Blurring the lines between small and large molecule manufacturing
The biopharmaceutical industry has grown impressively in recent years, with its global compound growth rate (CAGR) estimated to reach 8.5% between 2018-2023, outstripping traditional New Chemical Entity sectors1 . Emerging novel drugs show huge therapeutic potential, such as antibodydrug conjugates (ADCs), checkpoint inhibitors and viral gene therapy. But as the industry grows, it may face potential issues securing an expanded supply chain.
Until recently the bio industry’s primary focus was to simply get their products to clinic as quickly as possible, with little incentive to focus on product and supply chain efficiency. However, now that the industry is experiencing greater demand and product volumes are increasing – coupled with generics and healthcare reforms – there is an increased desire to explore how overall cost of production can be lowered. It’s a mirror image of the small molecule industries maturation some 10 or 20 years earlier. As a result innovators and biogeneric companies are exploring not only how to speed products to market, but also, how they might lower costs in the commercial phase (for which a majority of processes are set earlier in the development cycle).
This whitepaper assesses the current state of the large molecule sector, and how it may be able to learn from the small molecule industry in terms of its supply chain support infrastructure, as well as its acquisition of staff and the adoption of PAT. We also look at what the large molecule industry can offer the small molecule industry in terms of novel technologies currently adopted in biologics. Included here are expert insights across both industries, evaluating just some of the potential benefits that could be enjoyed through further collaboration. Large biopharma firms now have a greater number of drugs in the pipeline, and with an increased global prevalence of biosimilars, the supply chain will come under increasing pressure. But the industry is still in its relative infancy, and some of the key factors that may allow companies to meet these demands are not yet fully matured.
For example, the large molecule industry, according to some experts, has reported issues in terms of a fully supported infrastructure, with an increased need for supplier directories, talent recruitment, and appropriate support and consultancy services. Additionally, as biologics developers now are more comfortable using outsourcing providers, we are seeing a gradual shift away from performing all production activities in-house. In 2010, according to BioPlan Associates, 57% of biopharma did all of their mammalian bioprocessing in-house, whereas in 2017, only 44.2% undertook all work themselves. This is due in part to many Contract Development and Manufacturing Organisations (CDMOs) developing and investing in the skills and technologies required to make biologic drugs.
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