The U.S. generic injectables pharmaceutical contract manufacturing market size was valued at USD 2.65 Billion in 2023 and is poised to grow from USD 2.94 Billion in 2024 to USD 7.46 Billion by 2033, at a CAGR of 10.9% during the forecast period (2024-2033).
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U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Key Takeaways:
- The large molecule segment held the dominant revenue share of 62.3% in 2023.
- The small molecule segment is anticipated to register a stable CAGR of 10.5% during the forecast period.
- The oncology segment held the largest revenue share of 29.9% in 2023 in the U.S. generic injectables pharmaceutical contract manufacturing market.
- On the other hand, the neurology segment is expected to register the fastest CAGR of 11.3% during the forecast period.
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The major factor driving the market growth is the increasing frequency of injectables pharmaceutical contract manufacturing space. For example, in March 2022, in the U.S., Takeda Pharmaceutical Company Limited's blockbuster medication Velcade saw its patent exclusivity expire, owing to the introduction of generic additives.
The U.S. generic injectables pharmaceutical contract manufacturing market includes specialized contract manufacturers producing non-brand name injectable medications for pharmaceutical industries. This industry drives intricate manufacturing demands, patent expirations, technological advancements, and investment in research and development. It serves gene and cell therapies, ADC markets, HPAPI, and personalized medicines. Stakeholders collaborate to ensure accessibility, quality production, and regulatory compliance to affordable medications, with an ongoing need in global healthcare and a growing demand for cost-effective injectable drugs.
Major segments involve oncology-focused products and large molecule drugs, experiencing continuous innovation and growth in the pharmaceutical market further contributing to propel the U.S. generic injectables pharmaceutical contract manufacturing market.
In addition, the supply and manufacturing of injectables are capital-intensive and specialized. Injectables need dedicated manufacturing lines, which can cost millions. The contract manufacturing of generic injectables is gaining traction, leading to the aforementioned factors driving the market growth. In addition, the manufacturing demands of the pharmaceutical industry increased investments in pharmaceutical R&D activities to propel the generic injectables pharmaceutical contract manufacturing market.
U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Trends:
The increasing preference towards patent expirations and advanced technologies propels market growth.
The increasing demand for personalized medicines and cell and gene therapies contributed to driving the market growth.
The increasing demand for an increase in Antibody-drug Conjugates (ADC) and High-potency Active Pharmaceutical Ingredients (HPAPI).
Various stakeholders collaborate to address regulatory standards, meet healthcare needs for affordable and accessible injectable medications, and ensure quality production further enhancing the market growth.
U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Segment Insights
By molecule types
The large molecule segment held the dominant market share of 62.3% in 2023. The segment growth is driven by the growing emphasis on precision medicine and tailored treatment in the U.S. In addition, increasing product launches such as biosimilars is a key factor driving market growth. For example, in January 2023, in the U.S., Amgen announced the launch of a biosimilar to Humira, AMJEVITA. This was the first generic version of Humira approved by the FDA. These factors are expected to drive the segment growth.
The small molecule segment is expected to be the fastest during the forecast period. Small molecule-based injectable drugs hold a prominent position in the treatment of a broad range of illnesses, such as cardiovascular ailments, infectious diseases, blood diseases, and cancers. In addition, due to the increasing rates of generics launched in the U.S., the high growth of the segment is increasing rapidly. By entering the manufacturing business of generic injectables, various contract manufacturers are garnering profits. These are the major factors driving segment expansion during the forecast period.
By application types
The oncology segment led the U.S. generic injectables pharmaceutical contract manufacturing market share of 29.9% in 2023. The market segment is driven by increasing generic product launches concerning cancer treatment. Many contract manufacturers are concentrating on improving generic injectables for anti-cancer treatment therapy. In addition, with various generic drugs set to be introduced to the market, a substantial pipeline of generic products for anti-cancer therapies is in development. Moreover, the increasing prevalence of disease further enhances research and development activities about reduced new drug application of biosimilars for anti-cancer therapeutics are further expected to drive the segment growth during the forecast period.
The neurology segment is expected to grow fastest during the forecast period. The rising demand for biosimilars to treat various neurological diseases has contributed to driving the market growth. In addition, a large quantity of contract manufacturers are concentrating on the advancement of neurology-based biosimilars and are further expected to support the neurology segment growth. For example, in April 2023, for treating schizophrenia in adults, MedinCell and Teva Pharmaceuticals announced that the FDA had granted approval for UZEDY (risperidone) extended-release injectable suspension in the U.S. In addition, the increasing prevalence of neurological diseases, such as Parkinson's disease and Alzheimer's disease has been increasing steadily during the forecast period which is further expected to drive the segment growth.
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U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Company Insights
Some of the major companies in the generic injectables pharmaceutical contract manufacturing market are PCI Pharma Services, Baxter, Jubilant Pharma Limited, Sandoz AG, Fresenius Kabi, Pfizer Inc., Hikma Pharmaceuticals plc, and others. These major players operating in the market are undertaking various initiatives such as mergers & acquisitions, partnerships, collaborations, product launches, and others to increase the reach of their services and strengthen their market presence. These are the major strategic initiatives enhancing the industry dynamics. For instance, in March 2023, a biopharmaceutical contract manufacturer, PCI Pharma Services announced its intention to invest USD 50 million in expanding its sterile injectables facility.
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Geriatric Medicine Market : The global geriatric medicine market size was valued at USD 158.90 billion in 2023 and is anticipated to reach around USD 333.64 billion by 2033, growing at a CAGR of 7.7% from 2024 to 2033.
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Pharmaceutical Water Market : The global pharmaceutical water market size was valued at USD 39.85 billion in 2023 and is anticipated to reach around USD 96.97 billion by 2033, growing at a CAGR of 9.3% from 2024 to 2033.
Personalized Medicine Market : The global personalized medicine market size was valued at USD 530.11 billion in 2023 and is anticipated to reach around USD 1,176.66 billion by 2033, growing at a CAGR of 8.30% from 2024 to 2033.
Oncology Market ; The global oncology market size was estimated at USD 222.36 billion in 2023 and is projected to hit around USD 521.60 billion by 2033, growing at a CAGR of 8.9% during the forecast period from 2024 to 2033.
U.S. Pharmaceutical Market : The U.S. pharmaceutical market size was valued at USD 602.19 billion in 2023 and is projected to surpass around USD 1,093.79 billion by 2033, registering a CAGR of 6.15% over the forecast period of 2024 to 2033.
Some of the prominent players in the U.S. generic injectables pharmaceutical contract manufacturing market include:
- Hikma Pharmaceuticals plc
- Pfizer Inc.
- Fresenius Kabi
- Sandoz AG
- Jubilant Pharma Limited
- Baxter
- PCI Pharma Services
- Gland Pharma Limited (USA)
- Dr. Reddy’s Laboratories Ltd.
- Grand River Aseptic Manufacturing
U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Recent Developments
- On 20 May 2024, the multinational pharmaceutical group, Hikma Pharmaceuticals PLC is excited to announce the establishment of HIKMA ESPAÑA, S.L.U. (Hikma Spain). This marks Hikma’s official entry into Spain, which has a generic injectable market size of approximately $860 million1. The entry into the Spanish market strengthens the growing presence in Europe. This involved high-quality manufacturing plants in North Africa, Europe, and North America.
- In July 2022, Drugmaker ViiV Healthcare will allow 90 countries to access affordable generic versions of its bi-monthly HIV prevention shot as part of a new licensing agreement with the Medicines Patent Pool.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. generic injectables pharmaceutical contract manufacturing market
Molecule Type
- Small Molecule
- Large Molecule
Application
- Oncology
- Immunology
- Antidiabetic
- Neurology
- Cardiovascular
- Respiratory
- Others
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