US Tissue Diagnostics Market Size, Share, Analysis, Trends, Growth, Forecasts, 2032

US Tissue Diagnostics Industry Prospective:

The US tissue diagnostics market size was worth around USD 2,156 million in 2023 and is predicted to grow to around USD 3,897 million by 2032 with a compound annual growth rate (CAGR) of roughly 6.8% between 2024 and 2032.

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US Tissue Diagnostics Market: Overview

By determining the biological background of diseases, tissue diagnostics involves the examination and testing of particular tissue samples. They help uncover possible causes and treatment choices by revealing the precise type and degree of malignancy, which is utilized to detect specific medical illnesses like cancer and inflammatory disorders. Tissue diagnostics can be performed using a variety of methods, including core and open biopsy, and are very accurate and reasonably priced. These days, these diagnoses are also made using sophisticated technologies including digital pathology, in situ hybridization (ISH), immunohistochemistry (IHC), and special staining.

Key Insights

• As per the analysis shared by our research analyst, the US tissue diagnostics market is estimated to grow annually at a CAGR of around 6.8% over the forecast period (2024-2032).
• In terms of revenue, the US tissue diagnostics market size was valued at around USD 2,156 million in 2023 and is projected to reach USD 3,897 million, by 2032.
• The increasing prevalence of cancer is expected to propel the US Tissue Diagnostics market growth over the projected period.
• Based on the product, the immunohistochemistry segment is expected to dominate the market over the forecast period.
• Based on the application, the breast cancer segment is expected to capture a significant market share during the analysis period.
• Based on the state, California is expected to dominate the market over the projected period.

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US Tissue Diagnostics Market: Growth Drivers

Advancements in technology drive market growth

The US tissue diagnostics industry is anticipated to be impacted by developments in imaging technology. In the United States, breast cancer is among the most prevalent cancers to affect women. As imaging tools have advanced technologically, so has the sensitivity of breast cancer detection and diagnosis. Furthermore, compared to traditional methods, molecular imaging and autofluorescence-based diagnostics are beneficial to cancer patients. These methods provide a non-invasive diagnosis by reducing the necessity for a biopsy. The development of companion diagnostics and biomarkers, together with the declining cost of sequencing, is anticipated to boost this market's growth in the years to come.

US Tissue Diagnostics Market: Restraints

High-cost related R&D and clinical trials impede market growth

For pharmaceutical and biotech businesses, creating treatments and diagnostics for cancer patients is a dangerous endeavor because it requires significant investment in research and development. The companies seeking to commercialize a diagnostic test or medicinal therapy are responsible for covering the costs associated with obtaining clinical validation and regulatory approval. Moreover, clinical trial failure or a dearth of data supporting a novel diagnostic procedure or medication therapy greatly raises the costs to the business participants. The industry must concentrate on finding ways to lower the high failure rates as a remedy. The US tissue diagnostics market is negatively impacted by this circumstance. Nonetheless, it is anticipated that strengthening public-private partnerships and creating effective regulatory frameworks will aid in removing this obstacle.

US Tissue Diagnostics Market: Opportunities

Growing collaboration among the key market players provides a lucrative opportunity for market growth

The growing collaboration among the key market players is expected to offer a lucrative opportunity for US tissue diagnostics market expansion during the forecast period. For instance, in February 2023, to boost research and innovation efforts, Janssen Biotech Inc. (Janssen) and Roche extended their partnership to develop companion diagnostics for targeted treatments. With the new, enlarged partnership, Roche and Janssen will have more options to work together in the precision medicine space using a variety of companion diagnostics technologies, such as digital pathology, immunohistochemistry (IHC), polymerase chain reaction, next-generation sequencing, and immunoassays.

US Tissue Diagnostics Market: Challenges

A stringent approval process poses a major challenge to market expansion

The FDA's strict regulations have put an enormous amount of pressure on the tissue diagnostics business in the United States. To receive approval, any novel tissue diagnostic method or product must go through extensive testing and clinical trials. This process can discourage smaller businesses or startups from entering the US tissue diagnostics market because it frequently entails extensive documentation, protracted timescales, and significant financial expenditure.

US Tissue Diagnostics Market: Segmentation

The US tissue diagnostics industry is segmented based on technology, application, and state.

Based on the technology, the US tissue diagnostics market is bifurcated into immunohistochemistry, in situ hybridization, primary & special staining, digital pathology & workflow, and anatomic pathology. The immunohistochemistry segment is expected to dominate the market over the forecast period. The large market share of IHC can be ascribed to its widespread application in clinical research and development of cancer diagnostics and therapies. When it comes to analyzing tissues or specimens for early disease diagnosis, prognosis, and therapeutic response prediction in cancer patients, immunohistochemistry (IHC) is one of the most crucial tools and technologies. It is frequently chosen over more established techniques for particular enzyme staining because the latter can only identify a restricted range of enzymes, proteins, and tissue structures. IHC tests, on the other hand, are useful and specific in revealing the differences between various cancer types. It is regarded as the tissue diagnostics subsegment that is most profitable. The primary source of income for the IHC market has been slide-staining systems.

Based on the application, the US tissue diagnostics industry is segmented into breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric cancer, and other cancers. The breast cancer segment is expected to capture a significant market share during the analysis period. When diagnosing individuals with breast cancer, tissue diagnostics are essential. The three most popular tissue biopsy procedures for breast cancer are surgical, core needle, and fine-needle aspiration biopsy. Complementary diagnostics have been created by businesses to avoid the unfavorable prognosis of breast cancer variations with few available treatments. For instance, the PD-L1 IHC 22C3 pharmDx from Agilent Technologies, Inc. was approved by the U.S. FDA in November 2020 and aids in the identification of patients with triple-negative breast cancer, which can be treated with pembrolizumab, or KEYTRUDA.

US Tissue Diagnostics Market: Report Scope

US Tissue Diagnostics Market: State Analysis

California is expected to dominate the market over the forecast period

California is expected to dominate the US tissue diagnostics market over the forecast period. The market growth in the area is attributed to the high prevalence of cancer. The most populated state, California, has a high rate of cancer diagnoses, which is fueling the need for sophisticated tissue diagnostics for early diagnosis and treatment. For instance, as per the data published by the California Cancer Society, one in four Californians who have cancer will probably pass away from the disease, according to estimates indicating about one in every two persons born in the state will experience cancer at some point in their lives. This year in California, almost 176,140 people will receive a cancer diagnosis. This translates to around 20 new cases per hour of the day. Moreover, California is a center for tissue diagnostics development and commercialization because of the state's thriving biotechnology and medical device industries.

US Tissue Diagnostics Market: Tissue Diagnostics Competitive Analysis

The US tissue diagnostics market is dominated by players like:

• Thermo Fisher Scientific Inc.
• Merck KGaA
• F. Hoffmann-La Roche Ltd.
• Siemens Healthineers AG
• Abbott Laboratories
• Danaher
• QIAGEN
• bioMérieux SA
• Becton
• Dickinson & Company (BD
• Agilent Technologies Inc.
• DiaGenic ASA
• General Electric Company (GE Healthcare)
• BioGenex
• Cell Signaling Technology Inc.
• Abcam plc
• Bio SB
• Enzo Life Sciences Inc.
• VITRO SA (Master Diagnóstica)
• TissueGnostics GmbH

The US tissue diagnostics market is segmented as follows:

By Technology

• Immunohistochemistry
• In situ Hybridization
• Primary & Special Staining
• Digital Pathology & Workflow
• Anatomic Pathology

By Application

• Breast Cancer
• Non-Small Cell Lung Cancer (NSCLC)
• Prostate Cancer
• Gastric Cancer
• Other Cancers

By State

• California
• Florida
• New York
• Washington
• Texas
• New Jersey
• Georgia
• Oregon
• Arizona
• Colorado
• Others