U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market (By Molecule Type: Small Molecule, Large Molecule; By Application) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. generic injectables pharmaceutical contract manufacturing market was surpassed at USD 2.66 billion in 2023 and is expected to hit around USD 7.36 billion by 2033, growing at a CAGR of 10.72% from 2024 to 2033.

Key Pointers

• The large molecule segment held the largest revenue share of 63% in 2023. 
• The small molecule segment is expected to expand at a remarkable CAGR of 10.55% during the forecast period.
• The oncology segment held the largest revenue share of 29% in 2023.
• The neurology segment is expected to grow at a remarkable of 11.38% from 2024 to 2033.

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Overview

The U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market represents a pivotal segment within the broader pharmaceutical industry, marked by its dynamic growth, evolving regulatory landscape, and strategic significance in the provision of affordable healthcare solutions.

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

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Growth 

Expanding Healthcare Needs

• The evolving healthcare landscape, including the aging population and the increasing prevalence of chronic diseases, necessitates a steady supply of injectable medications. Contract manufacturers are well-positioned to meet these growing healthcare needs by ensuring a consistent and diverse portfolio of generic injectables.

Pharmaceutical Supply Chain Resilience:

• Recent disruptions to the global pharmaceutical supply chain have prompted a heightened focus on supply chain resilience. Contract manufacturing offers flexibility and redundancy in production, contributing to a more resilient and robust pharmaceutical supply chain.

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Dynamics

Driver

• Market Growth: The market continues to experience robust growth due to increasing demand for cost-effective healthcare solutions and the growing prominence of generic medications. This dynamic is fueled by factors such as an aging population, rising chronic diseases, and the need to control healthcare expenditure.
• Strategic Alliances: Collaborations, partnerships, and acquisitions between pharmaceutical companies and contract manufacturing organizations (CMOs) are dynamic strategies employed to enhance manufacturing capabilities, expand product portfolios, and gain access to new markets.

Restraint

• Regulatory Hurdles and Compliance Costs: Compliance with stringent regulatory requirements, especially those set forth by the U.S. FDA, can be a significant restraint. Meeting and maintaining compliance demands substantial investments in quality control, documentation, and facility upgrades, which can strain financial resources.
• Competition and Pricing Pressures: Intense competition among pharmaceutical companies and CMOs can lead to pricing pressures. Contract manufacturers may face demands for lower production costs, which can be challenging to meet while maintaining quality standards.

Opportunities

• Rising Demand for Generic Injectables: The continued growth in demand for cost-effective healthcare solutions positions generic injectables as a prime opportunity. Contract manufacturers can capitalize on this demand by expanding their production capabilities and diversifying their product portfolios.
• Emerging Therapeutic Areas: The expansion of injectable medications into emerging therapeutic areas, such as personalized medicine, targeted therapies, and immunotherapies, presents opportunities for specialized contract manufacturers.

Molecule Type Insights

The large molecule segment held the largest revenue share of 63% in 2023. large molecules, often referred to as biologics, are a distinct category of injectable pharmaceuticals. These molecules are considerably larger and more complex than small molecules, comprising proteins, peptides, and monoclonal antibodies. Large molecule injectables have gained prominence in recent years, particularly in the field of biopharmaceuticals and biosimilars. Their manufacturing requires specialized facilities and expertise due to the intricacies involved in bioprocessing and cell culture techniques. As such, contract manufacturing of large molecule injectables, while growing, is limited to CMOs with the necessary capabilities and infrastructure.

The small molecule segment is expected to expand at a remarkable CAGR of 10.55% during the forecast period. Small molecules are typically characterized by their low molecular weight and are chemically synthesized. They constitute a significant portion of the generic injectables market, offering a broad spectrum of therapeutic options. The production of small molecule generic injectables involves well-established manufacturing processes and technologies, making them more accessible for contract manufacturing organizations (CMOs) to handle.

Application Insights

The oncology segment has held a maximum revenue share of 30% in 2023 in the U.S. generic injectables pharmaceutical contract manufacturing market. Oncology, a key domain within the generic injectables market, focuses on the diagnosis and treatment of cancer. The production of injectable oncology medications requires precise formulations and sterile manufacturing processes. Contract manufacturing organizations (CMOs) play a vital role in producing generic injectable oncology drugs, offering pharmaceutical companies the capacity and expertise needed to meet the increasing demand for these life-saving treatments. The dynamic nature of cancer research and treatment advancements necessitates flexible and responsive contract manufacturing solutions.

For instance, from 2007 to 2020, the U.S. Food and Drug Administration (FDA) approved 16 oncology biosimilars.

The neurology segment is expected to register the fastest CAGR of 11.38% during the forecast period. Injectable pharmaceuticals are pivotal in addressing a range of neurological disorders and conditions. From pain management to the treatment of neurodegenerative diseases like multiple sclerosis and Parkinson's disease, neurology represents a diverse and vital sector of the generic injectables market. Contract manufacturers specializing in neurology-related injectables contribute to the production of essential therapies, ensuring that patients receive consistent and reliable treatments. The intricacies of neurological disorders require stringent quality control and adherence to regulatory standards, making contract manufacturing expertise in this area particularly valuable.

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 treating schizophrenia in adults.

U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Key Companies

• 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 Report Segmentation

By Molecule Type 

• Small Molecule
• Large Molecule

By Application 

• Oncology
• Immunology
• Antidiabetic
• Neurology
• Cardiovascular
• Respiratory
• Others