Contract biotech API manufacturing services market will grow by 6% in 2013

Wednesday 5 February 2014, Amsterdam

A new report forecasts the world market for outsourced biological active pharma ingredients (APIs) manufacturing will grow by 6% in 2013. High single-digit growth is forecasted for that global market through the period 2014-2024. That prediction and others appear in Biotech API Manufacturing Services: World Industry and Market 2014-2024, published in January 2014.

That analysis finds the mammalian cell culture submarket accounted for the largest proportion of biotech contract manufacturing organisation (CMO) revenues in 2012. That commercial sector will grow with a CAGR of more than 7.5% between 2012 and 2024. Demand will be strong from developers of novel monoclonal antibodies (mAbs), as well as those developing next-generation antibody therapies, including antibody-drug conjugates (ADCs). Demand for microbial fermentation production services will expand more slowly to 2024, with slimmer R&D pipelines for drugs produced from these expression systems. Other avenues will be explored by biotechs and CMOs towards the end of the decade, including plant-based processes. But other expression systems will account for just 1% of CMO revenues in 2024.

Richard Lang, a pharmaceutical industry analyst, said: “Increased development of new biologics by small biotechs will drive outsourcing of biopharmaceutical API manufacturing in this decade. CMOs already derive a significant proportion of revenues from clinical-stage projects, we believe. With increased funding becoming available for start-ups in the near future, the number of programmes advanced towards the clinic will rise fast.

“The growing market for biosimilars will also drive rises in demand for biomanufacturing services in this decade. Companies with drugs facing biosimilar competition may look to outsource manufacturing to lower drug costs, as well as freeing up internal capacity for novel biologics in development. Emerging-market biosimilar developers will look to developed-national-market CMOs to provide GMP manufacturing required for US and European medical approvals.

“Also single-use technologies will provide improved profit margins for CMOs, by providing lower-cost and more-flexible manufacturing. Single-use bioreactors (SUBs) for mammalian cell culture will offer cost reductions of up to 60% over traditional stainless steel systems. Increased development of orphan drugs and personalised medicines will lead to demand for lower manufacturing volumes, helping to overcome the scalability challenge encountered by CMOs in the past 10 years.”