Luton, Bedfordshire, United Kingdom, May 29, 2025 (GLOBE NEWSWIRE) — Market Overview
The global pathology devices market is projected to grow from an estimated $15.6 billion in 2024 to approximately $27.2 billion by 2034, registering a robust CAGR of 6.0% over the forecast period. This growth is fueled by rising prevalence of chronic diseases, technological advancements such as digital pathology and AI integration, and increased healthcare spending worldwide.
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Market Segmentation
- By Product Type:
- Digital Pathology Systems (largest share ~25%)
- Laboratory Information Systems (LIS) (~22%)
- Immunohistochemistry (IHC) Stains
- Slide Scanners
- Software Solutions
- By Technology:
- Optical Technology (dominant with ~30% share)
- Molecular Technology
- Digital Imaging Technology
- Artificial Intelligence Integration (growing rapidly, ~15% share)
- By Application:
- Cancer Diagnosis (largest application segment at ~35%)
- Infectious Disease Diagnosis (~20%)
- Genetic Testing
- Other Clinical Applications
- By End User:
- Hospitals (~40% share, largest segment)
- Diagnostic Laboratories (~25%)
- Research Institutions
- Biopharmaceutical Companies
- By Distribution Channel:
- Direct Sales (~30%)
- Distributors
- Online Sales (growing rapidly, ~18%)
Regional Insights
- North America leads the market with about 40% share due to advanced healthcare infrastructure and R&D investments.
- Europe accounts for approximately 30% with a CAGR of 5.5%, driven by aging populations and personalized medicine focus.
- Asia-Pacific is the fastest-growing region with a projected CAGR of 8%, supported by expanding healthcare infrastructure and rising disease burden.
- Emerging markets in Latin America (CAGR ~7%) and Middle East & Africa show promising growth potential but face challenges related to healthcare access and regulatory complexity.
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Market Dynamics
1. Increasing Chronic Disease Prevalence
The rising incidence of chronic diseases—such as cancer, diabetes, cardiovascular disorders, and infectious diseases—drives the demand for timely and accurate pathological testing. Pathology devices play a vital role in disease diagnosis, staging, and monitoring. According to the WHO, chronic diseases account for approximately 71% of global deaths annually, creating a sustained demand for advanced diagnostic infrastructure.
2. Advances in Digital Pathology and Artificial Intelligence (AI)
Digital pathology is transforming the field with its ability to digitize and analyze slides remotely. The integration of AI allows for faster, more precise image analysis, reducing the burden on pathologists and improving diagnostic consistency. AI can detect patterns undetectable by the human eye, improving diagnostic outcomes, especially in cancer pathology.
3. Growing Global Healthcare Expenditure
Worldwide, healthcare budgets are rising, particularly in emerging markets, which are investing in modernizing diagnostic infrastructure. Increased healthcare spending by governments and private sectors is facilitating the procurement of cutting-edge pathology devices and technologies to improve patient outcomes and reduce diagnostic errors.
4. Demand for Faster, More Accurate Diagnostics
The need for rapid and reliable diagnostic results has become crucial, especially in emergency care, oncology, and infectious disease management. Pathology devices equipped with automated and high-throughput capabilities are addressing this demand by shortening turnaround times and minimizing human error.
Market Challenges
1. Stringent and Costly Regulatory Approval Processes
Pathology devices are subject to rigorous validation and approval standards set by regulatory bodies such as the U.S. FDA, EMA, and others. The long timelines, high costs, and evolving compliance requirements can delay product launches and deter smaller companies from entering the market.
2. Supply Chain Disruptions Affecting Device Availability
Global supply chain constraints—exacerbated by events such as the COVID-19 pandemic and geopolitical tensions—have led to shortages of critical components and delayed production timelines. These disruptions impact the timely availability and servicing of pathology devices in hospitals and laboratories.
3. Pricing Pressures and Healthcare Budget Constraints
Despite growing demand, many healthcare systems are under financial strain. Pricing pressures from government reimbursement policies, insurance providers, and hospital procurement departments are forcing manufacturers to deliver high-performance pathology devices at lower margins.
4. Complexity and Cost Barriers for AI Adoption
While AI offers immense benefits, the high initial cost of implementation, need for skilled personnel, and interoperability issues with legacy systems pose significant adoption challenges. Smaller healthcare facilities often struggle to integrate these technologies due to limited budgets and technical expertise.
Market Opportunities
1. Expansion of Personalized Medicine and Precision Diagnostics
As medicine shifts toward personalized treatment regimens based on individual genetic and molecular profiles, pathology devices capable of advanced biomarker detection and genomic analysis are in high demand. This shift supports the development of companion diagnostics and tailored therapies, opening new revenue streams for device manufacturers.
2. Growth in Telemedicine and Remote Diagnostics
The acceleration of telehealth services, especially post-COVID-19, is fostering demand for remote diagnostics. Pathology devices that support digital slide sharing, cloud-based reporting, and telepathology are gaining traction, enabling remote consultations and second opinions.
3. Increasing Demand for Point-of-Care and Home Diagnostic Devices
There is a rising need for portable pathology tools that can deliver rapid diagnostics at the bedside, in rural clinics, or even at home. Innovations in miniaturized devices and non-invasive sample collection are expanding diagnostic access to underserved populations and reducing hospital visits.
4. Integration of AI and Machine Learning for Enhanced Workflow Efficiency
AI-enabled devices can streamline laboratory operations, reduce the diagnostic burden on pathologists, and minimize human error. Machine learning models are being increasingly used for predictive analytics, automated anomaly detection, and intelligent report generation, enhancing workflow efficiency and overall lab productivity.
Competitive Landscape
Key players shaping the market include:
- Thermo Fisher Scientific
- Abbott Laboratories
- Siemens Healthineers
- Roche Diagnostics
- Beckman Coulter
- BD (Becton, Dickinson and Company)
- bioMérieux
- QIAGEN
- Agilent Technologies
- PerkinElmer
- Ortho Clinical Diagnostics
- Sysmex Corporation
- LabCorp
- Siemens AG
- Illumina
Recent Developments:
1. Thermo Fisher Scientific
In October 2023, Thermo Fisher Scientific launched a high-throughput automated pathology device designed to streamline laboratory diagnostic workflows. This device integrates advanced artificial intelligence (AI) algorithms to assist pathologists in detecting cellular anomalies with improved accuracy and speed. The introduction of this technology aims to address the growing backlog of pathology samples, enhancing diagnostic outcomes and operational efficiency in laboratories.
2. Siemens Healthineers
In September 2023, Siemens Healthineers entered into a strategic partnership with DeepHealth, a subsidiary of RadNet, to enhance its pathology imaging platforms. This collaboration focuses on integrating machine learning capabilities into existing systems to improve diagnostic workflow and accuracy. The partnership aims to leverage the latest advancements in AI to enhance the performance and capabilities of Siemens Healthineers’ pathology imaging solutions.
3. Roche Diagnostics
In August 2023, Roche Diagnostics received regulatory approval for its next-generation molecular diagnostics platform, enhancing its capabilities in precision medicine. This platform allows for the testing of multiple biomarkers simultaneously, paving the way for more comprehensive diagnostic insights. The approval signifies an expansion of Roche’s product portfolio and aligns with a growing trend towards personalized medicine in pathology.
4. Abbott Laboratories
In July 2023, Abbott Laboratories completed the acquisition of a biotech firm specializing in advanced diagnostic testing technologies, significantly enhancing its capabilities in the pathology sector. This strategic move diversifies Abbott’s product offerings and strengthens its competitive position in a rapidly evolving market. The acquired technology specializes in digital pathology solutions that integrate seamlessly with existing Abbott systems, addressing the rising demand for integrated solutions in healthcare diagnostics.
5. BD (Becton, Dickinson and Company)
In June 2023, BD announced a breakthrough in its pathology devices, unveiling a multi-modal imaging technology that enhances visual interpretation of histopathology samples. This advancement facilitates real-time analysis and reporting, which is critical in fast-paced clinical environments. The introduction of such innovation is expected to improve diagnostic accuracy and speed, key factors in patient management and treatment decisions.
This report is also available in the following languages : Japanese (病理学機器市場), Korean (병리학 장비 시장), Chinese (病理学设备市场), French (Marché des dispositifs de pathologie), German (Markt für Pathologiegeräte), and Italian (Mercato dei dispositivi patologici), etc.
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More Research Finding –
Digital Pathology Scanner Market
The global digital pathology scanner market is poised for robust growth, with an estimated market value of approximately $2.6 billion in 2024. By 2034, the market is projected to reach around $5.8 billion, reflecting significant investment and innovation in healthcare technology. This indicates a CAGR of about 8.5% during the forecast period from 2025 to 2034.
https://exactitudeconsultancy.com/reports/60270/global-digital-pathology-scanner-market
Clinical Digital Pathology Market
The global clinical digital pathology market is projected to reach approximately $6.2 billion in 2024, with expectations to grow significantly during the forecast period from 2025 to 2034, potentially reaching around $13.5 billion. This reflects a robust Compound Annual Growth Rate (CAGR) of about 8.5%.
https://exactitudeconsultancy.com/reports/59983/global-clinical-digital-pathology-market
Histopathology Equipment Market
The global histopathology equipment market is projected to reach a value of approximately $3.2 billion in 2024, driven by advancements in diagnostic technologies and an increasing prevalence of chronic diseases. Over the forecast period from 2025 to 2034, the market is expected to grow to around $5.1 billion, representing a robust Compound Annual Growth Rate (CAGR) of 5.3%.
https://exactitudeconsultancy.com/reports/54144/global-histopathology-equipment-market
Laboratory Information Systems Market
The global Laboratory Information Systems (LIS) market is valued at approximately $3.5 billion, reflecting robust demand driven by the increasing need for efficient data management in laboratories. The projected market value is expected to reach about $6.2 billion by 2034, showcasing significant growth potential. This implies a Compound Annual Growth Rate (CAGR) of approximately 6.0% from 2025 to 2034.
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Cellular Pathology Market
The cellular pathology market is projected to reach a value of approximately $23 billion in 2024, driven by increasing healthcare spending and advancements in diagnostic technology. Over the forecast period from 2025 to 2034, the market is expected to expand significantly, with an estimated compound annual growth rate (CAGR) of 9.2%, potentially reaching around $56 billion by 2034.
https://exactitudeconsultancy.com/reports/51010/cellular-pathology-market
Artificial Intelligence In Pathology Market
As of 2024, the global market for artificial intelligence (AI) in pathology is valued at approximately $1.2 billion. The market is projected to grow significantly, reaching an estimated value of $4.5 billion by 2034, fueled by advancements in technology and increasing adoption of AI solutions in healthcare settings. The Compound Annual Growth Rate (CAGR) for the forecast period from 2025 to 2034 is anticipated to be around 15.1%.
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Pathological Microscopes Market
The global pathological microscopes market is valued at approximately $3.2 billion in 2024, with projections indicating growth to around $5.5 billion by 2034. This represents a Compound Annual Growth Rate (CAGR) of about 5.8% during the forecast period from 2025 to 2034.
https://exactitudeconsultancy.com/reports/49106/pathological-microscopes-market
AI-Based Digital Pathology Solutions Market
Global AI-Based Digital Pathology Solutions Market Size Was Estimated At USD 24.1 Billion In 2023 And Is Projected To Reach USD 34.9 Billion By 2032, At CAGR Of 8.60% (2024-2032)
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Anatomic Pathology Market
The global anatomic pathology market is projected to reach USD 58.90 billion by 2029 from USD 32.58 billion in 2022, at a CAGR of 6.8% from 2023 to 2029.
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Digital Pathology Market
The global digital pathology market is expected to grow at 13.1% CAGR from 2022 to 2029. It is expected to reach above USD 1.97 billion by 2029 from USD 0.65 billion in 2020.
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Skin Imaging Systems Market
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