무균 주사제 수탁생산 시장 규모, 점유율 및 동향 분석 보고서 : 분자 유형별, 투여 경로별, 치료 용도별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Sterile Injectable Contract Manufacturing Market Growth & Trends:

The global sterile injectable contract manufacturing market size is expected to reach USD 31.9 billion by 2030, registering a CAGR of 12.28% from 2025 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:

• Based on molecule type, the large molecule segment led the market with the largest revenue share of 67.07% in 2024. The growth of the segment is mainly due to rising investments by contract manufacturers in developing large molecule-based therapeutics, an expanding pipeline of biologics injectables, and a notable increase in U.S. FDA approvals for biosimilars.
• Based on therapeutic application, the cancer segment led the market with the largest revenue share of 28.17% in 2024. The increasing number of cancer cases, rising R&D investments, and growing requirements for oncology drugs & biologics are some of the factors driving the segment growth.
• Based on route of administration, the intravenous (IV) segment led the market with the largest revenue share of 30.35% in 2024. Several healthcare systems are shifting toward personalized medicine, which is boosting the demand for tailored intravenous therapies.
• Based on end use, the pharmaceutical companies segment led the market with the largest revenue share of 43.48% in 2024. Pharmaceutical companies are increasingly outsourcing their drug development and manufacturing operations to Contract Manufacturing Organizations (CMOs) to focus on their core competencies, such as R&D.
• North America sterile injectable contract manufacturing market dominated with the revenue share of 42.86% in 2024. The growth in the region is attributed to the factors such as to the region's advanced healthcare infrastructure, increasing R&D investment, technological developments, and the presence of major players.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Molecule Type Segment
  • 1.2.2. Molecule Therapeutic Application Segment
  • 1.2.3. Route of Administration Segment
  • 1.2.4. End Use Segment
• 1.3. Information analysis
  • 1.3.1. Market formulation & data visualization
• 1.4. Data validation & publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Total Market: CAGR Calculation
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

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
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Sterile Injectable Contract Manufacturing Market: Molecule Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Sterile Injectable Contract Manufacturing Market Molecule Type Movement Analysis
• 4.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Molecule Type, 2018 to 2030 (USD Million)
• 4.4. Small Molecule
  • 4.4.1. Small molecule market estimates and forecasts, 2018 to 2030 (USD Million)
• 4.5. Large Molecule
  • 4.5.1. Large molecule market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 5. Sterile Injectable Contract Manufacturing Market: Therapeutic Application Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Sterile Injectable Contract Manufacturing Market Therapeutic Application Movement Analysis
• 5.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Therapeutic Application, 2018 to 2030 (USD Million)
• 5.4. Cancer
  • 5.4.1. Cancer market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.5. Diabetes
  • 5.5.1. Diabetes market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.6. Cardiovascular Diseases
  • 5.6.1. Cardiovascular diseases market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.7. Central Nervous Systems Diseases
  • 5.7.1. Central nervous systems diseases market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.8. Infectious Disorders
  • 5.8.1. Infectious disorders market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.9. Musculoskeletal
  • 5.9.1. Musculoskeletal market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.10. Anti-Viral
  • 5.10.1. Anti-Viral market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.11. Others
  • 5.11.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 6. Sterile Injectable Contract Manufacturing Market: Route of Administration Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Sterile Injectable Contract Manufacturing Market Route of Administration Movement Analysis
• 6.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Route of Administration, 2018 to 2030 (USD Million)
• 6.4. Subcutaneous (SC)
  • 6.4.1. Subcutaneous (SC) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.5. Intravenous (IV)
  • 6.5.1. Intravenous (IV) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.6. Intramuscular (IM)
  • 6.6.1. Intramuscular (IM) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 7. Sterile Injectable Contract Manufacturing Market: End Use Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Sterile Injectable Contract Manufacturing Market End Use Movement Analysis
• 7.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 7.4. Pharmaceutical Companies
  • 7.4.1. Pharmaceutical companies market estimates and forecasts, 2018 to 2030 (USD Million)
• 7.5. Biopharmaceutical Companies
  • 7.5.1. Biopharmaceutical companies market estimates and forecasts, 2018 to 2030 (USD Million)
• 7.6. Others
  • 7.6.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 8. Sterile Injectable Contract Manufacturing Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 8.4. North America
  • 8.4.1. North America Market Estimates and Forecasts, 2018 to 2030 (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 Landscape
    • 8.4.2.4. U.S. market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key country dynamics
    • 8.4.3.2. Competitive scenario
    • 8.4.3.3. Regulatory Landscape
    • 8.4.3.4. Canada market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key country dynamics
    • 8.4.4.2. Competitive scenario
    • 8.4.4.3. Regulatory Landscape
    • 8.4.4.4. Mexico market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key country dynamics
    • 8.5.2.2. Competitive scenario
    • 8.5.2.3. Regulatory Landscape
    • 8.5.2.4. UK market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key country dynamics
    • 8.5.3.2. Competitive scenario
    • 8.5.3.3. Regulatory Landscape
    • 8.5.3.4. Germany market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key country dynamics
    • 8.5.4.2. Competitive scenario
    • 8.5.4.3. Regulatory Landscape
    • 8.5.4.4. France market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key country dynamics
    • 8.5.5.2. Competitive scenario
    • 8.5.5.3. Regulatory Landscape
    • 8.5.5.4. Italy market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key country dynamics
    • 8.5.6.2. Competitive scenario
    • 8.5.6.3. Regulatory Landscape
    • 8.5.6.4. Spain market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.7. Denmark
    • 8.5.7.1. Key country dynamics
    • 8.5.7.2. Competitive scenario
    • 8.5.7.3. Regulatory Landscape
    • 8.5.7.4. Denmark market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.8. Norway
    • 8.5.8.1. Key country dynamics
    • 8.5.8.2. Competitive scenario
    • 8.5.8.3. Regulatory Landscape
    • 8.5.8.4. Norway market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.9. Sweden
    • 8.5.9.1. Key country dynamics
    • 8.5.9.2. Competitive scenario
    • 8.5.9.3. Regulatory Landscape
    • 8.5.9.4. Sweden market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key country dynamics
    • 8.6.2.2. Competitive scenario
    • 8.6.2.3. Regulatory Landscape
    • 8.6.2.4. Japan market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key country dynamics
    • 8.6.3.2. Competitive scenario
    • 8.6.3.3. Regulatory Landscape
    • 8.6.3.4. China market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key country dynamics
    • 8.6.4.2. Competitive scenario
    • 8.6.4.3. Regulatory Landscape
    • 8.6.4.4. India market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.5. Australia
    • 8.6.5.1. Key country dynamics
    • 8.6.5.2. Competitive scenario
    • 8.6.5.3. Regulatory Landscape
    • 8.6.5.4. Australia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.6. South Korea
    • 8.6.6.1. Key country dynamics
    • 8.6.6.2. Competitive scenario
    • 8.6.6.3. Regulatory Landscape
    • 8.6.6.4. South Korea market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key country dynamics
    • 8.6.7.2. Competitive scenario
    • 8.6.7.3. Regulatory Landscape
    • 8.6.7.4. Thailand market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key country dynamics
    • 8.7.2.2. Competitive scenario
    • 8.7.2.3. Regulatory Landscape
    • 8.7.2.4. Brazil market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key country dynamics
    • 8.7.3.2. Competitive scenario
    • 8.7.3.3. Regulatory Landscape
    • 8.7.3.4. Argentina market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.8. MEA
  • 8.8.1. MEA Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key country dynamics
    • 8.8.2.2. Competitive scenario
    • 8.8.2.3. Regulatory Landscape
    • 8.8.2.4. South Africa market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key country dynamics
    • 8.8.3.2. Competitive scenario
    • 8.8.3.3. Regulatory Landscape
    • 8.8.3.4. Saudi Arabia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key country dynamics
    • 8.8.4.2. Competitive scenario
    • 8.8.4.3. Regulatory Landscape
    • 8.8.4.4. UAE market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key country dynamics
    • 8.8.5.2. Competitive scenario
    • 8.8.5.3. Regulatory Landscape
    • 8.8.5.4. Kuwait market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company/Competition Categorization
• 9.2. Strategy Mapping
• 9.3. Company Market Position Analysis, 2024
• 9.4. Company Profiles/Listing
  • 9.4.1. Baxter
    • 9.4.1.1. Company overview
    • 9.4.1.2. Financial performance
    • 9.4.1.3. Product benchmarking
    • 9.4.1.4. Strategic initiatives
  • 9.4.2. Catalent, Inc.
    • 9.4.2.1. Company overview
    • 9.4.2.2. Financial performance
    • 9.4.2.3. Product benchmarking
    • 9.4.2.4. Strategic initiatives
  • 9.4.3. Vetter Pharma
    • 9.4.3.1. Company overview
    • 9.4.3.2. Financial performance
    • 9.4.3.3. Product benchmarking
    • 9.4.3.4. Strategic initiatives
  • 9.4.4. Recipharm AB
    • 9.4.4.1. Company overview
    • 9.4.4.2. Financial performance
    • 9.4.4.3. Product benchmarking
    • 9.4.4.4. Strategic initiatives
  • 9.4.5. Aenova Group
    • 9.4.5.1. Company overview
    • 9.4.5.2. Financial performance
    • 9.4.5.3. Product benchmarking
    • 9.4.5.4. Strategic initiatives
  • 9.4.6. Fresenius Kabi AG
    • 9.4.6.1. Company overview
    • 9.4.6.2. Financial performance
    • 9.4.6.3. Product benchmarking
    • 9.4.6.4. Strategic initiatives
  • 9.4.7. Unither Pharmaceuticals
    • 9.4.7.1. Company overview
    • 9.4.7.2. Financial performance
    • 9.4.7.3. Product benchmarking
    • 9.4.7.4. Strategic initiatives
  • 9.4.8. FAMAR Health Care Services
    • 9.4.8.1. Company overview
    • 9.4.8.2. Financial performance
    • 9.4.8.3. Product benchmarking
    • 9.4.8.4. Strategic initiatives
  • 9.4.9. Cipla Inc.
    • 9.4.9.1. Company overview
    • 9.4.9.2. Financial performance
    • 9.4.9.3. Product benchmarking
    • 9.4.9.4. Strategic initiatives
  • 9.4.10. NextPharma Technologies
    • 9.4.10.1. Company overview
    • 9.4.10.2. Financial performance
    • 9.4.10.3. Product benchmarking
    • 9.4.10.4. Strategic initiatives