Automated Cell Block System Market - Regional Analysis
North America Market Insights
North America is the dominating region in the market and is projected to hold the market share of 40.5% by the end of 2035. The region's high cancer prevalence, well-established healthcare system, and federal funding are the main drivers fueling the market. In 2025, nearly 148 AI-enabled medical devices have received FDA approval, highlighting the region's leadership in integrating advanced diagnostic technologies into healthcare to improve accessibility, accuracy, and efficiency for both patients and providers.
The U.S. augmentation in the automated cell block system market is significantly attributed to the recent expansion of reimbursement territories. The NIH awarded large grants to advance cancer diagnostic technologies. According to the July 2024 Breast Cancer report, AI has decreased false positives for breast cancer in the United States by 6%. A key trend is the strategic shift towards value-based care, incentivized by CMS reimbursement policies that favor highly accurate and efficient diagnostic methods like automated cell blocks.
The market in Canada is driven by the federal and provincial investment and a focus on cancer care. The primary trend of the market is the push for centralized, automated pathology services within the public healthcare systems. Mainly in Ontario and British Columbia. As per the Canadian Medical Association report in 2025, the total healthcare budget reached USD 344 billion in 2023, a part of which is used to strengthen diagnostic capacity toward laboratory automation and advanced oncology services.
FDA Approvals for AI-Driven Medical Devices
|
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 market is predicted to register the highest pace of growth during the discussed tenure. The region consists of a large afflicted population, across emerging countries with few of the highest mortality rates. This is pushing governments to accommodate sufficient resources to improve the quality and scalability of healthcare delivery for associated ailments. The recent advances and surge in precision oncology are also propelling the region's pace of progress. APAC has taken the lead in cell therapy clinical trials, and holds the largest share globally in the first half of 2022. As per the 2023 DIA-CoRE Singapore Annual Meeting, by June 2022 there are over 2,000 ongoing trials, and 32 US FDA-approved cell, tissue, and gene therapy products.
Japan is emerging as the hub of innovation for the automated cell block system market with its significant contribution in establishing AI as a crucial and mainstream asset in the healthcare industry. The country also has an expanding patient pool, driven by rapid aging and cancer occurrence, which is pushing the government to prioritize this category. For example, a significant amount was invested to improve the national efficiency in cancer diagnostics and pathology by the Ministry of Health, Labour and Welfare (MHLW) in 2024.
China dominates the APAC region due to the large screening programs, advancing healthcare technologies and rapid hospital expansion, which yield high specimen throughput, favoring automated cell block adoption. The NLM report in September 2024 depicts that the country has got approvals for 59 AI medical devices, shaping the medical device and cell diagnosis gradually. Government initiative to modern hospitals and pathology networks aid capex procurement. Further, national cancer screening pilots and county-level hospital upgrades have driven diagnostics investment.
Europe Market Insights
Europe’s market is driven by a high cancer burden, strong government support for innovative diagnostics, and advanced healthcare infrastructure. The standardization of cancer diagnostics under EU guidelines, the combination of digital pathology and AI-based analytics, and rising investments in precision medicine are some of the major motivators. The NLM article in March 2025 depicts that the number of cancer cases registered in Europe was 4,471,422 in 2022, highlighting the demand for the market. Further, the adoption of the latest diagnostic technologies in the healthcare sector, such as automated cell block systems, surges the cross-border collaboration.
UK leads the Europe region and is expanding steadily due to the rising investments by the NHS in diagnostic infrastructure. Rising cancer cases is the primary driver of the country, and the House of Commons Library in December 2024 states that nearly 346,217 new cases of cancer were diagnosed. This rising number of cases surges the adoption of ACBS to enhance pathology workflows. The UK position on advanced diagnostic technologies is further driven by the NHS-backed automation pilots and the integration of digital pathology across hospitals.
Germany is projected to hold the highest revenue share in Europe's automated cell block system market. The market is fueled by the strong base for manufacturing medical technology, robust government support for digital health, and rising healthcare expenditure. As per the Federal Ministry of Health, Germany’s Digital Healthcare Act has surged the adoption of AI-integrated diagnostic systems to enhance the outcome by providing the accurate results, with funding for digital pathology. The country’s highly decentralized laboratory system, with numerous large private and university hospitals, creates sustained demand for automated, high-throughput solutions.
