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:
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)
- 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
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
APPENDIX: METHYLATION, HISTONES AND MICRORNA: WHICH MECHANISMS HAVE THE MOST POSITIVE COMMERICAL OUTLOOK?
Appendix Table 1
Comparative Commerical Outlook for Epigenetic Mechanisms
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
APPENDIX: METHYLATION, HISTONES AND MICRORNA: WHICH MECHANISMS HAVE THE MOST POSITIVE COMMERICAL OUTLOOK?
Appendix Table 1
Comparative Commerical Outlook for Epigenetic Mechanisms
