The transition from blockbuster drugs and large-scale manufacturing to more targeted therapies for smaller patient populations has had the greatest impact on the pharma industry and CDMOs over the past two decades. Additionally, drug formulations have become more complex, requiring advanced development and manufacturing techniques. Also, smaller pharma companies have become more numerous, and with that, has placed greater need for CDMOs for capabilities and capacity.
 
Matthew Moorcroft, Vice President, Marketing & Intelligence, Cambrex discusses the impact of pharmaceutical industry trends for small molecules over the past 20 years. –KB

Contract Pharma: What were some of the major pharmaceutical industry changes over the years that have greatly impacted CDMOs?

Matthew Moorcroft: From a small molecule manufacturing standpoint, the last two decades have witnessed pharmaceutical companies coming to terms with the evolution from the blockbuster model – and the reliance on a handful of drugs to generate large proportions of their revenue – in favour of multiple, niche therapies that typically have novel mechanisms of action, serve smaller patient groups, and as a result, require new and advanced manufacturing techniques. With legacy manufacturing facilities unsuitable for these new types of drugs, and a reluctance to build expensive, new internal capacity, outsourcing projects to CDMOs with the right capacity and expertise has increased.

This demand for CDMO services is supplemented by the increased proportion of clinical projects being developed by small or virtual pharmaceutical companies which lack internal manufacturing capabilities and are wholly reliant upon outsourcing.

CP: How have service offerings and operations for CDMOs evolved over the years?

MM: One of the biggest changes over the last few years has been in CDMOs having to adapt to the changing nature of the customer base, away from the traditional big pharmaceutical companies, to the position where the majority of new drugs in development are now being developed by smaller and virtual companies. These smaller companies typically lack the manufacturing assets required to produce the quantities required for clinical or commercial supply, so are reliant upon outsourcing They typically lack the internal resource to manage an extensive network of multiple CDMO suppliers, so further drive demand for end-to-end services, frequently using a CDMO that can handle all their needs from drug substance to drug product.

CP: What are some changes you anticipate for the future of the industry and outsourcing?

MM: Small molecule outsourcing is set to increase as more therapies are developed at smaller and virtual pharma companies at the same time as big pharma decreases its internal manufacturing footprint. The needs of these different customers vary greatly: from bridging internal gaps in capacity or capability with larger pharma companies; to offering end-to-end services to smaller biotech and virtual pharma that have little or no development or commercial capabilities.

To cater for this variety of needs, CDMOs must offer flexible and efficient manufacturing options to customers and be willing to introduce and invest in technologies to improve efficiency, while maintaining a focus on quality.

CP: What global market changes have had the greatest impact on the industry and CDMO services?

MM: From a small molecule API and fine chemical manufacturer perspective, the industry has evolved primarily as a result of the actions of big pharmaceutical companies. Initially the blockbuster wave in the 1990s placed huge demands on European manufacturing capacities and led to the birth of the CDMO industry. This eventually subsided following the dearth of new blockbusters reaching the market, and led to increased economic pressures and the rise of outsourcing to low-cost countries such as India and China. Contract manufacturers were all but commoditized and considered “capacity for hire” with reduced emphasis on a company’s experience or expertise. The industry has now come full circle driven in large by the quality concerns of low-cost manufacturing, and the new types of molecules in the pipeline requiring advanced capabilities. This has led to a focus on quality and expertise and projects being re-shored back to western CDMOs.