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AJY 24.01.26
Histology and Cytology - Market - IMG1

The Histology and Cytology Market size is estimated at USD 20.54 billion in 2024, and is expected to reach USD 38.70 billion by 2029, growing at a CAGR of 13.5% during the forecast period (2024-2029).

COVID-19 had a significant impact on the growth of the market. This is mainly due to the development of new cytology and histology tests during the pandemic. For instance, an article published by Frontiers in January 2022 stated a new method for the sputum cytology test without direct contact with specimens during the COVID-19 pandemic. Moreover, in an article published by PubMed Central in February 2021, a study was conducted in India, which showed a 92.6% reduction in cytology samples received during the pandemic. Thus, the development of such new cytology methods and the reduction in cytology tests had a significant impact on the market during the pandemic period. However, as the pandemic has subsided, the studied market is expected to have normal growth during the forecast period of the study.

The propelling factors for the growth of the histology and cytology market include the rising prevalence of cancer, increasing standardization of pathological laboratories, and technological advancements in diagnostic and molecular techniques,

The increasing prevalence of cancer is a major factor driving the market growth as histology and cytology tests are majorly used to diagnose cancer. For instance, according to the data published by the Spanish Network of Cancer Registries in January 2021, an estimated 276.2 thousand new cases of cancer were diagnosed in Spain in the previous year out of which 43.6 thousand were colorectal cancer cases, 35.8 thousand were prostate cancer cases, and 33.4 thousand breast cancer cases were diagnosed.

Moreover, according to an article published by the Indian Journal of Medical Research in November 2022, it was estimated that in India, the incidence of cancer cases would likely increase from 1.46 million in the previous year to 1.57 million in two years. The national average for the year 2022 of the crude rate of incidence per 100,000 was 100.4 for males and 95.6 for females. Thus, the increasing prevalence of cancer worldwide is a major factor driving the market growth.

Furthermore, the developments such as product launches by various organizations and market players are also expected to boost the market growth, leading to a higher adoption of histology and cytology products. For instance, in June 2022, the Fine Needle Aspiration Cytology (FNAC) test facility has been launched at the Almora Medical College. This test helps in the detection of chronic diseases like cancer, at an early stage.

Thus, the above mentioned factors such as the rising prevalence of cancer and the increasing developments such as product launches by various organizations and market players are expected to drive the growth of the studied market during the forecast period. However, safety issues and diagnostic accuracy issues with histopathological and cytopathological tests and the lack of awareness among the public for diagnostic tests are expected to hinder the market growth.

Histology and Cytology Market Trends

Cervical Cancer Segment is Expected to Have a Significant Market Share During the Forecast Period

Cytology tests are useful for both the diagnosis and screening of cervical cancer. The cytology segment has a wide range of applications in cervical cancer types. As companies focus more on molecular diagnosis, cytology is expected to play a vital role in the diagnosis of cervical cancer.

The rising prevalence of cervical cancer is a major factor driving the market growth. For instance, according to the data updated by Cancer Australia in August 2022, an estimated 942 new cases of cervical cancer were diagnosed in Australia in the current year, which will account for 1.3% of the latest female cancer cases diagnosed in the country. Thus, the country's high prevalence of cervical cancer is expected to boost segment growth.

Moreover, according to the data updated by ICO/IARC Information Centre on HPV and Cancer in March 2023, an estimated 4,666 cervical cancer cases are diagnosed in Germany every year, and about 3.2% of women in the general population of Germany are estimated to harbour cervical human papillomavirus (HPV)-16/18 infection at a given time, and 76.5% of invasive cervical cancers are attributed to HPVs 16 or 18. Thus, the country's high prevalence of HPV-related cervical cancers is also expected to enhance segment growth.

Moreover, the rising cervical cancer screening initiatives are also expected to enhance segment growth. For instance, in December 2021, BC Cancer launched an at-home cervix screening pilot in Central Vancouver Island and the Sunshine Coast in Canada, improving access to screening and helping to prevent cervical cancer.

Thus, owing to the above factors, such as the rising prevalence of cervical cancer, the demand for cervical cancer cytological methods is expected to increase.

Histology and Cytology - Market - IMG2

North America is Expected to Hold a Significant Share in the Market Over the Forecast Period

North America is expected to hold a significant market share in the histology and cytology market due to the increasing geriatric population, growing cancer incidence, and rising awareness about cancer screening in this region. For instance, according to the American Cancer Society's report in 2023, over 1.96 million new cancer cases are expected to be diagnosed in the United States in the current year. Additionally, 80% of the people diagnosed with cancer in the United States are 55 or older, and 57% are 65 or older. Thus, due to the high prevalence of cancer and the rising affected geriatric population, the demand for diagnostics contributes to the market's growth.

Moreover, according to the January 2022 update by breastcancer.org, around 1 in 8 women in the country (about 13%) develop invasive breast cancer over their lifetime. The same source reports that, in 2022, an estimated 287,850 new cases of invasive breast cancer are expected to be diagnosed in women in the United States, as well as 51,400 new cases of non-invasive (in situ) breast cancer. As per the same source, about 2,710 new cases of invasive breast cancer are expected to be diagnosed in men in 2022. A man's lifetime risk of breast cancer is about 1 in 833. Hence, all these factors are expected to help propel the histology and cytology market.

Product approvals in the United States are also expected to contribute to the market's growth. For instance, in May 2021, Hologic received the United States Food and Drug Administration's premarket approval of the Company's ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications.

Furthermore, awareness about advanced therapeutics and the presence of well-established healthcare infrastructure is also fueling the growth of the overall regional market to a large extent.

Histology and Cytology Industry Overview

The histology and cytology market is moderately competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some of the key players operating are Abbott Laboratories, Becton, Dickinson and Company, F. Hoffmann-La Roche Ltd, Hologic Inc., Sysmex Corporation, Thermo Fisher Scientific Inc., and Trivitron Healthcare.

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TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Prevalence of Cancer
    • 4.2.2 Increasing Standardization of Pathological Laboratories
    • 4.2.3 Technological Advancements in Diagnostic and Molecular Techniques
  • 4.3 Market Restraints
    • 4.3.1 Safety Issues and Diagnostic Accuracy Issues with Histopathological and Cytopathological Tests
    • 4.3.2 Lack of Awareness among the Public for Diagnostic Tests
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Bargaining Power of Suppliers
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD)

  • 5.1 By Type of Examination
    • 5.1.1 Histology
    • 5.1.2 Cytology
      • 5.1.2.1 Breast Cancer
      • 5.1.2.2 Cervical Cancer
      • 5.1.2.3 Others
  • 5.2 By Test Type
    • 5.2.1 Microscopy Tests
      • 5.2.1.1 Cytogenic Tests
      • 5.2.1.1.1 Karyotyping
      • 5.2.1.1.2 Fluorescent In-situ Hybridization (FISH)
      • 5.2.1.2 Polymerase Chain Reaction
      • 5.2.1.3 Other Microscopy Tests
    • 5.2.2 Molecular Genetics Tests
    • 5.2.3 Flow Cytomtery
  • 5.3 By End User
    • 5.3.1 Hospitals and Clinics
    • 5.3.2 Academic and Research Institutes
    • 5.3.3 Other End Users
  • 5.4 Geography
    • 5.4.1 North America
      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico
    • 5.4.2 Europe
      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South korea
      • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East and Africa
      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East and Africa
    • 5.4.5 South America
      • 5.4.5.1 Brazil
      • 5.4.5.2 Argentina
      • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Abbott
    • 6.1.2 Becton Dickinson and Company
    • 6.1.3 Danaher Corporation
    • 6.1.4 F. Hoffmann-La Roche Ltd
    • 6.1.5 Hologic Inc.
    • 6.1.6 Merck KGaA
    • 6.1.7 PerkinElmer Inc.
    • 6.1.8 Sysmex Corporation
    • 6.1.9 Thermo Fisher Scientific Inc.
    • 6.1.10 Trivitron Healthcare

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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