The high potent market and the role of a specialist CDMO

March 20, 2025

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The article discusses the growing demand for drug products containing highly potent active pharmaceutical ingredients (HPAPIs), particularly in oncology. It highlights the importance of specialist contract development and manufacturing organizations (CDMOs) in this field. Key points include:

- Market Growth: The small molecule drug discovery market is expected to grow at a compound annual growth rate (CAGR) of around 8% from 2023 to 2030, with oncology accounting for a significant portion of this growth.

- Regulatory Support: Regulatory agencies like the FDA have implemented accelerated approval pathways, promoting faster commercialization of novel oncology drugs.

- Outsourcing Trends: Pharmaceutical companies are increasingly outsourcing to CDMOs to optimize resources, leverage expertise, and accelerate drug development timelines.

- Formulation Development: Successful formulation development requires experienced cross-functional teams and comprehensive knowledge of equipment and processes.

- Safety and Compliance: Handling HPAPIs involves complex safety and regulatory requirements, making the selection of the right CDMO crucial.

The article emphasizes the critical role of CDMOs in ensuring the safe and effective development, manufacturing, and commercialization of HPAPI-containing products.