Global Companion Diagnostic Tests in Oncology Market Growth, Share, Size, Trends and Forecast (2024 - 2030)

By Detection Technique;

Protein Detection - Immunohistochemistry, DNA Detection - Polymerase Chain Reaction, Next Gen Sequencing and In-Situ Hybridization, Others.

By Bio-Markers;

EGFR , KRAS , BRAF V600E, HER2 and Others.

By Cancer Type;

Breast Cancer, Liver Cancer, Lung Cancer, Colorectal Cancer, Melanoma and Others.

By End User;

Hospitals , Specialty Clinics, Diagnostic Labs and Others.

By Geography;

North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2020 - 2030).
Report ID: Rn446595741 Published Date: April, 2024 Updated Date: May, 2024

Introduction

Global Companion Diagnostic Tests in Oncology Market (USD Million), 2020 - 2030

In the year 2023, the Global Companion Diagnostic Tests in Oncology Market was valued at USD 4,329.71 million. The size of this market is expected to increase to USD 7,919.45 million by the year 2030, while growing at a Compounded Annual Growth Rate (CAGR) of 9.0%.

A significant factor contributing to market growth is the regulatory approvals of new combinations and single-agent regimens paired with specific companion diagnostic assays. For instance, since January 2020, the FDA has approved ten new combinations and single-agent regimens that utilize companion diagnostic assays. Notably, in November 2022, the FDA approved the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay developed by Roche, an IHC-based companion diagnostic for detecting ovarian cancer patients eligible for ELAHERE therapy. Similarly, the FDA approval of the Ventana HER2 Dual ISH DNA Probe Cocktail assay in July 2020 facilitated quick detection of the HER2 biomarker for breast cancer and served as a companion diagnostic for Herceptin therapy.

Furthermore, advancements in diagnostic technologies have led to the FDA approvals of innovative assays, such as the Guardant360 CDx assay and FoundationOne Liquid CDx, in August 2020. These assays leverage circulating cell-free DNA and liquid biopsy techniques, respectively, to provide comprehensive genomic profiling across various tumor types.

The economic benefits offered by oncology companion diagnostics, including reduced clinical trial timelines and enhanced treatment effects, have led to increased adoption by pharmaceutical manufacturers. Companion diagnostics provide clinicians with clear clinical grounds for diagnosis and treatment decisions, optimizing patient management and resource allocation while aligning with national insurance policies.

Key players in the pharmaceutical and diagnostic sectors have forged strategic partnerships to co-develop drugs and companion diagnostic assays. For example, ThermoFisher Scientific and Agios Pharmaceuticals expanded their collaboration in June 2020 to co-develop a companion diagnostic for vorasidenib, an investigational drug for low-grade glioma. Similarly, Burning Rock Biotech Limited and CStone Pharmaceuticals partnered in June 2020 to commercialize and co-develop a companion diagnostic for pralsetinib in China.

Overall, the growing emphasis on personalized medicine, coupled with regulatory support and collaborative efforts between pharmaceutical and diagnostic companies, is driving the evolution and expansion of the oncology companion diagnostic market.

  1. Introduction
    1. Research Objectives and Assumptions
    2. Research Methodology
    3. Abbreviations
  2. Market Definition & Study Scope
  3. Executive Summary
    1. Market Snapshot, By Detection Technique
    2. Market Snapshot, By Bio-Markers
    3. Market Snapshot, By Cancer Type
    4. Market Snapshot, By End User
    5. Market Snapshot, By Region
  4. Global Companion Diagnostic Tests in Oncology Market Dynamics
    1. Drivers, Restraints and Opportunities
      1. Drivers
        1. Rising Incidence of Cancer
        2. Regulatory Approvals and Guidelines
        3. Growing Emphasis on Personalized Medicine
        4. Collaborations and Partnerships
        5. Growing Healthcare Expenditure
      2. Restraints
        1. Regulatory Hurdles
        2. High Development Costs
        3. Market Fragmentation
        4. Limited Reimbursement Policies
        5. Market Access Barriers
      3. Opportunities
        1. Technological Advancements
        2. Expanding Cancer Biomarkers Portfolio
        3. Personalized Medicine Adoption
        4. Emerging Markets Penetration
        5. Patient Engagement and Education
    2. PEST Analysis
      1. Political Analysis
      2. Economic Analysis
      3. Social Analysis
      4. Technological Analysis
    3. Porter's Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of Substitutes
      4. Threat of New Entrants
      5. Competitive Rivalry

  5. Market Segmentation
    1. Global Companion Diagnostic Tests in Oncology Market, By Detection Technique, 2022 - 2032 (USD Million)
      1. Protein Detection
      2. Immunohistochemistry
      3. DNA Detection
      4. Polymerase Chain Reaction
      5. Next Gen Sequencing
      6. In-Situ Hybridization
      7. Others
    2. Global Companion Diagnostic Tests in Oncology Market, By Bio-Markers, 2022 - 2032 (USD Million)
      1. EGFR
      2. KRAS
      3. BRAF V600E
      4. HER2
      5. Others
    3. Global Companion Diagnostic Tests in Oncology Market, By Cancer Type, 2022 - 2032 (USD Million)
      1. Breast Cancer
      2. Liver Cancer
      3. Lung Cancer
      4. Colorectal Cancer
      5. Melanoma
      6. Others
    4. Global Companion Diagnostic Tests in Oncology Market, By End User, 2022 - 2032 (USD Million)
      1. Hospitals
      2. Specialty Clinics
      3. Diagnostic Labs
      4. Others
    5. Global Companion Diagnostic Tests in Oncology Market, By Geography, 2022 - 2032 (USD Million)
      1. North America
        1. United States
        2. Canada
      2. Europe
        1. Germany
        2. United Kingdom
        3. France
        4. Italy
        5. Spain
        6. Nordic

        7. Benelux

        8. Rest of Europe
      3. Asia Pacific
        1. Japan
        2. China
        3. India
        4. Australia & New Zealand
        5. South Korea
        6. ASEAN (Association of South East Asian Countries)
        7. Rest of Asia Pacific
      4. Latin America
        1. Brazil
        2. Mexico
        3. Argentina
        4. Rest of Latin America
      5. Middle East & Africa
        1. GCC
        2. Israel
        3. South Africa
        4. Rest of Middle East & Africa
  6. Competitive Landscape
    1. Company Profiles
      1. Abbott
      2. Hoffman LA Roche Ltd
      3. Genomic Health, Inc
      4. QIAGEN
      5. Agilent Technologies, Inc
      6. AGENDIA NV
      7. bioMerieux SA
      8. Illumina, Inc
      9. Siemens Healthcare GmBH
      10. Thermo Fisher Scientific, Inc
      11. BioGenex
  7. Analyst Views
  8. Future Outlook of the Market

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