市場調査報告書：薬理ゲノム学のビジネスモデルの成功例

tools for pharmacogenomics carry the promise of achieving improved drug safety, earlier attrition rates, decreased drug development costs, a reduced drug development cycle, and resuscitation of failed drugs. Delivering on these promises will lead the way toward longer patent life and greater profits for new drugs. The challenge-and opportunity-for pharmaceutical companies is to figure out how to deploy the appropriate pharmacogenomics strategy into the drug sales model to facilitate maximum return.

Successful Pharmacogenomics Business Models is a new Cambridge Healthtech report that provides a theoretical framework to evaluate pharmacogenomics initiatives within pharmaceutical companies.

The objective of the framework is to

determine the situation where pharmacogenomics is viable within the current and future large pharmaceutical drug development model;
determine requirements for success for each viable pharmacogenomics strategy;
understand the implications for the pharmaceutical and diagnostics industries.

A key perceived risk in adopting pharmacogenomics is a decrease in market share due to smaller patient populations. Successful Pharmacogenomics Business Models examines how an appropriate pharmacogenomics strategy can actually open up additional revenue streams and contribute significantly to the bottom line by extending the patent protection period for a drug by reducing the time to market, saving costly Phase III trials through early attrition, and diminishing overall healthcare costs by improving safety profiles and Phase IV surveillance.

The report evaluates numerous factors driving the pharmacogenomics market, and addresses key issues shaping the adoption of pharmacogenomics testing including the following:

The rapidly decreasing cost of SNP genotyping as a catalyst for pharmacogenomics adoption.
A detailed analysis of the measurements used by pharmaceutical companies-cost-minimization, cost-benefit, cost-effectiveness and cost-utility-to evaluate pharmacogenomic testing.
An evaluation of the factors impacting the strategic, commercial and operational aspect of delivering pharmacogenomics to the marketplace.
The factors influencing the integration of pharmacogenomics into clinical trials, including an FDA proposal to address the following issues: the implications of existing regulations as they pertain to required or requested pharmacokinetic and pharmacogenetic/genomic data from the FDA; clarification on governance of pharmacogenomics tests in laboratories; whether a test is defined as clinical (drug specific) or non-clinical (research only); and future directions the FDA will take to drive the implementation of applied pharmacogenomics.
An evaluation of successful pharmacogenomic business models.
A scenario forecasting for the adoption of pharmacogenomics in industry based on two key variables-time to adoption and available capital to address hurdles in the industry.
A discussion of the issues of payer/provider support and physician adoption.

1. Executive Summary

2. Introduction

2.1. Genetic Variation and Implications for Medicine
2.2. Pharmacogenomic Applications in Research, Development and Medicine
2.3. Risks & Industry Issues Facing Pharmacogenomics Adoption
2.4. Factors Enabling Pharmacogenomics

3. Market Opportunities Arising from Pharmacogenomics

3.1. Overview
- 3.1.1. Pervasiveness of Pharmacogenomics
- 3.1.2. Applications of Use for Pharmacogenomics
- 3.1.3. Use of Diagnostics to Enable Drug Sales
- 3.1.4. Recent Pharmacogenomics Examples
3.2. Pharmacogenomics Applications in Practice
- 3.2.1. Three Pharmacogenomics-Enabled Drug Sales Models
- 3.2.2. Price Premium for Diagnostic-Influenced Drug Sales
3.3. P450 Pharmacology and Drug Applications
- 3.3.1. Targeted Therapies Leveraging Genetic Variation
3.4. Market Entry Theory and Implications for the Pharmaceutical Industry
- 3.4.1. Economic Viability of Using Diagnostics in the Drug Sales Model
- 3.4.2. Breakeven Analysis of the Diagnostic-Enabled Drug Model
3.5. Implications for Industry

4. Cost Opportunities Arising from Pharmacogenomics

4.1. Overview
- 4.1.1. Current and Required Costs for SNP Genotyping
- 4.1.2. Importance of Cost Versus Quality and Accuracy
- 4.1.3. Impact of Adverse Drug Reaction Costs
4.2. Elements of Cost in Drug Research & Development
- 4.2.1. Phased Drug Development Costs and Milestones
- 4.2.2. Opportunities and Cost Quantification for Clinical Productivity
- 4.2.3. Areas of Impact from Pharmacogenomics-Driven Clinical Productivity
4.3. Elements of Cost in Healthcare
- 4.3.1. Composition of Adverse Drug Reaction Costs
- 4.3.2. Drivers of Adverse Drug Reaction Costs
- 4.3.3. Variance Analysis of Increased Adverse Drug Reaction Costs
- 4.3.4. Avoidable Adverse Drug Reaction Costs Due to Pharmacogenomics
4.4. Cost Effectiveness of Pharmacogenomics
- 4.4.1. Effective Measurements for Pharmacogenomics Applications
- 4.4.2. Cost and Throughput Comparison of Competing Genotyping Technologies
- 4.4.3. Benefits and Hurdles with Linkage Disequilibrium and Haplotyping Techniques
4.5. Results of Pharmacogenomics
- 4.5.1. Impact of Pharmacogenomic Cost Advances

5. Industry Overview & Outlook

5.1. Key Elements of the Pharmaceutical Value-Chain
- 5.1.1. Why Molecular Diagnostics is Critical
- 5.1.2. Pharmaceutical and Biotechnology Companies
  - 5.1.2.1. NCE Introduction Drives Discovery Actions
  - 5.1.2.2. Marketing Strategy and Execution
  - 5.1.2.3. Clinical Trial Management
- 5.1.3. Molecular Diagnostics and Testing
  - 5.1.3.1. Integrated Diagnostics Capability in Practice
  - 5.1.3.2. Diagnostics Versus Therapeutic Value Proposition
- 5.1.4. Payer / Provider
  - 5.1.4.1. Impact on Industry Adoption
  - 5.1.4.2. Cost Efficiency Driven by Diagnostics
- 5.1.5. Physician and Healthcare Delivery
  - 5.1.5.1. Concentration of Prescribing Physicians
  - 5.1.5.2. Adverse Events, Negligence and Impact on Industry
  - 5.1.5.3. Pharmacogenomics Adoption Drivers for Physicians
- 5.1.6. Negligence, Litigation and Impact on Industry
  - 5.1.6.1. Negligence Criteria
  - 5.1.6.2. Therapeutic Surveillance and Impact on Companies
- 5.1.7. Relative Cost of Adverse Reactions
  - 5.1.7.1. Cost of Adverse Reactions Within Industry
  - 5.1.7.2. Quantification of Adverse Events

6. Creating and Optimizing the Pharmacogenomics Business Model

6.1. Existing Pharmacogenomics Business Models
6.2. Biotechnology Companies Stand-Alone Pharmacogenomics Business Models
- 6.2.1. Microarray Chip
- 6.2.2. Services and Diagnostic Kits
- 6.2.3. Platform Technologies
- 6.2.4. Bundled Drug and Test
6.3. Assessing Pharmacogenomic Business Models and Disruptive Technologies
- 6.3.1. Exploring the Rationale Behind New Business Models
- 6.3.2. Determining Characteristics of the Innovation
- 6.3.3. Assessing the Consequences of the Advancement Via Experiment
- 6.3.4. Finding a Viable Initial Market for Disruptive Technology
- 6.3.5. Carving-Out Responsibility for Implementation
- 6.3.6. Maintaining Independence for Operations
6.4. Large Pharma Pharmacogenomics-Enabled Business Models
- 6.4.1. Targeted Therapies
- 6.4.2. Ultra-Blockbuster
- 6.4.3. Development Rescue
6.5. Implications for Industry

7. Regulatory Overview

7.1. Current Regulatory Process for Drug Development
- 7.1.1. Influence of Current Federal Code on Pharmacogenomics
- 7.1.2. FDA Budget and Organizational Changes
7.2. FDA Pharmacogenomics Regulation Proposal
- 7.2.1. Procedure for Creating Regulatory Proposal
- 7.2.2. FDA Pharmacogenomics Regulatory Proposal
- 7.2.3. Key Issues Facing Industry
- 7.2.4. Issues Facing the FDA
7.3. Testing Kit Regulations and FDA Approval Process
- 7.3.1. Background and Changing Regulatory Dynamics
- 7.3.2. Testing Kit Regulations
- 7.3.3. Testing Kit FDA Approval Process
7.4. Impact to Industry from Pharmacogenomics Regulation
7.5. Pharmacogenomic Data Submitted to Regulatory Agencies
7.6. Implications for Industry
7.7. Conclusion

8. Intellectual Property and Ethical Issues

8.1. Overview
- 8.1.1. Intellectual Property Basics
- 8.1.2. Types of Patents
- 8.1.3. Duration of Patent and Patent Classifications
- 8.1.4. Criteria and Qualitative Benchmark for Meeting Criteria
8.2. What Is and Is Not Patentable
8.3. Pharmacogenomics and Intellectual Property
8.4. Strategic Considerations & Implications of Patenting
- 8.4.1. Scope, Value of Claims and Business Model Linkage
8.5. Ethical Issues
- 8.5.1. Respect for Persons
- 8.5.2. Beneficence
- 8.5.3. Justice
8.6. Pharmacogenomic Applications of Ethical Considerations
- 8.6.1. Race & Genotype
- 8.6.2. Negligence
- 8.6.3. Informed Consent
- 8.6.4. Privacy
- 8.6.5. Market Segmentation
- 8.6.6. Media and Opinion Leader Edification
- 8.6.7. Regulatory Implications