Biomarkers

The Expanding Global Market

Publication Date	November 2007
Publisher	BCC Research
Product Type	Report
Pages	243
ISBN Number	not applicable
Product Code	BCC00167

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Summary

Biomarker-based tests have been in existence for over a few decades now but their relevance to drug development and diagnostics applications in particular has gained momentum only recently. This is apparent from the increased research interest, and patent and regulatory activity with regards to biomarkers.

Biomarker discovery has been a major by-product of genomic sequencing since the completion of the Human Genome Project. The recent modernization in the molecular profiling techniques has moved biomarker discovery to the front-line of medical research. We were also interested in analyzing the impact of the various omics technologies on molecular biomarker identification.

The compelling need for classifying molecular markers based on the understanding of disease mechanisms has received immense emphasis owing to the significant challenges encumbering the drug development pipeline. It has been recognized that integration of biomarkers through the different phases of drug development can yield safer drugs with enhanced therapeutic efficacy in a cost-effective manner. Hence, we were interested in examining the role of biomarkers in early-stage drug discovery, preclinical studies and late-stage clinical trials of drug development. In order to confidently use biomarkers to assess the biological end-point of a target therapy, clinical validation of the marker is critical before using them on the candidate compounds.

We were also interested in gaining insight on biomarker validation from a regulatory perspective. Biomarkers have been playing a significant role in molecular diagnostics as well, and we analyzed the potential of these biomarkers to address unmet needs in different facets of disease management. These include disease screening and predisposition, monitoring disease progression and predicting therapeutic response.

The confluence of therapeutics and diagnostics known as theranostics is emerging and is expected to influence the use of molecular biomarkers in personalized medicine. We were particularly interested in identifying the advances in pharmacogenomic testing and examined their emerging potential as companion diagnostics to targeted therapies.

Scope of study

This report contains:

Descriptions of various types of biomarkers including genomics, proteomics, bioformatics and metabolomics
The current market status of biomarkers, trends, and forecasts for growth over the next 5 years
Technological issues including the latest trends and findings in different therapeutic research areas
An examination of the regulatory role of different federal agencies in U.S., Europe and the rest of the world that play an active role in biomarker discovery research
Analysis of the biomarkers industry on a global basis, both from a market and application perspective.

Report Highlights

The global market for biomarkers increased from $4.8 billion in 2006 to an estimated $5.6 billion by the end of 2007. It should reach $12.8 billion by 2012, a compound annual growth rate (CAGR) of 18%.
Global revenues for biomarker discovery technologies tailored to drug discovery, preclinical studies of drug development and diagnostics research applications accounted for 47.9% of the total market in 2007. Their value is projected to grow at a CAGR of 16.9% and is expected to reach a little less than $6 billion in 2012.
The use of biomarkers in oncology therapeutics is likely to be one of the foremost priorities in clinical trials in the next 3 to 7 years followed by cardiovascular applications.

Content

Chapter 1 - Summary
- Summary Table: Revenue Forecast for Global Biomarkers Market by Segments, through 2012 ($ Millions)
- Summary Figure: Revenue Forecast Projections for Global Biomarker Markets by Segments, through 2012 ($ Millions)
Chapter 2 - Overview
- Definition of Biomarkers
- Taxonomy of Biomarkers
  - Predictive Biomarkers
  - Prognostic Biomarkers
  - Efficacy Biomarkers
  - Translational Biomarkers
  - Target Biomarkers
  - Surrogate Biomarkers
  - Toxicity Biomarkers
  - Known Valid Biomarkers
  - Probable Valid Biomarker
- Applications of Biomarkers
- Biomarker Validation
Chapter 3 - Markets by Biomarker Discovery for Lifesciences Research
- Biomarker Discovery Technology
  - Overview of Enabling Technologies
    - Microarrays
    - Real Time Reverse Transcriptase- Pcr (RT-PCR)
    - Single Nucleotide Polymorphisms (SNP)
    - Epigenomics Technology
    - Protein Separation Techniques
      - 2D Gel Electrophoresis (2DGE)
      - Differential Gel Electrophoresis (DIGE)
      - Liquid Chromatography (LC)
    - Protein Identification Technologies
      - Seldi-Tof
      - Tissue Microarrays
      - Isotope Affinity Tagged Techniques
- Biomarker Discovery Technology Research -Industry Structure
  - Noteworthy Mergers and Acquisitions in The Biomarker
  - Swot Analysis
    - Technology Vendors with their Proprietary Platforms for Biomarker Discovery are Likely to Gain the Competitive Edge
    - Biomarkers Hold a Promising Potential along the Downstream Continuum of Drug Development.
    - Companies Embracing the Fda's Cpi Coupled with Constant Interaction with the Fda Can Strengthen Their Biomarker Pipeline
    - Strong Ip Portfolio to Maximize Revenues
    - Biomarker Discovery Companies are Aiming to Carve a Niche in Many Therapeutic Areas
    - Biomarkers : A Capital Intensive Market for the near-Term
    - Diagnostics and Biomarkers
    - Discovery out-Steps Biomarker Validation
    - Regulatory Framework
    - High Costs Associated with these Novel Technologies Might Deter Technology Adoption
    - Strategic Alliances and Technology Licensing Nurture the Growing Trend of Biomarkers
    - Growing Interest in Biomarker Panel Pursuits: "The More the Merrier"
    - Theranostics- The New Confluence of Pharmaceutical and Diagnostics Products
    - Personalized Medicine: The Ultimate Milestone Challenge for both Pharmaceutical and Diagnostics Companies
  - Biomarker Discovery Technology Spotlight
    - Determining Efficacy
    - Early Detection of Disease
    - Drug Delivery
    - Pharmacokinetics
    - Surrogate End-Points
    - Molecular Imaging for Cancer Detection
    - Imaging Biomarker Challenges
      - Standardization of Imaging Data: A Key Challenge Hindering Technology Adoption
      - Diverse Objectives among Stakeholders might Pose Difficulties in Data Sharing
      - Variability in Platforms across Different Clinical Sites Poses a Major Challenge
- Revenue Forecasts by Biomarker Discovery Technology
  - Market Trends and Revenue Forecast Projections
    - Observations:
  - Future Growth Potential
  - Revenue Forecasts and Trends
  - Revenue Forecast Projections
  - Revenue Forecast
- Revenue Projections for Global Biomarker Discovery, by Therapeutic Research Area
  - Revenue Forecast Projections for Cancer Biomarker Discovery
  - Revenue Forecast Projections for Cardiovascular Biomarkers
  - Revenue Projections for Cns Biomarker Discovery
- Promising Biomarkers Discovered for Different Therapeutic Disciplines
  - Biomarkers in Cardiovascular Applications
    - Galectin-3 - A Marker of Acute Heart Failure
    - Metabolic Biomarker for Myocardial Ischemia
    - Nt-Probnp Biomarker
    - Identification of Plasma Biomarkers for Statin-Induced Myopathy
    - Deciphering the Il-7R Pathway in a Mechanistic Understanding of Multiple Sclerosis (MS)
    - Biomarkers for Traumatic Brain Injury
    - Multi-Panel Biomarkers for Alzheimer's Disease (AD)
    - Common Challenges in Cancer Biomarkers
    - Promising Cancer Biomarkers
      - Biomarkers for Melanoma Recurrence
      - Promising Biomarker for Pancreatic Cancer
      - Prostrate Cancer Biomarkers
        
        B7-H3 Immune Molecule as a Promising Marker in Prostrate Cancer
    - Biomarkers for Gastric Cancer
      - Biomarker for Hepatocellular Carcinoma
      - Mitochondrial Dna Marker for Different Cancer Types
      - Promising Breast Cancer Biomarkers Using Functional Proteomics Platform
        
        Proteomics Technologies for Breast Cancer Biomarker Research
        
        FOXP3-a Potential Breast Cancer Biomarker
      - Dna Methylation Markers for Cancer
  - Protein Biomarkers Detected for Ischaemic Liver Injury
- Company Profiles
  - Epigenomics, Inc.
  - Digilab Biovision Gmbh
  - Caprion Proteomics
  - Calibrant Biosystems Inc.
  - Correlogic Systems, Inc.
  - Bg Medicine Inc.
  - Human Metabolome Technologies Inc.
  - Phenomenome Discoveries Inc.
  - Pronota Nv
    - Nonlinear USA Inc.
  - Banyan Biomarkers
  - Genenews Limited
  - Power3medical Products Inc.
  - Genedata Ag
    - Genedata Gmbh
    - Genedata Inc.
    - Genedata Inc.
    - Genedata Kk
  - Metanomics Health Gmbh
  - Exagen Diagnostics Inc.
  - U.S. Genomics
  - Rosetta Genomics Ltd.
    - Rosetta Genomics Inc.
  - Proteome Sciences Plc
  - Somalogic Inc.
  - Upstream Biosciences
  - Vermillion Inc.
  - Target Discovery Inc.
- Patent Analysis
  - Correlogic Systems, Inc. (Patent Number 7,096,206)
  - Roche Diagnostics Operations, Inc. (Patent Number 7,205,118)
  - Proteomyx Inc. (Patent Number 7,029,855)
  - Epigenomics Ag (Patent Number 7,229,759)
  - Lovelace Respiratory Research Institute (Patent Number 7,214,485)
  - Agensys Inc. (Patent Number 7,250,498)
  - Agensys Inc. (Patent Number 7,227,008)
  - Dana-Farber Cancer Institute (Patent Number 7,250,283)
  - B.R.A.H.M.S Aktiengesellschaft (Patent Number 7,235,368)
  - Nanogen Inc. (Patent Number 7,179,605)
  - Ciphergen Biosystems Inc. (Patent Number 7,160,734)
  - Myriad Genetics Inc. (Patent Number 7,250,497)
  - Artemis Proteomics, Ltd. (Patent Number 7,229,638)
  - Sanofi-Aventis Deutschland Gmbh (Patent Number 7,227,006)
  - Bristol-Myers Squibb Company (Patent Number 7,186,564)
  - Digilab Biovision Gmbh (Patent Number 7,202,044)
Chapter 4 - Regulatory Perspective on Biomarker Discovery
- Regulatory Framework
  - Regulatory Insights towards Molecular Diagnostics
    - Regulation on ASRs Specific Reagents
      - Tailor-Rx Trial for Oncotype Dx-Nci Funding Initiative
      - MammaPrint Clinical Study-European Organization for research and treatment of cancer and Agendia collaboration
      - Cpi: Critical Path Initiative
    - Need for Effective Biomarkers
- Overview of The Current Biomarker Initiatives
  - Biomarker Consortium
  - Hiv Surrogate Markers Collaborative Group
  - The Snp Consortium and The International Hapmap Project
  - Oncology Biomarkers Qualification Initiative (OBQI)-A Federal Initiative
  - Hesi Biomarkers Technical Committee
  - Translational Research Working Group
  - International Cancer Biomarker Consortium (ICBC)
  - Epa'S Star Research Grants for Biomonitoring
- International Scenario
  - Research Project under The Imi- Addneuromed
  - Medicamentos Innovadores (SPAIN)
  - Dti Safety Biomarkers Funding -United Kingdom
- Conclusion
Chapter 5 - Pharmaceutical R&D Outlook on Biomarkers
- Introduction
- Insights on Stratified Medicine
- Market Drivers
  - Integration of Biomarkers to Improve Success Rates in Clinical Trials
  - Encouragement from The Regulatory Framework Spurs Market Opportunities for Biomarker Research
  - Need for Biomarkers with High Specificity and Reliability
  - Systems Biology: The Rationalized Approach to Increased Efficiency of New Drug Development
  - Challenges Facing Biomarkers in Clinical Trials
- Targeted Therapies in The Oncology Product Portfolio
  - Herceptin
  - Gleevec/Glivec
  - Tykerb
  - Avastin
  - Tarceva
  - Nexavar
  - Erbitux
  - Exelixis' XL880
  - Avalon'S AVN944
  - Supergen'S MP470
  - Revenue Projections for Biomarkers in Clinical Trials
Chapter 6 - Markets by Molecular Diagnostics
- Introduction
- Outlook for Biomarkers from A Molecular Diagnostics Perspective
  - Biobanking: Critical to Realize The Maximum Potential of Modern Day Medicine
  - Standardization of Pre-Analytical Techniques
- Need for Biomarkers in Diagnostics
- Segmentation
- Outline on The Molecular Diagnostics Industry
  - Emerging Technology Platforms
- Global Forecast Projections by Different Diagnostic Applications
- Market Drivers
  - Rising Volumes in The Infectious Disease Diagnostics Segment Drive The Market for Molecular Testing
  - Technology Advancements in Molecular Markers: next Generation Launch Pad in Molecular Diagnostics
  - Quantitative Testing Measurements Provide An Impetus to Better Cancer Management
    - Improved Reimbursement Plans by Private Payers and Cms Fuel the Market for Molecular Based Cancer Tests
  - High Enabling Technologies Augment The Market for Biomarker Discovery and Development
  - Individualized Treatments and Companion Diagnostics Fuel Market Uptake for Molecular Diagnostics
  - Expiration of Roche'S Pcr Patents Creating A Wealth of Opportunities for Market Participants
- Market Restraints
  - Raising Concerns on The Validation of Novel Molecular Biomarkers: A near-Term Difficult Road Ahead
  - High Costs Associated with Biomarker Research and Development Stalls Product Introduction in Molecular Diagnostics
  - Uncertainties in Pharmacogenomic Testing Hinders Market Adoption
  - Intellectual Property Issues: Another Impediment in The World of Biomarkers
  - Hesitation from The Payer Sector Coupled with Skepticism in Reimbursement Further Hinder Market for Pharmacogenomic Applications
  - Ethical Issues regarding Patient'S Confidentiality and Rights Pose Another Area of Concern
- Competitive Landscape
  - United States Molecular Diagnostics Market
  - European Molecular Diagnostics
  - Molecular Infectious Disease Diagnostics
    - Asia-Pacific Nat Markets
- The Revenue Forecast for Global Infectious Disease Diagnostics Market
- Competitive Landscape
- Nat Cancer Diagnostics
  - Nat Cancer Diagnostics Market
    - Protein Isoform Testing
- Scope of The Nat Cancer Diagnostics Segment
- Revenue Forecast for Nat Cancer Diagnostics
  - Product Portfolio for Genetic Predisposition and Prognostic Testing in Cancer
    - Pathwork Tissue of Origin Test: under Fda Review
- Competitive Landscape
- Pharmacogenomic Applications /Companion Diagnostics
  - Market Overview
    - Her-2 Genetic Testing
    - Invader UGT1A1 Molecular Assay
    - Amplichip CYP450 Test
- Competitive Landscape
- Revenue Forecast for Global Pharmacogenomic Markets
List of Tables
- Table 1 Examples of Efficacy Exploratory Biomarkers
- Table 2 Known Valid Safety Biomarkers
- Table 3 Known Valid Efficacy Biomarkers
- Table 4 Efficacy Biomarkers in The Probably Valid Marker Category
- Table 5 Classification of Biomarkers Based on Their Utility
- Table 6 Uses of Biomarkers
- Table 7 Technologies for Biomarker Discovery
- Table 8 Common Limitations of 2DGE
- Table 9 Biomarker Discovery Technology Participants (Genomics/ Proteomics/ Bioinformatics)
- Table 10 New Technology Product Launches in The Biomarker Industry
- Table 11 Strategic Alliance/ Recent Industry Activities in Biomarker Discovery
- Table 12 Major Participants in The Metabolomics Technology Sector for Biomarker Discovery
- Table 13 Promising Imaging Biomarkers
- Table 14 Global Biomarker Discovery, Revenue Forecast by Technology Segments, through 2012 ($ Millions)
- Table 15 Global Biomarker Discovery Market, Revenue Split by Technology Segment, 2005-2012 (%)
- Table 16GLOBAL Biomarker Discovery Technology Market by Region, through 2012: Revenue Forecast, through 2012 ($ Millions)
- Table 17 Global Genomics Biomarker Technology Market by Region, through 2012 ($ Millions)
- Table 18 Global Genomics Biomarker Discovery Technology Markets, Products and Services, through 2012 ($ Millions)
- Table 19 Global Protein Biomarker Discovery Technology Market: by Region, through 2012 ($ Millions)
- Table 20 Global Metabolomic Technologies for Biomarker Discovery by Region, through 2012 ($ Millions)
- Table 21 Global Bioinformatics Market for Biomarker Discovery Applcations by Region, through 2012 ($ Millions)
- Table 22 Global Forecast Projections for Biomarker Research Markets by Therapeutic Area, through 2012 ($ Millions)
- Table 23 Major U.S. Patents Issued for Biomarkers, 2006 and 2007
- Table 24 U.S. Biomarker Patents Issued in 2007, by Different Disease Applications
- Table 25 European Patents Pertaining to Biomarker Discovery Issued in 2006 and 2007
- Table 26 Categories of Patient Stratification Based on Recurrence Score Using Oncotype Dx
- Table 27 Different Partnerships through The Cpi
- Table 28 Core Members of The Biomarker Consortium
- Table 29 Industry Partners in The Biomarker Consortium
- Table 30 Industry Participants Funding The Fdg-Pet Lung and Lymphoma Projects
- Table 31 Hesi Biomarker Committee-Industry Members
- Table 32 Industry Participant Members of The Imi Initiative
- Table 33 Multi-Disciplinary Projects Undertaken by Ti Pharma
- Table 34 Industry Participant Members of Ti Pharma
- Table 35 Predictive Safety Testing Consortium: Pharmaceutical Companies
- Table 36 Market Drivers for Biomarkers in Clinical Trials
- Table 37 Global Revenue Projections for Biomarkers in Clinical Trial Applications, through 2012 ($ Millions)
- Table 38 Examples of Common Biomarkers
- Table 39 Segmentation of Biomarker Applications in Molecular Diagnostics
- Table 40 Key Focus of Biomarkers in Molecular Diagnostics
- Table 41 Potential Clinical Applications for Pcr Technology
- Table 42 Nucleic Acid Amplification Technologies
- Table 43 Global Biomarker Markets, by Molecular Diagnostics Application, through 2012 ($ Millions)
- Table 44 Global Biomarkers Market, by Molecular Diagnostics Application, 2005-2012 (%)
- Table 45 Global Biomarker Markets for Molecular Diagnostics Application, by Region, through 2012 ($ Millions)
- Table 46 Market Drivers for Biomarkers in Molecular Diagnostics
- Table 47 Market Restraints for Biomarkers in Molecular Diagnostics
- Table 48 Fda-Approved Molecular Diagnostic Systems
- Table 49 Total European Molecular Diagnostics Market by Region, through 2012 ($ Millions)
- Table 50 Molecular Tests Available for Infectious Disease Pathogens
- Table 51 End-User Requirements for Molecular Assay Adoption
- Table 52GLOBAL Molecular Infectious Disease Diagnostics Market, by Region, through 2012 ($ Millions)
- Table 53 Potential Benefits Expected from Cancer Biomarkers
- Table 54 Companies Involved in Isoform Testing
- Table 55 Global Nat Cancer Diagnostics Market by Region, through 2012 ($ Millions)
- Table 56 Nat Cancer Diagnostic Products (Diagnostic and Prognostic Cancer Markers)
- Table 57 Fda- Approved Companion Diagnostics
- Table 58 Use of CYP2D6 for Metabolizing Drugs Used for Certain Diseases
- Table 59 Drug-Companion Diagnostic Products
- Table 60 Global Pharmacogenomics Market Forecast by Region, through 2012 ($ Millions)
List of Figures
- Figure 1 Biomarker Discovery Process
- Figure 2 Global Biomarker Discovery, Revenue Forecast by Technology Segment, 2005-2012 ($ Millions)
- Figure 3 Global Biomarker Discovery, Revenue Split by Technology Type, 2007 (%)
- Figure 4 Global Biomarker Discovery, Revenue Split by Technology Type, 2012 (%)
- Figure 5 Global Biomarker Discovery Technology Market, Revenue Projections by Different Geographical Segments, 2005-2012 ($ Millions)
- Figure 6 Global Genomics Biomarker Technology Market by Region, 2005-2012 ($ Millions)
- Figure 7 Global Genomics Biomarker Discovery Technology Markets, Products and Services, 2005-2012 ($ Millions)
- Figure 8 Global Protein Biomarker Discovery Technology Market: by Region, 2005-2012 ($ Millions)
- Figure 9 Global Metabolomic Technologies for Biomarker Discovery by Region, 2005-2012 ($ Millions)
- Figure 10 Global Bioinformatics Market for Biomarker Discovery Applcations by Region, through 2012 ($ Millions)
- Figure 11 Global Forecast Projections for Biomarker Research Markets by Therapeutic Area, 2005-2012 ($ Millions)
- Figure 12 Percent Contribution to Biomarker Discovery, by Therapeutic Area of Research, 2007 (%)
- Figure 13 Percent Contribution to Biomarker Discovery, by Therapeutic Area of Research, 2012 (%)
- Figure 14 U.S. Patent Trend Analysis, Biomarker Patents Issued for Disease Applications, 2004-2007
- Figure 15 European Patent Trend Analysis for Biomarker Discovery 2004-2007
- Figure 16 Global Biomarker Patents for Different Disease Applications, 2005-2007
- Figure 17 Global Revenue Projections for Biomarker Applications in Clinical Trials, 2005-2012 ($ Millions)
- Figure 18 Global Biomarker Markets, by Molecular Diagnostics Application, 2005-2012 ($ Millions)
- Figure 19 Global Biomarkers Market, by Molecular Diagnostics Application, 2007 (%)
- Figure 21 Global Biomarkers Market for Molecular Diagnostics Applications, by Region, 2005-2012 ($ Million)
- Figure 22 Total European Molecular Diagnostics Market by Region, 2005-2012
- Figure 23 Global Molecular Infectious Disease Diagnostics Market, by Region, 2005-2012 ($ Millions)
- Figure 24 Global Nat Cancer Diagnostics Market, by Region, 2005-2012 ($ Millions)
- Figure 25GLOBAL Pharmacogenomics Market Forecast by Region, 2005-2012 ($ Millions)