Global Clinical Oncology Biomarker Testing Market Report, Second Edition: 2023-2028

This report provides an overview of the clinical oncology biomarker testing market from 2023 to 2028. The predictive and prognostic oncology biomarker testing market, as defined in this report, is comprised of revenue from kits and reagents sold to clinical and reference lab customers, along with service revenues generated by commercial reference labs for biomarker testing in solid tumors. NGS, PCR, and IHC are the primary technologies utilized for clinical biomarker testing today, though a number of new technologies (e.g., spatial biology, digital biomarkers, etc.) are actively under investigation. Increased access to each of these technologies, as well as to the precision medicines requiring testing, is expected to drive significant growth of the biomarker testing market in the near-mid term.

The second edition of DeciBio’s clinical oncology biomarker testing report takes a completely updated and comprehensive look at the biomarker testing landscape.This report was informed by a combination of secondary research (e.g., analysis of quarterly and annual reports, earnings call transcripts, clinical trials, congress abstracts, company websites, etc.) and primary research (e.g., 28 interviews with oncologists, pathologists, lab directors, and biopharma) to assess the current and expected future adoption and utilization of biomarker testing in solid tumors, and to quantitatively and qualitatively characterize the key market dynamics. From our research and analysis, we estimate that the clinical oncology biomarker testing market is ~$6.7B in 2023 and is expected to grow at 13% p.a. over the next 5years, to reach ~$12.6B by 2028.

Quantitatively, we provide a 5-year (2023-2028) market forecast segmented by cancer type (lung cancer, colorectal cancer, breast cancer, prostate cancer, and other solid tumors), analyte (genomics, proteomics, transcriptomics, other), technology class (NGS, PCR, IHC, other), business model (kits, services), sample type (tissue, blood, other), and geography (U.S., Europe, APAC, ROW). For each of the subsegments analyzed, we present forecasted data from 2023-2028. In addition, we detail market drivers (e.g., growing number of predictive markers) and moderators (e.g., lack of access to precision medicine therapeutics in certain markets), market trends, and offer key information on top competitors. All analyses are based on publicly-reported data and DeciBio research and analysis.*

The global license of the report comes with a comprehensive database that outlines partnerships and approvals for solid tumor companion diagnostics from 1997-2023. This database includes background information on each partnership or approval (e.g., companies involved, indication, genetic alterations, geography), details on the biomarkers under investigation (e.g., assays developed, predictive / prognostic, technology utilized, -omics class), as well as information on the associated therapeutics (e.g., therapeutic name, mechanism of action, therapeutic modality, and phase of development).

* Disclaimer: Some of the companies listed in this report may be DeciBio Consulting clients and customers

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Technologies and Revenues Included:

• Predictive and prognostic biomarker testing for solid tumors, including the use of companion diagnostic assays, testing completed for the purposes of therapy selection, or germline testing for oncology-related biomarkers that influence treatment decisions
• Biomarker testing done in routine clinical care
• Biomarker testing completed on any sample type (e.g., tissue, blood, etc.)
• Kits /reagents (e.g., off the shelf assays and library prep) used in the testing of oncology biomarkers; the revenue captured is the revenue to the kit manufacturer
• Send-out services in which a sample is sent to a centralized testing location; the revenue captured is the revenue to the service provider

Technologies and Revenues Excluded:

• Applications outside of predictive or prognostic testing including biomarker testing done for cancer diagnosis, minimal residual disease /monitoring, or any other testing that does not inform therapy selection
• Clinical trials and research, including biopharma's biomarker R&D and CDx development services
• Applications outside of solid tumor oncology such as hematological tumors, organ transplant, reproductive health, prenatal screening, routine bloodwork
• Sequencing reagents used to perform NGS testing
• Instruments and platforms used to run / analyze samples, including software / bioinformatics support

Segmentations Covered in Market Analysis:

End Customer:

• Clinical

Cancer Type:

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Other Solid Tumors

Analyte:

• Genomics
• Proteomics
• Transcriptomics
• Other

Technology Class:

• NGS
• PCR
• IHC
• Other

Business Model:

• Kits (Distributed)
• Services (Centralized, Reference Labs)

Sample Type:

• Tissue
• Blood
• Other

Geography:

• United States
• Europe
• APAC
• Rest of World (ROW)

Companies Profiled:

• Agilent
• Caris Life Sciences
• Foundation Medicine
• Guardant Health
• Illumina
• Roche
• Tempus
• Thermo Fisher

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