Press Release   -

Global Medical Device Testing Industry Accelerates as Manufacturers Prioritize Safety, Certification, and Global Market Access

The global Medical Device Testing Market is entering a phase of robust growth, reflecting the increasing complexity of medical devices, stringent regulatory frameworks and rising demand for safety and compliance solutions across healthcare systems. Testing and certification services including functional, biocompatibility, performance, reliability and cybersecurity testing are becoming essential for device manufacturers and healthcare OEMs alike as they address evolving risk-profiles, software-driven devices and cross-border regulatory harmonisation. With device manufacturers striving to bring products faster to market without compromising safety, the testing ecosystem is positioning itself as a strategic partner in healthcare innovation.

Key Takeaways

1. The Medical Device Testing Market is estimated at USD 9.76 billion in 2024.
2. Forecasts project the market will reach USD 27.50 billion by 2035, growing at a compound annual growth rate (CAGR) of ~9.95% between 2025 and 2035.
3. Growth is being driven by advanced device complexity (software, connectivity, IoT), stricter regulatory requirements (pre-market and post-market), and increasing outsourcing of testing services by device manufacturers.
4. The market remains moderately fragmented, with major players and specialist testing labs offering a range of services from biocompatibility to system-level cybersecurity testing.
5. Emerging regions, especially Asia Pacific, show strong growth potential, driven by increasing device manufacturing, regulatory upgrades and healthcare investment.

Key Market Trends & Insights

Major trends shaping the medical device testing market include: the shift toward software-driven, connected and IoT-enabled medical devices which require novel testing protocols such as cybersecurity and interoperability assessments; increased outsourcing of testing services by device manufacturers seeking cost-efficiency and regulatory expertise; rapid improvements in automation, artificial intelligence and predictive analytics for testing operations; and the expansion of testing requirements into emerging markets as manufacturing and regulatory landscapes evolve. Together, these trends are raising the bar for device safety, accelerating demand for advanced test and certification services.

Market Size & Forecast

The market value for 2024 stands at USD 9.76 billion. Looking ahead to 2035, the market is expected to grow to approximately USD 27.50 billion, achieving a CAGR of 9.95% from 2025 to 2035. This forecast reflects the growing complexity of medical devices, increasing regulatory oversight, expanding device portfolios and the rising need for comprehensive testing across lifecycle stages.

The medical device testing market is moderately concentrated with a mix of global testing service firms, specialist labs and regional providers. Key characteristics include high regulatory barriers (compliance with U.S. Food & Drug Administration, European Medicines Agency, national bodies), long-term contracts, technical expertise demand, and increasing specialization (e.g., biocompatibility, performance, software safety, cybersecurity). Many device manufacturers either maintain in-house testing or outsource to specialist providers. Outsourcing is gaining momentum thanks to cost advantages, specialised labs and multi-modal testing capabilities. Barriers to entry include accreditation requirements, investment in advanced test equipment and deep regulatory knowledge, which tend to favour established players.

Service Type Insights

The Medical Device Testing Market is segmented by service type into testing services, inspection services, and certification services. Testing services dominate due to the increasing complexity of medical devices requiring rigorous validation for safety, performance, and compliance with regulatory standards like ISO 13485 and FDA guidelines. Inspection and certification services are witnessing growth as companies seek third-party validation to enhance global market access and product credibility, particularly in Europe and North America where compliance standards are stringent.

Sourcing Type Insights

Based on sourcing type, the market is classified into in-house and outsourced services. Outsourced testing holds a major share, driven by the growing demand for specialized expertise and advanced laboratory infrastructure offered by third-party service providers. This approach enables cost efficiency and regulatory compliance while allowing manufacturers to focus on innovation. Meanwhile, in-house testing is gaining traction among large medical device manufacturers aiming for faster product development and quality control through integrated internal processes.

Device Class Insights

The market by device class includes Class I, Class II, and Class III devices. Class II devices account for the largest market share due to the rising demand for diagnostic and monitoring equipment, such as infusion pumps and imaging systems, which require intermediate safety validation. Class III devices, including implantable and life-supporting equipment, are anticipated to grow significantly due to stringent testing and certification requirements for patient safety, while Class I devices require basic testing and dominate the volume of regulatory submissions.

Technology Insights

By technology, the market is segmented into active implant medical device testing, active medical device testing, in-vitro diagnostic device testing, and others. In-vitro diagnostic (IVD) device testing leads the market, supported by rising demand for rapid diagnostics and molecular testing solutions, especially after the pandemic. Active implantable devices are projected to grow rapidly owing to technological advancements in neurostimulators and cardiac implants, which require intensive testing for biocompatibility and performance assurance in complex biological environments.

Regional Insights

North America Medical Device Testing Market Trends

In North America, the medical device testing market is large and mature, driven by advanced device manufacturing, well-established regulatory oversight (FDA, CMS), high healthcare investment and strong demand for quality assurance across the device lifecycle. The U.S. has numerous major OEMs and specialised testing labs, and the trend toward connected and AI-enabled devices has increased demand for software, cybersecurity and interoperability testing services. Outsourcing, hybrid testing models and multi-site testing facilities are prominent features of the North American market.

Europe Market Medical Device Testing Trends

Europe’s testing market is influenced by stringent regulatory frameworks such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which demand extensive testing, certification and post-market surveillance. Many countries host advanced testing laboratories and notified-bodies, making the region a hub for device compliance services. Growth is steady, supported by device innovation, cross-border manufacturing (Eastern Europe) and increased emphasis on harmonisation of standards. However, the presence of multiple national regulatory jurisdictions adds complexity for manufacturers and testers alike.

Asia Pacific Medical Device Testing Market Trends

Asia Pacific is forecast to be the fastest-growing region, driven by rising device manufacturing, regulatory modernisation, increased healthcare spending and expansion of domestic testing infrastructure. Countries such as China, India, Japan and South Korea are investing heavily in local device production and compliance labs. Regulatory bodies are tightening testing requirements and global manufacturers are outsourcing tests to local labs to reduce cost and lead times. Growth is also supported by increasing exports of devices and demand for testing services from both domestic and international OEMs.

Latin America Medical Device Testing Market Trends

In Latin America, growth is moderate and supported by emerging device manufacturing clusters, increased regulatory oversight and demand for outsourced testing services. Brazil, Mexico and Argentina are the leading markets. Device OEMs are increasingly working with regional testing labs, enabling faster market entry. Cost sensitivity and infrastructural gaps remain challenges, but strategic partnerships and regional expansion by global testing firms are improving access and capability in the region.

Middle East & Africa Medical Device Testing Market Trends

The Middle East & Africa market is at an earlier stage of adoption but is gaining traction. Countries like the UAE, Saudi Arabia and South Africa are making strategic investments in healthcare infrastructure and regulatory frameworks, which in turn boost demand for device testing services. However, limited local testing infrastructure, reliance on imports and lower device manufacturing volumes constrain market size. Global testing providers entering the region and providing outsourced services present growth opportunities.

Top Key Players Medical Device Testing Market:

1. Eurofins Scientific
2. Intertek Group plc
3. SGS Société Générale de Surveillance SA
4. TÜV SÜD
5. DEKRA
6. Labcorp
7. NAMSA
8. Element Material Technology
9. Charles River Laboratories
10. WuXi AppTec

These companies offer comprehensive testing, inspection and certification services across device classes, geographies and regulatory regimes.

Recent Developments

1. In 2025, testing-services specialist labs expanded outsourcing ties and advanced their service portfolios to include AI-enabled automated testing and cybersecurity validation for connected medical devices — reflecting the evolving demands of the device ecosystem.
2. In 2024, India’s government launched a major initiative with ₹500 crore funding to strengthen the medical device industry, covering testing infrastructure and local manufacturing support — enabling local testing labs to scale capacity and serve regional markets.

Market Scope

The report from Vantage Market Research covers the global medical device testing market from base year 2024 through to 2035, providing revenue estimates, CAGR forecasts, and detailed segmentation by service type (testing, inspection, certification), sourcing type (in-house vs outsourced), device class (Class I, II, III), technology/application categories (active implant, active device, non-active, IVD, etc.) and geographic regions (North America, Europe, Asia Pacific, Latin America, Middle East & Africa). The scope includes competitive landscape, regional trend analysis, drivers, restraints, opportunities and challenges, helping stakeholders map strategic priorities.

Market Dynamics

Driver:

A key driver is the escalating complexity and connectivity of medical devices — integrating software, IoT, AI and cloud-connectivity — which heightens the need for rigorous testing to ensure device safety, functionality, interoperability and cybersecurity. Additionally, heightened regulatory scrutiny globally and stricter pre-market and post-market compliance requirements drive manufacturers to increase investment in testing services.

Restraint:

A significant restraint is the high cost, time and expertise required for comprehensive testing – particularly for small and mid-sized device manufacturers. Regulatory variations across geographies add complexity. Further, limited local testing infrastructure in emerging regions and long qualification/validation lead times can slow market entry and adoption of testing services.

Opportunity:

There is opportunity in outsourcing testing services to specialist labs, particularly in emerging markets where device manufacturing is increasing. The growth of connected/AI-enabled devices opens new service areas (cybersecurity, software validation, interoperability). Testing service providers can leverage automation, AI and remote testing models to reduce cost and accelerate turnaround, creating new business models.

Challenges:

Challenges include maintaining test-lab accreditation and regulatory compliance across global jurisdictions, keeping pace with rapidly evolving device technologies (e.g., AI/ML, wearable, implantable devices), talent shortage in specialised test disciplines, data-security concerns and harmonising standards across regions. Test service providers must also deliver fast, cost-effective solutions without compromising quality – a balancing act in a competitive market.

Market Segmentation

1. By Service Type: Testing Services, Inspection Services, Certification Services
2. By Sourcing Type: In-house, Outsourced
3. By Device Class: Class I, Class II, Class III
4. By Technology/Application: Active Implantable Device, Active Medical Device, Non-Active Medical Device, In-Vitro Diagnostic Device, Ophthalmic Device, Orthopaedic & Dental Device, Vascular Device, Other Device Technologies
5. By Region: North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Frequently Asked Questions

1. What is the estimated value of the medical device testing market in 2024?

USD 9.76 billion.

1. What is the projected size by 2035 and the CAGR from 2025-2035?

Projected size of USD 27.50 billion, CAGR of 9.95%.

1. Which region is expected to grow the fastest?
2. Asia Pacific shows the fastest growth as device manufacturing, regulatory infrastructure and testing demand expand.
3. What are common service types in the market?

Testing services (dominant), inspection services and certification services.

1. Which companies are major players in the medical device testing space?

Eurofins Scientific, Intertek Group plc, SGS, TÜV SÜD, DEKRA among others.

1. What are the main challenges facing this market?

High cost/time of testing, regulatory complexity, talent shortage, rapid device-technology changes, data security concerns.