GVR Report cover Pharmaceutical Sterility Testing Market Size, Share & Trends Report

Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Test Type, By End-use, By Sample (Sterile Drugs, Biologics & Therapeutics), And Segment Forecasts, 2018 - 2025

  • Report ID: GVR-2-68038-425-3
  • Number of Pages: 83
  • Format: Electronic (PDF)
  • Historical Range: 2014 - 2016
  • Industry: Healthcare

Report Overview

The global pharmaceutical sterility testing market size was valued at USD 733.7 Million in 2016. It is estimated to register a CAGR of 11.8% over the forecast period. Government investments in the healthcare industry, increasing R&D activities and number of drug launches, and rising focus on quality and sterility are projected to drive the market. According to the UNESCO report, the U.S., China, Japan, and Germany were among the top five nations in terms of R&D expenditure in 2016.

Global pharmaceutical sterility testing market size

The U.S. spends nearly 2.7% of its GDP on R&D, whereas China spends approximately 2.0% of GDP on R&D activities. Annual R&D expenditure of China has increased by nearly 70.9% from 2012, as per the CNBC report. Heavy R&D investments are anticipated to increase the number of product innovations; thereby, indirectly facilitating the sterility testing market.

Several developing nations streamlined their drug approval regulatory timelines to accelerate drug launch in order to meet rising healthcare demands. Such regulatory changes are projected to boost market growth. Moreover, drugs such as Elagolix and Lanadelumab are biopharmaceutical products requiring special sterility testing procedure, and thereby, launch of such products is said to bolster the growth of the market.

The FDA relaxed its regulatory guidelines allowing adoption of modern and sophisticated sterility testing techniques by contract labs and manufacturers. This initiative is estimated to provide flexibility to labs and manufacturers in adopting sterility procedures suitable for assuring safety of their innovative products.

Type Insights

On the basis of type, the market is segmented into in-house and outsourcing. The outsourcing segment led the market share accounting for USD 400.9 million in 2016 and is projected to grow at a rapid pace over the forecast period.

The in-house sterility testing market is an essential part of quality assurance and Goof Manufacturing Practices (GMP) for the manufacturers of pharmaceutical, biopharmaceuticals, and medical devices. Sterility testing is mandatory for release of each batch, which facilitates the segment’s growth.

Outsourcing of sterility testing is an attractive alternative. Some companies do not have the infrastructure to conduct quality sterility testing and therefore prefer to outsource these services. Moreover, outsourcing also saves time and cost by reducing the need of training personnel and purchase of sterility testing equipment. However, the quality of sterility testing services depends on the outsourced lab as an ill-equipped lab can deliver inaccurate test results. This facilitates the demand to outsource to high-quality sterility testing laboratories.

End-use Insights

The key end-use segments include compounding pharmacies, medical devices and pharmaceutical companies, and others such as hospitals, biopharmaceuticals, clinics, and research labs. The others segment is projected to register a lucrative CAGR over the forecast period owing to increasing R&D activities, outsourcing services, and rise in innovative biopharmaceutical products.

The pharmaceutical companies segment held the largest share in the pharmaceutical sterility testing market in 2016. This can be attributed to regulatory requirement to conduct sterility testing for each batch release to ensure product safety. These companies adhere to GMP and ICH standards prior to drug approval and launch, thereby contributing to market growth.

Test Type Insights

The bacterial endotoxin testing segment accounted for the highest market share in 2016 and is anticipated to register a lucrative CAGR over the forecast period. This can be attributed to the ongoing technological advancements in this segment.

The sterility and bioburden testing segments are anticipated to witness rapid growth over the forecast period. Increasing emphasis on product quality, along with the rising number of drug and medical devices launches, is anticipated to contribute towards the expansion of these segments.

Global pharmaceutical sterility testing market share

Bioburden and sterility testing along with sterilization process validation are crucial aspects of GMP for assuring the safety of the end products. Sterility and bioburden testing are conducted on medical devices or its components to determine the total viable microorganism count prior to the sterilization process, thereby facilitating the growth of these segments.

Sample Insights

Based on sample, the global market is segmented into sterile dugs, medical devices, and biologics and therapeutics. The sterile drugs held the largest market share in 2016 due to the high adoption of several techniques adopted for product safety.

The biologic and therapeutics segment would witness a remunerative growth over the forecast period. This is attributed to the factors such as growing number of technological advancements in sterility testing procedures, biosimilars, vaccines, and other biologics along with regulatory mandates to ensure the sterility of biologics & therapeutics.

Regional Insights

In terms of region, North America held the largest market share in 2016 and is anticipated to expand at CAGR of 11.7.over the forecast period. This can be attributed to the presence of a large number of international and domestic players in this region. Asia Pacific is anticipated to witness the fastest growth during the forecast period.

This can be attributed to increasing harmonization of the regulatory standards with the ICH standards in developing nations. Moreover, many emerging economies in the region are undertaking various initiatives to boost the domestic pharmaceutical market and are encouraging multinational companies to set up operations in the region. Such initiatives are likely to contribute towards the regional development.

Pharmaceutical Sterility Testing Market Share Insights

The global market is characterized by the presence of a large number of global and domestic companies. The market is also fragmented due to the presence of contract service providers and research laboratories.

Some of the key companies in this market are SGS SA; Toxikon, Inc.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories. Regional expansions and M&A activities are key strategies undertaken by most of these companies. For instance, in July 2015, Charles River Laboratories acquired Celsis International Ltd to strengthen the company’s microbiology testing capabilities.

Pharmaceutical Sterility Testing Market Report Scope

Report Attribute


Market size value in 2020

USD 1,017.5 million

Revenue forecast in 2025

USD 1,998.6 million

Growth Rate

CAGR of 11.8% from 2017 to 2025

Base year for estimation


Historical data

2014 - 2016

Forecast period

2017 - 2025

Quantitative units

Revenue in USD million and CAGR from 2017 to 2025

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

Segments covered

Type, test type, end-use, sample, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; U.K.; Germany; Japan; China; Brazil; Mexico; South Africa; Saudi Arabia

Key companies profiled

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

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global pharmaceutical sterility testing market report on the basis of type, test type, end-use, sample, and region:

  • Type Outlook (Revenue, USD Million, 2014 - 2025)

    • In-house

    • Outsourcing

  • Test type Outlook (Revenue, USD Million, 2014 - 2025)

    • Sterility Testing

    • Bioburden Testing

    • Bacterial Endotoxin Testing

  • End-use Outlook (Revenue, USD Million, 2014 - 2025)

    • Compounding Pharmacies

    • Medical Devices Companies

    • Pharmaceutical Companies

    • Others

  • Sample Outlook (Revenue, USD Million, 2014 - 2025)

    • Sterile Drugs

    • Medical Devices

    • Biologics & Therapeutics

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • The U.S.

      • Canada

    • Europe

      • The U.K.

      • Germany

    • Asia Pacific

      • Japan

      • China

    • Latin America

      • Brazil

      • Mexico

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

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