Global Sterile Injectable Contract Manufacturing Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2030

The global sterile injectable contract manufacturing market is on the verge of remarkable expansion, with a projected CAGR of 12% during the assessment period from 2023 to 2030. This substantial growth is expected to drive the market's total value to reach US$30 billion by the end of 2030.

Market Analysis in Brief

The increasing demand for sterile injectables has given rise to a surge in outsourced agreements between contract manufacturers and original drug sponsors, propelling the growth of the sterile injectable contract manufacturing industry. Several factors, including rapid drug absorption, reduced risk of drug degradation, quicker drug action, and lower drug concentration, have driven the demand for commercial injectable doses. Pharmaceutical companies with a focus on injectable manufacturing are gaining traction by offering development support for large molecule injectable drugs, monoclonal antibody therapies, and drugs for infectious diseases. Faster and more cost-effective research and development cycles for generic injectables, along with advances in treatments for rare diseases, are also contributing to the expansion of injectable contract manufacturers globally. However, several pharmaceutical giants and established contract manufacturers have faced challenges, including delays in the drug development process, risks of non-compliance with on-market products, and disruptions to business continuity.

Key Report Findings

• The sterile injectable contract manufacturing market is poised for massive revenue expansion from 2023 to 2030.
• The small molecule segment has claimed the largest market share, attributed to its extensive use, established production processes, and high demand for large-scale manufacturing.
• The intravenous (IV) mode of application dominates the sterile injectable contract manufacturing market due to its widespread use in critical medical conditions and its efficiency in delivering rapid and precise treatments.
• North America is expected to maintain its leadership, while Asia Pacific's sterile injectable contract manufacturing market will experience the most robust growth by 2030.

Growth Drivers

• Growing Pipeline and Approvals of Injectables: The expanding pipeline and approvals of injectables are significant drivers for the sterile injectable contract manufacturing industry. Pharmaceutical companies worldwide are increasingly concentrating on developing injectable drugs due to their numerous benefits, including quicker onset of action, precise dosing, and enhanced patient compliance. Consequently, the global pipeline of injectable drugs has substantially grown, spanning a wide range of therapeutic areas such as oncology, diabetes, and autoimmune diseases, fostering the growth of the injectables market.
• Increasing Demand for Cell & Gene Therapies: The rising demand for cell therapies significantly contributes to the growth of the sterile injectable contract manufacturing market. Cell and gene therapies have emerged as revolutionary treatment options for various genetic and chronic diseases, offering the potential for personalized and curative treatments. As the pipeline of these innovative therapies expands, there is a growing need for specialized manufacturing capabilities to produce sterile injectable products that adhere to strict regulatory requirements. Contract manufacturing organizations with expertise in sterile injectable manufacturing and specialized facilities are well-placed to cater to the unique manufacturing requirements of cell and gene therapies, making them essential as these therapies advance.

Overview of Key Segments

• Small Molecule Category Leads the Way: The small molecule segment holds the largest market share in the sterile injectable contract manufacturing market. Small molecule drugs are the most widely used and established class of pharmaceutical products, covering a broad range of therapeutic areas. Their well-known pharmacological properties and simple chemical structures make them more amenable to large-scale manufacturing and regulatory approval. The need for large-scale manufacturing and well-optimized production processes makes small molecule injectables a focal point for contract manufacturing organizations.
• IV Administration Route Remains Preferred: The intravenous (IV) route of administration continues to capture the largest market share in the sterile injectable contract manufacturing market due to its critical role in delivering rapid and precise treatments, particularly in emergency and hospital settings. The ongoing demand for IV injectables in the treatment of chronic conditions also contributes to its significant market share. CMOs specializing in large-scale production and reliable supply chain management are essential partners for pharmaceutical companies seeking to meet the growing demand for intravenous drugs.

Growth Opportunities Across Regions

• North America Holds Commanding Share: North America has claimed the largest market share in the Sterile Injectable Contract Manufacturing market due to its well-developed pharmaceutical and biotechnology industry, strong focus on research and development, and favorable regulatory environment. The United States Food and Drug Administration (FDA), and Health Canada have stringent regulations and quality standards for drug manufacturing, making them attractive destinations for contract manufacturing services. The region's strategic geographical location also contributes to its dominance, enabling efficient distribution and supply chain management.
• Asia Pacific Develops a Lucrative Market: Asia Pacific is expected to grow at a significant CAGR in the sterile injectable contract manufacturing market. The region's pharmaceutical industry has experienced substantial growth due to rising population, increased healthcare spending, and improved access to healthcare services. Asia Pacific offers cost advantages for pharmaceutical manufacturing, with lower labor costs and modern manufacturing facilities. Supportive government policies have encouraged foreign investment and the development of the pharmaceutical industry in the region, making it an attractive destination for contract manufacturing services.

Challenges Related to Quality Control

Challenges related to quality control pose significant restraints on the growth of the sterile injectable contract manufacturing market. Ensuring stringent quality standards is essential for producing sterile injectable drugs to guarantee patient safety and regulatory compliance. Maintaining consistent quality control throughout manufacturing can be complex and challenging. The global regulatory landscape has become increasingly stringent, demanding greater transparency and accountability in manufacturing processes.

Sterile Injectable Contract Manufacturing Market: Competitive Landscape

Leading players in the Sterile Injectable Contract Manufacturing market include Catalent, Inc., Grifols S.A., Aenova Group, Vetter Pharma, Recipharm AB, Baxter, Boehringer Ingelheim, Fresenius Kabi, Unither Pharmaceuticals, Famar, Cipla Ltd., and NextPharma Technologies, among others.