Healthcare Testing, Inspection, And Certification Outsourcing Market Size, Share & Trends Analysis Report By Services (Testing, Inspection, Certification), By Type, By Region (APAC, North America) And Segment Forecasts, 2022 - 2030

Report Overview

The global healthcare testing, inspection, and certification outsourcing market size was valued at USD 3.6 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.8% during the forecast period. The main driver of this market is the increasing demand for safe medical devices and pharmaceutical products, companies trying to maintain optimum standards and safety, and rising demand for biologics and small molecules for the treatment of diseases this creates new opportunities for testing, inspection, and certification services. Also, the COVID-19 pandemic created a rise in this market due to the manufacturing of biologics and medical devices for the treatment and prevention of the pandemic.

Initially, there was a halt in the manufacturing due to disruption in the supply chain and stay-at-home orders that led to delays in their testing. But the market experienced a rise in testing, inspection, and certification services in the second half of 2020 as the need for the acquisition of healthcare products started increasing, including medical supplies. For instance, in December 2021, Eurofins announced the acquisition of Genetic Lab Co., Ltd. This acquisition will enhance its global network, and COVID-19 testing will be performed in this facility.

The healthcare testing, inspection, and certification market is a fragmented market and has many local and regional players spread around the world. The top 10 companies of the testing contribute less than 40% of the overall market size. This sector is also largely growing due to the adoption of advanced technologies by healthcare industries and the introduction of new services such as virtual inspection, remote monitoring, and visual inspection by key players.

There is also a rise in demand for safe pharmaceuticals and medical device products by consumers, and to achieve this U.S. Food and Drug Administration provides ASCA accreditation which is a more consistent and efficient FDA Assessment of medical device performance and safety testing and reduces risk to public health. For instance, in April 2021, UL is accredited as ISO/IEC 17025 laboratory by FDA under Accreditation Scheme for Conformity Assessment (ASCA) for medical device safety testing.

Services Insights

The services segment is segmented into testing, inspection, and certification. The testing services segment accounted for the largest share of 52.3% in 2021 during the forecast period. The growth of the market is owing to the increasing influence of strict regulations by the government that has led to a rise in verification, validation, and certification. This also helped companies in maintaining the quality parameters and fulfilling the demands of customers, promoting the expansion of testing facilities and equipment by various companies. For instance, in December 2021, Labcorp completely acquired Toxikon Corp. (TC) to expand Labcorp’s development testing capabilities for biotech, pharmaceutical, and medical device clients.

The inspection services are anticipated to register the second fastest CAGR during the forecast period. This is a very important regulatory practice in gaining market approval and checking the safety of the product. Nowadays, inspection services have collaborated along with the prequalification application (laboratory information file, product dossier, and product streams) for promising and organizing inspections.

Type Insights

The medical devices segment dominated the market with a share of 79.1% during the forecast period. This is due to an increase in the manufacturing of medical device equipment that requires TIC services, which will create new opportunities for TIC services. Also, due to COVID-19, there is an increase in the production of medical devices for the prevention and treatment of diseases. For instance, in April 2020, Eurofins announced that its testing facility would support and ensure the safety of medical devices used in COVID-19.

The pharmaceutical segment accounted for the fastest growth rate during the forecast period. TIC services are in high demand because of increased demand for low-cost drugs, increased regulatory pressure, and consumer awareness about pharmaceutical safety. These are some of the driving factors in this market.

Regional Insights

Europe dominated the market with a revenue share of 44.3% in 2021. The high revenue share can be attributed to the majority of healthcare testing, inspection, and certification players in the market. Also, there is a rise in mergers and acquisitions among the market players in this region, leading to the growth of the market. For instance, in February 2022, Eurofins BPT Italy announced an expansion of its biologics testing capacity. The total laboratory space that has increased is 1000 m2 of BSL2 GMP laboratory space.

The Asia-Pacific region is expected to grow at a lucrative rate with a CAGR of 10.0% during the forecast period owing to the rising economic development in countries such as China, India, Japan, and South Korea. This has led to an increase in manufacturing activity in the region, which in turn has created new opportunities for testing, inspection, and certification. For instance, in November 2021, Labcorp expanded its footprint in the Asia-Pacific with the addition of a new integrated bioanalytical laboratory in Singapore. 

Key Companies & Market Share Insights

Key players are continuously involved in expanding their facilities, collaborating, and engaging in partnerships, mergers, and acquisitions of companies. These are key strategic initiatives that are influencing the industry dynamics. For instance, in January 2021, SGS SA announced the acquisition of the Lab Facilities of International Service Laboratory (ISL) of Novartis based in Ringaskiddy (Cork), Ireland. The main aim is to expand its pharmaceutical analytical testing and stability testing capabilities. This facility is also Good Manufacturing Practices (GMP) certified by U.S. FDA and Irish health authorities (HPRA). Some prominent players in the healthcare testing, inspection, and certification outsourcing market include:

• SGS SA

• Intertek Group plc

• Eurofins Scientific

• DEKRA CERTIFICATION B.V.

• UL LLC

• Nemko

• TÜV SÜD

• Element Materials Technology

• CSA Group Testing & Certification Inc.

• ALS

• Applus+

Healthcare Testing, Inspection And Certification Outsourcing Market Report Scope

Global Healthcare Testing, Inspection And Certification Outsourcing Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest trends and opportunities in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented Healthcare Testing, Inspection & Certification Outsourcing Market based on services, type and region:

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

  • Testing

  • Inspection

  • Certification

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

  • Medical Devices

  • Pharmaceutical

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

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Netherlands

    • Switzerland

    • Turkey

    • Sweden

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

    • Australia

    • Indonesia

    • Malaysia

    • Singapore

    • Thailand

    • Taiwan

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Egypt

    • Israel