의약품 무균 검사 시장 : 시장 규모, 점유율, 동향 분석 보고서 - 유형별, 시험별, 제품별, 샘플별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Pharmaceutical Sterility Testing Market Growth & Trends:

The global pharmaceutical sterility testing market size is estimated to reach USD 4.64 billion by 2033, registering a CAGR of 11.58% from 2025 to 2033, according to a new report by Grand View Research, Inc. A growing number of drug launches worldwide, and rising government investments are anticipated to influence the global market positively. As pharmaceutical companies are introducing an array of new drugs to the market, there is a parallel surge in the demand for rigorous sterility testing protocols. Besides, stringent regulatory requirements for pharmaceuticals products further support market growth. Thus, an upsurge in novel drug launches provided unprecedented growth opportunities to the pharmaceutical sterility testing market.

In addition, increasing emphasis on R&D activities in the pharmaceutical industry profoundly impacts the pharmaceutical sterility testing market. As pharmaceutical companies are proactively involved in the discovery and development of innovative & advanced drug formulations, there is a growing need for robust sterility testing protocols to ensure the safety and efficacy of these products. R&D activities drive the development of new pharmaceuticals, biologics, and vaccines, necessitating comprehensive sterility testing methodologies to comply with regulatory requirements.

Furthermore, stringent regulations by regulatory bodies for pharmaceutical product approval prompt pharmaceutical companies to invest significantly in R&D to meet these evolving standards. As a result, the market experiences a surge in demand for state-of-the-art testing solutions to align with the regulatory landscape. For instance, in September 2023, Sartorius AG introduced a sterisart septum for sampling from a sterility testing unit. It is a closed system for testing based on the membrane filtration method that mitigates the risk of secondary contamination. Such service launches offered a competitive edge in the market.

Moreover, the pharmaceutical industry's commitment to addressing unmet medical needs and discovering innovative therapeutic avenues further amplifies the importance of robust sterility testing protocols. The need for accuracy & reliability in detecting any potential contaminants becomes paramount to ensure the safety and efficacy of these newly launched drugs.

Pharmaceutical Sterility Testing Market Report Highlights:

• Based on type, the outsourcing segment led the market with the largest revenue share of 58.50% in 2024. The segment growth is driven by increasing requirements for Outsourcing sterility testing as attractive alternative for several small- & medium-sized pharmaceutical and medical device companies, which may lack the infrastructure to conduct quality sterility testing
• Based on product type, the kits and reagents segment held the market with the largest revenue share in 2024, attributing to a standardized and reliable techniques to determine the absence of live microorganisms in pharmaceutical products
• Based on test type, the bioburden testing segment led the market with the largest revenue share in 2024. The segment is driven by strict quality control processes and the demand for testing to quantify microbial contamination of a product at different stages of production from initial manufacturing to final distribution
• Based on sample, the pharmaceuticals segment led the market with the largest revenue share in 2024. The products are widely used dosage forms. The growing demand or these dosage forms globally is one of the major factors driving this segment
• Based on end-use, the medical device companies held the largest market share in 2024. By outsourcing noncore activities like sterility testing, medical device companies can concentrate on their core competencies, such as research, development, and manufacturing.
• North America dominated the market with a revenue share of 52.88% in 2024. The presence of a large number of major market players in this region is expected to contribute to the market growth significantly. Stringent regulatory requirements for sterility testing of pharmaceuticals and medical devices in this region further supports market growth.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. Pharmaceutical Sterility Testing Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Pharmaceutical Sterility Testing Market Dynamics
  • 3.2.1. Market Driver Impact Analysis
    • 3.2.1.1. Supportive Government Investment in the Healthcare Industry
    • 3.2.1.2. Increasing R&D Activities
    • 3.2.1.3. Increasing Number of Drug Launches
    • 3.2.1.4. Increasing Focus on Quality and Sterility
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance Issues While Outsourcing
    • 3.2.2.2. Third Party Performance
• 3.3. Technological Landscape
• 3.4. Pricing Model Analysis
• 3.5. Pharmaceutical Sterility Testing Market: Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis

Chapter 4. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Pharmaceutical Sterility Testing Market Movement Analysis
• 4.3. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Type, 2021 to 2033 (USD Million)
• 4.4. In-House
  • 4.4.1. In-house Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.5. Outsourcing
  • 4.5.1. Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Pharmaceutical Sterility Testing Market: Product Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Pharmaceutical Sterility Testing Market Movement Analysis
• 5.3. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
• 5.4. Kits and Reagents
  • 5.4.1. Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Instruments
  • 5.5.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Services
  • 5.6.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Pharmaceutical Sterility Testing Market Movement Analysis
• 6.3. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Test Type, 2021 to 2033 (USD Million)
• 6.4. Sterility Testing
  • 6.4.1. Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.1.1. Membrane Filtration
      • 6.4.1.1.1. Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.1.2. Direct Inoculation
      • 6.4.1.2.1. Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.1.3. Product Flush
      • 6.4.1.3.1. Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Bioburden Testing
  • 6.5.1.1. Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Bacterial Endotoxin Testing
  • 6.6.1.1. Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Pharmaceutical Sterility Testing Market Movement Analysis
• 7.3. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Sample, 2021 to 2033 (USD Million)
  • 7.3.1. Pharmaceuticals
    • 7.3.1.1. Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.3.2. Medical Devices
    • 7.3.2.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.3.3. Biopharmaceuticals
    • 7.3.3.1. Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Pharmaceutical Sterility Testing Market: End Use Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. Global Pharmaceutical Sterility Testing Market Movement Analysis
• 8.3. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
• 8.4. Compounding Pharmacies
  • 8.4.1. Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.5. Medical Device Companies
  • 8.5.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.6. Pharmaceutical Companies
  • 8.6.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.7. Others
  • 8.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Pharmaceutical Sterility Testing Market: Regional Estimates & Trend Analysis by Type, Product, Test, Sample, End Use

• 9.1. Regional Market Dashboard
• 9.2. Global Regional Market Snapshot
• 9.3. Market Size, & Forecasts, Trend Analysis, 2021 to 2033:
• 9.4. North America
  • 9.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.4.2. U.S.
    • 9.4.2.1. Key Country Dynamics
    • 9.4.2.2. Competitive Scenario
    • 9.4.2.3. Regulatory Framework
    • 9.4.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.4.3. Canada
    • 9.4.3.1. Key Country Dynamics
    • 9.4.3.2. Competitive Scenario
    • 9.4.3.3. Regulatory Framework
    • 9.4.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.4.4. Mexico
    • 9.4.4.1. Key Country Dynamics
    • 9.4.4.2. Competitive Scenario
    • 9.4.4.3. Regulatory Framework
    • 9.4.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.5. Europe
  • 9.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.2. UK
    • 9.5.2.1. Key Country Dynamics
    • 9.5.2.2. Competitive Scenario
    • 9.5.2.3. Regulatory Framework
    • 9.5.2.4. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.3. Germany
    • 9.5.3.1. Key Country Dynamics
    • 9.5.3.2. Competitive Scenario
    • 9.5.3.3. Regulatory Framework
    • 9.5.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.4. France
    • 9.5.4.1. Key Country Dynamics
    • 9.5.4.2. Competitive Scenario
    • 9.5.4.3. Regulatory Framework
    • 9.5.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.5. Italy
    • 9.5.5.1. Key Country Dynamics
    • 9.5.5.2. Competitive Scenario
    • 9.5.5.3. Regulatory Framework
    • 9.5.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.6. Spain
    • 9.5.6.1. Key Country Dynamics
    • 9.5.6.2. Competitive Scenario
    • 9.5.6.3. Regulatory Framework
    • 9.5.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.7. Denmark
    • 9.5.7.1. Key Country Dynamics
    • 9.5.7.2. Competitive Scenario
    • 9.5.7.3. Regulatory Framework
    • 9.5.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.8. Sweden
    • 9.5.8.1. Key Country Dynamics
    • 9.5.8.2. Competitive Scenario
    • 9.5.8.3. Regulatory Framework
    • 9.5.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5.9. Norway
    • 9.5.9.1. Key Country Dynamics
    • 9.5.9.2. Competitive Scenario
    • 9.5.9.3. Regulatory Framework
    • 9.5.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.6. Asia Pacific
  • 9.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.2. Japan
    • 9.6.2.1. Key Country Dynamics
    • 9.6.2.2. Competitive Scenario
    • 9.6.2.3. Regulatory Framework
    • 9.6.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.3. China
    • 9.6.3.1. Key Country Dynamics
    • 9.6.3.2. Competitive Scenario
    • 9.6.3.3. Regulatory Framework
    • 9.6.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.4. India
    • 9.6.4.1. Key Country Dynamics
    • 9.6.4.2. Competitive Scenario
    • 9.6.4.3. Regulatory Framework
    • 9.6.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.5. Australia
    • 9.6.5.1. Key Country Dynamics
    • 9.6.5.2. Competitive Scenario
    • 9.6.5.3. Regulatory Framework
    • 9.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.6. South Korea
    • 9.6.6.1. Key Country Dynamics
    • 9.6.6.2. Competitive Scenario
    • 9.6.6.3. Regulatory Framework
    • 9.6.6.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6.7. Thailand
    • 9.6.7.1. Key Country Dynamics
    • 9.6.7.2. Competitive Scenario
    • 9.6.7.3. Regulatory Framework
    • 9.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.7. Latin America
  • 9.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.7.2. Brazil
    • 9.7.2.1. Key Country Dynamics
    • 9.7.2.2. Competitive Scenario
    • 9.7.2.3. Regulatory Framework
    • 9.7.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.7.3. Argentina
    • 9.7.3.1. Key Country Dynamics
    • 9.7.3.2. Competitive Scenario
    • 9.7.3.3. Regulatory Framework
    • 9.7.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.8. MEA
  • 9.8.1. MEA Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.8.2. South Africa
    • 9.8.2.1. Key Country Dynamics
    • 9.8.2.2. Competitive Scenario
    • 9.8.2.3. Regulatory Framework
    • 9.8.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.8.3. Saudi Arabia
    • 9.8.3.1. Key Country Dynamics
    • 9.8.3.2. Competitive Scenario
    • 9.8.3.3. Regulatory Framework
    • 9.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.8.4. UAE
    • 9.8.4.1. Key Country Dynamics
    • 9.8.4.2. Competitive Scenario
    • 9.8.4.3. Regulatory Framework
    • 9.8.4.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.8.5. Kuwait
    • 9.8.5.1. Key Country Dynamics
    • 9.8.5.2. Competitive Scenario
    • 9.8.5.3. Regulatory Framework
    • 9.8.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 10. Competitive Landscape

• 10.1. Company Categorization
• 10.2. Pharmaceutical Sterility Testing Market Share Analysis, 2024
• 10.3. Company Profiles
  • 10.3.1. Pacific Biolabs
    • 10.3.1.1. Company overview
    • 10.3.1.2. Financial performance
    • 10.3.1.3. Product benchmarking
    • 10.3.1.4. Strategic initiatives
  • 10.3.2. Steris Plc
    • 10.3.2.1. Company overview
    • 10.3.2.2. Financial performance
    • 10.3.2.3. Product benchmarking
    • 10.3.2.4. Strategic initiatives
  • 10.3.3. Boston Analytical
    • 10.3.3.1. Company overview
    • 10.3.3.2. Financial performance
    • 10.3.3.3. Product benchmarking
    • 10.3.3.4. Strategic initiatives
  • 10.3.4. Nelson Laboratories, LLC (Sotera Health)
    • 10.3.4.1. Company overview
    • 10.3.4.2. Financial performance
    • 10.3.4.3. Product benchmarking
    • 10.3.4.4. Strategic initiatives
  • 10.3.5. Sartorius AG
    • 10.3.5.1. Company overview
    • 10.3.5.2. Financial performance
    • 10.3.5.3. Product benchmarking
    • 10.3.5.4. Strategic initiatives
  • 10.3.6. SOLVIAS AG
    • 10.3.6.1. Company overview
    • 10.3.6.2. Financial performance
    • 10.3.6.3. Product benchmarking
    • 10.3.6.4. Strategic initiatives
  • 10.3.7. SGS SA
    • 10.3.7.1. Company overview
    • 10.3.7.2. Financial performance
    • 10.3.7.3. Product benchmarking
    • 10.3.7.4. Strategic initiatives
  • 10.3.8. Labcorp
    • 10.3.8.1. Company overview
    • 10.3.8.2. Financial performance
    • 10.3.8.3. Product benchmarking
    • 10.3.8.4. Strategic initiatives
  • 10.3.9. Pace Analytical
    • 10.3.9.1. Company overview
    • 10.3.9.2. Financial performance
    • 10.3.9.3. Product benchmarking
    • 10.3.9.4. Strategic initiatives
  • 10.3.10. Charles River Laboratories
    • 10.3.10.1. Company overview
    • 10.3.10.2. Financial performance
    • 10.3.10.3. Product benchmarking
    • 10.3.10.4. Strategic initiatives
  • 10.3.11. Thermo Fisher Scientific, Inc.
    • 10.3.11.1. Company overview
    • 10.3.11.2. Financial performance
    • 10.3.11.3. Product benchmarking
    • 10.3.11.4. Strategic initiatives
  • 10.3.12. Rapid Micro Biosystems
    • 10.3.12.1. Company overview
    • 10.3.12.2. Financial performance
    • 10.3.12.3. Product benchmarking
    • 10.3.12.4. Strategic initiatives
  • 10.3.13. Almac Group
    • 10.3.13.1. Company overview
    • 10.3.13.2. Financial performance
    • 10.3.13.3. Product benchmarking
    • 10.3.13.4. Strategic initiatives
  • 10.3.14. Labor LS SE & Co. KG
    • 10.3.14.1. Company overview
    • 10.3.14.2. Financial performance
    • 10.3.14.3. Product benchmarking
    • 10.3.14.4. Strategic initiatives