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 Overview

The global oncology companion diagnostic market size was valued at USD 2.2 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 12.7% from 2020 to 2027. The evolving role of oncology companion diagnostics in the era of next-generation omics is expected to drive the market. The FDA has already approved ten new combinations and single-agent regimens that are being used with a specific CDx assay since January 2020. For instance, in July 2020, the FDA approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a quick novel method to detect HER2 biomarker for breast cancer and as a companion diagnostic for Herceptin therapy. Similarly, August 2020 witnessed FDA approvals of Guardant360 CDx assay; an NGS test that uses circulating cell-free DNA as a CDx; and FoundationOne Liquid CDx; a pan-tumor liquid biopsy test.

Economic benefits offered by oncology Companion Diagnostics (CDx) assays coupled with their ability to reduce clinical trial timelines have enhanced the adoption rate of these assays by pharmaceutical manufacturers. Companion diagnostics can enhance treatment effects of different diseases by providing clinicians with clear clinical grounds for diagnosis and treatment, as well as proper management of patient resources and national insurance policies by reducing unnecessary treatment of costly targeted chemotherapy drugs.

Drug and diagnostics co-development models have significantly improved since FDA issued “In Vitro Companion Diagnostic Devices” guidance in 2016 which emphasized the contemporaneous approval of a diagnostic assay along with its corresponding therapeutic product. This allows streamlining research between companies, enabling selection of a lead compound and corresponding biomarker from pharmaceutical and diagnostic companies, respectively.

Therefore, key pharmaceutical and diagnostic developers have collaborated to co-develop drugs and oncology companion diagnostic assays. For instance, in June 2020, ThermoFisher Scientific expanded its partnership with Agios Pharmaceuticals for the co-development of a companion diagnostic for vorasidenib; an investigational drug for low-grade glioma. Similarly, in June 2020, Burning Rock Biotech Limited entered into a strategic partnership with CStone Pharmaceuticals to commercialize and Co-develop CDx for pralsetinib in China.

Product and Service Insights

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.

Technology Insights

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.

Disease Type Insights

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.

End-use Insights

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.

Regional Insights

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 Companies & Market Share Insights

The market for oncology companion diagnostics is marked by the presence of high competition among market players. Roche holds a significant market share owing to its wide portfolio for oncology companion diagnostics. The company also acquired Foundation Medicine in June 2018 which further increased its penetration in the market for oncology companion diagnostics. Some of the prominent players in the oncology companion diagnostic market include:

• Agilent Technologies, Inc.

• Illumina, Inc.

• QIAGEN N.V.

• Thermo Fisher Scientific, Inc.

• F. Hoffmann-La Roche Ltd.

• ARUP Laboratories

• Abbott

• Myriad Genetics, Inc.

• bioMérieux SA

• Invivoscribe, Inc.

Oncology Companion Diagnostic Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global oncology companion diagnostic market report on the basis of product and service, technology, disease type, end-use, and region:

• Product & Service Outlook (Revenue, USD Million, 2016 - 2027)

  • Product

    • Instrument

    • Consumables

    • Software

  • Service 

• Technology Outlook (Revenue, USD Million, 2016 - 2027)

  • Polymerase Chain Reaction (PCR)

  • Next-Generation Sequencing (NGS)

  • Immunohistochemistry (IHC)

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

  • Other Technologies 

• Disease Type Outlook (Revenue, USD Million, 2016 - 2027)

  • Breast Cancer

  • Non-Small Cell Lung Cancer

  • Colorectal Cancer

  • Leukemia

  • Melanoma

  • Prostate Cancer

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Hospital

  • Pathology/Diagnostic Laboratory

  • Academic Medical Center

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • 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