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Epigenetics: Technologies, Applications, and the Commercial Landscape

Published by: CHI Insight Pharma Reports

Published: Feb. 1, 2008 - 130 Pages


Table of Contents


Chapter 1

EPIGENETICS TODAY

1.1 What Epigenetics is All About

Epigenetics Defined

Current and Potential Commercial Applications

1.2. DNA Methylation and Histone Modifications: Focus of This Report

1.3. The Etiology of Cancer: From a Mutational to Epigenetic Understanding

Cancer as a Mutational Disease

An Epigenetic Approach to Cancer Etiology

1.4. The Epigenetics of Noncancerous Diseases

Rett Syndrome

Schizophrenia

Alzheimer’s Disease

Chapter 2

DNA METHYLATION BIOMARKERS AND TECHNOLOGY: THE RACE IS ON

2.1. The Mechanisms of Epigenetics

A Focus on DNA Methylation

Histone Modifications as Biomarkers: A Field in its Infancy

2.2. The Power of DNA Methylation: Biomarker or Bust

Clinical Applications of Methylation Diagnostics

Major Challenges to Realizing the Potential of Epigenetic Diagnostics: Clinical Validation, Economic

Validation and Provider Education

Three Major Challenges to the Market Success of Epigenetic Diagnostics

2.3. Homebrew Methylation Testing

2.4. Epigenetic Diagnostic Companies

Epigenomics

OncoMethylome Sciences

Orion Genomics

Interview with Cathy-Lofton Day, PhD

Vice President of Molecular Biology, Diagnostics

Epigenomics

2.5. DNA Methylation Technology

Gene-by-Gene Technologies: The Bisulfite Revolution and Beyond

2.6. The Future is Genomewide

DNA Microarrays

High-Throughput Sequencing

ChIP-on-chip and ChIP-Seq: Frontrunner Epigenomic Technologies

Interview with Jeff Falk, PhD

Director of Technology and Business Applications

Aviva Systems Biology

2.7. DNA Methylation Research Prep Kits and Service Contracts: Making It Easy

Companies Who Supply Kits

QIAGEN

Zymo Research

BioChain

Human Genetic Signatures

Millipore

Sigma-Aldrich

Panomics

Invitrogen

Companies and Contract Services

Interview with Christopher Adams, PhD

Research Area Manager, Division of Epigenetic

Invitrogen

Chapter 3

EPIGENETIC DRUGS: THE RACE TO REVERSE SILENCING

3.1. The Dynamic Nature of the Epigenome

3.2. Demethylating Agents

Only 2 FDA-Approved Agents

Vidaza

Dacogen

Major Advantages and Disadvantages of Demethylating Drugs

3.3 Histone Modifications: Using Drugs to Restore Acetylation

3.4. Combination Therapy: Epigenetic Drugs Make Good Partners

Interview with Donald F. Corcoran

President and CEO

MethylGene

Chapter 4

The Business of Epigenetics

4.1. What is Driving Industry Interest in Epigenetics?

New Knowledge

New Technology

Dry Pipelines

Human Disease and Suffering

4.2. The "Epigenetics Industry"

Diagnostics

Therapeutics

Research Tools

4.3. Industry Snapshot #1: Recent Major Business Deals

4.4. Industry Snapshot #2: Recent Patent Applications Related to Epigenetics

Appendix

Insight Pharma Reports - Epigenetics Survey - January 2008

References

Company Index with Web Addresses




Tables

Table 1.1. Major Commercial Applications of Epigenetics

Table 1.2. Types of Epigenetic Control Factors and Their Potential Commercial Utility

Table 1-3 Total Sales for FDA-Approved Epigenetic Therapeutics Already on the Market

Table 1.4. Diseases With Epigenetic Etiologies: A Growing List

Table 2.1. Select List of Epigenetic Diagnostics in Development

Table 2.2. Ways to Analyze DNA Methylation

Table 2.3. Clinical Applications of DNA Methylation Biomarkers

Table 4.1. Future Market Growth: Diagnostics, Therapeutics, and Research Tools

Table 4.2. 10 Recent Major Business Transactions in the Emerging Epigenetic Sector of the Life Sciences Industry




Figures

Figure 4.1. The Rising Popularity of Epigenetics in the Scientific World

Figure 4.2. SWOT Analysis: Epigenetic Diagnostics

Figure 4.3. SWOT Analysis: Epigenetic Therapeutics

Figure 1A. Types of Organizations

Figure 2A. Titles of Respondents

Figure 3A. Responsibilities: Basic Science to Regulator

Figure 4A. Length of Time in Epigenetics

Figure 5A. Depth of Epigenetics Research

Figure 6A. Plans for Expansion

Figure 7A. Epigenetic Biomarker Discovery and Development

Figure 8A. Diagnostic and Therapeutic Categories

Figure 9A. Primary Focus of Research

Figure 10A. Primary Application of Epigenetic Profiling

Figure 11A. Growing Interest and Investment

Figure 12A. Gold Standard for DNA Methylation

Figure 13A. High-Throughput Technologies

Figure 14A. No Research Technology of Choice for Now

Figure 15A. No Clinical Technology of Choice

Figure 16A. Epigenetics Market Growth Projections

Figure 17A. Potential Commercial Availability of Epigenetic Products

Figure 18A. Advances in Diagnostic/Biomarker Development

Figure 19A. Advances in Therapeutics

Figure 20A. Gap or No Gap

Abstract

Epigenetics is one of the fastest-growing areas of the biological sciences. It’s also a budding industry. This new report offers in-depth analysis of:
  • The definition, history, and current status of epigenetics
  • Current and potential commercial applications
  • An epigenetic approach to cancer etiology
  • The epigenetics of noncancerous diseases
  • DNA methylation and histone modifications as biomarkers
  • The companies involved and their products
  • Epigenetic therapeutics: demethylating agents, histone modifications, and combinations
  • The drivers of the epigenetics industry, plus recent major industry deals and patent applications
  • Results of a quantitative online survey of individuals involved in epigenetics R&D
Epigenetics: Technologies, Applications, and the Commercial Landscape provides an overview of the scientific and technological landscape from which both the diagnostic and therapeutic sectors of the nascent “epigenetics industry” are emerging, plus a qualitative analysis of the scientific, technological, and commercial achievements and challenges facing both sectors.

The number of peer-reviewed research articles being published on epigenetics is increasing practically exponentially.

Biologists are recognizing that to understand human health and disease, they need to know more than the DNA sequence of any genes. Equally, if not more important, they need to know how cells use the information encoded in the genome. That information is essentially stagnant if a gene lies dormant. What turns genes on and off, and under what circumstances? That is what epigenetics is all about: how genomic information encoded in the DNA sequence is regulated by various nonDNA factors. The science and technology of epigenetics are aimed at understanding and, ultimately, manipulating the various chemical and physical chromatin modifications that control gene expression.

This report focuses on the 2 major types of epigenetic control factors:
  • DNA methylation patterns formed by the presence of methyl molecules (-CH3) attached to CpG dinucleotides along the entire length of the DNA double helix
  • Various covalent modifications to the histone proteins around which the DNA helix is wound
Epigenetics: Technologies, Applications, and the Commercial Landscape is a valuable tool for anyone involved in epigenetics R&D, portfolio management, and commercialization of diagnostics and therapeutics.

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