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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 Foreca

Publisher Knowledge Based Value (KBV) Research
Published Mar 29, 2024
Length 133 Pages
SKU # KBV18686941

Description

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


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).

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.

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

Table of Contents

133 Pages
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

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