2020 Report on Companion Diagnostics in the COVID-19 Era: Market Analysis and Opportunities - ResearchAndMarkets.com

The "Companion Diagnostics in the COVID-19 Era: Market Analysis and Opportunities" report has been added to ResearchAndMarkets.com's offering.

This report provides a comprehensive market analysis and business planning tool for the market for tests that are aligned with pharmaceutical treatment. Especially in oncology, companion diagnostics are rising to the forefront of pharmaceutical development and treatment.

Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. Companion diagnostics can also decrease costs by identifying the patient population that will most likely benefit from the therapy and ruling out therapies that are not likely to be effective. But what is the market for these therapy/test combinations? And who is winning in the quest to develop them? How much will the market be in the future? What specific drugs are seeing test product approvals, and sales of those products? How has COVID-19 impacted the sector? This resource provides answers to these questions and more.

Sense of the Market

• COVID-19 impacts on Companion Diagnostics- Where are We Now?
• Top Performing Targeted Therapies in Oncology with CDx Component, based on 2019 Sales
• FDA Cleared/Approved Companion Diagnostic Tests, 2010-2020
• Global In Vitro Companion Diagnostic (CDx) Market, 2019-2024 ($ millions)
• Global In Vitro Companion Diagnostic (CDx) Market by Region

Regulatory Picture

• FDA changes in CDx regulation: Shifting to Drug Classification CDx Labeling
• FDA Approved Companion Diagnostics Labeled for Identifying Patients with NSCLC whose Tumors have EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution - Mutations and the Associated Therapeutic Products Listed on the Companion Diagnostic Labels
• EU Companion Diagnostic Regulation Guidance

Companies Mentioned

• Abbott Diagnostics
• Agilent Technologies Inc./Dako
• Biocartis
• Foundation Medicine, Inc.
• Guardant Health, Inc.
• Illumina, Inc.
• Myriad Genetics, Inc.
• Neogenomics
• Qiagen N.V.
• Roche Diagnostics
• Thermo Fisher Scientific Inc.

The emergence of new technology has opened doors for companion diagnostic research, discovery, development and commercialization. This has resulted in a huge increase in exploratory studies, diagnostic developments, and clinical usefulness in the pursuit of personalized medicine. Companion diagnostics and biomarkers provide insight into understanding disease processes and ways that medicines can work to counteract the disease. Novel biomarkers and subsequent companion diagnostics have the potential to transform the current healthcare model from a one-size-fits-all approach to a personalized approach

Key Topics Covered:

Chapter 1: Executive Summary and COVID-19 Developments

• Overview
• Definitions of Companion Diagnostics and Personalized Medicine Used in This Report
• Terms Used in Companion Diagnostics and Personalized Medicine
• COVID-19 CDx Test Volume Impact: Minimal Ongoing Significant Disruptions
• Biomarker Development: COVID-19 Focus
• Addressing COVID-19 with a Personalized Medicine Approach
• Scope and Methodology
• Market Summary

Chapter 2: Introduction to Personalized Healthcare and Companion Diagnostics

• Overview
• Regulatory Changes
• FDA changes in CDx regulation: Shifting to Drug Classification CDx Labeling
• EU Companion Diagnostic Regulation Guidance
• The FDA and Identifying Pharmacogenetic Associations
• Reimbursement Breakthroughs and Challenges
• Next Generation Sequencing Coverage
• CDx Approvals: United States FDA
• The Market for Targeted Therapies: Oncology
• Targeted Therapies in Development
• Development in NGS for CDx
• Next Generation Sequencing or Massively Parallel Sequencing in Cancer Diagnostics
• The Evolving Opportunity in Japan
• Disease Profiles in CDx Markets
• Cancer
• Cardiovascular Disease
• Selected Blood Disorders
• Autoimmune and Immunological Diseases
• Infectious Diseases

Chapter 3: Companion Dx Market Analysis

• Market Overview
• Biomarkers in Therapeutic Labeling
• Companion Diagnostics in Oncology
• Market Review and Outlook
• Companion Diagnostics in Other Diseases
• Overview
• Autoimmune Disorders
• Cardiology and Hematology
• Infectious Disease
• Human Leukocyte Antigen (HLA) and COVID-19
• Neurology
• Market Review and Outlook
• Diagnostic Techniques
• Market Overview
• Immunohistochemistry (IHC)
• In Situ Hybridization
• Nucleic Acid Amplification Technologies
• Sequencing Technologies
• Flow Cytometry
• Microarrays
• Mass Spectrometry
• Liquid Biopsies - Circulating Tumor Cells and Circulating Tumor DNA (Cell Free DNA)
• Analysis of Gene Expression Patterns (Gene Signatures)
• Information Technology
• Regional Market Review
• U.S. Market
• European Market
• Reimbursement in European Markets
• Japanese Market
• Chinese Market
• Rest of World Market

Chapter 4: Competitive Analysis

• Competitive Landscape
• Alliances, Acquisitions and Collaborations
• Competitor Analysis
• CDx Product Mix: Leading IVD Companies

Chapter 5: Market Participant Profiles

For more information about this report visit https://www.researchandmarkets.com/r/rhww41

View source version on businesswire.com: https://www.businesswire.com/news/home/20201023005272/en/