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

List of Tables

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

Chapter 1.Market Scope & Methodology

1.1Market Definition
1.2Objectives
1.3Market Scope
1.4Segmentation
- 1.4.1North America Pharmaceutical Sterility Testing Market, by Type
- 1.4.2North America Pharmaceutical Sterility Testing Market, by Product Type
- 1.4.3North America Pharmaceutical Sterility Testing Market, by Sample
- 1.4.4North America Pharmaceutical Sterility Testing Market, by End Use
- 1.4.5North America Pharmaceutical Sterility Testing Market, by Test Type
- 1.4.6North America Pharmaceutical Sterility Testing Market, by Country
1.5Methodology for the research

Chapter 2.Market at a Glance

2.1Key Highlights

Chapter 3.Market Overview

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

Chapter 4.North America Pharmaceutical Sterility Testing Market by Type

4.1North America Outsourcing Market by Region
4.2North America In-House Market by Region

Chapter 5.North America Pharmaceutical Sterility Testing Market by Product Type

5.1North America Kits & Reagents Market by Country
5.2North America Instruments Market by Country
5.3North America Services Market by Country

Chapter 6.North America Pharmaceutical Sterility Testing Market by Sample

6.1North America Pharmaceuticals Market by Country
6.2North America Medical Devices Market by Country
6.3North America Biopharmaceuticals Market by Country

Chapter 7.North America Pharmaceutical Sterility Testing Market by End-use

7.1North America Pharmaceutical Companies Market by Country
7.2North America Medical Device Companies Market by Country
7.3North America Compounding Pharmacies Market by Country
7.4North America Others Market by Country

Chapter 8.North America Pharmaceutical Sterility Testing Market by Test Type

8.1North America Bioburden Testing Market by Country
8.2North America Sterility Testing Market by Country
8.3North America Bacterial Endotoxin Testing Market by Country

Chapter 9.North America Pharmaceutical Sterility Testing Market by Country

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

Chapter 10.Company Profiles

10.1Steris PLC
- 10.1.1Company Overview
- 10.1.2Financial Analysis
- 10.1.3Segmental and Regional Analysis
- 10.1.4Research & Development Expenses
- 10.1.5SWOT Analysis
10.2Charles River Laboratories International, Inc.
- 10.2.1Company Overview
- 10.2.2Financial Analysis
- 10.2.3Segmental and Regional Analysis
- 10.2.4Recent strategies and developments:
  - 10.2.4.1Product Launches and Product Expansions:
- 10.2.5SWOT Analysis
10.3Thermo Fisher Scientific, Inc.
- 10.3.1Company Overview
- 10.3.2Financial Analysis
- 10.3.3Segmental and Regional Analysis
- 10.3.4Research & Development Expenses
- 10.3.5Recent strategies and developments:
  - 10.3.5.1Geographical Expansions:
- 10.3.6SWOT Analysis
10.4SGS S.A.
- 10.4.1Company Overview
- 10.4.2Financial Analysis
- 10.4.3Segmental Analysis
- 10.4.4SWOT Analysis
10.5Sartorius AG
- 10.5.1Company Overview
- 10.5.2Financial Analysis
- 10.5.3Segmental and Regional Analysis
- 10.5.4Research & Development Expenses
- 10.5.5Recent strategies and developments:
  - 10.5.5.1Partnerships, Collaborations, and Agreements:
- 10.5.6SWOT Analysis
10.6Sotera Health Company
- 10.6.1Company Overview
- 10.6.2Financial Analysis
- 10.6.3Segmental and Regional Analysis
- 10.6.4SWOT Analysis
10.7Pacific Biolabs, Inc.
- 10.7.1Company Overview
- 10.7.2SWOT Analysis
10.8Laboratory Corporation of America Holdings
- 10.8.1Company Overview
- 10.8.2Financial Analysis
- 10.8.3Segmental and Regional Analysis
- 10.8.4SWOT Analysis
10.9Almac group
- 10.9.1Company Overview
- 10.9.2SWOT Analysis
10.10.Pace Analytical Services, LLC
- 10.10.1Company Overview
- 10.10.2Recent strategies and developments:
  - 10.10.2.1Acquisition and Mergers:
- 10.10.3SWOT Analysis

LIST OF TABLES

TABLE 1North America Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 2North America Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 3North America Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 4North America Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 5North America Outsourcing Market by Region, 2019 - 2022, USD Million
TABLE 6North America Outsourcing Market by Region, 2023 - 2030, USD Million
TABLE 7North America In-House Market by Region, 2019 - 2022, USD Million
TABLE 8North America In-House Market by Region, 2023 - 2030, USD Million
TABLE 9North America Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 10North America Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 11North America Kits & Reagents Market by Country, 2019 - 2022, USD Million
TABLE 12North America Kits & Reagents Market by Country, 2023 - 2030, USD Million
TABLE 13North America Instruments Market by Country, 2019 - 2022, USD Million
TABLE 14North America Instruments Market by Country, 2023 - 2030, USD Million
TABLE 15North America Services Market by Country, 2019 - 2022, USD Million
TABLE 16North America Services Market by Country, 2023 - 2030, USD Million
TABLE 17North America Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 18North America Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 19North America Pharmaceuticals Market by Country, 2019 - 2022, USD Million
TABLE 20North America Pharmaceuticals Market by Country, 2023 - 2030, USD Million
TABLE 21North America Medical Devices Market by Country, 2019 - 2022, USD Million
TABLE 22North America Medical Devices Market by Country, 2023 - 2030, USD Million
TABLE 23North America Biopharmaceuticals Market by Country, 2019 - 2022, USD Million
TABLE 24North America Biopharmaceuticals Market by Country, 2023 - 2030, USD Million
TABLE 25North America Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 26North America Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 27North America Pharmaceutical Companies Market by Country, 2019 - 2022, USD Million
TABLE 28North America Pharmaceutical Companies Market by Country, 2023 - 2030, USD Million
TABLE 29North America Medical Device Companies Market by Country, 2019 - 2022, USD Million
TABLE 30North America Medical Device Companies Market by Country, 2023 - 2030, USD Million
TABLE 31North America Compounding Pharmacies Market by Country, 2019 - 2022, USD Million
TABLE 32North America Compounding Pharmacies Market by Country, 2023 - 2030, USD Million
TABLE 33North America Others Market by Country, 2019 - 2022, USD Million
TABLE 34North America Others Market by Country, 2023 - 2030, USD Million
TABLE 35North America Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 36North America Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 37North America Bioburden Testing Market by Country, 2019 - 2022, USD Million
TABLE 38North America Bioburden Testing Market by Country, 2023 - 2030, USD Million
TABLE 39North America Sterility Testing Market by Country, 2019 - 2022, USD Million
TABLE 40North America Sterility Testing Market by Country, 2023 - 2030, USD Million
TABLE 41North America Bacterial Endotoxin Testing Market by Country, 2019 - 2022, USD Million
TABLE 42North America Bacterial Endotoxin Testing Market by Country, 2023 - 2030, USD Million
TABLE 43North America Pharmaceutical Sterility Testing Market by Country, 2019 - 2022, USD Million
TABLE 44North America Pharmaceutical Sterility Testing Market by Country, 2023 - 2030, USD Million
TABLE 45US Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 46US Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 47US Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 48US Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 49US Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 50US Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 51US Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 52US Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 53US Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 54US Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 55US Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 56US Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 57Canada Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 58Canada Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 59Canada Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 60Canada Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 61Canada Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 62Canada Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 63Canada Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 64Canada Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 65Canada Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 66Canada Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 67Canada Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 68Canada Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 69Mexico Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 70Mexico Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 71Mexico Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 72Mexico Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 73Mexico Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 74Mexico Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 75Mexico Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 76Mexico Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 77Mexico Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 78Mexico Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 79Mexico Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 80Mexico Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 81Rest of North America Pharmaceutical Sterility Testing Market, 2019 - 2022, USD Million
TABLE 82Rest of North America Pharmaceutical Sterility Testing Market, 2023 - 2030, USD Million
TABLE 83Rest of North America Pharmaceutical Sterility Testing Market by Type, 2019 - 2022, USD Million
TABLE 84Rest of North America Pharmaceutical Sterility Testing Market by Type, 2023 - 2030, USD Million
TABLE 85Rest of North America Pharmaceutical Sterility Testing Market by Product Type, 2019 - 2022, USD Million
TABLE 86Rest of North America Pharmaceutical Sterility Testing Market by Product Type, 2023 - 2030, USD Million
TABLE 87Rest of North America Pharmaceutical Sterility Testing Market by Sample, 2019 - 2022, USD Million
TABLE 88Rest of North America Pharmaceutical Sterility Testing Market by Sample, 2023 - 2030, USD Million
TABLE 89Rest of North America Pharmaceutical Sterility Testing Market by End-use, 2019 - 2022, USD Million
TABLE 90Rest of North America Pharmaceutical Sterility Testing Market by End-use, 2023 - 2030, USD Million
TABLE 91Rest of North America Pharmaceutical Sterility Testing Market by Test Type, 2019 - 2022, USD Million
TABLE 92Rest of North America Pharmaceutical Sterility Testing Market by Test Type, 2023 - 2030, USD Million
TABLE 93Key Information - STERIS PLC
TABLE 94key information - Charles River Laboratories International, Inc.
TABLE 95Key Information - Thermo Fisher Scientific, Inc.
TABLE 96Key Information - SGS S.A.
TABLE 97KEY INFORMATION - Sartorius AG
TABLE 98Key Information - SOTERA HEALTH COMPANY
TABLE 99Key Information - Pacific Biolabs, INC.
TABLE 100Key Information - Laboratory Corporation of America Holdings
TABLE 101Key Information - Almac Group
TABLE 102Key Information - Pace Analytical Services, LLC

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

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