The global specialty active pharmaceutical ingredients (API) market is anticipated to record a year-over-year growth rate of 7.9% and reach a market value of US$ 119,513.1 Mn in 2016. Small molecules will continue to account for the leading market revenue share by product type, accounting for over two-thirds share in 2016.
Staggering increase in the manufacturing of HPAPI (high potency API) will continue to influence the adoption of API positively. Popularity of peptide-based drugs and the patent expiry of blockbuster branded drugs in the near future is also expected to boost the growth of the market. However, complex manufacturing guidelines and stringent regulatory processes will continue to pose challenges to widespread adoption.
By product type, growth of the small molecules segment will be positively impacted by increasing outsourcing of active pharmaceutical ingredients manufacturing from European to Asian countries. In addition, rising preference for HPAPI to treat cancer will play a crucial role in the growth of small molecule segment of the global specialty API market.
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Based on the consumption pattern, the outsourced segment will continue to dominate market revenues, accounting for nearly 65% share in 2016. New pharmaceutical companies are increasingly entering the market with authorized and approved HPAPI, but lack of manufacturing facility infrastructure is providing an impetus to the outsourcing trend in terms of manufacturing. This factor is currently more pronounced in U.S.-based companies. Furthermore, the tendency of established pharmaceutical companies to curtail the operational and financial load of HPAPI manufacturing is anticipated to play a key role in elevating the outsourcing segment, boosting the growth of SMEs in the market.
FMI’s report has segmented the global specialty active pharmaceutical ingredient market on the basis of region into North America, Europe, and Rest of the World (ROW). The ROW is the leading region in terms of global revenue share, closely followed by Europe and North America. European API manufacturers are competing on the basis of high quality standards, advanced manufacturing installations, and high purity of intermediates (API), whereas ROW CMOs are focusing on bulk API manufacturing.
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The key players in the small molecule active pharmaceutical ingredients segment include Johnson Matthey, Almac, and Siegfried Holding AG, which follow advanced manufacturing technology, premium promotion strategies, and provide a range of development and diagnostic services.
Notable companies in the peptide API segment are PolyPeptide Laboratories, Corden Pharma International GmbH (International Chemical Investors Group), Pepscan Holding, Provence Technologies Group, BCN Peptides S.A., and Senn Chemicals AG. They are characterized on the basis of expertise in development and manufacturing, strong client base, and activity in a wide range of industries.
Major HPAPI players in the market are Ash Stevens, Inc., Orion Corporation, Farmhispania Group, S.L., Olon S.p.A., and AmbioPharm, Inc., based on widespread market presence, government approvals, and strong distribution channels.
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Long-term Outlook: The global specialty API market is expected to witness a CAGR of 8.8% during the forecast period 2016-2024. ROW will continue to be the leading region in terms of revenues during the forecast period.