Summary

Sterile Injectable Contract Manufacturing Market Growth & Trends

The global sterile injectable contract manufacturing market size is estimated to reach USD 31.92 billion by 2030, growing at a CAGR of 12.1% from 2023 to 2030, according to a new report by Grand View Research, Inc. Increasing pipeline and approvals of injectables, growing demand for biologics and biosimilars, rise in investment in research & development activities for the development of novel therapeutics, and increasing demand for cell & gene therapies are the key factors driving the growth of sterile injectable contract manufacturing industry. The market for sterile injectable contract manufacturing is fragmented, with several players having similar technological and processing capabilities.

Contract Manufacturing Organizations (CMOs) with unique capabilities, such as the management of high-potency drugs, are anticipated to dominate the industry. In Europe and the U.S., there are various sterile injectable CMOs with EU GMP and U.S. FDA-approved facilities. Moreover, developing economies such as India and China are anticipated to witness lucrative growth across the forecast period. This is attributable to the increasing demand for injectable sourcing services across these countries. India has over 20 CMOs with EU GMP/U.S. FDA injectable certifications. The Indian sterile injectable contract manufacturing industry is rapidly expanding due to rising demand for outsourcing services from the pharmaceutical giants to emerging markets for cost-effectiveness. Most Indian injectable CMOs have been catering to local demand, but the transition has been evident over the past few years.

The COVID-19 pandemic positively impacted the sterile injectable contract manufacturing industry. This was because of the huge surge in demand for COVID-19 vaccines from 2020 to 2021, as these vaccines are a major part of the injectables industry. In addition, major players in the market are adopting inorganic strategic initiatives such as mergers, acquisitions, and partnerships to enhance their market positions. Furthermore, for the past few years, several companies have focused on penetrating the injectable contract manufacturing industry. For instance, Bridgewest Group, a global private investment firm, announced the launch of a new contract development and manufacturing organization (CDMO) facility focused on sterile injectable drug products.

Sterile Injectable Contract Manufacturing Market Report Highlights

• The large molecule segment accounted for the largest share of 61.3% in 2022. The segment’s growth is driven by increasing demand for large molecule-based therapeutics such as cell & gene therapy, RNA therapy, etc., which constitute a vast portion of large molecules

• Based on therapeutic application, the cancer segment accounted for the largest share of 28.5% in 2022. The growth in the share of this segment is majorly due to the increasing demand for anti-cancer-based injectable therapeutics

• The Subcutaneous (SC) segment is anticipated to register the fastest CAGR of 12.6% during the forecast period. This is because of the high demand for SC injectables globally, owing to their associated benefits while administering vaccines, growth hormones, and insulin

• Biopharmaceutical companies are anticipated to witness the highest CAGR of 12.4% over the forecast period due to the increasing number of biopharmaceutical companies investing in developing novel sterile injectables

• Asia Pacific is anticipated to witness the highest CAGR of 13.1% during the forecast period. This high growth is primarily due to the increasing number of Western pharmaceutical companies outsourcing their manufacturing activities to developing economies such as India and China

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Table of Contents

Table of Contents

Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Segment Definitions
1.1.2. Molecule Type
1.1.3. Therapeutic Application
1.1.4. Route of Administration
1.1.5. End-use
1.2. Regional Scope
1.3. Estimates And Forecast Timeline
1.4. Objectives
1.4.1. Objective - 1
1.4.2. Objective - 2
1.4.3. Objective - 3
1.5. Research Methodology
1.6. Information Procurement
1.6.1. Purchased Database
1.6.2. GVR’s Internal Database
1.6.3. Secondary Sources
1.6.4. Primary Research
1.7. Information Or Data Analysis
1.7.1. Data Analysis Models
1.8. Market Formulation & Validation
1.9. Model Details
1.9.1. Commodity Flow Analysis
1.9.2. Parent Market Analysis
1.10. List Of Secondary Sources
1.11. List Of Abbreviations
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. Sterile Injectable Contract Manufacturing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/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. Sterile Injectable Contract Manufacturing Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.1.1. Supplier Power
3.3.1.2. Buyer Power
3.3.1.3. Substitution Threat
3.3.1.4. Threat Of New Entrant
3.3.1.5. Competitive Rivalry
3.3.2. PESTEL Analysis
3.3.3. COVID-19 Impact Analysis
Chapter 4. Sterile Injectable Contract Manufacturing Market: Molecule Type Estimates & Trend Analysis
4.1. Sterile Injectable Contract Manufacturing Market, By Molecule Type: Segment Dashboard
4.2. Sterile Injectable Contract Manufacturing Market, By Molecule Type: Movement Analysis
4.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Molecule Type, 2018 - 2030
4.3.1. Small Molecule
4.3.1.1. Small Molecule Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
4.3.2. Large Molecule
4.3.2.1. Large Molecule Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
Chapter 5. Sterile Injectable Contract Manufacturing Market: Therapeutic Application Estimates & Trend Analysis
5.1. Sterile Injectable Contract Manufacturing Market, By Therapeutic Application: Segment Dashboard
5.2. Sterile Injectable Contract Manufacturing Market, By Therapeutic Application: Movement Analysis
5.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Therapeutic Application, 2018 - 2030
5.3.1. Cancer
5.3.1.1. Cancer Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.2. Diabetes
5.3.2.1. Diabetes Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.3. Cardiovascular Diseases
5.3.3.1. Cardiovascular Diseases Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.4. Central Nervous System Diseases
5.3.4.1. Central Nervous System Diseases Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.5. Infectious Disorders
5.3.5.1. Infectious Disorders Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.6. Musculoskeletal
5.3.6.1. Musculoskeletal Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.7. Anti-Viral
5.3.7.1. Anti-Viral Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
5.3.8. Others
5.3.8.1. Others Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
Chapter 6. Sterile Injectable Contract Manufacturing Market: Route of Administration Estimates & Trend Analysis
6.1. Sterile Injectable Contract Manufacturing Market, By Route of Administration: Segment Dashboard
6.2. Sterile Injectable Contract Manufacturing Market, By Route of Administration: Movement Analysis
6.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Route of Administration, 2018 - 2030
6.3.1. Subcutaneous (SC)
6.3.1.1. Subcutaneous (SC) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
6.3.2. Intravenous (IV)
6.3.2.1. Intravenous (IV) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
6.3.3. Intramuscular (IM)
6.3.3.1. Intramuscular (IM) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
6.3.4. Others
6.3.4.1. Others Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
Chapter 7. Sterile Injectable Contract Manufacturing Market: End-use Estimates & Trend Analysis
7.1. Sterile Injectable Contract Manufacturing Market, By End-use: Segment Dashboard
7.2. Sterile Injectable Contract Manufacturing Market, By End-use: Movement Analysis
7.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By End-use, 2018 - 2030
7.3.1. Pharmaceutical Companies
7.3.1.1. Pharmaceutical Companies Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
7.3.2. Biopharmaceutical Companies
7.3.2.1. Biopharmaceutical Companies Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
7.3.3. Others
7.3.3.1. Others Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
Chapter 8. Sterile Injectable Contract Manufacturing Market: Regional Estimates & Trend Analysis
8.1. Regional Market Share Analysis, 2022 & 2030
8.2. Regional Market Dashboard
8.3. Global Regional Market Snapshot
8.4. North America
8.4.1. Market Estimates and Forecast, 2018 - 2030 (Revenue, USD Million)
8.4.2. U.S.
8.4.2.1. Key Country Dynamics
8.4.2.2. Competitive Scenario
8.4.2.3. Regulatory Framework
8.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030
8.4.3. Canada
8.4.3.1. Key Country Dynamics
8.4.3.2. Competitive Scenario
8.4.3.3. Regulatory Framework
8.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030
8.5. Europe
8.5.1. UK
8.5.1.1. Key Country Dynamics
8.5.1.2. Competitive Scenario
8.5.1.3. Regulatory Framework
8.5.1.4. UK Market Estimates and Forecasts, 2018 - 2030
8.5.2. Germany
8.5.2.1. Key Country Dynamics
8.5.2.2. Competitive Scenario
8.5.2.3. Regulatory Framework
8.5.2.4. Germany Market Estimates and Forecasts, 2018 - 2030
8.5.3. France
8.5.3.1. Key Country Dynamics
8.5.3.2. Competitive Scenario
8.5.3.3. Regulatory Framework
8.5.3.4. France Market Estimates and Forecasts, 2018 - 2030
8.5.4. Italy
8.5.4.1. Key Country Dynamics
8.5.4.2. Competitive Scenario
8.5.4.3. Regulatory Framework
8.5.4.4. Italy Market Estimates and Forecasts, 2018 - 2030
8.5.5. Spain
8.5.5.1. Key Country Dynamics
8.5.5.2. Competitive Scenario
8.5.5.3. Regulatory Framework
8.5.5.4. Spain Market Estimates and Forecasts, 2018 - 2030
8.5.6. Denmark
8.5.6.1. Key Country Dynamics
8.5.6.2. Competitive Scenario
8.5.6.3. Regulatory Framework
8.5.6.4. Denmark Market Estimates and Forecasts, 2018 - 2030
8.5.7. Sweden
8.5.7.1. Key Country Dynamics
8.5.7.2. Competitive Scenario
8.5.7.3. Regulatory Framework
8.5.7.4. Sweden Market Estimates and Forecasts, 2018 - 2030
8.5.8. Norway
8.5.8.1. Key Country Dynamics
8.5.8.2. Competitive Scenario
8.5.8.3. Regulatory Framework
8.5.8.4. Norway Market Estimates and Forecasts, 2018 - 2030
8.6. Asia Pacific
8.6.1. Japan
8.6.1.1. Key Country Dynamics
8.6.1.2. Competitive Scenario
8.6.1.3. Regulatory Framework
8.6.1.4. Japan Market Estimates and Forecasts, 2018 - 2030
8.6.2. India
8.6.2.1. Key Country Dynamics
8.6.2.2. Competitive Scenario
8.6.2.3. Regulatory Framework
8.6.2.4. India Market Estimates and Forecasts, 2018 - 2030
8.6.3. China
8.6.3.1. Key Country Dynamics
8.6.3.2. Competitive Scenario
8.6.3.3. Regulatory Framework
8.6.3.4. China Market Estimates and Forecasts, 2018 - 2030
8.6.4. South Korea
8.6.4.1. Key Country Dynamics
8.6.4.2. Competitive Scenario
8.6.4.3. Regulatory Framework
8.6.4.4. South Korea Market Estimates and Forecasts, 2018 - 2030
8.6.5. Australia
8.6.5.1. Key Country Dynamics
8.6.5.2. Competitive Scenario
8.6.5.3. Regulatory Framework
8.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030
8.6.6. Thailand
8.6.6.1. Key Country Dynamics
8.6.6.2. Competitive Scenario
8.6.6.3. Regulatory Framework
8.6.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030
8.7. Latin America
8.7.1. Brazil
8.7.1.1. Key Country Dynamics
8.7.1.2. Competitive Scenario
8.7.1.3. Regulatory Framework
8.7.1.4. Brazil Market Estimates and Forecasts, 2018 - 2030
8.7.2. Mexico
8.7.2.1. Key Country Dynamics
8.7.2.2. Competitive Scenario
8.7.2.3. Regulatory Framework
8.7.2.4. Mexico Market Estimates and Forecasts, 2018 - 2030
8.7.3. Argentina
8.7.3.1. Key Country Dynamics
8.7.3.2. Competitive Scenario
8.7.3.3. Regulatory Framework
8.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030
8.8. MEA
8.8.1. South Africa
8.8.1.1. Key Country Dynamics
8.8.1.2. Competitive Scenario
8.8.1.3. Regulatory Framework
8.8.1.4. South Africa Market Estimates and Forecasts, 2018 - 2030
8.8.2. Saudi Arabia
8.8.2.1. Key Country Dynamics
8.8.2.2. Competitive Scenario
8.8.2.3. Regulatory Framework
8.8.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030
8.8.3. UAE
8.8.3.1. Key Country Dynamics
8.8.3.2. Competitive Scenario
8.8.3.3. Regulatory Framework
8.8.3.4. UAE Market Estimates and Forecasts, 2018 - 2030
8.8.4. Kuwait
8.8.4.1. Key Country Dynamics
8.8.4.2. Competitive Scenario
8.8.4.3. Regulatory Framework
8.8.4.4. Kuwait Market Estimates and Forecasts, 2018 - 2030
Chapter 9. Competitive Landscape
9.1. Market Participant Categorization
9.1.1. Innovators
9.1.2. Market Leaders
9.1.3. Emerging Players
9.1.4. Company Market Share Analysis, 2022
9.2. Company Profiles
9.2.1. Baxter
9.2.1.1. Company Overview
9.2.1.2. Financial Performance
9.2.1.3. Service Benchmarking
9.2.1.4. Strategic Initiatives
9.2.2. Catalent, Inc
9.2.2.1. Company Overview
9.2.2.2. Financial Performance
9.2.2.3. Service Benchmarking
9.2.2.4. Strategic Initiatives
9.2.3. Vetter Pharma
9.2.3.1. Company Overview
9.2.3.2. Financial Performance
9.2.3.3. Service Benchmarking
9.2.3.4. Strategic Initiatives
9.2.4. Recipharm AB
9.2.4.1. Company Overview
9.2.4.2. Financial Performance
9.2.4.3. Service Benchmarking
9.2.4.4. Strategic Initiatives
9.2.5. Aenova Group
9.2.5.1. Company Overview
9.2.5.2. Financial Performance
9.2.5.3. Service Benchmarking
9.2.5.4. Strategic Initiatives
9.2.6. Fresenius Kabi
9.2.6.1. Company Overview
9.2.6.2. Financial Performance
9.2.6.3. Service Benchmarking
9.2.6.4. Strategic Initiatives
9.2.7. Unither Pharmaceuticals
9.2.7.1. Company Overview
9.2.7.2. Financial Performance
9.2.7.3. Service Benchmarking
9.2.7.4. Strategic Initiatives
9.2.8. Famar
9.2.8.1. Company Overview
9.2.8.2. Financial Performance
9.2.8.3. Service Benchmarking
9.2.8.4. Strategic Initiatives
9.2.9. Cipla Inc.
9.2.9.1. Company Overview
9.2.9.2. Financial Performance
9.2.9.3. Service Benchmarking
9.2.9.4. Strategic Initiatives
9.2.10. NextPharma Technologies
9.2.10.1. Company Overview
9.2.10.2. Financial Performance
9.2.10.3. Service Benchmarking
9.2.10.4. Strategic Initiatives