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?

Enhancing Supply Chain Flexibility and Resilience

Ashu Tandon: The pandemic reshaped the CDMO market, making diversity of supplier base a necessity and an important variable in the supplier selection process. In light of ongoing geopolitical tensions, customers are now looking again at options beyond China in their supply chain. This even extends to the back-end supply chains of CDMOs and reducing dependency on China and other overseas markets. In response, at Aragen, we’ve prioritized enhancing our supply chain flexibility and resilience, investing in capacities and adopting advanced digital tools, including AI and ML, to optimize efficiency and reduce errors. As a case in point, we’ve been working very hard to develop a local supplier base within India, including within 250 km radius of our labs to ensure continuity of materials. Additionally, imports of raw materials have reduced from around 60% of our total spend to about 20% in the last 3-5 years. As a consequence of these strategic investments, we are now very well positioned to manage future disruptions, ensuring seamless operations, even in uncertain times.

“We are very well positioned to manage future disruptions, ensuring seamless operations, even in uncertain times.”

Aragen’s growth strategy focuses on three key areas: investing in advanced facilities, expanding capacity and capabilities, and providing innovative solutions to meet customer requirements. We have been making strategic investments across all lines of our business. We recently strengthened our drug product service offerings by adding clinical manufacturing capacity that will allow us to provide integrated drug substance, drug product and related analytical services. While in our biologics manufacturing plant in Bangalore, we can now undertake non-GMP production for batches up to 50 L. And, by the end of the year, we will add further GMP manufacturing capacity that can deliver manufacturing batches at the 200 L to 2 KL scale. We have added large-scale biomanufacturing capacity at our campus in California. We are also strengthening capabilities in newer areas like oligonucleotides, peptides, and antibody drug conjugates (ADCs). Finally, we have also committed to an investment plan of around $250 million over the next five years — to expand both R&D and manufacturing facilities across the business.