Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges

SYDNEY--(BUSINESS WIRE)--As Live Biotherapeutic Products (LBPs) begin to transition from frontier science to clinical reality, Novotech, a leading global CRO and scientific advisory partner has published a new white paper examining the opportunities and challenges shaping this fast-evolving landscape of therapeutic class.

LBPs, which harness live microorganisms to restore or modulate human health, are being explored across a growing range of indications, from gastrointestinal and metabolic disorders to CNS and oncology. FDA approvals of Rebyota™ and Vowst™ have validated the category but for most biotech sponsors, the journey remains uncertain.

According to Novotech’s analysis, over 90% of LBP assets are still in early development stages, and nearly one-third of all trials from 2020 to 2025 have been withdrawn or suspended due to regulatory, manufacturing, or design complexities.

Highlights from the report include:

• A growing pipeline of preclinical and Phase I–II LBP candidates, with notable concentration in Alzheimer’s, IBD, diabetes, and NASH.
• Over 90 industry-sponsored trials launched since 2020, yet 32% have experienced discontinuation.
• North America and Europe leading in regulatory approvals and manufacturing activity, with rising interest from biotechs in Asia-Pacific.
• A projected CAGR of 38% for the LBP and microbiome CDMO market through 2030.

The global market for LBPs and microbiome contract development and manufacturing organizations (CDMOs) was valued at USD 31.84 million in 2023.

With growing investment in players like Vedanta Biosciences and MaaT Pharma, the LBP field is maturing but also becoming more competitive. Success will depend on smart trial design, global regulatory navigation, and efficient feasibility execution.

Drawing on deep therapeutic expertise in microbiome-related studies and gastrointestinal, metabolic, and immunologic indications, Novotech supports sponsors from early development through global trial delivery. With operations spanning Asia-Pacific, North America, and Europe, Novotech is uniquely positioned to help biotech and small to mid-size pharma companies translate LBP potential into clinical success.

Download the full white paper “Why Live Biotherapeutics Matter to Emerging Biotech” here.

For further information, please visit novotech-cro.com.

About Novotech Novotech-CRO.com

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase.

With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations.

Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide.

Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies.

Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results.

For more information or to speak to an expert team member visit www.Novotech-CRO.com