- Small Volume Products
- Large Volume Products
- Suspensions
- Lyophilized Products
- Others
Sterile Injectable Contract Manufacturing Market size was valued at USD 24.4 billion in 2023 and is expected to grow at a CAGR of 8.5% from 2024-2030. Sterile injectable contract manufacturing refers to the outsourcing of the production of sterile injectable pharmaceutical products to specialized manufacturing facilities, commonly known as contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs). Sterile injectable contract manufacturing encompasses various stages, including formulating, maintaining sterility, filling, quality testing, and adhering to regulatory requirements. The contracted manufacturer is accountable for guaranteeing that the final products satisfy the necessary standards for quality, safety, and effectiveness prior to their distribution to the market. Specialized expertise and facilities play a pivotal role in driving the growth of the sterile injectable contract manufacturing market. The production of sterile injectable pharmaceuticals requires stringent aseptic processes, advanced technologies, and specialized equipment to ensure product safety and efficacy.
Contract manufacturing organizations (CMOs) equipped with state-of-the-art facilities and knowledgeable personnel possess the technical know-how to formulate, manufacture, and package sterile injectables while adhering to the highest quality and regulatory standards. Pharmaceutical companies recognize the complexities involved in sterile production and seek CMOs with proven expertise in maintaining strict sterility, reducing contamination risks, and ensuring consistent product quality. Moreover, cost-efficiency serves as a significant driving factor in propelling the growth of the sterile injectable contract manufacturing market. Establishing and maintaining sterile manufacturing facilities can involve substantial capital investments and ongoing operational costs. Pharmaceutical companies recognize the financial advantages of outsourcing sterile injectable production to specialized contract manufacturing organizations (CMOs). By leveraging the existing state-of-the-art facilities and expertise of CMOs, pharmaceutical companies can avoid the capital expenditures associated with building and equipping sterile facilities. However, maintaining consistent product quality and ensuring proper adherence to regulatory standards can be challenging when manufacturing is outsourced. These strict regulatory requirements pose a challenge to the growth of the market. Meanwhile, rising government investments in advanced technologies offer several opportunities for the growth of the sterile injectable contract manufacturing market. Key market players' innovative launches, strategic collaborations, partnerships, and mergers and acquisitions further contribute to market expansion. For instance, in May 2023, Bridgewest Group launched a new contract development and manufacturing organization (CDMO), NovaCina, focused on sterile injectable drug products.
Study Period
Base Year
CAGR
Largest Market
Fastest Growing Market
Focusing on core competencies is a key driver of revenue growth in the sterile injectable contract manufacturing market. Pharmaceutical companies recognize the value of directing their resources toward research, development, regulatory compliance, and marketing, which are central to their strengths. By outsourcing sterile injectable manufacturing to specialized contract manufacturing organizations (CMOs), pharmaceutical companies can streamline operations and allocate their expertise and capital where they have the most impact. The speed-to-market factor is a crucial driver of the sterile injectable contract manufacturing market's growth and success. Collaborating with contract manufacturers can expedite the timeline for product development, regulatory approval, and commercial launch. This is particularly important in the fast-paced pharmaceutical industry were getting products to market quickly can be a competitive advantage.
Sterile injections are capturing the market of solid dosage form which may be lucrative for outsourcing market in the forecasted years.
Manufacturing costs in Asia Pacific region is much cheaper than North America and Europe. This is the key opportunity for outsourcing manufacturing process of sterile injectable products.
Demand for prefilled syringes is growing at a significant rate which will drive the global market. However, the high cost of prefilled syringes may hamper the market growth.
The stringent regulations regarding approval of products are hampering the global market growth.
1.Executive Summary |
2.Global Sterile Injectable Contract Manufacturing Market Introduction |
2.1.Global Sterile Injectable Contract Manufacturing Market - Taxonomy |
2.2.Global Sterile Injectable Contract Manufacturing Market - Definitions |
2.2.1. By Type |
2.2.2. By Services Type |
2.2.3. By Drug Type |
2.2.4. By Therapeutic Area |
2.2.5. By Region |
3.Global Sterile Injectable Contract Manufacturing Market Dynamics |
3.1. Drivers |
3.2. Restraints |
3.3. Opportunities/Unmet Needs of the Market |
3.4. Trends |
3.5. Product Landscape |
3.6. New Product Launches |
3.7. Impact of COVID 19 on Market |
4.Global Sterile Injectable Contract Manufacturing Market Analysis, 2018 - 2022 and Forecast 2023 - 2029 |
4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) |
4.3. Market Opportunity Analysis |
5.Global Sterile Injectable Contract Manufacturing Market By Type , 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
5.1. Small Volume Products |
5.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
5.1.3. Market Opportunity Analysis |
5.2. Large Volume Products |
5.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
5.2.3. Market Opportunity Analysis |
5.3. Suspensions |
5.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
5.3.3. Market Opportunity Analysis |
5.4. Lyophilized Products |
5.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
5.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
5.4.3. Market Opportunity Analysis |
5.5. Others |
5.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
5.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
5.5.3. Market Opportunity Analysis |
6.Global Sterile Injectable Contract Manufacturing Market By Services Type, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
6.1. Formulation |
6.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
6.1.3. Market Opportunity Analysis |
6.2. Analytical Services |
6.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
6.2.3. Market Opportunity Analysis |
6.3. Packaging |
6.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
6.3.3. Market Opportunity Analysis |
6.4. Others |
6.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
6.4.3. Market Opportunity Analysis |
7.Global Sterile Injectable Contract Manufacturing Market By Drug Type, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
7.1. Immunoglobulins |
7.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.1.3. Market Opportunity Analysis |
7.2. Cytokines |
7.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.2.3. Market Opportunity Analysis |
7.3. Monoclonal Antibodies |
7.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.3.3. Market Opportunity Analysis |
7.4. Vaccines |
7.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.4.3. Market Opportunity Analysis |
7.5. Insulin |
7.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.5.3. Market Opportunity Analysis |
7.6. Peptide Hormones |
7.6.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.6.3. Market Opportunity Analysis |
7.7. Antibiotics |
7.7.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.7.3. Market Opportunity Analysis |
7.8. Others |
7.8.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
7.8.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
7.8.3. Market Opportunity Analysis |
8.Global Sterile Injectable Contract Manufacturing Market By Therapeutic Area, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
8.1. Diabetes |
8.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.1.3. Market Opportunity Analysis |
8.2. Cancer |
8.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.2.3. Market Opportunity Analysis |
8.3. Infectious Diseases |
8.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.3.3. Market Opportunity Analysis |
8.4. Neurological Diseases |
8.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.4.3. Market Opportunity Analysis |
8.5. Cardiovascular Diseases |
8.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.5.3. Market Opportunity Analysis |
8.6. Musculoskeletal Diseases |
8.6.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.6.3. Market Opportunity Analysis |
8.7. Others |
8.7.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
8.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
8.7.3. Market Opportunity Analysis |
9.Global Sterile Injectable Contract Manufacturing Market By Region, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
9.1. North America |
9.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
9.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
9.1.3. Market Opportunity Analysis |
9.2. Europe |
9.2.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
9.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
9.2.3. Market Opportunity Analysis |
9.3. Asia Pacific (APAC) |
9.3.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
9.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
9.3.3. Market Opportunity Analysis |
9.4. Middle East and Africa (MEA) |
9.4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
9.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
9.4.3. Market Opportunity Analysis |
9.5. Latin America |
9.5.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (Sales Value USD Million) |
9.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
9.5.3. Market Opportunity Analysis |
10.North America Sterile Injectable Contract Manufacturing Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
10.1. Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
10.1.1.Small Volume Products |
10.1.2.Large Volume Products |
10.1.3.Suspensions |
10.1.4.Lyophilized Products |
10.1.5.Others |
10.2. Services Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
10.2.1.Formulation |
10.2.2.Analytical Services |
10.2.3.Packaging |
10.2.4.Others |
10.3. Drug Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
10.3.1.Immunoglobulins |
10.3.2.Cytokines |
10.3.3.Monoclonal Antibodies |
10.3.4.Vaccines |
10.3.5.Insulin |
10.3.6.Peptide Hormones |
10.3.7.Antibiotics |
10.3.8.Others |
10.4. Therapeutic Area Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
10.4.1.Diabetes |
10.4.2.Cancer |
10.4.3.Infectious Diseases |
10.4.4.Neurological Diseases |
10.4.5.Cardiovascular Diseases |
10.4.6.Musculoskeletal Diseases |
10.4.7.Others |
10.5. Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
10.5.1.United States of America (USA) |
10.5.2.Canada |
11.Europe Sterile Injectable Contract Manufacturing Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
11.1. Type Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
11.1.1.Small Volume Products |
11.1.2.Large Volume Products |
11.1.3.Suspensions |
11.1.4.Lyophilized Products |
11.1.5.Others |
11.2. Services Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
11.2.1.Formulation |
11.2.2.Analytical Services |
11.2.3.Packaging |
11.2.4.Others |
11.3. Drug Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
11.3.1.Immunoglobulins |
11.3.2.Cytokines |
11.3.3.Monoclonal Antibodies |
11.3.4.Vaccines |
11.3.5.Insulin |
11.3.6.Peptide Hormones |
11.3.7.Antibiotics |
11.3.8.Others |
11.4. Therapeutic Area Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
11.4.1.Diabetes |
11.4.2.Cancer |
11.4.3.Infectious Diseases |
11.4.4.Neurological Diseases |
11.4.5.Cardiovascular Diseases |
11.4.6.Musculoskeletal Diseases |
11.4.7.Others |
11.5. Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
11.5.1.Germany |
11.5.2.France |
11.5.3.Italy |
11.5.4.United Kingdom (UK) |
11.5.5.Spain |
12.Asia Pacific (APAC) Sterile Injectable Contract Manufacturing Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
12.1. Type Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
12.1.1.Small Volume Products |
12.1.2.Large Volume Products |
12.1.3.Suspensions |
12.1.4.Lyophilized Products |
12.1.5.Others |
12.2. Services Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
12.2.1.Formulation |
12.2.2.Analytical Services |
12.2.3.Packaging |
12.2.4.Others |
12.3. Drug Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
12.3.1.Immunoglobulins |
12.3.2.Cytokines |
12.3.3.Monoclonal Antibodies |
12.3.4.Vaccines |
12.3.5.Insulin |
12.3.6.Peptide Hormones |
12.3.7.Antibiotics |
12.3.8.Others |
12.4. Therapeutic Area Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
12.4.1.Diabetes |
12.4.2.Cancer |
12.4.3.Infectious Diseases |
12.4.4.Neurological Diseases |
12.4.5.Cardiovascular Diseases |
12.4.6.Musculoskeletal Diseases |
12.4.7.Others |
12.5. Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
12.5.1.China |
12.5.2.India |
12.5.3.Australia and New Zealand (ANZ) |
12.5.4.Japan |
12.5.5.Rest of APAC |
13.Middle East and Africa (MEA) Sterile Injectable Contract Manufacturing Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
13.1. Type Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
13.1.1.Small Volume Products |
13.1.2.Large Volume Products |
13.1.3.Suspensions |
13.1.4.Lyophilized Products |
13.1.5.Others |
13.2. Services Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
13.2.1.Formulation |
13.2.2.Analytical Services |
13.2.3.Packaging |
13.2.4.Others |
13.3. Drug Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
13.3.1.Immunoglobulins |
13.3.2.Cytokines |
13.3.3.Monoclonal Antibodies |
13.3.4.Vaccines |
13.3.5.Insulin |
13.3.6.Peptide Hormones |
13.3.7.Antibiotics |
13.3.8.Others |
13.4. Therapeutic Area Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
13.4.1.Diabetes |
13.4.2.Cancer |
13.4.3.Infectious Diseases |
13.4.4.Neurological Diseases |
13.4.5.Cardiovascular Diseases |
13.4.6.Musculoskeletal Diseases |
13.4.7.Others |
13.5. Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
13.5.1.GCC Countries |
13.5.2.South Africa |
13.5.3.Rest of MEA |
14.Latin America Sterile Injectable Contract Manufacturing Market ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
14.1. Type Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
14.1.1.Small Volume Products |
14.1.2.Large Volume Products |
14.1.3.Suspensions |
14.1.4.Lyophilized Products |
14.1.5.Others |
14.2. Services Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
14.2.1.Formulation |
14.2.2.Analytical Services |
14.2.3.Packaging |
14.2.4.Others |
14.3. Drug Type Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
14.3.1.Immunoglobulins |
14.3.2.Cytokines |
14.3.3.Monoclonal Antibodies |
14.3.4.Vaccines |
14.3.5.Insulin |
14.3.6.Peptide Hormones |
14.3.7.Antibiotics |
14.3.8.Others |
14.4. Therapeutic Area Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
14.4.1.Diabetes |
14.4.2.Cancer |
14.4.3.Infectious Diseases |
14.4.4.Neurological Diseases |
14.4.5.Cardiovascular Diseases |
14.4.6.Musculoskeletal Diseases |
14.4.7.Others |
14.5. Country Analysis 2018 - 2022 and Forecast 2023 - 2029 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
14.5.1.Brazil |
14.5.2.Mexico |
14.5.3.Rest of LA |
15. Competition Landscape |
15.1. Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) |
15.2.1.Baxter |
15.2.2.Catalent, Inc. |
15.2.3.Bryllon LLC |
15.2.4.Pfizer CentreOne (Pfizer, Inc.) |
15.2.5.Vetter Pharma |
15.2.6.West Pharmaceutical Services, Inc. |
15.2.7.Aenova Group |
15.2.8.Fresenius Kabi |
15.2.9.Jubilant HollisterStier LLC |
15.2.10.Unither Pharmaceuticals |
15.2.11.Famar |
15.2.12.AbbVie, Inc. |
15.2.13.Cipla Inc |
15.2.14.NextPharma Technologies |
16. Research Methodology |
17. Appendix and Abbreviations |