Companion Diagnostics - Thematic Research

Companion Diagnostics - Thematic Research

Summary

Companion diagnostics (CDx) are molecular assays that measure levels of proteins, genes, or specific mutations to reveal a specific, efficacious therapy for an individual’s condition. CDx are a form of personalized, stratified, and precision medicine, and they herald a new era of treatment in which a patient’s treatment will become increasingly individualized.

CDx are developed in parallel to the drug using the drug-diagnostic co-development model. The field has expanded from a handful of oncology drugs with corresponding diagnostics to include multiple therapeutic areas, and the number of combinations has grown significantly over the years. However, oncology remains the largest segment for FDA-defined marketed drugs with CDx. The FDA has cleared or approved more than 40 CDx in the field of oncology. GlobalData expects that oncology will likely remain the therapeutic area at the forefront of CDx in the future. Although precision medicine encompasses many areas, oncology is the area that is expected to exhibit high growth.

This report looks at the CDx medical devices market and some of the oncology biomarkers, indications, and diagnostic technologies being utilized. The market for biomarker testing continues to increase due to increases in disease, awareness, improved accessibility to personalized medicine, and technological advancements.

Scope

  • This report is a thematic brief, which identifies those companies most likely to succeed in a world filled with disruptive threats. Inside, we predict how each theme will evolve and identify the leading and disrupting companies.
  • The report covers the companion diagnostics theme.
Reasons to Buy
  • GlobalData’s thematic research ecosystem is a single, integrated global research platform that provides an easy-to-use framework for tracking all themes across all companies in all sectors. It has a proven track record of identifying the important themes early, enabling companies to make the right investments ahead of the competition, and secure that all-important competitive advantage.
  • Develop and design your corporate strategies through an in-house expert analysis of companion diagnostics by understanding the primary ways in which this theme is impacting the medical devices industry.
  • Stay up to date on the industry’s major players and where they sit in the value chain.
  • Identify emerging industry trends to gain a competitive advantage.


  • Executive Summary
  • Players
    • Table Figure 1: Who are the leading players in the companion diagnostics theme and where do they sit in the value chain?
  • Technology Briefing
    • Immunohistochemistry
    • In Situ Hybridization
    • Nucleic Acid Amplification
    • Sanger Sequencing
    • Next-Generation Sequencing
  • Trends
    • Technology trends
      • Table Technology trends
    • Macroeconomic trends
      • Table Macroeconomic trends
    • Regulatory trends
      • Table Regulatory trends
  • Industry Analysis
    • BRCA
      • Table Figure 2: The most common method used to evaluate BRCA status in the US is NGS
    • HER2
      • Table Figure 3: The most common method used to evaluate HER2 status in the US is IHC
    • BRAF
      • Table Figure 4: The most common method used to evaluate BRAF status in the US is NAAT
    • BCR-ABL Tests
      • Table Figure 5: The most common method used to evaluate BCR-ABL status in the US is NAAT
    • ALK Tests
      • Table Figure 6: The most common method used to evaluate ALK status in the US is ISH
    • Mergers and acquisitions
      • Table Mergers and acquisitions
    • Timeline
      • Table Figure 7: The companion diagnostics story
  • Value Chain
    • Table Figure 8: Companion diagnostics value chain
    • Immunohistochemistry tests
      • Table Figure 9: The immunohistochemistry tests segment
    • In situ hybridization tests
      • Table Figure 10: The in situ hybridization tests segment
    • Nucleic acid amplification tests
      • Table Figure 11: The Nucleic acid amplification tests segment
    • Sanger sequencing tests
      • Table Figure 12: The Sanger sequencing tests segment
    • Next-generation sequencing tests
      • Table Figure 13: The next-generation sequencing tests segment
  • Companies
    • Public companies
      • Table Public companies
    • Private companies
      • Table Private companies
  • Further reading
    • GlobalData reports
      • Table GlobalData reports
  • Our thematic research methodology
    • Table Figure 14: Our five-step approach for generating a sector scorecard
  • About GlobalData
  • Contact Us

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