Automated Cell Block System Market Outlook:
Automated Cell Block System Market size was valued at USD 18.4 billion in 2025 and is projected to reach USD 45.1 billion by the end of 2035, rising at a CAGR of 9.4% during the forecast period 2026-2035. In 2026, the industry size of automated cell block system is evaluated at USD 20.1 billion.
A rapid surge for advanced diagnostic solutions is observed all across the world, which is majorly driven by the increasing prevalence of chronic illnesses, such as cancers. As evidence of the continuously growing patient population, the WHO in February 2025 projected that the volume of deaths due to cancer was registered as 10 million worldwide. On the other hand, a report from the National Cancer Institute (NCI) data in May 2025 also testified to this by predicting that the total cancer population in the U.S. is 2,041,910. This is pushing global healthcare authorities to opt for more efficient and scalable pathology solutions to improve public access to advanced diagnostic solutions. Moreover, the growing demand for large-scale detection and prevention measures is driving the automated cell block system market.
Investment in research, development, and deployment (RDD) is mainly made by the public and private sectors to improve diagnostic accuracy and laboratory productivity. In the U.S. National Institutes of Health (NIH), the funding for the research and development of cancer-related diagnostics has experienced steady investment, driving innovation in pre-analytical sample preparation. From the trade perspective, importation and exportation of completed automated systems and their supplies are substantial. The United States International Trade Commission statistics indicate active trade of medical devices under harmonized system codes, including 9018 for instruments and appliances used in medical sciences. Countries with a strong manufacturing base lead the market. The OEC 2023 data depicts that the global trade of medical instruments reached USD 167 billion, highlighting the market growth.
Automated Cell Block System Market - Growth Drivers and Challenges
Growth Drivers
- Financial and promotional support from governments: Considering the rising mortality and severity of associated illnesses, several authorized investors are allocating funds to the market to combat and prevent this widespread. For instance, the ADLM report in January 2025 states that Medicare Part B spending on genetic testing, which includes advanced diagnostics for cancer, surged 29% in 2023 to about USD 1.8 billion. Furthermore, initiatives commenced by governing bodies are promoting the benefits and efficiency of modernized pathology, influencing both MedTech companies and patients to invest in this category. This ultimately secures a gradual magnification of business flow in this sector.
- Increasing research and tech-based advances: Robust amplification of R&D investments from both public and private organizations is revolutionizing the efficacy of products available in the automated cell block system market. For instance, the University Hospitals report in December 2024 states that NIH continuously funds multiple AI-based projects and research initiatives in biomedical fields, which include cancer and imaging, such as a USD 2.78 million grant for AI use in rectal cancer treatment. Similar funding in disease-related research projects also fosters lucrative opportunities for this sector.
- Rising incidence of cancer cases: The increasing global cancer burden directly expands the patient pool requiring advanced diagnostic procedures. According to an article published by NLM in February 2024, the National Center for Health Statistics has stated that in the U.S., nearly 611,720 deaths from cancer were registered. Though the death via cancer has decreased since 2021, there is always a threat on the rise in the increasing incidence of cancer impacting the market growth. This rise demands enhanced oncology treatments, preventive measures, and diagnostic solutions.
Trade Flow of Medical Instruments in 2023
|
Country |
Import (USD) |
Export (USD) |
|
Germany |
13.1 billion |
18.4 billion |
|
U.S. |
37.7 billion |
34.8 billion |
|
China |
10.6 billion |
12.3 billion |
|
Japan |
6.47 billion |
7.21 billion |
|
India |
2.47 billion |
1.46 billion |
Source: OEC 2023
Challenges
- Concerns about the liability of data-driven assessment: Consumers often become skeptical about the long-term efficacy and reliability of the products from the automated cell block system market for critical medical decision-making. The social stigma and stringent regulations regarding data security raise questions about the liability of diagnostic outputs among payers. This may foster a serious issue for wide adoption in this sector. Additionally, the lack of sufficient clinical proof to establish the effectiveness of ACBS may slow its uptake in developing regions. It also creates hesitation among insurers to subsidize these technologies, limiting patient accessibility and hence the sector's expansion.
- Limited reimbursement policies: The U.S. Medicaid programs in 2023 provided a considerable amount of funding for automated cell block procedures, providing a significant obstacle to adoption in low-income populations. This problem generates a disparity in the equitable access to advanced diagnostic technologies. To address this issue, companies and advocacy groups are aggressively advocating state-specific efforts to expand Medicaid coverage, with an emphasis on standardizing reimbursement practices and enhancing patient access to breakthrough diagnostic procedures across states.
Automated Cell Block System Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
9.4% |
|
Base Year Market Size (2025) |
USD 18.4 billion |
|
Forecast Year Market Size (2035) |
USD 45.1 billion |
|
Regional Scope |
|
Automated Cell Block System Market Segmentation:
Application Segment Analysis
The cancer diagnostics segment is poised to hold the highest share of 65% in the market over the assessed period. Cancer is the leading cause of death and the NLM report in January 2023 depicts that approximately 19.3 million new diagnoses and 10 million deaths are registered globally. As more clinical studies establish the importance of early detection and intervention in cancer care to get a better patient response and minimal financial exhaustion, investments from this segment are magnifying. In this regard, in 2022, a study from the National Cancer Institute highlighted the contribution of ACBS in enhancing accuracy and specificity in precision oncology.
Product Segment Analysis
Instruments and systems lead the market and hold a considerable share in 2035. The segment is dominated to the high capital costs and the transformation towards integrated and high-throughput platforms. As per the CMS report in August 2025, nearly 320,000 clinical laboratories are certified under the Clinical Laboratory Improvement Amendments in the U.S., ensuring high standard in testing quality and accuracy. This creates a recurring revenue model for manufacturers via initial sales of system and long-term service contracts.
End user Segment Analysis
The hospitals & diagnostic labs segment is anticipated to dominate the automated cell block system market throughout the forecasted timeframe. The worldwide trend of modernizing healthcare infrastructure and workflow is a primary driver in the segment's leadership. Additionally, the continuously surging volume of patient admissions and registrations in these organizations garners a greater consumer base and higher revenue for this sector, making it a major distribution channel for global leaders. Moreover, the accumulative investments from government and private companies in hospitals to enhance accessibility ensures a lucrative economic and functional turnaround in this category.
Our in-depth analysis of the global automated cell block system market includes the following segments:
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Subsegments |
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Product
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Technology
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Application |
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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.
Key Automated Cell Block System Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The presence of giant manufacturers and MedTech pioneers makes the automated cell block system market a highly competitive merchandise. The strategic commercial activities of key players in this sector shape the progress and revenue generation of this sector. In the current dynamics, Thermo Fisher Scientific and Merck KGaA stand at the forefront of the global landscape due to their exceptional manufacturing capacity. This leadership is further followed by the excellence of GE Healthcare and Siemens Healthineers in AI-integrated innovations.
Below is the list of some prominent players operating in the market:
|
Company Name |
Origin |
Estimated Market Share 2025 (%) |
Industry Focus |
|
Thermo Fisher Scientific Inc. |
U.S. |
18% |
Global life sciences leader. Offers the Tissue-Tek AutoTEC and Genie systems for high-volume, integrated tissue processing and embedding. |
|
Danaher Corporation (Leica Biosystems) |
U.S. |
15% |
Core pathology player. Provides the Peloris tissue processors and HistoCore automated embedding systems, known for reliability and integration. |
|
Roche Diagnostics |
Switzerland |
10% |
Focuses on integrated diagnostics. Its Ventana unit provides automated staining systems with advanced sample tracking and management. |
|
Sakura Finetek Co., Ltd. |
U.S. |
8% |
A pure-play histology leader (Japanese-owned). Manufactures the extensive Tissue-Tek line of automated stainers, embedders, and processors. |
|
Agilent Technologies, Inc. |
U.S. |
7% |
Provides a comprehensive portfolio via Dako and BioGenex, offering automated staining and coverslipping instruments for diagnostic labs. |
|
Becton, Dickinson and Company (BD) |
U.S. |
xx% |
Focuses on pre-analytical solutions. Its BD Kiestra brand offers total lab automation that can interface with histology equipment. |
|
Siemens Healthineers |
Germany |
xx% |
Offers laboratory automation systems (Atellica brand) focusing on connecting analytical workflows, including histology processing modules. |
|
Sysmex Corporation |
Japan |
xx% |
Global hematology leader expanding into histopathology with automated staining systems and digital pathology integration. |
|
BioMerieux SA |
France |
xx% |
Expertise in microbiology automation and sample tracking, which is applied to adjacent cellular pathology fields. |
|
Abbott Laboratories |
U.S. |
xx% |
Major diagnostics player. Its Alinity suite includes automation solutions that emphasize efficiency and connectivity. |
|
Intelsint S.r.l. |
Italy |
xx% |
Specializes in lab automation for histology/cytology, offering stand-alone and integrated systems for processing, embedding, and staining. |
|
Medite Medical GmbH |
Germany |
xx% |
Develops histological equipment, including the TPC 15 Duo tissue processor and automated embedding stations. |
|
Milestone Medical |
Italy |
xx% |
Known for innovative histological equipment like the TruCore biopsy system and automated tissue processors. |
|
Jokoh Co., Ltd. |
South Korea |
xx% |
Specializes in automated tissue processors and embedding systems designed for efficiency and compact footprints. |
|
Amos Scientific Pty Ltd |
Australia |
xx% |
Leading distributor and manufacturer in Australasia, providing and supporting automated histology solutions for the regional market. |
|
Trivitron Healthcare |
India |
xx% |
Major medtech company in India, manufacturing and distributing lab equipment, including automated histology systems. |
|
Tokyo Electron Limited |
Japan |
xx% |
Semiconductor giant applying its precision automation and robotics expertise to develop advanced life sciences instrumentation. |
|
A&T Corporation |
Japan |
xx% |
Specializes in clinical laboratory automation systems, including conveyor-based total lab automation (TLA) solutions. |
|
Japan Electron Optics Laboratory (JEOL) Ltd. |
Japan |
xx% |
Known for electron microscopes; also develops precision instruments for scientific research, including sample prep equipment. |
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Sakura Finetek Japan Co., Ltd. (Parent Co.) |
Japan |
xx% |
The parent company drives R&D and manufacturing for the globally recognized Tissue-Tek brand of automated histology equipment. |
Below are the areas covered for each company in the market:
Recent Developments
- In August 2025, Sartorius Stedim Biotech and Nanotein Technologies join together to advance the cell therapy manufacturing and provide new solutions for cell and gene therapy markets.
- In December 2024, Merck has acquired the HUB Organoids Holding B.V., advancing next generation biology portfolio. This acquisition is mainly done to enhance the cell culture portfolio with internationally recognized pioneer in organoid development.
- Report ID: 1099
- Published Date: Sep 29, 2025
- Report Format: PDF, PPT
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