U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis Report By Molecule (Small Molecule, Large Molecule), By Application (Oncology, Immunology, Antidiabetic, Neurology, Cardiovascular), And Segment Forecasts, 2025 - 2030

Market Size & Trends

The U.S. generic injectables pharmaceutical contract manufacturing market size was estimated at USD 3.0 billion in 2024 and is projected to grow at a CAGR of 10.8% from 2025 to 2030. Growth in the market can be attributed to the rising frequency of patent expirations for blockbuster drugs, streamlined regulatory pathways and low cost of generics, and the increasing number of market players entering generic injectables CDMOs. Currently, one of the major factors fueling the market growth is the rising frequency at which injectable medications are losing their patent protection. For instance, in July 2023, the patent for Sanofi's highly successful medication Mozobil expired, leading to the introduction of generic versions of Plerixafor. 

Moreover, growing outsourcing by pharmaceutical companies, growing drug shortage, rising prevalence of cancer and age-related disorders, and increasing investment & expansion of new facilities in the U.S. are among the key factors driving market growth. In addition, smaller to mid-sized pharmaceutical companies increasingly rely on external service providers for their research, development, and manufacturing needs, fueling the trend towards increased outsourcing and creating opportunities for expansion in generic injectables pharmaceutical contract manufacturing. Similarly, emerging R&D activities and trends of drug discovery for generic injectables are expected to drive the market. Furthermore, the manufacturing and supply of injectables are specialized and capital-intensive. Injectables require dedicated manufacturing lines, costing around USD 30 - USD 35 million. Hence, owing to the factors above, the contract manufacturing of generic injectables is gaining traction, thus augmenting the growth of the market.

The COVID-19 pandemic has significantly impacted the pharmaceutical industry, including the sector of generic injectables. This, in turn, affected the manufacturing process of generic injectables, leading to potential supply shortages for injectables, excluding the injectables for COVID-19 treatment. Moreover, regulatory bodies in the U.S. had to prioritize reviewing medical products and drugs for COVID-19 treatment, further delaying the approval of new generic injectables. Furthermore, post-pandemic, the pharmaceutical industry is expected to reach a patent cliff by 2030, with nearly 200 molecules losing exclusivity & 100+ biosimilars in development as of 2023. It further creates opportunities for generic API manufacturers, including over 60 molecules in oncology with complex & high revenue-generating APIs.

Some key companies providing generic injectables pharmaceutical contract manufacturing in the U.S. are Hikma Pharmaceuticals PLC, Pfizer Inc., Fresenius Kabi, Jubilant Pharma Limited, and Baxter among others. The growing presence of these companies expanding their manufacturing facilities to cater to the rising demand for generic injectables is likely to propel market growth.

Molecule Insights

On the basis of molecule segment, the market is segregated into small molecule, and large molecule. In 2024, the large molecule segment dominated the market, accounting for a revenue share of 58.02%. This growth can be attributed to the growing emphasis on tailored treatments and precision medicine is one of the major factors augmenting the growth of the large molecule generic injectable drugs segment in the U.S. Moreover, contract manufacturing specializing in generic injectables provides several benefits to pharmaceutical companies, leading to their increased adoption. The benefits of collaborating with companies specializing in manufacturing include streamlining the development process, offering enhanced manufacturing flexibility, further providing expertise, and decreasing reliance on in-house resources. Furthermore, increasing product launches including biosimilars is one of prominent factors supporting the growth of the segment. For instance, in January 2023, Amgen announced the launch of AMJEVITA a biosimilar to Humira, in the U.S. AMJEVITA was the first generic version of Humira that was approved by the Food and Drug Administration (FDA). Hence, the aforementioned factors are anticipated to support the segment’s growth.

The small molecule segment is anticipated to register the CAGR of 10.40% during the forecast period. Small molecule-based injectable drugs continue to hold an essential position in the treatment of a wide range of illnesses, including cancer, blood disorders, infectious diseases, and cardiovascular ailments. The segment growth can be attributed to the constant developments in new technologies and the growing burden of cancer, blood disorders, infectious diseases, and cardiovascular diseases, among others, increasing innovation and product launches of new generics across the U.S. market. Such factors are anticipated to drive the segment growth.

Application Insights

On the basis of application segment, the market is segregated into oncology, immunology, antidiabetic, neurology, cardiovascular, respiratory, and others. In 2024, the oncology segment dominated the market, accounting for a revenue share of 29.42%. This growth can be attributed to increasing generic product launches and growing number of CMOs focusing on the development of generic injectables for anti-cancer treatment therapy. Additionally, a substantial pipeline of generic products for anti-cancer therapies is in development, with numerous generic drugs set to be introduced to the market. Furthermore, growing significantly due to the extensive use of generic injectables in oncology treatment while providing the efficacy and safety of the reference injectables has fueled the segment growth.

For instance, as per the Lancet Oncology, from 2007 to 2020, the U.S. Food and Drug Administration (FDA) approved 16 oncology biosimilars. It is anticipated that this number will continue to increase in the forecast period, contributing to the expansion of this segment. Furthermore, the growing prevalence of the condition further supports the research and development activities pertaining to abbreviated new drug application (ANDA) of biosimilars for anti-cancer therapeutics.

The neurology segment is anticipated to register the fastest CAGR of 11.64% during the forecast period. This is mainly due to the rise in demand for biosimilars to treat several neurological conditions. Moreover, large scale contract manufacturers are focusing on the development of neurology based biosimilars, thereby supporting the segment’s growth. For instance, in April 2023, Teva Pharmaceuticals and MedinCell announced that the U.S. FDA had granted approval for UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Additionally, the incidence of neurological disorders such as Alzheimer's disease and Parkinson's disease has been steadily increasing over the past decade, which is further anticipated to support the growth of the segment.

Key U.S. Generic Injectables Pharmaceutical Contract Manufacturing Company Insights

The key players operating across the U.S. market are adopting in-organic strategic initiatives such as partnerships, mergers, and acquisitions, etc. The strategies adopted by companies are mergers & acquisitions/joint ventures merger, service launches, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge drives the market growth. Hence, increasing adoption of in-organic strategic initiatives is highly anticipated to boost market share of prominent players operating across the market. For instance, in March 2023, PCI Pharma Services, a biopharmaceutical-based contract manufacturer, announced its intention to invest USD 50 million in expanding its sterile injectables facility located in Rockford, Illinois U.S. Moreover, in January 2024, Fresenius Kabi launched the Posaconazole Injection. These injections are a generic substitute for Noxafil and can be used to treat and prevent fungal infections in children and adults. Posaconazole injection is a new addition to the company’s product portfolio of 30+ anti-infective molecules and is available in the U.S. market.

Recent Developments

• In July 2024, Sodium Acetate Injection was launched by Hikma Pharmaceuticals PLC in the U.S. market. The injection is available in 40 mEq per 20 mL vials and was approved by U.S. FDA with a competitive generic therapy designation, making it eligible for 180 days of exclusive competitive generic therapy.

• In April 2024, Baxter International Inc. mentioned the pharmaceutical portfolio expansion with five injectable product launches in the U.S. market. The new products include Vasopressin in 0.9% Sodium Chloride Injection, Norepinephrine Bitartrate in 5% Dextrose Injection, Vancomycin Injection, Regadenoson Injection pre-filled syringe and Ropivacaine Hydrochloride Injection.

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Report Scope

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. generic injectables pharmaceutical contract manufacturing market report based on molecule and application:

• Molecule Outlook (Revenue, USD Million, 2018 - 2030)

  • Small Molecule

  • Large Molecule

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Immunology

  • Antidiabetic

  • Neurology

  • Cardiovascular

  • Respiratory

  • Others