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miRNA Research and Diagnostics Markets

  • September 2014
  • -
  • Kalorama Information
  • -
  • 200 pages

This report considers the diagnostic promise of non-coding RNA molecules, with a particular focus on the microRNAs. miRNAs (MicroRNAs) are short, single stranded RNAs that regulate mRNA expression at the post-transcriptional level. These small bits of RNA, members of a class of non-translated molecules that do not produce protein, shut off gene transcription by base pairing with the target molecules. They are now recognized as pivotal regulators of gene expression; including development, proliferation, differentiation, and apoptosis and serving widespread functions as regulatory molecules in post-transcriptional gene silencing. As the report details, a large number of companies, both small biotechs and big pharmaceutical companies are committed to miRNA diagnostics.

As part of its coverage of this topic, this report includes the following:
Overview of miRNAs
Positive Factors for miRNA Diagnostic Technologies
Negative Factors
miRNAs and Neurological Disorders
miRNA and Metastatic Brain Lesions
Prostate Cancer Screening and miRNAs
miRNAs and Resistance to Anti-Cancer Drugs
Theoretical Limitations
Discussion of Patent Issues
Interviews with Industry Experts
Market Estimate

One the positive side of the equation, the technology is innovative, and offers the promise of non-invasive diagnostics for cancer and other disorders that could be cheaper, faster and more accurate than existing tests, which are either non-existent or leave much to be desired. On the negative side of the equation, there are many complex challenges that must be resolved before the technology can be applicable. There is a need for large scale clinical trials, and rigorous standardization of the assay conditions, given the fact that the assessments of serum levels of miRNA molecules are quantitative. This report considers the potential for the miRNA market in research and diagnostics and the challenges. In doing so, the report looks at several companies currently developing research and diagnostic miRNA technologies.

As part of its coverage, the miRNA offerings and products in developments in the following companies are profiled in detail.
Agilent Technologies
Alnylam
AMSBIO
Applied Biosystems
Asuragen
DiamiR, LLC
Dicerna
Eisai Biomarkers and Personalized Medicine
Diagnostics
Exiqon
Genomic Health Inc.
Gensignia
GlaxoSmithKline Discovery and Molecular Toxicology
Groove Biopharma (formerly Mirina)
Hologic-Gen Probe Inc.
Illumina, Inc.
Isis Pharmaceuticals
Mello Biotechnology Inc.
Microlin Bio
MiRagen Therapeutics
MiRNA Therapeutics
Novartis
Pacific Edge Biotechnology
Prolias Technologies
Regulus Therapeutics
Rosetta Genomics
Santaris Pharma A/S
Sirnaomics, Inc.
Somagenics
Diagnostics: Small RNA Assays and Biomarker Validation
Tekmira Pharmaceuticals Corporation
Thermadiag
Thermo Fisher Scientific, Inc.

Table Of Contents

miRNA Research and Diagnostics Markets
1. Executive Summary
2. Introduction
2.1. Junk DNA: Is There Such a Thing?
2.2. An Animated Debate
2.3. RNA Molecules Regulate Gene Expression
2.4. Types of Non-coding RNAs
2.5. Types of Small RNAs
3. Current State of the Art
3.1. A Game Changer for Improved Diagnosis
3.1.1. MicroRNAs Are a Factor in Many Diseases
3.1.2. miRNAs and Neurological Disorders
3.1.3. miRNA and Metastatic Brain Lesions
3.1.4. miRNA Involvement in Cancers Is Widespread
3.1.5. Prostate Cancer Screening and miRNAs
3.1.6. Bladder Cancer and MicroRNAs in Urine
3.1.7. Colorectal Cancer
3.1.8. miRNAs and Resistance to Anti-Cancer Drugs
3.2. MicroRNA Nomenclature
3.3. MicroRNA Biogenesis
3.4. MicroRNA Cellular Functions
3.5. MicroRNA and Other Diseases
3.5.1. How Are microRNAs Linked to Disease?
3.5.2. Circulating microRNAs as Disease Markers
3.5.3. miRNAs and Tissue Injury
3.5.4. The Exosome
3.6. Exploring Therapeutic Applications
3.6.1. A Cautionary Tale: The History of Antibody Development
3.6.2. A Mixed Assessment of miRNA Therapeutic Potential
4. Companies Developing microRNA Diagnostic Technologies
4.1. Agilent Technologies
4.2. Alnylam
4.3. AMSBIO
4.4. Applied Biosystems
4.5. Asuragen
4.6. DiamiR, LLC
4.7. Dicerna
4.8. Eisai Biomarkers and Personalized Medicine
4.9. Diagnostics
4.10. Exiqon
4.11. Genomic Health Inc.
4.12 Gensignia
4.13. GlaxoSmithKline Discovery and Molecular Toxicology
4.14. Groove Biopharma (formerly Mirina)
4.15. Hologic-Gen Probe Inc.
4.16. Illumina, Inc.
4.17. Isis Pharmaceuticals
4.18. Luminex (Millipore)
4.19. Mello Biotechnology Inc.
4.20. Microlin Bio
4.21. MiRagen Therapeutics
4.22. MiRNA Therapeutics
4.23. Novartis
4.24. Pacific Edge Biotechnology
4.25. Prolias Technologies
4.26 Regulus Therapeutics
4.26.1. Biomarker Studies of miRNAs through the Application of Microarrays
4.26.2. Clinical Trials
4.27. Rosetta Genomics
4.28. Santaris Pharma A/S
4.29. Sirnaomics, Inc.
4.30. Somagenics
4.30.1. Diagnostics: Small RNA Assays and Biomarker Validation
4.31. Tekmira Pharmaceuticals Corporation
4.32. Thermadiag
4.33. Thermo Fisher Scientific, Inc.
5. Market Estimates and Forecasts
5.1. Long Range Estimate
5.2. Negative Forces That Can Affect the Outlook for miRNA Diagnostic Technologies
5.2.1. Theoretical Limitations of miRNAs
5.2.2. Resistance to miRNA RandD on the Part of Big Pharma
5.2.3. Lack of Basic Science Support by Government Funding Agencies
5.2.4. Patent Issues
5.3. Positive Factors That Move the Estimates
5.3.1. Inherent Shortcomings of Competitive Detection Systems
5.3.2. miRNA Technological Improvements
5.3.3. Current Studies Are Encouraging
5.3.4. Availability of Venture Capital
5.3.5. Specific Venture Capital Funding Opportunities
6. Interviews with Industry Experts: Biomarkers
6.1. Anton Wellstein MD, PhD
6.2. Kai Wang, PhD
6.3. Samuil R. Umansky, MD, PhD
6.4. Dr. Mustafa Ozen
6.5. Dr. Nader Rifai
7. The Future of miRNA-Based Diagnostics
7.1. Future Perspectives
7.2. Summary Recommendations
7.2.1. MicroRNA Compares Well with Competing Technologies
7.2.2. MicroRNA Assessment, Based on Its Own Performance
7.2.3. A Nuanced Endorsement
LIST OF EXHIBITS
1. Executive Summary
Table 1.1: Forms of RNA and Abbreviations Explained
2. Introduction
Table 2.1: Different Classes of RNA Molecules
3. Current State of the Art
Figure 3.1: Increasing Number of Publications on miRNA
Figure 3.2: Results of microRNA Microarray Analysis
Table 3.1: Colorectal Cancer-Associated miRNA Markers
Figure 3.3: Method Validation: miRNAs Associated with Prostate Cancer
Table 3.2: Verification of Known Tissue-Specific Expression Patterns of Three mRNAs as Markers of Tissue Injury (miR-122, miR-133a and miR-124 Concentrations in Nine Rat Tissues)
Figure 3.4: Exosomes
Figure 3.5: Lagging Rate of Therapeutic Antibody Approval
4. Companies Developing microRNA Diagnostic Technologies
Figure 4.1: Biogenesis of microRNAs (Gensignia)
Table 4.1: Regulus' Clinical Map Initiative Outlines Current Status of Its microRNA Therapeutics Pipeline
Figure 4.2: Natural microRNA Precursors Marketed by Mello Biotech
Table 4.2: Summary of Data from Regulus miRNA Assessment Study
5. Market Estimates and Forecasts
Table 5.1: miRNA Testing Market
Table 5.2: Major Providers of miRNA Tools and Services
Table 5.3: Top 10 Pharmaceutical Companies by RandD Expenditures in 2013
Figure 5.1: Funding Trends for Basic Research, 1950-2019
Table 5.4: Some Venture Capital Funding Opportunities

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