Medical device testing market to hit $12.75 billion by 2030

The medical device testing, inspection and certification market is projected to grow from $8.64 billion in 2025 to $9.35 billion in 2026, with North America leading today and Asia-Pacific set to grow fastest. The outlook reflects stricter regulation, rising healthcare spending and more demand for safer devices as manufacturers expand globally.

Why it matters: - Medical device testing, inspection and certification helps determine whether devices meet safety, performance and regulatory standards before they reach hospitals and patients. - The market is expanding as manufacturers face tighter oversight, more recalls and more pressure to prove product quality. - The sector matters for device makers, regulators and healthcare providers because testing failures can delay launches and raise patient-risk concerns.

What happened: - The Business Research Company said the global medical device testing, inspection and certification market is projected to grow from $8.64 billion in 2025 to $9.35 billion in 2026. - The report puts the market on track to reach $12.75 billion by 2030. - The forecast implies an 8.3% compound annual growth rate from 2025 to 2026 and an 8.1% CAGR through 2030. - The company released a free sample of the report and the full market report online: More information and the full report.

The details: - The market’s recent growth is tied to stricter regulatory oversight, more medical device recalls, rising demand for better device quality, globalized manufacturing and more outsourcing of testing services. - Future growth is expected to come from AI-powered testing, wider use of international standards, combination products, stronger device cybersecurity and real-time production monitoring. - The report flags automation of regulatory compliance, AI-based testing, improved quality assurance, global certification harmonization and integrated risk assessments as major trends. - Medical device testing includes functional tests, biocompatibility assessments, reliability checks and certification aligned with international regulations. - Rising healthcare spending is adding to demand for testing and certification services. - The UK Office for National Statistics reported a 5.6% nominal increase in total healthcare expenditure from 2022 to 2023 in May 2024, compared with 0.9% growth in 2022.

Between the lines: - The forecast suggests compliance is becoming more technology-driven as manufacturers look to automate parts of testing and certification. - North America’s lead in 2025 points to a mature regulatory market, while Asia-Pacific’s expected growth signals expanding manufacturing and testing activity. - The emphasis on cybersecurity shows that device review is moving beyond physical safety and into connected-device risk.

What's next: - The report expects Asia-Pacific to be the fastest-growing region during the forecast period. - The company says 2026 report updates now include market attractiveness scoring, TAM analysis, company scoring matrix graphics and tables, Excel-based forecasting dashboards and market hotspots infographics. - The report also includes key technology and future trend analysis, plus updated graphics and tables.

The bottom line: - Medical device testing and certification is moving from a back-end compliance step to a bigger growth market shaped by regulation, software and cybersecurity.