A new white paper from contract research organisation Novotech has outlined the opportunities and ongoing challenges facing sponsors of live biotherapeutic products (LBPs), as the field moves from scientific promise to clinical application.

LBPs, which use living microorganisms to help modulate or restore human health, are being studied in a widening range of diseases including inflammatory bowel disease, diabetes, NASH, Alzheimer’s and cancer. Although a small number of therapies have reached the market – including Rebyota and Vowst – the majority of assets remain in early-stage development.

According to Novotech, more than 90% of LBP candidates are still in preclinical or Phase I–II trials. Analysis of recent trial activity suggests that nearly one-third of LBP studies initiated between 2020 and 2025 were subsequently withdrawn or suspended, often due to regulatory, manufacturing, or design hurdles.

The white paper highlights:

• More than 90 industry-sponsored LBP trials launched since 2020

• A growing concentration of activity in Alzheimer’s, metabolic and inflammatory diseases

• 32% of trials experiencing discontinuation

• Market leadership in North America and Europe, with growing sponsor interest in Asia-Pacific

• A projected compound annual growth rate (CAGR) of 38% for the LBP and microbiome CDMO market through 2030

The global market for LBPs and microbiome contract development and manufacturing organisations was valued at around $32 million in 2023.

Industry investment continues to build around companies such as Vedanta Biosciences and MaaT Pharma. However, the field remains complex, and sponsors will need to carefully navigate regulatory demands, trial design, and manufacturing feasibility to bring their candidates forward successfully.

Novotech, which supports early development and clinical delivery for small to mid-size biotechs, says its experience in gastrointestinal, immunological, and metabolic indications can help address many of the practical constraints that continue to limit progress in the LBP field.