Sterile Injectable Contract Manufacturing Market Size is valued at USD 13.1 Bn in 2023 and is predicted to reach USD 22.9 Bn by the year 2031 at an 7.5% CAGR during the forecast period for 2024-2031.
Sterile injectable contract manufacturing plays a vital role in the pharmaceutical industry by enabling the production of safe and effective injectable medications. This process involves outsourcing the manufacturing of sterile injectable drugs to specialized contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs). These organizations have the necessary facilities, expertise, and technologies to ensure that sterile injectable products meet stringent regulatory standards and are safe for patient use. The manufacturing of sterile injectables requires complex procedures and strict aseptic techniques to maintain sterility, making this outsourcing essential for pharmaceutical companies.
The demand for sterile injectable contract manufacturing is growing, driven by the increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular conditions. As these diseases become more common, the need for effective injectable therapies rises, leading to higher demand for sterile injectables. Outsourcing to specialized CMOs or CDMOs allows pharmaceutical companies to focus on research, marketing, and distribution while ensuring that the production of these critical medications is handled by experts, offering flexibility, scalability, and cost-effectiveness.
The sterile injectable contract manufacturing market is segmented by molecules type, therapeutic applications, route of administration, end users and by region. By molecules type the market is segmented into biologics, small molecules, by therapeutic applications market is cancer, diabetes, cardiovascular disease, neurological disorders, infectious disorders, musculoskeletal disorders, others. By route of administration market is categorized subcutaneous, intravenous, intramuscular, others. By end users the market is categorized into pharmaceutical companies, biopharmaceutical companies, and others.
The biologics segment is driving significant growth in the sterile injectable contract manufacturing market due to the increasing demand for biologics, which are effective in treating complex diseases like cancer and autoimmune disorders. The complexity of biologics manufacturing, requiring specialized processes and strict sterility, often leads pharmaceutical companies to outsource production to CMOs with the necessary expertise and facilities. Rapid advancements in biotechnology are also fueling the demand for sterile injectables, as new biologic drugs enter the market. The growing trend of outsourcing biologics manufacturing to CMOs, driven by cost reduction and streamlined production, further expands the market, particularly in this segment.
The infectious disorders segment is experiencing significant growth in the sterile injectable contract manufacturing market due to the rising global prevalence of infectious diseases like HIV/AIDS, hepatitis, malaria, and tuberculosis, driven by factors such as population growth and climate change. The emergence of new pathogens, like the COVID-19 virus, has further highlighted the need for a robust supply of injectable anti-infectives, accelerating demand for contract manufacturing services to produce vaccines and treatments. Injectable antibiotics and antivirals are preferred for their rapid therapeutic effects and improved bioavailability, making them crucial for managing acute and severe infections.
The growth of the sterile injectable contract manufacturing market in North America is driven by several key factors, including the region's well-established network of CMOs with state-of-the-art facilities capable of producing complex biologics and vaccines. The stringent yet favorable regulatory environment, governed by agencies like the FDA and Health Canada, ensures compliance with high-quality standards, making North America a preferred location for manufacturing. Additionally, the rising prevalence of chronic diseases and the growing demand for biologics are prompting pharmaceutical companies to outsource production to specialized manufacturers. Strategic collaborations and acquisitions further enhance the region's manufacturing capabilities, enabling it to meet the increasing demand for sterile injectables.
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Report Attribute |
Specifications |
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Market Size Value In 2022 |
USD 13.1 Bn |
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Revenue Forecast In 2031 |
USD 22.9 Bn |
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Growth Rate CAGR |
CAGR of 7.54% from 2024 to 2031 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
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Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Molecules Type, Therapeutic Applications, Route of Administration , End Users |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; Southeast Asia |
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Competitive Landscape |
Aenova Group, Baxter, Boehringer Ingelheim, Catalent, Cipla, Fresenius Kabi, Famar, Grifols, NextPharma Technologies, Recipharm, Unither Pharmaceuticals, Vetter Pharma |
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Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Sterile Injectable Contract Manufacturing Market Snapshot
Chapter 4. Global Sterile Injectable Contract Manufacturing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis
Chapter 5. Market Segmentation 1: by Molecules Type Estimates & Trend Analysis
5.1. by Molecules Type & Market Share, 2019 & 2031
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Molecules Type:
5.2.1. Biologics
5.2.2. Small molecules
Chapter 6. Market Segmentation 2: by Therapeutic Applications Estimates & Trend Analysis
6.1. by Therapeutic Applications & Market Share, 2019 & 2031
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Therapeutic Applications:
6.2.1. Diabetes
6.2.2. Cardiovascular Disease
6.2.3. Neurological Disorders
6.2.4. Infectious Disorders
6.2.5. Musculoskeletal Disorders
6.2.6. Others
Chapter 7. Market Segmentation 3: by Route of Administration Estimates & Trend Analysis
7.1. by Route of Administration & Market Share, 2019 & 2031
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Route of Administration:
7.2.1. Subcutaneous
7.2.2. Intravenous
7.2.3. Intramuscular
7.2.4. Others
Chapter 8. Market Segmentation 4: by End Users Estimates & Trend Analysis
8.1. by End Users & Market Share, 2019 & 2031
8.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by End Users:
8.2.1. Pharmaceutical Companies
8.2.2. Biopharmaceutical Companies
8.2.3. Others
Chapter 9. Sterile Injectable Contract Manufacturing Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. North America
9.1.1. North America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Molecules Type, 2023-2031
9.1.2. North America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Therapeutic Applications, 2023-2031
9.1.3. North America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Route of Administration, 2023-2031
9.1.4. North America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by End Users, 2023-2031
9.1.5. North America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031
9.2. Europe
9.2.1. Europe Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Molecules Type, 2023-2031
9.2.2. Europe Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Therapeutic Applications, 2023-2031
9.2.3. Europe Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Route of Administration, 2023-2031
9.2.4. Europe Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by End Users, 2023-2031
9.2.5. Europe Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031
9.3. Asia Pacific
9.3.1. Asia Pacific Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Molecules Type, 2023-2031
9.3.2. Asia Pacific Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Therapeutic Applications, 2023-2031
9.3.3. Asia-Pacific Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Route of Administration, 2023-2031
9.3.4. Asia-Pacific Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by End Users, 2023-2031
9.3.5. Asia Pacific Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031
9.4. Latin America
9.4.1. Latin America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Molecules Type, 2023-2031
9.4.2. Latin America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Therapeutic Applications, 2023-2031
9.4.3. Latin America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Route of Administration, 2023-2031
9.4.4. Latin America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by End Users, 2023-2031
9.4.5. Latin America Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031
9.5. Middle East & Africa
9.5.1. Middle East & Africa Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Molecules Type, 2023-2031
9.5.2. Middle East & Africa Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Therapeutic Applications, 2023-2031
9.5.3. Middle East & Africa Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by Route of Administration, 2023-2031
9.5.4. Middle East & Africa Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by End Users, 2023-2031
9.5.5. Middle East & Africa Sterile Injectable Contract Manufacturing Market Revenue (US$ Million) Estimates and Forecasts by country, 2023-2031
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. Aenova Group
10.2.2. Baxter
10.2.3. Boehringer Ingelheim
10.2.4. Catalent
10.2.5. Cipla
10.2.6. Fresenius Kabi
10.2.7. Famar
10.2.8. Grifols
10.2.9. NextPharma Technologies
10.2.10. Recipharm
10.2.11. Unither Pharmaceuticals
10.2.12. Vetter Pharma
10.2.13. Other Prominent Players
Sterile Injectable Contract Manufacturing Market by Molecules Type -
Sterile Injectable Contract Manufacturing Market by Therapeutic Applications -
Sterile Injectable Contract Manufacturing Market by Route of Administration -
Sterile Injectable Contract Manufacturing Market by End Users -
Sterile Injectable Contract Manufacturing Market by Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
