD 2050.55 million by 2035.
Regional Insights: North America dominates the market with advanced CDMO infrastructure, a strong base of microbiome-focused biotech companies, and supportive regulatory guidance, fostering robust development and manufacturing capabilities. Europe is steadily progressing, supported by early-stage regulatory frameworks and coordinated investments in microbiome innovation, clinical trial networks, and biopharmaceutical research clusters across leading countries.
Product: Live biotherapeutic products (LBPs), microbiome therapeutics, probiotics, prebiotics, synbiotics, and microbiome-derived small molecules developed for therapeutic and preventive healthcare applications.
Service: Process development, analytical development, manufacturing services, formulation development, packaging and labeling, regulatory support, and stability testing services provided to support microbiome-based product development and commercialization.
Therapeutic Area: Gastrointestinal disorders, infectious diseases, oncology, immunology, metabolic disorders, neurological disorders, and other therapeutic areas where microbiome-based interventions are applied.
Microbiome Type: Gut microbiome, skin microbiome, oral microbiome, vaginal microbiome, respiratory microbiome, and other microbiome types targeted for research and therapeutic solutions.
End User: Pharmaceutical and biopharmaceutical companies, research institutes, contract manufacturing organizations (CMOs), and other entities involved in the development and production of live biotherapeutic and microbiome-based products.
The report provides a detailed competitive analysis, profiling leading players such as Lonza Group,Recipharm,AGC Biologics,Abzena.These companies are expanding their microbiome development platforms, investing in high-capacity manufacturing facilities, and forging strategic partnerships with drug developers to advance clinical programs.
Recent developments include Gilead Sciences entering a long-term collaboration with Assembly Biosciences to advance research and development of antiviral therapeutics, initially targeting herpesviruses, hepatitis B, and hepatitis D, and AGC Biologics preparing commercial-scale lentiviral vector manufacturing in Milan for Adaptimmune’s Lete-Cel cell therapy aimed at treating solid tumor cancers.
Although the live biotherapeutic products and microbiome contract development and manufacturing organization (CDMO) sector is experiencing strong growth prospects, it continues to encounter multiple challenges. Challenges include complex manufacturing requirements for live organisms, stringent regulatory frameworks, and high costs associated with maintaining microbial viability throughout production and distribution. Limited global standardization for microbiome drug development present additional barriers for rapid market adoption.
The outlook for the live biotherapeutic products and microbiome CDMO market remains highly positive, supported by scientific advancements and growing pharmaceutical interest in microbiome-based drug modalities. Quintile Reports recommends that stakeholders invest in scalable, GMP-compliant manufacturing capabilities, enhance formulation and delivery technologies, and pursue strategic alliances to accelerate clinical-to-commercial transitions.
Opportunities lie in developing region-specific CDMO services to cater to rising demand in emerging biotech hubs, leveraging multi-omics and AI-driven analytics for strain selection and efficacy prediction, and advancing precision microbiome therapies tailored to patient-specific needs. Companies that effectively integrate innovation with regulatory excellence and robust supply chain solutions are expected to achieve long-term leadership in this evolving sector.
Quintile Reports, a part of Quintile Group, is a global market intelligence firm delivering actionable insights across industries including MedTech, Pharmaceuticals, Biotechnology, Consumer Goods, Automotive, Agriculture, Aerospace & Defense, Semiconductors, Energy & Power and Financial Services. With expert analysts and a presence across the U.S., UK, and APAC, we help businesses navigate market complexities, identify growth opportunities, and make informed decisions. At Quintile Reports, we turn data into strategy—fueling innovation through trusted research and secure, in-depth analysis.
Sarah Singh (Chief Strategic Marketing)
Quintile Reports
Email: sales@quintilereports.com
India, Jan 02, 2026 - Quintile Reports, a leading provider of strategic healthcare market intelligence, has unveiled its latest research report on the Innovations Boost Live Biotherapeutic & Microbiome CDMO Market.The study highlights the rapid evolution of microbiome-based therapeutics and the expanding role of CDMOs in supporting advanced drug development and commercialization globally.
The report examines how live biotherapeutic products, including next-generation probiotics and microbiome-derived treatments, are emerging as a transformative approach in managing chronic diseases, gastrointestinal disorders, and immune-related conditions. It outlines how CDMOs are playing a critical role in offering specialized development capabilities, large-scale GMP manufacturing, formulation optimization, and regulatory support for these innovative therapies.
The global live biotherapeutic products and microbiome contract development and manufacturing organization (CDMO) market is projected to grow at a compound annual growth rate (CAGR) of 38.66% between 2025 and 2035. Key growth drivers include rising incidence of chronic diseases linked to gut microbial imbalance, increasing investments by pharma and biotech companies in microbiome-based drug development, streamlined regulatory pathways accelerating clinical progress, growing private funding and collaborations between large pharma and microbiome startups, and rising demand for targeted live biotherapeutic products offering localized treatment with fewer side effects.
Market Size: The global live biotherapeutic products and microbiome contract development and manufacturing organization market was valued at USD 78.05 million in 2025 and is expected to reach USD 2050.55 million by 2035.
Regional Insights: North America dominates the market with advanced CDMO infrastructure, a strong base of microbiome-focused biotech companies, and supportive regulatory guidance, fostering robust development and manufacturing capabilities. Europe is steadily progressing, supported by early-stage regulatory frameworks and coordinated investments in microbiome innovation, clinical trial networks, and biopharmaceutical research clusters across leading countries.
Product: Live biotherapeutic products (LBPs), microbiome therapeutics, probiotics, prebiotics, synbiotics, and microbiome-derived small molecules developed for therapeutic and preventive healthcare applications.
Service: Process development, analytical development, manufacturing services, formulation development, packaging and labeling, regulatory support, and stability testing services provided to support microbiome-based product development and commercialization.
Therapeutic Area: Gastrointestinal disorders, infectious diseases, oncology, immunology, metabolic disorders, neurological disorders, and other therapeutic areas where microbiome-based interventions are applied.
Microbiome Type: Gut microbiome, skin microbiome, oral microbiome, vaginal microbiome, respiratory microbiome, and other microbiome types targeted for research and therapeutic solutions.
End User: Pharmaceutical and biopharmaceutical companies, research institutes, contract manufacturing organizations (CMOs), and other entities involved in the development and production of live biotherapeutic and microbiome-based products.
The report provides a detailed competitive analysis, profiling leading players such as Lonza Group,Recipharm,AGC Biologics,Abzena.These companies are expanding their microbiome development platforms, investing in high-capacity manufacturing facilities, and forging strategic partnerships with drug developers to advance clinical programs.
Recent developments include Gilead Sciences entering a long-term collaboration with Assembly Biosciences to advance research and development of antiviral therapeutics, initially targeting herpesviruses, hepatitis B, and hepatitis D, and AGC Biologics preparing commercial-scale lentiviral vector manufacturing in Milan for Adaptimmune’s Lete-Cel cell therapy aimed at treating solid tumor cancers.
Although the live biotherapeutic products and microbiome contract development and manufacturing organization (CDMO) sector is experiencing strong growth prospects, it continues to encounter multiple challenges. Challenges include complex manufacturing requirements for live organisms, stringent regulatory frameworks, and high costs associated with maintaining microbial viability throughout production and distribution. Limited global standardization for microbiome drug development present additional barriers for rapid market adoption.
The outlook for the live biotherapeutic products and microbiome CDMO market remains highly positive, supported by scientific advancements and growing pharmaceutical interest in microbiome-based drug modalities. Quintile Reports recommends that stakeholders invest in scalable, GMP-compliant manufacturing capabilities, enhance formulation and delivery technologies, and pursue strategic alliances to accelerate clinical-to-commercial transitions.
Opportunities lie in developing region-specific CDMO services to cater to rising demand in emerging biotech hubs, leveraging multi-omics and AI-driven analytics for strain selection and efficacy prediction, and advancing precision microbiome therapies tailored to patient-specific needs. Companies that effectively integrate innovation with regulatory excellence and robust supply chain solutions are expected to achieve long-term leadership in this evolving sector.
Quintile Reports, a part of Quintile Group, is a global market intelligence firm delivering actionable insights across industries including MedTech, Pharmaceuticals, Biotechnology, Consumer Goods, Automotive, Agriculture, Aerospace & Defense, Semiconductors, Energy & Power and Financial Services. With expert analysts and a presence across the U.S., UK, and APAC, we help businesses navigate market complexities, identify growth opportunities, and make informed decisions. At Quintile Reports, we turn data into strategy—fueling innovation through trusted research and secure, in-depth analysis.
Sarah Singh (Chief Strategic Marketing)
Quintile Reports
Email: sales@quintilereports.com
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