Contract development and manufacturing organizations (CDMOs) have been on the rise in the last decade. Historically, CDMOs operated on a business model which predominantly focused on serving as external service providers for manufacturing pharmaceuticals. This model included the addition of capacity by the acquisition of manufacturing facilities from (bio)pharma companies or own capital investments. However, CDMOs have increasingly become innovation leaders and cover more areas of the pharma business, not just manufacturing, opening up additional revenue streams.

This change of focus has been accompanied by a change in the M&A landscape in the market. Some CDMOs are expanding their services and swapping their “contracts” for “partnerships”, evolving the term “CDMO” into “PDMO.” By getting closer to their partners, CDMOs can move past some of the pressure and offer consultative support or innovation to develop products in new ways.
The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine.

CHEManager asked executives and industry experts from a broad range of CDMOs to share their views on how their companies are dealing with this changing economic environment and the resulting opportunities and challenges. We proposed to discuss the following aspects:

• (How) have the rules of the CDMO market changed since the pandemic of 2020/21?
• What do you consider the most important growth drivers for CDMOs?
• What is your company’s strategy to grow the market share in the CDMO industry?

Increasing Complexity in Clinical Pipelines

Gordon Bates: Small molecules still make up the majority of the pharmaceutical market, with small and emerging biopharma companies increasingly driving the growth and innovation of small molecule-based therapies. Increasing complexity is evident in clinical pipelines, which demands both deep scientific expertise and strong process development and manufacturing innovation to resolve technical challenges.
Much of this needed expertise resides with CDMOs, who, over many years, have gained unparalleled experience through exposure to thousands of molecules and are now harnessing this heritage with digital innovations to support drug developers’ quest to bring innovative new therapies to market ever quicker.

“Managing shortened development timelines for drug molecules will continue to be a top priority for drug developers.”

Managing shortened development timelines for drug molecules will continue to be a top priority for drug developers. We observed that API synthesis has been becoming increasingly complex and lengthy — often requiring more than 20 synthetic steps — and limiting developers’ speed-to-clinic.
To address this trend, our expert teams developed and implemented an AI-driven solution for route scouting that delivers route designs and associated robustness assessment of raw material supply chains.

Following the launch of this new AI-based route scouting service, drug developers are now provided with insights for optimal route design, leading to accelerated speed-to-clinic with confidence in an efficient and scalable API manufacturing process and supply chain.