Oncology Companion Diagnostic Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

Published Date : Feb 2021 | No. of Pages : 250 Pages | Category : Healthcare

The global Oncology Companion Diagnostic market size is expected to be worth around US$ 7.7 billion by 2030, according to a new report by Vision Research Reports.

The global Oncology Companion Diagnostic market size was valued at US$ 3.2 billion in 2020 and is anticipated to grow at a CAGR of 137% during forecast period 2021 to 2030.

Growth Factors

Expanding access to important genomic information with the aid of companion diagnostics enables informed decision making for designing the targeted treatment approaches for their patients, thereby increasing demand for comprehensive genomic testing and oncology companion diagnostics.

The commercial launch of drugs including Gleevec (imatinib) and Herceptin (trastuzumab) that require (CDx) testing before prescription has increased revenue generation in the oncology companion diagnostics field. This growth is expected to continue in the future owing to a substantial number of CDx associated oncology drugs in. Apart from functioning as exclusive or inclusive tests for therapies, CDx also plays a crucial role during participant selection in clinical trials. This is because there is an increased potential for a novel drug candidate to show a better response rate if the patient has its target.

The economic incentives associated with the use of CDx have encouraged drug developers to combine their drugs with diagnostic tests. However, the diagnostic manufacturers face conflicting demands from payers/providers on one hand and drug manufacturers on the other hand. The regulatory bodies also have stringent policies to align the development timelines of diagnostics and drugs. Therefore, the diagnostic companies are expected to broaden their scope of CDx development instead of focusing on the attainment of a match between a single diagnostic with a specific drug.

Report Highlights

The product segment accounted for a significant revenue share of 66.0% in 2019 in the market for the oncology companion diagnostics market. The segment is anticipated to grow at a healthy pace during the forecast period owing to the emergence of highly sensitive technologies such as NGS for cancer diagnosis. Leading companies such as Illumina, Roche, and ThermoFisher Scientific are expected to see lucrative growth opportunities in the coming years, as a result of increased use of cancer companion diagnostic equipment due to the rising disease burden across the globe.

Consumables and reagents play a crucial role in maintaining the result reliability of cancer testing through various technologies. Therefore, key players are engaged in the development of consumables for oncology CDx. For instance, in February 2020, Biocare Medical launched seven novel IVD IHC antibody markers. Such initiatives are anticipated to enhance the growth of the consumables segment in the market for oncology companion diagnostics.

Fujifilm Wako Diagnostics, Thermo Fisher Scientific, Sysmex Corporation, Abbott Diagnostics, and Roche Diagnostics are some of the major companies offering reagents for cancer diagnosis, as well as various cancer research products. Similarly, the presence of service providers including Covance, Q2 Solutions, and LabCorp that offer CDx development services is anticipated to propel the growth of the services segment in the market for oncology companion diagnostics.

Immunohistochemistry (IHC) accounted for the largest revenue share of 60.7% in 2019 owing to the wide availability of IHC-based CDx solutions in the oncology companion diagnostics market. Key players are also continuously engaged in product approvals and launches in the market space, thus propelling segment growth. IHC-based CDx helps in facilitating the rapid drug development process and leads to a high chance of successful approvals.

The adoption of IHC-based oncology companion diagnostic assays tends to aid at every stage of the development process. A wide variety of antibody therapies such as Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), Antibody Drug Conjugates (ADC), immune checkpoint blockade, and signal transduction blockade utilize the beneficial features of IHC technology as a CDx, thus, aiding in accelerating clinical trials and marketing procedures.

The Next-Generation Sequencing (NGS) segment is projected to grow at the fastest rate over the forecast period in the market for oncology companion diagnostics. This is because NGS-based tools are accurate and can provide detailed information on biomarkers. In addition, NGS-based CDx tests are widely used for Non-small Cell Lung Cancer (NSCLC) diagnosis as these uncover a broad range of actionable driver mutations along with the related therapy options. Owing to this, the market has witnessed the launch of novel NGS-based CDx such as FoundationOne CDx and FoundationFocus CDx BRCA LOH.

Non-small Cell Lung Cancer (NSCLC) dominated the disease type segment with a revenue share of 25.3% in 2019 in the market for oncology companion diagnostics. This is because of a high incidence rate of NSCLC coupled with a rise in the development of oncology companion diagnostic tests for the disease. For instance, In May 2020, FDA approved FoundationOne CDx assay for use with Capmatinib for the treatment of metastatic NSCLC.

The breast cancer segment is anticipated to grow with a lucrative rate over the forecast period in the market for oncology companion diagnostics. Breast cancer is one of the most common types of cancer with a high mortality rate, which, in turn, is driving demand for oncology companion diagnostics for the disease. According to data published by the National Cancer Institute (NIH), in 2019, around 271,270 new cases of cancer were diagnosed in the U.S. and around 42,260 people died due to it.

Furthermore, a favorable reimbursement scenario for novel breast cancer diagnostic solutions in key regions is anticipated to facilitate their adoption. In January 2020, CMS expanded its coverage of NGS as a diagnostic tool for patients with germline (inherited) breast cancer. The growth of the leukemia segment with a substantial rate is attributed to an increase in strategic initiatives by key players for the development and launch of novel NGS and CDx solutions for leukemia diagnosis.

The hospital segment accounted for the largest share of 52.6% in 2019 in the market for oncology companion diagnostics. Well-equipped facilities, coupled with the presence of a substantial number of skilled healthcare professionals, are anticipated to drive this segment’s growth. In addition, improving healthcare coverage and favorable reimbursement policies for early diagnosis & cancer prevention provided in the U.S. hospitals are expected to contribute to the market share of this segment.

The presence of sensitive and accurate cancer screening and diagnostic tests is expected to boost revenue generation in the pathology/diagnostic laboratory segment. CSI Laboratories, Laboratory Corporation of America Holdings, Quest Diagnostics, Sonic Healthcare Limited, and Bio-Reference Laboratories are some of the leading diagnostic laboratory service providers that offer testing in the market.

The penetration of oncology companion diagnostics is relatively low in academic medical centers owing to lower testing volume for clinical oncology. However, the segment is expected to witness a considerable CAGR throughout the forecast period in the market for oncology companion diagnostics. This is owing to an increase in partnerships of academic centers with diagnostic developers. For instance, QIAGEN has a global co-exclusive license with Johns Hopkins University for PCR-based oncology companion diagnostics to detect mutations of the PIK3CA gene. This led to the CE approval of the therascreen PIK3CA RGQ PCR kit in February 2020.

North America dominated the market for oncology companion diagnostics and accounted for a revenue share of 39.3% in 2019. Funding and grants provided by bodies, such as the National Cancer Institute (NCI), to accelerate precision therapy development are anticipated to positively influence the market in the region. Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) initiatives by NCI are aimed at the promotion and development of novel technologies and products for the prevention, detection, and treatment of cancer.

The presence of effective regulations pertaining to the approval of oncology companion diagnostic tests for cancer coupled with accelerated R&D for integrated and personalized medicine in the U.S. is expected to drive the market over the forecast period. Moreover, several conferences conducted in Canada to improve awareness about the trends and innovations in CDx further supplements this growth.

Key Players

  • Agilent Technologies, Inc.

  • Illumina, Inc.


  • Thermo Fisher Scientific, Inc.

  • F. Hoffmann-La Roche Ltd.

  • ARUP Laboratories

  • Abbott

  • Myriad Genetics, Inc.

  • bioMérieux SA

  • Invivoscribe, Inc.

Market Segmentation

  • Product & Service Outlook

    • Product

      • Instrument

      • Consumables

      • Software

    • Service 

  • Technology Outlook 

    • Polymerase Chain Reaction (PCR)

    • Next-Generation Sequencing (NGS)

    • Immunohistochemistry (IHC)

    • In situ hybridization (ISH)/Fluorescence in situ hybridization (FISH)

    • Other Technologies 

  • Disease Type Outlook 

    • Breast Cancer

    • Non-Small Cell Lung Cancer

    • Colorectal Cancer

    • Leukemia

    • Melanoma

    • Prostate Cancer

    • Others

  • End-use Outlook 

    • Hospital

    • Pathology/Diagnostic Laboratory

    • Academic Medical Center

  • Regional Outlook 

    • North America

      • The U.S.

      • Canada

    • Europe

      • Germany

      • France

      • The U.K.

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • South Korea

      • Singapore

      • Taiwan

      • Hong Kong

    • Latin America

      • Brazil

      • Mexico

    • The Middle East and Africa (MEA)

      • South Africa

      • Saudi Arabia

The Oncology Companion Diagnostic market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Oncology Companion Diagnostic market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Oncology Companion Diagnostic market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Oncology Companion Diagnostic market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Oncology Companion Diagnostic market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Oncology Companion Diagnostic capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Oncology Companion Diagnostic by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Oncology Companion Diagnostic market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Oncology Companion Diagnostic market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Oncology Companion Diagnostic market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Oncology Companion Diagnostic industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Oncology Companion Diagnostic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Oncology Companion Diagnostic market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Oncology Companion Diagnostic market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Oncology Companion Diagnostic market. These factors have benefited the growth of the global market for Oncology Companion Diagnostic. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Oncology Companion Diagnostic. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Oncology Companion Diagnostic are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

To strategically profile the key players and comprehensively analyze their growth strategies.

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