The North America Tissue Diagnostics Market is expected to reach $2.96 billion by 2030, at a CAGR of 7% during the forecast period 2023–2030. Tissue diagnostics involves the study of tissue to diagnose disease and determine the type of the tissue, whether it's cancerous, and the characteristics of observed cancer. It uses instruments such as slide staining systems, slide scanners, tissue processing systems, embedding systems, and tissue microarrays.
The increasing prevalence of cancer, rising healthcare expenditure, advanced infrastructure for cancer diagnosis, recommendations/guidelines and programs for cancer screening and government initiatives for cancer research are the key factors driving the tissue diagnostics market in North America. In addition, the inclination towards personalized healthcare, growing awareness regarding early disease diagnosis, and adoption of digital pathology & automation in tissue diagnostics are expected to offer significant growth opportunities in the market.
Rising Prevalence of Cancer Cases Drive the North America Tissue Diagnostics Market
According to the American Cancer Society, cancer is a leading cause of death, accounting for around 608,570 deaths in the U.S. in 2021. Prostate, lung, and colorectal cancers are common in men and breast and colorectal cancers in women. Cancer incidence is increasing due to unhealthy diets, tobacco use, alcohol consumption, sedentary lifestyles, carcinogen exposure, obesity, and pollution. Early detection is critical in reducing mortality, improving the chances of survival, and saving on treatment costs. The burden of cancer is growing in North America due to the growing population, changing lifestyles, people living longer and others.
Lung cancer is the second most common cancer in men and women. According to the GLOBOCAN, in 2020, it is estimated that around 253,537 new lung cancer cases were diagnosed, and it is expected to reach up to 352,415 by 2040. Most older adults are diagnosed with cancer due to declining bodily functions and immunity. The people diagnosed with lung cancer are usually 65 years and above.
Early diagnosis and the exact nature of the tumor detected are important in cancer diagnostics. Early cancer detection and access to effective anti-cancer treatments can improve patients’ survival rates and quality of life. Thus, the overall scenario indicates that the rising prevalence of cancer is expected to boost the demand for tissue diagnostics in North America, driving the market.

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Recommendations/Guidelines and Programs for Cancer Screening Drives the North America Tissue Diagnostics Market
Screening tests are used to detect cancer before a person has any symptoms. Cancer screening programs aim to reduce mortality and morbidity through early detection and treatment. The American Cancer Society's (ACS) recommendations & guidelines for screening certain cancers are useful for early detection. In 2021, the American Cancer Society launched the ‘Get Screened’ campaign to encourage people to schedule regular cancer screening tests. Although the COVID-19 pandemic resulted in cancer screening procedures being put on hold, the American Cancer Society's Get Screened initiative aimed to increase cancer screening rates by raising awareness about the importance of recommended screenings. In June 2021, PatientPoint, a patient engagement platform, launched a point-of-care campaign to promote the ACS Get Screened initiative. This point-of-care campaign highlighted the importance of routine cancer screening across nearly 100,000 healthcare providers in more than 25,000 offices in the country.
Key Findings of North America Tissue Diagnostics Market Study:
The Consumables Segment is Expected to Dominate the North America Tissue Diagnostics Market in 2023
Among the product types, in 2023, the consumables segment is expected to account for the largest share of the market. Factors such as the recurring requirement for consumables and research in developing novel reagents, the frequent use of antibodies, assays & kits in the detection of various infectious diseases, commercial availability of a diverse range of reagents, and increasing demand for COVID-19 testing products are driving the growth of this segment.
The Immunohistochemistry (IHC) Segment is Expected to Dominate the North America Tissue Diagnostics Market in 2023
Among the techniques, in 2023, the immunohistochemistry (IHC) segment is expected to account for the largest share of the market. This segment’s large share is mainly attributed to the high cancer screening rate, technological advancements in IHC, and the availability of reimbursement policies for IHC-based tests. Immunohistochemistry provides variations between different types of tumors; hence it is preferred over conventional enzyme staining techniques, especially in cancer screening.
Based on Application, the Breast Cancer Segment is Expected to Dominate the North America Tissue Diagnostics Market in 2023
Among the applications, in 2023, the breast cancer segment is expected to account for the largest share of the market. The large market share of this segment is mainly attributed to the high incidence rate of breast cancer. Breast cancer is the most prevalent cancer in the world. In 2020, there were 281,591 women diagnosed with breast cancer. The incidence of breast cancer is estimated to reach 316,632 cases by 2030 in the region. (Source: International Agency for Research on Cancer)
In 2023, the Hospitals & Diagnostic Laboratories Segment is Expected to Account for the Largest Share of the North America Tissue Diagnostics Market
Among the end users, in 2023, the hospitals & diagnostics laboratories segment is expected to account for the largest share of the North America tissue diagnostics market. The large market share of this segment is attributed to the high cancer incidence rate, the aging population, the availability of several cancer screening programs, and awareness regarding cancer diagnostics. Hospitals & diagnostic laboratories are the first point of contact for diagnosing or treating diseases. These laboratories perform various tests to help diagnose diseases and ensure the appropriate clinical treatment and prevention planning. They are also adopting advanced technologies to boost cancer diagnosis.
U.S.: Fastest Growing Market
The U.S. is expected to account for the largest share of the North America tissue diagnostics market in 2023. The large market share of the segment is attributed to the high geriatric population coupled with the growing number of cancer cases, government funding and initiatives to promote cancer screenings and the presence of key players in the region.
Key Players
The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presence, and key strategic developments adopted by leading market players in the industry over the years. The key players profiled in the North America tissue diagnostics market 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), Cell Signaling Technology, Inc. (U.S.), BIO SB Inc.(U.S.), Bio-Genex Laboratories (U.S.), HOLOGIC, INC. (U.S.), and Sakura Finetek Japan Co., Ltd. (Japan).
Scope of the Report:
North America Tissue Diagnostics Market Assessment, by Product Type
- Consumables
- Kits & Reagents
- Antibodies
- Instruments
- Slide Staining Systems
- Tissue Microarrays
- Slide Scanners
- Tissue Processors
- Other Instruments
(Note: Other instruments comprise embedding systems, PCR, and NGS systems).
North America Tissue Diagnostics Market Assessment, by Technique
- Immunohistochemistry (IHC)
- In-situ hybridization (ISH)
- Digital Pathology
- H&E and Special Staining
- Molecular Diagnostics
- Other Techniques
(Note: Other techniques comprise flow cytometry, ELISA, image cytometry, and electron microscopy).
North America Tissue Diagnostics Market Assessment, by Application
- Breast Cancer
- Lung Cancer
- Colorectal & Gastrointestinal Cancer
- Prostate Cancer
- Lymphoma
- Other Applications
(Note: Other applications include cervical, skin, and lip & oral cavity cancers).
North America Tissue Diagnostics Market Assessment, by End User
- Hospitals & Diagnostic Laboratories
- Research Institutes
- Pharmaceutical Companies
- Contract Research Organizations
North America Tissue Diagnostics Market Assessment, by Country
Key questions answered in the report: