An integrated offering of drug substance and drug product:
only a buzz or the next evolution of the CDMO Industry?
Lukas Utiger, President, DPx Fine Chemicals, DPx Holdings B.V., discusses how the 2014 merger between Patheon and DSM Pharmaceutical Products continues to create impactful changes in the chemical CMO world, notably with the manufacturing company’s new integrated supply chain offering, Patheon OneSourceTM.
The pharmaceutical and biopharmaceutical industries have been outsourcing product development and manufacturing for years but the Contract Development and Manufacturing Organization (CDMO) model must be optimized to meet increased customer demands. Decreasing the drug development cycle time and customer management responsibilities through integrated, end-to-end offerings is a large benefit to small and mid-size pharma companies.
Shifts in the ownership of early phase compounds to mid-size and smaller pharma companies with increased involvement from external venture capital and private equity funds leads to more outsourcing of drug substance, drug product, and analytical and regulatory services. Captive manufacturing is only favored by large pharma and generic companies (Figure 1).
Pharmaceutical outsourcing continues to increase each year throughout the value chain. In 2014, outsourcing of API manufacturing rose by almost 20 percent from the previous year, while commercial final dosage manufacturing rose 9 percent from 2013 to 2014 (Figure 2).
In recent years, CDMOs have adapted to customer demand for a more simplified supply chain that drives faster, hig ...