Biotechs are increasingly driving innovation in research and development. However, this innovation requires specialist support, and it is important to choose the right outsourcing partner to overcome challenges around data, infrastructure and expertise. In this article, Stephen Corson, Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar, explores the outsourcing challenges facing biotechs, considers opportunities for effective collaboration and shares four tips for partner selection.
A rapidly changing clinical trial landscape is driving a shift in the balance of research and development (R&D). Large pharma companies’ share of the clinical trial pipeline decreased from 40% to 20% from 2011 to 2021.1 Meanwhile, the global biotech market size is expected to reach USD 5.68 trillion by 2033, growing at a compound annual growth (CAGR) of 13.95%.2 Key areas driving growth are likely to include nanobiotechnology, biosimilars and precision medicine.
This evolving landscape is resulting in an increase in outsourcing as biotechs seek to tap into the specialised knowledge, resources and infrastructure offered by clinical contract research organisations (CROs). The CRO market is projected to reach USD 188.54 billion by 2030, growing at a CAGR of 12.6%.3 However, despite its advantages, outsourcing is not without its challenges. This makes it vital for biotechs to choose the right partner for them.
Why Biotechs Work with CROs
There are several reasons why biotechs choose to outsource to a trusted CRO. The first is to overcome global market and data concerns. A survey of 150 biotech executives found their top concerns were rising interest rates (39%), labour shortages (36%) and difficulty accessing necessary data (33%).2 While some of the challenges appear to be beyond the control of biotechs, they can interconnect. For example, improving data access, storage and analysis can reduce costs and increase efficiencies making biotechs more resilient to global pressures like rising interest rates.
The second reason biotechs choose to outsource is because access to top-tier talent within CROs significantly enhances their capabilities. Biotech companies’ constant innovation is helping to drive a rapid growth in market share. This can identify areas where a lack of in-house expertise can impact the success of R&D activities. For example, specialist biometrics CROs, can bring innovative solutions and expertise in biostatistics and regulatory interactions, resulting in cost-savings and accelerated timelines which can boost trial success.
The third reason biotechs may choose to outsource is to overcome barriers to successful trial execution. For example, over the past decade, clinical trial designs have become more complex, driving massive increases in data volume and complexity. Data deficiencies, either via poor data design, or execution, are among the largest drivers of failure for R&D assets. Data CRO teams are well-versed in the intricacies of handling complex trial designs and clinical data, ensuring that studies are conducted with the highest standards of accuracy and reliability.
