Artificial Intelligence (AI) in Medical Diagnostics Market - Regional Analysis
North America Market Insights
North America is predicted to dominate the global artificial intelligence in medical diagnostics market by capturing 32.4% by the end of 2035. Its proprietorship is highly pledged to the growing population of cancer-afflicted patients and ongoing advancements in oncology. According to the Intuition Labs report in July 2025, nearly 18.7% of the hospitals in the U.S. have adopted AI to improve diagnosis. Further, well-established healthcare infrastructure, the presence of internationally recognized AI pioneers, constant regulatory support, and enhanced reimbursement coverage are accumulatively amplifying growth in the North America landscape.
The projections display the dominance of the U.S. over the regional artificial intelligence in medical diagnostics market by 2035, generating a considerable revenue. The NIH is actively interested in AI studies, with the National Cancer Institute investing more in AI oncology diagnostic-related research. According to the Breast Cancer report of July 2024, AI has minimized the false positives of breast cancer by 6% in the U.S. The key trend related to AI applications in medical imaging is transforming the radiology and pathology domains to address the limitations in the diagnostic bottlenecks and enhance accuracy.
Approvals for AI Enabled Medical Devices (2015-2023)
|
Year |
Number of FDA approvals for AI/ML-enabled medical devices |
Licensed for children (percentage relative to total FDA approvals %) |
|
2015 |
5 |
1 (20.0) |
|
2016 |
19 |
0 (0.0) |
|
2017 |
26 |
1 (3.8) |
|
2018 |
63 |
7 (11.1) |
|
2019 |
76 |
4 (5.3) |
|
2020 |
108 |
13 (12.0) |
|
2021 |
123 |
10 (8.1) |
|
2022 |
139 |
24 (17.3) |
|
2023 |
108 |
9 (8.3) |
Source: NLM, October 2024
APAC Market Insights
The Asia Pacific AI in medical diagnostics market is anticipated to exhibit the highest CAGR over the discussed tenure. Its pace of propagation is accelerated with rapid aging, digitalization, and modernization. Particularly, the proactive governments in emerging economies, such as China and India, are participating in this transformation, fueling adoption in this sector. For instance, in 2024, the Ministry of Health and Family Welfare, Government of India, has depicted that the total teleconsultations under eSanjeevani were 21.60 crore, enhancing the health services with the latest technology and accessible to every individual in the society. This is further attracting both domestic and foreign AI pioneers to invest.
China leads the AI in medical diagnostics market in the Asia Pacific region through regulatory backing and the growing medical device sector. According to the NLM report in September 2024, almost 59 AI medical devices were approved in China, shaping the medical device and diagnosis practice gradually. This growth highlights the growing innovation and proactive regulatory landscape, changing the diagnostic practices and speeding the adoption of AI-driven solutions. The approvals make China the leading region in the adoption of AI applications in healthcare.
Europe Market Insights
Europe is the second-largest region in artificial intelligence in medical diagnostics market, and is expected to hold a considerable share by 2035. The region is driven by the solid regulatory framework, government digital health portfolio expansion, and the urgent need to improve efficiency in healthcare. The September 2024 Frontiers report has clearly stated that almost 42% of hospitals in the EU have already adopted AI for disease diagnosis, indicating a desire to adopt new and innovative solutions. Supportive regulations from the EMA for software as a medical device (SaMD) are also streamlining market entry for innovative AI solutions.
UK is dominating artificial intelligence in medical diagnostics market in Europe and fueling the demand for AI diagnostics to overcome the challenges of the workforce shortages and backlogs. According to the the National AI Strategy report in September 2021, £250 million is allocated develop the NHS AI Lab at NHSX to surge the safe adoption of AI in health and care. Furthermore, the UK’s unique centralized health data from the NHS provides an unparalleled resource for training and validating diagnostic algorithms, attracting significant investment from global AI developers and securing its strong market position.
