Healthcare Testing, Inspection, and Certification (TIC) - Market Insights, Competitive Landscape, and Market Forecast - 2032

Healthcare Testing, Inspection, and Certification (TIC) Market by Service Type (Testing, Inspection, and Certification), Sourcing Type (In-house and Out-sourced), End-User (Pharma and Biotechnology Companies and Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising number of product recalls due to stringent regulatory requirements and increasing R&D activities among pharma and MedTech companies.

The healthcare testing, inspection, and certification market is estimated to grow at a CAGR of 8.63% during the forecast period from 2025 to 2032. The healthcare testing, inspection, and certification (TIC) market is set to experience substantial growth, driven by several key trends. A significant rise in product recalls and stringent regulatory requirements for product approval has heightened the demand for TIC services to ensure safety and compliance. Simultaneously, the growing adoption of digital health solutions and medical devices continues to expand the scope of TIC applications. Moreover, increased R&D efforts and investments by pharmaceutical and MedTech companies in the development of innovative drugs and medical technologies are further accelerating the need for stringent testing, inspection, and certification processes to meet regulatory approval standards. Collectively, these factors are expected to propel the robust growth of the healthcare TIC market throughout the forecast period from 2025 to 2032.

Healthcare Testing, Inspection, and Certification Market Dynamics:

According to the State of Pharmaceutical Quality Report (2023), a total of 912 recalls were reported across 166 sites in fiscal year 2022 by the FDA, the highest in five years. The primary causes of these recalls were consistent issues with current Good Manufacturing Practices (CGMP), storage temperature deviations, and excipient contaminations. This surge in recalls highlights the increasing need for rigorous Testing, Inspection, and Certification (TIC) services to ensure product safety and compliance, thereby driving the market growth.

Simultaneously, the global landscape of medical devices is expanding rapidly. As per the World Health Organization (2022), over two million types of medical devices were categorized into more than 7,000 generic device groups. This growth is driven by the increasing use of devices for diagnosis, treatment, and disease prevention. TIC services are critical in identifying and rectifying functional and compliance issues in these devices, ensuring adherence to regulatory standards and contributing to market expansion.

Digital health technologies are also reshaping the healthcare landscape. According to the U.S. Department of Health and Human Services (2022), about 22% of adults in the U.S. reported using telehealth services in 2022. In Europe, WHO (2024) reported that over 84% of people had adopted telehealth solutions. The proliferation of digital tools such as wearable devices, remote monitoring systems, and electronic health records (EHRs) has intensified the need for TIC services to validate safety, performance, and cybersecurity standards.

Stringent regulatory requirements further accelerate the demand for TIC. For instance, under the new Japanese regulation (PMDA, 2024; PSB/PSD 0115 No. 2), vulnerabilities in medical devices must be identified, evaluated, disclosed, and corrected to ensure cybersecurity and regulatory compliance. As regulatory frameworks evolve to address complex technological and safety concerns, the role of TIC services becomes even more vital.

Moreover, robust R&D investment is driving the need for advanced quality testing and certification. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA, 2023), R&D investment in drugs and medical devices reached USD 48.26 billion (EUR 44.5 billion) in 2022, reflecting a consistent upward trend. This surge in innovation necessitates comprehensive TIC processes to support product development and regulatory approval.

In response to this growing demand, major industry players are expanding their TIC capabilities. For example, in June 2024, Stryker announced the expansion of its operations in India by launching a new facility under its Stryker Global Technology Centre (SGTC). This expansion is aimed at strengthening product development lifecycle testing and enhancing compliance with global regulatory standards.

However, the high cost of TIC services and stringent regulatory standards and guidelines, among others, are some of the key constraints that may limit the growth of the healthcare testing, inspection, and certification market.

Healthcare Testing, Inspection, and Certification Market Segment Analysis:

Healthcare Testing, Inspection, and Certification (TIC) Market by Service Type (Testing, Inspection, and Certification), Sourcing Type (In-house and Out-sourced), End-User (Pharma and Biotechnology Companies and Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the service type segment of the healthcare testing, inspection, and certification market, the testing category is estimated to account for the largest market share in 2024. The growth of this category is primarily driven by the increasing number of product recalls and the critical role of testing services in meeting stringent regulatory requirements for both pharmaceuticals and medical devices.

Testing offers numerous advantages, including enhanced patient safety, regulatory compliance, data protection, and cost optimization. For medical device manufacturers, maintaining high standards of quality, transparency, and assurance is crucial to ensuring product reliability and market success. Testing plays an essential role in complying with global regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and World Health Organization (WHO). It ensures adherence to GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice) guidelines to significantly reduce the risk of regulatory penalties or product recalls.

By identifying defects, impurities, or deviations early in the development or production lifecycle, testing helps maintain consistent product quality across batches. This consistency is crucial for maintaining brand trust and industry reputation. In response to growing industry needs, leading TIC providers are expanding their capabilities and facilities. For example, in December 2023, TÜV SÜD, a Germany-based leader in certification and testing services, inaugurated a state-of-the-art laboratory in Bangalore. This facility offers a wide range of testing services for active and non-active medical devices, in vitro diagnostic devices, and other electrical components. Key services include biocompatibility testing, toxicity assessments, and microbiological evaluations, ensuring compliance and patient safety.

In the pharmaceutical sector, testing is vital across all stages of research, development, and manufacturing. It plays a critical role in optimizing formulations for stability, bioavailability, and therapeutic efficacy. This involves precise measurement of active pharmaceutical ingredients (APIs), excipients, and impurities, and meticulous quality control throughout the manufacturing process. In March 2024, Element Materials Technology, a UK-based TIC provider, launched a Rapid Response Pharmaceutical Testing Service from its Manchester Life Sciences laboratory. This initiative aims to deliver fast, comprehensive testing solutions to meet the increasing demand for accelerated product approvals, while ensuring regulatory compliance and product safety.

Overall, testing services support compliance with regulatory guidelines, facilitate compatibility assessments between drugs and excipients, and ensure the safe interaction of medical components. Given their broad applicability across both pharmaceuticals and medical devices, testing services are expected to continue driving significant growth within the healthcare TIC market during the forecast period.

North America is expected to dominate the overall healthcare testing, inspection, and certification market:
North America is expected to hold the largest share of the healthcare testing, inspection, and certification (TIC) market in 2024. This growth is primarily attributed to the increasing number of product recalls driven by stringent regulatory standards enforced by the U.S. Food and Drug Administration (FDA). The region is also home to several major pharmaceutical and medical device companies, whose ongoing innovations and product development activities necessitate comprehensive TIC services. Additionally, the widespread adoption of digital health solutions, coupled with a well-established and advanced healthcare infrastructure, further supports the expansion of the TIC market in North America.

According to data from the U.S. Food and Drug Administration (2025), a total of 103 medical device recalls were reported in 2024, an increase from 63 in 2023, marking a significant year-over-year increase. This rise in recalls is fueling the demand for Healthcare Testing, Inspection, and Certification (TIC) services, as manufacturers aim to ensure regulatory compliance, detect defects early, and mitigate risks of penalties and reputational damage. The growing incidence of product recalls is, therefore, a key driver of TIC market growth in North America.

In addition, the increasing adoption of digital health technologies is further propelling the market. As reported by the American Hospital Association (2025), over 12.6% of Medicare beneficiaries received telehealth services in 2023. The widespread use of digital health tools necessitates robust TIC processes to validate safety, performance, and regulatory adherence, thereby contributing to market expansion in the region.

Furthermore, strategic initiatives by key industry players are strengthening the healthcare TIC landscape. For example, in March 2025, NAMSA completed the acquisition of WuXi AppTec’s U.S. medical device testing business. This merger brings together two of the most trusted names in medical device biological safety testing, collectively serving over 4,000 manufacturers worldwide. Such strategic developments are expected to further accelerate the growth of the healthcare TIC market in North America.

Collectively, the rising number of product recalls and strategic initiatives is propelling the demand for healthcare testing, inspection, and certification in North America, reinforcing its position as a leading region in the global market.

Healthcare Testing, Inspection, and Certification Market Key Players:

Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) market include SGS Société Générale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TÜV SÜD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.

Recent Developmental Activities in the Healthcare Testing, Inspection, and Certification Market:

• In September 2024, the Eurofins network expanded its BioPharma Product Testing services in the United States through the acquisition of Infinity Laboratories, Inc. Infinity brings a strong microbiology testing presence, supported by best-in-class systems and a network of local service facilities across key U.S. regions. In addition to microbiology, the company offers a comprehensive range of services, including chemistry, sterilization, and package testing, serving clients in the pharmaceutical, biotechnology, and medical device sectors.
• In April 2024, Smithers, a US-based provider of testing, consulting, information, and compliance services, announced the launch of its Generic Pharmacokinetic (PK) Assay. This assay highlights the increasing demand for flexible PK testing solutions in preclinical bioanalysis and helps to streamline the development of PK immunoassays tailored to specific test articles, thus expediting the drug development timeline.
• In June 2023, Applus+, a Spain-based testing, inspection, and certification (TIC) company, announced that it had completed the acquisition of Rescoll for an undisclosed amount. With this acquisition, Applus+ strengthened its position in medical device testing and services with biocompatibility and mechanical tests on implants and biomaterials.

Key takeaways from the healthcare testing, inspection, and certification market report study

• Market size analysis for the current healthcare testing, inspection, and certification market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the healthcare testing, inspection, and certification market.
• Various opportunities available for the other competitors in the healthcare testing, inspection, and certification market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current healthcare testing, inspection, and certification market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for healthcare testing, inspection, and certification market growth in the coming future?

Target audience who can benefit from this healthcare testing, inspection, and certification market report study

• Healthcare testing, inspection, and certification product providers
• Research organizations and consulting companies
• Healthcare testing, inspection, and certification-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in healthcare testing, inspection, and certification
• Various end-users who want to know more about the healthcare testing, inspection, and certification market, and the latest technological developments in the healthcare testing, inspection, and certification market.

Frequently Asked Questions for the Healthcare Testing, Inspection, and Certification Market:

1. What are healthcare testing, inspection, and certification?

• The healthcare testing, inspection, and certification (TIC) is a service provided to pharmaceutical and medical device companies to meet established safety, efficacy, and regulatory standards. It encompasses comprehensive evaluations, including chemical, physical, biological, and microbiological analyses, to assess product quality and performance. Inspection focuses on verifying compliance throughout the manufacturing process, while certification confirms adherence to national and international regulatory requirements.

2. What is the market for healthcare testing, inspection, and certification?

• The healthcare testing, inspection, and certification market is estimated to grow at a CAGR of 8.63% during the forecast period from 2025 to 2032.

3. What are the drivers for the healthcare testing, inspection, and certification market?

• The demand for healthcare Testing, Inspection, and Certification (TIC) is driven by several key factors. The rising number of product recalls and increasingly stringent regulatory standards are intensifying the demand for TIC services. Additionally, the rapid adoption of digital health technologies and growing R&D activities and substantial investments by pharmaceutical and MedTech companies in the development of novel drugs and devices further underscore the need for rigorous TIC processes to ensure product safety, efficacy, and regulatory compliance. Together, these factors are expected to drive robust growth in the healthcare TIC market from 2025 to 2032.

4. Who are the key players operating in the healthcare testing, inspection, and certification market?

• Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) market include SGS Société Générale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TÜV SÜD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.

5. Which region has the highest share in the healthcare testing, inspection, and certification market?

• North America is expected to hold the largest share of the healthcare Testing, Inspection, and Certification (TIC) market in 2024. This growth is primarily attributed to the increasing number of product recalls driven by stringent regulatory standards. The region is also home to several major pharmaceutical and medical device companies, whose ongoing innovations and product development activities necessitate comprehensive TIC services. Additionally, the widespread adoption of digital health solutions, coupled with a well-established and advanced healthcare infrastructure, further supports the expansion of the TIC market in North America.

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