Histology and Cytology Market

Market Overview

The global histology and cytology market size was valued at USD 16.20 billion in 2022. It is estimated to reach USD 54.29 billion by 2031, growing at a CAGR of 14.54% during the forecast period (2023–2031). Factors such as rising incidence of cancer and increasing awareness programs for cancer screening, significantly drives the histology and cytology market demand by 2031.

Histology and cytology are two distinct subfields of pathology. Often, cytology entails examining single cells or collections of cells. In addition to helping diagnose cancer, cytology is frequently used to look into disorders affecting various body regions, including detecting several infectious diseases and other inflammatory conditions. The Pap smear, a screening test employed to find precancerous cervical lesions that may develop into cervical cancer, is one example of a common application of cytology.

In contrast to cytology, histology entails evaluating a complete tissue segment with various cell types. It is commonly referred to as microscopic anatomy or microanatomy as it examines the microscopic anatomy of biological tissues. Histology is the microscopic equivalent of gross anatomy, which examines larger structures visible without a microscope. Histopathology, a branch of histology used in medicine, is the study of damaged tissue at the microscopic level. Trained medical professionals carry out histopathological examinations, and many qualified pathologists then offer diagnostic information based on their findings.

Highlights

• Cytology dominates thetype of examination segment
• Consumables and reagents dominate theproduct segment
• Drug discovery and designing dominates the application segment
• North America is the highest shareholder in the global market

Market Dynamics

Global Histology and Cytology Market Drivers

Rising Incidence of Cancer

A rise in demand for the detection of cell and tissue characteristics and the prevalence of cell-based diseases like cancer are anticipated to expedite the market over the forecast period. Cancer is among the leading reasons of death worldwide. As per the National Cancer Institute, the number of new cancer cases is expected to increase to 23.6 million by 2030; as per WHO, cancer accounted for approximately 8.8 million deaths in 2015. Similarly, according to Cancer Facts and Figures, 2020, published by the American Cancer Society, cancer is the second most common cause of death in the U.S., with an expected 1.8 million new cancer cases and 606,520 related deaths in 2020. Africa, Asia, and Central and South America account for nearly 60% of cancer deaths worldwide, and more than 60% of new cancer cases are diagnosed annually in similar regions.

Increasing Awareness Programs for Cancer Screening

The global histology and cytology market is bolstered by the growing demand for histology and cytology products due to surging screening awareness. The growth in awareness programs undertaken by organizations such as National Cervical Cancer Coalition, WHO, CDC, and the U.S. Preventive Services Task Force (USPSTF), for cancer screening, is a crucial factor expected to boost the market in the coming years. In addition, major market players are also undertaking initiatives to increase awareness about cervical and vaginal cancer screening, helping avoid deaths.

Additionally, National Breast and Cervical Cancer Early Detection Program (NBCCEDP) is a program initiated by the CDC. It provides access to timely cervical and breast cancer screening and diagnostic assistance to uninsured, underserved, and low-income women. Tennessee Breast & Cervical Screening Program is an initiative of the Tennessee government that aims to reduce breast cancer disparities. Such initiatives are expected to drive the market soon.

Global Histology and Cytology Market Restraints

Low Sensitivity of Cytology Tests

Cytology plays an important role in the detection of cancer. However, it is observed that cytology and histological testing sensitivity is low for early-stage cancer. A risk of an unreliable cytopathologic diagnosis of low-grade neoplasms has been observed, which is attributed to the poor manifestation of cellular and nuclear signs of neoplasm malignancy. Many different markers were developed to improve the sensitivity during the diagnosis of cancer samples. According to the study published by the National Institutes of Health, sensitivity for low-grade and high-grade bladder cancer was 38.0% and 52.0%, respectively. Hence, the low sensitivity of the cytological tests is likely to restrain the histology and cytology market growth.

Global Histology and Cytology Market Opportunities

Technological Developments

Histological techniques have largely been considered the primary means of determining tissue organization. However, these methods are also vital diagnostic tools for assessing chronic diseases due to several developments over the past three decades. Rapid advancements in microscopy and immunohistochemistry will likely drive these developments and the market. For instance, in July 2020, researchers from the University of Chicago's Medicine Comprehensive Cancer Center worked with European researchers to create a deep-learning algorithm that could deduce molecular alterations from histology images for several tumor types. It also provided a distinction between normal tissue and spatially resolved tumors. Such potential of implementing AI in the analysis of histology images is expected to assist clinicians in developing personalized treatment plans for patients.

Additionally, liquid-based cytology—a recent advancement—offers better clarity, requires less screening time, facilitates uniform smearing, and results in improved handling of inflammatory and hemorrhagic samples. Increasing demand for advanced diagnostic procedures to screen cancer is a pivotal aspect expected to create opportunities for the cytology and histology testing market over the forecast period.

Regional Analysis

Based on region, the global histology and cytology market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global histology and cytology market shareholder and is estimated to exhibit a CAGR of 14.09% during the forecast period. The high prevalence of cancer, the existence of important players, substantial R&D efforts, and the developed research infrastructure for pathology services are just a few of the reasons contributing to the expansion of the regional market. The area's high product approval and commercialization rate also affect the market's expansion. The U.S. dominated the regional market. The presence of organized and quality-assured cytology screening programs in the U.S. has increased the demand for these services. These programs are high quality and cover a large percentage of the population.

In addition, operating players are coming out with new products to satisfy the ever-increasing demand. For instance, in August 2021, BD introduced BD COR PX/GX System, a fully automated high-throughput diagnostic system, to expand its offerings in the U.S. market. This system is initially available with the company's Onclarity HPV Assay with extended genotyping. Periodic cervical cancer cytology screening has caused a 50% decrease in the prevalence of cervical cancer in the United States over the past 30 years. The efficiency of sample collection and cell detection has improved program effectiveness. All such factors together drive regional histology and cytology market growth.

Europe is estimated to exhibit a CAGR of 14.20% over the forecast period. Cancer is a crucial public health burden across European Union. According to WHO, Europe has more than 1.9 million mortalities and 3.7 million new cancer cases yearly. Hence, there is a need for large-scale adoption of advanced histology and cytology solutions. The European market is anticipated to grow owing to the aging population and increased access to healthcare. Similarly, European sample analysis guidelines aimed at achieving better quality in cancer screening procedures ensure and guide all aspects of organized screening programs. For instance, in August 2021, Unilabs, a Swiss company, in collaboration with Ibex Medical Analytics, announced the launch of a new AI-powered digital pathology platform across 16 European countries. Such initiatives are estimated to spur market growth.

In the Asia-Pacific, the market for histology and cytology is anticipated to grow quickly over the forecast period. The regional market is expanding due to several factors, including increased cancer awareness, a sizable target population, and improved healthcare infrastructure. In addition, researchers are evaluating new cytology more frequently, further boosting the market's expansion in the region. For instance, researchers in Japan assessed the effectiveness of liquid-based cytology versus traditional cytology in screening cervical cancer in February 2020. The study's findings suggested that, from a practical perspective, liquid-based cytology was more advantageous than traditional cytology.

In the Middle East and Africa, owing to poor economic conditions and underdeveloped healthcare services, many patients die due to cancer without registering any histological or cytological sampling or diagnosis of the disease. As a result, the actual number of cases is higher than the reported number. "Project Screen Soweto," a planned cervical cancer screening program in Soweto (an African township outside Johannesburg, South Africa), failed due to inadequate healthcare infrastructure deemed insufficient to cater to the needs of the country's poor population. However, in August 2017, South Africa's Department of Health launched cervical and breast cancer policies to address the high mortality from these cancers. Programs like these are likely to boost the market in the coming years.

Segmental Analysis

The global histology and cytology market is segmented by type of examination, product, and application.

Based on the type of examination, the global histology and cytology market is bifurcated into histology and cytology. 

The cytology segment dominates the global market and is projected to exhibit a CAGR of 15.89% over the forecast period. Cytology involves identifying and diagnosing diseases through microscopic examination of single and small clusters of cells in different types of smears. It is the safest, simplest, and quickest means of diagnosing diseases through analysis at a cellular level. Hence, owing to increased efforts in research and development, the adoption of this technique is growing all over the world. In addition, cytology tests are preferred over histological tests as specimens are easily available; they cause less discomfort and minimal serious complications and are cost-effective. The cost-effectiveness and advancements in cytological testing, such as FISH and Digital Image Analysis (DIA), are some of the factors accelerating the growth of the cytology segment.

Some major techniques used in histological studies are frozen section and semi-thin section techniques. Histological staining has undergone significant changes, and staining techniques have been modified through molecular biology assays and chemical and immunological techniques over the past few years. These techniques are generally referred to as histochemistry. Another significant branch is histopathology, which is a microscopic study of diseased tissue and is widely utilized in studying anatomical pathology. Investments by major market players and increasing commercialization of products are likely to drive the market.

Based on the product, the global histology and cytology market is bifurcated into instruments and analysis software systems and consumables and reagents. 

The consumable and reagents segment accounts for the most significant market share and is predicted to exhibit a CAGR of 15.25% over the forecast period. Histology and cytology consumable products include cassettes, coverslips, microscope slides, paraffin, reagents and solutions, embedding spare O-rings, slide storage boxes, biopsy foam pads, embedding base molds, cassettes storage drawers, plastic coplin staining jars, easy dip slide staining system, and centrifuge tubes. These consumables cater to most laboratories and research organizations. In addition, IHC reagents are used to visualize or identify proteins in tissue with the help of fluorescently labeled antibodies. These are used to identify the anatomy of the tissue and visualize the intensity of a specific antigen on a tissue section. Increasing investments, mergers and acquisitions, and regional expansion are expected to boost market growth.

Pathology and histology and instruments include microtomes, tissue processors, microscopes, cryostats, and tissue embedders that help prepare and examine tissues. Microtomes produce thin tissue slices and automatically prepare tissue samples for study and freezing stages. Automated histology instruments help enhance the productivity and processing of diagnostic samples, improve treatments, and decrease the risk of infection. Furthermore, the launch of new products and approval and adoption of innovative technologies are expected to propel market growth. For instance, in January 2021, Roche launched uPath Dual ISH image analysis and uPath HER2 (4B5) image analysis, automated digital pathology algorithms, to help determine treatment strategies for breast cancer patients. The image analysis algorithm utilizes AI to help pathologists diagnose accurately and faster.

Based on application, the global histology and cytology industry is segmented into drug discovery and designing, clinical diagnostics, and research. 

The drug discovery and designing segment owns the highest market share and is estimated to exhibit a CAGR of 14.83% during the forecast period. The broad applications of histology and cytology in drug discovery and designing propel segment growth. Pharmaceutical and biotechnology companies use digital histology and cytology instruments for various toxicological and oncological studies. Pathology study is fundamental to successful drug development by facilitating clinical trials and basic research. Moreover, the approval of diagnostic instruments, a rise in collaborations with research laboratories, and the adoption of advanced technology for testing and diagnosis are expected to propel market growth.

The clinical diagnostics segment is divided into point-of-care (PoC) and non-PoC. Factors contributing to the market growth are favorable reimbursement policies, product launches, advanced technology adoption, and increasing awareness about diagnosis and treatment. For instance, in March 2020, Roche declared that the FDA approved the CINtec PLUS cytology test to aid clinicians in improving cervical cancer diagnosis.

Recent Developments

• April 2023- AIxMed, an early-stage smart cytology business at the intersection of artificial intelligence (AI) and medicine, revealed that it raised USD 2.75 million in a SAFE round of financing from existing investors to further develop its digital cytology platform.
• March 2023- HistoWiz, Inc., the leading provider of digital histology, established a new 10,197-square-foot central laboratory in the Alexandria Center for Life Science – Long Island City in Queens, New York. The HistoWiz laboratory facility houses the Company's core histology services group, which includes tissue processing, paraffin embedding, sectioning, and staining.