Sterile Injectables CDMO Market Size, Share, and Trends 2025 to 2034

The global sterile injectables CDMO market size is calculated at USD 4.73 billion in 2025 and is forecasted to reach around USD 10.91 billion by 2034, accelerating at a CAGR of 9.73% from 2025 to 2034. The North America market size surpassed USD 1.77 billion in 2024 and is expanding at a CAGR of 9.85% during the forecast period. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.

  • Last Updated : June 2025
  • Report Code : 6188
  • Category : Healthcare

Chapter 1. Introduction

1.1. Research Objective

1.2. Scope of the Study

1.3. Definition

Chapter 2. Research Methodology

2.1. Research Approach

2.2. Data Sources

2.3. Assumptions & Limitations

Chapter 3. Executive Summary

3.1. Market Snapshot

Chapter 4. Market Variables and Scope 

4.1. Introduction

4.2. Market Classification and Scope

4.3. Industry Value Chain Analysis

4.3.1. Raw Material Procurement Analysis 

4.3.2. Sales and Distribution Analysis

4.3.3. Downstream Buyer Analysis

Chapter 5. COVID 19 Impact on Sterile Injectables CDMO Market 

5.1. COVID-19 Landscape: Sterile Injectables CDMO Industry Impact

5.2. COVID 19 - Impact Assessment for the Industry

5.3. COVID 19 Impact: Global Major Government Policy

5.4. Market Trends and Opportunities in the COVID-19 Landscape

6.1. Market Dynamics

6.1.1. Market Drivers

6.1.2. Market Restraints

6.1.3. Market Opportunities

6.2. Porter’s Five Forces Analysis

6.2.1. Bargaining power of suppliers

6.2.2. Bargaining power of buyers

6.2.3. Threat of substitute

6.2.4. Threat of new entrants

6.2.5. Degree of competition

Chapter 7. Competitive Landscape

7.1.1. Company Market Share/Positioning Analysis

7.1.2. Key Strategies Adopted by Players

7.1.3. Vendor Landscape

7.1.3.1. List of Suppliers

7.1.3.2. List of Buyers

Chapter 8. Global Sterile Injectables CDMO Market, By Molecule Type

8.1. Sterile Injectables CDMO Market, by Molecule Type

8.1.1. Small Molecules         

8.1.1.1. Market Revenue and Forecast

8.1.2. Large Molecules

8.1.2.1. Market Revenue and Forecast

Chapter 9. Global Sterile Injectables CDMO Market, By Product

9.1. Sterile Injectables CDMO Market, by Product

9.1.1. Pre-filled Syringes

9.1.1.1. Market Revenue and Forecast

9.1.2. Vials and Ampoules

9.1.2.1. Market Revenue and Forecast

9.1.3. Specialty Injectables

9.1.3.1. Market Revenue and Forecast

9.1.4. Others

9.1.4.1. Market Revenue and Forecast

Chapter 10. Global Sterile Injectables CDMO Market, By Service

10.1. Sterile Injectables CDMO Market, by Service

10.1.1. Formulation Development

10.1.1.1. Market Revenue and Forecast

10.1.2. Analytical and Testing Services

10.1.2.1. Market Revenue and Forecast

10.1.3. Manufacturing

10.1.3.1. Market Revenue and Forecast

10.1.4. Packaging

10.1.4.1. Market Revenue and Forecast

10.1.5. Storage

10.1.5.1. Market Revenue and Forecast

10.1.5. Others

10.1.5.1. Market Revenue and Forecast

Chapter 11. Global Sterile Injectables CDMO Market, By Therapeutic Area

11.1. Sterile Injectables CDMO Market, by Therapeutic Area

11.1.1. Oncology       

11.1.1.1. Market Revenue and Forecast

11.1.2. Cardiovascular Diseases

11.1.2.1. Market Revenue and Forecast

11.1.3. Central Nervous System Diseases

11.1.3.1. Market Revenue and Forecast

11.1.4. Infectious Disorders

11.1.4.1. Market Revenue and Forecast

11.1.5. Musculoskeletal Diseases

11.1.5.1. Market Revenue and Forecast

11.1.6. Others

11.1.6.1. Market Revenue and Forecast

Chapter 12. Global Sterile Injectables CDMO Market, By Route of Administration

12.1. Sterile Injectables CDMO Market, by Route of Administration

12.1.1. Subcutaneous (SC)

12.1.1.1. Market Revenue and Forecast

12.1.2. Intravenous (IV)

12.1.2.1. Market Revenue and Forecast

12.1.3. Intramuscular (IM)

12.1.3.1. Market Revenue and Forecast

12.1.4. Others

12.1.4.1. Market Revenue and Forecast

Chapter 13. Global Sterile Injectables CDMO Market, By End-use

13.1. Sterile Injectables CDMO Market, by End-use

13.1.1. Pharmaceutical Companies

13.1.1.1. Market Revenue and Forecast

13.1.2. Biopharmaceutical Companies

13.1.2.1. Market Revenue and Forecast

13.1.3. Others

13.1.3.1. Market Revenue and Forecast

Chapter 14. Global Sterile Injectables CDMO Market, Regional Estimates and Trend Forecast

14.1. North America

14.1.1. Market Revenue and Forecast, by Molecule Type

14.1.2. Market Revenue and Forecast, by Product

14.1.3. Market Revenue and Forecast, by Service

14.1.4. Market Revenue and Forecast, by Therapeutic Area

14.1.5. Market Revenue and Forecast, by Route of Administration

14.1.6. Market Revenue and Forecast, by End-use

14.1.7. U.S.

14.1.7.1. Market Revenue and Forecast, by Molecule Type

14.1.7.2. Market Revenue and Forecast, by Product

14.1.7.3. Market Revenue and Forecast, by Service

14.1.7.4. Market Revenue and Forecast, by Therapeutic Area

14.1.8. Market Revenue and Forecast, by Route of Administration

14.1.8.1. Market Revenue and Forecast, by End-use  

14.1.9. Rest of North America

14.1.9.1. Market Revenue and Forecast, by Molecule Type

14.1.9.2. Market Revenue and Forecast, by Product

14.1.9.3. Market Revenue and Forecast, by Service

14.1.9.4. Market Revenue and Forecast, by Therapeutic Area

14.1.10. Market Revenue and Forecast, by Route of Administration

14.1.11. Market Revenue and Forecast, by End-use

14.1.11.1.

14.2. Europe

14.2.1. Market Revenue and Forecast, by Molecule Type

14.2.2. Market Revenue and Forecast, by Product

14.2.3. Market Revenue and Forecast, by Service

14.2.4. Market Revenue and Forecast, by Therapeutic Area  

14.2.5. Market Revenue and Forecast, by Route of Administration

14.2.6. Market Revenue and Forecast, by End-use

14.2.7.

14.2.8. UK

14.2.8.1. Market Revenue and Forecast, by Molecule Type

14.2.8.2. Market Revenue and Forecast, by Product

14.2.8.3. Market Revenue and Forecast, by Service

14.2.9. Market Revenue and Forecast, by Therapeutic Area  

14.2.10. Market Revenue and Forecast, by Route of Administration

14.2.10.1. Market Revenue and Forecast, by End-use  

14.2.11. Germany

14.2.11.1. Market Revenue and Forecast, by Molecule Type

14.2.11.2. Market Revenue and Forecast, by Product

14.2.11.3. Market Revenue and Forecast, by Service

14.2.12. Market Revenue and Forecast, by Therapeutic Area

14.2.13. Market Revenue and Forecast, by Route of Administration

14.2.14. Market Revenue and Forecast, by End-use

14.2.14.1.

14.2.15. France

14.2.15.1. Market Revenue and Forecast, by Molecule Type

14.2.15.2. Market Revenue and Forecast, by Product

14.2.15.3. Market Revenue and Forecast, by Service

14.2.15.4. Market Revenue and Forecast, by Therapeutic Area

14.2.16. Market Revenue and Forecast, by Route of Administration

14.2.16.1. Market Revenue and Forecast, by End-use

14.2.17. Rest of Europe

14.2.17.1. Market Revenue and Forecast, by Molecule Type

14.2.17.2. Market Revenue and Forecast, by Product

14.2.17.3. Market Revenue and Forecast, by Service

14.2.17.4. Market Revenue and Forecast, by Therapeutic Area

14.2.18. Market Revenue and Forecast, by Route of Administration

14.2.18.1. Market Revenue and Forecast, by End-use

14.3. APAC

14.3.1. Market Revenue and Forecast, by Molecule Type

14.3.2. Market Revenue and Forecast, by Product

14.3.3. Market Revenue and Forecast, by Service

14.3.4. Market Revenue and Forecast, by Therapeutic Area

14.3.5. Market Revenue and Forecast, by Route of Administration

14.3.6. Market Revenue and Forecast, by End-use

14.3.7. India

14.3.7.1. Market Revenue and Forecast, by Molecule Type

14.3.7.2. Market Revenue and Forecast, by Product

14.3.7.3. Market Revenue and Forecast, by Service

14.3.7.4. Market Revenue and Forecast, by Therapeutic Area

14.3.8. Market Revenue and Forecast, by Route of Administration

14.3.9. Market Revenue and Forecast, by End-use

14.3.10. China

14.3.10.1. Market Revenue and Forecast, by Molecule Type

14.3.10.2. Market Revenue and Forecast, by Product

14.3.10.3. Market Revenue and Forecast, by Service

14.3.10.4. Market Revenue and Forecast, by Therapeutic Area

14.3.11. Market Revenue and Forecast, by Route of Administration

14.3.11.1. Market Revenue and Forecast, by End-use

14.3.12. Japan

14.3.12.1. Market Revenue and Forecast, by Molecule Type

14.3.12.2. Market Revenue and Forecast, by Product

14.3.12.3. Market Revenue and Forecast, by Service

14.3.12.4. Market Revenue and Forecast, by Therapeutic Area

14.3.12.5. Market Revenue and Forecast, by Route of Administration

14.3.12.6. Market Revenue and Forecast, by End-use

14.3.13. Rest of APAC

14.3.13.1. Market Revenue and Forecast, by Molecule Type

14.3.13.2. Market Revenue and Forecast, by Product

14.3.13.3. Market Revenue and Forecast, by Service

14.3.13.4. Market Revenue and Forecast, by Therapeutic Area

14.3.13.5. Market Revenue and Forecast, by Route of Administration

14.3.13.6. Market Revenue and Forecast, by End-use

14.4. MEA

14.4.1. Market Revenue and Forecast, by Molecule Type

14.4.2. Market Revenue and Forecast, by Product

14.4.3. Market Revenue and Forecast, by Service

14.4.4. Market Revenue and Forecast, by Therapeutic Area

14.4.5. Market Revenue and Forecast, by Route of Administration

14.4.6. Market Revenue and Forecast, by End-use

14.4.7. GCC

14.4.7.1. Market Revenue and Forecast, by Molecule Type

14.4.7.2. Market Revenue and Forecast, by Product

14.4.7.3. Market Revenue and Forecast, by Service

14.4.7.4. Market Revenue and Forecast, by Therapeutic Area

14.4.8. Market Revenue and Forecast, by Route of Administration

14.4.9. Market Revenue and Forecast, by End-use

14.4.10. North Africa

14.4.10.1. Market Revenue and Forecast, by Molecule Type

14.4.10.2. Market Revenue and Forecast, by Product

14.4.10.3. Market Revenue and Forecast, by Service

14.4.10.4. Market Revenue and Forecast, by Therapeutic Area

14.4.11. Market Revenue and Forecast, by Route of Administration

14.4.12. Market Revenue and Forecast, by End-use

14.4.13. South Africa

14.4.13.1. Market Revenue and Forecast, by Molecule Type

14.4.13.2. Market Revenue and Forecast, by Product

14.4.13.3. Market Revenue and Forecast, by Service

14.4.13.4. Market Revenue and Forecast, by Therapeutic Area

14.4.13.5. Market Revenue and Forecast, by Route of Administration

14.4.13.6. Market Revenue and Forecast, by End-use

14.4.14. Rest of MEA

14.4.14.1. Market Revenue and Forecast, by Molecule Type

14.4.14.2. Market Revenue and Forecast, by Product

14.4.14.3. Market Revenue and Forecast, by Service

14.4.14.4. Market Revenue and Forecast, by Therapeutic Area

14.4.14.5. Market Revenue and Forecast, by Route of Administration

14.4.14.6. Market Revenue and Forecast, by End-use

14.5. Latin America

14.5.1. Market Revenue and Forecast, by Molecule Type

14.5.2. Market Revenue and Forecast, by Product

14.5.3. Market Revenue and Forecast, by Service

14.5.4. Market Revenue and Forecast, by Therapeutic Area

14.5.5. Market Revenue and Forecast, by Route of Administration

14.5.6. Market Revenue and Forecast, by End-use

14.5.7. Brazil

14.5.7.1. Market Revenue and Forecast, by Molecule Type

14.5.7.2. Market Revenue and Forecast, by Product

14.5.7.3. Market Revenue and Forecast, by Service

14.5.7.4. Market Revenue and Forecast, by Therapeutic Area

14.5.8. Market Revenue and Forecast, by Route of Administration

14.5.8.1. Market Revenue and Forecast, by End-use

14.5.9. Rest of LATAM

14.5.9.1. Market Revenue and Forecast, by Molecule Type

14.5.9.2. Market Revenue and Forecast, by Product

14.5.9.3. Market Revenue and Forecast, by Service

14.5.9.4. Market Revenue and Forecast, by Therapeutic Area

14.5.9.5. Market Revenue and Forecast, by Route of Administration

14.5.9.6. Market Revenue and Forecast, by End-use

Chapter 15. Company Profiles

15.1. Aenova Group

15.1.1. Company Overview

15.1.2. Product Offerings

15.1.3. Financial Performance

15.1.4. Recent Initiatives

15.2. Ajinomoto Bio-Pharma

15.2.1. Company Overview

15.2.2. Product Offerings

15.2.3. Financial Performance

15.2.4. Recent Initiatives

15.3. Alcami Corporation

15.3.1. Company Overview

15.3.2. Product Offerings

15.3.3. Financial Performance

15.3.4. Recent Initiatives

15.4. Baxter (Simtra BioPharma Solutions)             

15.4.1. Company Overview

15.4.2. Product Offerings

15.4.3. Financial Performance

15.4.4. Recent Initiatives

15.5. Boehringer Ingelheim International GmbH

15.5.1. Company Overview

15.5.2. Product Offerings

15.5.3. Financial Performance

15.5.4. Recent Initiatives

15.6. Eurofins Scientific

15.6.1. Company Overview

15.6.2. Product Offerings

15.6.3. Financial Performance

15.6.4. Recent Initiatives

15.7. FAMAR Health Care Services

15.7.1. Company Overview

15.7.2. Product Offerings

15.7.3. Financial Performance

15.7.4. Recent Initiatives

15.8. Fareva Group

15.8.1. Company Overview

15.8.2. Product Offerings

15.8.3. Financial Performance

15.8.4. Recent Initiatives

15.9. Fresenius Kabi Contract Manufacturing (Fresenius Kabi AG)

15.9.1. Company Overview

15.9.2. Product Offerings

15.9.3. Financial Performance

15.9.4. Recent Initiatives

15.10. IDT Biologika GmbH

15.10.1. Company Overview

15.10.2. Product Offerings

15.10.3. Financial Performance

15.10.4. Recent Initiatives

Chapter 16. Research Methodology

16.1. Primary Research

16.2. Secondary Research

16.3. Assumptions

Chapter 17. Appendix

17.1. About Us

17.2. Glossary of Terms

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Frequently Asked Questions

The global sterile injectables CDMO market is expected to increase from USD 4.31 billion in 2024 to USD 10.91 billion by 2034.

The sterile injectables CDMO market is expected to grow at a compound annual growth rate (CAGR) of around 9.73% from 2025 to 2034.

The major players in the sterile injectables CDMO market include Aenova Group, Ajinomoto Bio-Pharma, Alcami Corporation, Baxter (Simtra BioPharma Solutions), Boehringer Ingelheim International GmbH, Eurofins Scientific, FAMAR Health Care Services, Fareva Group, Fresenius Kabi Contract Manufacturing (Fresenius Kabi AG), IDT Biologika GmbH, PCI Pharma Services, Pfizer CentreOne (Pfizer Inc), Recipharm AB, Siegfried AG, Torbay Pharmaceuticals, Unither Pharmaceuticals, and Vetter Pharma International GmbH.

The driving factors of the sterile injectables CDMO market are the expanding pipeline of biologics and biosimilars is increasing demand for sterile injectables and subsequently, contract development and manufacturing organizations, or CDMOs, extended their capability to handle complex formulations and aseptic fill-finish services. 

North America region will lead the global sterile injectables CDMO market during the forecast period 2025 to 2034.

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