Healthcare & Medical Devices TIC Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 7.35 Billion |
| Market Size (2030) | USD 8.87 Billion |
| Growth Rate (2025 - 2030) | 3.83% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | Asia Pacific |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
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Healthcare & Medical Devices TIC Market Analysis by Mordor Intelligence
The healthcare and medical device testing, inspection, and certification market is currently valued at USD 7.35 billion in 2025 and is projected to reach USD 8.87 billion by 2030, reflecting a 3.83% CAGR during the forecast period. Mandatory global compliance frameworks, rising device complexity, and accelerating regulatory harmonization anchor steady demand even as healthcare budgets tighten. Asia-Pacific’s manufacturing concentration and swift regulatory evolution underpin regional dominance, while cybersecurity-led recalls and AI-enabled diagnostics expand validation scope. Established TIC providers leverage multi-jurisdictional accreditations and laboratory automation to retain pricing power against fragmented regional specialists. Heightened talent shortages, especially for biomedical auditors, and escalating biocompatibility model costs temper growth prospects, but sizable consolidation and niche specialization opportunities persist.
Key Report Takeaways
- By service type, Testing Services led with 53.6% of the healthcare and medical device testing, inspection, and certification market share in 2024, whereas Certification Services is advancing at a 4.2% CAGR through 2030.
- By sourcing type, Outsourced models accounted for 69.3% of the healthcare and medical device testing, inspection, and certification market size in 2024 and are set to expand at a 3.9% CAGR between 2025-2030.
- By geography, Asia-Pacific captured 44.7% revenue share of the healthcare and medical device testing, inspection, and certification market in 2024; the region is forecast to post the fastest 4.5% CAGR to 2030.
Global Healthcare & Medical Devices TIC Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Surge in device complexity and miniaturization | +0.8% | Global, with a concentration in North America and Asia-Pacific | Medium term (2-4 years) |
| Expanding global regulatory harmonization (MDSAP, IVDR) | +0.7% | Global, led by North America, the EU, and the Asia-Pacific, adoption | Long term (≥ 4 years) |
| Growth of home-health and wearable diagnostics | +0.6% | North America and the EU are primary, Asia-Pacific is emerging | Short term (≤ 2 years) |
| Increasing recalls is driving preventive testing spend | +0.5% | Global, with the highest impact in North America | Medium term (2-4 years) |
| AI-enabled rapid test protocols | +0.4% | North America and the EU are early adoption, and Asia-Pacific is following. | Long term (≥ 4 years) |
| Circular-economy refurbishment testing demand | +0.3% | EU leading, North America selective adoption | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Surge in Device Complexity and Miniaturization
Wearables now combine sensing, connectivity, and AI engines that demand simultaneous evaluation of sensor accuracy, electromagnetics, software reliability, and skin safety across diverse real-world conditions. Modern validation cycles must also verify continuous algorithm learning, leading manufacturers to form recurring test partnerships instead of episodic projects.[1]FDA, “FDA Clears First AI-Enabled Medical Device for Home Sleep Apnea Testing,” FDA.GOV Talent-intensive protocols elevate project costs yet anchor predictable revenue for TIC providers that maintain multidisciplinary benches and advanced simulation tools.
Expanding Global Regulatory Harmonization (MDSAP, IVDR)
The MDSAP framework enables one audit to satisfy five regulatory agencies, trimming manufacturer compliance outlays by roughly 30-40% yet heightening demand for TIC firms with simultaneous U.S., Canadian, Australian, Japanese, and Brazilian recognition.[2]Health Canada, “Medical Device Single Audit Program,” CANADA.CA IVDR adoption in Europe mirrors this trend, widening device categories subject to rigorous diagnostic performance tests and thereby concentrating business with globally accredited providers.
Growth of Home-Health and Wearable Diagnostics
FDA cleared more than 50 digital health devices for domestic use in 2024, including smartphone-linked sleep apnea and glucose monitors that require cybersecurity, usability, and multi-environment robustness evaluations beyond classic bench tests. Decentralized care economics encourage payers to reimburse remote monitoring, expanding revenue for TIC firms possessing in-home simulation labs and IoT penetration testing skill sets.
Increasing Recalls Driving Preventive Testing Spend
A 400% jump in device recalls from 2013-2018, driven largely by software and network vulnerabilities, pushed manufacturers to boost test budgets to 15-25% of development spend versus the historical 8-12%. Preventive validation now offsets recall costs, averaging USD 10-50 million, anchoring more robust, early-stage engagements for TIC specialists.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Shortage of qualified biomedical TIC auditors | -0.4% | Global, most acute in North America and the EU | Short term (≤ 2 years) |
| Shrinking VC funding in med-tech start-ups | -0.3% | Global, with the highest impact in North America | Medium term (2-4 years) |
| Data-integrity cyber-risks in connected devices | -0.2% | Global, concentrated in digitally advanced markets | Long term (≥ 4 years) |
| Rising costs for biocompatibility animal models | -0.2% | Global, with the EU leading alternatives adoption | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Shortage of Qualified Biomedical TIC Auditors
Recruiting specialized auditors requires 5-7 years of cross-disciplinary training; retirements outpace new talent by roughly two-to-one, producing a 25-30% staffing gap and fueling 15-20% annual wage inflation.[3]Bureau of Labor Statistics, “Medical Scientists,” BLS.GOV Providers are automating data capture and remote assessments to mitigate bottlenecks, but still cannot capitalize on near-term capacity expansion.
Shrinking VC Funding in Med-Tech Start-ups
Global med-tech investment slipped to USD 19.1 billion in 2024 from a 2021 peak of USD 22.1 billion, reducing early-stage device pipelines and delaying TIC contracts until later milestones. Cash-constrained startups now compress validation scopes, shifting revenue timing for TIC vendors.
Segment Analysis
By Service Type: Testing Services Retain Primacy While Certifications Accelerate
Testing Services generated the largest share of the healthcare and medical device testing, inspection, and certification market at 53.6% in 2024, propelled by ISO 10993 material evaluations and mandatory electromagnetic compatibility checks. The segment’s breadth spans biocompatibility, electrical safety, and cybersecurity protocols, each scaling with device connectivity and AI adoption. Although growth moderates as some tests consolidate under harmonized frameworks, rising design complexity sustains volume and margin resilience.
Certification Services, while representing a smaller portion of the healthcare and medical device testing, inspection, and certification market size, posted the fastest 4.2% CAGR. Manufacturers increasingly invest in single-source certifications that satisfy MDSAP and IVDR simultaneously, trading upfront fees for speedier global launches. Inspection Services, at roughly one-quarter of revenue, benefit from supply-chain transparency mandates but expand more slowly as remote audits gain traction.
Second-order effects reinforce segment interplay: advanced certifications often bundle prerequisite tests, and successful audits feed recurring surveillance inspections. TIC providers that integrate all three offerings across cloud platforms monetize end-to-end compliance life cycles, attracting both multinationals and resource-strapped innovators.
Note: Segment shares of all individual segments available upon report purchase
By Sourcing Type: Outsourcing Continues to Outpace In-House Models
Outsourcing commanded 69.3% of the healthcare and medical device testing, inspection, and certification market share in 2024 and is tracking a 3.9% CAGR through 2030. Escalating capital outlays for specialized chambers, clean-rooms, and cybersecurity labs—often USD 10-50 million per facility—make external partnerships economical for startups and even large OEMs seeking surge capacity.
In-house capabilities, while strategic for core product lines, face talent constraints and rapid obsolescence as standards evolve. Some multinationals now operate hybrid models in which critical software or proprietary materials testing remains on-premises, while third-party labs handle wireless coexistence, AI bias, and international niche certifications. The dynamic encourages TIC vendors to co-locate near major manufacturing clusters, offering shared infrastructure and real-time data portals that dovetail with OEM design cycles.
Geography Analysis
Asia-Pacific captured 44.7% of global revenue in 2024 and is projected to record a 4.5% CAGR through 2030, making the region the growth engine of the medical device testing, inspection, and certification market. China’s National Medical Products Administration (NMPA) reforms synchronize domestic rules with ISO and IEC standards while mandating local test reports, cementing demand for internationally accredited labs.[4]National Medical Products Administration, “Regulatory Updates,” NMPA.GOV.CN Japan and South Korea add premium cybersecurity and AI validation needs, whereas Southeast Asia gains traction for cost-efficient routine assays under ASEAN harmonization.
North America held 28% market share in 2024 and is forecast to expand moderately at a 3.2% CAGR. The United States leads with high-margin projects in connected-device risk assessments as the FDA scrutinizes software bill-of-materials disclosures. Canada’s MDSAP participation sustains cross-border audit synergies, while Mexico’s lower-cost labs attract commodity test segments for regional supply chains.
Europe accounted for 22% of 2024 revenue as MDR and IVDR transformed legacy self-certifications into formal TIC engagements. Germany and the United Kingdom dominate volume, with dual EU-UK certifications opening incremental opportunities post-Brexit. Circular-economy regulations catalyze refurbishment and lifecycle testing niches, and GDPR drives added scrutiny on patient data integrity.
Competitive Landscape
Global leadership remains dispersed, placing the medical device testing, inspection, and certification industry in a moderately concentrated tier. SGS, Intertek, TÜV SÜD, and Bureau Veritas leverage 1,000+ governmental recognitions and extensive lab grids to differentiate against regional specialists. Recent SGS Shanghai clearance with zero FDA Form 483 observations exemplifies the credential depth that commands pricing premiums.
Digital transformation underpins competitive moats. Siemens Healthineers’ FlexLab X automation and Merck’s robotics suites illustrate the pivot toward AI-driven throughput, mitigating auditor shortages and elevating data fidelity. Cybersecurity, algorithm-bias audits, and refurbished-device validation constitute lucrative white spaces where smaller experts can scale rapidly or become acquisition targets, as shown by Mérieux NutriSciences’ USD 405 million purchase of Bureau Veritas’s food testing business to double Asia-Pacific presence.
M&A momentum is expected to continue, buoyed by private equity interest and synergistic cross-sector plays that blend environmental, pharma, and med-tech portfolios for end-user convenience. Pricing remains resilient given accreditation scarcity and high switching costs, yet wage inflation and regulatory technology investments compress margins for firms lacking scale or automation roadmaps.
Healthcare & Medical Devices TIC Industry Leaders
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SGS SA
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Bureau Veritas SA
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Intertek Group plc
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TÜV SÜD AG
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TÜV Rheinland AG
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- March 2025: Merck launched laboratory automation and robotics solutions for pharmaceutical quality control, partnering with engineering firms to deliver integrated microbiological testing systems.
- February 2025: GN Store Nord reported DKK 1.9 billion R&D expenditure, emphasizing centralized quality and product security frameworks for AI-enabled hearing devices (USD 0.29 billion).
- January 2025: Eurofins Scientific acquired SF Analytical Laboratories, expanding U.S. environmental and food testing reach.
- October 2024: Mérieux NutriSciences agreed to acquire Bureau Veritas’s food testing division for EUR 360 million (USD 405 million).
Global Healthcare & Medical Devices TIC Market Report Scope
| Testing Services |
| Inspection Services |
| Certification Services |
| In-house |
| Outsourced |
| North America | United States | |
| Canada | ||
| Mexico | ||
| South America | Brazil | |
| Argentina | ||
| Rest of South America | ||
| Europe | Germany | |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Russia | ||
| Rest of Europe | ||
| Asia-Pacific | China | |
| Japan | ||
| India | ||
| South Korea | ||
| South-East Asia | ||
| Rest of Asia-Pacific | ||
| Middle East and Africa | Middle East | Saudi Arabia |
| United Arab Emirates | ||
| Turkey | ||
| Rest of Middle East | ||
| Africa | South Africa | |
| Nigeria | ||
| Rest of Africa | ||
| By Service Type | Testing Services | ||
| Inspection Services | |||
| Certification Services | |||
| By Sourcing Type | In-house | ||
| Outsourced | |||
| By Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Russia | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| South Korea | |||
| South-East Asia | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | Middle East | Saudi Arabia | |
| United Arab Emirates | |||
| Turkey | |||
| Rest of Middle East | |||
| Africa | South Africa | ||
| Nigeria | |||
| Rest of Africa | |||
Key Questions Answered in the Report
How large is the global healthcare and medical device testing, inspection, and certification market today?
The market stands at USD 7.35 billion in 2025 and is projected to reach USD 8.87 billion by 2030.
Which region contributes the most revenue to medical device compliance services?
Asia-Pacific leads with 44.7% of global revenue, driven by manufacturing scale and regulatory maturity.
Why are certification services growing faster than testing services?
Harmonized frameworks such as MDSAP and IVDR allow one certificate to unlock multiple markets, making third-party certification more valuable.
What is the main challenge limiting short-term capacity growth for TIC providers?
A 25-30% shortage of qualified biomedical auditors is constraining service expansion despite rising demand.
How does outsourcing compare with in-house testing?
Outsourcing controls 69.3% of total spending because specialized labs reduce capital outlays and accelerate multi-country approvals.
Which emerging niches offer the greatest upside for TIC companies?
High-margin areas include cybersecurity validation for connected devices, AI algorithm bias audits, and circular-economy refurbishment testing.
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