Sterile Injectables Market 2019 | Revenue Opportunies By Top Players Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Novartis AG, and Johnson & Johnson Services, Inc.

Increasing use of biologics in healthcare industry, with the gaining prominence, the emergence of antibody-drug conjugates (ADCs) and monoclonal antibodies (MA) into the drug development and clinical pipeline, has spurred growth of the sterile injectable market worldwide. According to Piramal, the development and manufacturing of sterile injectables is highly complex and capital intensive. The operative cost for injectable is high as almost all injectables in present pharma market are toxic and infectious in natural, consequently, requiring a higher level of quality and significant care needs to be taken in order to ensure safe manufacture, packaging, storage, and distribution. Furthermore, strict regulations by Food and Drugs Administration on manufacturing facilities and equipment dissuades pharma players and potential new entrants from venturing into this lucrative sterile injectables market. Many sterile manufacturing facilities have closed down in the U.S. and many parts worldwide due to the alliance of in-house manufacturing capacities, which have led to an acute shortage of sterile injectables, adversely affecting the sterile injectables market. Earlier, there were individual companies developing injectables have now merged and acquired similar product profile companies in order to make up for operational cost required to develop the injectable. This in turn has adversely affected the sterile injectable market, leading to dearth of drugs.

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The global sterile injectable market was valued at US$ 299.7 billion in 2015 and is expected to witness a CAGR of 6.9% during the forecast period (2016 – 2024).

Market Dynamics

Accessibility of broader treatment therapy choice and growing prevalence of chronic illnesses prominently cancer globally is likely to fuel market demand for sterile injectables s over the forecast period. The high demand for sterile injectables is also driven by a large number of drug manufacturers/producers concentrating on developing drugs to treat cancer. Fast-track regulatory approvals of sterile injectables and minimization of approval timelines for innovative drug development to cure cancer is indirectly helping accelerate the drug supply and is significantly fueling growth of the global sterile injectables  market. High operative costs and abrupt termination of injectables drugs for cancer treatment is expected to hamper revenue growth of the market across the globe. Manufacturing of sterile products necessitate the high end equipment for manufacturing and also the equipment needs regulatory certification and sterilization before production process. Hence, these activities lead to high operating costs and high debt levels. Furthermore, the FDA has stringent regulations pertaining to sterilization of drug and equipment, which further adds to the cost burden of the manufacturer as it entails maintaining a high degree of care in the manufacturing, packaging, storage, and distribution of sterile injectables drugs.

Market Taxonomy

This report segments the sterile injectables market on the basis of molecule type, drug type, application, end user, and geography. On the basis of molecule type, the market is categorized into large molecules and small molecules. On the basis of drug type, the market is categorized into Monoclonal Antibodies (mAbs), Cytokines, Insulin, Peptide Hormones, Vaccines, Immunoglobulins, Blood Factors, Peptide Antibiotics, and Others. On the basis of application, the market is categorized into Cancer, Diabetes, Cardiovascular Diseases, Central Nervous Systems, Infectious Disorders, Musculoskeletal and Others. On the basis of end user, the market is categorized into Hospitals, Drug Stores, Pharmacies and online pharmacies. For comprehensive understanding of market dynamics, the global sterile injectables market is analyzed across key geographical regions namely North America, Europe, Asia Pacific, Latin America, Africa, and Middle East. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Key companies covered as a part of this study include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Novartis AG, and Johnson & Johnson Services, Inc.

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