Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Product Type, By Test Type, By End-use, By Sample, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global pharmaceutical sterility testing market size was valued at USD 1,270.2 million in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 11.5% from 2022 to 2030. Government investments in the healthcare industry, increasing R&D activities, a surge in the number of drug launches, and a rising focus on quality and sterility are the factors expected to drive the market. Clinical studies on COVID-19 vaccines are still being conducted, as there is a growing need to find a safe and effective treatment for COVID-19 for all the new variants of the virus. A significant number of research undergoing for COVID-19 treatments are likely to have a positive impact on the market in the post-pandemic period.

There is a growing demand for pharmaceuticals all over the world owing to the high burden of chronic and infectious diseases. For instance, in February 2021, the World Health Organization (WHO) stated that cardiovascular diseases are one of the major causes of death, worldwide, accounting for the deaths of 17.9 million people every year. The high burden of diseases in the future is expected to improve demand for the pharmaceuticals and thus support the demand for pharmaceutical sterility testing.

In order to address the growing demand for healthcare, several emerging countries shortened their regulatory schedules for drug approval and accelerated drug launches. It is anticipated that these regulatory adjustments will accelerate market expansion. Additionally, because drugs like Elagolix and Lanadelumab are biopharmaceutical products that need unique sterility testing, their introduction is significantly supporting the market's expansion.

In the post-pandemic period, drug companies are focused on developing and manufacturing biologics and biosimilars as they are highly effective in treating some serious diseases such as cancer, psoriasis, and Alzheimer's disease. For instance, in June 2021, Lonza collaborated with Pint eon Therapeutics, a biotechnology company focused on developing therapeutics for Alzheimer's.

As per this collaboration agreement Lonza decided to manufacture PNT001, Novel Tau Antibody of Pinteon Therapeutics used in the treatment of Alzheimer’s and traumatic brain injury. The growing burden of these diseases, worldwide, is expected to improve R&D and the manufacturing of these drugs. This is expected to boost demand for sterility testing in the post-pandemic period, thereby supporting the market growth.

Type Insights

The outsourcing segment held the largest market share, accounting for 55.0%in 2021. Based on type, the market is segmented into outsourcing and in-house. Outsourcing sterility testing is an attractive alternative. Small and medium-sized pharmaceutical and medical device companies may lack the infrastructure to conduct quality sterility testing and therefore prefer to outsource these services to pass the FDA requirements.

Moreover, outsourcing also saves time and cost of pharmaceutical and medical device companies, as they don’t have to hire and train employees and they are also not required to invest in any new equipment. Big pharmaceutical companies are now trying to focus on their core competencies like R&D and marketing, therefore they outsource pharmaceutical sterility testing services. These factors have been a prime factor supporting the segment's growth.

The in-house segment is expected to grow with a CAGR of 11.3% during the forecast period. Quality issues and compliance issues associated with outsourcing pharmaceutical sterility testing are expected to promote the segment market throughout the forecast period. Small outsourcing firms lack the necessary infrastructure, and this is expected to hamper the quality of sterility testing. These reasons are likely to improve demand for in-house pharmaceutical sterility testing in the market.

Testing Type Insights

The bacterial endotoxin testing segment accounted for the highest market share of 39.4% in 2021. Based on testing type, the market is segmented into sterility testing, bioburden testing, bacterial endotoxin testing, membrane filtration, direct inoculation, container closure integrity testing, antimicrobial effectiveness testing, and Rapid micro test.

Bacterial endotoxin testing is required for all drugs administered via parenteral routes. These tests are also used for testing medical devices such as implants. The growing demand for parenteral drugs and implants is supporting the growth of the segment market. There is an increasing emphasis on product quality, along with a rising number of drug and medical device launches. This is anticipated to contribute towards the expansion of the segments.

Bioburden testing is expected to expand at the fastest rate of 11.6% CAGR during the forecast period. Bioburden testing is performed for pharmaceuticals, biologics, and all medical devices, including class I, II, and III. The growing demand for the aforementioned products is one of the major reasons supporting segment growth. Furthermore, this testing is very important during the production process, as microbial growth in the product could lead to recalls later.

Sample Insights

Pharmaceuticals held the largest market share of 37.7% in 2021. Based on the sample, the market is segmented into pharmaceuticals, medical devices, and biopharmaceuticals. Pharmaceutical includes products such as parenteral, aerosols, ointments, eye drops, and others. These are the most widely used dosage forms. Growing demand for the aforementioned dosage forms, globally, is one of the major factors supporting the market's growth. Furthermore, the rising number of recalls of these dosage forms due to the lack of sterility is further supporting the demand for sterility testing of pharmaceuticals.

The biopharmaceutical segment is expected to grow with a CAGR of 11.7% during the forecast period. This is attributed to the factors such as the growing demand for biologics and biosimilar drugs owing to their effectiveness in treating serious diseases like cancer, neurological disorders, infectious diseases, and others. The improvement in the approvals of biologics and biosimilars during the last 5 years and growing demand for the biologics such as COVID-19 vaccines have further supported the segment market growth.

End-Use Insights

The other segment is projected to expand at a CAGR of 11.7% during the forecast period. Based on end-use, the market is segmented into pharmaceutical companies, medical device companies, compounding pharmacies and others. Other segment includes biopharmaceutical firms and partnered CROs, hospitals, clinics, and research laboratories.

Research laboratories have to ensure that test subjects and lab equipment are free from the contamination. Other end-users require sterility testing for the routine quality control and detection of microbial contamination of the devices and pharmaceutical products, in order to ensure patient safety. This further supports the segment's growth.

The pharmaceutical companies segment has held the largest share of 42.9% in 2021. Pharmaceutical companies have to conduct sterility tests to ensure the safety of the products, especially oral dosage forms, as most of these products are ingested by the patients. There are specific guidelines set in the pharmacopeia of each country, which describe the necessary sterility tests that are required to be performed for a given drug.

Regional Insights

In terms of region, North America held the largest market share of 49.6% in 2021. This may be attributed to the increasing number of pharmaceutical industries within the U.S. and Canada. The presence of a large number of major market players in this region is expected to contribute significantly to the market growth. Stringent regulatory requirements for the sterility testing of pharmaceuticals and medical devices in this region further support the growth of the regional market.

Asia Pacific is anticipated to witness the fastest growth during the forecast period. This can be attributed to the 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 (collaborations that support outsourcing activities). Such initiatives are likely to contribute towards regional development.

Key Companies & Market Share Insights

The market is characterized by the presence of a large number of global and domestic companies. The market is highly fragmented due to the presence of various local and MNC contract service providers and research laboratories. Regional expansions, digitalization of service delivery for sterility testing and M&A activities are the key strategies undertaken by most of these companies. For instance, in September 2019, Charles River Laboratories launched EndoScan-V software platform for endotoxin testing and Celsisautomated detection solution for checking the rapid sterility of pharmaceutical drugs. Some of the prominent players in the global pharmaceutical sterility testing market include:

• Pacific Bio labs

• STERIS

• Boston Analytical

• Nelson Laboratories, LLC

• Sartorius AG

• SOLVIAS AG

• SGS SA

• Laboratory Corporation of America Holding

• Pace Analytical

• Charles River Laboratories

• Thermo Fisher Scientific, Inc.

• Rapid Micro Biosystems, Inc.

• Thermo Fisher Scientific Inc

• Almac Group

Pharmaceutical Sterility Testing Market Report Scope

Global Pharmaceutical Sterility Testing Market Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018-2030. For this study, Grand View Research has segmented the global Pharmaceutical Sterility Testing Market based on the type, product type, test type, sample, end-use, and region:

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • In-house

  • Outsourcing

• Product Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Kits and Reagents

  • Instruments

  • Service

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Sterility Testing

    • Membrane Filtration

    • Direct Inoculation

  • Bioburden Testing

  • Bacterial Endotoxin Testing

  • Container closure integrity testing

  • Antimicrobial effectiveness testing

  • Rapid micro test

    • ATP bioluminescence

    • Fluorescent labeling

    • Electrical resistance

  • Others

• Sample Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceuticals

  • Medical Devices

  • Biopharmaceuticals

• End-Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Compounding Pharmacies

  • Medical Devices Companies

  • Pharmaceutical Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Sweden

    • Switzerland

    • Russia

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

    • Philippines

    • Malaysia

    • New Zealand

    • Singapore

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • Egypt

    • Israel

    • UAE