US Pharmaceutical Sterility Testing Market

US Pharmaceutical Sterility Testing Market by Types (In-house and Outsourced), Test Types (Bacterial Endotoxin, Bioburden, and Sterility), End-users (Compounding Pharmacies, Medical Device Companies, Pharmaceutical Companies, and Others), Samples (Sterility Drugs, Medical Devices, and Biologics & Therapeutics), and Country - Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

  • Report ID: HC-1807
  • Author: Growth Market Reports
  • Rating: 4.9
  • Total Reviews: 2
  • No. Of Pages: 217
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The US pharmaceutical sterility testing market size was valued at USD 420.5 million in 2020 and is estimated to expand at a substantial CAGR during the forecast period, 2021–2028. The growth of the market is attributed to the rising number of diagnostic kits or pharmaceutical devices approvals and increase in R&D activities.

US Pharmaceutical Sterility Testing Market

Pharmaceutical sterility testing involves a screening process to make all devices, equipment, or other products related to pharmaceutical and biologics safe and sterile for the use of diseases treatment. One key aspect of the market growth in the US is due to the easy approval of biologic devices by regulatory bodies. For instance, the US Food and Drug Administration (FDA) approved 43 drugs in 2017 and the introduction of several products were made possible as a consequence of the existing favorable policies from government agencies. The FDA set a standardized guideline for product sterility testing and the regional players are actively engaged in several market strategies to enhance their product portfolio by following the agencies guidelines. Another key factor for propelling the US market is due to the presence of key global pharmaceutical players and their massive investment on various product development research and study.

Market Trends, Drivers, Restraints, and Opportunities

  • Growing number of chronic illness such as arthritis, diabetes, and cancer as well as infectious diseases globally is driving the market growth.
  • Favorable government policies especially in developed countries that encourage the development of various pharmaceutical clinical products for diseases treatment are projected to boost the market.   
  • Introduction of various innovative technology for effective functioning of sterility testing devices is expected to fuel the market expansion in the coming years.
  • Increasing R&D activities and increasing approvals for products from regulatory bodies are estimated to create several opportunities for the market growth during the forecast period.

Scope of the Report

The report on the global US pharmaceutical sterility testing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Attributes

Details

Report Title

US Pharmaceutical Sterility Testing Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast

Base Year

2020

Historic Data

2018–2019

Forecast Period

2021–2028

Segmentation

Types (In-house and Outsourced), Test Types (Bacterial Endotoxin, Bioburden, and Sterility), End-users (Compounding Pharmacies, Medical Device Companies, Pharmaceutical Companies, and Others), and Samples (Sterility Drugs, Medical Devices, and Biologics & Therapeutics)

Country

The US

Report Coverage

Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast

Key Players Covered in the Report

SGS SA; Toxikon, Inc.; Boston Analytical; Charles River Laboratories International, Inc.; Pacific Biolabs; STERIS; Pace Analytical; Gibraltar Laboratories; Infinity Laboratories; and DYNALABS LLC

Market Segment Insights

Outsourced segment is projected to constitute a key market share

Based on types, the US pharmaceutical sterility testing market is bifurcated into in-house and outsourced. The outsourced segment is expected to constitute a key share of the market during the forecast period due to certain advantages such as cost-effective and wide availability of the platform as compared to in-house sterile pharmaceutical testing. In-house sterile pharmaceutical testing is an expensive and high cost technique as it takes into account for operating costs such as cleanroom construction and maintenance as well as the need for an isolator, which are costly consumables. As a result, US pharmaceutical companies are consistently outsourcing their businesses in emerging economies such as India and China.

US Pharmaceutical Sterility Testing Market

Sterility testing segment is anticipated to expand at a rapid CAGR

On the basis of test types, the market is segregated into bacterial endotoxin, bioburden, and sterility. The sterility testing segment is expected to expand at a rapid CAGR during the forecast period due to wide adoption of the testing type across the globe.  The information gathered during sterility tests is crucial for further treatment of disease, as it provides the assurance of consistency needed for treatment approval. However, the bacterial endotoxin testing segment is expected to constitute a key share of the market during the forecast period as it offers accurate results due to the use of more advanced instruments than other studies. However, it is costly techniques as compared to sterility testing.

Sterility drugs segment dominated the market

Based on samples, the US pharmaceutical sterility testing market is segregated into sterility drugs, medical devices, and biologics & therapeutics. The sterility drugs segment dominated the market in 2020 and the trend is expected to continue in the coming years due to increasing development of new products and ongoing R&D spending for the drugs discovery.

US Pharmaceutical Sterility Testing Market

Pharmaceutical companies segment to hold a major market share

In terms of end-users, the market is divided into compounding pharmacies, medical device companies, pharmaceutical companies, and others. The pharmaceutical companies segment is anticipated to hold a major market share in the coming years these companies are widely engaged in the activities to ensure the safety of their products, especially oral dosage forms for human use.

US Pharmaceutical Sterility Testing Market

1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. Pharmaceutical Sterility Testing Market Overview
  4.1. Introduction
     4.1.1. Market Taxonomy
     4.1.2. Market Definition
  4.2. Macro-Economic Factors
     4.2.1. Industry Outlook
  4.3. Pharmaceutical Sterility Testing Market Dynamics
     4.3.1. Market Drivers
     4.3.2. Market Restraints
     4.3.3. Opportunity
     4.3.4. Market Trends
  4.4. Pharmaceutical Sterility Testing Market - Supply Chain
  4.5. Global Pharmaceutical Sterility Testing Market Forecast
     4.5.1. Pharmaceutical Sterility Testing Market Size (US$ Mn) and Y-o-Y Growth
     4.5.2. Pharmaceutical Sterility Testing Market Size (000’ Units) and Y-o-Y Growth
     4.5.3. Pharmaceutical Sterility Testing Market Absolute $ Opportunity
5. Global Pharmaceutical Sterility Testing Market Analysis and Forecast by Region
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by Region
     5.2.2. Y-o-Y Growth Projections by Region
  5.3. Pharmaceutical Sterility Testing Market Size and Volume Forecast by Region
     5.3.1. North America
     5.3.2. Latin America
     5.3.3. Europe
     5.3.4. Asia Pacific
     5.3.5. Middle East and Africa (MEA)
  5.4. Absolute $ Opportunity Assessment by Region
  5.5. Market Attractiveness/Growth Potential Analysis by Region
  5.6. Global Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
6. North America Pharmaceutical Sterility Testing Market Analysis and Forecast
  6.1. Introduction
     6.1.1. Basis Point Share (BPS) Analysis by Country
     6.1.2. Y-o-Y Growth Projections by Country
  6.2. North America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     6.2.1. U.S.
     6.2.2. Canada
  6.3. Absolute $ Opportunity Assessment by Country
  6.4. Market Attractiveness/Growth Potential Analysis
     6.4.1. By Country
     6.4.2. By Product Type
     6.4.3. By Application
  6.5. North America Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
7. Latin America Pharmaceutical Sterility Testing Market Analysis and Forecast
  7.1. Introduction
     7.1.1. Basis Point Share (BPS) Analysis by Country
     7.1.2. Y-o-Y Growth Projections by Country
     7.1.3. Latin America Average Pricing Analysis
  7.2. Latin America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
      7.2.1. Brazil
      7.2.2. Mexico
      7.2.3. Rest of Latin America
   7.3. Absolute $ Opportunity Assessment by Country
  7.4. Market Attractiveness/Growth Potential Analysis
     7.4.1. By Country
     7.4.2. By Product Type
     7.4.3. By Application
  7.5. Latin America Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
8. Europe Pharmaceutical Sterility Testing Market Analysis and Forecast
  8.1. Introduction
     8.1.1. Basis Point Share (BPS) Analysis by Country
     8.1.2. Y-o-Y Growth Projections by Country
     8.1.3. Europe Average Pricing Analysis
  8.2. Europe Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     8.2.1. Germany
     8.2.2. France
     8.2.3. Italy
     8.2.4. U.K.
     8.2.5. Spain
     8.2.6. Russia
     8.2.7. Rest of Europe
  8.3. Absolute $ Opportunity Assessment by Country
  8.4. Market Attractiveness/Growth Potential Analysis
     8.4.1. By Country
     8.4.2. By Product Type
     8.4.3. By Application
  8.5. Europe Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
9. Asia Pacific Pharmaceutical Sterility Testing Market Analysis and Forecast
  9.1. Introduction
     9.1.1. Basis Point Share (BPS) Analysis by Country
     9.1.2. Y-o-Y Growth Projections by Country
     9.1.3. Asia Pacific Average Pricing Analysis
  9.2. Asia Pacific Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     9.2.1. China
     9.2.2. Japan
     9.2.3. South Korea
     9.2.4. India
     9.2.5. Australia
     9.2.6. Rest of Asia Pacific (APAC)
  9.3. Absolute $ Opportunity Assessment by Country
  9.4. Market Attractiveness/Growth Potential Analysis
     9.4.1. By Country
     9.4.2. By Product Type
     9.4.3. By Application
  9.5. Asia Pacific Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
10. Middle East & Africa Pharmaceutical Sterility Testing Market Analysis and Forecast
  10.1. Introduction
     10.1.1. Basis Point Share (BPS) Analysis by Country
     10.1.2. Y-o-Y Growth Projections by Country
     10.1.3. Middle East & Africa Average Pricing Analysis
  10.2. Middle East & Africa Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     10.2.1. Saudi Arabia
     10.2.2. South Africa
     10.2.3. UAE
     10.2.4. Rest of Middle East & Africa (MEA)
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Market Attractiveness/Growth Potential Analysis
     10.4.1. By Country
     10.4.2. By Product Type
     10.4.3. By Application
  10.5. Middle East & Africa Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
11. Competition Landscape
  11.1. Global Pharmaceutical Sterility Testing Market: Market Share Analysis
  11.2. Pharmaceutical Sterility Testing Distributors and Customers
  11.3. Pharmaceutical Sterility Testing Market: Competitive Dashboard
  11.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     11.4.1. SGS SA. Toxikon, Inc. Boston Analytical. Charles River Laboratories International, Inc. Pacific Biolabs. STERIS  

Segments Covered in the Report

The US pharmaceutical sterility testing market has been segmented on the basis of

Types

  • In-house
  • Outsourced

Test Types

  • Bacterial Endotoxin
  • Bioburden
  • Sterility

End-users

  • Compounding Pharmacies
  • Medical device Companies
  • Pharmaceutical companies
  • Others

Samples

  • Sterility drugs
  • Medical devices
  • Biologics & therapeutics

Regions

  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa

Key Players

  • SGS SA.
  • Toxikon, Inc.
  • Boston Analytical.
  • Charles River Laboratories International, Inc.
  • Pacific Biolabs.
  • STERIS
  • Pace Analytical
  • Gibraltar Laboratories
  • Infinity Laboratories
  • DYNALABS LLC

Key players competing in the US pharmaceutical sterility testing market are SGS SA; Toxikon, Inc.; Boston Analytical; Charles River Laboratories International, Inc.; Pacific Biolabs; STERIS; Pace Analytical; Gibraltar Laboratories; Infinity Laboratories; and DYNALABS LLC.

These companies have adopted several strategic initiatives including regional and service portfolio expansions, mergers, and acquisitions. For example, a Massachusetts-based contract research organisation, Agilux Laboratories, Inc., was acquired by Charles River Laboratories in September 2016 with an aim to expand its business operation that offers integrated drug discovery and bio-analytical testing services.

US Pharmaceutical Sterility Testing Market

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