What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Veeva Systems’ senior director of Vault Quality strategy, Ashley McMillan, shares her thoughts with Contract Pharma.

Data access controls will enable stronger quality partnerships
As companies began collaborating more closely with contract partners, a pioneering few invited preferred CDMOs into their quality networks. Others didn’t consider this approach because of security and data access concerns. This is quickly changing.

With technical advances allowing seamless access and granular control over data, more biopharmas and CDMOs will invite suppliers to participate in key processes within their quality management systems. CDMOs will also begin granting access to customers directly in their quality management, documentation, and training systems to share information in real-time and increase visibility into critical processes.

Closer collaboration with partners, suppliers, and customers will make it easier for smaller innovators to accept products, sign off and approve batches, review quality events, and share information. Looking ahead, more companies will start developing data-sharing strategies, enablement programs, and new processes tailored to each partner.

Greater focus on modernizing operations will accelerate the shift to digital quality management
With the biologics contract manufacturing market predicted to exceed $47 billion by 2031, established, and fast-growing CDMOs are evolving their processes and systems to keep up with industry demand. This includes larger manufacturers who may have been more ‘legacy minded,’ relying on traditional systems and processes. These industry leaders are changing their mindset and beginning modernization initiatives focused on cloud-based, digital quality systems.

Emerging CDMOs have been leading the way and charting a path for transformation, showcasing improvements in efficiency and collaboration with customers and partners. The change in approach will be critical in moving the industry forward to deliver innovations in manufacturing services.

CDMOs will continue specialization to match biotech needs
Emerging biotechs are responsible for 65% of the drugs in active development, including over 800 focused on niche areas like cell and gene or RNA therapeutics. As CDMOs increasingly become strategic partners to the industry, these biotechs are looking for manufacturers that specialize in their specific therapeutic focus. This has led to both a rise in new entrants in contract manufacturing and increased M&A activity in novel segments. In 2021, 40% of CDMO M&As included companies with a specialized focus.

Looking ahead, contract manufacturers will continue prioritizing niche areas while expanding the services and processes traditionally offered to clients. Leveraging advanced technology and state-of-the-art facilities, these companies will be well equipped to scale and innovate while adapting to changing biotech business requirements.