Cancer Tissue Diagnostics Market Size and Forecasts (2021 - 2031), Global and Regional Share, Trends, and Growth Opportunity Analysis

Coverage: Cancer Tissue Diagnostics Market covers analysis By Test Type (Immunohistochemical Tests and In Situ Hybridization Tests), and Geography (North America, Europe, Asia Pacific, and South and Central America)

Publication Month : Mar 2024

  • Report Code : TIPRE00005672
  • Category : Medical Device
  • Status : Upcoming
  • No. of Pages : 158
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The cancer tissue diagnostics market is projected to reach US$ 3,640.87 million by 2028 from US$ 2,538.31 million in 2022; it is estimated to grow at a CAGR of 6.2% from 2022 to 2028.

Cancer tissue diagnostics techniques are used to detect a tumor in malignant tissues. In the last few years, immunohistochemistry (IHC) was used to increase the detection of specific antigens in tumor tissue. With the help of nonfluorescent chromogens, the screening is analyzed with conventional microscopy. There are recent techniques developed for cancer tissue diagnosis. Fluorescence in situ hybridization is used to examine a genetic abnormality in the genome. The hybridized deoxyribonucleic acid (DNA) is examined with particular probes.

The cancer tissue diagnostics market is segmented on the basis of test type and geography. Based on test type, the market is segmented into immunohistochemical tests and in situ hybridization tests. In 2022, the immunohistochemical tests segment held a larger market share. The market in the same segment is also anticipated to grow at a faster rate in the coming years. By geography, the cancer tissue diagnostics market is broadly segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. The market in Asia Pacific is expected to grow at the highest rate during the forecast period owing to the rising prevalence of cancer and the increasing aging population in Asian countries. The Japanese Government has been formulating and laying down multiple initiatives and programs to enhance the quality of cancer treatment and increase awareness regarding cancer in the country. In China, as per data by the WHO, 45,68,754 new cancer cases were detected, and 30,02,899 cancer deaths were recorded in the country in 2020. The cancer tissue diagnostics report offers insights and in-depth analysis of the market, emphasizing parameters such as market trends, technological advancements, market dynamics, and the competitive analysis of the globally leading market players.

Strategic Insights

Lucrative Regions for Cancer Tissue Diagnostics Market

Lucrative Regions for Cancer Tissue Diagnostics Market

Market Insights

New Product Launches and FDA Approvals and growing investments in Cancer Tissue Diagnostics to Fuel Cancer Tissue Diagnostics Market During Forecast Period

Most major market players are involved in manufacturing a wide range of cancer diagnostics products offering maximum advantages and early diagnosis. In June 2022, Roche announced the launch of the BenchMark ULTRA PLUS system, its newest advanced tissue staining platform. The system enables quick and accurate test results so clinicians can make timely decisions regarding a patient’s care journey.

In March 2022, Illumina launched a new in vitro diagnostic test in Europe designed to profile various cancer mutations and help direct patients to targeted therapies. Thus, the constant technological developments in diagnostics and FDA approvals accelerate the market growth.

Furthermore, tissue diagnostics is crucial in cancer treatment. Cancer tissue diagnostics play a significant role in determining the treatment pace and procedure. Early detection can help reduce the mortality rates of cancer; hence, medical professionals, market players, and government authorities implement new diagnostics and treatment facilities. Thus, the rise in investments and better policies of reimbursement favor the growth of the cancer tissue diagnostics market.

In May 2021, QIAGEN N.V. launched an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN). Furthermore, In January 2020, Illumina and Roche signed a 15-year, non-exclusive collaboration agreement designed to realize NGS’ potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring. The value of the partnership—which includes in vitro diagnostic (IVD) and companion diagnostics (CDx) initiatives—was not disclosed. In 2019, the company launched AIforia cloud platform that accelerates image processing and provides automated pathology image analysis. Thus, the increasing collaborations and new technological platforms in cancer tissue diagnostics have led to the advent of breakthrough techniques, which are expected to fuel the growth of the market in the coming years.

Test Type-Insights

Based on test type, the cancer tissue diagnostics market is segmented into immunohistochemical tests and in situ hybridization tests. In 2022, the immunohistochemical tests segment held a larger market share. In addition, the market in the same segment is expected to grow at a faster rate in the coming years owing to the cost-effectiveness of the technique. Moreover, the technique is easily accessible, and growth in the number of products based on technology are further expected to drive the segment growth. 

Test Type-Insights

Product launches and collaborations are highly adopted strategies by the global cancer tissue diagnostics market players. A few of the recent key market developments are listed below: 

  • In June 2022, Roche announced the launch of the BenchMark ULTRA PLUS system, its newest advanced tissue staining platform. The system enables quick and accurate test results so clinicians can make timely decisions regarding a patient’s care journey.
  • In March 2022, Illumina launched a new in vitro diagnostic test in Europe designed to profile various cancer mutations and help direct patients to targeted therapies.
  • In May 2021, QIAGEN N.V. launched an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN).
  • In January 2020, Illumina and Roche signed a 15-year, non-exclusive collaboration agreement designed to realize NGS’ potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring. The value of the partnership—which includes in vitro diagnostic (IVD) and companion diagnostics (CDx) initiatives—was not disclosed.
  • In June 2019, Agilent Technologies Inc. received the U.S. Food and Drug Administration (FDA) approval for its PD-L1 IHC 22C3 pharmDx assay. The assay is approved to identify patients with head and neck squamous cell carcinoma (HNSCC) for treatment with KEYTRUDA (pembrolizumab), anti-PD-1 therapy manufactured by Merck.
  • In June 2019, Thermo Fisher Scientific's Oncomine Dx Target Test received reimbursement coverage from Japan's Ministry of Health, Labour and Welfare. The test is now commercially available in Japan. The reimbursement has helped the company to offer the diagnosis of NSCLC.\
  • In May 2019, Roche launched the VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody, an in vitro diagnostic ROS1 immunohistochemistry (IHC) assay. The launch has enabled the company to offer better innovative products.

Company Profiles

  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific Inc
  • Bio Rad Laboratories Inc
  • Abbott
  • Enzo Life Sciences, Inc
  • Agilent Technologies, Inc
  • Cancer Genetics Inc
  • Merck KGaA (Sigma-Aldrich Co. LLC)
  • Danaher Corporation
  • Abcam plc.

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REGIONAL FRAMEWORK
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Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Test Type

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

The List of Companies

  1. F. Hoffmann-La Roche Ltd.
  2. Danaher Corporation
  3. Thermo Fisher Scientific Inc.
  4. Bio Rad Laboratories Inc.
  5. Abbott
  6. Enzo Life Sciences, Inc.
  7. Agilent Technologies, Inc.
  8. Cancer Genetics Inc.
  9. Merck KGaA (Sigma-Aldrich Co. LLC)
  10. Abcam plc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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