The global generic sterile injectables market is estimated to be valued at US$ 46.33 Bn in 2024 and is expected to exhibit a CAGR of 10.% over the forecast period 2024 to 2031. Key Takeaways
Key players operating in the generic sterile injectables market are Baxter International Inc., AstraZeneca plc, Merck and Co., Inc., Pfizer Inc., Fresenius Kabi, Novartis International AG, Teva Pharmaceuticals, Hikma Pharmaceuticals, Dr. Reddy's Laboratory, Mylan N.V., Sun Pharmaceutical Industries Ltd. These players are focusing on introducing biosimilars and launching affordable generic versions of specialty products as a core business strategy. Some notable products launched recently include Adalimumab (Humira), Etanercept (Enbrel) and Rituximab (MabThera/Rituxan).
The key opportunities in the Generic Sterile Injectables Market Trends include significant entry of biosimilars and biologics going off-patent. Biosimilar approvals are expected to increase from $10 billion in 2024 to $26-30 billion by 2031. Furthermore, patents of biologics such as Remicade, Avastin, Herceptin, MabThera, Erbitux, and others will expire between 2023 to 2028 providing opportunities for biosimilar launches.
Advancements in drug delivery systems have enabled long-acting injectables with reduced dosing frequencies. Technologies such as controlled drug delivery, targeted drug delivery, and self-injection devices are being adopted to enhance patient convenience and compliance.
Market Drivers
The rising prevalence of chronic diseases marks a key driver for the generic sterile injectables market. Chronic diseases such as cancer, diabetes, autoimmune disorders among others require lifelong treatment often involving injectable biologics and therapeutics. It is estimated that over 133 million Americans are currently living with at least one chronic disease. Another major market driver is the increasing demand for affordable healthcare solutions. The high cost of specialty drugs especially biologics has made generic sterile injectables an attractive alternative. Patent expiries of blockbuster biologics also supplement market growth by enabling biosimilar competition and reduced prices.
Current Challenges In Generic Sterile Injectables Market
The generic sterile injectables market is facing various challenges currently including drug shortages, stringent regulations, and manufacturing complexities. Drug shortages have been a persistent problem over the last decade for sterile injectable drugs across the world. Manufacturing issues due to quality concerns and compliance failures are a major reason for drug shortages.
Get more insights on Generic Sterile Injectables Market
Get More Insights—Access the Report in the Language that Resonates with You
