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Molecular Diagnostics: New Growth, New Markets


Publication Date   November 2005
Publisher   Cambridge Healthtech Advisors
Product Type   Strategic Report
Pages   208
ISBN Number   not applicable
Product Code   CHA024
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approximately: $3,902 | €2,442

Summary


Molecular Diagnostics: New Growth, New Markets highlights current trends in the molecular diagnostic industry and the major prospects and challenges ahead. Advancing technologies are pushing the diagnostics industry to the fore, and the molecular diagnostics industry in particular is emerging as a powerful health care player with tremendous potential. Advances in PCR (polymerase chain reaction), multiplexing, sequencing, and other technologies are propelling both new and old companies forward with novel capabilities.

The molecular diagnostic industry is characterized by a very diverse, constantly changing technology base that continuously produces new opportunities and applications. Similarly, a growing understanding of the molecular basis of cancer and other chronic diseases is opening up new realms of medicine to the possibilities of molecular diagnostic testing. While the infectious disease sector, particularly viral load testing, will continue to occupy the largest sector of the molecular diagnostics market, other areas, particularly oncology, will see greater rates of growth in the near future.

Molecular Diagnostics: New Growth, New Markets offers a comprehensive evaluation of this dynamic market. Highlights include the following:

  • A historical overview of molecular diagnostics, an analysis of the role of diagnostics in the growing field of personalized medicine, and a summary of major market trends and drivers.
  • A review of the dominant and emerging applications of molecular diagnostics, with a focus on major areas of robust growth. Although PCR is the most important molecular diagnostic technology, there are other dominant techniques generating considerable profits. The report identifies and evaluates the tremendous opportunities in the marketplace for new, improved technologies.
  • An assessment of the industry-landscape in terms of key non-technological trends and challenges, with a focus on regulation, consumer and health care provider education and marketing, and reimbursement.
  • An evaluation of the emergence and growth of personalized, or pharmacogenomic, medicine, which is providing tremendous revenue opportunities for molecular diagnostics. The challenge for molecular diagnostics companies will be to generate profits while forming cooperative relationships with pharma, regulatory agencies, consumers, and other stakeholders in ways that facilitate drug-diagnostic co-development and end in a win-win-win situation for all parties.
  • An examination of molecular diagnostic business models in the context of factors that are expected to drive the industry forward.
  • Profiles of a select list and description of companies that have shown remarkable progress in the field, smaller companies that are expected to emerge as dominant players in particular content or technological areas, and companies that exemplify a noteworthy aspect of molecular diagnostic business.

Content


Chapter 1. Introduction

1.1. Historical Overview of Molecular Diagnostics
1.2. The Molecular Diagnostics Market Today and in the Near Future
1.3. Personalized Medicine and Molecular Diagnostics
The Twofold Role of Molecular Diagnostics in Personalized Medicine
Historical Overview of Pharmacogenetics and Pharmacogenomics
Separating the Utopian Vision of Personalized Medicine from its Utilitarian Reality
1.4. Market Drivers
1.5. What Molecular Diagnostics Cannot Do: Predict the Environment

Chapter 2. The Technological Landscape

2.1. Introduction
2.2. Nucleic Acid Amplification Technologies
Polymerase Chain Reaction (PCR)
Post-PCR Analysis
The $1,000 Genome
Reverse Transcription–PCR
Real-Time, or Quantitative, PCR
PCR Patent Expirations
Non-PCR Target Amplification Technologies
2.3. Signal Amplification Tests (Direct Probe Tests)
2.4. The Microarray Platform
Gene Expression Analysis
The AmpliChip CYP450 Array
A Word About Single Nucleotide Polymorphisms
2.5. Molecular Cytogenetics: Fluorescence In Situ Hybridization
2.6. Gene Methylation, or Epigenetic, Technology
2.7. Proteomic Diagnostics
Aptamers
2.8. Nanodiagnostics
2.9. Enabling Technological Trends
Multiplexing
Noninvasive Technology
Miniaturization
Integration
Automation
2.10. Lack of Standardization: A Major Challenge

Chapter 3. Molecular Diagnostics Applications

3.1. Infectious Disease Diagnostics
Human Immunodeficiency Virus (HIV)
HIV Resistance Testing
Hepatitis C Virus
Hepatitis B Virus
Bacterial Infectious Disease Testing
3.2. "Traditional" Genetic Testing: Monogenic Disease Risk Assessment and Prenatal Testing
Cystic Fibrosis
Prenatal Testing
3.3. Oncology
Leukemias and Lymphomas
HER-2/neu Testing
Other Uses of Pharmacogenomics in Oncology
Human Papillomavirus Testing
The Case for Human Papillomavirus Testing
Gene Expression Technology and Cancer
3.4. Cardiovascular Testing
Cardiovascular Pharmacogenomics
3.5. Molecular Diagnostics Outside of the Clinic
Biothreat Detection
Agricultural and Livestock Applications
Identity Testing

Chapter 4. The Molecular Diagnostic Landscape: Obstacles Ahead

4.1. Regulatory Challenges
FDA-Regulated versus Homebrew Testing
Pharmacogenetic/Genomic Regulation
"Guidance for Industry: Pharmacogenomic Data Submissions"
Drug-Diagnostics Co-Development: Regulatory Challenges
Multiplex Test Regulation
4.2. Reimbursement and Coverage of Molecular Diagnostic Tests and Services
Genetic Discrimination
4.3. Consumer and Clinician Education
Direct-to-Consumer Marketing: Consumers Changing Health Care
Clinician Awareness
4.4. The Path of Least Resistance

Chapter 5. The Business of Molecular Diagnostics

5.1. Introduction
5.2. Major Types of Molecular Diagnostic Companies
5.3. How Personalized Medicine Will Impact Molecular Diagnostics
The Cost-Effectiveness of Pharmacodiagnostics
5.4. Advantages for Pharma

Chapter 6. Expert Interviews

Charles R. Cantor, Ph.D., SEQUENOM, Inc.
Steven I. Gutman, M.D., U.S. Food and Drug Administration
Nathan D. Lakey, Orion Genomics, LLC
Jorge A. Leon, Ph.D., Leomics Associates
Attila T. Lörincz, Ph.D., Digene Corporation
David A. Okrongly, Ph.D., Bayer HealthCare, LLC

Chapter 7. Selected Company Profiles

Digene Corporation
Genaissance Pharmaceuticals, Inc.
MetriGenix Corporation
Monogram Biosciences
Orchid Cellmark
Orion Genomics
SEQUENOM, Inc.
Solexa, Inc.
Stratagene
Third Wave Technologies, Inc.

References


Glossary


Index


List of Figures


Figure 1.1. Major Molecular Diagnostic Products
Figure 5.1. The Use of Molecular Diagnostics in Personalized Medicine

List of Tables


Table 2.1. Summary of Major Nucleic Acid Amplification Technologies
Table 2.2. FDA-Approved Fluorescence In Situ Hybridization Assays
Table 3.1. FDA-Approved HIV Tests
Table 3.2. FDA-Approved HCV Tests
Table 3.3. FDA-Approved Chlamydia trachomatis and Neisseria gonorrhoeae Tests
Table 3.4. FDA-Approved Tests for Bacterial Agents Other than Chlamydia trachomatis and Neisseria gonorrhoeae
Table 3.5. FDA-Approved Leukemia/Lymphoma Tests
Table 4.1. Stakeholder Perception of Three Different Types of Genetic Testing
Table 5.1. A Rough Sketch of the Top 10 Molecular Diagnostic Companies