Expert Statement: Federico Pollano, Rentschler
The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine.
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?
The Value of External Expertise
Federico Pollano: Development & Client Program Management, Rentschler
The international CDMO sector is experiencing substantial growth, driven by rising demand across therapeutic areas such as oncology, autoimmune, neurological diseases, infections, and rare diseases. According to Frost & Sullivan, the BioCDMO market is projected to grow at a compound annual growth rate of 14.3% from 2023 to 2029. Specifically, protein and antibody therapeutics are expected to grow at over 8%, while advanced therapies, including cell and gene therapies, are anticipated to surge by approximately 33%.
This growth is significantly fueled by a robust pipeline of next-generation therapeutics developed by innovative companies that do not possess their own production capabilities. These companies represent 70% of the R&D pipeline and increasingly depend on CDMOs for manufacturing support. Additionally, Big Pharma is increasingly outsourcing late-stage product candidates and market products to CDMOs, recognizing the value of external expertise.
“Growth is significantly fueled by a robust pipeline of
next-generation therapeutics
developed by innovative companies that do not possess
their own production capabilities.”
At Rentschler Biopharma, we support clients from Phase I development through to commercial production for the market. Our recent contribution to successful FDA approvals — contributing to four out of 17 biopharmaceuticals approved in 2023 — showcases our ability to deliver integrated services, including world-class consulting, regulatory support, process development, technology transfer, and cGMP manufacturing.
We are also deeply engaged in the field of advanced therapies, which demands specialized expertise and cutting-edge technology platforms. Our objective is to assist clients in navigating the complex regulatory landscape and securing essential funding, thereby facilitating the advancement of innovative therapies.
In summary, the expansion of therapeutic areas, the rise of advanced modalities, and the growing reliance on CDMOs by both innovative and established companies are key drivers of growth in the sector.
