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Oncology Biomarkers: Global Markets

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    Report

  • 186 Pages
  • June 2023
  • Region: Global
  • BCC Research
  • ID: 5830666

This study provides a comprehensive analysis of oncology biomarkers on a global basis. It aims to offer a range of information, from detailed market analyses within cancer types to overall industry trends, to quantify and qualify the market for products and services in the oncology biomarkers segment. Current and projected market forecasts during the forecast period (2023 to 2028) are discussed. Figures for 2023 are estimated, except where actual results have been reported.



This report includes forecasts by biomarker type, cancer type, application, and region from 2023 through 2028. The report also includes an analysis of leading and emerging competitors in the current worldwide oncology biomarkers market. The competitive environment is examined with a particular focus on how new products and technologies influence the current standard of care.

Report Includes

  • 21 data tables and 60 additional tables
  • An in-depth analysis of the global oncology biomarkers market
  • Analyses of global market trends, with data from 2020, 2021, 2022, and projections of compound annual growth rates (CAGRs) through 2028
  • Characterization and quantification of biomarkers market by type, profiling technology, application, cancer type, and region
  • Discussion on market drivers, challenges and key market strategies and trends
  • Information on emerging products and technologies, new analytical platforms, novel immunoassays, and bioinformatics tools and discussion on the use of biomarkers in cancer drug development
  • Profiles of the competitive landscape with an overview of competitor growth strategies and opportunities
  • Company profiles of major players within the industry, including Abbott, F. Hoffmann-La Roche Ltd., Merck KGaA, Siemens Healthineers AG, and Thermo Fisher Scientific Inc.

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Methodology and Information Sources
  • Geographic Breakdown
  • Analyst’s Credentials
  • Custom Research
  • Related Research Reports
Chapter 2 Summary and HighlightsChapter 3 Market Outlook
Chapter 4 Market and Technology Background
  • Overview of Biomarkers
  • Classification of Biomarkers
  • Types of Biomarkers
  • Biomarker Discovery, Verification and Validation
  • Overview of Cancer
  • Cancer/Oncology Biomarkers
  • Oncology Biomarkers Testing Methods
  • Oncology Biomarkers Testing Types
  • Biomarker Test Development and Marketing
Chapter 5 Market Dynamics
  • Drivers
  • Rising Incidence of Cancer
  • Increasing Use of Biomarkers in Drug Discovery and Development
  • Developments in Analytical Technologies and Assay Methods
  • Increased Availability and Ease of Biomarker Testing
  • Support from Regulatory Agencies
  • Barriers
  • Inadequate Patient Access to and Insurance Coverage of Biomarker Testing
  • Technical Errors and Delayed Test Results
  • Low Provider and Patient Awareness
  • Suboptimal Tissue Procurement and Triaging
  • Shortages of Laboratories and Personnel
Chapter 6 Market Breakdown by Biomarker Type
  • Protein Biomarkers
  • Protein Biomarkers Profiling Technologies
  • Genomic Biomarker
  • Genomic Biomarkers Profiling Technologies
  • Other Biomarkers
  • Metabolomic Biomarkers
  • Cellular Biomarkers
  • Global Market for Oncology Biomarkers, by Biomarker Type
  • Protein Biomarkers
  • Genomic Biomarkers
  • Other Biomarkers
Chapter 7 Market Breakdown by Application
  • Life Science Research
  • Risk Assessment and Screening
  • Diagnostics
  • Prognostics
  • Therapeutic Selection and Clinical Trials
  • Monitoring
  • Response Monitoring
  • Recurrence/Minimal Residual Disease (MRD) Monitoring
  • Global Market for Oncology Biomarkers by Application
  • Life Science Research
  • Risk Assessment and Screening
  • Diagnostics
  • Prognostics
  • Therapeutic Selection and Clinical Trials
  • Monitoring
Chapter 8 Market Breakdown by Cancer Type
  • Market Overview
  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer (CRC)
  • Prostate Cancer
  • Bladder Cancer
  • Melanoma
  • Leukemia
  • Others
  • Ovarian Cancer
  • Liver Cancer
  • Thyroid Cancer
  • Cervical Cancer
  • Kidney Cancer
  • Endometrial Cancer
  • Global Market for Oncology Biomarkers by Cancer Type
  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Melanoma
  • Leukemia
  • Other Cancers
Chapter 9 Market Breakdown by Region
  • Global Market for Oncology Biomarkers by Region
  • North America
  • Market Revenue by Application
  • Market Revenue by Country
  • Europe
  • Market Revenue by Application
  • Market Revenue by Country
  • Asia-Pacific
  • Market Revenue by Application
  • Market Revenue by Country
  • Rest of World
  • Market Revenue by Application
Chapter 10 Impact of COVID-19
  • Overview
  • Implications on Cancer Diagnosis
  • Implications on Cancer Treatment
  • Impact on Oncology Biomarkers Market
Chapter 11 Emerging Trends and Technologies in the Market
  • Emerging Technologies and Trends in the Market
  • Liquid Biopsy
  • Circulating Free Nucleic Acids
  • Circulating Cell-Free DNA (CfDNA)
  • “Organ Agnostic” Biomarker Testing
  • PD-L1
  • Homologous Recombination De?ciency (HRD)
  • Blood Test for Early-Stage Cancer Detection
Chapter 12 Competitive Landscape
  • Overview
  • Mergers and Acquisitions
  • SWOT Analysis for Global Oncology Biomarker Market
  • Porter’s Five Forces Analysis of Global Oncology Biomarker Market
Chapter 13 Company Profiles
  • AGENDIA INC.
  • ABBOTT
  • AGILENT TECHNOLOGIES INC.
  • BIOCARTIS NV
  • BIOMERIEUX S.A.
  • BIO-RAD LABORATORIES INC.
  • BECTON, DICKINSON & CO.
  • EXACT SCIENCES CORP.
  • F. HOFFMANN-LA ROCHE AG
  • GUARDANT HEALTH INC.
  • HOLOGIC INC.
  • ILLUMINA INC.
  • LEICA BIOSYSTEMS
  • MERCK KGAA
  • MYRIAD GENETICS INC.
  • QIAGEN N.V.
  • SIEMENS HEALTHINEERS AG
  • THERMO FISHER SCIENTIFIC INC.
  • VERACYTE INC.
Chapter 14 Appendix: Acronyms
List of Tables
Summary Table: Global Market for Oncology Biomarkers, by Biomarker Type, Through 2028
Table 1: Different Categories of Biomarkers
Table 2: Multiple Paths to Market for Biomarker Test
Table 3: Biomarkers: Drug Development
Table 4: FDA Issued Letters of Support to Cancer Biomarkers
Table 5: Three Biggest Barriers to Biomarker Testing
Table 6: Selected Protein Biomarkers Used in Oncology
Table 7: Examples of Genomic Biomarkers
Table 8: NGS Methods Used in Oncology
Table 9: PMA Approved NGS Oncology Panel, Somatic or Germline Variant Detection System
Table 10: Selected Genomic Biomarkers Used in Oncology
Table 11: Potential Applications of CTC-Based Diagnostics
Table 12: Global Market for Oncology Biomarkers, by Biomarker Type, Through 2028
Table 13: FDA Novel Drug Approvals with Predictive Biomarkers, Jan. 2021-Jan. 2023
Table 14: Total Number of Biomarkers Used in FDA Approved Therapeutic Selection Tests or CDx, by Cancer Type, 2022
Table 15: Global Market for Oncology Biomarkers, by Application, Through 2028
Table 16: NIH Funding for Cancer Research, by Cancer Type, Through 2024
Table 17: Total Number of Drugs with Approved CDx, by Cancer Type, 2021
Table 18: Estimated Numbers for All Cancers Excl. Non-Melanoma Skin Cancer in 2020
Table 19: Selected Key Biomarkers for Breast Cancer
Table 20: Biomarkers Used in Breast Cancer Therapy Selection
Table 21: Selected Key Biomarkers for Lung Cancer
Table 22: Biomarkers Used in Lung Cancer Therapy Selection
Table 23: Selected CRC Screening Products/Tests
Table 24: Selected Key Biomarkers for CRC
Table 25: Biomarkers Used in CRC Therapy Selection
Table 26: Selected Prostate Cancer Screening Tests
Table 27: Biomarkers Used in Prostrate Cancer Therapy Selection
Table 28: Selected Key Biomarkers for Prostate Cancer
Table 29: Selected Key Biomarkers for Bladder Cancer
Table 30: Biomarkers Used in Bladder Cancer Therapy Selection
Table 31: Selected Key Biomarkers for Melanoma
Table 32: Biomarkers Used in Melanoma Therapy Selection
Table 33: Selected Key Biomarkers for Leukemia
Table 34: Biomarkers Used in Leukemia Therapy Selection
Table 35: Selected Key Biomarkers for Ovarian Cancer
Table 36: Biomarkers Used in Ovarian Cancer Therapy Selection
Table 37: Global Market for Oncology Biomarkers, by Cancer Type, Through 2028
Table 38: Global Market for Breast Cancer Biomarkers, by Biomarker Type, Through 2028
Table 39: Global Market for Lung Biomarkers, by Biomarker Type, Through 2028
Table 40: Global Market for Colorectal Cancer Biomarkers, by Biomarker Type, Through 2028
Table 41: Global Market for Prostate Cancer Biomarkers, by Biomarker Type, Through 2028
Table 42: Global Market for Bladder Cancer Biomarkers, by Biomarker Type, Through 2028
Table 43: Global Market for Melanoma Biomarkers, by Biomarker Type, Through 2028
Table 44: Global Market for Leukemia Biomarkers, by Biomarker Type, Through 2028
Table 45: Global Market for Other Cancers Biomarkers, by Biomarker Type, Through 2028
Table 46: Global Market for Oncology Biomarkers, by Region, Through 2028
Table 47: Estimated Numbers of New Cases and Deaths for Common Cancer Type in the U.S. in 2023
Table 48: North American Market for Oncology Biomarkers, by Application, Through 2028
Table 49: North American Market for Oncology Biomarkers, by Country, Through 2028
Table 50: Challenges to Biomarker Testing in Europe
Table 51: Demographic, Cancer and Healthcare Statistics for Selected European Countries
Table 52: Estimated Cancer Incidence and Mortality, Age Standardized Rate in the EU Countries, by Cancer Type, 2020
Table 53: European Market for Oncology Biomarkers, by Application, Through 2028
Table 54: European Market for Oncology Biomarkers, by Country, Through 2028
Table 55: Oncology Statistics in Select Asia-Pacific Countries, 2020
Table 56: Estimated Cancer Cases in Asia-Pacific Countries, by Notable Cancer Types, 2020
Table 57: Asia-Pacific Market for Oncology Biomarkers, by Application, Through 2028
Table 58: Asia-Pacific Market for Oncology Biomarkers, by Country, Through 2028
Table 59: Cancer Statistics, South America and Africa, 2020
Table 60: RoW Market for Oncology Biomarkers, by Application, Through 2028
Table 61: Selected CfDNA-Based Cancer Tests
Table 62: Leading Market Players in Oncology Biomarkers Market, 2022
Table 63: Recent Mergers and Acquisitions in Oncology Biomarkers Market, 2020-2022
Table 64: Porter’s Five Forces Analysis: Global Oncology Biomarkers Market
Table 65: Agilent Technologies Inc.: Selected Key Developments, January 2021-March 2023
Table 66: Biocartis: Selected Key Developments, January 2020-March 2023
Table 67: Bio-Rad Laboratories: Selected Key Developments, January 2020-March 2023
Table 68: BD: Business Segments
Table 69: BD: Selected Key Developments, January 2020-March 2023
Table 70: Exact Sciences Corp.: Key Developments, January 2021 to December 2022
Table 71: Roche: Selected Recent Developments, January 2021 to March 2023
Table 72: Guardant Health: Key Developments, 2021-2022
Table 73: Hologic Inc.: Key Developments, January 2021 to December 2022
Table 74: Illumina Inc: Key Developments, 2021 and 2022
Table 75: Leica Biosystems: Key Developments, January 2021 to December 2022
Table 76: Myriad Genetics: Key Developments, January 2021 to December 2022
Table 77: Qiagen: Key Recent Developments, 2021-April 2023
Table 78: Thermo Fisher Scientific Inc.: Key Developments, January 2021 to January 2023
Table 79: Veracyte: Key Recent Developments, Jan 2021-Jan 2023
Table 80: Abbreviations Used in This Report
List of Figures
Summary Figure: Global Market for Oncology Biomarkers, by Biomarker Type, 2020-2028
Figure 1: Biomarker Types Categorized by Application and Use in Drug Development and Disease Management
Figure 2: Molecular and Imaging Biomarkers
Figure 3: Biomarker Discovery, Verification and Validation
Figure 4: Cancer Care Spectrum
Figure 5: Types of Biomarker Testing and Their Definitions
Figure 6: Biomarkers in Personalized Treatment
Figure 7: Global Cancer Incidence, by Region, 2020
Figure 8: Global Cancer Incidence, by Region, 2020 vs. 2040
Figure 9: Distribution Shares of R&D Investment in Drug Development, by Function, 2020
Figure 10: Overview of Biomarker Test Benefits for Each Stakeholder
Figure 11: Barriers to the Use of Biomarker Tests Throughout the Patient Journey
Figure 12: Top Barriers to Biomarker Testing in the U.S., 2021
Figure 13: Common Biomarker Testing Methodologies
Figure 14: Four Main Classes of Genomic Alterations
Figure 15: Types of Genomic Biomarkers
Figure 16: Genomic Biomarker Testing Methods
Figure 17: Key Advantages of NGS for Precision Oncology Applications
Figure 18: Evolution of Biomarkers in Clinical Practice
Figure 19: Global Market for Oncology Biomarkers, by Biomarker Type, 2020-2028
Figure 20: Global Market Shares of Oncology Biomarkers, by Biomarker Type, 2022
Figure 21: Hallmark of Cancer
Figure 22: Stages of Cancer
Figure 23: Companion Diagnostics Co-Development Process from Biomarker Discovery to Regulatory Approval
Figure 24: Clinical Applications of Biomarkers in Oncology
Figure 25: Global Market for Oncology Biomarkers, by Application, 2020-2028
Figure 26: Global Market Shares of Oncology Biomarkers, by Application, 2022
Figure 27: Five-Year Overall Survival Rates in the U.S., by Cancer Type
Figure 28: Global Market for Oncology Biomarkers, by Cancer Type, 2020-2028
Figure 29: Global Market Shares of Oncology Biomarkers, by Cancer Type, 2022
Figure 30: Global Market Shares of Breast Cancer Biomarkers, by Biomarker Type, 2022
Figure 31: Global Market Shares of Lung Biomarkers, by Biomarker Type, 2022
Figure 32: Global Market Shares of Colorectal Cancer Biomarkers, by Biomarker Type, 2022
Figure 33: Global Market Shares of Prostate Cancer Biomarkers, by Biomarker Type, 2022
Figure 34: Global Market Shares of Bladder Cancer Biomarkers, by Biomarker Type, 2022
Figure 35: Global Market Shares of Melanoma Biomarkers, by Biomarker Type, 2022
Figure 36: Global Market Shares of Leukemia Biomarkers, by Biomarker Type, 2022
Figure 37: Global Market Shares of Other Cancers Biomarkers, by Biomarker Type, 2022
Figure 38: Global Market for Oncology Biomarkers, by Region, 2020-2028
Figure 39: Global Market Shares of Oncology Biomarkers, by Region, 2022
Figure 40: NIH's Cancer and Cancer Genomics Research Funding, by Year, 2018-2024
Figure 41: North American Market Shares of Oncology Biomarkers, by Application, 2022
Figure 42: European Market Shares of Oncology Biomarkers, by Application, 2022
Figure 43: Asia-Pacific Market Shares of Oncology Biomarkers, by Application, 2022
Figure 44: RoW Market Shares of Oncology Biomarkers, by Application, 2022
Figure 45: Emerging Trends/Technologies in the Oncology Biomarkers Market
Figure 46: Advantages of Liquid Biopsy
Figure 47: PubMed Article Count: “Liquid Biopsy”, 2014-2022
Figure 48: Pan-Cancer Genomic Biomarkers
Figure 49: SWOT Analysis of the Global Oncology Biomarkers Market
Figure 50: Abbott: Diagnostics Revenue, 2020-2022
Figure 51: Abbott: Diagnostics Market Share, by Business Segment, 2022
Figure 52: Agilent Technologies Inc.: Diagnostics and Genomics Revenue, 2020-2022
Figure 53: Biocartis: Annual Net Revenue, 2020-2022
Figure 54: Biocartis: Market Share, by Business Segment, 2022
Figure 55: BioMérieux SA: Annual Net Revenue, 2020-2022
Figure 56: BioMérieux SA: Market Share, by Application, 2022
Figure 57: Bio-Rad Laboratories: Annual Net Revenue, 2020-2022
Figure 58: Bio-Rad Laboratories: Market Share, by Business Segment, 2022
Figure 59: BD’s Biosciences Segment: Annual Revenue, 2020-2022
Figure 60: Exact Sciences Corp.: Annual Net Revenue, 2020-2022
Figure 61: Exact Sciences Corp.: Market Share, by Business Segment, 2022
Figure 62: F. Hoffmann-La Roche Ltd.’s Diagnostics Division: Annual Revenue, 2020-2022
Figure 63: F. Hoffmann-La Roche Ltd.’s Diagnostics Division: Market Share, by Customer Area, 2022
Figure 64: Guardant Health: Annual Net Revenue, 2020-2022
Figure 65: Guardant Health: Market Share, by Segment, 2022
Figure 66: Hologic Inc.: Annual Net Revenue, 2020-2022
Figure 67: Hologic Inc.: Market Share, by Business Segment, 2022
Figure 68: Illumina Inc.: Annual Net Revenue, 2020-2022
Figure 69: Illumina Inc.: Market Share, by Business Segment, 2022
Figure 70: Merck KGaA: Annual Revenue, 2020-2022
Figure 71: Merck KGaA: Market Share, by Business Segment, 2022
Figure 72: Myriad Genetics: Annual Net Revenue, 2021 and 2022
Figure 73: Myriad Genetics: Market Share, by Business Segment, 2022
Figure 74: Qiagen: Annual Net Revenue, 2020-2022
Figure 75: Qiagen: Market Share, by Product Type, 2022
Figure 76: Siemens Healthineers AG: Annual Net Revenue, 2020-2022
Figure 77: Siemens Healthineers AG: Market Share, by Business Segment, 2022
Figure 78: Thermo Fisher Scientific Inc.: Annual Revenue, 2020-2022
Figure 79: Thermo Fisher Scientific Inc.: Market Share, by Business Segment, 2022
Figure 80: Veracyte: Annual Revenue, 2020-2022
Figure 81: Veracyte: Market Share, by Business Segment, 2022

Executive Summary

By definition, biomarkers are any measurable substance that changes in quantity or appears or disappears with a change in a body’s state. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers.

Biomarkers allow early disease identification, improved diagnoses, and safer and more efficacious treatments, leading to better patient outcomes and efficient and effective public expenditure on health. Thus, biomarkers are accelerating throughout the cancer care spectrum (screening, diagnosis, prognosis, therapy selection, prediction, response monitoring, and recurrence monitoring) to improve patient care and treatment outcomes. Also, given the growing burden of cancer on the healthcare ecosystem, there is significant growth in research funding and initiatives to find new clinically relevant biomarkers to understand cancer biology. The discovery of cancer biomarkers is expanding at an unprecedented rate, as previous investments in genomic and proteomic sciences are enabling an improved understanding of disease mechanisms and individual patient responses to therapy. Several cancer biomarkers identified in the past decade are under investigation for their potential applications. Once these biomarkers are validated and subsequently enter clinical and research applications, the oncology biomarkers market is expected to grow significantly.

The global oncology biomarkers market was valued at $15.5 billion in 2022. That is projected to grow to $35.2 billion in 2028. There is a clear shift toward treating cancers based on their tumor genetics rather than their site of origin in the body. The increasing role of biomarkers in clinical diagnostics, precision medicine, and clinical trial management supports growth in this market. Driven by the rising prevalence of cancer, increasing demand in the therapeutic selection and prognosis, precision medicine, and clinical diagnostics, and a growing number of public/private collaborations and government support, the global market for oncology biomarkers is projected to rise at a CAGR of 14.9% through 2028.

Genomic biomarkers are more expensive to assay than protein biomarkers. However, with patients gaining access, oncologists and other providers are becoming more accustomed to incorporating genomic diagnostics into routine care, and the genomic biomarkers market is expected to witness rapid growth in coming years. This market is expected to reach $14.2 billion in 2028, growing at a CAGR of 16.6% through the forecast period.


Companies Mentioned

  • AGENDIA INC.
  • ABBOTT
  • AGILENT TECHNOLOGIES INC.
  • BIOCARTIS NV
  • BIOMERIEUX S.A.
  • BIO-RAD LABORATORIES INC.
  • BECTON, DICKINSON & CO.
  • EXACT SCIENCES CORP.
  • F. HOFFMANN-LA ROCHE AG
  • GUARDANT HEALTH INC.
  • HOLOGIC INC.
  • ILLUMINA INC.
  • LEICA BIOSYSTEMS
  • MERCK KGAA
  • MYRIAD GENETICS INC.
  • QIAGEN N.V.
  • SIEMENS HEALTHINEERS AG
  • THERMO FISHER SCIENTIFIC INC.
  • VERACYTE INC.

Table Information