Generic sterile injectables are used mainly in hospitals for parenteral administration of medicines to patients. They include active pharmaceutical ingredients and excipients which are required to formulate the final sterile dosage form. Some key advantages of generic sterile injectables are high therapeutic efficacy, rapid onset of action, bypass of first-pass metabolism in liver and direct access to systemic circulation. The growing burden of chronic diseases worldwide has increased the demand for such injectables for therapy.
The global generic sterile injectables market is estimated to be valued at US$ 38,706.5 Mn in 2024 and is expected to exhibit a CAGR of 10.% over the forecast period 2023 to 2030. Key players operating in the generic sterile injectables are Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Pfizer Inc., Fresenius Kabi, Novartis International AG, Teva Pharmaceuticals, Hikma Pharmaceuticals, Dr. Reddy’s Laboratory, Mylan N.V., Sun Pharmaceutical Industries Ltd.
Key Takeaways
Key players: Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Pfizer Inc. are some of the leading players in the generic sterile injectables market. They are focusing on expanding their product portfolio and strengthening their distribution networks globally.
Key opportunities: Growing demand for affordable healthcare presents significant opportunities for generic sterile injectable manufacturers. Developing economies with large patient pools offer lucrative prospects for investment and partnerships.
Global Expansion: Leading companies are expanding their presence in high growth regions through acquisitions and new manufacturing plants. They are also targeting new therapeutic areas and patent expiries of biologics to capture additional market share.
Market drivers: Rising prevalence of chronic diseases such as cancer, diabetes is a major growth driver. Increasing access to healthcare facilities and focus on cost-effective treatments are propelling the demand for generic sterile injectables.
Market restraints: Stringent regulatory requirements and product recalls delay the launch of new generic sterile injectables. Long duration of clinical trials and high manufacturing costs also restrain market growth to some extent.
Segment Analysis
– Lyophilized/Dry powder fill vials segment dominates the overall market currently. This is because lyophilized sterile injectables have a longer shelf life of upto 3 years as compared to liquid sterile injectables which have a shelf life of only 18-24 months. Their stability allows for less strict transportation and storage requirements.
– Prefilled syringes segment is witnessing highest growth. Ease of administration, reduced risk of contamination and needle-stick injuries make prefilled syringes a preferred format. With technology advancements reducing manufacturing complexities and costs of prefilled syringes, more pharmaceutical companies are switching to this segment.
Global Analysis
Regionally, North America holds the largest share currently due to prominent pharmaceutical markets of U.S. and Canada. However, Asia Pacific region is witnessing fastest growth owing to rising generic drug production in India and China coupled with growing healthcare investments in other emerging Asian countries. As leading pharmaceutical manufacturing shifts bases to Asia, the region will emerge as the dominating market for generic sterile injectables over the forecast period. In terms of regulations, ICH Q7 guidelines help harmonize good manufacturing practices across major markets like U.S., Europe, Japan, Canada, Australia and others, facilitating global supply of quality generic sterile injectables
