Industry Overview
The U.S. Medical Device Industry's Testing, Inspection, And Certification Market reached USD 5.6 billion in 2030, currently market is USD 3.2 Billion in 2023, at with a projected compound annual growth rate (CAGR) of 2.4% from 2025 to 2030.
Conformance evaluation services that confirm if products fulfil necessary standards are referred to as TIC (Testing, Inspection, Certification).
The complexity of regulations, technical advancements, and the strategic change toward outsourcing are driving the rapid growth of the U.S. TIC market for medical devices. Despite being relatively small (hundreds of millions), the niche outsourcing market is growing quickly, suggesting a growing need for specialist TIC providers to promote innovation and compliance. The need for rigorous testing to ensure safety and effectiveness, the increasing complexity of medical devices, and the rising need for cyber security in connected medical devices are the main factors driving the market.
Top TIC providers offer a wide range of services to help manufacturers navigate the complex compliance environment, particularly in light of regulations like the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). These services include clinical evaluations, chemical and physical testing, and regulatory consulting.
U.S. TIC Market for Medical Devices Industry Trends/ Growth Drivers:
The requirement for extensive testing and certification to ensure the quality, safety, and performance of medical devices and IVDs has increased significantly as a result of the MDR and IVDR, among other factors that have an impact on the TIC market for the medical devices sector. OEMs are outsourcing TIC services in order to expedite product releases due to market dynamics and competitive challenges. Strong TIC services are necessary to increase brand confidence and meet the high standards for product safety and efficacy maintained by American patients and healthcare practitioners. Because U.S. manufacturers sell internationally, they must prove compliance in multiple jurisdictions and deal with a variety of standards (ISO, CE, etc.), which increases the need for third-party TIC for standardized assessment.
The rapid development of new medical technology and related devices necessitates specialized testing to tackle increasing threats, particularly in cyber security. Since certifications testify to compliance with U.S. rules and standards, manufacturers must engage TIC services in order to access the U.S. market.
U.S. TIC Market for Medical Devices Industry Report Coverage
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Report Metric
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Details
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Historical Period
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2018 - 2023
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Base Year Considered
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2024
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Forecast Period
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2025 - 2030
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Market Size in 2024
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U.S.D. 3.2 Billion
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Revenue Forecast in 2030
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U.S.D. 5.6 Billion
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Growth Rate
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2.4%
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Segments Covered in the Report
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By Sourcing Type, By Service Type and By Industry Vertical
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Report Scope
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Market Trends, Drivers, and Restraints; Revenue Estimation and Forecast; Segmentation Analysis; Impact of COVID-19; Companies’ Strategic Developments; Market Share Analysis of Key Players; Company Profiling
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Regions Covered in the Report
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U.S
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U.S. TIC Market for Medical Devices Industry Challenges
Global discrepancies and regulatory fragmentation, as well as the high expense of testing and certification, impede market expansion. Furthermore, there is a developing skill shortage in the TIC industry, especially for positions that call for individuals with experience in regulatory science, biocompatibility and toxicity, software validation, and cyber-security testing.
U.S. TIC Market for Medical Devices Industry Opportunities
TIC prospects, such as electrical safety and EMC testing, wireless performance and interoperability, and data privacy and cyber-security validation, are made possible by the growth of wearables, home-use diagnostics, and remote patient monitoring in the U.S. medical device TIC industry. Long-term business can be ensured by forming strategic alliances with OEMs early in the development cycle.
Recent Developments by the Key Players
In order to promote global quality and skills transformation, TÜV Rheinland has reinforced its partnership with India. The goal of TÜV Rheinland India and Generation India Foundation's strategic partnership is to deliver high-quality skilling programs in mutually agreed-upon locations by putting the Generation Methodology a tried-and-true, outcome-based training approach into practice.
U.S. TIC Market for Medical Devices Industry Segmentation
VynZ Research provides an analysis of the key trends in each segment of U.S. TIC Market for Medical Devices Industry report, along with forecasts at the regional and country levels from 2025-2030. Our report has categorized the market based on sourcing type, service type, and industry vertical.
Insight by Sourcing Type
Based on the kind of sourcing—in-house and outsourced—the U.S. TIC market for the medical devices industry is split into two areas. The in-house category is predicted to outperform the other segment in the medical devices industry's TIC market over the projected time frame. If companies perform their own testing and inspection, they will have complete control over technology, skilled personnel, full-service labs, and testing and measurement tools. Furthermore, it helps the medical device manufacturers in the TIC market reduce internal compliance costs and quickly satisfy the demands of the worldwide market. The medical devices sector chose in-house services over outsourcing due to the criticality of applications.
Insight by Service Type
- Testing
- Inspection
- Certification
Based on the kind of service, the U.S. TIC market for medical devices is separated into three segments: certification, testing, and inspection. The testing sector dominates the market among these segments because of a number of product standards, stringent regulations, the need for greater safety and efficacy, expanding industrialization, the requirement to validate and verify medical equipment, and brand protection. The medical device industry should test surgical tools, syringes, medical needles, sterilization, implanted medical devices, biocompatibility, electromedical devices, and medical personal protective equipment (PPE).
Insight by Industry Vertical
- Implantable devices
- batteries and medical components
- home healthcare devices
- in-vitro diagnostics
- dental and ophthalmic devices
- diagnostic equipment
- hospital supplies
- cardiovascular and surgical devices
- patient monitoring devices
- orthopaedic devices
- diabetes care devices
- nephrology and urology devices
- ENT devices
- anesthesia and respiratory devices
- neurology devices
- wound care devices
- more
Implantable devices, batteries and medical components, home healthcare devices, in-vitro diagnostics, dental and ophthalmic devices, diagnostic equipment, hospital supplies, cardiovascular and surgical devices, patient monitoring devices, orthopaedic devices, diabetes care devices, nephrology and urology devices, ENT devices, anesthesia and respiratory devices, neurology devices, wound care devices, and more are all included in the medical devices industry's TIC market, which is segmented by industry vertical. Because quick testing kits and other diagnostic tools are becoming more and more necessary in various industries, the in-vitro diagnostic segment leads the medical device TIC market.
U.S. TIC Market for Medical Devices Industry: Geographic Overview
Due to the largest number of FDA-registered facilities and medical device companies in the nation, California leads the U.S. TIC Market for Medical Devices Industry. It also boasts a robust ecosystem of cyber-security companies, business incubators, regulatory consultants, and TIC labs.
U.S. TIC Market for Medical Devices Industry: Competitive Insights
U.S. TIC Market for Medical Devices Industry report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.
