Pharmaceutical Sterility Testing Market Research Reportβ€”Global Forecast till 2027

Pharmaceutical Sterility Testing Market: by Sample (Sterile Drugs, Medical Devices, and Biologics), by Product Type (Instruments, Kits & Reagents, and Services), by Type (In-house and Outsourcing), by Test Type (Sterility Testing, Bioburden Testing, and Bacterial Endotoxin Testing), by End User (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, and Others), and by Region (North America, Europe, Asia-Pacific, and Rest of the World)β€”Forecast to 2027

ID: MRFR/HC/9236-HCR | November 2021 | Region: Global | 120 Pages         

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

2. MARKET INTRODUCTION

2.1. Definition

2.2. Scope of the Study

2.2.1. Research Objective

2.2.2. Assumptions

2.2.3. Limitations

3. RESEARCH METHODOLOGY

3.1. Overview

3.2. Data Mining

3.3. Secondary Research

3.4. Primary Research

3.4.1. Primary Interviews and Information Gathering Process

3.4.2. Breakdown of Primary Respondents

3.5. Forecasting Techniques

3.6. Market Size Estimation

3.6.1. Bottom-Up Approach

3.6.2. Top-Down Approach

3.7. Data Triangulation

3.8. Validation

4. MARKET DYNAMICS

4.1. Overview

4.2. Drivers

4.3. Restraints

4.4. Opportunities

5. MARKET FACTOR ANALYSIS

5.1. Porter’s Five Forces Analysis

5.1.1. Bargaining Power of Suppliers

5.1.2. Bargaining Power of Buyers

5.1.3. Threat of New Entrants

5.1.4. Threat of Substitutes

5.1.5. Intensity of Rivalry

5.2. Value Chain Analysis

5.3. COVID-19 Impact Analysis

5.3.1. Market Impact Analysis

5.3.2. Impact on Supply Chain

5.3.3. Regional Impact

5.3.4. Opportunity and Threat Analysis

6. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE

6.1. Overview

6.2. Sterile Drugs

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

6.3. Medical Devices

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

6.4. Biologics

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

7. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE

7.1. Overview

7.2. Instruments

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

7.3. Kits & Reagents

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

7.4. Services

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

8. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE

8.1. Overview

8.2. In-house

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

8.3. Outsourcing

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

9. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE

9.1. Overview

9.2. Sterility Testing

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

9.3. Bioburden Testing

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

9.4. Bacterial Endotoxin Testing

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

10. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER

10.1. Overview

10.2. Compounding Pharmacies

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

10.3. Medical Devices Companies

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

10.4. Pharmaceutical Companies

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

10.5. Others

Market Estimates & Forecast, by Region, 2018–2027

Market Estimates & Forecast, by Country, 2018–2027

11. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY REGION

11.1. Overview

11.2. North America

11.2.1. US

11.2.2. Canada

11.3. Europe

11.3.1. Germany

11.3.2. France

11.3.3. Italy

11.3.4. Spain

11.3.5. UK

11.3.6. Rest of Europe

11.4. Asia-Pacific

11.4.1. Japan

11.4.2. China

11.4.3. India

11.4.4. Australia

11.4.5. South Korea

11.4.6. Rest of Asia-Pacific

11.5. Rest of the World

11.5.1. Middle East

11.5.2. Africa

11.5.3. Latin America

12. COMPANY LANDSCAPE

12.1. Overview

12.2. Competitive Analysis

12.3. Market Share Analysis

12.4. Major Growth Strategy in the Global Pharmaceutical Sterility Testing Market

12.5. Competitive Benchmarking

12.6. Leading Players in terms of Number of Developments in the Global Pharmaceutical Sterility Testing Market

12.7. Key developments and Growth Strategies

12.7.1. New Product Launch/Service Deployment

12.7.2. Mergers & Acquisitions

12.7.3. Joint Ventures

12.8. Major Players Financial Matrix

12.8.1. Sales & Operating Income, 2020

12.8.2. Major Players R&D Expenditure, 2020

13. COMPANY PROFILES

13.1. Merck KGaA

13.1.1. Company Overview

13.1.2. Key Financials

13.1.3. Products Offered

13.1.4. Key Developments

13.1.5. SWOT Analysis

13.1.6. Key Strategies

13.2. Rapid Micro Biosystems

13.2.1. Company Overview

13.2.2. Key Financials

13.2.3. Products Offered

13.2.4. Key Developments

13.2.5. SWOT Analysis

13.2.6. Key Strategies

13.3. Sartorius AG

13.3.1. Company Overview

13.3.2. Key Financials

13.3.3. Products Offered

13.3.4. Key Developments

13.3.5. SWOT Analysis

13.3.6. Key Strategies

13.4. Solvias AG

13.4.1. Company Overview

13.4.2. Key Financials

13.4.3. Products Offered

13.4.4. Key Developments

13.4.5. SWOT Analysis

13.4.6. Key Strategies

13.5. SGS SA

13.5.1. Company Overview

13.5.2. Key Financials

13.5.3. Products Offered

13.5.4. Key Developments

13.5.5. SWOT Analysis

13.5.6. Key Strategies

13.6. Boston Analytical

13.6.1. Company Overview

13.6.2. Key Financials

13.6.3. Products Offered

13.6.4. Key Developments

13.6.5. SWOT Analysis

13.6.6. Key Strategies

13.7. BioMΓ©rieux, Inc.

13.7.1. Company Overview

13.7.2. Key Financials

13.7.3. Products Offered

13.7.4. Key Developments

13.7.5. SWOT Analysis

13.7.6. Key Strategies

13.8. Charles River Laboratories International, Inc.

13.8.1. Company Overview

13.8.2. Key Financials

13.8.3. Products Offered

13.8.4. Key Developments

13.8.5. SWOT Analysis

13.8.6. Key Strategies

13.9. Thermo Fisher Scientific, Inc.

13.9.1. Company Overview

13.9.2. Key Financials

13.9.3. Products Offered

13.9.4. Key Developments

13.9.5. SWOT Analysis

13.9.6. Key Strategies

13.10. Pace Analytical Services, LLC

13.10.1. Company Overview

13.10.2. Key Financials

13.10.3. Products Offered

13.10.4. Key Developments

13.10.5. SWOT Analysis

13.10.6. Key Strategies

13.11. Toxikon, Inc.

13.11.1. Company Overview

13.11.2. Key Financials

13.11.3. Products Offered

13.11.4. Key Developments

13.11.5. SWOT Analysis

13.11.6. Key Strategies

13.12. Sotera Health

13.12.1. Company Overview

13.12.2. Key Financials

13.12.3. Products Offered

13.12.4. Key Developments

13.12.5. SWOT Analysis

13.12.6. Key Strategies

13.13. Pacific Biolabs Inc.

13.13.1. Company Overview

13.13.2. Key Financials

13.13.3. Products Offered

13.13.4. Key Developments

13.13.5. SWOT Analysis

13.13.6. Key Strategies

13.14. STRERIS Corporation

13.14.1. Company Overview

13.14.2. Key Financials

13.14.3. Products Offered

13.14.4. Key Developments

13.14.5. SWOT Analysis

13.14.6. Key Strategies

13.15. WuXi AppTec

13.15.1. Company Overview

13.15.2. Key Financials

13.15.3. Products Offered

13.15.4. Key Developments

13.15.5. SWOT Analysis

13.15.6. Key Strategies

14. APPENDIX

14.1. References

14.2. Related Reports

LIST OF TABLES

TABLE 1 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SYNOPSIS, 2018–2027

TABLE 2 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET ESTIMATES & FORECAST, 2018– 2027 (USD MILLION)

TABLE 3 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 4 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 5 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 6 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 7 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 8 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY COUNTRY, 2018–2027 (USD MILLION)

TABLE 9 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 10 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 11 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 12 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 13 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 14 US: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 15 US: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 16 US: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 17 US: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 18 US: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 19 CANADA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 20 CANADA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 21 CANADA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 22 CANADA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 23 CANADA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 24 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY COUNTRY, 2018–2027 (USD MILLION)

TABLE 25 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 26 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 27 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 28 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 29 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 30 GERMANY: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 31 GERMANY: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 32 GERMANY: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 33 GERMANY: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 34 GERMANY: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 35 FRANCE: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 36 FRANCE: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 37 FRANCE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 38 FRANCE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 39 FRANCE: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 40 ITALY: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 41 ITALY: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 42 ITALY: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 43 ITALY: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 44 ITALY: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 45 SPAIN: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 46 SPAIN: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 47 SPAIN: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 48 SPAIN: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 49 SPAIN: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 50 UK: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 51 UK: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 52 UK: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 53 UK: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 54 UK: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 55 REST OF EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 56 REST OF EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 57 REST OF EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 58 REST OF EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 59 REST OF EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 60 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY COUNTRY, 2018–2027 (USD MILLION)

TABLE 61 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 62 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 63 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 64 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 65 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 66 JAPAN: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 67 JAPAN: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 68 JAPAN: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 69 JAPAN: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 70 JAPAN: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 71 CHINA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 72 CHINA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 73 CHINA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 74 CHINA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 75 CHINA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 76 INDIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 77 INDIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 78 INDIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 79 INDIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 80 INDIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 81 AUSTRALIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 82 AUSTRALIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 83 AUSTRALIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 84 AUSTRALIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 85 AUSTRALIA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 86 SOUTH KOREA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 87 SOUTH KOREA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 88 SOUTH KOREA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 89 SOUTH KOREA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 90 SOUTH KOREA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 91 REST OF ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 92 REST OF ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 93 REST OF ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 94 REST OF ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 95 REST OF ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 96 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY REGION, 2018–2027 (USD MILLION)

TABLE 97 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 98 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 99 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 100 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 101 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 102 MIDDLE EAST: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 103 MIDDLE EAST: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 104 MIDDLE EAST: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 105 MIDDLE EAST: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 106 MIDDLE EAST: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 107 AFRICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 108 AFRICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 109 AFRICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 110 AFRICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 111 AFRICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

TABLE 112 LATIN AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY SAMPLE, 2018–2027 (USD MILLION)

TABLE 113 LATIN AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY PRODUCT TYPE, 2018–2027 (USD MILLION)

TABLE 114 LATIN AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TYPE, 2018–2027 (USD MILLION)

TABLE 115 LATIN AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY TEST TYPE, 2018–2027 (USD MILLION)

TABLE 116 LATIN AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET, BY END USER, 2018–2027 (USD MILLION)

LIST OF FIGURES

FIGURE 1 RESEARCH PROCESS

FIGURE 2 MARKET STRUCTURE FOR THE GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET

FIGURE 3 MARKET DYNAMICS FOR THE GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET

FIGURE 4 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY SAMPLE, 2020 (%)

FIGURE 5 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY PRODUCT TYPE, 2020 (%)

FIGURE 6 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY TYPE, 2020 (%)

FIGURE 7 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY TEST TYPE, 2020 (%)

FIGURE 8 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY END USER, 2020 (%)

FIGURE 9 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY REGION, 2020 (%)

FIGURE 10 NORTH AMERICA: PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY REGION, 2020 (%)

FIGURE 11 EUROPE: PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY REGION, 2020 (%)

FIGURE 12 ASIA-PACIFIC: PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY REGION, 2020 (%)

FIGURE 13 REST OF THE WORLD: PHARMACEUTICAL STERILITY TESTING MARKET SHARE, BY REGION, 2020 (%)

FIGURE 14 GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET: COMPANY SHARE ANALYSIS, 2020 (%)

FIGURE 15 MERCK KGAA PHARMACEUTICALS: FINANCIAL OVERVIEW

FIGURE 16 MERCK KGAA PHARMACEUTICALS: SWOT ANALYSIS

FIGURE 17 RAPID MICRO BIOSYSTEMS: FINANCIAL OVERVIEW

FIGURE 18 RAPID MICRO BIOSYSTEMS: SWOT ANALYSIS

FIGURE 19 SARTORIUS AG: FINANCIAL OVERVIEW

FIGURE 20 SARTORIUS AG: SWOT ANALYSIS

FIGURE 21 SOLVIAS AG: FINANCIAL OVERVIEW

FIGURE 22 SOLVIAS AG: SWOT ANALYSIS

FIGURE 23 SGS SA: FINANCIAL OVERVIEW

FIGURE 24 SGS SA: SWOT ANALYSIS

FIGURE 25 BOSTON ANALYTICAL: FINANCIAL OVERVIEW

FIGURE 26 BOSTON ANALYTICAL: SWOT ANALYSIS

FIGURE 27 BIOMÉRIEUX, INC.: FINANCIAL OVERVIEW

FIGURE 28 BIOMÉRIEUX, INC.: SWOT ANALYSIS

FIGURE 29 CHARLES RIVER LABORATORIES INTERNATIONAL, INC.: FINANCIAL OVERVIEW

FIGURE 30 CHARLES RIVER LABORATORIES INTERNATIONAL, INC.: SWOT ANALYSIS

FIGURE 31 THERMO FISHER SCIENTIFIC, INC.: FINANCIAL OVERVIEW

FIGURE 32 THERMO FISHER SCIENTIFIC, INC.: SWOT ANALYSIS

FIGURE 33 PACE ANALYTICAL SERVICES, LLC: FINANCIAL OVERVIEW

FIGURE 34 PACE ANALYTICAL SERVICES, LLC: SWOT ANALYSIS

FIGURE 35 TOXIKON, INC.: FINANCIAL OVERVIEW

FIGURE 36 TOXIKON, INC.: SWOT ANALYSIS

FIGURE 37 SOTERA HEALTH: FINANCIAL OVERVIEW

FIGURE 38 SOTERA HEALTH: SWOT ANALYSIS

FIGURE 39 PACIFIC BIOLABS INC.: FINANCIAL OVERVIEW

FIGURE 40 PACIFIC BIOLABS INC.: SWOT ANALYSIS

FIGURE 41 STRERIS CORPORATION: FINANCIAL OVERVIEW

FIGURE 42 STRERIS CORPORATION: SWOT ANALYSIS

FIGURE 43 WUXI APPTEC: FINANCIAL OVERVIEW

FIGURE 44 WUXI APPTEC: SWOT ANALYSIS

Pharmaceutical Sterility Testing Market

The global pharmaceutical sterility testing market is expected to cross USD 1,285.8 million by 2027 at a CAGR of 6.6%.

Segmentation

By Sample Sterile Drugs Medical Devices Biologics
By Product Type Instruments Kits & Reagents Services
By Type In House Outsourcing
By Test Type Sterility Testing Bioburden Testing Bacterial Endotoxin Testing
By End User Compounding Pharmacies Medical Devices Companies Pharmaceutical Companies

Key Players

  • Merck KGaA (Germany)
  • Rapid Micro Biosystems (US)
  • Sartorius AG (Germany)
  • Solvias AG (Switzerland)
  • SGS SA (Switzerland)
  • Boston Analytical (US)
  • bioMΓ©rieux Inc. (France)
  • Charles River Laboratories International Inc. (US)
  • Thermo Fisher Scientific Inc. (US)
  • Pace Analytical Services LLC (US)
  • Toxikon Inc. (US)

Drivers

  • Increasing number of drug approvals and new drug launches
  • Increasing cases of patients suffering from cardiovascular diseases and cancer
  • New technological developments
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Pharmaceutical Sterility Testing Market Forecast


The global pharmaceutical sterility testing market is expected to cross USD 1,285.8 million by 2027 at a CAGR of 6.6%.  


Market Overview:


Sterility is the non-appearance of viable microorganisms, dust, fibers, foreign particles, and other biological agents. Pharmaceutical sterility testing is a major aspect of good manufacturing practice (GMP) microbiology and is crucial for tissue materials, pharmaceutical preparations, and medical devices, all of which must be sterile due to their intended use. Moreover, it is also used for cell banks, raw materials, and pharmacological finished goods. According to the laws of the European Pharmacopoeia and United States Pharmacopoeia, pharmaceutical preparations and substances must be made sterile. For instance, all parenteral biological formulations intended for human use must be sterile; hence sterility testing is required. The major factors driving the pharmaceutical sterility testing market include an increasing number of drug launches, expansion of the biotechnology & pharmaceutical industry, and increasing R&D in life science research. Moreover, new technological development and improving focus on quality control in accordance with regulatory requirements further contribute to the market growth. However, time-consuming and stringent regulatory policies are the factors that may hamper market growth.


COVID-19 Analysis


The global pharmaceutical sterility testing market emerged from the COVID-19 shut down due to the pharmaceutical and biotech companies' race to discover a vaccine for the COVID-19. Speedy testing is essential to verify that a vaccine is safe, effective, and approved by regulatory agencies. Every vaccine and injection given to patients must pass final product sterility testing to be considered safe. This will drive the pharmaceutical sterility testing market and is expected to grow at a rapid pace during the pandemic period. However, many vaccine manufacturers currently utilize a 14-day sterility test, which means each lot of vaccine must wait two weeks before being released to the public. Due to this time-consuming factor, market growth may be hampered.


Market Dynamics


Drivers


  • Increasing number of new drug launches and expansion of the biotechnology & pharmaceutical industry





    • The number of new drug approvals and drug launches has increased over the years. In 2020, The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research has approved around 53 novel drugs as new molecular entities under the New Drug Applications (NDAs). Similarly, according to the Pharma and Annual Review 2021 report, 1,324 new drugs were launched in the global market in 2020. These new product launches are boosting the adoption of pharmaceutical sterility testing, and the global market for pharmaceutical sterility testing is expected to grow during the forecast period.  Furthermore, pharmaceutical sterility testing is performed at all levels of manufacturing in the pharmaceutical and biopharmaceutical sectors to reduce the possibility of product contamination. As a result, the expansion of this biotechnology & pharmaceutical industry will significantly increase the overall usage of pharmaceutical sterility testing in the future years.



  • New technological developments 

    • The technological advances in pharmaceutical sterility testing methods resulted in a decrease in procedural time and human interaction, increasing the test's efficiency and accuracy, thereby driving the market. For instance, in October 2019, Alcami Corporation (US) launched a new rapid sterility offering, Milliflex Rapid System, that uses cutting-edge microbiological testing technology to provide consumers with much faster testing results. It uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days. More advanced computer-generated findings are also included in the technology, which eliminates observer bias.



  • Rising investment in R&D activities in life science researc


Market Restraints


  • Time-consuming and stringent regulatory policies

    • The process of establishing the quality of pharmaceutical medications begins with sterility testing. However, strict regulatory policies, regulations, and time-consuming processes in many countries may hamper the growth of the pharmaceutical sterility testing market to some extent.



  • Shortage of skilled professionals


Market Opportunities

Growing government initiatives towards the biotechnology sector


Value Chain Analysis


  • An increasing number of patients are suffering from cardiovascular diseases such as heart failure, heart attack, stroke, arrhythmias, high blood pressure, and cancer-related diseases. As a result, pharmaceutical sterility testing is projected to gain more importance. The pharmaceutical sterility testing market is predicted to grow in the next years, and it will be useful in determining the quality of pharmaceutical drugs. Moreover, market development is mostly determined by technical advancements and their application during the process.


Segment Overview

By Sample



  • Sterile Drugs: Sterile drugs should be free from all types of microorganisms and should be isotonic.Sterile dosage forms include parenteral preparations and ophthalmic preparations. Parenteral preparations include injections, transfusions fluids, sterile suspensions, sterile solids, sterile solutions or emulsions, and ophthalmic preparations include eye drops, eye lotions, eye ointments, eye gels, eye suspensions, and contact lens solutions.

  • Medical Devices: Medical equipment manufacturers strive to provide safe and effective goods, and sterility assurance is an important part of that process. Soybean-casein digest medium is used to assess the sterility of medical devices.

  • Biologics: Biologics are a type of potent medicine that reduces the harmful effects of inflammation. It includes biosimilars and vaccines.


By Product Type


  • Instruments: The instruments segment encompasses a wide variety of equipment and machinery. Each instrument plays a vital role in the success of each step in the manufacturing process. The instruments required in the pharmaceutical sterility testing industry are high-temperature sterilization instruments, low-temperature sterilization instruments, ionizing radiation instruments, non-ionizing radiation instruments, and filtration sterilization instruments.

  • Kits & Reagents: Kits & reagents consist of sterile fluid thioglycollate medium and sterile soybean casein digest medium. It is cost-efficient, easy to use, and known as a rapid pharmaceutical sterility testing method. The repeated purchasing of these products by end users all over the world is a crucial factor contributing to the growth of the kits & reagent segment.

  • Services: Services are designed to address problems at different stages during the sterility test. Companies in the pharmaceutical sterility testing market are establishing new sterility testing services to augment their product portfolio and expand their market presence. The corporates have launched well-equipped services to exploit the growth potential of the pharmaceutical sterility testing market. For instance, in 2019, Reading Scientific Services Ltd (UK) established a sterility testing solution for pharmaceutical and medical device firms that is fast, responsive, and adaptable. This service reduces the risks of particulate contamination, as well as endotoxin to analyze potential pyrogen contamination.


By Type (In-house, Outsourcing)


  • In-house For pharmaceuticals, biopharmaceuticals, and medical devices companies, in-house sterility testing is an important aspect of quality assurance and Good Manufacturing Practices (GMP). Each batch must pass sterility testing before being released, allowing the segment to expand.

  • Outsourcing Pharmaceutical sterility testing can be outsourced because some pharmaceutical and medical device companies lack the necessary infrastructure to perform high-quality sterility testing. They prefer to outsource these services. Moreover, many organizations outsource sterility testing to save money.


By Test Type


  • Sterility Testing: Sterility testing is one of the most significant components of the healthcare industry, which verifies the purity and safety of a product or substance. There are several types of sterility tests available such as membrane filtration sterility testing, direct transfer sterility testing, and fluid path sterility testing. A membrane filtration sterility testing is one of the most popular sterility testings for filterable pharmaceuticals.

  • Bioburden Testing: Bioburden testing is the measure of microbial contamination levels on a product that has not been sterilized. Bioburden testing is conducted on medical devices, pharmaceuticals, raw materials, packaging, human tissue, and animal tissue to determine the total viable microorganism count prior to the sterilization process. Bioburden testing, sterility testing, and sterilization process validation are crucial aspects of GMP for assuring the safety of the end products.

  • Bacterial Endotoxin Testing: Bacterial endotoxin testing is an in-vitro assay that detects and quantifies bacterial endotoxins, part of gram-negative bacteria's cell wall. Endotoxins can reduce a medicinal product's effectiveness and induce side effects such as fever, hypotension, pulmonary edema, and widespread coagulation events in humans and animals. Thus, bacterial endotoxin testing is widely used for pharmaceutical manufacturing, medical device manufacturing, raw materials production, and packaging manufacture. For Instance, in May 2020, Suez S.A. launched the Sievers Eclipse Bacterial Endotoxin Testing platform, which saves pipetting processes, lowers operator-to-operator variability, and boosts laboratory productivity.


By End User


  • Compounding Pharmacies: The Drug Quality and Security Act provides the FDA authority to monitor and regulate the compounding of drugs, thereby increasing the adoption of sterility testing procedures by the compounding pharmacies. Moreover, the regulatory framework for sterile products in pharmacies is increasingly becoming stringent to avoid any adverse events. For instance, in August 2019, the US Food and Drug Administration (USFDA) has warned patients and health care providers not to use Pacifico National Inc.'s sterile drug products due to significant quality and sterility concerns.

  • Medical Devices Companies: Medical devices companies provide several medical devices such as instruments, apparatus, machines, and implants are supplied to the final user as sterile products. The government support for medical device companies and advancement in sterilization technologies drives the demand for pharmaceutical sterility testing for the medical device companies.

  • Pharmaceutical Companies: Pharmaceutical companies carried out sterility testing to determine the quality of raw materials and process control and end-product validation. The "pharmacopeia" methods and good manufacturing practices (GMP) guidelines are usually used by pharmaceutical companies for testing medicinal products. The increasing number of drug launches across the globe and the rising number of pharmaceutical companies drive the market's growth. For instance, the US Food and Drug Administration (USFDA) has approved 31 novel drugs in 2021 till July.

  • Others: Other end users include academic research institutes and centers and cell banks. Moreover, an increase in the number of cell banks is likely to fuel market growth.


Regional Analysis


  • North America

    • The North American market accounted for the largest market share in 2020 due to the presence of a large number of international and domestic players in the region and innovative technologies. Furthermore, the advanced healthcare infrastructure and rising R&D investment are expected to influence the growth of the pharmaceutical sterility testing market over the forecast period. For instance, according to the Congressional Budget Office's April 2021 report on "Research and Development in the Pharmaceutical Industry," the pharmaceutical industry spent USD 83 billion on R&D in 2019.



  • Europe

    • The European pharmaceutical sterility testing market is driven by increasing government initiatives and the extensive availability of research grants. The European market is rich with developed, well-equipped outsourcing companies for pharmaceutical sterility testing due to the rising biopharmaceutical product development and technological advancements in the region. For instance, the New Sterisart Universal Pump has the special software of the high-end version that guides the user by individual menu prompts. These technological advancements save time and money and help ensure reliable sterility test results. Moreover, countries such as the Netherlands, which has a rich tradition of public-private cooperation and has been further stimulated by multiple government-initiated programs, are expected to increase the market growth in this region.



  • Asia-Pacific:

    • The pharmaceutical sterility testing market is projected to be the fastest-growing regional market due to the increasing harmonization of the regulatory standards with the International Council for Harmonisation (ICH) standards in developing nations. Moreover, technological advances and rising disposable income levels in developing countries such as China and India. Moreover, several growing economies in the region are taking steps to improve the domestic pharmaceutical market and are encouraging global corporations to set up operations in the region, driving the growth of the pharmaceutical sterility testing market in the Asia-Pacific region.



  • Rest of the World:

    • The Rest of the World is segmented into the Middle East, Africa, and Latin America. The pharmaceutical sterility testing market in the region is driven by technological development and developing healthcare infrastructure.




Competitive Landscape


  • The global pharmaceutical sterility testing market is characterized by the presence of many global, regional, and local players. The high prevalence rate of patients with cardiovascular diseases and cancer, an increasing number of drug approvals & new drug launches, and technological developments make the pharmaceutical sterility testing market lucrative. To expand their reach and optimize their operational costs, the major players focus on mergers & acquisitions, regional expansion, product launches, contractual agreements, and joint ventures to gain a substantial market share. For instance, in August 2020, Pace Analytical Services, LLC acquired Emerson Resources Inc. (US), a contract production and manufacturing organization (CDMO). The acquisition will enable the company to service pharmaceutical and biopharmaceutical industries from early-stage product development to phase II clinical trial material manufacturing.


List of Key Companies Covered in this Report:  


  • Merck KGaA (Germany)

  • Rapid Micro Biosystems (US)

  • Sartorius AG (Germany)

  • Solvias AG (Switzerland)

  • SGS SA (Switzerland)

  • Boston Analytical (US)

  • BioMérieux, Inc. (France)

  • Charles River Laboratories International, Inc. (US)

  • Thermo Fisher Scientific, Inc. (US)

  • Pace Analytical Services, LLC (US)

  • Toxikon, Inc. (US)

  • Sotera Health (US)

  • Pacific Biolabs Inc. (US)

  • STRERIS Corporation (US)

  • WuXi AppTec (China)


Recent Developments


  • In August 2020, Pace Analytical Services, LLC acquired Emerson Resources Inc. (US), a contract production and manufacturing organization (CDMO). The acquisition will enable the company to service pharmaceutical and biopharmaceutical industries from early-stage product development to phase II clinical trial material manufacturing.

  • In May 2020, Suez S.A. launched the Sievers Eclipse Bacterial Endotoxin Testing platform, which saves pipetting processes, lowers operator-to-operator variability, and boosts laboratory productivity.

  • In October 2019, Alcami Corporation launched a new rapid sterility offering, a service that uses cutting-edge microbiological testing technology to provide consumers with much faster testing results.

  • In August 2018, Sotera Health acquired Gibraltar Laboratories (US). The acquisition is expected to expand the business of analytical testing capabilities of Sotera Health's Nelson Labs.


Report Overview


  • The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID on the market


Scope of the Report & Segmentation

By Sample


  • Sterile Drugs

  • Medical Devices

  • Biologics


By Product Type


  • Instruments

  • Kits & Reagents

  • Services


By Type


  • In-house

  • Outsourcing


By Product Type


  • Sterility Testing

  • Bioburden Testing

  • Bacterial Endotoxin Testing


By End User


  • Compounding Pharmacies

  • Medical Devices Companies

  • Pharmaceutical Companies

  • Others



Report Scope:
Report Attribute/Metric Details
  Market Size   2027: USD 1,285.8 Million
  CAGR   6.6%
  Base Year   2020
  Forecast Period   2021-2027
  Historical Data   2018-2019
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Sample, Product Type, Type, Test Type, and End User
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   β€’ Merck KGaA (Germany) β€’ Rapid Micro Biosystems (US) β€’ Sartorius AG (Germany) β€’ Solvias AG (Switzerland) β€’ SGS SA (Switzerland) β€’ Boston Analytical (US) β€’ bioMΓ©rieux, Inc. (France) β€’ Charles River Laboratories International, Inc. (US) β€’ Thermo Fisher Scientific, Inc. (US) β€’ Pace Analytical Services, LLC (US) β€’ Toxikon, Inc. (US) β€’ Sotera Health (US) β€’ Pacific Biolabs Inc. (US) β€’ STRERIS Corporation (US) β€’ WuXi AppTec (China)
  Key Market Opportunities   β€’ Growing government initiatives towards the biotechnology sector
  Key Market Drivers   β€’ Increasing number of drug approvals and new drug launches β€’ Increasing cases of patients suffering from cardiovascular diseases and cancer β€’ New technological developments


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