U.S. Tissue Diagnostics Market Size Worth $2.81 Billion By 2028

June 2021 | Report Format: Electronic (PDF)

U.S. Tissue Diagnostics Market Growth & Trends

The U.S. tissue diagnostics market size is estimated to reach USD 2.81 billion by 2028, registering a CAGR of 3.91% over the forecast period, according to a new report by Grand View Research, Inc. Pivotal factors supplementing the market growth include continuous rise in the cases of cancer, growth in organ transplantation & donation, and increased acceptance toward personalized medicine & companion diagnostics in the U.S. Increase in the number of research activities targeted toward the development of novel tissue diagnostics solutions is also expected to drive the market.

The field of anatomic pathology has witnessed a paradigm shift, which can be attributed to the exponential growth in cancer incidence in the U.S., thereby expanding the clinical pathology industry. Also, steady convergence of molecular pathology with anatomic pathology, steep adoption of novel biopsies for cancer detection, and integration of digital technologies is expected to collaboratively make a positive impact on market growth.

Tissue analysis provides significant information, which is difficult to understand using conventional molecular techniques. Currently, companion diagnostic tests are rapidly being adopted by pharmaceutical companies for obtaining first-line therapy designations/approvals for their products. In addition, their use in the identification of patient cohorts, which are likely to benefit from targeted therapeutics, has increased the significance of tissue diagnostics in the development of precision medicine.

In addition, the field of tissue diagnostics has witnessed gradual evolution with the introduction of upgraded technologies, including Fluorescence In Situ Hybridization (FISH), Immunohistochemistry (IHC), Immunofluorescence (IF), comparative genomic hybridization, and Next-Generation Sequencing (NGS). Key players are focused on identifying novel biomarkers and developing assays for advanced cancer diagnosis. Furthermore, companies are conducting biomarker pathologist training programs to boost the adoption rate of modern pathological solutions.

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U.S. Tissue Diagnostics Market Report Highlights

  • The IHC segment held the highest revenue share of over 28% in 2020. The segment’s dominance is attributed to the wide acceptance of IHC across clinical laboratories for different workflows

  • These workflows include tissue examination targeted toward disease prognosis and anticipating therapeutic response among patients with cancer

  • The digital pathology segment is anticipated to register the fastest CAGR during the forecast period mainly due to heavy investments in infrastructure as well as an onsite server for image digitization

  • In addition, the lack of skilled pathologists has propelled the demand for automated systems in disease diagnosis, thereby boosting the segment growth

  • An increase in the prevalence of breast cancer along with the launch of novel products dedicated to breast cancer detection have led to the dominance of this application segment

  • Moreover, the advent of genomic technologies aimed at gaining a better understanding of the genetic markup of a tumor is further offering lucrative growth opportunities to companies

  • The market players are investing significantly in novel product development and acquisition of small players to increase their revenue share

U.S. Tissue Diagnostics Market Segmentation

Grand View Research has segmented the U.S. tissue diagnostics market on the basis of technology & product and application:

U.S. Tissue Diagnostics Technology & Product Outlook (Revenue, USD Million, 2017 - 2028)

  • Immunohistochemistry

    • Instruments

      • Slide Staining Systems

      • Tissue Microarrays

      • Tissue Processing Systems

      • Slide Scanners

      • Other Products

    • Consumables

      • Reagents

      • Antibodies

      • Kits

  • In situ Hybridization

    • Instruments

    • Consumables

    • Software

  • Primary & Special Staining

    • H&E Staining

    • Special Staining

  • Digital Pathology &Workflow

    • Whole Slide Imaging

    • Image Analysis Informatics

    • Information Management System Storage & Communication

  • Anatomic Pathology
    • Instruments

      • Microtomes & Cryostat Microtomes

      • Tissue Processors

      • Automatic Strainers

      • Other Products

    • Consumables

      • Reagents & Antibodies

      • Probes & Kits

      • Others

U.S. Tissue Diagnostics Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Breast Cancer

  • Non-Small Cell Lung Cancer (NSCLC)

  • Prostate Cancer

  • Gastric Cancer

  • Other Cancers

List of Key Players of U.S. Tissue Diagnostics Market

  • Merck KGaA

  • Thermo Fisher Scientific, Inc.

  • F. Hoffmann-La Roche Ltd.

  • Abbott Laboratories

  • Siemens Healthineers AG

  • Danaher

  • bioMérieux SA


  • Becton, Dickinson & Company (BD)

  • Agilent Technologies, Inc.

  • General Electric Company (GE Healthcare)

  • BioGenex

  • Cell Signaling Technology, Inc.

  • Bio SB

  • DiaGenic ASA

  • Sakura Finetek Japan Co., Ltd.

  • Abcam plc

  • Enzo Life Sciences, Inc.

  • VITRO SA (Master Diagnóstica)

  • TissueGnostics GmbH

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