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North America Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type, By Product Type, By Sample, By End-use, By Test Type, (Bioburden Testing, Sterility Testing, and Bacterial Endotoxin Testing). By Country and Growth Forecast, 2023 - 2030

Published Date : 08-Apr-2024

Pages: 133

Formats: PDF

The North America Pharmaceutical Sterility Testing Market would witness market growth of 10.2% CAGR during the forecast period (2023-2030).

The US market dominated the North America Pharmaceutical Sterility Testing Market by Country in 2022 and would continue to be a dominant market till 2030; thereby, achieving a market value of $1,038.4 Million by 2030. The Canada market is experiencing a CAGR of 12.7% during (2023 - 2030). Additionally, The Mexico market would exhibit a CAGR of 12.3% during (2023 - 2030).

North America Pharmaceutical Sterility Testing Market

The pharmaceutical sterility testing market plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products, with a primary focus on preventing microbial contamination. As an integral component of quality control within the pharmaceutical industry, sterility testing is designed to detect the presence of viable microorganisms in drug products, ensuring that they meet the stringent regulatory standards set by health authorities.

Additionally, sterility testing applications span various stages of the pharmaceutical manufacturing process, covering many products, including injectables, ophthalmic solutions, vaccines, and parenteral drugs. The testing is conducted on final drug products and raw materials to identify and eliminate potential sources of contamination. The growing drug demand necessitates an increase in sterility testing.

The United States Food and Drug Administration (FDA) imposes strict regulatory requirements on pharmaceuticals and medical devices. Sterility testing is a fundamental aspect of ensuring compliance with these regulations. As the medical device sector expands, the need for rigorous sterility testing grows parallel to meet regulatory standards. The U.S. medical device sector covers many products, including implantable devices, diagnostic equipment, and in vitro diagnostic devices. Hence, North America's rising medical device sector is expected to boost the region's demand for pharmaceutical sterility testing.

Free Valuable Insights: The Pharmaceutical Sterility Testing Market is Predict to reach USD 3.1 Billion by 2030, at a CAGR of 10.7%

Based on Type, the market is segmented into Outsourcing, and In-House. Based on Product Type, the market is segmented into Kits & Reagents, Instruments, and Services. Based on Sample, the market is segmented into Pharmaceuticals, Medical Devices, and Biopharmaceuticals. Based on End-use, the market is segmented into Pharmaceutical Companies, Medical Device Companies, Compounding Pharmacies, and Others. Based on Test Type, the market is segmented into Bioburden Testing, Sterility Testing, and Bacterial Endotoxin Testing. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.

List of Key Companies Profiled

  • Steris PLC
  • Charles River Laboratories International, Inc.
  • Thermo Fisher Scientific, Inc.
  • SGS S.A.
  • Sartorius AG
  • Sotera Health Company
  • Pacific Biolabs, Inc.
  • Laboratory Corporation of America Holdings
  • Almac Group
  • Pace Analytical Services, LLC

North America Pharmaceutical Sterility Testing Market Report Segmentation

By Type

  • Outsourcing
  • In-House

By Product Type

  • Kits & Reagents
  • Instruments
  • Services

By Sample

  • Pharmaceuticals
  • Medical Devices
  • Biopharmaceuticals

By End Use

  • Pharmaceutical Companies
  • Medical Device Companies
  • Compounding Pharmacies
  • Others

By Test Type

  • Bioburden Testing
  • Sterility Testing
  • Bacterial Endotoxin Testing

By Country

  • US
  • Canada
  • Mexico
  • Rest of North America
Chapter 1. Market Scope & Methodology
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 North America Pharmaceutical Sterility Testing Market, by Type
1.4.2 North America Pharmaceutical Sterility Testing Market, by Product Type
1.4.3 North America Pharmaceutical Sterility Testing Market, by Sample
1.4.4 North America Pharmaceutical Sterility Testing Market, by End Use
1.4.5 North America Pharmaceutical Sterility Testing Market, by Test Type
1.4.6 North America Pharmaceutical Sterility Testing Market, by Country
1.5 Methodology for the research

Chapter 2. Market at a Glance
2.1 Key Highlights

Chapter 3. Market Overview
3.1 Introduction
3.1.1 Overview
3.1.1.1 Market Composition and Scenario
3.2 Key Factors Impacting the Market
3.2.1 Market Drivers
3.2.2 Market Restraints
3.2.3 Market Opportunities
3.2.4 Market Challenges
3.3 Porter’s Five Forces Analysis

Chapter 4. North America Pharmaceutical Sterility Testing Market by Type
4.1 North America Outsourcing Market by Region
4.2 North America In-House Market by Region

Chapter 5. North America Pharmaceutical Sterility Testing Market by Product Type
5.1 North America Kits & Reagents Market by Country
5.2 North America Instruments Market by Country
5.3 North America Services Market by Country

Chapter 6. North America Pharmaceutical Sterility Testing Market by Sample
6.1 North America Pharmaceuticals Market by Country
6.2 North America Medical Devices Market by Country
6.3 North America Biopharmaceuticals Market by Country

Chapter 7. North America Pharmaceutical Sterility Testing Market by End-use
7.1 North America Pharmaceutical Companies Market by Country
7.2 North America Medical Device Companies Market by Country
7.3 North America Compounding Pharmacies Market by Country
7.4 North America Others Market by Country

Chapter 8. North America Pharmaceutical Sterility Testing Market by Test Type
8.1 North America Bioburden Testing Market by Country
8.2 North America Sterility Testing Market by Country
8.3 North America Bacterial Endotoxin Testing Market by Country

Chapter 9. North America Pharmaceutical Sterility Testing Market by Country
9.1 US Pharmaceutical Sterility Testing Market
9.1.1 US Pharmaceutical Sterility Testing Market by Type
9.1.2 US Pharmaceutical Sterility Testing Market by Product Type
9.1.3 US Pharmaceutical Sterility Testing Market by Sample
9.1.4 US Pharmaceutical Sterility Testing Market by End-use
9.1.5 US Pharmaceutical Sterility Testing Market by Test Type
9.2 Canada Pharmaceutical Sterility Testing Market
9.2.1 Canada Pharmaceutical Sterility Testing Market by Type
9.2.2 Canada Pharmaceutical Sterility Testing Market by Product Type
9.2.3 Canada Pharmaceutical Sterility Testing Market by Sample
9.2.4 Canada Pharmaceutical Sterility Testing Market by End-use
9.2.5 Canada Pharmaceutical Sterility Testing Market by Test Type
9.3 Mexico Pharmaceutical Sterility Testing Market
9.3.1 Mexico Pharmaceutical Sterility Testing Market by Type
9.3.2 Mexico Pharmaceutical Sterility Testing Market by Product Type
9.3.3 Mexico Pharmaceutical Sterility Testing Market by Sample
9.3.4 Mexico Pharmaceutical Sterility Testing Market by End-use
9.3.5 Mexico Pharmaceutical Sterility Testing Market by Test Type
9.4 Rest of North America Pharmaceutical Sterility Testing Market
9.4.1 Rest of North America Pharmaceutical Sterility Testing Market by Type
9.4.2 Rest of North America Pharmaceutical Sterility Testing Market by Product Type
9.4.3 Rest of North America Pharmaceutical Sterility Testing Market by Sample
9.4.4 Rest of North America Pharmaceutical Sterility Testing Market by End-use
9.4.5 Rest of North America Pharmaceutical Sterility Testing Market by Test Type

Chapter 10. Company Profiles
10.1 Steris PLC
10.1.1 Company Overview
10.1.2 Financial Analysis
10.1.3 Segmental and Regional Analysis
10.1.4 Research & Development Expenses
10.1.5 SWOT Analysis
10.2 Charles River Laboratories International, Inc.
10.2.1 Company Overview
10.2.2 Financial Analysis
10.2.3 Segmental and Regional Analysis
10.2.4 Recent strategies and developments:
10.2.4.1 Product Launches and Product Expansions:
10.2.5 SWOT Analysis
10.3 Thermo Fisher Scientific, Inc.
10.3.1 Company Overview
10.3.2 Financial Analysis
10.3.3 Segmental and Regional Analysis
10.3.4 Research & Development Expenses
10.3.5 Recent strategies and developments:
10.3.5.1 Geographical Expansions:
10.3.6 SWOT Analysis
10.4 SGS S.A.
10.4.1 Company Overview
10.4.2 Financial Analysis
10.4.3 Segmental Analysis
10.4.4 SWOT Analysis
10.5 Sartorius AG
10.5.1 Company Overview
10.5.2 Financial Analysis
10.5.3 Segmental and Regional Analysis
10.5.4 Research & Development Expenses
10.5.5 Recent strategies and developments:
10.5.5.1 Partnerships, Collaborations, and Agreements:
10.5.6 SWOT Analysis
10.6 Sotera Health Company
10.6.1 Company Overview
10.6.2 Financial Analysis
10.6.3 Segmental and Regional Analysis
10.6.4 SWOT Analysis
10.7 Pacific Biolabs, Inc.
10.7.1 Company Overview
10.7.2 SWOT Analysis
10.8 Laboratory Corporation of America Holdings
10.8.1 Company Overview
10.8.2 Financial Analysis
10.8.3 Segmental and Regional Analysis
10.8.4 SWOT Analysis
10.9 Almac group
10.9.1 Company Overview
10.9.2 SWOT Analysis
10.10. Pace Analytical Services, LLC
10.10.1 Company Overview
10.10.2 Recent strategies and developments:
10.10.2.1 Acquisition and Mergers:
10.10.3 SWOT Analysis
TABLE 1 North America Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 2 North America Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 3 North America Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 4 North America Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 5 North America Outsourcing Market by Region, 2019 - 2022, USD Million
TABLE 6 North America Outsourcing Market by Region, 2023 - 2030, USD Million
TABLE 7 North America In-House Market by Region, 2019 - 2022, USD Million
TABLE 8 North America In-House Market by Region, 2023 - 2030, USD Million
TABLE 9 North America Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 10 North America Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 11 North America Kits & Reagents Market by Country, 2019 - 2022, USD Million
TABLE 12 North America Kits & Reagents Market by Country, 2023 - 2030, USD Million
TABLE 13 North America Instruments Market by Country, 2019 - 2022, USD Million
TABLE 14 North America Instruments Market by Country, 2023 - 2030, USD Million
TABLE 15 North America Services Market by Country, 2019 - 2022, USD Million
TABLE 16 North America Services Market by Country, 2023 - 2030, USD Million
TABLE 17 North America Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 18 North America Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 19 North America Pharmaceuticals Market by Country, 2019 - 2022, USD Million
TABLE 20 North America Pharmaceuticals Market by Country, 2023 - 2030, USD Million
TABLE 21 North America Medical Devices Market by Country, 2019 - 2022, USD Million
TABLE 22 North America Medical Devices Market by Country, 2023 - 2030, USD Million
TABLE 23 North America Biopharmaceuticals Market by Country, 2019 - 2022, USD Million
TABLE 24 North America Biopharmaceuticals Market by Country, 2023 - 2030, USD Million
TABLE 25 North America Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 26 North America Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 27 North America Pharmaceutical Companies Market by Country, 2019 - 2022, USD Million
TABLE 28 North America Pharmaceutical Companies Market by Country, 2023 - 2030, USD Million
TABLE 29 North America Medical Device Companies Market by Country, 2019 - 2022, USD Million
TABLE 30 North America Medical Device Companies Market by Country, 2023 - 2030, USD Million
TABLE 31 North America Compounding Pharmacies Market by Country, 2019 - 2022, USD Million
TABLE 32 North America Compounding Pharmacies Market by Country, 2023 - 2030, USD Million
TABLE 33 North America Others Market by Country, 2019 - 2022, USD Million
TABLE 34 North America Others Market by Country, 2023 - 2030, USD Million
TABLE 35 North America Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 36 North America Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 37 North America Bioburden Testing Market by Country, 2019 - 2022, USD Million
TABLE 38 North America Bioburden Testing Market by Country, 2023 - 2030, USD Million
TABLE 39 North America Sterility Testing Market by Country, 2019 - 2022, USD Million
TABLE 40 North America Sterility Testing Market by Country, 2023 - 2030, USD Million
TABLE 41 North America Bacterial Endotoxin Testing Market by Country, 2019 - 2022, USD Million
TABLE 42 North America Bacterial Endotoxin Testing Market by Country, 2023 - 2030, USD Million
TABLE 43 North America Pharmaceutical Sterility Testing Market by Country, 2019 - 2022, USD Million
TABLE 44 North America Pharmaceutical Sterility Testing Market by Country, 2023 - 2030, USD Million
TABLE 45 US Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 46 US Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 47 US Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 48 US Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 49 US Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 50 US Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 51 US Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 52 US Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 53 US Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 54 US Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 55 US Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 56 US Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 57 Canada Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 58 Canada Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 59 Canada Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 60 Canada Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 61 Canada Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 62 Canada Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 63 Canada Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 64 Canada Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 65 Canada Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 66 Canada Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 67 Canada Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 68 Canada Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 69 Mexico Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 70 Mexico Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 71 Mexico Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 72 Mexico Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 73 Mexico Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 74 Mexico Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 75 Mexico Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 76 Mexico Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 77 Mexico Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 78 Mexico Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 79 Mexico Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 80 Mexico Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 81 Rest of North America Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 82 Rest of North America Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 83 Rest of North America Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 84 Rest of North America Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 85 Rest of North America Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 86 Rest of North America Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 87 Rest of North America Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 88 Rest of North America Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 89 Rest of North America Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 90 Rest of North America Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 91 Rest of North America Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 92 Rest of North America Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 93 Key Information – STERIS PLC
TABLE 94 key information – Charles River Laboratories International, Inc.
TABLE 95 Key Information – Thermo Fisher Scientific, Inc.
TABLE 96 Key Information – SGS S.A.
TABLE 97 KEY INFORMATION – Sartorius AG
TABLE 98 Key Information – SOTERA HEALTH COMPANY
TABLE 99 Key Information – Pacific Biolabs, INC.
TABLE 100 Key Information – Laboratory Corporation of America Holdings
TABLE 101 Key Information – Almac Group
TABLE 102 Key Information – Pace Analytical Services, LLC

List of Figures
FIG 1 Methodology for the research
FIG 2 North America Pharmaceutical Sterility Testing Market, 2019 - 2030, USD Million
FIG 3 Key Factors Impacting Pharmaceutical Sterility Testing Market
FIG 4 Porter’s Five Forces Analysis – pharmaceutical sterility testing market
FIG 5 North America Pharmaceutical Sterility Testing Market share by Type, 2022
FIG 6 North America Pharmaceutical Sterility Testing Market share by Type, 2030
FIG 7 North America Pharmaceutical Sterility Testing Market by Type, 2019 - 2030, USD Million
FIG 8 North America Pharmaceutical Sterility Testing Market share by Product Type, 2022
FIG 9 North America Pharmaceutical Sterility Testing Market share by Product Type, 2030
FIG 10 North America Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2030, USD Million
FIG 11 North America Pharmaceutical Sterility Testing Market share by Sample, 2022
FIG 12 North America Pharmaceutical Sterility Testing Market share by Sample, 2030
FIG 13 North America Pharmaceutical Sterility Testing Market by Sample, 2019 - 2030, USD Million
FIG 14 North America Pharmaceutical Sterility Testing Market share by End-use, 2022
FIG 15 North America Pharmaceutical Sterility Testing Market share by End-use, 2030
FIG 16 North America Pharmaceutical Sterility Testing Market by End-use, 2019 - 2030, USD Million
FIG 17 North America Pharmaceutical Sterility Testing Market share by Test Type, 2022
FIG 18 North America Pharmaceutical Sterility Testing Market share by Test Type, 2030
FIG 19 North America Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2030, USD Million
FIG 20 North America Pharmaceutical Sterility Testing Market share by Country, 2022
FIG 21 North America Pharmaceutical Sterility Testing Market share by Country, 2030
FIG 22 North America Pharmaceutical Sterility Testing Market by Country, 2019 - 2030, USD Million
FIG 23 SWOT Analysis: STERIS PLC
FIG 24 Swot Analysis: Charles River Laboratories International, Inc.
FIG 25 SWOT Analysis: Thermo Fisher Scientific, Inc.
FIG 26 Swot Analysis: SGS S.A.
FIG 27 SWOT Analysis: Sartorius AG
FIG 28 SWOT Analysis: SOTERA HEALTH COMPANY
FIG 29 Swot Analysis: Pacific Biolabs, Inc.
FIG 30 Swot Analysis: Laboratory Corporation of America Holdings
FIG 31 Swot Analysis: Almac group
FIG 32 Swot Analysis: Pace Analytical Services, LLC

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