Tissue Diagnostics Market by Product Type (Antibodies, Kits, Reagents, Instruments [Slide Stainer, Scanner]), Technology (Digital Pathology, IHC, ISH, H&E Staining), Cancer Type (Breast, NSCLC, Colorectal, Prostate), and End user - Global Forecast to 2029

The Tissue Diagnostics Market is projected to reach $8.52 billion by 2029, at a CAGR of 7.4% from 2022 to 2029. Biopsy, a procedure for detecting cancer, is recommended when an initial diagnostics test suggests an abnormality in an area of tissue in the body. It involves removing a small amount of abnormal tissue, which is sent to a laboratory for examination under a microscope. This process is called tissue diagnosis. Tissue diagnostics involves the study of tissue to diagnose disease and determine whether the tissue is cancerous, its type, and the characteristics of observed cancer. Tissue diagnostics uses instruments such as slide staining systems, slide scanners, tissue processing systems, embedding systems, and microarray.

The tissue diagnostics market is growing due to the rising prevalence of cancer globally, the availability of biomarkers and research on biomarkers, recommendations for cancer screening, the growing number of clinical trials for oncology drugs, and the availability of tissue-based companion diagnostics. Furthermore, the rising focus on personalized healthcare and the advent of digital pathology and tissue diagnosis automation offer significant market growth opportunities.

COVID-19 Impact Assessment

The COVID-19 pandemic negatively impacted the tissue diagnostics market due to the decrease in the number of people getting screened for cancer during the pandemic. In the U.S., screenings for cancers of the breast, colon, and cervix dropped by 94%, 86%, and 94% between 20^th January 2020 and 21^st April 2020, respectively (Source: Epic Research Journal). Many screening facilities closed temporarily, while others faced severe staffing shortages. Similarly, in Europe, cancer services were disrupted by 50% by the end of 2021 (Source: Global Pulse Survey). People were afraid to go to hospitals and other medical facilities for non-emergency procedures due to the fear of COVID-19, which negatively affected cancer screening practices.

In 2020, during the first lockdown, national screening programs for many cancers, such as colorectal carcinoma, breast carcinoma and cervical carcinoma, were paused in many countries. For instance,

• In May 2020, the Government of India suspended the population-based screening as part of the national program based on the risk associated with oral cavity examination. The Government launched the country’s first national cancer screening program in 2016 under the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS).
• In March 2020, the Scottish Government temporarily suspended the national screening programs for cervical, breast, and bowel cancers.

Thus, there was a decline in the screening rate, which affected the tissue diagnostics market. Apart from this, there were temporary supply chain disruptions due to lockdowns and travel restrictions, which also negatively affected the tissue diagnostics market.

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The Rising prevalence of Cancer Globally is Driving the Market Growth

According to World Health Organization (WHO), cancer is a leading cause of death worldwide, which accounted for 10 million deaths globally in 2020. Nearly 70% of cancer deaths occur in low and middle-income countries. Its early detection is important in reducing mortality, improving the chances of survival, and saving on treatment costs. The burden of cancer is growing globally, exerting tremendous economic strain on the countries. According to GLOBOCAN 2020, the number of new cancer cases is projected to reach 24.6 million in 2030 from 19.3 million in 2020. The International Agency for Research on Cancer (IARC) estimates that globally, 1 in 5 people develop cancer during their lifetime, and 1 in 8 men and 1 in 11 women die from the disease. Factors such as geriatric populations and socio-economic risks are driving this increase.

The Advent of Digital Pathology and Automation in Tissue Diagnostics is the Trend Prevailing in the Market

Automated tissue diagnostics are gaining acceptance due to the improved technical performance of the assays, which reduces reagent costs and assay time. Management of huge data and the lack of availability of skilled pathologists also contribute to the need for automation in tissue diagnostic systems. Innovations in the automation of staining equipment and novel platforms such as digital immunohistochemistry (IHC) are among the developments in tissue diagnostics.

Additionally, advanced laboratory information system (LIS) is also emerging in the field of tissue diagnostics. In the tissue diagnostics market, the development of end-to-end integrated workflow solutions will lead to the expansion of the market in the future. This can be achieved by collaborating with anatomic pathology LIS (APLIS) vendors and partnering with instrument distributors in emerging countries.

Automating the process is necessary as most of the workflow in a histology laboratory is manual. Many diagnostic equipment manufacturers are launching automated platforms to improve laboratory efficiency, reduce time, and provide pathologists with advanced systems for diagnosis. A few examples are mentioned below:

• In May 2022, Leica Biosystems (Germany) launched its BOND-PRIME, an advanced staining solution to expand diagnostic productivity in laboratories. This system enables lab technicians to load any slides in any combination, with any reagent, at any time.
• In August 2021, Lumito AB (Sweden) launched its instrument and staining reagents based on up-converting nanoparticles (UCNPs) used in tissue diagnostics. This provides visual depictions of tissue samples as input for making a diagnosis to the pathologists. The technology has several application areas, but the company initially focused on tissue diagnostics and digital pathology.

Key Findings in the Global Tissue Diagnostics Market Study:

Based on product type, in 2022, the consumables segment is expected to account for the largest share

Diagnostic consumables are one-time or limited-use items used during diagnosis. The large market share of this segment is attributed to the recurring requirement for consumables and research in developing novel reagents and other consumables. For example, the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), a collaborative consortium of academic and private-sector investigators, focuses on the systematic discovery, development, and validation of biomarkers and imaging methods to detect early-stage cancers and to assess the risk associated to developing cancer. Such research studies are driving the demand for consumables for tissue diagnostics.

Based on technique, in 2022, the immunohistochemistry (IHC) segment is expected to account for the largest share

Immunohistochemistry provides variations between different types of tumors, which is why it is preferred over conventional enzyme staining techniques, especially in cancer screenings. Thus, the high adoption of cancer screening, technological developments in immunohistochemistry, and availability of reimbursement policies for IHC-based tests contribute to the large market share of this segment.

Based on application, in 2022, the breast cancer segment is expected to account for the largest share

The prevalence of breast cancer is high and rising gradually across the globe. According to WHO, in 2020, 2.3 million women were globally diagnosed with breast cancer. Thus, the high prevalence of breast cancer and the presence of funding programs to support research and early screening of breast cancer are the factors contributing to the large market share of this segment. For instance, in October 2021, The Breast Cancer Research Foundation (BCRF) announced a USD 47.5 million commitment to fund breast cancer research from 2021–2022.

Based on end user, in 2022, the hospitals & diagnostic laboratories segment is expected to account for the largest share

The high flow of patient pool to the hospitals & diagnostic laboratories due to the rising prevalence of cancer globally and an increase in the budget for adopting advanced technologies contribute to the large market share of this segment.

Asia-Pacific: Lucratively Growing Regional Market

The growth of this regional market is attributed to the growing cancer prevalence, improving healthcare services, rising healthcare spending, and early cancer screening in Asia-Pacific.

Key Players

The report includes a competitive landscape based on an extensive assessment of the key strategic developments the key market players adopted over the past three years. The key players profiled in the global tissue diagnostics market report are F. Hoffmann-La Roche Ltd. (Switzerland), Thermo Fisher Scientific Inc. (U.S.), Abbott Laboratories (U.S.), Danaher Corporation (U.S.), QIAGEN N.V. (Netherlands), Becton, Dickinson and Company (U.S.), Abcam plc (U.K.), Agilent Technologies, Inc. (U.S.), Merck KGaA (Germany), Sakura Finetek Japan Co., Ltd. (Japan), Cell Signaling Technology, Inc. (U.S.), Bio-Genex Laboratories (U.S.), Bio SB, INC (U.S.), 3DHISTECH (Hungary), and HOLOGIC, INC. (U.S.)

Scope of the Report:

Tissue Diagnostics Market, by Product Type

• Consumables

• Kits & Reagents
• Antibodies

• Instruments

• Slide Staining Systems
• Slide Scanners
• Tissue Processors
• Tissue Microarrays
• Other Instruments

Note: Other instruments majorly include embedding systems, PCR, and NGS

Tissue Diagnostics Market, by Technique

• Immunohistochemistry (IHC)
• In-situ Hybridization (ISH)
• Digital Pathology
• H&E and Special Staining
• Molecular Diagnostics
• Other Techniques

Note: Other techniques majorly include flow cytometry, image cytometry, electron microscopy, and ELISA

Tissue Diagnostics Market, by Application

• Breast Cancer
• Lung Cancer
• Colorectal and Gastrointestinal Cancer
• Prostate Cancer
• Lymphoma
• Other Applications

Note: Other applications majorly include cervical cancer, skin cancer, and lip & oral cavity cancer

Tissue Diagnostics Market, by End User

• Hospitals & Diagnostic Laboratories
• Research Institutes
• Pharmaceutical Companies
• Contract Research Organizations

Tissue Diagnostics Market, by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • China
  • Japan
  • India
  • Rest of APAC (RoAPAC)
• Latin America
• Middle East & Africa

Key questions answered in the report: