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, 2023 - 2030

Report Overview

The global oncology companion diagnostic market size was valued at USD 3.1 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 12.9 from 2023 to 2030. The evolving role of oncology companion diagnostics in the era of next-generation omics is expected to drive the market. The FDA has approved ten new combinations and single-agent regimens that have been used with a specific CDx assay since January 2020. For instance, in November 2022, the FDA approved VENTANA FOLR1 (FOLR1-2.1) RxDx Assay developed by Roche as an IHC-based companion diagnostic to detect patients with ovarian cancer that are eligible for ELAHERE. In addition, the FDA approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay in July 2020, as a quick 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.

The economic benefits offered by oncology companion diagnostics (CDx) assays and their ability to reduce clinical trial timelines have enhanced the adoption rate of these assays by pharmaceutical manufacturers. Companion diagnostics can enhance the treatment effects of different diseases by providing clinicians with clear clinical grounds for diagnosis and treatment and 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 the FDA issued “In Vitro Companion Diagnostic Devices” guidance in 2016, emphasizing the contemporary approval of a diagnostic assay and its corresponding therapeutic product. This allows for streamlining research between companies, enabling the 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 and Agios Pharmaceuticals expanded their partnership 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 partnered with CStone Pharmaceuticals to commercialize and Co-develop CDx for pralsetinib in China.

Product and Service Insights

The product segment accounted for the largest revenue share of over 65.8% in 2022, 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 due to the increased use of cancer companion diagnostic equipment and the rising global disease burden. For instance, In October 2022, the first companion diagnostic from Roche was approved by the FDA to help doctors determine whether patients suffering from HER2 low metastatic breast cancer are eligible for Enhertu. AstraZeneca and Daiichi Sankyo are jointly developing and commercializing Enhertu, an antibody-drug conjugate (ADC).

Consumables and reagents play a crucial role in maintaining the result reliability of cancer testing through various technologies. Therefore, key players are engaged in developing 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 consumables segment's growth in the oncology companion diagnostics market. Fujifilm Wako Diagnostics, Thermo Fisher Scientific, Sysmex Corporation, Abbott Diagnostics, and Roche Diagnostics are some of the major companies offering reagents for cancer diagnosis and various cancer research products.

The service segment is expected to grow at the fastest CAGR of 13.3% during the forecast period. The presence of service providers, including Covance, Q2 Solutions, and LabCorp, that offer CDx

development services are anticipated to propel the growth of the services segment in the market for oncology companion diagnostics. In June 2023, the FDA launched a pilot program to reduce the risks of using laboratory tests for cancer biomarker identification. This program aims to help clinicians select suitable cancer treatments for patients.

Technology Insights

The market is segmented based on technology: PCR, NGS, IHC, ISH/FISH, and other technologies. Immunohistochemistry (IHC) accounted for the largest revenue share of over 60.0% in 2022, 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 facilitate the rapid drug development process and leads to a high chance of successful approvals.

Adopting 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 expected to grow at the fastest rate of 18.5% 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 and related therapy options. The market has witnessed the launch of novel NGS-based CDx such as FoundationOne CDx and FoundationFocus CDx BRCA LOH.

Disease Type Insights

Based on disease type, the market is segmented into leukemia, non-small cell lung cancer, breast cancer, colorectal cancer, melanoma, prostate cancer, and others. The other disease-type segment dominated the market with the largest revenue share. The non-small cell lung cancer (NSCLC) segment accounted for the largest revenue share of 25.5% in 2022, owing to the increasing incidence of NSCLC and the development of several oncology companion diagnostic tests for the disease. For instance, In December 2022, the FDA approved a companion diagnostic, Agilent Resolution ctDx FIRST, for NSCLC patients having KRAS G12C mutation who may be eligible for adagrasib (Krazati). The assay can also help healthcare professionals in profiling tumors of EGFR genes. In May 2020, the FDA approved the FoundationOne CDx assay for use with Capmatinib to treat metastatic NSCLC.

The breast cancer segment is expected to grow at the fastest CAGR of 13.6% during the forecast period. 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. As per the World Health Organization (WHO), in 2020, 2.3 million women were diagnosed with breast cancer, and 685,000 deaths were reported globally. Similarly, data published by the Centers for Disease Control and Prevention suggests about 264,000 breast cancer cases are diagnosed in women and 2,400 in men every year in the U.S.

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 germline (inherited) breast cancer patients. The growth of the leukemia segment at a substantial rate is attributed to an increase in strategic initiatives by key players for developing and launching novel NGS and CDx solutions for leukemia diagnosis.

End Use Insights

The hospital segment accounted for the largest share of 53.0% in 2022 and is expected to grow at the fastest CAGR of 13.2% during the forecast period. Well-equipped facilities and 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 due to lower clinical oncology testing volume. 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 increased 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 development led to the CE approval of the therascreen PIK3CA RGQ PCR kit in February 2020.

In December 2022, the FDA approved QIAGEN's therascreen KRAS RGQ PCR kit as a companion diagnostic test for Mirati Therapeutics' drug KRAZATI for NSCLC to help in the identification of patients with NSCLC with a KRAS G12C mutation.

Regional Insights

North America dominated the market for oncology companion diagnostics and accounted for a revenue share of 39.8% in 2022. Funding and grants provided by bodies, such as the National Cancer Institute (NCI), to accelerate precision therapy development are anticipated to influence the market in the region positively. Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) initiatives by NCI aim to promote and develop advanced technologies and products for cancer prevention, detection, and treatment. Moreover, several conferences conducted in Canada to improve awareness about the trends and innovations in CDx further supplement this growth.

In July 2021, Labcorp, an American global life sciences company, launched therascreen KRAS PCR Mutation Analysis, a diagnostic tool for identifying NSCLC patients eligible for LUMAKRAS treatment developed by Amgen.

Asia Pacific is expected to grow at the fastest CAGR of 14.0% over the forecast period from 2023-2030. Effective regulations pertaining to the approval of oncology companion diagnostic tests for cancer and accelerated R&D for integrated and personalized medicine in the U.S. are expected to drive the market over the forecast period.

Key Companies & Market Share Insights

The oncology companion diagnostic market has several major players engaged in strategies such as new product development, product approvals, mergers, and acquisitions to gain a competitive edge. 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. The following are some of the major participants in the global oncology companion diagnostic market:

• Agilent Technologies, Inc.

• Illumina, Inc.

• QIAGEN N.V.

• Thermo Fisher Scientific, Inc.

• F. Hoffmann-La Roche Ltd.

• Roche Ltd.

• ARUP Laboratories

• Abbott

• Myriad Genetics, Inc.

• bioMérieux SA

• Invivoscribe, Inc.

Oncology Companion Diagnostic Market Report Scope

Global Oncology Companion Diagnostic Market Report Segmentation

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 2018 to 2030. For this study, Grand View Research has segmented the global oncology companion diagnostic market report based on product and service, technology, disease type, end use, and region:

• Product & Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Product

    • Instrument

    • Consumables

    • Software

  • Service 

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • 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, 2018 - 2030)

  • Breast Cancer

  • Non-Small Cell Lung Cancer

  • Colorectal Cancer

  • Leukemia

  • Melanoma

  • Prostate Cancer

  • Others

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital

  • Pathology/Diagnostic Laboratory

  • Academic Medical Center

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Norway

    • Denmark

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait