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Epigenomics, Present and Future Applications for Pharmaceuticals and Diagnostics

August 2012 | 160 pages | ID: E57D29282B3EN
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'Mabs' and molecular tests are among the growth industries of pharmaceuticals and diagnostics, but they may have competition long-term from an unexpected source. Epigenomics is a potential game-changer in the clinical therapeutics market and significant in testing as well. It refers to technologies involving changes in genetic material that find their origins in causes other than base pairs alterations in the DNA of the host. Examples of such changes include DNA methylation and histone acetylation, both of which have been known for many years to cause changes in gene expression. This report 'Epigenomics, Present and Future Applications for Pharmaceuticals and Diagnostics' describes the progress that has been made in our understanding of the basic science of epigenomics and considers the practical accomplishments being reported by the private sector.

Epigenomics constitutes a challenge to the long held paradigm of DNA base pair sequences as the prime determinant of the phenotype. Because of this profound intellectual shift, a vast new area of biological investigation is rapidly unfolding. This presents significant opportunities for understanding disease processes and developing the means of combating them.

Epigenomic Mechanisms Discussed in the report include:
  • DNA methylation
  • Histone Acetylation
  • Histone Phosphorylation
  • Methylation
  • Sumoylation
  • Histone “chaperones”
  • MicroRNAs (miRNAs)
The examination of many diseases in a completely new light means there exist a wealth of opportunities to develop new diagnostic and therapeutic approaches. At the same time it means that outdated concepts will have to be revised. This report looks at the science behind epigenomics and deals with opportunities for product development based on epigenetic technologies and the outlook for the future in this exciting area of pharmaceutical technologies. In doing so, the report provides:
  • Discussion of the Basic Science and Mechanisms Behind Epigenomics
  • Activities of Top Companies in the Market
  • Interviews with Researchers and Private Sector Leaders
  • Market Estimates for Current Epigenomic Drugs and Forecast to 2017
  • Market Estimates for Current Epigenomic Diagnostics and Comparison to Next Gen Cancer Diagnostics Market
  • Analyst Conclusions Regarding the Future Market for Epigenomics
  • Key Healthcare Segments Impacted by Epigenomics
  • Examples of Clinically Relevant Epigenetic Biomarkers
  • Currently Approved Epigenomic Drugs
  • Epigenetic Drivers of Disease
  • Pharmaceutical R&D: A Need for Better Returns
  • Look at Applications in Alzheimer’s Disease, Mental Illness, Auto-Immune Diseases, Autism and Cardiovascular Disease
CHAPTER ONE: EXECUTIVE SUMMARY

The Basic Science of Epigenetics- Basic Life Science R&D
Epigenetics and Diagnostics
Outlook for epigenetics R&D

CHAPTER TWO: THE BASIC SCIENCE OF EPIGENETICS

A New Look at Health and Disease.
  Lamarck
  Weissmann
The History of Epigenetics to the Present
What This Report Covers
What is Epigenetics?
  The concept.
A New Level of Challenge
Implications for the Healthcare industry
The Big Picture: An interview with Dr. Michael Skinner
The Molecular Biology of Epigenetic Control Mechanisms
  DNA methylation
Histone acetylation and other modifications
  Complex; not well understood
  Histone Acetylation
  Histone phosphorylation
  Methylation
  Sumoylation
  Histone “chaperones”
  MicroRNAs (miRNAs)
Summary, Conclusions

CHAPTER THREE: EPIGENETIC AND DIAGNOSIS

Epigenetic drivers of disease
  Epigenetics and DNA methylation
Role of histones
Early cancer diagnosis
Methylation Markers
  Challenges in the Identification of Epigenetic Involvement in Non-Cancerous Diseases
Summary, Conclusions

CHAPTER FOUR: MARKET DRIVERS

Epigenetics and Therapeutics: Market by major diseases
Cancers
  Hypo/Hypermethylation
Anti-Cancer Therapy
  Covalent histone modifications
  Aberrant miRNA expression
  Autoimmune dysfunction
  Cardiovascular
Mental Disorders
  A classic Vision of Mental Illness
  Schizophrenia
  Bipolar disorder
  Autism
  Alzheimer’s Disease
  Spinal muscular Atrophy (SMA)
  Parkinson’s Disease
  Imprinting Disorders
  Praeder-Willi Syndrome
  Angelman Syndrome
  Beckwith-Wiedemann Syndrome
Fragile X Syndrome
Friedreich’s Ataxia
Concluding on a Cautionary Note

CHAPTER FIVE: COMPANIES ACTIVE IN EPIGENOMICS

Diagnostic companies
Enzo Life Sciences
Epigenomics AG
  Epiontis
Exact Sciences
  Illumina
  Novus Biologicals
  Oncomethylome Sciences
  Valirx
  Volition Singapore
Therapeutic Companies
  Acetylon Pharmaceuticals
  Acylin Therapeutics
  CellCentric
  Celdex
  Celgene
  Celzome (UK/DE)
  Chroma Therapeutics
  Constellation Pharma
  Eisai Co. Ltd
  Epitherapeutics
  EpiZyme
  Methyl Gene
  Novartis:
  Orion
  RaNA Therapeutics
  Syndax Pharmaceuticals Inc.
  ValiRX (UK)
Epigenetics research products supply companies
  Active Motif
  Diagenode
  Epigentek
  Life Technologies
  Qiagen
  Sigma-Aldrich
  Zymo Research Products
Summary, Conclusions

CHAPTER SIX: OUTLOOK FOR THE EPIGENETICS MARKET

Growth in World Markets; Overall
Dim Prospects for Pharma: How to Upend them
Upsides, Opportunities: A huge market for epigenetic-based cancer treatments.
The IVD market
The Overall IVD Market
Specific Epigenetic IVD market breakdown
Personalized medicine and epigenetics
Industry Challenges and Strategic Recommendations
Competitive landscape
Total Epigenetics Market 2008-2017
Market Drivers and Restraints
Market Forecasts and Competitive Analysis
  Revenue Forecasts
  Competitive Structure
  Competitive Metrics
  Market Share Analysis: Product segments
WW Epigenetic Market 2008-2017
  North America
  EU
  Japan
  Asia Pacific
  Ominous signs from China
The Way Forward
  South America
Summary, Conclusions

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1:The most common epigenetic alterations
CHAPTER TWO: THE BASIC SCIENCE OF EPIGENETICS
Figure 2-1 Timeline of epigenetic discoveries ourtesy Constellation Pharma
Table 2-1 The most common epigenetic alterations
Figure 2-2 Agouti Mice
Figure 2-3 Classic DNA methylation reaction
Figure 2-4 The molecule 5-hydroxymethylcytosine
Figure 2-5 DNA molecule wrapped twice around a Hisotne Octamer to make a Nucleosome
Table 2-2 Varieties of histone modification and their properties
Figure 2-6 Acetylation and deacetylation of lysene residues
Figure 2-7 Shilatifard A. 2008
CHAPTER THREE: EPIGENETIC AND DIAGNOSIS
Table 3-1: Examples of Clinically Relevant Epigenetic Biomarkers
CHAPTER FOUR: MARKET DRIVERS
Table 4-1: Currently FDA-approved Epigenetic-Based Drugs
Figure 4-1: Structures of (A) 5-aza 2’-deoxycytidine (5 aza –dC, decitabine) and (B) zebularine
Figure 4-2: U.S. FDA-approved Epigenetic-Acting Drugs
Table 4-3: Prevalance of Autism as a Function Time, 200-2008
Table 4-4: Current Autism Therapies
Figure 4-3: Map of the 11p15 imprinted region
CHAPTER FIVE: COMPANIES ACTIVE IN EPIGENOMICS
Table 5-1: Some Important Epigenetics Diagnostics Companies
Table 5-2: The Epigenetics Land Grab: R&D from Major Pharma Companies
Figure 5-2: JUN/EPIZYME An Example of one of Epizyme’s inhibitors interacting with an epigenetic enzyme
Figure 5-3: Structure of LBH589 (panobinostat)
Figure 5-4: Action of Panbinostat
Figure 5-5: Structure of Entinostat
CHAPTER SIX: OUTLOOK FOR THE EPIGENOMICS MARKET
Table 6.1:GNP Growth by Country, Region
Table 6.2: Conflicting Worldwide Economic Drivers And Their Impact On Epigenomics Technologies
Figure 6.1: Vast Expenditures, Poor Returns
Table 6.3: Guidelines For A New Stage Of Drug Development
Table 6.4: Epigenomics Therapeutics Market, 2011 and 2017 (millions)
Table 6.5: Global Pharma Market, 2010 and 2015 (billions)
Figure 6.2: Epigenomic Drug Market, 2011 and 2017
Table 6.6: FDA-Approved Epigenetic Anti-Cancer Agents
Figure 6.3: Epigenomics Diagnostics Market, 2010 and 2015
Table 6.7: Next Gen Cancer Diagnostics Market, 2010-2015
Table 6.8: Epigenomics in Cancer Diagnostics, 2010-2015
Table 6.9: Total IVD Market 2007-2011
Table 6.10: Some Current Epigenomics Research Goals
Table 6.11: Cancer Diagnostics Market
Table 6.12: Some Major Companies And Their Activities
Figure 6.4: Publications on Epigenomics and Cardiovascular Disease
Table 6.13: Takeda regional Portfolio Blance As a Bellweather


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