Overview


According to FutureWise analysis the market for pharmaceutical sterility testing in 2023 is US$ 1.56 billion, and is expected to reach US$ 3.77 billion by 2031 at a CAGR of 11.60%.

Pharmaceutical sterilization is the process of removing all living bacteria from a product or environment. Sterilization's purpose is to protect patients from infection while also ensuring the safety and efficacy of pharmaceuticals. Micro organisms are detected and counted in pharmaceutical items and environmental samples using sterility testing. The number of live micro organisms on or in a product or environment is determined by bioburden testing. The technique of determining the sterility of an object or substance is known as sterility testing. This form of testing is used to determine whether something is free of live microorganisms like bacteria, viruses etc., In either an aseptic or non-aseptic setting, sterility can be determined. All potential pollutants are removed in an aseptic atmosphere, leaving only sterile things. Non-aseptic environments are less stringent, yet they nonetheless strive to reduce the quantity of pollutants present.

The quantity of viable microorganisms present on or in a product, raw material, packaging material, water sample, or cleanroom swab is determined by bioburden testing. It is an important measure for evaluating sterilization techniques and biocidal efficiency since it offers quantitative information regarding the level of microbiological contamination. Bioburden testing can be done using a variety of approaches, including old culture-based procedures and newer molecular techniques. A poison produced by bacteria is known as bacterial endotoxin. The presence of this toxin in pharmaceutical items is detected using this method of testing. The test can assist guarantee that these products are safe and of good quality. The bacterial endotoxin test is used to verify if product samples are free of contamination. Medical device manufacturers utilize sterility testing to verify that their goods are free of bacteria. Implants, catheters, and syringes are among the products that must pass the test since they come into touch with sterile bodily tissues or fluids. Sterility testing can also be performed to guarantee that medical items are not contaminated throughout the production process. Market growth is expected to be boosted as a result of such regulatory reforms.

FutureWise Market Research has instantiated a report that provides an intricate analysis of Pharmaceutical Sterility Testing Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.

According to the research study conducted by FutureWise research analysts, the Pharmaceutical Sterility Testing Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.

  • SGS SA
  • Toxikon, Inc
  • Pace Analytical Services, LLC
  • Boston Analytical
  • Charles River Laboratories International, Inc
  • Nelson Laboratories LLC

(Note: The list of the major players will be updated with the latest market scenario and trends)

By Type

  • In-house
  • Outsourcing

By Test Type

  • Sterility Testing
  • Bioburden Testing
  • Bacterial Endotoxin Testing

By Sample

  • Sterile Drugs
  • Medical Devices
  • Biologics and Therapeutics

By End User

  • Compounding Pharmacies
  • Medical Devices Companies
  • Pharmaceutical Companies
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa
  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants
  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth
  • To provide with an exhaustive analysis on the Pharmaceutical Sterility Testing Market By Type, By Test Type, By Sample, By End User and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions
  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Pharmaceutical Sterility Testing Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Pharmaceutical Sterility Testing Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Pharmaceutical Sterility Testing Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Pharmaceutical Sterility Testing Market, By Type Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. In-house
        2. Outsourcing

  • 8.   Pharmaceutical Sterility Testing Market, By Test Type Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Sterility Testing
        2. Bioburden Testing
        3. Bacterial Endotoxin Testing

  • 9.   Pharmaceutical Sterility Testing Market, By Sample Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Sterile Drugs
        2. Medical Devices
        3. Biologics and Therapeutics

  • 10.   Pharmaceutical Sterility Testing Market, By End User Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Compounding Pharmacies
        2. Medical Devices Companies
        3. Pharmaceutical Companies
        4. Others

  • 11.   North America Pharmaceutical Sterility Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 12.   Latin America Pharmaceutical Sterility Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 13.   Europe Pharmaceutical Sterility Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 14.   Asia Pacific Pharmaceutical Sterility Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 15.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 16.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 17.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. SGS SA
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Toxikon, Inc
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Pace Analytical Services, LLC
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Boston Analytical
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Charles River Laboratories International, Inc
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Nelson Laboratories LLC
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview

  • 18.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by administrations
        5. The overall economic slowdown of the developing and developed nations
  • 19.   FutureWise SME Key Takeaway Points for Client
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