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시장보고서
The Landscape of Companion Diagnostics: Challenges, Opportunities, and Future Trends
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Abstract
Introduction
Diagnostics can be used to identify subgroups of patients who may or may not
benefi t from a companion drug, who may have adverse reactions to that drug,
or who may require different doses of that drug because of their particular
metabolic activity. The concept of companion diagnostics as an integral
component of personalized medicine-RxDx-is an emerging and critical paradigm
for drug development and use. What is driving that paradigm?
Get the Answers You Need to Shape Your Strategy
- More than a dozen companion diagnostic tests are approved for use in the
United States and guide the prescription of products in oncology,
cardiovascular disease, and infectious diseases. What are the most
successful RxDx products, and will their success encourage further
development? Why are companies reluctant to abandon the blockbuster model in
favor of personalized medicine?
- Personalized medicine continues to be heavily debated within the industry,
and future growth depends on more attention from all stakeholders. What is
each stakeholder' s role in RxDx collaborations, and how can these
collaborations drive development? What does each player have to offer the
others to encourage development and reconcile debate? Why are parallel
development programs critical?
- Reimbursement issues are an important factor that will determine whether
the pharmaceutical industry is willing to invest in RxDx, but current
reimbursement policies can be discouraging. What evidence must companies
provide to third-party payers to demonstrate value and ensure reimbursement?
What are the policies and issues surrounding reimbursement? With few RxDx
products on the market and even fewer reimbursed, how can R&D costs ever be
recovered?
Scope
- Key players: Abbott Diagnostics, Clinical Data, Dako, Genzyme
Genetics.
- Challenges in RxDx development: technological challenges,
regulation, drug labeling, reimbursement.
- Emerging companion diagnostics by therapeutic area: oncology,
infectious diseases, cardiology, central nervous system (CNS) indications,
diabetes, respiratory therapeutics; profi les of select companies working in
RxDx.
- Outlook: future of companion diagnostics development, company
buy-in, the affect of personalized medicine on prescription sales, the role of
regulatory agencies.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Why Companion Diagnostics?
- RxDx Market Status
- Companion Diagnostic Tests on the Market
- Key Current Players in Companion Diagnostics
- Abbott Diagnostics
- Clinical Data
- Dako
- Genzyme Genetics
- Determinants of Codeveloping Companion Diagnostics
- Why Should Companies Codevelop Targeted Therapies and Companion
Diagnostics?
- Why Do Pharmaceutical Companies Need to Establish Parallel Programs?
- Economics of Producing Companion Diagnostics
- Challenges in Developing Companion Diagnostics
- Technological Challenges
- Regulation of Diagnostic Tests
- Drug Labeling
- Reimbursement Issues and Challenges
- Personalized Medicines
- Payers
- Reimbursement Policies
- Coding Issues
- Determining Prospects and Potential for Reimbursement
- Emerging Companion Diagnostics by Therapeutic Area
- Oncology
- Biodesix
- bioMérieux
- Celera
- GE Healthcare
- Monogram Biosciences
- Roche
- Source MDx
- Infectious Diseases
- Abbott
- Monogram Biosciences
- Roche
- Visible Genetics
- Cardiology
- PGxHealth
- LabCorp
- Nanosphere
- Central Nervous System Indications
- Adlyfe
- Curidium
- Clinical Data
- ExonHit Therapeutics
- Vanda Pharmaceuticals
- Diabetes
- Perlegen
- Tethys Bioscience
- Respiratory Therapeutics
- Market Opportunities for Companion Diagnostics
- Getting the "Buy-In" from Companies
- Expanding Therapeutic Area Coverage
- Outlook
- Will We See More Companion Diagnostics on the Market?
- Will RxDx Negatively Affect Rx Sales?
- Will More Companies Join the Personalized Medicine Bandwagon?
- Will There Be More Codevelopment of Therapeutics and Diagnostics?
Sidebars
- Common Defi nitions of Terms Associated with Companion Diagnostics
- Regulation of Diagnostic Tests in the United States
- Third-Party Payers Infl uencing Reimbursement for Diagnostic Tests
- Case Study: An RxDx Partnership Informing HIV Treatment
Tables
- 1. Select FDA-Approved Companion Diagnostic Tests and Associated
Therapeutics
- 2. Collaborations of Leading Companion Diagnostics Developers, 2007-2008
- 3. Select Companion Diagnostic Tests for Warfarin Dosing
- 4. Recent Key Collaborations for Companion Diagnostic Development
- 5. Advantages and Disadvantages of Establishing a Drug and Diagnostic
Codevelopment Program
- 6. Comparison of the Pharma and Diagnostics Industries Business Models
Figures
- 1. RxDx Codevelopment Process
- 2. Potential Biomarkers to Guide Treatment with AstraZeneca' s Iressa (Gefi
tinib)
- 3. Impact of Biomarkers on Therapeutic Development and Prescription
- 4. Benefi t of Companion Diagnostics in the Characterization and
Validation of Targeted Therapeutics
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