Generic Injectables Market Size, Share & Trends | Industry Analysis Report, 2025

Generic Injectables Market - Snapshot

The global generic injectables market was valued at over US$ 49.0 Bn in 2016 and is projected to expand at a CAGR of around 13.6% during the forecast period from 2017 to 2025. Rise in pressure to increase health care costs, growth in demand for affordable medicines, expected loss of patents during the forecast period, surge in adoption of biosimilar products, increase in research & development activities for the development of complex molecules suitable for injectable dosage forms, and technological advancements in the form of premixes and prefilled syringes are expected to propel the global generic injectables market. However, uncertainty of regulations in the U.S. for large molecule generic injectables, complexity of the formulation, requirement for high initial investment for injectable manufacturing plant, and stringent regulatory requirements governing sterility requirements of injectables are preventing the entry of new players in the global generic injectables market.

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The global generic injectables market has been segmented based on product type, container type, application, route of administration, and region. In terms of product type, the global market has been classified into large molecule injectables, also known as generic biologics or biosimilar products, and small molecule injectables. The large molecule injectables segment has been further divided into monoclonal antibodies (mAB), insulin, and others. The large molecule injectables segment is anticipated to expand at a rapid pace due to expected patent expiry of blockbuster molecules, rise in incidence of cancer, and rapidly increasing new product launches. For instance, Teva Pharmaceuticals Ltd. is engaged in the development of its first biosimilar version of rituximab, Pfizer, Inc., a leading player in the global generic injectables market, has signed an agreement with Biocon for the development of insulin biosimilars.

global generic injectables market
Based on container type, the global generic injectables market has been categorized into vials, ampoules, premixes, prefilled syringes, and others. The vials segment held a major share of the market in 2016. However, the prefilled syringes segment is projected to expand at a rapid pace during the forecast period. This is attributed to increase new product launches in the segment, surge in adoption of technologically advanced products, and rise in self-administration of injectables. Moreover, dose accuracy and ease of administration are major benefits of prefilled syringe container type. Prefilled syringes are largely used for the administration of vaccines, blood stimulants, and therapeutic proteins.

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In terms of application, the global generic injectables market has been classified into oncology, infectious diseases, cardiology, diabetes, immunology, and others. The oncology segment is expected to dominate the global generic injectables market due to rise in incidence of cancer, increase in demand for oncology biosimilars, and large number of pipeline products.

Based on route of administration, the global generic injectables market has been divided into intravenous, intramuscular, subcutaneous, and others. The intravenous segment held a significant share of the market in 2016. However, the intramuscular and subcutaneous segments are expected to expand at a faster pace driven by high demand for self-administered injectables and prefilled syringes.

Geographically, the global generic injectables market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Asia Pacific dominates the global generic injectables market due to high consumption of generic injectable products owing to their affordability over high cost biological and branded products. Moreover, surge in government initiatives to increase adoption of generic products, government support to start a generic medical store, high prevalence of infectious and lifestyle diseases in the region are some factors that are projected to boost the generic injectables market in the region during the forecast period. For example, in 2016, the Government of India launched a scheme named Pradhan Mantri Jan Aushadhi Yojana to support the establishment of generic medical stores in rural areas.

North America is expected to account for the second largest share of the global generic injectables market by 2025 due to expected new abbreviated new drug application (ANDA) approvals by 2020, patent loss of blockbuster biological drugs prescribed in key therapeutic areas such as oncology, and increasing shortages of the generic injectables the U.S. Europe is a favorable market for biosimilar product launches due to well-established regulations. Moreover, government initiatives to reduce the burden of health care cost by supporting the use of generic medicines is making the market expand at a considerable pace.

Major players operating in the global generic injectables market include Pfizer, Inc., Novartis AG (Sandoz International GmbH), Baxter, Fresenius SE & Co. KGaA, Mylan N.V., Teva Pharmaceutical Industries Ltd., Hikma Pharmaceuticals plc, Lupin Ltd., Sanofi, and Biocon. The other prominent players in the global generic injectables market include Dr. Reddy's Laboratories, Aurobindo Pharma, Sagent Pharmaceuticals Inc., Zydus Cadila, GlaxoSmithKline plc, and AstraZeneca plc. These players are expanding their product portfolio by engaging in strategies such as mergers & acquisitions and new product launches by increasing research & development activities.

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