Global Histopathology Services Market

Histopathology Services Market size was valued at USD 25.90 Mn. in 2024 and the total Histopathology Services revenue is expected to grow by 8 % from 2025 to 2032, reaching nearly USD 47.95 Mn.

Histopathology Services Market Overview:

Histopathology services are used to examine biological tissues in order to diagnose diseases. Tissues are examined under a microscope as part of the procedure. Biopsies can now be obtained from previously inaccessible sites such as the pancreas and the peritoneum using imaging techniques. Growing demand for biologics and the increasing prevalence of chronic diseases drive histopathology services market growth. Histopathology and immunohistochemistry limitations hamper the growth of the histopathology services market.

Histopathology tests are performed in histopathology research centers or laboratories, where a pathologist identifies changes or variations from normal tissues caused by disease. One of the major factors driving the global histopathology services market is the alarming increase in the number of such fatal medical conditions. Aside from an increase in the prevalence of such chronic conditions, an increase in health care expenditure, an increase in the geriatric population, and an increase in the use and effectiveness of biomarkers for disease diagnosis all contribute to the growth of the global histopathology services market.

Additionally, technological advancements have resulted in more sophisticated pathology methods and services. This increases the histopathology services market demand. Disease diagnosis and treatment research and development are thriving, particularly in developed countries.

Developing countries are also contributing to market demand as a result of government initiatives to raise awareness about new cutting-edge technologies. Because of their low cost, diagnostic centers for histopathology services fuel demand.

The histopathology services market for biologics is growing at an unprecedented rate, owing to the growth of biologics pipelines, increased manufacturing complexity, and a shift in company focus toward core activities. Biologics manufacturing has seen a significant increase. Once novel technologies have received approval from domestic and international approving bodies, there is an urgent need to scale up production. With the introduction of more biological products and biosimilars to the market, competition within the biopharmaceutical sector is becoming violent.To know about the Research Methodology :- Request Free Sample Report

Histopathology Services Market Dynamics:

Bolstering demand for the disease detection

Increased demand for the detection of cell and tissue characteristics, as well as an increase in the global prevalence of cell-based diseases such as cancer, are expected to drive the histopathology services market during the forecast period. The incorporation of digital solutions into histopathology diagnosis provides the benefit of quick interpretation of primary diagnostic data. Additionally, businesses are introducing new and advanced digital histology systems to aid in the rapid on-site evaluation of histology samples. Antech Diagnostics, for example, will launch a Digital histology Scanner in North America in June 2022.

This scanner can deliver whole-slide interpretations in less than 2 hours, which helps to reduce examination time and assess a large number of samples in POC settings. The growing popularity of immunohistochemistry for visualizing cellular components to diagnose a wide range of diseases, including cancer and other infectious diseases, is fueling the histopathology services market growth. Several companies are working to create cutting-edge immunohistochemistry instruments and reagents. For example, Biocare Medical, LLC released ONCORE Pro in January 2022, a fully automated staining platform for Immunohistochemistry (IHC) and In Situ Hybridization (ISH) applications.

The In Vitro Diagnostic (IVD) labeled system will allow diagnostic laboratories to increase sample throughput while maintaining an optimal turnaround time. The COVID-19 pandemic is acting as a positive catalyst for histopathology services market growth. The strategic collaboration is observed between the companies for developing antibodies specific for immunohistochemistry validation. For example, in September 2020, GeneTex, Inc. collaborated with HistoWiz, Inc. to develop various validated antibodies for immunohistochemistry in human COVID-19-infected tissues.

Increasing demand from the healthcare professionals

Growing cancer prevalence, increasing standardization of pathological laboratories, and technological advancements in diagnostic and molecular techniques are driving the growth of the histopathology services market. Cancer's growing social burden has been identified as a major threat to developing countries, owing to lower disposable income and changing demographics. Cancer has been the leading cause of death worldwide, accounting for the greatest proportion of deaths.

According to the World Health Organization's (WHO) September 2022 update, the most common cancers in 2020 (in terms of new cases of cancer) were: breast (2.36 million cases); lung (2.23 million cases); colon and rectum (1.92 million cases); prostate (1.42 million cases); skin (non-melanoma) (1.25 million cases); and stomach (1.22 million cases) (1.10 million cases). As a result, the growing number of cancer patients has a direct impact on the histology service market. These histological methods thus contribute to the improvement of diagnostic methods' sensitivity, specificity, and accuracy.

Additionally, according to the Globocan 2020 report, approximately 2,206,772 new cases of lung cancer were diagnosed globally in 2020, and approximately 1,796,145 people died from lung cancer globally in 2020, indicating a lung cancer burden. In addition, according to World Health Organization data published in 2020, the number of lung cancer cases in 2040 is expected to be 3,503,379. The market is expected to grow due to an increase in lung cancer among the global population. As a result, the prevalence of cancer plays a significant role in increasing demand for the histopathology services market.

Histopathology Services Market Restraints

High Initial Costs for Histopathology Service Installation

Although incorporating and utilizing these systems in modern medicine has its advantages and applications in pathology, digitization of tools necessitates a large upfront cost for installation and training in using those systems to regularise workflow. Digital devices are expensive, and they require software to analyze, share, and store data, which can be purchased separately or as part of an end-to-end full-system product offering.

According to a 2022 article in the Journal of Pathology Informatics, pathology digitization necessitates imaging hardware, information technology infrastructure, and trained scanning technicians. Imaging hardware, such as whole slide scanners, can cost between USD 100,050 and USD 400,050 million. Software purchased on a subscription basis can cost up to USD 15,000 per year. Furthermore, value-added software services and customized tools may increase the cost. The high cost of integration impedes the adoption of this technology and, as a result, the growth of the histopathology services market.

In recent years, there has been an increase in the number of pathologists retiring compared to the number of pathologists entering the workforce. Because of a critical shortage of pathologists, this factor has had a direct impact on the market. This factor has also impacted the potential consumer base for adopting and training these systems, negatively affecting the
histopathology services market.

Histopathology Services Market Opportunity

Growing Adoption of Digital Tools Based on Artificial Intelligence to boost market

The increased adoption of artificial intelligence-based digital tools by key consumers as a result of increased demand for workflow management is expected to boost histopathology services market growth. The increased focus of major players on patenting innovative technology in order to provide a customized platform for key digital pathology stakeholders provides the companies with a competitive advantage in the histopathology services market. In addition, key market participants now prefer to obtain IPS certifications for their patent registrations.

The certification is part of a collaborative program involving five major patent offices around the world, including the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO), among others. These certifications allow companies to distribute their digital tools in key countries without having to apply for individual patents.

For example, OptraSCAN, an end-to-end solution provider, was awarded a US patent for its digital imaging technology in May 2022. OS-SiA scanner The patent now gives the company equipped with inbuilt Artificial Intelligence a competitive advantage. Intelligence (Al) to analyze the scanned tissue and provide real-time predictive analysis. Additionally, strategic initiatives to develop and standardize sharing platforms to enable seamless data transfer across the industry are expected to support the adoption of artificial intelligence in pathology and, as a result, for histopathology services market growth.

Histopathology Services Market Segment Analysis:

Based on Type, The histopathology services market is divided into surgical specimens, breast biopsy, gastrointestinal biopsy, lung biopsy, renal biopsy, gastrointestinal biopsy, pancreatic biopsy, skin tissue biopsy, testicular biopsy, and others. As it is performed for all surgical resections provided for diagnosis by surgeons, the surgical specimen segment accounted for the largest market share. It is extracted during a surgical procedure on any organ or entire diseased part in order to diagnose a suspected disease.

A surgical specimen is histopathologically examined to confirm the proximity of previously analyzed disease, stage or extent of chronic disease, guarantee that the entire disease area has been expelled, recognize the proximity of unknown concurrent ailments, and provide information for postoperative treatment.

Based on the End User, the histopathology services market is divided into hospitals & clinics, diagnostic laboratories & reference laboratories, research institutes, and others. In 2023, hospitals and clinics had the largest share of the 45% of the histopathology services market. The segment's dominance can be attributed to the growing number of hospital admissions and pathology services provided by major hospitals.

Additionally, strategic collaborations to introduce advanced products through partnerships with key hospitals, as well as higher adoption of digital tools due to increased footfall, is expected to drive the segment's growth. Leading hospitals in the United States, the United Kingdom, and other developed countries have invested in pathology tools and systems to improve workflow, which has been critical in attracting a large patient pool. Sectra, for example, announced an agreement with UniHA, a cooperative of French public hospitals, in May 2022.

The agreement will allow UniHA-affiliated hospitals to purchase Sectra's solution on predetermined terms and conditions. The collaboration enables the hospital network to manage its workflow, thereby supporting the segment's growth. The diagnostic laboratories & reference laboratories segment, on the other hand, is expected to grow during the forecast period due to an increase in the number of diagnostic laboratories & reference laboratories developing databases through digitizing slides is expected to support the adoption of digital tools through clinical laboratories.

Furthermore, key solution providers are collaborating to expand their product portfolio by offering customized solutions, which is expected to fuel the segment's growth. e For example, in March 2022, F. Hoffmann-La Roche Ltd. announced a collaboration with Bristol Myers Squibb to support the advancement and deployment of two new pathology algorithms. The two assay methods created are intended for use in clinical trials.

The goal of the collaboration is to develop an Al-based image analysis algorithm to help pathologists interpret the VENTANA PD-L1 (SP142) Assay. Such collaborations aimed at providing key solutions to meet rising demand in clinical laboratories are expected to drive the segment's growth. Furthermore, the increased use of telepathology for remote diagnostics during the pandemic has given clinical laboratories an advantage in raising awareness among key consumers.

Histopathology Services Market Regional Insights:

North America is expected to hold a significant market share in the histopathology services market due to the region's growing geriatric population, rising cancer incidence, and increased awareness about cancer screening.

For example, the American Cancer Society predicts that over 1.9 million new cancer cases will be diagnosed in the United States in 2022. Furthermore, 80% of people diagnosed with cancer in the United States are 55 or older, with 57% being 65 or older. As a result of the high prevalence of cancer and the growing affected geriatric population, the demand for diagnostics contributes to the histopathology services market growth.

According to breastcancer.org's January 2022 update, approximately one in eight women in the United States (13.5%) will develop invasive breast cancer during their lifetime. According to the same source, an estimated 287,850 new cases of invasive breast cancer in women in the United States will be diagnosed in 2022, along with 51,400 new cases of non-invasive (in situ) breast cancer.

According to the same source, approximately 2,710 new cases of invasive breast cancer in men will be diagnosed in 2022. The lifetime risk of breast cancer for a man is approximately 1 in 833. As a result, all of these factors are expected to contribute to the growth of the histopathology services market. Additionally, product approvals in the United States are expected to contribute to the histopathology services market growth. For example, in May 2022, Hologic received US Food and Drug Administration premarket approval for the Company's ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications.

Moreover, increased awareness of advanced therapeutics and the presence of well-established healthcare infrastructure are driving the overall regional histopathology services market to a large extent.

Histopathology Services Market Scope: Inquiry Before Buying

Histopathology Services Market, by Region

North America (United States, Canada and Mexico)
 Europe (UK, France, Germany, Italy, Spain, Sweden, Austria and Rest of Europe)
Asia Pacific (China, South Korea, Japan, India, Australia, Indonesia, Malaysia, Vietnam, Taiwan, Bangladesh, Pakistan and Rest of APAC)
 Middle East and Africa (South Africa, GCC, Egypt, Nigeria and Rest of ME&A)
South America (Brazil, Argentina Rest of South America)

Histopathology Services Market, Key Players are

North America

1. Becton, Dickinson and Company (United States)
2. Thermo Fisher Scientific Inc. (United States)
3. Danaher Corporation (United States)
4. Laboratory Corporation of America Holdings (United States)
5. Cureline, Inc. (United States)
6. Experimental Pathology Laboratories Inc. (United States)
7. Charles River Laboratories International, Inc. (United States)
8. Comparative Biosciences, Inc. (United States)
9. SeqMatic LLC (United States)
10. CellCarta (Canada)

Asia Pacific

11. Sysmex Corporation (Japan)
12. SMC Laboratories Inc. (Japan)
13. Trivitron Healthcare Pvt. Ltd. (India)
14. Sonic Healthcare Limited (Australia)

Europe

15. F. Hoffmann-La Roche Ltd. (Switzerland)
16. Merck KGaA (Germany)
17. Koninklijke Philips N.V. (Netherlands)
18. Scantox A/S (Denmark)
19. HistologiX Ltd. (United Kingdom)

Middle East and Africa

20. The Lancet Group of Laboratories (South Africa)

Frequently Asked Questions:

1] What segments are covered in the Global Histopathology Services Market report?
Ans. The segments covered in the Histopathology Services Market report are based on Type of Examination and End User.

2] Which region is expected to hold the highest share in the Global Histopathology Services Market?
Ans. The North America region is expected to hold the highest share in the Histopathology Services Market.

3] What is the market size of the Global Histopathology Services Market by 2032?
Ans. The market size of the Histopathology Services Market by 2030 is expected to reach US$ 47.95 Mn.

4] What is the forecast period for the Global Histopathology Services Market?
Ans. The forecast period for the Histopathology Services Market is 2025-2032.

5] What was the market size of the Global Histopathology Services Market in 2024?
Ans. The market size of the Histopathology Services Market in 2024 was valued at USD 25.90 Mn.