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

Epigenetics (“Epi”; “over “ or “above” genetics) is recognized as those systems that control the expression of DNA-coded genes, but do not reside in the base pair sequences of the DNA. Rather, these control mechanisms are based on factors or molecules that bind to specific regions of the DNA (the genome), affecting gene expression. The three most important, and best understood mechanisms, are:

  • Methylation, 
  • Histone Modulation and
  • Micro RNA (or miRNA) Regulation
This report an assessment of commercial outlook for each one of these categories.  It includes market size and forecast for epigenetics in pharmaceutical and diagnostic applications.  Epigenetics 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.

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 At the same time it means that outdated concepts will have to be revised.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 epigenetics 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:
  • Which Mechanisms Are Mostly Likely to  Produce Working Therapeutic Products?
  • Discussion of the Basic Science and Mechanisms Behind Epigenetics
  • 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.  

Mabs" and molecular tests are among the growth industries of pharmaceuticals and diagnostics, but they may have competition long-term from an unexpected source. 


Epigenetics 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 Epigenetics, 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. 

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.  


PUBLICATION TSUNAMI SURROUNDING EPIGENETICS

As I noted inmy report on Epigenetics, published by Kalorama in 2012, the field is on thecusp of an explosion, which is now taking place.  According to an assessment in GeneticEngineering and Biotechnology News (http://www.genengnews.com/gen-articles/en-bloc-analysis-of-b-epigenetic-b-b-publications-b/4704/),publications are proliferating at an exponential rate, particularly in thefield of cancer research. The authors also claim that other epigenetic-baseddisease research areas are expanding rapidly, including cardiovascular,neurological and obesity targeted investigations.

 The authorsretrieved 28,000 publications on epigenetics-related topics from a Medlinesearch. Examples of this publication tsunami are already translating into drugsapprovals (currently six) or into clinical trials , with much of the effort in oncology.Because model of epigenetic mechanisms in other areas are not far advanced, wecan anticipate that translational research in these areas will proceed moreslowly, but nonetheless will soon ramp up.

"In the examination of Google hits for “Epigenetics,” the phrases “exciting”, “state of the art”, “cutting edge”, “innovative”, “breakthrough” and other clichés 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."

  • Executive Summary
    • THE BASIC SCIENCE OF EPIGENETICS- BASIC LIFE SCIENCE R&D
      • Table The Most Common Epigenetic Alterations
    • EPIGENETICS AND DIAGNOSTICS
    • OUTLOOK FOR EPIGENETICS R&D
  • 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
        • Table The Most Common Epigenetic Alterations
    • A NEW LEVEL OF CHALLENGE
    • IMPLICATIONS FOR THE HEALTHCARE INDUSTRY
    • THE BIG PICTURE:AN INTERVIEW WITH DR.MICHAEL SKINNER
    • THEMOLECULAR BIOLOGY OF EPIGENETIC CONTROL MECHANISMS
      • DNA methylation
    • HISTONE ACETYLATION AND OTHER MODIFICATIONS
      • Complex; Not Well Understood
        • Table Varieties of histone modification and their properties
      • Histone Acetylation
      • Histone phosphorylation
      • Methylation
      • Sumoylation
      • Histone "chaperones"
      • MicroRNAs (miRNAs)
    • SUMMARY, CONCLUSIONS
  • Epigenetic and Diagnosis
    • Table Examples of Clinically Relevant Epigenetic Biomarkers
    • EPIGENETIC DRIVERS OFDISEASE
      • 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
  • Market Drivers
    • EPIGENETICS AND THERAPEUTICS:MARKET BY MAJOR DISEASES
      • Table Currently FDA-Approved Epigenetic-Based Drugs
    • CANCERS
      • Hypo/Hypermethylation
        • Table U.S. FDA-Approved Epigenetic-Acting Drugs
    • ANTI-CANCER THERAPY
      • Covalent Histone Modifications
      • Aberrant miRNA expression
      • Autoimmune dysfunction
      • Cardiovascular
    • MENTAL DISORDERS
      • A Classic Vision Of Mental Illness
      • Schizophrenia
      • Bipolar disorder
      • Autism
        • Table Prevalence of autism as a function time, 2000-2008
        • Table Current Autism Therapies
      • 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
  • Companies Active in Epigenetics
    • DIAGNOSTIC COMPANIES
      • Table Some important epigenetics diagnostics companies
    • Enzo Life Sciences
    • Epigenomics AG
      • Epiontis
    • Exact Sciences
      • Illumina
      • Novus Biologicals
      • MDxHealth
      • Valirx
      • Volition Singapore
    • THERAPEUTIC COMPANIES
      • Table The Epigenetics Land Grab: R&D from major pharma 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 Sigma-Aldrich
      • Zymo Research Products
    • SUMMARY, CONCLUSIONS
  • Outlook for the Epigenetics Market
    • Opportunities and Challenges
      • Stephen Baylin, M.D.: Epigenetics Will Generate Clues On Biomarker Strategy
    • GROWTH IN WORLD ECONOMIES
      • Table GNP Growth by Country, Region
      • Testing: Need for Rapid, Easy to Use Technologies
        • Table Conflicting Worldwide Economic Drivers And Their Impact On Epigenetics Technologies
      • Dim Prospects for Pharma: How to Upend them
        • Table Guidelines For A New Stage Of Drug Development
      • Dr. Pedro Cuatrecasas on Corporate Policies and Innovation
    • MARKET POTENTIAL FOR EPIGENETIC-DRUGS
      • Table Epigenetics Therapeutics Market, 2011 and 2017 (millions)
      • Table Global Pharma Market, 2010 and 2015 (billions)
      • Table FDA-Approved Epigenetic Anti-Cancer Agents
      • Dr. Ping Chi: Confident That Discovery Will Lead to "Tumor Achillies Heel"
    • EPIGENETICS MARKET IN DIAGNOSTICS
      • Table Next Gen Cancer Diagnostics Market, 2010-2015
      • Table Epigenetics in Cancer Diagnostics, 2010-2015
      • Table Total IVD Market 2007-2011
    • THERAPEUTIC MARKET AREAS
      • Table Some Current Epigenetics Research Goals
      • Table Cancer Diagnostics Market
    • PERSONALIZED MEDICINE AND EPIGENETICS
    • INDUSTRY CHALLENGES AND STRATEGIC RECOMMENDATIONS
      • Table Some Major Companies And Their Activities
      • Competitive landscape
    • EPIGENETICS MARKET CONSIDERATIONS
    • MARKET DRIVERS AND RESTRAINTS
      • Market Forecasts and Competitive Analysis
      • Competitive Structure
      • Regional Market Considerations
      • Market Share Analysis: Product Segments
    • BIOTECHNOLOGY MARKET WORLDWIDE
      • North America
      • EU
      • Japan
        • Table Takeda regional portfolio balance
      • Asia Pacific
    • THEWAY FORWARD
      • South America
    • SUMMARY, CONCLUSIONS
  • Appendix
    • Table Comparative Commerical Outlook for Epigenetic Mechanisms

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