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?

Create Access Equity for Biological Assets

Russel Miller: Enzene’s strategy to grow market share in the CDMO industry is anchored in our innovative fully connected continuous manufacturing process, EnzeneX. Through this technology, we aim to make biologics manufacturing more accessible and affordable for small and emerging biotechs, as well as animal health companies. We understand the challenges these companies face in achieving cost-effective production, and EnzeneX addresses these needs by ensuring high yields and quality outcomes — essential for the success of complex biomolecules like fusion proteins and bispecific/trispecific antibodies.

Our expansion into the US market is a key element of our growth strategy. The upcoming launch of the 54,000 sq. ft. facility in New Jersey, equipped with 500 L bioreactors and additional capacity planned beyond phase 1, will enhance our ability to serve the US market, bringing our continuous manufacturing processes closer to our clients and supporting both clinical and commercial manufacturing needs.
Our intention is to create access equity for biological assets whether human or animal and in any phase of development, by providing cost-effective local manufacturing. With the growing concerns over the uncertainty of the BioSecure act, a lot of biotechs are looking for alternatives and preferring US manufacturing, and the new site will create access equity by providing state-of-the-art, cost-effective continuous manufacturing to small and mid-size companies.

“Our expansion into the US market is a key element of our growth strategy.”

We constantly strive to improve our processes and are working on EnzeneX 2.0. This upgraded version of our technology is being designed to enhance various aspects of the manufacturing process, aligning with industry demands for greater functionality. Additionally, we are developing new cell lines capable of achieving 8-9 g/L yields, with the goal of breaking the $40/g cost barrier.
Lastly, both at our Indian site and in the US, we’re expanding our services by launching a discovery arm, offering fully integrated services from discovery to commercialization.