The Global Sterile Injectables Market was valued at US$ 299.7 billion in 2015 and is projected to expand at a CAGR of 6.9% during the forecast period (2016–2024), as highlighted in a new report published by Coherent Market Insights.
According to Piramal Enterprises Ltd. there are 2,400 sterile injectable products are under development phase, which would lead to introduction of advanced products in the global sterile injectables market. Generic market is, the primary driver behind the growth in injectable. Many pharmaceutical companies are focused on developing generic injectables. The expansion and manufacturing of sterile injectable products is highly complex and requires major investment. The manufacturing costs are comparatively high when compared to conventional drugs, since injectables are highly toxic and infectious in nature and therefore, necessitate a high level observation of quality and care in their manufacturing, packaging, storage, and distribution.
Complex regulations imposed by U.S. FDA on manufacturing facilities and equipment has become a great hurdle for both the current pharma players and new emerging players globally. On the other hand though, the regulatory body has shortened the approval timeline for biologics, as there are many compounds which could potentially be used to treat cancer and anti-infective diseases. Some of the other reasons for shortening of drug approval are strategic mergers & acquisitions that have led to a single source of drug availability, suspension of older injectable drugs, and wide availability of newer drugs.
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The last five to six years has witnessed major activities by many pharma giants involved in mergers and acquisitions in the sterile injectables market. To keep pace with the rapidly growing and ever-changing market, firms are acquiring high-quality sterile injectable players to enhance their product portfolio and manufacturing abilities. For instance, Pfizer acquired Hospira for US$ 17 billion in 2015. This has boosted Pfizer’s Global Established Pharmaceutical (GEP) business by combining Hospira’s generic sterile injectable products. Pfizer acquired InnoPharma for $360 million. This led to the inclusion of InnoPharma’s 19 pipeline drugs filed to USFDA and around 30 injectable and ophthalmic products under development to Pfizer’s product portfolio.
Hikma acquired Bedford laboratories for US$ 300 million. This merger strengthened Hikma’s position in the US generic injectable market. Sun Pharmaceutical acquired Pharmalucence Inc., which has a sterile injectable manufacturing and R&D capabilities. In 2013, Mylan acquired Strides Arcolab for US$1.75 billion. With this acquisition, Mylan extended its injectable product portfolio, pipeline, and capabilities. In 2015, Piramal acquired Coldstream Laboratories, an injectable manufacturer to augment its formulation offering. These inorganic strategies are leading to consolidation of the sterile injectables market, augmenting growth.
Sterile injectables manufacturing requires major capital investment for the equipment and the production process. Fresenius Kabi, plans to invest around US$ 250 million over the following decade to expand the company’s Melrose Park site, where it manufactures generic, sterile injectable pharmaceuticals. Dr. Reddy’s has marked up its multifaceted injectables business since past 5 years to US$ 280 million in 2015. Complex manufacturing process and stringent regulations are restricting the entry of new players but at the same time challenging the survival of existing players in the sterile injectables market.
Key takeaways of the Sterile Injectables market:
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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.
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