Generic Injectables Market Report 2025

The generic injectables market size has grown rapidly in recent years. It will grow from $124.61 billion in 2024 to $143.13 billion in 2025 at a compound annual growth rate (CAGR) of 14.9%. The growth in the historic period can be attributed to cost-effectiveness, patent expirations, healthcare access initiatives, market competition, and global pharmaceutical trends.

The generic injectables market size is expected to see rapid growth in the next few years. It will grow to $238.43 billion in 2029 at a compound annual growth rate (CAGR) of 13.6%. The growth in the forecast period can be attributed to the increasing aging population, strategic alliances, regulatory changes, rising healthcare awareness, and market innovation. Major trends in the forecast period include a focus on quality and regulatory compliance, adoption of the 505 (b) (2) regulatory pathway, development of novel drug delivery technologies, collaborations and partnerships in the industry, and increased focus on specialty injectable therapies.

The generic injectables market size is expected to see rapid growth in the next few years. It will grow to $209.47 billion in 2028 at a compound annual growth rate (CAGR) of 13.6%. Anticipated growth in the forecast period is expected due to various factors, notably the expanding aging population, strategic alliances between industry players, regulatory shifts, heightened awareness about healthcare, and a surge in market innovation.

The anticipated increase in cancer and cardiovascular diseases is set to drive the growth of the generic injectable market. Cancer, characterized by uncontrolled cell growth, and cardiovascular diseases affecting the heart and blood vessels are prevalent health concerns. Generic injectables play a vital role in treating these conditions by offering pharmaceutical equivalence to brand-name drugs. In 2022, approximately 74% of the 41 million global deaths attributed to noncommunicable diseases (NCDs) were due to cardiovascular diseases (17.9 million deaths) and cancer (9.3 million deaths). The availability of these injectables enhances treatment accessibility and affordability, contributing to the market's growth.

The expanding population of elderly individuals is expected to fuel the growth of the generic injectables market. As populations age due to increased life expectancy and declining fertility rates, the demand for generic injectables rises. These pharmaceuticals are commonly used in managing health conditions prevalent among older individuals, such as diabetes, cardiovascular diseases, and osteoporosis. For instance, projections indicate that by 2041, Australia's population aged 65 and above will grow by 54% to 6.66 million from an estimated 4.31 million in 2021. This demographic shift drives the demand for generic injectables catering to the healthcare needs of aging populations.

Product innovation emerges as a prominent trend shaping the generic injectables market. Key players in this market focus on advancing generic injectables to maintain competitiveness. In April 2022, Dr. Reddy’s Laboratories, an Indian pharmaceutical company, introduced Treprostinil Injection in the U.S. market. This injection, approved by the U.S. Food and Drug Administration (USFDA), serves as a therapeutic equivalent generic version of Remodulin (treprostinil) Injection. It facilitates a smooth transition for patients requiring a shift from epoprostenol, aiding in the reduction of clinical deterioration.

Major companies in the generic injectables market are forging strategic partnerships and collaborations to fortify their market position. These partnerships, aimed at achieving specific business objectives, play a pivotal role in sustaining market presence. For example, in December 2023, ITAAN Pharma, a Canadian pharmaceutical company specializing in injectable medications, collaborated with ACIC Pharmaceuticals, also based in Canada. This strategic alliance aims to jointly develop generic injectables targeting the North American market, leveraging the strengths of both entities for mutual growth and success.

In April 2022, Hikma Pharmaceuticals PLC, a US-based biopharmaceutical firm, completed the acquisition of Custopharm Inc for $425 million. This strategic move by Hikma is geared towards broadening its portfolio of injectable medications while bolstering its research and development capabilities. Custopharm, also based in the US, specializes in generic pharmaceutical products, notably in the realm of generic injectables, aligning well with Hikma's objectives for portfolio expansion and R&D advancement.

Major companies operating in the generic injectables market include Baxter International Inc., Sanofi SA, AstraZeneca plc., Fresenius Medical Care AG & Co. KGaA, Johnson & Johnson, Merck & Co. Inc., Biocon Limited, Lupin Limited, Dr. Reddy's Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Cipla Limited, Aurobindo Pharma Limited, Samsung Biologics Co. Ltd., Piramal Pharma Limited, Bristol-Myers Squibb Company, Pfizer Inc., Hikma Pharmaceuticals PLC, Par Pharmaceutical, Pharmascience Inc., SAGENT Pharmaceuticals, AmerisourceBergen Corporation, Hospira Inc., Sandoz International GmbH, Singota Solutions Inc., MVASI Bevacizumab-awwb Syringes, Mylan N.V., Sun Pharmaceutical Industries Ltd., Endo International plc, Akorn Pharmaceuticals Inc., Wockhardt Limited.

Generic injectables, also known as sterile injectables, are medications identical in dosage, strength, performance, intended use, potential side effects, and method of administration to branded injectables. These drugs demonstrate bioequivalence, ensuring they function in the same way as their brand-name counterparts, delivering equivalent therapeutic benefits.

Within the realm of generic injectables, diverse categories exist, including monoclonal antibodies, cytokines, insulin, vaccines, and more. Monoclonal antibodies, for instance, are artificial proteins mirroring natural antibodies in the human body. They find application in treating various conditions such as breast cancer, leukemia, asthma, macular degeneration, arthritis, Crohn's disease, and transplant-related issues.

These injectables are packaged in various containers such as vials, ampoules, premix solutions, and prefilled syringes. Their administration involves different routes such as intravenous, intramuscular, subcutaneous, and others. These medications are distributed through channels including hospital pharmacies, retail pharmacies, drug stores, and online prescription outlets. They serve diverse medical conditions spanning oncology, diabetes, infectious diseases, blood disorders, musculoskeletal disorders, hormonal disorders, pain management, central nervous system (CNS) ailments, and cardiovascular diseases.

North America was the largest region in the generic injectable market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the generic injectables market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the generic injectables market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The generic injectables market consists of sales of drug solutions, dry solid injectables, drug solids suspended in a liquid medium, drug suspension for injection, drug emulsions, and biological injectables. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 3-5 business days.