NEW YORK, Nov. 9, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Central Nervous System (CNS) Biomarkers: Technologies and Global Markets
The global CNS biomarker market was estimated at $1.3 billion in 2009 and is expected to reach close to $3.2 billion by 2015, with a compound annual growth rate (CAGR) of 17.1% from 2010 to 2015.
The CNS molecular diagnostic market will see the largest growth, with a compound annual growth rate (CAGR) of 172.3% from 2010 to 2015 due to the number of diagnostic tests that are in the pipeline. This sector is valued at $2 million in 2010 and is expected to be worth $302 million in 2015.
The growth rate for the CNS biomarker market for drug development will increase as more validated biomarkers become available for patient segmentation and assessment of efficacy for clinical trials. This sector is worth an estimated $162 million in 2010 and is expected to reach $355 million in 2015, a 17% compound annual growth rate (CAGR).
INTRODUCTION
Biomarkers are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, and predict treatment response. They have played, and will continue to play, an important role in drug R&D and in diagnostics. They are important tools for understanding disease mechanism, developing more effective treatments, and improving the quality of patient care. The discovery of biomarkers for CNS disorders has gained considerable interest within the pharmaceutical industry due to the many unmet needs in current treatments and diagnostics.
Here we examine the role of CNS biomarkers in early discovery, in drug development, and for future diagnostics. We assess the global CNS biomarker market and make forecasts from 2010 to 2015. We further segment the market by application, technology (genomics, proteomics, and molecular imaging), and region. We discuss the different disease segments, describing gaps in treatment and limitations of current methods of diagnosis. The process of developing biomarkers from discovery to commercialization is discussed along with the forces in the industry that play an integral role, such as payers, providers, and suppliers. We also address the growth drivers and growth inhibitors that can affect CNS biomarker adoption.
STUDY GOALS AND OBJECTIVES
To assess the various technologies used for CNS biomarker discovery and future diagnostics.
To understand the process of CNS biomarker development from discovery to commercialization and the path towards adoption.
To examine the regulatory landscape and government's role.
To examine the unmet needs in diagnosis and treatment of various CNS disorders.
To determine current and future CNS biomarker markets.
REASONS FOR DOING THE STUDY
This study was conducted to determine the current and future global demand for CNS biomarkers, taking into account various competitive forces, growth drivers, and growth barriers that are at play.
SCOPE OF REPORT
This market research report:
Reviews technologies used to identify biomarkers for drug discovery, drug development, and diagnostic purposes specifically within the central nervous system (CNS) market
Analyzes global market trends, with data for 2009, estimates for 2010, and projections of compound annual growth rates through 2015
Evaluates technologies such as genomics, proteomics, and imaging, and weighs their advantages and disadvantages
Discusses CNS disease segments, prevalence, and gaps in treatment for Alzheimer's disease, depression, Parkinson's disease, multiple sclerosis, and others
Presents comprehensive company profiles and patent analyses.
INTENDED AUDIENCE
The study examines the current and future role of CNS biomarkers and their effect on various industries. Biotechnology companies, pharmaceutical companies, research institutions, physicians, hospitals, and manufacturers of genomic/proteomic supplies and technologies can all potentially benefit from strategic use of the market data and analysis contained in this report.
INFORMATION SOURCES
BCC conducted primary and secondary market research to obtain market data for analysis and forecast projections. Interviews were conducted with experts in the industry, and data and information were compiled from government and public data sources, press releases, trade journals, publications, and selected databases.
ANALYST'S CREDENTIALS
Munish Das is founder of BioEvolution LLC, a business research and consulting firm focused on healthcare. He has worked in the biotech and pharmaceutical industry for the past 10 years. He holds a master's degree in biotechnology and business administration.
Chapter- 1: INTRODUCTION
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 2
INTENDED AUDIENCE 2
INFORMATION SOURCES 2
ANALYST'S CREDENTIALS 2
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
Chapter-2: SUMMARY
SUMMARY TABLE GLOBAL CNS BIOMARKER MARKET, BY APPLICATION, THROUGH 2015 ($ MILLIONS) 4
SUMMARY FIGURE GLOBAL CNS BIOMARKER MARKET, BY APPLICATION, 2008?2015 ($ MILLIONS) 5
Chapter-3: OVERVIEW
BIOMARKER DEFINITION 6
TYPES OF BIOMARKERS 6
WHY USE BIOMARKERS? 7
WHY USE BIOMARKERS? (CONTINUED) 8
HISTORY 9
BIOMARKER DISCOVERY PROCESS 10
BIOMARKER IDENTIFICATION 10
BIOMARKER VALIDATION 11
BIOMARKER VERIFICATION 11
Sensitivity and Specificity 12
Biomarker Assay Validation 12
Qualification of Biomarker Assay 12
Utilization Analysis 12
REGULATORY APPROVAL 13
Analytical Validation 13
Clinical Validation 14
Clinical Utility 14
REGULATORY APPROVAL FOR MOLECULAR IMAGING AGENTS 14
Chapter-4: TECHNOLOGIES
GENOMICS 15
GENETIC BIOMARKERS 15
SNP Examples in Neurology 16
Limitations of SNPs 17
TRANSCRIPTIONAL BIOMARKERS 18
TECHNOLOGY ADVANCEMENT IN GENOMICS 19
EMERGING TECHNOLOGIES IN THE FIELD OF GENOMICS 20
RNA Interference (RNAi) 20
MicroRNA (miRNA) 20
Epigenetics 20
PROTEINS AND PROTEOMICS 20
PROTEIN ARRAYS AND OTHER PROTEIN TECHNOLOGIES 21
FUNCTIONAL PROTEIN ARRAY 21
ANALYTICAL CAPTURE ARRAY 22
LYSATE ARRAYS 22
PROTEOMICS FOR NEUROLOGICAL DISEASES 22
METABOLOMICS 23
TABLE 1 ADVANTAGES AND DISADVANTAGES OF EACH TECHNOLOGY FOR BIOMARKER STUDY 24
TECHNOLOGIES FOR BIOMARKER ANALYSIS: BIOINFORMATIONS AND SUPERCOMPUTING 25
MOLECULAR IMAGING 26
MAGNETIC RESONANCE IMAGING (MRI) 26
MRI FOR ALZHEIMER'S DISEASE 27
DIFFUSION TENSOR MRI (DTI) 27
FUNCTIONAL MRI (FMRI) 27
POSITRON EMISSION TOMOGRAPHY 28
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) 29
Single Photon Emission …(Continued) 30
Chapter-5: FACTORS INFLUENCING DEMAND OF BIOMARKERS
CHALLENGES IN FINDING EFFECTIVE TREATMENTS TO CNS DISORDERS 31
SINGLE TARGET APPROACH 31
GENETIC ASSOCIATIONS 31
ANIMAL MODELS 31
CNS DISEASES ARE COMPLEX 32
INCREASED IN CHRONIC DISEASE AND INCREASED ACCESS TO HEALTH INSURANCE IN THE U.S. 33
LOW R&D PRODUCTIVITY IN THE BIOPHARMACEUTICAL INDUSTRY AND INCREASING COSTS OF CLINICAL TRIAL 34
UNMET NEEDS 35
GROWTH IN PUBLIC-PRIVATE PARTNERSHIPS 35
FNIH BIOMARKER CONSORTIUM 35
PREDICTIVE SAFETY CONSORTIUM 36
ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE (ADNI) 36
NEWMEDS CONSORTIUM 36
FDA SUPPORT 37
CRITICAL PATH INITIATIVE (CPI) 38
VOLUNTARY GENOMIC DATA SUBMISSIONS 38
IMPACT OF VOLUNTARY EXPLORATORY DATA SUBMISSION (VXDS) 39
Chapter-6: GLOBAL REGULATORY ENVIRONMENT AND RECENT ECONOMIC CONDITIONS
INTRODUCTION 40
U.S. REQUIREMENTS 41
REIMBURSEMENT IN THE U.S. 41
Reimbursement in the U.S. (Continued) 42
EUROPE'S REGULATORY ENVIRONMENT 43
RECENT ECONOMIC CONDITIONS AND THEIR AFFECT ON BIOMARKER DEVELOPMENT 43
FIGURE 1 NASDAQ BIOTECHNOLOGY INDEX FROM JULY 2006 TO JULY 2010 44
FIGURE 2 STOCK PERFORMANCE OF TOP SUPPLIERS FOR BIOMARKER DISCOVERY 45
TABLE 2 REVENUES AND MARKET SHARE OF BIOMARKER DISCOVERY AND DRUG DEVELOPMENT SUPPLIERS, THROUGH Q1 2010 ($ MILLIONS/%) 45
TABLE 2 (CONTINUED) 46
Chapter-7: CNS DISEASE SEGMENTS, PREVALENCE, AND GAPS IN TREATMENT
INTRODUCTION 47
TABLE 3 NUMBER OF CASES OF CNS DISEASES FROM WHO, 2004 (THOUSANDS) 47
TABLE 3 (CONTINUED) 48
TABLE 4 NUMBER OF CASES OF CNS DISEASE, 2004 (THOUSANDS) 48
TABLE 5 ESTIMATED NUMBER OF CASES OF CNS DISEASE, 2008 (THOUSANDS) 48
TABLE 5 (CONTINUED) 49
TABLE 6 ESTIMATED NUMBER OF CASES OF CNS DISEASE, 2008 (THOUSANDS) 49
NEURODEGENERATION AND NEUROLOGICAL DISORDERS 49
ALZHEIMER'S DISEASE 49
Alzheimer's Disease (Continued) 50
Alzheimer's Disease (Continued) 51
AD Treatment Gaps 52
Gaps in Diagnosing AD 52
PARKINSON'S DISEASE (PD) 52
Gaps in Treatment 52
Gaps in Diagnosis 53
MULTIPLE SCLEROSIS (MS) 53
Number of Cases and Cost of Treatment 53
Gaps in Treatment 54
Gaps in Diagnosing Multiple Sclerosis 54
AMYOTROPHIC LATERAL SCLEROSIS (ALS) 55
Gaps in Treatment and Diagnosis 55
HUNTINGTON'S DISEASE 55
Gaps in Treatment and Diagnosis 56
NEUROPSYCHIATRIC DISORDERS 56
ANXIETY DISORDERS (PTSD, PANIC DISORDER, OCD, SAD, GAD) 56
Panic Disorder 56
Obsessive Compulsive Disorder 56
Social Anxiety Disorder (SAD) 57
Generalized Anxiety Disorder (GAD) 57
Depression 57
Treatment Gaps for Anxiety Disorders and Depression 58
Gaps in Diagnosis 59
Serotonin 2A Receptor Gene (HTR2A) 60
B-cell Lymphoma 2 Gene (Bcl-2) 60
Glutamate Receptor, Ionotropic Kainate 2 Gene (GRIK2) 60
SCHIZOPHRENIA 60
Gaps in Treatment 61
Gaps in Diagnosis 61
BIPOLAR 61
Bipolar I Disorder 62
Bipolar II Disorder 62
Cyclothymic Disorder 62
Gaps in Treatment and Diagnosis 62
ADHD 62
Gaps in Treatment and Diagnosis 63
AUTISM 63
Gaps in Treatment and Diagnosis 63
Chapter-8: GLOBAL CNS MARKET AND GROWTH
OVERVIEW 64
TABLE 7 MAJOR CNS COMPANIES, TREATMENTS, TOTAL MARKET, AND MARKET SHARE 2008 ($ MILLIONS/%) 65
Chapter-9: MARKETS BY APPLICATION
INTRODUCTION 66
TABLE 8 GLOBAL CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 66
DISCOVERY 66
MARKET ASSESSMENT AND FORECASTING METHOD 67
RECENT ADVANCES AND DEVELOPMENTS IN DISCOVERY 67
GROWTH DRIVERS 68
Growth in Chronic Diseases 68
Favorable Funding Environment 68
Public-Private Partnerships 69
GROWTH INHIBITORS 69
Lack of Short-Term Returns 69
Potential for Loss in Market Share 70
Lack of Standardized Methods 70
High Cost 70
DRUG DEVELOPMENT 70
MARKET ASSESSMENT AND FORECASTING METHOD 71
MOLECULAR DIAGNOSTICS 72
MARKET ASSESSMENT AND FORECASTING METHOD 72
GROWTH DRIVERS 73
GROWTH INHIBITORS 74
TABLE 9 CNS DIAGNOSTIC COMPANIES AND DISEASE INDICATION 75
TABLE 9 (CONTINUED) 76
ALZHEIMERS DISEASE 76
Applied NeuroSolutions 76
Satoris 76
Diagenic 76
Solvay 77
Proteome Sciences 77
ExonHit 77
OTHER CNS DISEASES 77
Psynova Neurotech Ltd. 77
Glycominds, Ltd. 78
TABLE 10 NUMBER OF CNS DIAGNOSTIC BIOMARKERS IN DEVELOPMENT, BY INDICATION 78
TABLE 11 GLOBAL CNS BIOMARKER DISCOVERY MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 79
TABLE 12 GLOBAL CNS BIOMARKER DEVELOPMENT MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 80
TABLE 13 GLOBAL CNS BIOMARKER MOLECULAR DIAGNOSTIC MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 80
TABLE 14 GLOBAL CNS BIOMARKER DISCOVERY MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 81
TABLE 15 GLOBAL CNS BIOMARKER DEVELOPMENT MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 82
TABLE 16 GLOBAL CNS BIOMARKER MOLECULAR DIAGNOSTIC MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 82
Chapter-10: MARKET BY REGIONS
MARKET ASSESSMENT AND FORECASTING 83
TABLE 17 GLOBAL CNS BIOMARKER MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 83
FIGURE 3 GLOBAL CNS BIOMARKER MARKET BY REGION, 2008-2015 ($ MILLIONS) 84
TABLE 18 U.S. CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 85
TABLE 19 CANADA CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 86
TABLE 20 EUROPEAN CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 86
TABLE 21 U.S. CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 86
TABLE 22 CANADIAN CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 87
TABLE 23 EUROPEAN CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 87
JAPAN 87
Japan (Continued) 88
TABLE 24 JAPAN CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 89
TABLE 25 JAPAN CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 89
EMERGING COUNTRIES 89
TABLE 26 CHINA CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 90
TABLE 27 INDIA CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 91
TABLE 28 CHINA CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 91
TABLE 29 INDIA CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 91
Chapter-11: MARKETS BY TECHNOLOGY
TABLE 30 GLOBAL CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS) 92
TABLE 31 GENOMIC CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 92
TABLE 32 PROTEOMIC CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 93
TABLE 33 OLECULAR IMAGING CNS BIOMARKER MARKET BY APPLICATION, THROUGH 2015 ($ MILLIONS) 93
TABLE 34 GENOMIC CNS BIOMARKER MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 93
TABLE 35 PROTEOMIC CNS BIOMARKER MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 94
TABLE 36 MOLECULAR IMAGING CNS BIOMARKER MARKET BY REGION, THROUGH 2015 ($ MILLIONS) 94
Chapter-12: MARKET BY CONDITION
TABLE 37 GLOBAL CNS BIOMARKER MARKET BY CONDITION, THROUGH 2015 ($ MILLIONS) 95
FIGURE 4 GLOBAL CNS BIOMARKER MARKET BY CONDITION, 2008-2015 ($ MILLIONS) 96
Chapter-13: INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS
INTRODUCTION 97
TECHNOLOGY AS DRIVING FORCE 98
BUYERS AS DRIVING FORCE 98
THIRD-PARTY PAYERS AS DRIVING FORCE 98
COMPETITION 99
STRATEGIES FOR A DIAGNOSTIC TO REMAIN COMPETITIVE 100
SIGNIFICANT IMPACT OF BIOMARKERS 101
SIGNIFICANT IMPACT OF BIOMARKERS (CONTINUED) 102
FIGURE 5 PORTER MODEL 103
STRENGTHS, WEAKENESSES, OPPORTUNITIES AND THREATS (SWOT) ANALYSIS 103
FIGURE 6 SWOT ANALYSIS 104
MOVING TOWARD PERSONALIZED MEDICINE 104
Moving Toward Personalized …(Continued) 105
Moving Toward Personalized …(Continued) 106
Chapter-14: PATENT INFORMATION
TABLE 38 PATENT APPLICATIONS FOR CNS BIOMARKERS, 2009 107
TABLE 38 (CONTINUED) 108
TABLE 38 (CONTINUED) 109
TABLE 38 (CONTINUED) 110
TABLE 38 (CONTINUED) 111
TABLE 39 PATENT APPLICATIONS FOR CNS BIOMARKERS, 2008 111
TABLE 39 (CONTINUED) 112
TABLE 40 ALSERES PHARMACEUTICALS, INC. PATENT APPLICATIONS 113
TABLE 41 APOSENSE LTD. PATENT APPLICATIONS 113
TABLE 42 APPLIED NEUROSOLUTIONS PATENT APPLICATIONS 113
TABLE 43 AVID RADIOPHARMACEUTICALS PATENT APPLICATIONS 114
TABLE 44 DIAGENIC PATENTS AND PATENT APPLICATIONS 114
TABLE 45 EXONHIT ASSOCIATED PATENTS AND PATENT APPLICATIONS 114
TABLE 45 (CONTINUED) 115
TABLE 46 INNOGENETICS PATENTS AND PATENT APPLICATIONS 115
TABLE 47 OLIGOMERIX, INC. PATENT APPLICATIONS 115
TABLE 48 PROTEOME SCIENCES, PLC PATENT APPLICATIONS 116
TABLE 49 RIDGE DIAGNOSTICS PATENTS 116
TABLE 50 PSYNOVA NEUROTECH LTD. PATENTS 117
TABLE 51 NUMBER OF PATENT APPLICATIONS AND ASSOCIATED INDICATION, 2008-2009 118
Chapter-15: COMPANY PROFILES
ABASTAR MDX INC. 119
ABIANT, INC. 120
ACUMEN PHARMACEUTICALS, INC. 120
ADLYFE INC. 121
ALSERES PHARMACEUTICALS, INC. 122
APITOPE 122
APITOPE TECHNOLOGY (BRISTOL) LTD. 122
APOSENSE 123
APPLIED NEUROSOLUTIONS, INC. 124
AVID RADIOPHARMACEUTICALS, INC. 124
BANYAN BIOMARKERS 125
BRAHMS GMBH 126
THERMO FISHER SCIENTIFIC BRAHMS BIOMARKERS 126
CURIDIUM LTD. 126
DIAGENIC ASA 127
PXBIOVISION GMBH 128
EXONHIT THERAPEUTICS 128
EXONHIT THERAPEUTICS INC. 128
GENE SOLUTIONS, LLC 129
GENENEWS LTD. 130
GENIZON BIOSCIENCES INC. 130
GLYCOMINDS LTD. 131
GLYCOMINDS INC 131
INNOVATIVE NEUROTECHNOLOGIES, INC. 132
METABOLON, INC. 132
OLIGOMERIX, INC. 133
OPKO HEALTH INC. 134
OSTA BIOTECHNOLOGIES INC. 134
POWER3 MEDICAL PRODUCTS, INC. 135
PROTEOME SCIENCES PLC 135
PROVISTA LIFE SCIENCES 136
PSYNOVA NEUROTECH LIMITED 136
RULES-BASED MEDICINE, INC. (RBM) 137
SATORIS, INC. 137
SOLVAY S.A. 138
INNOGENETICS BIOLOGICALS 138
RIDGE DIAGNOSTICS 139
Chapter-16: APPENDIX
APPENDIX A 140
TABLE 52 CNS BIOMARKER ALLIANCES, 2008?2010 140
TABLE 52 (CONTINUED) 141
TABLE 53 RECENT TECHNOLOGY DEVELOPMENTS 141
TABLE 53 (CONTINUED) 142
TABLE 53 (CONTINUED) 143
Chapter-17: APPENDIX
APPENDIX B 144
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Biotechnology Industry: Central Nervous System (CNS) Biomarkers: Technologies and Global Markets
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