U.S. Tissue Diagnostics Market Analysis By Application, And Segment Forecasts, 2021-2028

 U.S. Tissue Diagnostics Industry Overview

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.

 

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:

Based on the Technology & Product Insights, the market is segmented into Immunohistochemistry, In situ Hybridization, Primary & Special Staining, Digital Pathology &Workflow, and Anatomic Pathology.

  • The Immunohistochemistry(IHC) segment dominated the market in 2020 accounting for a revenue share of 28.02%. The IHC technology is widely used for clinical research & development of cancer diagnostics and therapeutics; which is attributed to the high share of the segment.

 

  • It is widely preferred over traditional special enzyme staining methods as the conventional methods only identify a limited number of enzymes, tissue structures, and proteins. Whereas IHC tests are specific and helpful in highlighting the distinction between different types of cancer. It is considered the most profitable sub-segment under tissue diagnostics. Slide staining systems have been the key contributors to the revenue generated by the IHC segment.

 

Based on the Application Insights, the market is segmented into Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Prostate Cancer, Gastric Cancer, and Other Cancers.

  • The breast cancer application segment accounted for the highest revenue share of over 49% in 2020. Tissue diagnostics are crucial in evaluating breast cancer in patients. The most commonly used tissue biopsy tests for breast cancer include fine-needle aspiration biopsy, core needle biopsy, and surgical biopsy.

 

  • Whereas tissue diagnostics is set to gain immense traction across gastric cancer and Non-Small Cell Lung Cancer (NSCLC) applications. The gastric cancer application segment is expected to grow at a CAGR of 4.03% from 2021 to 2028. Innovations in the detection of cancers in samples/specimens are expected to drive the segment growth.

 

Key Companies & Market Share Insights

Industry participants are focusing on novel product development collaborations with other participants to sustain market competition and gain a competitive edge. For instance, in January 2021, F. Hoffmann-La Roche Ltd. launched the CE-IVD digital automated algorithms for pathology, uPath HER2 Dual ISH image analysis and uPath HER2 (4B5) image analysis for diagnosis of breast cancer. These algorithms facilitate the quick determination of whether the tumors are positive for HER2 biomarkers.

In August 2020, Thermo Fisher Scientific, Inc. signed an agreement with (HTI) Hengrui Therapeutics, Inc., a U.S. subsidiary of a Chinese pharmaceutical company, for developing a Companion Diagnostic (CDx) for identifying NSCLC by using Oncomine Precision Assay. The assay helps in the detection of around 50 cancer-related biomarkers from FFPE tumor tissues or liquid biopsy specimens. Some key participants operating in the U.S. tissue diagnostics market include:

  • Merck KGaA
  • Thermo Fisher Scientific, Inc.
  • Hoffmann-La Roche Ltd.
  • Abbott Laboratories
  • Siemens Healthineers AG
  • Danaher
  • bioMérieux SA
  • QIAGEN
  • 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

 

Order a free sample PDF of the U.S. Tissue Diagnostics Market Intelligence Study, published by Grand View Research.

 

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

 

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