Increased investments in the biosimilar segment, as well as the pooling of resources from pharmaceutical companies and CDMOs for their growth, are expected to offer lucrative opportunities for market expansion. Breach of IP rights and patents, on the other hand, may represent a market challenge.
- Definition / Scope
- Market Overview
- Market Risks
- Top Market Opportunities
- Market Drivers
- Market Restraints
- Industry Challenges
- Technology Trends
- Pricing Trends
- Regulatory Trends
- Post COVID-19 Recovery
- Market Size and Forecast
- Market Outlook
- Technology Roadmap
- Competitive Landscape
- Competitive Factors
- Key Market Players
- Strategic Conclusion
Definition / Scope
A contract development and manufacturing company (CDMO) is a corporation that provides drug development and manufacturing services to the pharmaceutical sector. CDMOs and pharmaceutical corporations collaborate to outsource medication development and manufacture.
Some of the services offered by Biologics Contract Development and Manufacturing Organizations (CDMOs) include:
CDMO activities can broadly be divided into three fields: product development, manufacture of active pharmaceutical ingredients (API), and manufacture of finished dosage forms (FDF are all required from small-scale clinical batches to large-scale commercial production. As such, once a dedicated manufacturing line is established and validated at a CDMO.
Active Pharmaceutical Ingredients (API)
Originator products and generics account a roughly equal share of the commercial small molecule API industry. Although generic APIs often provide lower margins to manufacturers, this is frequently offset by the possibility to supply the same API to several customers.
Despite the fact that small molecule commercial revenues now constitute for the majority of the CDMO business, biologics are the fastest growing sub-sector due to increased biologic approvals and the emerging biosimilar market (as increasing numbers of biologics reach patent expiry).
Finished Dosage Forms (FDF)
FDF has a smaller market share than API, with oral solids accounting for the majority of the market. Oral solids, on the other hand, are a more mature market with slower development than other FDFs such as liquids, semi-solids, and injectables.
The fastest-growing FDF segment is injectables. Manufacturing shortages of sterile injectables have resulted from increased demand for injectables (mainly due to the rise of biologics and oncolytic) paired with high technological hurdles to entry. The fastest-growing category include pre-filled syringes (PFS) and other more complicated injectable delivery devices (including auto-injectors).
Despite the fact that clinical manufacturing accounts for a small percentage of the CDMO business (due to lower volumes), it is critical for securing customers and developing partnerships that will support commercial scale manufacturing.