Histology And Cytology Market Size, Share & Trends Analysis Report By Type of Examination (Histology, Cytology), By Product (Instruments & Analysis Software System, Consumables & Reagents), By Application, By Region, And Segment Forecasts, 2025 - 2030

Histology And Cytology Market Summary

Moreover, favorable reimbursement policies and government initiatives promoting healthcare infrastructure development are also expected to boost the market by 2030.

The histology and cytology industry is poised for significant growth, driven by technological advancements and regulatory approvals that enhance diagnostic accuracy and efficiency. For instance, in February 2024, Hologic, Inc. received FDA clearance for its Genius Digital Diagnostics System, the first and only FDA-cleared digital cytology system that integrates deep-learning-based AI with advanced volumetric imaging. This breakthrough enables more precise detection of pre-cancerous lesions and cervical cancer cells, improving early diagnosis and patient outcomes. Also, in January 2024, QIAGEN introduced the QIAstat-Dx Gastrointestinal Panel 2 and Meningitis/Encephalitis Panel, expanding its portfolio alongside the existing Respiratory SARS-CoV-2 Panel. The QIAstat-Dx system leverages multiplex real-time PCR to detect multiple pathogens simultaneously, providing crucial Ct values and amplification curves for more informed clinical decision-making. These innovations support efficient, timely, and patient-centered care for communicable diseases, driving demand for advanced histology and cytology solutions. Such developments underscore the increasing adoption of AI-driven diagnostics and multiplex molecular testing, propelling market expansion and improving patient care.

Rising acceptance of immunohistochemistry to get an advanced and comprehensive view of cellular components to diagnose a wide range of diseases, such as infectious diseases and cancers, is contributing to the growth of the market for histology and cytology. Several companies are developing innovative solutions for immunohistochemistry, which are further expected to propel the market growth. For instance, in June 2023, Aiosyn, a major player in AI-based digital pathology solutions, announced the expansion of its AI-powered module to offer extended capabilities in immunohistochemistry staining.

The increasing prevalence of cancer and associated diseases is also projected to contribute to market growth during the forecast period. As cancer diagnosis heavily relies on histological and cytological examinations to determine the type, stage, and progression of the disease, an increasing prevalence of cancer is expected to have a positive impact on the market. For instance, according to data published by the National Library of Medicine, an estimated 1.9 million new cases and 609,820 deaths in the United States are estimated to occur due to cancer in 2023.

Moreover, technological advancements in the field have also fueled market growth. Automated systems, digital imaging techniques, and computer-assisted analysis have improved the accuracy and efficiency of histological and cytological examinations. These innovations have not only enhanced diagnostic capabilities but also reduced turnaround times, leading to increased adoption by healthcare professionals.

Furthermore, the growing awareness about early disease detection and preventive healthcare has propelled the demand for histology and cytology services. Regular screening programs for cervical, breast, and other types of cancers have become more prevalent, contributing to the market expansion. In addition, the aging population and the associated increase in chronic diseases have further boosted the need for histopathological and cytopathological analysis. The histology and cytology industry has also benefited from the expanding healthcare infrastructure in developing regions. Improvements in healthcare facilities, increased accessibility to advanced diagnostic services, and government initiatives to enhance cancer screening programs have all contributed to market growth.

Market Concentration & Characteristics

The histology and cytology industry is experiencing a high degree of innovation, driven by advancements in digital pathology, artificial intelligence, and molecular diagnostics. Cutting-edge technologies such as AI-powered image analysis, next-generation sequencing (NGS), and automation in slide processing are enhancing diagnostic accuracy and efficiency. In addition, the development of liquid biopsy techniques, multiplex biomarker assays, and novel staining methods are revolutionizing early disease detection and personalized medicine.

The histology and cytology industry has witnessed a moderate-to-high level of mergers and acquisitions as companies seek to expand their diagnostic portfolios and enhance technological capabilities. Major players are acquiring AI-driven pathology firms, molecular diagnostic companies, and reagent manufacturers to strengthen their market presence. Strategic acquisitions and collaborations are also enabling geographic expansion, particularly in emerging markets and digital pathology segments, fostering industry consolidation and innovation. 

Regulations play a crucial role in shaping the histology and cytology industry, ensuring diagnostic accuracy, patient safety, and standardization of laboratory procedures. Stringent approvals from agencies like the FDA, EMA, and WHO impact the adoption of new technologies, particularly in AI-driven digital pathology and molecular diagnostics. Compliance with evolving guidelines can slow product launches but also enhance credibility and market acceptance, driving innovation and quality improvements in diagnostic solutions. 

In the histology and cytology industry, product substitutes include liquid biopsy, molecular diagnostics, and AI-driven imaging technologies, which offer non-invasive or faster diagnostic alternatives. Advances in next-generation sequencing (NGS) and PCR-based tests are increasingly complementing or replacing traditional tissue-based methods. However, histology and cytology remain gold standards for definitive diagnosis, ensuring continued demand despite emerging alternatives. 

The histology and cytology industry is witnessing significant geographical expansion, driven by rising cancer prevalence, increasing healthcare investments, and improved diagnostic infrastructure in emerging markets. Companies are expanding into Asia-Pacific, Latin America, and the Middle East, leveraging partnerships, acquisitions, and regulatory approvals. North America and Europe continue to dominate, but developing regions are rapidly adopting advanced diagnostic solutions, fueling market growth.

Type of Examination Insights

The cytology segment held the largest revenue share of 72.20% in 2024 and is expected to continue the trend during the forecast period. The integration of Artificial Intelligence (AI) for developing advanced cytology systems can be attributed to segment growth. For instance, in March 2025, Synergy Laboratories, a leading full-service diagnostic laboratory, introduced Hologic's Genius Digital Diagnostics System with the Genius Cervical AI algorithm to the Gulf Coast. This cutting-edge system, which integrates deep-learning-based AI with volumetric imaging technology, significantly enhances the detection of precancerous lesions and cervical cancer cells. By setting a new benchmark for precision medicine, companies are advancing diagnostic accuracy and efficiency for healthcare providers.

In addition, the cytology segment is driven by the increasing adoption of advanced biomarker-based diagnostics and regulatory endorsements. Roche’s CINtec PLUS Cytology test, the only FDA-approved and CE-marked dual-stain test for triaging HPV-positive cervical cancer screening results, has gained global recognition, including inclusion in the World Health Organization (WHO) cervical cancer prevention guidelines and recommendations from the American Society for Colposcopy and Cervical Pathology (ASCCP). By improving the detection of cervical precancer, dual-stain biomarker technology reduces unnecessary colposcopy procedures while enabling earlier intervention for high-risk individuals, enhancing diagnostic accuracy and patient outcomes. These advancements are accelerating the integration of dual-stain cytology into cervical cancer screening programs, fueling the growth of the cytology market.

Product Insights

The consumable and reagents segment held the largest revenue share of 60.49% in 2024. The region is expected to continue its dominance from 2025 to 2030. Several consumables are used for the histology and cytology process, such as tissue sample containers, kits, stain reagents, fixative solutions, medium reagents, and other reagents. The large share of the segment can be primarily attributed to the routine adoption of histology and cytology consumables. In addition, companies are developing cost-effective kits and reagents, further driving the market for histology and cytology.

The segment is expanding, driven by advancements in genomic profiling and the increasing demand for efficient, decentralized molecular testing solutions. In November 2024, Biofidelity launched Aspyre Lung Reagents (research use only) for liquid biopsy samples, offering a groundbreaking alternative to next-generation sequencing (NGS) for identifying non-small cell lung cancer (NSCLC) biomarkers. Aspyre Lung streamlines biomarker detection from both DNA and RNA in tissue and blood through a simple four-step workflow that runs on existing qPCR platforms, facilitating seamless integration into laboratories worldwide. With its high-performance capabilities, even with challenging samples, and the ability to provide fast, simplified, and decentralized testing, Aspyre Lung is driving demand for innovative reagents, accelerating the adoption of Simplified Genomic Profiling (SGP), and fueling growth in the histology and cytology industry.

Application Insights

The drug discovery and designing segment dominated the market and accounted for the largest revenue share of 47.56% in 2024. The segment is expected to continue its dominance over the forecast period. The growth in the segment can be attributed to the wide use of histomorphometry and IHC staining in pharmaceutical and biotechnology companies for drug development. The image analysis is applied across several steps of drug discovery & development, such as drug efficacy & safety studies, target validation, drug repositioning, patient stratification, and biomarker expression studies. 

The clinical diagnostics segment is expected to witness a CAGR of 14.88% over the forecast period, owing to the increasing application of histopathology studies for the diagnosis of different types of cancer. The cells and tissues are removed from suspicious lump sites for identifying abnormalities and malignancy. They are widely used for screening of various types of cancers, such as breast, bowel, and cervical cancer.

Regional Insights

North America histology and cytology industry dominated globally with a share of 39.82% in 2024, driven by the presence of well-established pharmaceutical and medical device industries. The growing focus on innovation and automation in in-vitro diagnostics is a key driver for North America's histology and cytology industry. For instance, the 76th Annual American Congress of Clinical Chemistry and Exposition of Clinical Laboratory Medicine, held in July-August 2024, attracted over 20,000 professionals from 110 countries, highlighting the increasing global interest in advanced diagnostic solutions. Wondfo Biotech’s new product launches, including the fully automatic chemiluminescence immunoassay analyzer FC-2100, the Finecare FIA Meter X1, and X2, and the automatic blood gas analyzer Ucare-6000, demonstrate the industry's shift toward automation, efficiency, and high-throughput diagnostic solutions. As laboratories across North America seek to enhance diagnostic accuracy, workflow efficiency, and early disease detection, the adoption of automated and AI-driven diagnostic systems is expected to accelerate market growth in the histology and cytology segment.

U.S. Histology And Cytology Market Trends

The U.S. histology and cytology industry is experiencing robust growth owing to the expansion of advanced technologies. For instance, in January 2025, Molecular Instruments launched HCR Gold and HCR Pro, enhancing the HCR imaging platform to support fluorescent and chromogenic assays for simultaneous RNA and protein imaging. By enabling high-resolution visualization with well-preserved sample morphology in both manual and automated workflows, these innovations are improving biopharma drug development and academic research. The increasing adoption of cutting-edge imaging solutions is accelerating advancements in disease diagnostics, biomarker discovery, and precision medicine, fueling market growth in the U.S.

Europe Histology And Cytology Market Trends

Europe histology and cytology industry is a key region for MAT adoption, with countries like Germany, Italy, and France leading the market. The expansion of strategic collaborations and OEM partnerships is one of the major driving factors in the European market. For instance, in April 2024, Sysmex Corporation and Siemens Healthineers began independently distributing their combined hemostasis testing solutions under their respective brands in the United States and EU countries, following a global OEM agreement. By integrating hemostasis instruments and reagents with broader diagnostic portfolios, this initiative enhances laboratory efficiency, automation, and accuracy in clinical diagnostics. As European laboratories increasingly adopt advanced hemostasis and cytology solutions, the demand for high-performance reagents, imaging systems, and automated diagnostic workflows is expected to accelerate, driving market expansion across the region.

The histology and cytology industry in France is driven by the advancement of digital pathology solutions and strategic industry acquisitions. In March 2025, Epredia received U.S. FDA 510(k) clearance for its E1000 Dx Digital Pathology Solution, a high-speed, automated whole-slide imaging system capable of processing up to 1,500 tissue samples daily, improving laboratory efficiency and cancer diagnostics. This follows Epredia’s expansion into the French anatomical pathology market through the acquisition of Microm Microtech France and Laurypath in 2022, strengthening its presence in Europe’s diagnostic landscape. As France continues to adopt advanced digital pathology and AI-driven imaging solutions, the demand for automated, high-throughput histology and cytology technologies is expected to rise, accelerating market growth.

Germany histology And pathology industry is propelled by the pharmaceutical industry, which is a significant contributor to the European market, with the country's expansion of specialized histology and pathology service providers. For instance, in November 2024, StageBio announced the relocation of its European division to a state-of-the-art facility in Freiburg, Germany, enhancing its capacity to support preclinical and clinical research. With advanced resources, an expanded workspace, and a team of over 125 experts, the new facility strengthens GLP-compliant histology, pathology, image analysis, and archiving services. As Germany remains a hub for biomedical research and pharmaceutical development, the demand for high-quality histopathological analysis, automated imaging solutions, and regulatory-compliant laboratory services is expected to grow, fueling market expansion.

Asia Pacific Histology And Cytology Market Trends

The Asia Pacific histology and pathology industry is experiencing significant growth owing to the expansion of advanced diagnostic laboratories and the adoption of cutting-edge technologies. For instance, in January 2025, the American Institute of Pathology & Laboratory Sciences (Ampath), in collaboration with Parashar Pathology Clinic, launched a state-of-the-art pathology laboratory in Meerut, India, reinforcing efforts to enhance comprehensive diagnostic services across the region. Equipped with advanced technologies and offering over 2,500 diagnostic tests, including cytology, histopathology, immunohistochemistry, molecular diagnostics, and next-generation sequencing (NGS), this facility highlights the growing demand for high-precision and automated pathology solutions. As healthcare infrastructure in the Asia-Pacific region continues to expand and modernize, the rising need for accurate and timely disease diagnostics is expected to fuel the growth of the market.

The histology and cytology industry in Japan is driven by the advancement of noninvasive diagnostic technologies and strong patent protection. In October 2024, bioAffinity Technologies secured a Japanese patent for its CyPath Lung diagnostic test, which uses flow cytometry to detect early-stage lung cancer. This patent strengthens intellectual property protection and marks a major milestone in expanding innovative, noninvasive cancer diagnostics in Japan. With rising lung cancer incidence and increasing demand for early detection solutions, the adoption of advanced cytology-based assays is expected to grow. Additionally, Japan’s emphasis on technological innovation and precision medicine is fueling market expansion, driving the integration of cutting-edge diagnostic solutions into routine clinical practice.

Latin America Histology And Cytology Market Trends

Latin America histology and cytology industry is witnessing a gradual increase, with countries like Brazil leading the market. Also, the rising demand for early cancer detection, increasing government healthcare investments, and the adoption of advanced diagnostic technologies drive the market growth. Strategic partnerships in the region are enhancing cytology services and infrastructure. Additionally, the growing prevalence of cervical and other cancers is fueling the demand for Pap tests, liquid-based cytology, and molecular diagnostics, further propelling market growth in the region.

The histology and cytology industry in Brazil is driven by the expansion of cytology services through strategic partnerships. In September 2024, Ikonisys and BIO BRASIL BIOTECNOLOGIA strengthened their collaboration to enhance diagnostic capabilities in Sao Paulo, acquiring 10 additional Cytofast Plus systems and 50,000 reagent kits to meet the rising demand for Pap tests and urinary cytology diagnostics. This initiative significantly bolsters Brazil’s diagnostic infrastructure, enabling faster and more accurate detection of cervical and urinary tract cancers. Additionally, the pilot implementation of fluorescence in situ hybridization (FISH) technology for Pap test enhancements introduces cutting-edge innovations in cytological screening, further driving market growth. With the support of public healthcare initiatives and increasing adoption of advanced cytology solutions, Brazil's histology and cytology industry is poised for rapid expansion, improving early cancer detection and patient outcomes across the region.

Middle East & Africa Histology and Cytology Market Trends

The histology and cytology industry in the Middle East and Africa is driven by the local production of advanced pathology equipment. In January 2024, Iran successfully developed a domestically made cryostat device, a critical tool for freezing and microscopically cutting human tissue samples to aid in the immediate diagnosis of lesions. This innovation not only enhances early disease detection but also supports immunofluorescence and enzyme immunochemistry studies, which are crucial for pathology and cytology applications. The local manufacturing of high-quality medical devices reduces reliance on imports, improves affordability and accessibility, and strengthens the region’s healthcare infrastructure. With a growing focus on technological self-sufficiency and advancements in diagnostic tools, the demand for histology and cytology solutions is expected to expand across the Middle East and Africa, driving market growth.

The histology and cytology industry in Saudi Arabia is being driven by the increasing adoption of digital pathology and AI-based diagnostic solutions, as highlighted by the 13th World Digital Pathology & AI UCGCongress in Abu Dhabi. With Saudi Arabia's Vision 2030 focusing on advancing healthcare infrastructure and digital transformation, the integration of artificial intelligence, machine learning, and computational pathology is enhancing diagnostic accuracy and efficiency. The country's growing investment in smart healthcare technologies and its commitment to modernizing pathology services are key factors accelerating market growth in the region.

Key Histology And Cytology Company Insights

Some of the key market players include Hologic, Inc., Abbott, Becton, Dickinson, and Company, among others. These players are undertaking various strategic initiatives to increase their share in the market. New product development, collaborations, and partnerships are some such endeavors.

Histology And Cytology Market Report Scope

Global Histology And Cytology Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented global histology and cytology market report based on type of examination, product, application, and region:

• Type of Examination Outlook (Revenue, USD Million, 2018 - 2030)

  • Histology

    • By Technique

      • Microscopy

      • Immunohistochemistry

      • Molecular pathology

      • Cryostat & Microtomy

  • Cytology

    • By Technique

      • Microscopy

      • Immunohistochemistry

      • Molecular pathology

      • Cryostat & Microtomy

    • By Application

      • Breast Cancer

      • Cervical Cancer

      • Bladder Cancer

      • Lung Cancer

      • Other Cancers

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments and Analysis Software System

  • Consumable and Reagents

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Drug Discovery & Designing

  • Clinical Diagnostics

    • Point-of-Care (PoC)

    • Non-PoC

  • Research

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • Kuwait

    • UAE