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 from 2023 to 2030. Generic sterile injectables refer to injectable drug products that are made to copy the reference listed medicines. They provide cost-effective treatment options for various chronic and acute diseases such as cancer, CVDs, and infectious diseases. Sterile injectables are administered through various routes such as intravenous, intramuscular, and subcutaneous. The rising prevalence of chronic diseases, technological advancements in biologic drug development, and patent expiration of blockbuster drugs are major factors driving the growth of this market.
Key Takeaways
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., Sun Pharmaceutical Industries Ltd.
The global generic sterile injectables market is expected to witness lucrative opportunities due to growing demand for biosimilars and complex generics. Biosimilars provide similar therapeutic benefits at a significantly lower cost than biologics and are expected to witness the highest growth over the forecast period.
Advancements in recombinant DNA technology, synthetic biology, and manufacturing capabilities have enabled the development of biosimilars for various complex drugs. Many blockbuster drugs patent expirations such as Remicade, Rituxan, Herceptin, Avastin, Neulasta, and others provide immense opportunities for biosimilar developers and generic sterile injectable companies.
Market Drivers
The increasing prevalence of chronic diseases such as cancer, CVDs, diabetes, and infectious diseases coupled with rising healthcare expenditure is a major growth driver for the generic sterile injectables market. According to the WHO, cancer is projected to become the leading cause of death worldwide by 2030 with an estimated 13 million annual cancer deaths. Sterile injectables are widely used in chemotherapy regimens for the treatment of various cancers accounting for significant market growth. Similarly, rising cases of CVDs and diabetes due to rapidly aging populations and sedentary lifestyles will further propel the demand for generic sterile injectables in coming years.
Current challenges in Generic Sterile Injectables Market
The global generic sterile injectables market is facing certain challenges which are hampering its growth. Price erosion is a major challenge being faced by manufacturers as competition increases in the market. High regulatory approvals and compliances are also restricting new market entrants. Shortage of skilled workforce and lack of advanced manufacturing capabilities are key hindrances for smooth operations. Maintaining supply chain integration and ensuring product quality are continuous challenges. Rising costs of Active Pharmaceutical Ingredients (APIs) and drug shortages are negatively impacting production volumes.
SWOT Analysis
Strength: Low cost of production and ability to provide access to affordable treatments. Wide therapeutic applications in critical care.
Weakness: High capital investments and long development timelines. Stringent regulations around quality and sterilization.
Opportunity: Increased uptake in emerging countries. Shift towards generic drugs. Greater acceptance of biosimilars.
Threats: Patent expiries of blockbuster drugs. Price control policies imposed by governments. Supply chain disruptions and trade issues.
The United States accounts for the largest share in terms of value currently in the global generic sterile injectables market. This is mainly attributed to rising healthcare spending, growing prevalence of chronic diseases, and declining costs of generics. Europe holds the second largest position driven by favorable regulatory norms and acceptance of biosimilars.
Asia Pacific is expected to be the fastest growing region during the forecast period due to expanding healthcare infrastructure, increasing healthcare access and rising consumption of generics in large population countries like India and China. Limited manufacturing capabilities are pushing regional players to collaborate with international developers for smooth technology transfers and product launches.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
