Sterile Injectables Market Accrues Phenomenally by 2026 with a Staggering CAGR

The Global Sterile Injectables 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).

The last decade has witnessed a major paradigm shift in the healthcare industry, with increasing inclination towards biologics over conventional drugs. Therapeutic areas such as Oncology, drugs are been overtaken by biologics as they are highly absorbable in the body with quick therapeutic response. Furthermore, the pharmaceutical industry too has been swept by winds of change, with strong biologics pipeline under their product portfolio. Novel drug delivery systems that deliver specific targeted therapies are gaining importance.

These aspects, among others, have in turn led to a spike in growth of the sterile injectables market. Globally, around 2,400 injectables s are under development pipeline, which are potent and non-potent. This is a major factor directly fueling growth of the sterile injectables s market. The generic market is the largest target market for sterile injectables s. Major generics players such as Teva Pharmaceuticals, Hospira, Hikma, and Fresenius Kabi are also involved in development of sterile injectables.

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.

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.

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Competitive Landscape

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.

Sterile Injectables Market Scenario: Indian companies are increasingly focusing on developing complex generics:

Some of the prominent pharma companies based in India have strived hard to achieve success by attaining approval for various novel biologics processes. The manufacturing facilities for development of biologics are GMP certified. There are many complex injectable drugs such as lyophilized products, high potency active pharmaceutical ingredients, long-acting suspensions, and liposomes which necessitate multifaceted manufacturing capabilities. For injectables, new drug, including drug delivery systems such as self-injection devices such as auto and pen injectors that improve patient compliance and enable differentiation is a strategy employed by various market players.

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