The Generic Sterile Injectables Market is estimated to be valued at US$ 287.03 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.
Generic sterile injectables are injectable equivalents of brand-name sterile injectable drugs that have the same active ingredients, dosage form and administration routes, but can differ in characteristics such as inactive ingredients, coloring or flavoring agents. Generic sterile injectables are used for the treatment of several chronic and acute diseases and conditions such as cancer, infectious diseases and auto-immune diseases. The growing prevalence of such chronic and acute diseases worldwide has boosted the demand for affordable generic sterile injectables thereby driving the market growth.
Market Overview:
Generic sterile injectables include different dosage forms such as vials, ampoules and prefilled syringes. They contain drugs in sterile form intended for parenteral administration through routes such as intravenous, intramuscular, intrathecal etc. The rising demand for cost-effective treatment options along with increasing prevalence of diseases has boosted the adoption of generic sterile injectables.
Market key trends:
The key trend fueling the growth of the generic sterile injectables market is the increasing preference for affordable generic alternatives over expensive branded drugs. The high costs associated with branded sterile injectables is driving patients towards generic substitutes which offer similar therapeutic efficacy but are more affordable. According to a study, the adoption of generic sterile injectables saved the U.S. health care payers up to US$ 7 billion in 2013. Moreover, patent expiry of major branded sterile drugs is expected to further drive the market share of generic versions in the forecast period.
Porter's Analysis
Threat of new entrants: The generic sterile injectables market requires high capital investment and stringent regulatory approvals which acts as a barrier for new players.
Bargaining power of buyers: The presence of many generic players puts downward pressure on prices, increasing buyers' bargaining power. However, strict FDA regulations create high switching costs.
Bargaining power of suppliers: A limited number of suppliers for active pharmaceutical ingredients (API) and contract manufacturing organizations (CMOs) increases suppliers' bargaining power.
Threat of new substitutes: There exist no close substitutes for injectable products in therapy areas like oncology. This shields players from major threats of substitution.
Competitive rivalry: The market is highly competitive due to many global and local players offering low-cost generics. This intensifies competition.
SWOT Analysis
Strength: Strong pipeline of products, ability to manufacture challenging complex injectables, compliance with Good Manufacturing Practices.
Weakness: High R&D and manufacturing costs, intense price competition eroding margins, over-dependence on few generic drugs or API suppliers.
Opportunity: Rising prevalence of chronic diseases, favorable government policies for generics, growth in emerging economies with lower healthcare access.
Threats: Regulatory hurdles, shifts in drug patent expiries impacting product sales, currency fluctuations affecting key markets.
Key Takeaways
The Global Generic Sterile Injectables Market Size is expected to witness high growth, exhibiting CAGR of 10% over the forecast period, due to increasing prevalence of chronic diseases. The generic sterile injectables market size for 2023 is US$ 287.03 Mn.
Regional analysis: North America dominates the market currently due to favorable reimbursement policies and availability of advanced healthcare facilities. However, Asia Pacific is poised to grow at a fastest rate owing to rising medical tourism, low-cost manufacturing and growing private healthcare expenditure in China and India.
Key players: 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. These players have widespread production facilities and market their products across major markets globally.
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