Healthcare And Medical Devices TIC - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The healthcare and medical devices TIC market size is expected to increase from USD 7.35 billion in 2025 to USD 7.67 billion in 2026 and reach USD 9.47 billion by 2031, growing at a CAGR of 4.31% over 2026-2031. This report is Segmented by Service Type (Testing, Inspection, and Certification), Sourcing Type (In-House, and Outsourced), Mode of Service Delivery (On-Site, Off-site/Laboratory, and Remote/Digital), and Geography (North America, Europe, Asia-Pacific, Middle East, Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Healthcare And Medical Devices TIC Market Trends and Insights

Tightening Global Regulatory and Market-Access Requirements

Multiple regulatory systems are now moving through increasingly enforcement-heavy phases simultaneously, which is a major demand driver for the healthcare and medical devices TIC market. In the United States, the QMSR took effect on February 2, 2026, and aligned device quality expectations more closely with ISO 13485, which raised the importance of design controls, supplier oversight, and software documentation in routine compliance work. In Europe, Commission Implementing Regulation (EU) 2026/977 introduced uniform procedural and quality requirements for conformity assessment activities carried out by notified bodies, providing manufacturers with a more formal, more demanding review environment to navigate. Technical documentation expectations also remain extensive under the EU MDR, and Team-NB’s 2026 best-practice guidance shows the extent of the structured evidence manufacturers must assemble to support conformity review. This raises the value of providers that can guide manufacturers through multiple rulebooks rather than running single test programs. As a result, the healthcare and medical devices TIC market is moving toward longer client relationships built around recurring compliance oversight rather than isolated certification events.

Rising Device Complexity and Combination Product Testing Needs

The healthcare and medical devices TIC market is also gaining support from the rising complexity of devices, especially drug-device combinations and software-rich platforms. In June 2025, the FDA published draft guidance on unique device identifier requirements for combination products, adding another documentation layer to products already subject to a complex multi-center review pathway. Under EU MDR Article 117, integral drug-device combinations require a notified body's opinion on the device constituent, creating a new certification step that did not exist under the older framework. A connected drug delivery product can now require electrical safety, software validation, usability, biocompatibility, and drug-related manufacturing reviews within the same development cycle, which often spreads work across several specialist providers. The FDA also clarified current good manufacturing practice expectations for combination products under 21 CFR Part 4, which widened the quality system documentation perimeter that auditors and test partners must assess. That expands the revenue-per-device program and strengthens the role of specialist testing and certification support in the healthcare and medical devices TIC market.

High Cost of Multijurisdictional Compliance Programs

The cost of running parallel compliance programs across the United States, the European Union, the United Kingdom, China, Japan, and Brazil remains a real constraint on the healthcare and medical devices TIC market. The European Commission’s 19th Notified Body Survey showed that many product-level MDR assessments were taking 13 to 18 months, which means compliance budgets are now tied up for longer periods before revenue can be realized. Manufacturers that adopt MDSAP can simplify some audit pathways, but the initial cycle still requires multiple qualified audit days across registered sites, which remains expensive for companies with limited scale. Smaller firms, academic spinouts, and single-site manufacturers often carry the weakest compliance budgets even when their product pipelines are technically strong. That mismatch reduces the number of programs that move into full certification readiness at any one time. It also means the healthcare and medical devices TIC market can lose near-term volume from sub-scale innovators, even while larger manufacturers continue to spend.

Other drivers and restraints analyzed in the detailed report include:

• Growing Outsourcing by Small and Mid-Sized Medtech Firms
• Increasing Recalls Driving Preventive Testing Spend
• Notified Body and Specialist Lab Capacity Bottlenecks

Segment Analysis

Testing held 53.11% of the healthcare and medical devices testing, inspection, and certification (TIC) market in 2025, reflecting the fact that every new product or market entry usually begins with a mandatory testing package. The healthcare and medical devices TIC market still relies heavily on testing because electrical safety, biocompatibility, electromagnetic compatibility, sterility validation, and software verification are separate workstreams rather than a single bundled task. A single device can require 6 to 10 parallel or sequential protocols across accredited laboratories before the regulatory dossier is ready, front-loading revenue into testing even before certification is completed. Inspection services sat between testing and certification in terms of revenue, supported by supplier audits, factory acceptance tests, goods-in-process checks, and post-market review activities. This part of the healthcare and medical devices TIC industry has also benefited from EU MDR expectations for continuous post-market data collection, which supports recurring inspections after the initial launch phase.

Certification is the fastest-growing service segment and is projected to expand at a 5.05% CAGR from 2026 to 2031, indicating that the revenue mix is moving toward approval and system-level assurance. The healthcare and medical devices TIC market is seeing this shift because legacy devices still need transition work under the EU MDR, while North American quality systems are also aligning more closely with ISO 13485. Providers with notified body status are in the strongest position because certification demand is compressed into tight windows for higher-risk classes, and manufacturers cannot move forward without those approvals. ISO 13485 requirements are also expanding certification beyond finished device manufacturers to contract manufacturers, component suppliers, and software developers, who now need recognized quality credentials to remain in approved supply chains. The MDSAP model adds another layer of pull toward firms that can support multiple jurisdictions through a single structured audit cycle, giving scale players an edge in the healthcare and medical devices TIC industry.

Complete Report Scope:

• By Service Type
  • Testing
  • Inspection
  • Certification
• By Sourcing Type
  • In-house
  • Outsourced
• By Mode of Service Delivery
  • On-site
  • Off-site / Laboratory
  • Remote / Digital
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Rest of Asia-Pacific
  • Middle East
    • Saudi Arabia
    • United Arab Emirates
    • Turkey
    • Rest of Middle East
  • Africa
    • South Africa
    • Egypt
    • Rest of Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

Asia-Pacific held 44.73% of the healthcare and medical devices TIC market share in 2025 and is also the fastest-growing regional market at a 4.87% CAGR through 2031. China remains the largest national market in the region because of its broad manufacturing base and the pull of local registration requirements that favor established testing and certification capacity. The healthcare and medical devices TIC market in Asia-Pacific is also benefiting from a broader manufacturing map, with strong investment across India, Vietnam, South Korea, and Thailand. Each new facility increases demand for qualification, validation, submission testing, and export compliance before output can scale to commercial levels. In April 2026, CJ Medtech broke ground on a new orthopedic device factory in South Korea, which reflects the kind of plant expansion that directly feeds regional demand for inspection and certification services.

North America holds the second-largest regional position and continues to generate some of the highest-value assignments in the healthcare and medical devices TIC market. The United States remains the core of that demand because it combines a large research and development base, a deep commercial pipeline, and strict regulatory expectations across software, cybersecurity, and quality systems. The FDA’s 2026 guidance cycle widened the documentation burden for connected devices and products that rely on real-world data after launch, thereby increasing testing and review workloads for service providers. Canada continues to channel manufacturers toward MDSAP-recognized audit routes, and Mexico supports testing demand through its role in regional supply chains tied to the United States. North America also retains the deepest pool of specialist laboratories for biocompatibility, cybersecurity, and combination product assessment, though some of that capability is now being mirrored in Asia-Pacific as manufacturing shifts closer to end markets.

Europe holds a notable share of the healthcare and medical devices TIC market and remains central, as the MDR and IVDR transition continues to reshape compliance needs across the region. The European Commission’s 19th Notified Body Survey confirmed 33,175 MDR applications and 17,549 issued certificates through December 2025, which shows why backlog-driven support demand remains elevated. Germany and the United Kingdom remain the largest individual markets in Europe, and manufacturers serving both the EU and UK still face extra work because the approval paths are no longer identical. Providers such as SGS have used their notified body and UK Approved Body positions to meet that dual requirement, thereby supporting recurring regional revenue from certification, surveillance, and system audits. Middle East and Africa, along with South America, remain smaller in current value, but hospital investment, rising local production ambitions, and growing regulatory formalization are giving the healthcare and medical devices TIC market a broader long-term geographic base.

List of Companies Covered in this Report:

• SGS SA
• Intertek Group plc
• TÜV SÜD AG
• Eurofins Scientific SE
• Bureau Veritas SA
• DEKRA SE
• UL Solutions Inc.
• BSI Group The Netherlands B.V.
• TÜV Rheinland AG
• DNV Product Assurance AS
• Kiwa N.V.
• Applus Services, S.A.
• CSA Group Testing & Certification Inc.
• NSF International
• Element Materials Technology Group Limited
• Nemko AS
• North American Science Associates, LLC
• Nelson Laboratories, LLC

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support