Biomarkers: The Expanding Global Market

Published by: BCC Research

Published: Nov. 30, 2007 - 243 Pages

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THIS STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

METHODOLOGY

INFORMATION SOURCES

ABOUT THE AUTHOR

RELATED BCC RESEARCH REPORTS

BCC ON-LINE SERVICES

DISCLAIMER

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)

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)

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 16 GLOBAL 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

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) .... 141

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)

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

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)

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 52 GLOBAL 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 (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 25 GLOBAL PHARMACOGENOMICS MARKET FORECAST BY REGION, 2005-2012 ($ MILLIONS)

REVENUE FORECAST FOR GLOBAL … (CONTINUED)

LIST OF TABLES

SUMMARY TABLE REVENUE FORECAST FOR GLOBAL BIOMARKERS

MARKET BY SEGMENTS, THROUGH 2012 ($ MILLIONS)

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 16 GLOBAL 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.... 172

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 52 GLOBAL MOLECULAR INFECTIOUS DISEASE

DIAGNOSTICS MARKET, BY REGION, THROUGH 2012 ($ MILLIONS) .... 213

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

SUMMARY FIGURE REVENUE FORECAST PROJECTIONS FOR

GLOBAL BIOMARKER MARKETS BY SEGMENTS, THROUGH 2012

($ MILLIONS)

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 13 (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

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 25 GLOBAL PHARMACOGENOMICS MARKET FORECAST BY

REGION, 2005-2012 ($ MILLIONS)

Abstract

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.

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