Summary

Pharmaceutical Sterility Testing Market Growth & Trends

The global pharmaceutical sterility testing market size is anticipated to reach USD 3.28 billion by 2030 and is projected to grow at a CAGR of 11.02% from 2024 to 2030, 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 59.25% in 2023. 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 of 60.30% in 2023, 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 of 41.71% in 2023. 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 of 42.45% in 2023. 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 pharmaceutical companies dominated the market in 2023. These companies conduct sterility tests to ensure the safety of the products, especially oral dosage forms, as most of these products are ingested by patients

• North America dominated the market with a revenue share of 49.45% in 2023. 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

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Table of Contents

Table of Contents

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
1.3.5. Details Of 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 Primary Sources
1.10. List of Abbreviations
1.11. Objectives
1.11.1. Objective - 1
1.11.2. Objective - 2
1.11.3. Objective - 3
1.11.4. Objective - 4
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
2.4. Market Lineage Outlook
2.4.1. Parent Market Outlook
2.4.2. Ancillary Market Outlook
2.5. Pharmaceutical Sterility Testing Market Dynamics
2.5.1. Market Driver Impact Analysis
2.5.1.1. Supportive Government Investment In The Healthcare Industry
2.5.1.2. Increasing R&D Activities
2.5.1.3. Increasing Number Of Drug Launches
2.5.1.4. Increasing Focus On Quality And Sterility
2.5.2. Market Restraint Analysis
2.5.2.1. Compliance Issues While Outsourcing
2.5.2.2. Third Party Performance
2.6. Pharmaceutical Sterility Testing Market: Analysis Tools
2.6.1. Porter’s Five Forces Analysis
2.6.2. PESTEL Analysis
2.7. Impact Of Covid-19 On Pharmaceutical Sterility Testing Market
2.8. Post Covid-19 Reformation Strategies In The Market
Chapter 3. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
3.1. Definitions and Scope
3.1.1. In-House
3.1.2. Outsourcing
3.2. Segment Dashboard
3.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
3.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
3.4.1. In-House
3.4.1.1. Market estimates and forecast 2018 to 2030 (USD million)
3.4.2. Outsourcing
3.4.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 4. Pharmaceutical Sterility Testing Market: Product Type Estimates & Trend Analysis
4.1. Definitions and Scope
4.1.1. Kits and Reagents
4.1.2. Instruments
4.1.3. Services
4.2. Segment Dashboard
4.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
4.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Product Type, 2018 to 2030 (USD Million)
4.4.1. Kits and Reagents
4.4.1.1. Market estimates and forecast 2018 to 2030 (USD Million)
4.4.2. Instruments
4.4.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
4.4.3. Services
4.4.3.1. Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 5. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis
5.1. Definitions and Scope
5.1.1. Sterility Testing
5.1.1.1. Membrane Filtration
5.1.1.2. Direct Inoculation
5.1.1.3. Product Flush
5.1.2. Bioburden Testing
5.1.3. Bacterial Endotoxin Testing
5.2. Segment Dashboard
5.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
5.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Product Type, 2018 to 2030 (USD Million)
5.4.1. Sterility Testing
5.4.1.1. Market estimates and forecast 2018 to 2030 (USD Million)
5.4.1.2. Membrane Filtration
5.4.1.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
5.4.1.3. Direct Inoculation
5.4.1.3.1. Market estimates and forecast 2018 to 2030 (USD Million)
5.4.1.4. Product Flush
5.4.1.4.1. Market estimates and forecast 2018 to 2030 (USD Million)
5.4.2. Bioburden Testing
5.4.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
5.4.3. Bacterial Endotoxin Testing
5.4.3.1. Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 6. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
6.1. Definitions and Scope
6.1.1. Pharmaceuticals
6.1.2. Medical Devices
6.1.3. Biopharmaceuticals
6.2. Segment Dashboard
6.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
6.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Sample, 2018 to 2030 (USD Million)
6.4.1. Pharmaceuticals
6.4.1.1. Market estimates and forecast 2018 to 2030 (USD Million)
6.4.2. Medical Devices
6.4.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
6.4.3. Biopharmaceuticals
6.4.3.1. Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 7. Pharmaceutical Sterility Testing Market: End-use Estimates & Trend Analysis
7.1. Definitions and Scope
7.1.1. Compounding Pharmacies
7.1.2. Medical Device Companies
7.1.3. Pharmaceutical Companies
7.1.4. Others
7.2. Segment Dashboard
7.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
7.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
7.4.1. Compounding Pharmacies
7.4.1.1. Market estimates and forecast 2018 to 2030 (USD Million)
7.4.2. Medical Device Companies
7.4.2.1. Market estimates and forecast 2018 to 2030 (USD Million)
7.4.3. Pharmaceutical Companies
7.4.3.1. Market estimates and forecast 2018 to 2030 (USD Million)
7.4.4. Others
7.4.4.1. Market estimates and forecast 2018 to 2030 (USD Million)
Chapter 8. Pharmaceutical Sterility Testing Market: Regional Estimates & Trend Analysis by Type, Product Type, Test Type, Sample, End-use
8.1. Regional Market Dashboard
8.2. Global Regional Market Snapshot
8.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
8.4. North America
8.4.1. Market estimates and forecast, 2018 - 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 Scenario
8.4.2.4. Market estimates and forecast, 2018 - 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 Scenario
8.4.3.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.5. Europe
8.5.1. Market estimates and forecast, 2018 - 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 Scenario
8.5.2.4. Market estimates and forecast, 2018 - 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 Scenario
8.5.3.4. Market estimates and forecast, 2018 - 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 Scenario
8.5.4.4. Market estimates and forecast, 2018 - 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 Scenario
8.5.5.4. Market estimates and forecast, 2018 - 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 Scenario
8.5.6.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.5.7. Netherlands
8.5.7.1. Key Country Dynamics
8.5.7.2. Competitive Scenario
8.5.7.3. Regulatory Scenario
8.5.7.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.5.8. Switzerland
8.5.8.1. Key Country Dynamics
8.5.8.2. Competitive Scenario
8.5.8.3. Regulatory Scenario
8.5.8.4. Market estimates and forecast, 2018 - 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 Scenario
8.5.9.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.5.10. Belgium
8.5.10.1. Key Country Dynamics
8.5.10.2. Competitive Scenario
8.5.10.3. Regulatory Scenario
8.5.10.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.5.11. Russia
8.5.11.1. Key Country Dynamics
8.5.11.2. Competitive Scenario
8.5.11.3. Regulatory Scenario
8.5.11.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6. Asia Pacific
8.6.1. Market estimates and forecast, 2018 - 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 Scenario
8.6.2.4. Market estimates and forecast, 2018 - 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 Scenario
8.6.3.4. Market estimates and forecast, 2018 - 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 Scenario
8.6.4.4. Market estimates and forecast, 2018 - 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 Scenario
8.6.5.4. Market estimates and forecast, 2018 - 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 Scenario
8.6.6.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6.7. Philippines
8.6.7.1. Key Country Dynamics
8.6.7.2. Competitive Scenario
8.6.7.3. Regulatory Scenario
8.6.7.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6.8. Malaysia
8.6.8.1. Key Country Dynamics
8.6.8.2. Competitive Scenario
8.6.8.3. Regulatory Scenario
8.6.8.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6.9. New Zealand
8.6.9.1. Key Country Dynamics
8.6.9.2. Competitive Scenario
8.6.9.3. Regulatory Scenario
8.6.9.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6.10. Singapore
8.6.10.1. Key Country Dynamics
8.6.10.2. Competitive Scenario
8.6.10.3. Regulatory Scenario
8.6.10.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.6.11. Thailand
8.6.11.1. Key Country Dynamics
8.6.11.2. Competitive Scenario
8.6.11.3. Regulatory Scenario
8.6.11.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.7. Latin America
8.7.1. Market estimates and forecast, 2018 - 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 Scenario
8.7.2.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.7.3. Mexico
8.7.3.1. Key Country Dynamics
8.7.3.2. Competitive Scenario
8.7.3.3. Regulatory Scenario
8.7.3.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.7.4. Argentina
8.7.4.1. Key Country Dynamics
8.7.4.2. Competitive Scenario
8.7.4.3. Regulatory Scenario
8.7.4.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.7.5. Colombia
8.7.5.1. Key Country Dynamics
8.7.5.2. Competitive Scenario
8.7.5.3. Regulatory Scenario
8.7.5.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.7.6. Chile
8.7.6.1. Key Country Dynamics
8.7.6.2. Competitive Scenario
8.7.6.3. Regulatory Scenario
8.7.6.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.8. MEA
8.8.1. Market estimates and forecast, 2018 - 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 Scenario
8.8.2.4. Market estimates and forecast, 2018 - 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 Scenario
8.8.3.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.8.4. Egypt
8.8.4.1. Key Country Dynamics
8.8.4.2. Competitive Scenario
8.8.4.3. Regulatory Scenario
8.8.4.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.8.5. Israel
8.8.5.1. Key Country Dynamics
8.8.5.2. Competitive Scenario
8.8.5.3. Regulatory Scenario
8.8.5.4. Market estimates and forecast, 2018 - 2030 (USD Million)
8.8.6. UAE
8.8.6.1. Key Country Dynamics
8.8.6.2. Competitive Scenario
8.8.6.3. Regulatory Scenario
8.8.6.4. Market estimates and forecast, 2018 - 2030 (USD Million)
Chapter 9. Competitive Landscape
9.1. Company Categorization
9.2. Pharmaceutical Sterility Testing Market Share Analysis, 2023
9.3. Major Deals and Strategic Alliances Analysis
9.3.1. Strategy Mapping
9.3.2. Expansion
9.3.3. Partnerships
9.3.4. Acquisitions
9.4. Vendor Landscape
9.4.1. Key company market share analysis, 2023
9.4.2. Pacific Biolabs
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. Steris Plc
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. Boston Analytical
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. Nelson Laboratories, LLC (Sotera Health)
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. Sartorius 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. SOLVIAS AG
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. SGS SA
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. Labcorp
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. Pace Analytical
9.4.10.1. Company overview
9.4.10.2. Financial performance
9.4.10.3. Product benchmarking
9.4.10.4. Strategic initiatives
9.4.11. Charles River Laboratories
9.4.11.1. Company overview
9.4.11.2. Financial performance
9.4.11.3. Product benchmarking
9.4.11.4. Strategic initiatives
9.4.12. Thermo Fisher Scientific, Inc.
9.4.12.1. Company overview
9.4.12.2. Financial performance
9.4.12.3. Product benchmarking
9.4.12.4. Strategic initiatives
9.4.13. Rapid Micro Biosystems
9.4.13.1. Company overview
9.4.13.2. Financial performance
9.4.13.3. Product benchmarking
9.4.13.4. Strategic initiatives
9.4.14. Almac Group
9.4.14.1. Company overview
9.4.14.2. Financial performance
9.4.14.3. Product benchmarking
9.4.14.4. Strategic initiatives
9.4.15. Labor LS SE & Co. KG
9.4.15.1. Company overview
9.4.15.2. Financial performance
9.4.15.3. Product benchmarking
9.4.15.4. Strategic initiatives