Sterile Injectables CDMO Market Size, Share & Trends Analysis Report By Molecule (Small Molecule, Large Molecule), By Product, By Service, By Therapeutic Area, By Route of Administration, By End Use, By Region, And Segment Forecasts, 2024

The global sterile injectables CDMO market size was estimated at USD 3.94 billion in 2023 and is projected to grow at a CAGR of 9.92% from 2024 to 2030. The market growth is primarily driven by increasing pipeline and approvals of injectable drugs. Pharmaceutical companies are proactively focusing on developing injectable medications due to their numerous benefits, such as quicker onset of action, precise dosing, and enhanced patient adherence. For instance, as per the U.S. Food and Drug Administration (FDA) report published in January 2024, the Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023. These medications included injectables, indicating a robust pipeline that is anticipated to drive an increase in the demand for contract manufacturing services for both commercial and research purposes, hence contributing to overall market growth.

The increasing demand for cellular and genetic therapies is driving the market's growth. With the expansion of therapy pipelines, there is a rising requirement for specialized manufacturing capabilities provided by contract manufacturing organizations (CMOs). For instance, according to ClinicalTrials.gov, as of March 2024, over 581 clinical trials were focused on cell therapies and related approaches for treating various diseases in North America is anticipated to drive an increase in contract manufacturing throughout the projected period.

Furthermore, strategic initiatives undertaken by market participants, such as expanding sterile manufacturing facilities and engaging in collaborations and partnerships, are anticipated to bolster market growth throughout the projected period. For instance, in November 2023, NorthEdge invested in Torbay Pharmaceuticals to support its upcoming phase of international expansion. In March 2023, PCI Pharma Services has announced a USD 50 million expansion project at its Rockford, Illinois facility, which will involve the construction of a new 200,000-square-foot building to increase the site's capacity for manufacturing injectable drug-device combination products.

The high demand for sterile injectables propels growth in outsourced agreements amongst contract manufacturers and biopharmaceutical companies, thereby boosting the growth of the sterile injectable CDMO industry. The growing need for faster drug action, rapid absorption, and less drug concentration are a few major aspects contributing to the adoption of sterile injectables CDMO industry. Further, pharmaceutical firms actively involved in sterile injectable development and manufacturing are gaining traction to support monoclonal antibody therapies, large-molecule injectable drugs, and infectious disease-treating drugs. Several factors, including reduced time and cost-affordable research and development cycles of generic injectables and the growing advancements in rare disease treatments, are accelerating the growth of sterile injectable CDMO's in the global market.

Moreover, advanced manufacturing techniques are crucial for ensuring the stability and efficacy of cancer therapies. Contract manufacturers specializing in sterile injectables, particularly those experienced in handling complex formulations and biologics, are well-equipped to address the specific requirements of oncology drugs. Sterile injectables are essential for delivering complex biologics and innovative treatment methods in cancer treatment, driving the growth of the sterile injectable contract manufacturing sector. The growth in outsourcing practices is expected to drive the expansion of the segment over the forecast period. Pharmaceutical companies, particularly those specializing in oncology, are increasingly turning to outsourcing manufacturing operations to streamline processes, cut costs, and capitalize on the specialized expertise offered by contract manufacturers. This shift has notably boosted the cancer sector's sterile injectable contract development and manufacturing market.

Global Sterile Injectables CDMO Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global Sterile Injectables CDMO market report based on molecule type, product, service, therapeutic area, route of administration, end use, and region:

Molecule Outlook (Revenue, USD Million, 2018 - 2030)
Small Molecule
Large Molecule
Product Outlook (Revenue, USD Million, 2018 - 2030)
Sterile Liquid Injectables
Pre-filled Syringes
Vials and Ampoules
Service Outlook (Revenue, USD Million, 2018 - 2030)
Contract Development
Contract Manufacturing
Packaging
Quality Control and Assurance
Lyophilization Services
Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
Cardiovascular Diseases
Central Nervous System Diseases
Infectious Disorders
Musculoskeletal Diseases
Hormonal Diseases
Others
Route of Administration Outlook (Revenue, USD Million, 2018 - 2030)
Subcutaneous (SC)
Intravenous (IV)
Intramuscular (IM)
Others
End Use Outlook (Revenue, USD Million, 2018 - 2030)
Pharmaceutical Companies
Biopharmaceutical Companies
Others
Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America

U.S.

Canada

Mexico

Europe

Germany

France

Italy

Spain

Denmark

Sweden

Norway

Asia Pacific

China

Japan

India

Australia

South Korea

Thailand

Latin America

Brazil

Argentina

Middle East and Africa (MEA)

South Africa

Saudi Arabia

UAE

Kuwait

Product Code: GVR-4-68040-363-5

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope
- 1.1.1. Regional Scope
- 1.1.2. Estimates and Forecast Timeline
1.2. Research Methodology
1.3. Information Procurement
- 1.3.1. Purchased Database
- 1.3.2. GVR's Internal Database
- 1.3.3. Secondary Sources
- 1.3.4. Primary Research
1.4. Information or Data Analysis
- 1.4.1. Data Analysis Models
1.5. Market Formulation & Validation
- 1.5.1. Region Wise Market: Base Estimates
- 1.5.2. Global Market: CAGR Calculation
1.6. Model Details
- 1.6.1. Commodity Flow Analysis (Model 1)
- 1.6.2. Value-Chain-Based Sizing & Forecasting (Model 2)
- 1.6.3. QFD Model Sizing & Forecasting (Model 3)
- 1.6.4. Bottom-Up Approach (Model 4)
1.7. Market Definitions
1.8. List of Secondary Sources
1.9. List of Abbreviations
1.10. Objectives

Chapter 2. Executive Summary

2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights

Chapter 3. Sterile Injectables CDMO Market Variables, Trends & Scope

3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Ancillary Market Outlook
3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
  - 3.2.1.1. Increasing Pipeline and Approvals of Injectables
  - 3.2.1.2. Growing Demand for Biologics and Biosimilars Significantly Supported Market Growth
  - 3.2.1.3. Rise in Investment Across Research & Development Activities for the Development of Novel Therapeutics
  - 3.2.1.4. Increasing Demand for Cell & Gene Therapies
- 3.2.2. Market Restraint Analysis
  - 3.2.2.1. Low Barriers to Market Penetration Have Resulted in Pricing Pressure
  - 3.2.2.2. Challenges Related to Quality Control
3.3. Technological Advancements
3.4. Pricing Model Analysis
3.5. Clinical Trials Volume Analysis, 2023
- 3.5.1. Total Number of Clinical Trials, by Region (2023)
- 3.5.2. Total Number of Clinical Trials, by Phase (2023)
- 3.5.3. Total Number of Clinical Trials, by Study Design (2023)
- 3.5.4. Total Number of Clinical Trials, by Key Therapeutic Area (2023)
3.6. Sterile Injectables CDMO Market: Analysis Tools
- 3.6.1. Porter's Five Forces Analysis
- 3.6.2. PESTEL Analysis
3.7. COVID-19 Impact Analysis

Chapter 4. Sterile Injectables CDMO Market: Molecule Estimates & Trend Analysis

4.1. Segment Dashboard
4.2. Global Sterile Injectables CDMO Market Movement Analysis
4.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, by Molecule, 2018 to 2030 (USD Million)
4.4. Small Molecule
- 4.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
4.5. Large Molecule
- 4.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 5. Sterile Injectables CDMO Market: Product Estimates & Trend Analysis

5.1. Segment Dashboard
5.2. Global Sterile Injectables CDMO Market Movement Analysis
5.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, by Product, 2018 to 2030 (USD Million)
5.4. Sterile Liquid Injectables
- 5.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
5.5. Pre-filled Syringes
- 5.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
5.6. Vials and Ampoules
- 5.6.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 6. Sterile Injectables CDMO Market: Service Estimates & Trend Analysis

6.1. Segment Dashboard
6.2. Global Sterile Injectables CDMO Market Movement Analysis
6.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
6.4. Contract Development
- 6.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
6.5. Contract Manufacturing
- 6.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
6.6. Packaging
- 6.6.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
6.7. Quality Control and Assurance
- 6.7.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
6.8. Lyophilization Services
- 6.8.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 7. Sterile Injectables CDMO Market: Therapeutic Area Estimates & Trend Analysis

7.1. Segment Dashboard
7.2. Global Sterile Injectables CDMO Market Movement Analysis
7.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, Therapeutic Area, 2018 to 2030 (USD Million)
7.4. Oncology
- 7.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.5. Cardiovascular Diseases
- 7.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.6. Legal Representation
- 7.6.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.7. Central Nervous System Diseases
- 7.7.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.8. Infectious Disorders
- 7.8.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.9. Musculoskeletal Diseases
- 7.9.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.10. Hormonal Diseases
- 7.10.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
7.11. Others
- 7.11.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 8. Sterile Injectables CDMO Market: Route of Administration Estimates & Trend Analysis

8.1. Segment Dashboard
8.2. Global Sterile Injectables CDMO Market Movement Analysis
8.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, Route of Administration, 2018 to 2030 (USD Million)
8.4. Subcutaneous (SC)
- 8.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
8.5. Intravenous (IV)
- 8.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
8.6. Intramuscular (IM)
- 8.6.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
8.7. Others
- 8.7.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 9. Sterile Injectables CDMO Market: Modality by End Use Estimates & Trend Analysis

9.1. Segment Dashboard
9.2. Global Sterile Injectables CDMO Market Movement Analysis
9.3. Global Sterile Injectables CDMO Market Size & Trend Analysis, End Use, 2018 to 2030 (USD Million)
9.4. Pharmaceutical Companies
- 9.4.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
9.5. Biopharmaceutical Companies
- 9.5.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)
9.6. Others
- 9.6.1. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 10. Sterile Injectables CDMO Market: Regional Estimates & Trend Analysis

10.1. Regional Market Dashboard
10.2. Global Regional Market Snapshot
10.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
10.4. North America
- 10.4.1. North America Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.4.2. U.S.
  - 10.4.2.1. Key Country Dynamics
  - 10.4.2.2. Competitive Scenario
  - 10.4.2.3. Regulatory Scenario
  - 10.4.2.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.4.3. Canada
  - 10.4.3.1. Key Country Dynamics
  - 10.4.3.2. Competitive Scenario
  - 10.4.3.3. Regulatory Scenario
  - 10.4.3.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.4.4. Mexico
  - 10.4.4.1. Key Country Dynamics
  - 10.4.4.2. Competitive Scenario
  - 10.4.4.3. Regulatory Scenario
  - 10.4.4.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
10.5. Europe
- 10.5.1. Europe Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.2. UK
  - 10.5.2.1. Key Country Dynamics
  - 10.5.2.2. Competitive Scenario
  - 10.5.2.3. Regulatory Scenario
  - 10.5.2.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.3. Germany
  - 10.5.3.1. Key Country Dynamics
  - 10.5.3.2. Competitive Scenario
  - 10.5.3.3. Regulatory Scenario
  - 10.5.3.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.4. France
  - 10.5.4.1. Key Country Dynamics
  - 10.5.4.2. Competitive Scenario
  - 10.5.4.3. Regulatory Scenario
  - 10.5.4.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.5. Italy
  - 10.5.5.1. Key Country Dynamics
  - 10.5.5.2. Competitive Scenario
  - 10.5.5.3. Regulatory Scenario
  - 10.5.5.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.6. Spain
  - 10.5.6.1. Key Country Dynamics
  - 10.5.6.2. Competitive Scenario
  - 10.5.6.3. Regulatory Scenario
  - 10.5.6.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.7. Denmark
  - 10.5.7.1. Key Country Dynamics
  - 10.5.7.2. Competitive Scenario
  - 10.5.7.3. Regulatory Scenario
  - 10.5.7.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.8. Sweden
  - 10.5.8.1. Key Country Dynamics
  - 10.5.8.2. Competitive Scenario
  - 10.5.8.3. Regulatory Scenario
  - 10.5.8.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.5.9. Norway
  - 10.5.9.1. Key Country Dynamics
  - 10.5.9.2. Competitive Scenario
  - 10.5.9.3. Regulatory Scenario
  - 10.5.9.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
10.6. Asia Pacific
- 10.6.1. Asia Pacific Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.2. China
  - 10.6.2.1. Key Country Dynamics
  - 10.6.2.2. Competitive Scenario
  - 10.6.2.3. Regulatory Scenario
  - 10.6.2.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.3. Japan
  - 10.6.3.1. Key Country Dynamics
  - 10.6.3.2. Competitive Scenario
  - 10.6.3.3. Regulatory Scenario
  - 10.6.3.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.4. India
  - 10.6.4.1. Key Country Dynamics
  - 10.6.4.2. Competitive Scenario
  - 10.6.4.3. Regulatory Scenario
  - 10.6.4.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.5. Australia
  - 10.6.5.1. Key Country Dynamics
  - 10.6.5.2. Competitive Scenario
  - 10.6.5.3. Regulatory Scenario
  - 10.6.5.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.6. South Korea
  - 10.6.6.1. Key Country Dynamics
  - 10.6.6.2. Competitive Scenario
  - 10.6.6.3. Regulatory Scenario
  - 10.6.6.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.6.7. Thailand
  - 10.6.7.1. Key Country Dynamics
  - 10.6.7.2. Competitive Scenario
  - 10.6.7.3. Regulatory Scenario
  - 10.6.7.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
10.7. Latin America
- 10.7.1. Latin America Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.7.2. Brazil
  - 10.7.2.1. Key Country Dynamics
  - 10.7.2.2. Competitive Scenario
  - 10.7.2.3. Regulatory Scenario
  - 10.7.2.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.7.3. Argentina
  - 10.7.3.1. Key Country Dynamics
  - 10.7.3.2. Competitive Scenario
  - 10.7.3.3. Regulatory Scenario
  - 10.7.3.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
10.8. MEA
- 10.8.1. MEA Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.8.2. South Africa
  - 10.8.2.1. Key Country Dynamics
  - 10.8.2.2. Competitive Scenario
  - 10.8.2.3. Regulatory Scenario
  - 10.8.2.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.8.3. Saudi Arabia
  - 10.8.3.1. Key Country Dynamics
  - 10.8.3.2. Competitive Scenario
  - 10.8.3.3. Regulatory Scenario
  - 10.8.3.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.8.4. UAE
  - 10.8.4.1. Key Country Dynamics
  - 10.8.4.2. Competitive Scenario
  - 10.8.4.3. Regulatory Scenario
  - 10.8.4.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)
- 10.8.5. Kuwait
  - 10.8.5.1. Key Country Dynamics
  - 10.8.5.2. Competitive Scenario
  - 10.8.5.3. Regulatory Scenario
  - 10.8.5.4. Market Estimates and Forecast, 2018 to 2030 (USD Million)

Chapter 11. Competitive Landscape

11.1. Market Participant Categorization
- 11.1.1. Market Leaders
- 11.1.2. Emerging Players
11.2. Service Heat Map Analysis (a comparative analysis of the players together)
11.3. Company Profiles
- 11.3.1. Boehringer Ingelheim GmbH
  - 11.3.1.1. Company Overview
  - 11.3.1.2. Financial Performance
  - 11.3.1.3. Service Benchmarking
  - 11.3.1.4. Strategic Initiatives
- 11.3.2. Boehringer Ingelheim GmbH
  - 11.3.2.1. Company Overview
  - 11.3.2.2. Financial Performance
  - 11.3.2.3. Service Benchmarking
  - 11.3.2.4. Strategic Initiatives
- 11.3.3. Vetter Pharma
  - 11.3.3.1. Company Overview
  - 11.3.3.2. Financial Performance
  - 11.3.3.3. Service Benchmarking
  - 11.3.3.4. Strategic Initiatives
- 11.3.4. Recipharm AB
  - 11.3.4.1. Company Overview
  - 11.3.4.2. Financial Performance
  - 11.3.4.3. Service Benchmarking
  - 11.3.4.4. Strategic Initiatives
- 11.3.5. Aenova Group
  - 11.3.5.1. Company Overview
  - 11.3.5.2. Financial Performance
  - 11.3.5.3. Service Benchmarking
  - 11.3.5.4. Strategic Initiatives
- 11.3.6. Fresenius Kabi
  - 11.3.6.1. Company Overview
  - 11.3.6.2. Financial Performance
  - 11.3.6.3. Service Benchmarking
  - 11.3.6.4. Strategic Initiatives
- 11.3.7. Famar
  - 11.3.7.1. Company Overview
  - 11.3.7.2. Financial Performance
  - 11.3.7.3. Service Benchmarking
  - 11.3.7.4. Strategic Initiatives
- 11.3.8. NextPharma Technologies
  - 11.3.8.1. Company Overview
  - 11.3.8.2. Financial Performance
  - 11.3.8.3. Service Benchmarking
  - 11.3.8.4. Strategic Initiatives
- 11.3.9. Ajinomoto Bio-Pharma Services
  - 11.3.9.1. Company Overview
  - 11.3.9.2. Financial Performance
  - 11.3.9.3. Service Benchmarking
  - 11.3.9.4. Strategic Initiatives
- 11.3.10. PCI Pharma Services
  - 11.3.10.1. Company Overview
  - 11.3.10.2. Financial Performance
  - 11.3.10.3. Service Benchmarking
  - 11.3.10.4. Strategic Initiatives
- 11.3.11. IDT Biologika
  - 11.3.11.1. Company Overview
  - 11.3.11.2. Financial Performance
  - 11.3.11.3. Service Benchmarking
  - 11.3.11.4. Strategic Initiatives
- 11.3.12. Alcami Corporation
  - 11.3.12.1. Company Overview
  - 11.3.12.2. Financial Performance
  - 11.3.12.3. Service Benchmarking
  - 11.3.12.4. Strategic Initiatives
- 11.3.13. Fareva Group
  - 11.3.13.1. Company Overview
  - 11.3.13.2. Financial Performance
  - 11.3.13.3. Service Benchmarking
  - 11.3.13.4. Strategic Initiatives
- 11.3.14. Eurofins CDMO
  - 11.3.14.1. Company Overview
  - 11.3.14.2. Financial Performance
  - 11.3.14.3. Service Benchmarking
  - 11.3.14.4. Strategic Initiatives
- 11.3.15. Siegfried Holding AG
  - 11.3.15.1. Company Overview
  - 11.3.15.2. Financial Performance
  - 11.3.15.3. Service Benchmarking
  - 11.3.15.4. Strategic Initiatives