Global $5.7 Billion Oncology Companion Diagnostic (CDx) Market to 2027

DUBLIN, Oct. 20, 2020 /PRNewswire/ -- The "Oncology Companion Diagnostic Market Size, Share & Trends Analysis Report by Product & Service, by Technology (IHC, NGS), by Disease Type (Breast Cancer, Leukemia), by End-use, by Region, and Segment Forecasts, 2020 - 2027" report has been added to's offering.

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The global oncology companion diagnostic market size is expected to reach USD 5.7 billion by 2027, expanding at a CAGR of 12.7%

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 Companion Diagnostics (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 clinical trials. 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 biomarker 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 held the largest market share in 2019 owing to increased adoption and usage rate of CDx tests

  • A significant increase in the approval rate of CDx and a rise in investments for co-development of drugs and their CDx is expected to increase the revenue generation in the product segment

  • Consumables occupied a major share of the product segment owing to the frequent use and purchase of media, buffers, reagents, and other consumables required for CDx assay

  • Immunohistochemistry (IHC) occupied a major portion of the technology segment owing to the benefits offered by IHC technology including cost and time effectiveness, the suitability of the technique for small tumor types, high adoption of IHC for routine oncology CDx, and low technological requirements associated with IHC

  • Presence of a substantial number of FDA approved IHC based CDx assays such as EGFR pharmDx Kits, ER/PR pharmDx Kits, HercepTest Kits, PD-L1 IHC 28-8 pharmDx, VENTANA PD-L1 (SP142) Assay, VENTANA ALK (D5F3) CDx Assay, and VENTANA ALK IHC assay is also expected to increase revenue generation within the IHC segment

  • The Non-Small Cell Lung Cancer (NSCLC) segment dominated the market in 2019 and is expected to maintain its dominance during the forecast period

  • NSCLC is a lung cancer subtype that accounts for approximately 84.0% of all cases of lung cancer. According to data published by the American Cancer Society (ACS), in 2020, around 228,820 new cases of lung cancer are projected to be diagnosed in the U.S.

  • The breast cancer and leukemia segments are expected to grow with substantial rates owing to a rise in the number of cancer cases

  • The hospital segment held the largest share in the market in 2019 and is expected to exhibit a considerable growth rate, owing to a rise in the number of cancer diagnostic tests in the hospitals

  • North America dominated the market in 2019 owing to the presence of a substantial number of players in this region, as well as the presence of a large number of FDA-approved CDx solutions in cancer therapeutics

  • Advancements in technologies and improvements in the economic condition are anticipated to drive the market at the fastest growth rate in the Asia Pacific

  • The presence of communities in Asian countries that are actively involved in monitoring and discovery of genetic biomarkers is expected to positively influence the market

  • The key players in the market are involved in mutually beneficial partnerships with global entities, including sponsors and diagnostic commercialization partners, which enables them to leverage their market potential globally.

Market Dynamics

Market driver analysis

  • Accelerating demand for targeted cancer treatment & tailored drugs

  • Collaborations between diagnostic and pharma entities

  • Rise in approval rate for companion diagnostics

  • Rise in cancer incidence across the globe

Market Restraint Analysis

  • Broken clinical diagnostic testing landscape

  • Constraints associated with the clinical implementation of companion diagnostic tests

Market Opportunity Analysis

  • Increase in adoption of companion diagnostics for precision medicine

Market Challenge Analysis

  • Reimbursement Challenges associated with companion diagnostic tests

Companies Mentioned

  • Agilent Technologies, Inc.

  • Illumina, Inc.


  • Thermo Fisher Scientific, Inc.

  • F. Hoffmann-La Roche Ltd.

  • ARUP Laboratories

  • Abbott

  • Myriad Genetics, Inc.

  • bioMerieux SA

  • Invivoscribe, Inc.

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