Histology And Cytology Market Size, Share & Trends Analysis Report By Type Of Examination (Histology, Cytology), By Product, By Application, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global histology and cytology market size was valued at USD 12.35 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 14.74% from 2021 to 2028. An increase in the demand for the detection of cell and tissue characteristics and a global increase in the prevalence of cell-based diseases, such as cancer, are major factors expected to drive the market throughout the forecast period. The integration of digital solutions to cytological diagnosis offers the advantage of the rapid interpretation of primary diagnostic data. In addition, companies are launching new and advanced digital cytology systems for assisting in the rapid on-site evaluation of cytology samples. For instance, in June 2021, Antech Diagnostics introduced a Digital Cytology Scanner in North America. This scanner allows the delivery of whole-slide interpretations within 2 hours, which facilitates in reducing the examination time and assessing a large number of samples at POC settings.

The rise in the popularity of immunohistochemistry for visualizing cellular components to diagnose a wide range of diseases, such as cancers and other infectious diseases, is contributing to the growth of the market. Several companies are developing innovative immunohistochemistry instruments and reagents. For instance, in January 2021, Biocare Medical, LLC released ONCORE Pro, a completely automated staining platform for Immunohistochemistry (IHC) and In Situ Hybridization (ISH) applications.

The In Vitro Diagnostic (IVD) labeled system will enable the diagnostic laboratories to maximize their sample throughput processing with an ideal turnaround time. The theCOVID-19 pandemic is acting as a positive catalyst for the growth of the market. The strategic collaboration is observed between the companies for developing antibodies specific for validation with immunohistochemistry. For instance, in September 2020, GeneTex, Inc. entered into a partnership with HistoWiz, Inc., for establishing various validated antibodies for immunohistochemistry in human COVID-19 infected tissues.

The companies will also put collaborative efforts into developing an automated immunohistochemistry assay with GeneTex for detecting SARS-CoV-2 viral infection in different types of tissues. They also emphasized that IHC helps in the identification of the virus replication by the detection of viral proteins in infected tissues, unlike RT-PCR that only amplifies viral RNA fragments in the sample specimen.

Type Of Examination Insights

The cytology segment dominated the market with a revenue share of over 65.0% in 2020 and the trend is expected to continue during the forecast period. The integration of Artificial Intelligence (AI) for developing advanced cytology systems is contributing to the segment growth. For instance, in February 2021, Hologic Inc. collaborated with Google Cloud for the integration of machine learning technologies in its Genius Digital Diagnostics System. This agreement is focused on improving cervical cancer screening with the help of machine learning and Artificial Intelligence (AI).

In the cytology segment, by application, breast cancer accounted for the second-largest revenue share in 2020. The prognosis of breast cancer depends on early screening and detection. Fine Needle Aspiration Cytology (FNAC) is the most affordable procedure used to detect breast cancer. FNAC is crucial for the preoperative pathological evaluation of breast cancer management. Fine needle aspiration cytology is an operator-dependent method and reporting of breast cytological results is more demanding than histological analysis.

Low- and middle-income countries particularly create a favorable environment for the emerging industry participants keen on establishing market presence owing to a comparatively high incidence of cancer. Hence, for reducing the mortality rate, effective screening methods and early detection of Human Papillomavirus (HPV) are essential.

The WHO has recommended Papanicolaou cytology (Pap smear) for cervical cytology screening as it has the ability to detect precursor lesions of cervical cancer at low cost, with flexibility, and at high rates. Hence, an increase in the employment of innovative cytology solutions in cervical cancer screening is set to contribute to the growth of the market.

Advanced histology technologies have improved the workflow by speeding up the diagnostic capabilities of clinical laboratories. Moreover, companies are focusing on integrating AI platforms in histology. For instance, in September 2020, Cernostics, in collaboration with Deciphex, evaluated the use of AI technology-based image analysis tools for facilitating the early detection of cancer in patients with Barrett's esophagus.

Product Insights

The consumables and reagents segment dominated the market with a revenue share of more than 55.0% in 2020. The segment is expected to maintain its lead from 2021 to 2028. 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 segment growth 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. For instance, in August 2020, Biocare Medical LLC, in collaboration with Bethyl Laboratories, released the TIGIT [BLR047F] antibody, a new rabbit monoclonal antibody, for qualitative identification of the TIGIT protein by using Immunohistochemistry (IHC). The antibody will be a cost-effective immunohistochemistry solution for pharmaceutical and biotech research institutions.

The instruments and analysis software system segment is expected to grow from 2021 to 2028 owing to the increasing application of technologically advanced instruments, such as multimodal nonlinear microscopy, photoacoustic microscopy, and stimulated Raman spectroscopy for histopathology. However, the significant infrastructure costs, along with technical and practical limitations, in the pathology industry have affected the adoption of such large-scale digital transformative solutions. Hence, the reduction in the cost of the digitization process will improve the rate of digital adoption in pathology.

Application Insights

The drug discovery and designing segment dominated the market with a revenue share of over 45.0% in 2020. The segment is expected to maintain its position over the forecast period. The growth of 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 and development such as drug efficacy and safety studies, target validation, drug repositioning, patient stratification, and biomarker expression studies.

The clinical diagnostics segment is expected to register a CAGR of 14.31% 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 the screening of various types of cancer, such as breast, bowel, and cervical cancer.

Regional Insights

North America dominated the market with a revenue share of over 40.0% in 2020. The growth of the regional market can be attributed to several factors such as the high incidence of cancer, extensive R&D activities, the presence of key players, and established research infrastructure for pathology services. In addition, the high rate of product approval and commercialization in the region is contributing to the growth of the market.

In Asia Pacific, the market for histology and cytology is expected to register the fastest growth rate of 15.83% from 2021 to 2028. The growth of the regional market is due to several factors such as the rising cancer awareness, a large target population, and improving healthcare infrastructure. In addition, researchers are increasingly evaluating new cytology, which is further fueling the growth of the market in the region.

For instance, in February 2020, researchers in Japan evaluated the efficacy of liquid-based cytology over conventional cytology in cervical cancer screening. The results of the study indicated that liquid-based cytology was comparatively more useful than conventional cytology from practical standpoints.

Key Companies & Market Share Insights

Rapid introduction and approvals attained by different cancer screening pathology solutions have been witnessed in recent years. For instance, in May 2021, Hologic, Inc., received premarket approval from the U.S. FDA for its ThinPrep Genesis Processor. This instrument combines sample aliquoting and cytology processing with improved workflow.

The features of this processor include barcode scanning, automated tube and slide labeling, sample aliquoting, and vial uncapping/capping. These features offer reduced hands-on time and repetitive motions. The company offers a vast portfolio of products for cancer testing and automated testing platforms for cervical cancer. Some prominent players in the global histology and cytology market include:

• Hologic, Inc.

• Abbott

• Becton, Dickinson and Company

• F. Hoffmann-La Roche Ltd.

• Merck KGaA

• Thermo Fisher Scientific, Inc.

• Danaher

• Sysmex Corporation

• Trivitron Healthcare

• Koninklijke Philips N.V.

Histology And Cytology Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2017 to 2028. For the purpose of this report, Grand View Research has segmented the global histology and cytology market report on the basis of type of examination, product, application, and region:

• Type Of Examination Outlook (Revenue, USD Million, 2017 - 2028)

  • 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, 2017 - 2028)

  • Instruments and Analysis Software System

  • Consumable and Reagents

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Drug Discovery & Designing

  • Clinical Diagnostics

    • Point-of-Care (PoC)

    • Non-Point-of-Care

  • Research

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Spain

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa