Market Research Report

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

cover Published by Kalorama Information
Published Product code 248850
Content info 160 Pages
Price

Introduction

Abstract

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 At the same time it means that outdated concepts will have to be revised.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

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

Epigenetics: Applications for Pharmaceuticals and Diagnostics (Methylation, Histone Modification and miRNA expression published by Kalorama Information in August 10, 2012. This report consists of 160 Pages and the price starts from US $ 3995.

Press Release

Drugs That Switch Genes Back "On" May Represent Future of Cancer Treatment

October 5th, 2012

Global Information Inc. would like to present a new market research report, "Epigenetics: Applications for Pharmaceuticals and Diagnostics (Methylation, Histone Modification and miRNA expression" by Kalorama Information.

Methylation treatments that can re-activate stagnant "controller" genes might be a common cancer treatment in the near future, according to Kalorama Information. In a new report, the healthcare market research publisher said that of the rapidly-developing epigenetic approaches--treatments based on new theories outside of what was previously the mainstream thinking of genomics (not involving DNA base pair alterations), these drugs are the more realistic bet. The report, Epigenetics: Applications for Pharmaceuticals and Diagnostics (Methylation, Histone Modification and miRNA expression), suggests that most new epigenetic drugs will be methylation-based, while other epigenetic candidates such as miRNA treatments will take longer to see marketability.

Methylation of genes is a mechanism that is associated with cancer but can be reversible with the right drugs. It is the process by which stretches of alternating "Cs" and "Gs" -- the cytosine and guanine acids that represent two of the four acids in human DNA -- are modified through the production of methane-derived alkyls and the addition to the "C" acids, the cytosines. When "controller" genes are methylized, they are shut off and in turn, shut down the structural genes that they control.

This is not a good thing, the report says, because some of these genes are oncogenes, intimately involved in the regulation of cellular behavior. When methylated, these regulatory or "controller" genes fail to function, and when control is lost the normal tissue can be transformed into a malignancy. The good news, according to the report, is that the introduction of inhibitor chemicals has been shown to not only stop methylation but actually to reverse this process, or in effect turn the controller gene back "on" and improve the patients condition.

"Its not exactly like turning on a light switch, because it involves a far more complicated chemical process, but it is one way to understand the end result," said Bruce Carlson, publisher of Kalorama Information. "DNA methylation is the dominant approach, with approved products and products in trial, and our analysts project more approvals from this mechanism in the next five years."

Only four epigenetic cancer treatments have been approved thus far: Mercs Zolinza, Celgends Vidaza, Eisais Dacogen and Celgenes Istodax. But the report says that every major drug company has a robust research program in methylation and histone modification drug development, targeting a variety of cancers. The next five years will certainly be dominated by epigenetics, Kalorama suggests. In some trials, epigenetic-based drugs are well tolerated and clinically effective against hematologic cancers, even though results vary when used against solid tumors as a monotherapy.

This report, Epigenetics: Applications for Pharmaceuticals and Diagnostics (Methylation, Histone Modification and miRNA expression), describes the ongoing research in this area and forecasts potential markets for epigenetic-based therapeutics and testing. It discusses the key companies in the market, the revenues of current products in the market, and the progress that has been made in our understanding of the basic science of epigenomics and it considers the practical accomplishments being reported by the private sector.

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