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Companion Diagnostics in the COVID-19 Era
Publication Date: June 17, 2020
Tags: COVID-19, Infectious Diseases, Oncology and Cancer, Personalized Medicine, Precision Oncology
Pages: 180
SKU: 20-032
Companion diagnostics are revolutionizing pharmaceutical development and treatment, particularly in oncology. By identifying patients with specific biomarkers or disease-specific therapeutic targets, companion diagnostics significantly improve clinical success rates and patient outcomes. They also reduce costs by pinpointing the patient population most likely to benefit from a therapy and excluding those for whom the therapy would be ineffective, a critical advantage given the high cost of many new cancer treatments.
The medical industry is undergoing significant transition, with increasing demand for advanced medical technology products driven by an aging population. Companion diagnostics play a crucial role in delivering cost-effective and efficient healthcare. This comprehensive report, Companion Diagnostics in the COVID-19 Era, provides essential data and resources for understanding the market for tests aligned with pharmaceutical treatments. Discover market size, leading players, regulatory changes, and the impact of COVID-19 on the sector.
Market Insights:
- COVID-19 Impact on Companion Diagnostics: Analysis of current market conditions and future prospects.
- Top Performing Targeted Therapies in Oncology: Based on 2019 sales.
- FDA Cleared/Approved Companion Diagnostic Tests: Data from 2010-2020.
- Global In Vitro Companion Diagnostic (CDx) Market: Projections from 2019-2024.
Regulatory Overview:
- FDA Regulatory Changes: Shifts in CDx regulation and drug classification labeling.
- FDA Approved Companion Diagnostics: Detailed overview for NSCLC patients with specific genetic mutations.
- EU Regulatory Guidance: Latest developments and guidelines for companion diagnostics in Europe.
Competitive Analysis:
- Companies Offering Companion and Complementary Diagnostics: Analysis by therapeutic area, including autoimmune disorders, cardiology, hematology, infectious diseases (including COVID-19), and neurology.
- Deep Dives into the CDx Market: Comprehensive data on the value and distribution of commercialized targeted therapies and companion diagnostics by cancer type, drug class, and technique.
Market Segmentation:
- Estimated Value of Non-Oncology Companion Diagnostics: Distribution by cancer type (2019).
- Commercialized Targeted Therapies Revenues: Comparison with companion diagnostic market value from 2015-2019.
- Global CDx Market by Region: Breakdown for the US, EU, Asia, and Rest of the World (2019-2024).
Technological Advancements:
Emerging technologies are driving companion diagnostic research, discovery, development, and commercialization, leading to an increase in exploratory studies and clinical applications in personalized medicine. Novel biomarkers and companion diagnostics are transforming healthcare from a one-size-fits-all approach to a personalized model.
Table: Global CDx Market, by Region, 2019-2024 ($ millions)
| Region | 2019 | 2024 | CAGR 2019-2024 |
| United States | $XX Million | $XX Million | XX% |
| Europe | $XX Million | $XX Million | XX% |
| Japan | $XX Million | $XX Million | XX% |
| China | $XX Million | $XX Million | XX% |
| Rest of World | $XX Million | $XX Million | XX% |
| Global | $XX Million | $XX Million | XX% |
Source: Kalorama Information
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Table of Contents
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
- Profile Scope
- Abbott Diagnostics
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Agilent Technologies Inc./Dako
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Biocartis
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Foundation Medicine, Inc.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Guardant Health, Inc.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Illumina, Inc.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Myriad Genetics, Inc.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- NeoGenomics
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- QIAGEN N.V.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
- Roche Diagnostics
- Company Overview
- Financial Review
- Company Overview: Companion Dx
- Thermo Fisher Scientific Inc.
- Company Overview
- Financial Review
- Product Overview: Companion Dx
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