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Global Pharmaceutical Sterility Testing Market Size study, by Product (Kits & Reagents, Services, Instruments), by Test (Membrane Filtration, Direct Inoculation, Rapid Microbial Method, Other Tests), by Type (In-house Testing, Outsourced Testing), by Sample (Sterile Drugs, Biologics and Therapeutics), by End-user (Pharmaceutical & Biotechnology Companies, CROs and Contract Testing Laboratories, Compounding Pharmacies, Other End-users) and Regional Forecasts 2022-2032

September 2024 | 200 pages | ID: GD977D822FCAEN
Bizwit Research & Consulting LLP

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The Global Pharmaceutical Sterility Testing Market was valued at USD 741.3 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 10.8% from 2024 to 2032, reaching USD 61.1 Billion by 2032. Sterility testing is a crucial quality control procedure that ensures pharmaceutical products, including drugs and medical devices, are free from viable microorganisms. It involves testing samples for microbial contamination using methods such as membrane filtration or direct inoculation. Sterility testing is essential for verifying the safety and efficacy of injectable drugs, biologics, and aseptically produced products. By preventing infections and ensuring regulatory compliance, sterility testing maintains product quality and patient safety.
The market growth is driven by stringent regulatory requirements enforced by agencies like the FDA and EMA, compelling pharmaceutical companies to invest in comprehensive sterility testing procedures. Additionally, the rising investment in pharmaceutical R&D, particularly in biologics and advanced therapies, has increased the need for rigorous sterility testing. The expanding biopharmaceutical sector, with a focus on biologics, vaccines, and gene therapies, further boosts the demand for specialized sterility testing. These products are highly susceptible to contamination, making sterility testing critical to their safety and efficacy. Also, advancements in sterility testing technologies, such as automated testing systems and real-time monitoring, present significant opportunities by enhancing testing efficiency, accuracy, and speed. Emerging markets, particularly in Asia-Pacific and Latin America, offer new growth opportunities as these regions increase their pharmaceutical manufacturing capabilities and regulatory standards. However, the high costs and complexity associated with advanced sterility testing technologies and maintaining compliance with evolving regulatory standards pose significant challenges. Small and mid-sized pharmaceutical companies may struggle with the financial and logistical burden, potentially hindering market growth.
North America dominated the market with a revenue share of 49% in 2023, driven by the increasing number of pharmaceutical industries and major market players in the U.S. and Canada. The region's market growth is attributed to the presence of technologically advanced CROs & CDMOs, increased allocation of grants, heightened drug development endeavors, and strategic measures such as innovation & acquisitions. Asia Pacific is expected to grow at the fastest CAGR over the forecast period, driven by investments from developed countries, regulatory amendments to facilitate local manufacturing & contract services, and rising healthcare demand due to population growth.
Major market players included in this report are:
Pacific Biolabs
Steris Plc
Boston Analytical
Sotera Health Company (Nelson Labs)
Sartorius Ag
Solvias Ag
SGS SA
Labcorp
Pace Analytical
Charles River Laboratories
The detailed segments and sub-segment of the market are explained below:
By Product:
• Kits & Reagents
• Services
• Instruments
By Test:
• Membrane Filtration
• Direct Inoculation
• Rapid Microbial Method
• Other Tests
By Type:
• In-house Testing
• Outsourced Testing
By Sample:
• Sterile Drugs
• Biologics and Therapeutics
By End-user:
• Pharmaceutical & Biotechnology Companies
• CROs and Contract Testing Laboratories
• Compounding Pharmacies
• Other End-users
By Region:
• North America
• U.S.
• Canada
• Europe
• UK
• Germany
• France
• Spain
• Italy
• ROE
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• RoAPAC
• Latin America
• Brazil
• Mexico
• RoLA
• Middle East & Africa
• Saudi Arabia
• South Africa
• RoMEA
Years considered for the study are as follows:
• Historical year – 2022
• Base year – 2023
• Forecast period – 2024 to 2032
Key Takeaways:
• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market
CHAPTER 1. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET EXECUTIVE SUMMARY

1.1. Global Pharmaceutical Sterility Testing Market Size & Forecast (2022-2032)
1.2. Regional Summary
1.3. Segmental Summary
  1.3.1. By Product
  1.3.2. By Test
  1.3.3. By Type
  1.3.4. By Sample
  1.3.5. By End-user
1.4. Key Trends
1.5. Recession Impact
1.6. Analyst Recommendation & Conclusion

CHAPTER 2. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET DEFINITION AND RESEARCH ASSUMPTIONS

2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
  2.3.1. Inclusion & Exclusion
  2.3.2. Limitations
  2.3.3. Supply Side Analysis
    2.3.3.1. Availability
    2.3.3.2. Infrastructure
    2.3.3.3. Regulatory Environment
    2.3.3.4. Market Competition
    2.3.3.5. Economic Viability (Consumer’s Perspective)
  2.3.4. Demand Side Analysis
    2.3.4.1. Regulatory frameworks
    2.3.4.2. Technological Advancements
    2.3.4.3. Environmental Considerations
    2.3.4.4. Consumer Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates

CHAPTER 3. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET DYNAMICS

3.1. Market Drivers
  3.1.1. Increasing Regulatory Requirements
  3.1.2. Rising Pharmaceutical R&D Activities
  3.1.3. Expanding Biopharmaceutical Sector
3.2. Market Challenges
  3.2.1. High Costs and Complexity
3.3. Market Opportunities
  3.3.1. Technological Advancements
  3.3.2. Emerging Markets

CHAPTER 4. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET INDUSTRY ANALYSIS

4.1. Porter’s 5 Force Model
  4.1.1. Bargaining Power of Suppliers
  4.1.2. Bargaining Power of Buyers
  4.1.3. Threat of New Entrants
  4.1.4. Threat of Substitutes
  4.1.5. Competitive Rivalry
  4.1.6. Futuristic Approach to Porter’s 5 Force Model
  4.1.7. Porter’s 5 Force Impact Analysis
4.2. PESTEL Analysis
  4.2.1. Political
  4.2.2. Economical
  4.2.3. Social
  4.2.4. Technological
  4.2.5. Environmental
  4.2.6. Legal
4.3. Top investment opportunity
4.4. Top winning strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspective
4.7. Analyst Recommendation & Conclusion

CHAPTER 5. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY PRODUCT 2022-2032

5.1. Segment Dashboard
5.2. Global Pharmaceutical Sterility Testing Market: Product Revenue Trend Analysis, 2022 & 2032 (USD Million)
  5.2.1. Kits & Reagents
  5.2.2. Services
  5.2.3. Instruments

CHAPTER 6. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY TEST 2022-2032

6.1. Segment Dashboard
6.2. Global Pharmaceutical Sterility Testing Market: Test Revenue Trend Analysis, 2022 & 2032 (USD Million)
  6.2.1. Membrane Filtration
  6.2.2. Direct Inoculation
  6.2.3. Rapid Microbial Method
  6.2.4. Other Tests

CHAPTER 7. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY TYPE 2022-2032

7.1. Segment Dashboard
7.2. Global Pharmaceutical Sterility Testing Market: Type Revenue Trend Analysis, 2022 & 2032 (USD Million)
  7.2.1. In-house Testing
  7.2.2. Outsourced Testing

CHAPTER 8. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY SAMPLE 2022-2032

8.1. Segment Dashboard
8.2. Global Pharmaceutical Sterility Testing Market: Sample Revenue Trend Analysis, 2022 & 2032 (USD Million)
  8.2.1. Sterile Drugs
  8.2.2. Biologics and Therapeutics

CHAPTER 9. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY END-USER 2022-2032

9.1. Segment Dashboard
9.2. Global Pharmaceutical Sterility Testing Market: End-user Revenue Trend Analysis, 2022 & 2032 (USD Million)
  9.2.1. Pharmaceutical & Biotechnology Companies
  9.2.2. CROs and Contract Testing Laboratories
  9.2.3. Compounding Pharmacies
  9.2.4. Other End-users

CHAPTER 10. GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET SIZE & FORECASTS BY REGION 2022-2032

10.1. North America Pharmaceutical Sterility Testing Market
  10.1.1. U.S. Pharmaceutical Sterility Testing Market
    10.1.1.1. Product breakdown size & forecasts, 2022-2032
    10.1.1.2. Test breakdown size & forecasts, 2022-2032
    10.1.1.3. Type breakdown size & forecasts, 2022-2032
    10.1.1.4. Sample breakdown size & forecasts, 2022-2032
    10.1.1.5. End-user breakdown size & forecasts, 2022-2032
  10.1.2. Canada Pharmaceutical Sterility Testing Market
    10.1.2.1. Product breakdown size & forecasts, 2022-2032
    10.1.2.2. Test breakdown size & forecasts, 2022-2032
    10.1.2.3. Type breakdown size & forecasts, 2022-2032
    10.1.2.4. Sample breakdown size & forecasts, 2022-2032
    10.1.2.5. End-user breakdown size & forecasts, 2022-2032
10.2. Europe Pharmaceutical Sterility Testing Market
  10.2.1. U.K. Pharmaceutical Sterility Testing Market
  10.2.2. Germany Pharmaceutical Sterility Testing Market
  10.2.3. France Pharmaceutical Sterility Testing Market
  10.2.4. Spain Pharmaceutical Sterility Testing Market
  10.2.5. Italy Pharmaceutical Sterility Testing Market
  10.2.6. Rest of Europe Pharmaceutical Sterility Testing Market
10.3. Asia-Pacific Pharmaceutical Sterility Testing Market
  10.3.1. China Pharmaceutical Sterility Testing Market
  10.3.2. India Pharmaceutical Sterility Testing Market
  10.3.3. Japan Pharmaceutical Sterility Testing Market
  10.3.4. Australia Pharmaceutical Sterility Testing Market
  10.3.5. South Korea Pharmaceutical Sterility Testing Market
  10.3.6. Rest of Asia Pacific Pharmaceutical Sterility Testing Market
10.4. Latin America Pharmaceutical Sterility Testing Market
  10.4.1. Brazil Pharmaceutical Sterility Testing Market
  10.4.2. Mexico Pharmaceutical Sterility Testing Market
  10.4.3. Rest of Latin America Pharmaceutical Sterility Testing Market
10.5. Middle East & Africa Pharmaceutical Sterility Testing Market
  10.5.1. Saudi Arabia Pharmaceutical Sterility Testing Market
  10.5.2. South Africa Pharmaceutical Sterility Testing Market
  10.5.3. Rest of Middle East & Africa Pharmaceutical Sterility Testing Market

CHAPTER 11. COMPETITIVE INTELLIGENCE

11.1. Key Company SWOT Analysis
  11.1.1. Company
  11.1.2. Company
  11.1.3. Company
11.2. Top Market Strategies
11.3. Company Profiles
  11.3.1. Pacific Biolabs
    11.3.1.1. Key Information
    11.3.1.2. Overview
    11.3.1.3. Financial (Subject to Data Availability)
    11.3.1.4. Product Summary
    11.3.1.5. Market Strategies
  11.3.2. Steris Plc
  11.3.3. Boston Analytical
  11.3.4. Sotera Health Company (Nelson Labs)
  11.3.5. Sartorius Ag
  11.3.6. Solvias Ag
  11.3.7. SGS SA
  11.3.8. Labcorp
  11.3.9. Pace Analytical
  11.3.10. Charles River Laboratories

CHAPTER 12. RESEARCH PROCESS

12.1. Research Process
  12.1.1. Data Mining
  12.1.2. Analysis
  12.1.3. Market Estimation
  12.1.4. Validation
  12.1.5. Publishing
12.2. Research Attributes

LIST OF TABLES

TABLE 1. Global Pharmaceutical Sterility Testing market, report scope
TABLE 2. Global Pharmaceutical Sterility Testing market estimates & forecasts by Region 2022-2032 (USD Million)
TABLE 3. Global Pharmaceutical Sterility Testing market estimates & forecasts by Product 2022-2032 (USD Million)
TABLE 4. Global Pharmaceutical Sterility Testing market estimates & forecasts by Test 2022-2032 (USD Million)
TABLE 5. Global Pharmaceutical Sterility Testing market by segment, estimates & forecasts, 2022-2032 (USD Million)
TABLE 6. Global Pharmaceutical Sterility Testing market by region, estimates & forecasts, 2022-2032 (USD Million)
TABLE 7. Global Pharmaceutical Sterility Testing market by segment, estimates & forecasts, 2022-2032 (USD Million)
TABLE 8. Global Pharmaceutical Sterility Testing market by region, estimates & forecasts, 2022-2032 (USD Million)
TABLE 9. Global Pharmaceutical Sterility Testing market by segment, estimates & forecasts, 2022-2032 (USD Million)
TABLE 10. Global Pharmaceutical Sterility Testing market by region, estimates & forecasts, 2022-2032 (USD Million)
TABLE 11. Global Pharmaceutical Sterility Testing market by segment, estimates & forecasts, 2022-2032 (USD Million)
TABLE 12. Global Pharmaceutical Sterility Testing market by region, estimates & forecasts, 2022-2032 (USD Million)
TABLE 13. Global Pharmaceutical Sterility Testing market by segment, estimates & forecasts, 2022-2032 (USD Million)
TABLE 14. Global Pharmaceutical Sterility Testing market by region, estimates & forecasts, 2022-2032 (USD Million)
TABLE 15. U.S. Pharmaceutical Sterility Testing market estimates & forecasts, 2022-2032 (USD Million)
TABLE 16. U.S. Pharmaceutical Sterility Testing market estimates & forecasts by segment 2022-2032 (USD Million)
TABLE 17. U.S. Pharmaceutical Sterility Testing market estimates & forecasts by segment 2022-2032 (USD Million)
TABLE 18. Canada Pharmaceutical Sterility Testing market estimates & forecasts, 2022-2032 (USD Million)
TABLE 19. Canada Pharmaceutical Sterility Testing market estimates & forecasts by segment 2022-2032 (USD Million)
TABLE 20. Canada Pharmaceutical Sterility Testing market estimates & forecasts by segment 2022-2032 (USD Million)
... (The list is not complete; the final report contains more than 100 tables. The list may be updated in the final deliverable.)

LIST OF FIGURES

FIG 1. Global Pharmaceutical Sterility Testing market, research methodology
FIG 2. Global Pharmaceutical Sterility Testing market, market estimation techniques
FIG 3. Global market size estimates & forecast methods
FIG 4. Global Pharmaceutical Sterility Testing market, key trends 2023
FIG 5. Global Pharmaceutical Sterility Testing market, growth prospects 2022-2032
FIG 6. Global Pharmaceutical Sterility Testing market, porters 5 force model
FIG 7. Global Pharmaceutical Sterility Testing market, PESTEL analysis
FIG 8. Global Pharmaceutical Sterility Testing market, value chain analysis
FIG 9. Global Pharmaceutical Sterility Testing market by segment, 2022 & 2032 (USD Million)
FIG 10. Global Pharmaceutical Sterility Testing market by segment, 2022 & 2032 (USD Million)
FIG 11. Global Pharmaceutical Sterility Testing market by segment, 2022 & 2032 (USD Million)
FIG 12. Global Pharmaceutical Sterility Testing market by segment, 2022 & 2032 (USD Million)
FIG 13. Global Pharmaceutical Sterility Testing market by segment, 2022 & 2032 (USD Million)
FIG 14. Global Pharmaceutical Sterility Testing market, regional snapshot 2022 & 2032
FIG 15. North America Pharmaceutical Sterility Testing market 2022 & 2032 (USD Million)
FIG 16. Europe Pharmaceutical Sterility Testing market 2022 & 2032 (USD Million)
FIG 17. Asia Pacific Pharmaceutical Sterility Testing market 2022 & 2032 (USD Million)
FIG 18. Latin America Pharmaceutical Sterility Testing market 2022 & 2032 (USD Million)
FIG 19. Middle East & Africa Pharmaceutical Sterility Testing market 2022 & 2032 (USD Million)
FIG 20. Global Pharmaceutical Sterility Testing market, company market share analysis (2023)
... (The list is not complete; the final report contains more than 50 figures. The list may be updated in the final deliverable.)


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