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The generic sterile injectables market comprises sterile pharmaceutical formulations that are administered by injection or intravenous infusion for various therapeutic applications. Sterile injectables include active pharmaceutical ingredients that are supplied as single-dose vials or prefilled syringes ready for administration. Monoclonal antibodies, peptides, proteins, vaccines, blood factors and antibiotics are some of the commonly administered generic sterile injectables. They aid in the treatment of various chronic and life-threatening conditions such as cancer, diabetes, infections and autoimmune diseases. Biosimilar drugs are cheaper equivalents to biologics that are expected to lose patent protection over the coming years. The expiry of major biologic patents coupled with the commercial availability of biosimilar products is anticipated to fuel demand for generic sterile injectables.
The global generic sterile injectables market is estimated to be valued at US$ 38,706.5 Mn in 2023 and is expected to exhibit a CAGR of 10% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics:
Growth of biosimilars: The expiration of patents for biologic drugs such as insulin, erythropoietin and monoclonal antibodies is projected to provide significant cost savings via introduction of biosimilar alternatives. Several patents for blockbuster biologics will expire between 2023-2030. This represents a major driver which is expected to fuel demand for generic sterile injectables.
Increased prevalence of chronic diseases: The rising prevalence of chronic and life-threatening conditions such as cancer and diabetes globally is expected to increase uptake of sterile injectables. According to WHO estimates, chronic disease prevalence is increasing worldwide with over 75% of all deaths annually being attributed to chronic diseases. Growing disease burden favours demand for therapeutic sterile injectables.
Segment Analysis
The global generic sterile injectables market can be segmented based on product, application, distribution channel and geography. Based on product, the market can be categorized into vials, ampoules, prefilled syringes and others. The vials segment dominates the market owing to its wide applications in hospitals as well as other healthcare facilities. Based on application, the market can be divided into oncology, cardiovascular, hematology, neurology and others. The oncology segment accounts for the largest market share due to increasing prevalence of cancer globally. Based on distribution channel, the market is classified into hospital pharmacies, retail pharmacies and online pharmacies. Hospital pharmacies dominate the segment due to higher demand from hospitals and other healthcare settings.
PEST Analysis
Political: Stringent regulations regarding quality and safety of generic sterile injectables may impact the market growth. However, favorable government policies for generic drugs is a major growth driver.
Economic: Growing healthcare expenditures and rising demand for low-cost treatment options are driving the adoption of generic sterile injectables. Strong economic growth in developing nations also aids market expansion.
Social: Increasing prevalence of chronic diseases such as cancer and cardiovascular disorders is fueling the demand. Rising patient awareness regarding cost benefits of generic drugs is positively influencing the market.
Technological: Advancements in formulation development and container closure systems ensure improved stability and sterility of generic sterile injectables during manufacturing and storage. Track-and-trace serialization technologies facilitate supply chain management.
Key Takeaways
The global generic sterile injectables market is expected to witness high growth over the forecast period owing to rising chronic disease burden worldwide.
Regionally, North America dominates the market led by the US. However, Asia Pacific is projected to exhibit the fastest growth rate during the forecast period. Factors such as growing healthcare infrastructure, increasing healthcare expenditures, rising geriatric population susceptible to chronic illnesses and favorable government policies will drive the Asia Pacific market.
Key players operating in the generic sterile injectables market 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., and Sun Pharmaceutical Industries Ltd. The market is highly competitive in nature due to presence of many large and small players. Leading companies are engaged in new product launches, geographical expansions and acquisition strategies to strengthen their market position.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
