Generic Injectables Market Share, Size and Growth Analysis By 2029

The generic injectables sector is anticipated to grow significantly, reaching a valuation of US$ 150.65 billion by 2028, up from US$ 74.73 billion in 2021. This growth represents a compound annual growth rate (CAGR) of 10.5% from 2021 to 2028.

Several factors are propelling the expansion of the generic injectables market, including low research and development (R&D), marketing, and manufacturing costs, alongside a rising demand for cost-effective medications. However, the stringent inspection protocols for prefilled injections pose challenges to the market's growth.

Generic injectables are considered to be as safe and effective as their branded counterparts due to their bioequivalence, yet they are not protected by patents for various reasons. These drugs can only be manufactured for commercial purposes after the original branded drug's patent has expired. Since the drug molecules in both branded and generic formulations are essentially the same, the R&D costs associated with generic injectables are minimal or nonexistent. This reduction in initial R&D expenses enables manufacturers to offer generic injectables at significantly lower prices. According to the US FDA, the presence of a single generic competitor can lead to a price reduction of approximately 30%, while the introduction of five generics can result in price drops of around 85%. Furthermore, generic injectables contributed to savings of US$ 2.2 trillion for the US healthcare system between 2009 and 2019. A report from the Congressional Budget Office indicated that the pharmaceutical industry invested US$ 83 billion in R&D in 2019. However, generic injectables do not require the repetition of clinical trials to prove their safety and efficacy, which further contributes to their affordability.

Moreover, the approval timeline for generic medications is generally shorter than that for branded drugs. In 2019, the US FDA approved 107 first generic drugs and 110 complex generic drugs, which accounted for 11% of all generic drug approvals that year. Overall, the generic drug program approved or tentatively approved a total of 1,014 generic drug applications in 2019. The development of a new chemical entity typically takes nearly a decade, a process that is circumvented in the creation of generic injectables. Consequently, the lower costs associated with generic injectables are a significant draw for new entrants into the market, further stimulating growth in this sector.

Additionally, the impending expiration of patents for branded injectables in various regions is expected to create numerous lucrative opportunities for manufacturers of generic injectables. A recent report by Business Standard highlighted that patented drugs valued at US$ 240 billion are set to lose their patent protection globally in the near future. In India, the shortage of branded medications and the expiration of patents have encouraged generic injectable manufacturers to innovate with advanced drug delivery systems, such as self-injection devices. For instance, Biological E Limited, a biotechnology and biopharmaceutical firm based in Hyderabad, is expanding its portfolio by adding 20 new routine and injectable products. As a result, companies in the generic injectables market are exploring regulated markets and other regions to enhance their revenue streams and ensure financial stability. Furthermore, manufacturers are preparing for future challenges by maintaining robust supply chains to mitigate vulnerabilities similar to those experienced during the COVID-19 pandemic. For example, Zydus Cadila is significantly lowering the price of its generic version of remdesivir, known as Remdac. Thus, the approaching expiration of patents for branded drugs is likely to present substantial opportunities for generic drug manufacturers, including those specializing in injectables.

The generic injectables market is categorized by product type into large molecule injectables and small molecule injectables. In 2021, the large molecule injectables segment held a larger share of the market, attributed to the increasing adoption of biologics in healthcare and advancements in monoclonal antibodies and antibody-drug conjugates (ADCs) in drug development.

In terms of container type, the global generic injectables market is divided into vials, premix, prefilled syringes, ampoules, and others. The vials segment is expected to lead the market in 2021, driven by heightened health awareness and the rising incidence of new life-threatening diseases.

When categorized by application, the global generic injectables market includes oncology, infectious diseases, cardiology, diabetes, immunology, and others. The oncology segment is projected to capture the largest market share in 2021, fueled by the increasing incidence of cancer and the launch of new drugs, alongside initiatives from leading global players that are contributing to the overall growth of this market segment.

Based on the route of administration, the global generic injectables market is classified into intravenous, intramuscular, subcutaneous, and others. The intravenous route is expected to dominate the market share in 2021, driven by the rising prevalence of chronic diseases and an increasing number of product launches, which are propelling demand for this administration route.

Key secondary sources utilized in the preparation of the report on the generic injectables market include the National Institutes of Health (NIH), National Healthcare Service (NHS), Centers for Disease Control and Prevention (CDC), Statistics Canada 2020, National Center for Biotechnology Information, National Cancer Institute, Globocan Statistics 2020, World Bank Data, American Association of Retired Persons (AARP), Association for Accessible Medicines (AAM), Plastic Packaging Facts Organization, Italian National Institute of Statistics, Australian Institute of Health and Welfare, and the World Health Organization (WHO).