The global sterile injectable contract manufacturing market was valued at USD 28.40 Billion in 2024 driven by the rising demand for biopharmaceuticals across the globe. It is expected to grow at a CAGR of 10.50% during the forecast period of 2025-2034 and attain a market value of USD 77.08 Billion by 2034.
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Historical Year
Forecast Year
The growing complexity of biopharmaceuticals is driving the demand for specialized sterile injectable contract manufacturers. Enhancements in automated manufacturing processes and freeze-drying techniques are improving efficiency, further fueling market expansion.
In July 2023, WuXi STA, a contract research, development, and manufacturing organization (CRDMO) launched a high-potency sterile injectable production line in China, expanding its capacity to meet the increasing demand for complex medications. This development aligns with the rising need for customized manufacturing solutions, which is expected to accelerate market growth in the forecast period.
North America is expected to dominate the market due to its robust pharmaceutical infrastructure, significant biopharmaceutical activity and favorable environment for clinical trials solidifies the market presence of the region.
Sterile injectable contract manufacturing involves outsourcing the production of injectable medications that require stringent sterilization and quality controls. The market growth is driven by factors such as surging demand for biopharmaceuticals, particularly vaccines and monoclonal antibodies as they offer several therapeutic benefits. Additionally, advancements in automation and freeze-drying technologies are enhancing efficiency and safety in production. Rising global investments in pharmaceutical infrastructure are expected to fuel market growth in the forecast period.
Rising Demand for Biopharmaceuticals Boost Market Growth
The growing demand for biopharmaceuticals, such as monoclonal antibodies and vaccines, is significantly driving the market. As these products become more complex, the need for specialized manufacturers adept at managing stringent sterilization and production processes is rising. Outsourcing production allows biopharmaceutical companies to scale operations efficiently, thereby supporting the broader growth of the industry.
Several trends and developments are being observed in the market to enhance the current situation. Some of the noteworthy trends are as follows:
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Molecule Type
Market Breakup by Route of Administration
Market Breakup by Application
Market Breakup by End User
Market Breakup by Region
Market Segmentation Based on End User Is Likely to Witness Substantial Growth
The market breakup by end user includes pharmaceutical companies, biopharmaceutical companies, and others. Among these, the biopharmaceutical companies segment is poised to lead the market share due to the increasing demand for biologics, including vaccines and monoclonal antibodies, which require specialized sterile injectable manufacturing. The growing number of biopharmaceutical firms developing complex therapeutics, along with advancements in biologic drug production, is expected to drive this segment's growth in the forecast year.
Based on region, the market report covers North America, Europe, Asia Pacific, Latin America, the Middle East and Africa. Among these, North America is expected to dominate the market share. The significant presence of large corporations in the region generates new opportunities for expansion in the sterile injectable contract manufacturing sector. The region also offers more affordable market conditions for clinical trials, creating opportunities for the sterile injectable contract manufacturing market in the forecast period.
The key features of the market report include patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies are:
Founded in 1897 and based in Basel, Switzerland, the company has a diverse product portfolio. It supports parenteral drug development by addressing challenges posed by the increasing complexity of biotherapeutics and an evolving regulatory landscape. Its services include cell and gene therapies, biologics, and small molecule manufacturing to facilitate drug development and production.
Founded in 2006, Thermo Fisher Scientific is headquartered in Waltham, Massachusetts, USA. The company offers solutions in life sciences, diagnostics, and pharmaceutical development, including sterile injectables, biologics, and customized drug manufacturing services.
Founded in 2007 and headquartered in Somerset, NJ, USA, Catalent specializes in drug delivery solutions, biologics, and sterile injectable contract manufacturing. Its services include dosage form development, biologic drug substance production, and clinical supply services.
WuXi Biologics is a multinational biologics company founded in the year 2010 and is headquartered in Wuxi, China. It provides end-to-end solutions, biologics discovery, development, and manufacturing for monoclonal antibodies, cell therapies, and vaccine production, supporting global pharmaceutical and biotech companies.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other companies include Samsung Biologics, Siegfried Holding AG, Fujifilm Diosynth Biotechnologies, Recipharm AB, and Baxter BioPharma Solutions.
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2024 |
| Historical Period | 2018-2024 |
| Forecast Period | 2025-2034 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Molecule Type |
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| Breakup by Route of Administration |
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| Breakup by Application |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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+1-415-325-5166
Australia
63 Fiona Drive, Tamworth, NSW
+61-448-061-727
India
C130 Sector 2 Noida, Uttar Pradesh 201301
+91-723-689-1189
Philippines
40th Floor, PBCom Tower, 6795 Ayala Avenue Cor V.A Rufino St. Makati City, 1226.
+63-287-899-028, +63-967-048-3306
United Kingdom
6 Gardner Place, Becketts Close, Feltham TW14 0BX, Greater London
+44-753-713-2163
Vietnam
193/26/4 St.no.6, Ward Binh Hung Hoa, Binh Tan District, Ho Chi Minh City
+84-865-399-124
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