The healthcare testing, inspection, and certification market size is estimated to be USD 3,728.1 million in 2022 and is expected to witness a CAGR of 8.91% during the forecast period 2023-2033. Surge in demand for secure pharmaceutical and medical device products, companies working to enforce the highest standards of safety, and the growing need for biologics and small molecules to treat diseases are projected to drive the market growth in near future. Furthermore, increase in testing, inspection, and certification and escalating consumer demand for safer drugs and medical equipment is expected to support the market growth. However, lack of awareness and high price of testing, inspection, certification are predicted to limit market growth.

Increase in testing, inspection, and certification is projected to fuel the market growth during the forecast period. The demand for medical supplies and other healthcare products led to an increase in the market for testing, inspection, and certification services. For instance, Eurofins announced in December 2021 that it had acquired Genetic Lab Co., Ltd. Through this acquisition, its global network will be strengthened, and this facility will be used for COVID-19 testing.

Escalating consumer demand for safer drugs and medical equipment is estimated to spur the market growth during the projected period. Consumer demand for safe prescription drugs and medical devices is also on the rise. To meet this demand, the US Food and Drug Administration (FDA) offers ASCA accreditation, which is a more uniform and effective FDA Assessment of medical device performance and safety testing and lowers risk to the public health. For instance, the FDA will certify UL as an ISO/IEC 17025 laboratory in April 2021 as part of the Accreditation Scheme for Conformity Assessment (ASCA) for assessing the safety of medical devices.

Segmentation

By Services

The market is categorized into inspection, testing, and certification. In 2022, the testing segment accounted for the highest revenue share due to the government’s stringent rules, which have increased demand for certification, validation, and verification. This promoted the expansion of testing facilities and equipment by various industries and assisted companies in keeping quality standards and meeting client requests.  For instance, in order to increase its development testing capabilities for clients in the biotech, pharmaceutical, and medical device industries, Labcorp fully acquired Toxikon Corp. (TC) in December 2021. The second quickest CAGR throughout the forecast period is expected to be obtained by the inspection services. This is a key regulatory procedure for acquiring a product approved for the market and ensuring its safety. Inspection services are collaborating with prequalification applications (laboratory information files, product dossiers, and product streams) to guarantee and schedule inspections.

By Type

The market is categorized into pharmaceutical and medical devices. In the global market, the medical devices segment accounted for the largest revenue share in 2022 owing to rise in the production of medical device equipment that needs for TIC services, which will open up new market opportunities for TIC services. In addition, COVID-19 has increased the production of medical devices for disease treatment and prevention. For instance, Eurofins declared in April 2020 that its testing facility would assist and guarantee the safety of medical devices used in COVID-19. The pharmaceutical segment exhibits the fastest growth rate during the predicted period. Higher customer knowledge of pharmaceutical safety, increasing regulatory pressure, and high demand for affordable pharmaceuticals have all contributed to the high demand for TIC services.

Regional Markets

In 2022, Europe region accounted for the highest revenue in the healthcare testing, inspection, and certification market and is expected to maintain its dominance during the forecast period. This is attributed to majority of inspection, healthcare testing, and certification market participants. Additionally, market participants in this region are merging and acquiring more frequently, which is boosting market expansion. For instance, Eurofins BPT Italy announced in February 2022 an increase in its capacity for biologics testing. A total of 1000 m2 of BSL2 GMP laboratory space has been added to the area available for testing. Asia-Pacific area is predicted to grow at a profitable rate throughout the projection period due to the expanding economic development in countries including China, India, Japan, and South Korea. The region’s manufacturing activity has increased as a result, providing new opportunities for testing, inspection, and certification. For instance, Labcorp expanded its presence in the Asia-Pacific in November 2021 by opening a new comprehensive bioanalytical laboratory in Singapore.

Competitor Insights

Some of the key players operating in the healthcare testing, inspection, and certification market are Eurofins Scientific, Intertek Group plc, UL LLC, Nemko, Element Materials Technology, TÜV SÜD, DEKRA CERTIFICATION B.V., SGS SA, and CSA Group Testing & Certification Inc.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, SGS SA declared in January 2021 that it had acquired the lab facilities of Novartis’ International Service Laboratory (ISL), which is situated in Ringaskiddy (Cork), Ireland. The main objective is to increase its analytical testing and stability testing skills for pharmaceuticals.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including services and type from 2022 to 2033.

Report Scope:

Segmentation: Healthcare Testing, Inspection, And Certification Market Report 2022 – 2033

Services (Revenue, USD Million), 2022 – 2033

• Inspection
• Testing
• Certification

Type (Revenue, USD Million), 2022 – 2033

• Pharmaceutical
• Medical Devices

By Region (Revenue, USD Million), 2022 – 2033

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA