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Epigenetics: Applications for Pharmaceuticals and Diagnostics (Methylation, Histone Modification and miRNA expression)

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 At the same time it means that outdated concepts will have to be revised.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

The report strives to predict the potential for epigenomics while reminding market-watchers of the challenges and possible limiting factors in this market. As the report states:

"In the examination of Google hits for “Epigenomics,” the phrases “exciting”, “state of the art”, “cutting edge”, “innovative”, “breakthrough” and other cliches are encountered over and over. These terms are frequently employed to cover up ideas, concepts and scientific discoveries that may NOT be cutting edge or state of the art and may be past their time, or may never have reached their time. For this reason the report will consider which of these technologies have value and may be ripe for exploitation."

The study of epigenomics today finds itself at a tuningpoint, with many unanswered questions and a proliferation of opportunities forproducts based on the constant flow of new research findings. This report is essential for pharmaceutical and diagnostic marketers looking to develop future business plans and determine opportunities in a promising field.

Table of Contents

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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