薬理ゲノム学における発展

Abstract

Pressure to Optimize Drug Discovery Drives Adoption

Considering that the development of a single drug costs an average of $500 million and that only 30 percent of approved drugs even recover these costs, the pharmaceutical industry is under growing pressure to streamline and optimize the identification of novel therapeutics. In addressing this need, pharmacogenomic profiling has the potential not only to increase the efficiency and speed with which new medicines are developed, but also to improve diagnostics for drugs already in the market. As a result, there is a growing awareness among pharmaceutical and biotechnology companies about the benefits of using pharmacogenomics in the selection of compounds with a favorable safety and efficacy profile.

This Frost & Sullivan research service provides technical insights into developments in pharmacogenomics. This analysis reviews technologies that are expected to impact the pharmacogenomics industry and includes coverage of key participants and their developments. The study distinguishes itself by focusing on user concerns by examining the practical and pragmatic applications of emerging technologies.

NitroMed looking at Identifying Genes Involved in the Positive Response to its Heart Failure Drug, BiDil

Among the notable developments related to pharmacogenomics research in North America, NitroMed is focusing on determining the genes involved in the positive response to its BiDil, a drug that remedies heart failure. This orally-administered medication, which enhances nitric oxide levels in the body and protects the compound after it is formed, was developed on the basis of pharmacogenomic evidence that suggests that African American heart failure patients often suffer from a greater deficiency of nitric oxide than non-African Americans. After their initial setbacks, the company successfully conducted clinical trials on 1,050 African American patients and in June 2005, the Food and Drug Administration (FDA) voted to recommend approval of BiDil for the treatment of heart failure in African American patients. Encouraged by this approval, the company is now conducting pharmacogenomic studies to determine the genes that might be involved in the positive response to BiDil. Researchers are looking at the endothelial nitric oxide synthase (NOS3) gene, which encodes the nitric oxide synthesizing enzyme in the heart as well as vasculature and is important in treating hypertension and heart failure

"In Europe, the UK-based Solexa is developing genome sequencing systems for a comprehensive and economical analysis of individual genomes, which can be used in a wide range of applications from basic research to the development and implementation of personalized medicine," notes the analyst of this research service. "The long-term goal of this project is to reduce the cost of human resequencing to a few thousand dollars, thus providing an individuals total genetic information for less than the cost of a CT scan."

Pharmacogenomics Hold Tremendous Potential in Reducing Market Withdrawals

Apart from bringing about improvements in drug discovery and approvals, the potential benefits of pharmacogenomics are likely to extend even after FDA approvals. In the last decade, a considerable number of approved drugs, including Vioxx, Rezulin, Pondimin, Redux, Propulsid, Seldane, Posicor, and Baycol (Cerivastatin) have been withdrawn from the market. In most cases, the withdrawal was precipitated by adverse effects that occurred in less than 0.1 percent of patients receiving the drug. Examining genetic variation provides the opportunity to uncover genotype-phenotype correlations that may allow the exclusion of a subset of at-risk individuals.

"Despite the explosive growth in proteomics, genetic information is expected to continue playing a major role in healthcare and drug discovery," says the analyst. "Pharmacogenomic testing (research, clinical, and diagnostic) is one of the fastest growing sectors of healthcare and its market potential is projected to grow to 3-4 billion dollars by the end of this year."

Table of Contents

1. Executive Summary

• 1. Introduction
  • 1. Introduction to Pharmacogenomics
  • 2. Variable Drug Response and Adverse Reactions
  • 3. SNP Profiling
  • 4. FISH
  • 5. Companies Involved in Pharmacogenomics Research
• 2. Scope and Methodology
  • 1. Scope
  • 2. Methodology

2. Technology and Applications Viewpoint

• 1. Applications Analysis and Trends
  • 1. Primary Applications: Drug Discovery and Molecular Diagnostics
  • 2. Diagnosis Plus Therapy
  • 3. Personalized Medicine
• 2. Industry Trends and Assessments
  • 1. Market Factors
  • 2. Enabling Technologies and Their Markets

3. Innovative Developments in North America

• 1. Companies
  • 1. NitroMed: Genetic Variation Determines Response to Heart-Failure Drug
  • 2. Genecor: Second-Generation Interferon-Beta Molecule for Treatment of Multiple Sclerosis
  • 3. Monogram Biosciences: Cancer-Specific Dimers Determine Response to Chemotherapy
  • 4. Genizon BioSciences: Small Founder Population Allows Easier Linkage and SNP Mapping
  • 5. Nanogen: Improved Circuitry Increases Biochip Performance
  • 6. Affymetrix: CYP450 Test Approved in USA and Europe
  • 7. DNAPrint: Fewer SNPs Lower Genotyping Costs
  • 8. SimPheny: Computer Modeling for Predictions of Cellular Metabolism and Behavior
  • 9. Nanosphere: Gold Nanoparticles Allow Molecular Analysis without PCR
  • 10. Additional Companies-I
  • 11. Additional Companies-II
• 2. Academic and Government-Related Institutions
  • 1. Ohio State University: New Molecular Understanding to Tailor Treatments for Addiction
  • 2. Mayo Clinic: Protein Misfolding Leads Aggrosome to Disrupt Thiopurine Metabolism
  • 3. University of Florida: Researchers Identify Genes that Influence Response of Heart Failure Patients to Beta-Blockers
  • 4. University of Michigan: Herbal Therapy Potentiates Effect of Blood Thinner by Increasing CYP3A4 Activity
  • 5. Stanford University: Microarrays Predict Drug Response
  • 6. NIST: Fluorescent Quantum Dots Reduce FISH Uncertainty
  • 7. UCSF: E-Map Looks at Epistatic Interactions
  • 8. Harvard University: Automated Microscopy to Track Broad Effects of Drugs

4. Innovative Developments in Europe and Asia-Pacific

• 1. Companies
  • 1. Iceland: deCODE Genetics
  • 2. UK: Solexa
  • 3. Switzerland: Roche
  • 4. France: Serono Genetics Institute
  • 5. Germany: Epigenomics
  • 6. Netherlands: Qiagen N.V.
  • 7. India: Ocimum
  • 8. India: Avestha Gengraine
  • 9. India: Strand Genomics
• 2. Academic and Government-Related Institutions
  • 1. France: Magnetic Particles Speed DNA Separations on Chip
  • 2. Germany: Genetic Analysis without Labels
  • 3. Australia: CSIRO

5. Technology Adoption Factor Analysis

• 1. Development Restraints and Market Challenges
  • 1. Introduction
  • 2. Too Much Complexity
  • 3. Too Much Simplicity
  • 4. Too Much Optimism
  • 5. Clinical Trial Design
  • 6. Understanding Business Fundamentals
  • 7. Practicality of Point-of-Care
  • 8. Pharmaceutical Industry Reluctance
  • 9. Governmental Support--Financial and IP Protection
  • 10. Others
• 2. Adoption Drivers
  • 1. Drug Side Effects
  • 2. Pressure on Big Pharma to Accelerate Drug Discovery
  • 3. Need for Faster Identification of Failed Targets
  • 4. Identify Suitable Patient Population for Clinical Trials
  • 5. Demand for Personalized Medicine
  • 6. Others
• 3. Technology Features and Benefits
  • 1. Part I
  • 2. Part II
• 4. Analysis of Funding Sources
  • 1. European Government Funding for R&D
  • 2. USA: Pharmacogenetics Research Network
  • 3. Canadian Pharmacogenomic Funding

6. Database of Key Industry Participants and Selected Patents

• 1. Key Industry Participants
  • 1. North America
  • 2. Europe and Asia Pacific
• 2. Patents
  • 1. Patents--I
  • 2. Patents--II
  • 3. Patents--III

7. Frost & Sullivan 2005 Science & Technology Awards

• 1. Excellence in Technology Award
  • 1. Award Description
  • 2. Award Recipient
• 2. Technology Innovation Award
  • 1. Award Description
  • 2. Award Recipient
• 3. Technology Leadership Award
  • 1. Award Description
  • 2. Award Recipient

8. Critical Reference Tables

• 1. Healthcare and Pharma R&D Expenditure
  • 1. Total Healthcare Expenditure (1999-2006)
  • 2. Pharma R&D Expenditure (1999-2006)
• 2. Biotechnology R&D Expenditure
  • 1. Number of Biotechnology Companies (1999-2006)
  • 2. Government Investment in Biotechnology R&D (1999-2006)
  • 3. Private Investment in Biotechnology R&D (1999-2006)