发布时间：2007.11

摘要

INTRODUCTION

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.
METHODOLOGY

BCC's methodology for market analysis and forecast projections made in the report encompassed primary and secondary data sources and calculations. Based on interaction with industry stakeholders and experts, we analyzed the potential of the omics technologies for biomarker discovery, disease-related biomarkers, validated biomarker applications in clinical trials and molecular diagnostics. Revenue projections for the aforementioned segments were developed and corroborated through primary interviews with respondents from participating organizations.

INFORMATION SOURCES

BCC interacted with over 68 biomarker discovery platform, pharmaceutical and diagnostics companies to obtain data for this study. In addition, data was also compiled from government and other public research data sources.

ABOUT THE AUTHOR

Vanita Khetan is an entrepreneur and market analyst. She holds a bachelors degree in Chemistry and a Post Graduate degree in management. During the course of her career, she has analyzed U.S., European and Asian markets in biotechnology, pharmaceuticals, medical devices, wound care and surgical goods.

目录及图表

• 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
• Table 1 EXAMPLES OF EFFICACY EXPLORATORY BIOMARKERS
  • PREDICTIVE BIOMARKERS
  • PROGNOSTIC BIOMARKERS
  • EFFICACY BIOMARKERS
  • TRANSLATIONAL BIOMARKERS
  • TARGET BIOMARKERS
  • SURROGATE BIOMARKERS
  • TOXICITY BIOMARKERS
  • KNOWN VALID BIOMARKERS
• Table 2 KNOWN VALID SAFETY BIOMARKERS
• Table 3 KNOWN VALID EFFICACY BIOMARKERS
  • PROBABLE VALID BIOMARKER
• Table 4 EFFICACY BIOMARKERS IN THE PROBABLY VALID MARKER CATEGORY
• Table 5 CLASSIFICATION OF BIOMARKERS BASED ON THEIR UTILITY
  • APPLICATIONS OF BIOMARKERS
• Table 6 USES OF BIOMARKERS
  • BIOMARKER VALIDATION
    • BIOMARKER VALIDATION (CONTINUED)
    • BIOMARKER VALIDATION (CONTINUED)
• Chapter 3 - MARKETS BY BIOMARKER DISCOVERY FOR LIFESCIENCES RESEARCH
  • BIOMARKER DISCOVERY TECHNOLOGY
• Table 7 TECHNOLOGIES FOR BIOMARKER DISCOVERY
• Table 7 (CONTINUED)
• Figure 1 BIOMARKER DISCOVERY PROCESS
  • 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)
• Table 8 COMMON LIMITATIONS OF 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
    • BIOMARKER DISCOVERY TECHNOLOGY…(CONTINUED)
    • BIOMARKER DISCOVERY TECHNOLOGY…(CONTINUED)
    • NOTEWORTHY MERGERS AND ACQUISITIONS IN THE BIOMARKER
      • Noteworthy Mergers and Acquisitions…(Continued)
• Table 9 BIOMARKER DISCOVERY TECHNOLOGY PARTICIPANTS (GENOMICS/ PROTEOMICS/ BIOINFORMATICS)
• Table 9 (CONTINUED)
• Table 9 (CONTINUED)
• Table 9 (CONTINUED)
• Table 9 (CONTINUED)
• Table 9 (CONTINUED)
• Table 9 (CONTINUED)
• Table 10 NEW TECHNOLOGY PRODUCT LAUNCHES IN THE BIOMARKER INDUSTRY
• Table 10 (CONTINUED)
• Table 10 (CONTINUED)
• Table 11 STRATEGIC ALLIANCE/ RECENT INDUSTRY ACTIVITIES IN BIOMARKER DISCOVERY
• Table 11 (CONTINUED)
• Table 11 (CONTINUED)
• Table 11 (CONTINUED)
• Table 11 (CONTINUED)
  • 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
    • Metabolomics (Continued)
• Table 12 MAJOR PARTICIPANTS IN THE METABOLOMICS TECHNOLOGY SECTOR FOR BIOMARKER DISCOVERY
• Table 12 (CONTINUED)
  • Determining Efficacy
  • Early Detection of Disease
  • Drug Delivery
  • Pharmacokinetics
  • Surrogate End-Points
  • Molecular Imaging for Cancer Detection
  • Molecular Imaging …(Continued)
    • Molecular Imaging …(Continued)
• Table 13 PROMISING IMAGING BIOMARKERS
  • 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
  • Table 14 GLOBAL BIOMARKER DISCOVERY, REVENUE FORECAST BY TECHNOLOGY SEGMENTS, THROUGH 2012 ($ MILLIONS)
  • Figure 2 GLOBAL BIOMARKER DISCOVERY, REVENUE FORECAST BY TECHNOLOGY SEGMENT, 2005-2012 ($ MILLIONS)
  • Table 15 GLOBAL BIOMARKER DISCOVERY MARKET, REVENUE SPLIT BY TECHNOLOGY SEGMENT, 2005-2012 (%)
  • Figure 3 GLOBAL BIOMARKER DISCOVERY, REVENUE SPLIT BY TECHNOLOGY TYPE, 2007 (%)
  • Figure 4 GLOBAL BIOMARKER DISCOVERY, REVENUE SPLIT BY TECHNOLOGY TYPE, 2012 (%)
  • Table 16GLOBAL BIOMARKER DISCOVERY TECHNOLOGY MARKET BY REGION, THROUGH 2012: REVENUE FORECAST, THROUGH 2012 ($ MILLIONS)
  • Figure 5 GLOBAL BIOMARKER DISCOVERY TECHNOLOGY MARKET, REVENUE PROJECTIONS BY DIFFERENT GEOGRAPHICAL SEGMENTS, 2005-2012 ($ MILLIONS)
    • REVENUE FORECASTS BY …(CONTINUED)
• Market Trends and Revenue Forecast Projections
  • Table 17 GLOBAL GENOMICS BIOMARKER TECHNOLOGY MARKET BY REGION, THROUGH 2012 ($ MILLIONS)
  • Figure 6 GLOBAL GENOMICS BIOMARKER TECHNOLOGY MARKET BY REGION, 2005-2012 ($ MILLIONS)
  • Table 18 GLOBAL GENOMICS BIOMARKER DISCOVERY TECHNOLOGY MARKETS, PRODUCTS AND SERVICES, THROUGH 2012 ($ MILLIONS)
  • Figure 7 GLOBAL GENOMICS BIOMARKER DISCOVERY TECHNOLOGY MARKETS, PRODUCTS AND SERVICES, 2005-2012 ($ MILLIONS)
    • Market Trends and …(Continued)
    • Market Trends and …(Continued)
    • Market Trends and …(Continued)
    • Observations:
  • Future Growth Potential
  • Revenue Forecasts and Trends
• Table 19 GLOBAL PROTEIN BIOMARKER DISCOVERY TECHNOLOGY MARKET: BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 8 GLOBAL PROTEIN BIOMARKER DISCOVERY TECHNOLOGY MARKET: BY REGION, 2005-2012 ($ MILLIONS)
• Revenue Forecasts … (Continued)
• Revenue Forecasts … (Continued)
• Table 20 GLOBAL METABOLOMIC TECHNOLOGIES FOR BIOMARKER DISCOVERY BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 9 GLOBAL METABOLOMIC TECHNOLOGIES FOR BIOMARKER DISCOVERY BY REGION, 2005-2012 ($ MILLIONS)
  • Revenue Forecast Projections
    • Revenue Forecast Projections (Continued)
  • Revenue Forecast
• Table 21 GLOBAL BIOINFORMATICS MARKET FOR BIOMARKER DISCOVERY APPLCATIONS BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 10 GLOBAL BIOINFORMATICS MARKET FOR BIOMARKER DISCOVERY APPLCATIONS BY REGION, THROUGH 2012 ($ MILLIONS)
• REVENUE PROJECTIONS FOR GLOBAL BIOMARKER DISCOVERY, BY THERAPEUTIC RESEARCH AREA
• Table 22 GLOBAL FORECAST PROJECTIONS FOR BIOMARKER RESEARCH MARKETS BY THERAPEUTIC AREA, 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 13 (CONTINUED)
• Revenue Forecast Projections for Cancer Biomarker Discovery
• Revenue Forecast Projections…(Continued)
• 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)
  • Multi-Panel Biomarkers…(Continued)
  • Multi-Panel Biomarkers…(Continued)
• 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
    • Protein Biomarkers Detected for…(Continued)
  • COMPANY PROFILES
    • Epigenomics, Inc.
  • DIGILAB BIOVISION GMBH
  • CAPRION PROTEOMICS
    • Caprion Proteomics (Continued)
  • CALIBRANT BIOSYSTEMS INC.
  • CORRELOGIC SYSTEMS, INC.
  • BG MEDICINE INC.
    • BG Medicine Inc. (Continued)
  • 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
    • PATENT ANALYSIS (CONTINUED)
• 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
• Table 23 MAJOR U.S. PATENTS ISSUED FOR BIOMARKERS, 2006 AND 2007
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• Table 23 (CONTINUED)
• 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 25 (CONTINUED)
• Table 25 (CONTINUED)
• Table 25 (CONTINUED)
• Table 25 (CONTINUED)
  • 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
        • Regulation on ASRs … (Continued)
          • TAILOR-Rx Trial for Oncotype Dx-NCI Funding Initiative
• Table 26 CATEGORIES OF PATIENT STRATIFICATION BASED ON RECURRENCE SCORE USING ONCOTYPE DX
  • MammaPrint Clinical Study-European Organization for research and treatment of cancer and Agendia collaboration
  • CPI: Critical Path Initiative
  • Need for Effective Biomarkers
• Table 27 DIFFERENT PARTNERSHIPS THROUGH THE CPI
• Table 27 (CONTINUED)
  • OVERVIEW OF THE CURRENT BIOMARKER INITIATIVES
    • BIOMARKER CONSORTIUM
• Table 28 CORE MEMBERS OF THE BIOMARKER CONSORTIUM
• Table 29 INDUSTRY PARTNERS IN THE BIOMARKER CONSORTIUM
• Table 29 (CONTINUED)
• Table 30 INDUSTRY PARTICIPANTS FUNDING THE FDG-PET LUNG AND LYMPHOMA PROJECTS
  • 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
• Table 31 HESI BIOMARKER COMMITTEE-INDUSTRY MEMBERS
  • TRANSLATIONAL RESEARCH WORKING GROUP
  • INTERNATIONAL CANCER BIOMARKER CONSORTIUM (ICBC)
  • EPA' S STAR RESEARCH GRANTS FOR BIOMONITORING
• INTERNATIONAL SCENARIO
  • Table 32 INDUSTRY PARTICIPANT MEMBERS OF THE IMI INITIATIVE
    • RESEARCH PROJECT UNDER THE IMI- ADDNEUROMED
    • MEDICAMENTOS INNOVADORES (SPAIN)
• Table 33 MULTI-DISCIPLINARY PROJECTS UNDERTAKEN BY TI PHARMA
• Table 34 INDUSTRY PARTICIPANT MEMBERS OF TI PHARMA
  • DTI SAFETY BIOMARKERS FUNDING -UNITED KINGDOM
• CONCLUSION
• Chapter 5 - PHARMACEUTICAL R&D OUTLOOK ON BIOMARKERS
  • INTRODUCTION
• Table 35 PREDICTIVE SAFETY TESTING CONSORTIUM: PHARMACEUTICAL COMPANIES
  • INTRODUCTION (CONTINUED)
  • INTRODUCTION (CONTINUED)
• INSIGHTS ON STRATIFIED MEDICINE
  • INSIGHTS ON STRATIFIED MEDICINE (CONTINUED)
  • MARKET DRIVERS
• Table 36 MARKET DRIVERS FOR BIOMARKERS IN CLINICAL TRIALS
  • 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
• Table 37 GLOBAL REVENUE PROJECTIONS FOR BIOMARKERS IN CLINICAL TRIAL APPLICATIONS, THROUGH 2012 ($ MILLIONS)
• Figure 17 GLOBAL REVENUE PROJECTIONS FOR BIOMARKER APPLICATIONS IN CLINICAL TRIALS, 2005-2012 ($ MILLIONS)
  • REVENUE PROJECTIONS (CONTINUED)
• 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
• Table 38 EXAMPLES OF COMMON BIOMARKERS
  • SEGMENTATION
• Table 39 SEGMENTATION OF BIOMARKER APPLICATIONS IN MOLECULAR DIAGNOSTICS
  • OUTLINE ON THE MOLECULAR DIAGNOSTICS INDUSTRY
• Table 40 KEY FOCUS OF BIOMARKERS IN MOLECULAR DIAGNOSTICS
• Table 41 POTENTIAL CLINICAL APPLICATIONS FOR PCR TECHNOLOGY
• Table 42 NUCLEIC ACID AMPLIFICATION TECHNOLOGIES
  • EMERGING TECHNOLOGY PLATFORMS
  • GLOBAL FORECAST PROJECTIONS BY DIFFERENT DIAGNOSTIC APPLICATIONS
• Table 43 GLOBAL BIOMARKER MARKETS, BY MOLECULAR DIAGNOSTICS APPLICATION, THROUGH 2012 ($ MILLIONS)
• Figure 18 GLOBAL BIOMARKER MARKETS, BY MOLECULAR DIAGNOSTICS APPLICATION, 2005-2012 ($ MILLIONS)
• Table 44 GLOBAL BIOMARKERS MARKET, BY MOLECULAR DIAGNOSTICS APPLICATION, 2005-2012 (%)
• Figure 19 GLOBAL BIOMARKERS MARKET, BY MOLECULAR DIAGNOSTICS APPLICATION, 2007 (%)
• Table 45 GLOBAL BIOMARKER MARKETS FOR MOLECULAR DIAGNOSTICS APPLICATION, BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 21 GLOBAL BIOMARKERS MARKET FOR MOLECULAR DIAGNOSTICS APPLICATIONS, BY REGION, 2005-2012 ($ MILLION)
  • GLOBAL FORECAST PROJECTIONS…(CONTINUED)
  • GLOBAL FORECAST PROJECTIONS…(CONTINUED)
  • MARKET DRIVERS
• Table 46 MARKET DRIVERS FOR BIOMARKERS IN MOLECULAR DIAGNOSTICS
  • 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
• Table 47 MARKET RESTRAINTS FOR BIOMARKERS IN MOLECULAR DIAGNOSTICS
  • 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
• Table 48 FDA-APPROVED MOLECULAR DIAGNOSTIC SYSTEMS
• Table 48 (CONTINUED)
  • UNITED STATES MOLECULAR DIAGNOSTICS MARKET
  • EUROPEAN MOLECULAR DIAGNOSTICS
• Table 49 TOTAL EUROPEAN MOLECULAR DIAGNOSTICS MARKET BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 22 TOTAL EUROPEAN MOLECULAR DIAGNOSTICS MARKET BY REGION, 2005-2012
  • MOLECULAR INFECTIOUS DISEASE DIAGNOSTICS
• Table 50 MOLECULAR TESTS AVAILABLE FOR INFECTIOUS DISEASE PATHOGENS
• Table 50 (CONTINUED)
• Table 51 END-USER REQUIREMENTS FOR MOLECULAR ASSAY ADOPTION
• Asia-Pacific NAT Markets
  • THE REVENUE FORECAST FOR GLOBAL INFECTIOUS DISEASE DIAGNOSTICS MARKET
  • THE REVENUE FORECAST FOR GLOBAL…(CONTINUED)
• Table 52GLOBAL MOLECULAR INFECTIOUS DISEASE DIAGNOSTICS MARKET, BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 23 GLOBAL MOLECULAR INFECTIOUS DISEASE DIAGNOSTICS MARKET, BY REGION, 2005-2012 ($ MILLIONS)
  • COMPETITIVE LANDSCAPE
  • COMPETITIVE LANDSCAPE (CONTINUED)
  • NAT CANCER DIAGNOSTICS
• Table 53 POTENTIAL BENEFITS EXPECTED FROM CANCER BIOMARKERS
  • NAT CANCER DIAGNOSTICS MARKET
    • Protein Isoform Testing
• Table 54 COMPANIES INVOLVED IN ISOFORM TESTING
  • SCOPE OF THE NAT CANCER DIAGNOSTICS SEGMENT
  • REVENUE FORECAST FOR NAT CANCER DIAGNOSTICS
• Table 55 GLOBAL NAT CANCER DIAGNOSTICS MARKET BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 24 GLOBAL NAT CANCER DIAGNOSTICS MARKET, BY REGION, 2005-2012 ($ MILLIONS)
  • REVENUE FORECAST FOR NAT CANCER … (CONTINUED)
  • REVENUE FORECAST FOR NAT CANCER … (CONTINUED)
  • PRODUCT PORTFOLIO FOR GENETIC PREDISPOSITION AND PROGNOSTIC TESTING IN CANCER
  • Pathwork Tissue of Origin Test: Under FDA Review
• Table 56 NAT CANCER DIAGNOSTIC PRODUCTS (DIAGNOSTIC AND PROGNOSTIC CANCER MARKERS)
• Table 56 (CONTINUED)
  • COMPETITIVE LANDSCAPE
    • COMPETITIVE LANDSCAPE (CONTINUED)
  • PHARMACOGENOMIC APPLICATIONS /COMPANION DIAGNOSTICS
  • Market Overview
    • Market Overview (Continued)
    • Market Overview (Continued)
• Table 57 FDA- APPROVED COMPANION DIAGNOSTICS
  • HER-2 Genetic Testing
  • Invader UGT1A1 Molecular Assay
  • Amplichip CYP450 Test
• Table 58 USE OF CYP2D6 FOR METABOLIZING DRUGS USED FOR CERTAIN DISEASES
  • Amplichip CYP450 Test (Continued)
• Table 59 DRUG-COMPANION DIAGNOSTIC PRODUCTS
  • COMPETITIVE LANDSCAPE
    • COMPETITIVE LANDSCAPE (CONTINUED)
  • COMPETITIVE LANDSCAPE (CONTINUED)
  • REVENUE FORECAST FOR GLOBAL PHARMACOGENOMIC MARKETS
• Table 60 GLOBAL PHARMACOGENOMICS MARKET FORECAST BY REGION, THROUGH 2012 ($ MILLIONS)
• Figure 25GLOBAL PHARMACOGENOMICS MARKET FORECAST BY REGION, 2005-2012 ($ MILLIONS)
  • REVENUE FORECAST FOR GLOBAL … (CONTINUED)