SEATTLE--(BUSINESS WIRE)--According to Coherent Market Insights, the global specialty injectable generics market was valued at US$ 31,300 million in 2017, and is projected to exhibit a CAGR of 10.4% over the forecast period (2018 – 2026).
Key Trends and Analysis of the Specialty Injectable Generics Market:
Increasing prevalence of chronic diseases such as cancer and cardiovascular diseases and patent expiry of leading branded products is paving the entry for generics. Market players are actively having a lookout on patent expiry of leading brands to substitute it with generics and make the treatment cost effective. Moreover, the players are focused on offering new and improved products in order to address the critical unmet needs of patients. According to Bloomberg Intelligence in 2016, generic market is poised for significant growth, particularly in the injectables category. Injectables are important additions to the generic product portfolio as they are relatively protected by price pressure and comparatively commoditized than their oral counterparts.
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Since 2011, there has been gradual a loss of patents on major complex injectables, which paved the entry of generics through an Abbreviated New Drug Application (ANDA) Fillings. Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor that is indicated for the treatment of metastatic colorectal cancer and head and neck cancer. It is manufactured under the patent by Bristol-Myers Squibb and Eli Lily Company in Europe. The drug’s patent expired in 2018 and thus is expected to provide opportunity for a large number of market players to manufacture its generic version.
Moreover, key players operating in the market are focused on adopting acquisition strategies in order to gain access to innovative products and expand their product offerings in the potential markets. For instance, in September 2018, Aurobindo Pharma USA Inc. — a wholly-owned subsidiary of Aurobindo Pharma Limited – acquired the generics oral solids business and dermatology business of generic division of Novartis’ Sandoz, Inc.
However, The FDA implemented cGMP guidelines for manufacturing of generic sterile injectables. Moreover, these generic drugs are priced at reduced compared to that of the branded drugs leading to significantly low profit margins for manufacturers. Moreover, the FDA has enhanced efforts to enforce GMP on manufacturers and hence, they are unable to capitalize on generic drugs. This is expected to be factor hampering growth of the global specialty injectables generics market.
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Key Market Takeaways:
- The specialty injectable generics market is expected to exhibit a CAGR of 10.4 % during the forecast period (2018 – 2026), attributed to increasing incidences of chronic diseases such as cancer, cardiovascular diseases, and patent expiry leading to entry for generics in market. For instance, Sanofi’s Zaltrap —indicated in combination with 5-fluorouracil, irinotecan (FOLFIRI) for the treatment of metastatic breast cancer – is expected to face a U.S. patent expiry by 2020. Various other drugs in line for patent expiry will lead to development of generic versions leading to improvement in the availability for cancer treatment.
- The market growth is attributed to approval and launch of generics for cost effective treatment of cancer and other diseases. For instance, in the 2017, the U.S. Food and Drug Administration (FDA) approved around 80 first generic drug, whereas 5 biosimilar products were approved in the same year.
- Key players in the market are focused on adopting merger and acquisition strategies to enhance their product portfolio, which in turn is expected to propel the market growth over the forecast period. For instance, in 2016, Lupin Ltd. completed acquisition of U.S.-based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). This strategic acquisition enhanced Lupin’s scale in both the U.S. generics and branded market as well as increased products in its pipeline in dermatology, controlled substance products, and other niche generics.
- Key players operating in the specialty injectable generics market include, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Fresenius SE & Co. KGaA, Endo International Plc., Hikma Pharmaceuticals PLC, Lupin Ltd., Sagent Pharmaceuticals, Inc., Cipla Limited, Sun Pharmaceutical Industries Limited, and Dr. Reddy's Laboratories
About Coherent Market Insights:
Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.
