Pharmaceutical Sterility Testing Market Size Forecast | 2030

Segments - Pharmaceutical Sterility Testing Market by Types (In-house and Outsourcing), Test Types (Sterility Testing, Bioburden Testing, and Bacterial Endotoxin Testing), End-users (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, and Others), Samples (Sterile Drugs, Medical Devices, and Biologics & Therapeutics), and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

Author : Raksha Sharma

Fact-checked by : Vineet Pandey

Editor : Vishal Golekar

Report Description

The global pharmaceutical sterility testing market size is anticipated to register a substantial CAGR during the forecast period, 2021–2028. The growth of the market is attributed to Government investments in the healthcare industry, increasing R&D activities and number of drug launches, and rising focus on quality and sterility.

Sterility testing is a technique primarily used to check the presence of microorganisms in biological parenteral that are intended for human use. Sterility testing is necessary process to ensure that all biopharmaceutical products, medical devices, and pharmaceutical products are free from microorganisms. Fungistasis and bacteriostasis tests are the two popular names for the sterility process. The pharmaceutical industry has benefited due to increase in public awareness of various threats from microorganisms. Over the years, the industry has been constantly developing several drugs and testing devices to eliminate the contamination of these from bacteria and others, which lead to discarding of non-sterile medical devices. Sterility testing is used in both pharmaceutical manufacturing and bioproduction. Moreover, the pharmaceuticals sterility testing is mostly used for research and development as well as to ensure the safety of manufactured drugs. It is a crucial step for every manufacturer to ensure that drugs are safe to use.

Global Pharmaceutical Sterility Testing Market Summary

Market Trends, Drivers, Restraints, and Opportunities

Increasing investments in R&D to develop innovative products and rising demand for innovative testing devices are projected to drive the market growth during the forecast period.
Accelerating drug approval from various regulatory bodies especially in developed regions in order to meet the growing healthcare demand act a major factor propelling the market growth.
Increasing number of patients suffering from cardiovascular disorders such as heart failure, heart attack, high blood pressure, and cancer-related diseases is expected to drive the market growth.
Lack of development of advanced medical facilities and poor establishment of diagnostic centers especially in the low-income countries are expected to restrict the market growth.
Increasing investments from developing economies such as China and India for developing cost effective medications are estimated to create lucrative opportunities for the market expansion.

Scope of the Report

The report on the global 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	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 Outsourcing), Test Types (Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing), End-use (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, and Others), and Samples (Sterile Drugs, Medical Devices, and Biologics & Therapeutics)
Regional Scope	Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories

Market Segment Insights

Outsourcing segment is expected to account for a key market share
Based on types, the pharmaceutical sterility testing market is bifurcated into in-house and outsourcing. The outsourcing segment is expected to account for a key share of the market during the forecast period owing to factors such as saving time and cost by reducing the need of training personnel and purchase of sterility testing equipment. The option of outsourcing sterility testing is appealing due to its cost efficiency to provide the services. Some businesses lack the necessary resources to perform high-quality sterility tests, this tends to outsource these services.

Global Pharmaceutical Sterility Testing Market Type

Bacterial endotoxin testing segment is expected to constitute a major key share
On the basis of test types, the market is segmented into sterility testing, bioburden testing, and bacterial endotoxin testing. The bacterial endotoxin testing segment is expected to constitute a key share of the market during the forecast period owing to the ongoing technological advancements. On the other hand, the sterility testing and bioburden testing segment in combined is expected to register a significant growth during the forecast period. The segment growth is expected due to growing emphasis on product quality as well as an increase in the number of drug and medical device launches.

Pharmaceutical companies segment is expected to rapid growth
Based on end-users, the pharmaceutical sterility testing market is segmented into compounding pharmacies, medical devices companies, pharmaceutical companies, and others. The other segment consists of hospitals, biopharmaceuticals, clinics, and research labs. The others segment is expected to represent a key share of the market during the forecast period owing to increasing R&D activities, outsourcing services, and rise in innovative biopharmaceutical products. However, the pharmaceutical companies segment is anticipated to expand at a rapid pace during the forecast period owing to regulatory requirement to conduct sterility testing for each batch release to ensure product safety.

Global Pharmaceutical Sterility Testing Market End User

Sterile drugs segment is expected to constitute a large market share
In terms of samples, the market is segmented into sterile drugs, medical devices, and biologics & therapeutics. The sterile drugs segment is expected to constitute a large share of the market during the forecast period owing to high adoption of several techniques, which are widely adopted for product safety. On the other hand, the biologic 7 therapeutics segment is anticipated to expand at a robust growth rate during the forecast period due to technological advancements in sterility testing procedures, biosimilars, vaccines, and other biologics, as well as regulatory standards to ensure the sterility of biologics and therapeutics.

North America is anticipated to dominate the market
On the basis of regions, the pharmaceutical sterility testing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is anticipated to dominate the market CAGR during the forecast period owing to the presence of a large number of global and domestic players in this region. On the other hand, the market in Asia Pacific is expected to exhibit a rapid growth rate in the coming years owing to increasing harmonization of the regulatory standards with the ICH standards in developing nations. Furthermore, many developing economies in the region such as China and India are taking steps to improve the domestic pharmaceutical market and are encouraging multinational firms to set up operations in the region. Such initiatives are certainly leading to the regional market development.

Global Pharmaceutical Sterility Testing Market Region

Segments

Segments Covered in the Report
The global pharmaceutical sterility testing market has been segmented on the basis of

Types

In-house
Outsourcing

Test Types

Sterility Testing
Bioburden Testing
Bacterial Endotoxin Testing

End-users

Compounding Pharmacies
Medical Devices Companies
Pharmaceutical Companies
Others

Samples

Sterile Drugs
Medical Devices
Biologics & Therapeutics

Regions

Asia Pacific
North America
Latin America
Europe
Middle East & Africa

Key Players

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

Competitive Landscape

Key players competing in the pharmaceutical sterility testing market include SGS SA; Toxikon, Inc.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories.

Regional expansions, mergers, and acquisitions are some of the widely adopted business strategies by these players to increase their market shares. For instance, On July 2015, Charles River Laboratories bought Celsis International Ltd. to expand its microbiology testing capability.

Global Pharmaceutical Sterility Testing Market Key Players

Table Of Content

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 (000â€™ 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 Types
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by Types
     5.2.2. Y-o-Y Growth Projections by Types
  5.3. Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     5.3.1. In-house
     5.3.2. Outsourcing
  5.4. Absolute $ Opportunity Assessment by Types
  5.5. Market Attractiveness/Growth Potential Analysis by Types
6. Global Pharmaceutical Sterility Testing Market Analysis and Forecast by End Users
  6.1. Market Trends
  6.2. Introduction
     6.2.1. Basis Point Share (BPS) Analysis by End Users
     6.2.2. Y-o-Y Growth Projections by End Users
  6.3. Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     6.3.1. Compounding Pharmacies
     6.3.2. Medical Devices Companies
     6.3.3. Pharmaceutical Companies
     6.3.4. Others
  6.4. Absolute $ Opportunity Assessment by End Users
  6.5. Market Attractiveness/Growth Potential Analysis by End Users
7. Global Pharmaceutical Sterility Testing Market Analysis and Forecast by Region
  7.1. Market Trends
  7.2. Introduction
     7.2.1. Basis Point Share (BPS) Analysis by Region
     7.2.2. Y-o-Y Growth Projections by Region
  7.3. Pharmaceutical Sterility Testing Market Size and Volume Forecast by Region
     7.3.1. North America
     7.3.2. Latin America
     7.3.3. Europe
     7.3.4. Asia Pacific
     7.3.5. Middle East and Africa (MEA)
  7.4. Absolute $ Opportunity Assessment by Region
  7.5. Market Attractiveness/Growth Potential Analysis by Region
  7.6. Global Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
8. North America 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
  8.2. North America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     8.2.1. U.S.
     8.2.2. Canada
  8.3. Absolute $ Opportunity Assessment by Country
  8.4. North America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     8.4.1. In-house
     8.4.2. Outsourcing
  8.5. Basis Point Share (BPS) Analysis by Types
  8.6. Y-o-Y Growth Projections by Types
  8.7. North America Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     8.7.1. Compounding Pharmacies
     8.7.2. Medical Devices Companies
     8.7.3. Pharmaceutical Companies
     8.7.4. Others
  8.8. Basis Point Share (BPS) Analysis by End Users
  8.9. Y-o-Y Growth Projections by End Users
  8.10. Market Attractiveness/Growth Potential Analysis
     8.10.1. By Country
     8.10.2. By Product Type
     8.10.3. By Application
  8.11. North America Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
9. Latin America 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. Latin America Average Pricing Analysis
  9.2. Latin America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
      9.2.1. Brazil
      9.2.2. Mexico
      9.2.3. Rest of Latin America
   9.3. Absolute $ Opportunity Assessment by Country
  9.4. Latin America Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     9.4.1. In-house
     9.4.2. Outsourcing
  9.5. Basis Point Share (BPS) Analysis by Types
  9.6. Y-o-Y Growth Projections by Types
  9.7. Latin America Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     9.7.1. Compounding Pharmacies
     9.7.2. Medical Devices Companies
     9.7.3. Pharmaceutical Companies
     9.7.4. Others
  9.8. Basis Point Share (BPS) Analysis by End Users
  9.9. Y-o-Y Growth Projections by End Users
  9.10. Market Attractiveness/Growth Potential Analysis
     9.10.1. By Country
     9.10.2. By Product Type
     9.10.3. By Application
  9.11. Latin America Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
10. Europe 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. Europe Average Pricing Analysis
  10.2. Europe Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     10.2.1. Germany
     10.2.2. France
     10.2.3. Italy
     10.2.4. U.K.
     10.2.5. Spain
     10.2.6. Russia
     10.2.7. Rest of Europe
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Europe Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     10.4.1. In-house
     10.4.2. Outsourcing
  10.5. Basis Point Share (BPS) Analysis by Types
  10.6. Y-o-Y Growth Projections by Types
  10.7. Europe Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     10.7.1. Compounding Pharmacies
     10.7.2. Medical Devices Companies
     10.7.3. Pharmaceutical Companies
     10.7.4. Others
  10.8. Basis Point Share (BPS) Analysis by End Users
  10.9. Y-o-Y Growth Projections by End Users
  10.10. Market Attractiveness/Growth Potential Analysis
     10.10.1. By Country
     10.10.2. By Product Type
     10.10.3. By Application
  10.11. Europe Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
11. Asia Pacific Pharmaceutical Sterility Testing Market Analysis and Forecast
  11.1. Introduction
     11.1.1. Basis Point Share (BPS) Analysis by Country
     11.1.2. Y-o-Y Growth Projections by Country
     11.1.3. Asia Pacific Average Pricing Analysis
  11.2. Asia Pacific Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     11.2.1. China
     11.2.2. Japan
     11.2.3. South Korea
     11.2.4. India
     11.2.5. Australia
     11.2.6. Rest of Asia Pacific (APAC)
  11.3. Absolute $ Opportunity Assessment by Country
  11.4. Asia Pacific Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     11.4.1. In-house
     11.4.2. Outsourcing
  11.5. Basis Point Share (BPS) Analysis by Types
  11.6. Y-o-Y Growth Projections by Types
  11.7. Asia Pacific Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     11.7.1. Compounding Pharmacies
     11.7.2. Medical Devices Companies
     11.7.3. Pharmaceutical Companies
     11.7.4. Others
  11.8. Basis Point Share (BPS) Analysis by End Users
  11.9. Y-o-Y Growth Projections by End Users
  11.10. Market Attractiveness/Growth Potential Analysis
     11.10.1. By Country
     11.10.2. By Product Type
     11.10.3. By Application
  11.11. Asia Pacific Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
12. Middle East & Africa Pharmaceutical Sterility Testing Market Analysis and Forecast
  12.1. Introduction
     12.1.1. Basis Point Share (BPS) Analysis by Country
     12.1.2. Y-o-Y Growth Projections by Country
     12.1.3. Middle East & Africa Average Pricing Analysis
  12.2. Middle East & Africa Pharmaceutical Sterility Testing Market Size and Volume Forecast by Country
     12.2.1. Saudi Arabia
     12.2.2. South Africa
     12.2.3. UAE
     12.2.4. Rest of Middle East & Africa (MEA)
  12.3. Absolute $ Opportunity Assessment by Country
  12.4. Middle East & Africa Pharmaceutical Sterility Testing Market Size and Volume Forecast by Types
     12.4.1. In-house
     12.4.2. Outsourcing
  12.5. Basis Point Share (BPS) Analysis by Types
  12.6. Y-o-Y Growth Projections by Types
  12.7. Middle East & Africa Pharmaceutical Sterility Testing Market Size and Volume Forecast by End Users
     12.7.1. Compounding Pharmacies
     12.7.2. Medical Devices Companies
     12.7.3. Pharmaceutical Companies
     12.7.4. Others
  12.8. Basis Point Share (BPS) Analysis by End Users
  12.9. Y-o-Y Growth Projections by End Users
  12.10. Market Attractiveness/Growth Potential Analysis
     12.10.1. By Country
     12.10.2. By Product Type
     12.10.3. By Application
  12.11. Middle East & Africa Pharmaceutical Sterility Testing Demand Share Forecast, 2019-2026
13. Competition Landscape
  13.1. Global Pharmaceutical Sterility Testing Market: Market Share Analysis
  13.2. Pharmaceutical Sterility Testing Distributors and Customers
  13.3. Pharmaceutical Sterility Testing Market: Competitive Dashboard
  13.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     13.4.1. SGS SA
     13.4.2. Toxikon, Inc.
     13.4.3. Pace Analytical Services, LLC
     13.4.4. Boston Analytical
     13.4.5. Charles River Laboratories International, Inc.
     13.4.6. Nelson Laboratories