REPORT SCOPE

INTRODUCTION

Biomarkers are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, indicate what treatment options may be most effective in an individual patient’s case and predict treatment response. They play a role both in new drug R&D and in predicting the outcome of treatment in the medical setting. They are important tools for understanding disease mechanism, developing more effective treatments and improving the quality of patient care.

The report examines the role of CNS biomarkers in early discovery, in drug development and for future diagnostics. The global CNS biomarker market is discussed, and forecasts are made for this segment of the industry for the five-year period from 2012 to 2017. The technological segments of the market (genomics, proteomics and molecular diagnostics) are discussed by application, technology and geographic region. Individual disease segments are also discussed and describe gaps in treatment and limitations of current methods of diagnosis. The process of developing biomarkers from discovery to commercialization is described along with the forces in the industry that play an integral role, such as payers, providers and suppliers. Growth drivers and inhibitors that can affect CNS biomarker development and adoption are also discussed.

STUDY GOALS AND OBJECTIVES

• Assess the various technologies used for CNS biomarker discovery and future diagnostics.
• Understand the process of CNS biomarker development from discovery to commercialization and the path towards adoption.
• Examine the regulatory landscape and government’s role.
• Examine the future advances that need to be made in the diagnosis and treatment of various CNS disorders.
• Determine current and future CNS biomarker markets.

REASONS FOR DOING THE STUDY

For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.

The CNS biomarker market presents an increasingly significant part of the overall pharmaceutical product market worldwide. The study investigates the specific classes of biomarkers involved in CNS disease and the current and potential future pharmaceutical products associated with them. Existing drug products and potential drugs in the pipelines of the major pharmaceutical players in this market are reviewed.
CNS disorders exist in all countries worldwide. Growing health concerns in developing countries are expected to continue to contribute substantially to market growth through the forecast period (2012 to 2017). The report analyzes existing research, emerging markets and biomarker technology categories. Continued growth is expected in emerging geographies, driven by the increase in health awareness of the growing middle class in emerging countries such as the BRIC countries: Brazil, Russia, India, China.

The report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and products, strategies for accessing emerging markets, specific disease prevalence and geographies in order to allocate resources and make effective decisions.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period of 2012 to 2017 are discussed. New product launches will be discussed. Revenue figures for 2011 are actual figures. Revenue figures for 2012 are actual figures except where actual results have not been reported, due to the timing of the release of the report.

The report includes an analysis of leading and emerging CNS biomarkers and related drugs for each CNS disorder. Profiles of producers of leading products and their specific products are provided. The report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products will alter the quality of life of patients receiving CNS biomarker diagnostics and treatment with associated drugs.

Market figures are based on revenues at the manufacturers’ level and are projected at a 2012-dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, for new product introductions, expanded markets for existing products and other factors affecting the market.
Included in this report are forecasts by product, product category and by company from 2012 through 2017. The study is arranged to offer an overview of existing biomarker technology, drug markets for CNS diseases, drug and disease mechanism of action and companies, with forecasts broken down and covered by geographic region or country.

Patent and clinical trial information is reviewed for various candidate biomarkers. The status of approval by the FDA and regulatory agencies in other countries of biomarker diagnostics in each segment is reviewed.

Figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.
All market share data presented is on a global basis, unless specifically noted.

INTENDED AUDIENCE

The report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants and anyone interested in the biomarker and CNS drug markets, its products, its industry participants and its future.

The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:

Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development and R&D.
Emerging players in the segment must understand specific opportunities for out-licensing originating from the elements of differentiation of their product or technology as compared to leading, competitive and emerging products. In addition, market forecasts can support investment, provided thorough and detailed substantiation is provided for the market forecast, as is found in this study.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights as to the opportunity and risks that are being encountered in the industry, in a product and company specific analysis.
Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.

METHODOLOGY AND INFORMATION SOURCES

In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts and leading individuals in the field.

The CNS biomarker and drug markets comprise drug products for treatment of a number of specific diseases afflicting both men and women. For completeness, the current and forecasted markets comprise the total market opportunity for each respective segment.

Information to prepare this report was obtained from participating and emerging companies in the biomarker and CNS drug areas and from the following institutes within the National Institutes of Health (NIH): National Institute of Mental Health (NIMH), the National Institute of Aging (NIA), the National Institute of Neurological Diseases and Stroke (NINDS), National Human Genomic Research Institute (NHGRI), the NIH’s Center of Information Technology (CIT) and the National Library of Medicine (NLM).
Additional information was obtained from a variety of medical and technical journals on the various specialties within biomarker and CNS applications. Other sources included the New York Times, Wall Street Journal, Washington Post,other newspapers, company documents and Internet websites. Population estimates are based on those reported by the International Data Base of the U.S. Census Bureau. Statistical data was obtained from the World Health Organization (WHO) and the Collaborating Centre for Drug Statistics Methodology (Norway).

Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.

ANALYST’S CREDENTIALS

Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. Jackson has been consulting with specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that, he worked at a large research and consulting firm where he focused on in-depth research; he also has worked at a large pharmaceutical company involved a wide range of medical therapeutics in early- and mid-stage drug development.

REPORT HIGHLIGHTS

This report provides:
• An overview of the global market for central nervous system (CNS) biomarkers, which are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, and predict treatment response.
• Analyses of global market trends, with data from 2010 through 2012, and projections of compound annual growth rates (CAGRs) through 2017.
• Evaluations of technologies such as genomics, proteomics, and imaging, and assessments of their advantages and disadvantages.
• Discussion of CNS disease segments, prevalence, and gaps in treatment for Alzheimer’s disease, depression, Parkinson’s disease, multiple sclerosis, and others.
• Patent analyses.
• Comprehensive company profiles of major players.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 3
INTENDED AUDIENCE 4
METHODOLOGY AND INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 5
RELATED BCC REPORTS 5
BCC ON-LINE SERVICES 5
DISCLAIMER 6

CHAPTER 2 SUMMARY 8

SUMMARY TABLE GLOBAL CNS BIOMARKER MARKET BY APPLICATION,
THROUGH 2017 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL CNS BIOMARKER MARKET BY APPLICATION,
2010-2017 ($ MILLIONS) 8

CHAPTER 3 OVERVIEW 12

BIOMARKER DEFINITION 12
TYPES OF BIOMARKERS 13
HOW BIOMARKERS WORK 14
POTENTIAL BENEFITS OF USING BIOMARKERS 15
HISTORY 17
BIOMARKER DISCOVERY PROCESS 18
BIOMARKER IDENTIFICATION 18
Genetic Biomarkers 19
Transcriptional Biomarkers 20
Protein Indicating Biomarkers 20
Metabolic Biomarkers 20
BIOMARKER QUALIFICATION 20
BIOMARKER VERIFICATION 21
REGULATORY APPROVAL 21
TABLE 1 FDA REGULATORY REQUIREMENTS FOR BIOMARKER DIAGNOSTIC
TESTS 22
BIOMARKERS AS DIAGNOSTIC TOOLS 22
SENSITIVITY AND SPECIFICITY 22
BIOMARKER ASSAY VALIDATION 23
QUALIFICATION OF BIOMARKER ASSAY 23
UTILIZATION ANALYSIS 24
Analytical Validation 24
Clinical Validation 24
Clinical Utility 24

CHAPTER 4 TECHNOLOGIES 26

GENOMICS 26
GENETIC BIOMARKERS 26
Genome-wide Association Scanning 27
Identification of SNPs 27
Examples of SNPs in Neurology 28
Limitations of SNPs 28
Transcriptional Biomarkers 29
TECHNOLOGY ADVANCEMENTS IN GENOMICS 30
Emerging Technologies in the Field of Genomics 31
RNA Interference 31
MicroRNA 31
EPIGENETICS 31
PROTEINS AND PROTEOMICS 32
PROTEIN ARRAYS AND OTHER PROTEIN TECHNOLOGIES 33
Functional Protein Array 33
Analytical Capture Array 33
Lysate Arrays 34
PROTEOMICS FOR NEUROLOGICAL DISEASES 34
METABOLOMICS 35
ADVANTAGES AND DISADVANTAGES OF VARIOUS BIOMARKER
IDENTIFICATION TECHNOLOGIES 35
TABLE 2 ADVANTAGES AND DISADVANTAGES OF EACH TECHNOLOGY FOR
BIOMARKER STUDY 36
DETECTION OF RNA 36
DETECTION OF DNA 37
PROTEIN EXPRESSION 37
SURROGATE BIOMARKERS OR COMPANION DIAGNOSTIC BIOMARKERS 37
TABLE 3 COMPANION DIAGNOSTIC BIOMARKERS WITH FDA PMA APPROVAL 39
TABLE 4 EXAMPLES OF PHARMACEUTICAL/DIAGNOSTIC COMPANY
PARTNERSHIPS TO DEVELOP COMPANION DIAGNOSTIC BIOMARKERS 47
TECHNOLOGIES FOR BIOMARKER ANALYSIS: BIOINFORMATICS AND
SUPERCOMPUTING 47
MOLECULAR IMAGING 48
Magnetic Resonance Imaging 49
MRI for Alzheimer's Disease 49
Diffusion Tensor MRI 49
Functional MRI 50
Positron Emission Tomography 50
Single Photon Emission Computed Tomography 51

CHAPTER 5 FACTORS INFLUENCING DEMAND FOR CNS BIOMARKERS 54

CHALLENGES IN FINDING EFFECTIVE TREATMENTS 54
SINGLE TARGET APPROACH 54
GENETIC ASSOCIATIONS 54
ANIMAL MODELS 54
CNS DISEASES ARE COMPLEX 55
INCREASE IN CHRONIC DISEASE AND INCREASING ACCESS TO
HEALTH INSURANCE IN THE U.S. 56
LOW RandD PRODUCTIVITY IN THE BIOPHARMACEUTICAL INDUSTRY
AND INCREASING COSTS OF CLINICAL TRIAL 57
UNMET NEEDS 58
FDA SUPPORT OF BIOMARKERS 58
NEURODEGENERATION AND NEUROLOGICAL DISORDERS 58
ALZHEIMER'S DISEASE 58
Gaps in Diagnosing AD 60
Biomarkers in Alzheimer's Disease 60
TABLE 5 ESTABLISHED BIOMARKERS FOR ALZHEIMER'S DISEASE 62
TABLE 6 PREDICTIVE VALUE OF CURRENT AD BIOMARKERS 63
Alzheimer's Treatments 63
Treatment for Mild to Moderate Alzheimer's 63
Treatment for Moderate to Severe Alzheimer's 64
PARKINSON'S DISEASE 64
GAPS IN TREATMENT 65
GAPS IN DIAGNOSIS 65
PARKINSON'S DISEASE BIOMARKERS 65
TABLE 7 POTENTIAL BIOMARKERS FOR PARKINSON'S DISEASE 66
MULTIPLE SCLEROSIS 68
PREVALENCE/INCIDENCE OF MS 68
GAPS IN TREATMENT 69
GAPS IN DIAGNOSING MULTIPLE SCLEROSIS 70
MULTIPLE SCLEROSIS BIOMARKERS 70
TABLE 8 POTENTIAL BIOMARKERS FOR MULTIPLE SCLEROSIS 71
AMYOTROPHIC LATERAL SCLEROSIS 72
GAPS IN TREATMENT AND DIAGNOSIS 72
TABLE 9 ALS DRUGS IN CLINICAL TRIALS 73
TABLE 10 RECENT ALS DRUGS THAT FAILED IN PHASE III CLINICAL TRIALS 74
ALS BIOMARKERS 74
TABLE 11 POTENTIAL ALS BIOMARKERS 74
TABLE 12 PROTEINS IDENTIFIED IN NEXTGEN SCIENCES ASSAY 19-PLEX
ALS TEST 76
TABLE 13 PROTEINS IDENTIFIED IN NEXTGEN SCIENCES' ASSAY 26-PLEX
ALS TEST 76
HUNTINGTON'S DISEASE 78
GAPS IN TREATMENT AND DIAGNOSIS 78
NEUROPSYCHIATRIC DISORDERS 78
ANXIETY DISORDERS 79
Panic Disorder 79
Obsessive-Compulsive Disorder 79
Social Anxiety Disorder (SAD) 79
Depression 80
TREATMENT GAPS FOR ANXIETY DISORDERS AND DEPRESSION 80
GAPS IN DIAGNOSIS 81
BIOMARKERS FOR DEPRESSION AND ANXIETY DISORDERS 81
Serotonin 2A Receptor Gene (HTR2A) 81
B-cell Lymphoma 2 Gene (Bcl-2) 81
Glutamate Receptor, Ionotropic Kainate 4 Gene (GRIK4) 81
SCHIZOPHRENIA 82
GAPS IN TREATMENT 82
GAPS IN DIAGNOSIS 82
BIOMARKERS FOR SCHIZOPHRENIA 83
TABLE 14 MAJOR POTENTIAL BIOMARKERS FOR SCHIZOPHRENIA 83
BIPOLAR DISORDER 84
BIPOLAR I DISORDER 84
BIPOLAR II DISORDER 84
CYCLOTHYMIACS DISORDER 84
GAPS IN TREATMENT AND DIAGNOSIS 84
BIPOLAR DISEASE BIOMARKERS 85
TABLE 15 POTENTIAL BIOMARKERS FOR BIPOLAR DISEASE 85
ATTENTION DEFICIT HYPERACTIVITY DISORDER 86
GAPS IN TREATMENT AND DIAGNOSIS 86
BIOMARKERS FOR ADHD 87
TABLE 16 POTENTIAL BIOMARKERS FOR ADHD 87
AUTISM 88
BIOMARKERS FOR AUTISM 88
GAPS IN TREATMENT AND DIAGNOSIS 88

CHAPTER 6 GLOBAL PHARMACEUTICAL MARKET 90

REGIONAL ANALYSIS OF THE GLOBAL PHARMACEUTICAL MARKET 90
TABLE 17 GLOBAL PHARMACEUTICAL REVENUES, 2012 ($ BILLIONS/%) 90
TABLE 18 PERCENTAGE OF DRUGS THAT ACHIEVE FDA APPROVAL BY
DISEASE CATEGORY (%) 91
PHARMACEUTICAL MARKETS IN CHINA AND INDIA 91
Pharmaceutical Market in China 91
Pharmaceutical Market in India 92
EMERGING PHARMACEUTICAL MARKETS 92
BRIC Countries 93
TABLE 19 BRIC PHARMACEUTICAL REVENUES BY COUNTRY, THROUGH 2017
($ MILLIONS) 93
Brazilian Pharmaceutical Market 93
Russian Pharmaceutical Market 94
Next 11 Market 94
ROLE OF GENOTYPING IN DRUG SUCCESS OR FAILURE 94

CHAPTER 7 CNS PHARMACEUTICAL AND BIOMARKER MARKETS 98

CNS PHARMACEUTICAL MARKET 98
TABLE 20 ALZHEIMER'S SCHIZOPHRENIA AND DEPRESSION DRUGS IN
CLINICAL TRIALS 99
CNS BIOMARKER MARKET 99
TABLE 21 GLOBAL CNS BIOMARKER MARKET BY APPLICATION, THROUGH
2017 ($ MILLIONS) 100
BIOMARKER DISCOVERY 101
Growth Drivers 101
Growth in Chronic Diseases 101
Favorable Funding Environment 101
Public-Private Partnerships 102
FNIH Biomarker Consortium 102
Alzheimer's Disease Neuroimaging Initiative (ADNI) 102
Predictive Safety Consortium 103
Growth Inhibitors 103
Lack of Short-Term Returns 103
Potential for Loss in Market Share 103
Lack of Standardized Methods 103
High Cost 103
BIOMARKERS IN DRUG DEVELOPMENT 104
Growth Drivers 104
Growth Inhibitors 104
MOLECULAR IMAGING AS BIOMARKER MODALITY 104
Growth Drivers 104
Growth Inhibitors 105
TABLE 22 GLOBAL CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH
2017 ($ MILLIONS) 105
BIOMARKER DIAGNOSTIC TEST KITS 106
MAJOR PLAYERS IN THE CNS BIOMARKER DIAGNOSTIC MARKET 106
TABLE 23 CNS DIAGNOSTICS COMPANIES AND DISEASE INDICATION 107
TABLE 24 CNS DIAGNOSTIC BIOMARKERS IN DEVELOPMENT BY
INDICATION (NO.) 108
GLOBAL CNS BIOMARKER MARKET BY REGION 108
TABLE 25 GLOBAL CNS BIOMARKER MARKET BY REGION, 2010-2017 ($
MILLIONS/%) 109
CNS BIOMARKER REVENUES BY TECHNOLOGY 109
TABLE 26 DISTRIBUTION OF REVENUES AMONG CNS DISEASES, 2012 ($
MILLIONS/%) 110

CHAPTER 8 CNS BIOMARKER PIPELINE 112

TABLE 27 PERCENTAGE OF CNS REVENUE FROM EACH MAJOR CNS
DISEASE SEGMENT AS OF 2012 (%) 112
TABLE 28 CNS DISEASE BIOMARKERS IN COMPANY PIPELINES 113

CHAPTER 9 BIOMARKER INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 116

INTRODUCTION 116
MAJOR MARKET DRIVERS 116
TECHNOLOGY 116
BUYERS 117
COMPETITION 117
IMPACT OF BIOMARKERS ON PHARMACEUTICAL INDUSTRY 118
IMPACT OF BIOMARKERS ON HEALTHCARE INDUSTRY 118
STRENGTHS, WEAKNESSES, OPPORTUNITIES AND THREATS (SWOT)
ANALYSIS 118
TABLE 29 SWOT ANALYSIS 119
MOVING TOWARD PERSONALIZED MEDICINE 119
CHALLENGES TOWARD ADOPTION 120
BENEFITS OF PERSONALIZED MEDICINE 120

CHAPTER 10 CNS BIOMARKER CLINICAL TRIALS 123

TABLE 30 CLINICAL TRIALS ON MAJOR CNS DISEASES (NO.) 123
ONGOING CLINICAL TRIALS FOR MAJOR CNS DISEASES 123
TABLE 31 ONGOING CLINICAL TRIALS ON DRUG BIOMARKERS IN MAJOR
CNS DISEASES 124
TABLE 32 ONGOING CLINICAL TRIALS ON DIAGNOSTIC TEST BIOMARKERS
IN MAJOR CNS DISEASES 125
CLINICAL TRIALS ON CNS BIOMARKERS BEGINNING RECRUITMENT 126
TABLE 33 CLINICAL TRIALS ON DRUG BIOMARKERS IN MAJOR CNS
DISEASES BEGINNING RECRUITMENT 126
TABLE 34 CLINICAL TRIALS ON CNS DIAGNOSTIC BIOMARKER TESTS
BEGINNING RECRUITMENT 129

CHAPTER 11 PATENT ANALYSIS 133

U.S. PATENTS ISSUED FOR ALZHEIMER'S DISEASE BIOMARKERS 133
TABLE 35 U.S. PATENTS ISSUED FOR ALZHEIMER'S DISEASE BIOMARKERS,
2009-2013 133
U.S. PATENTS ISSUED FOR MULTIPLE SCLEROSIS BIOMARKERS 134
TABLE 36 U.S. PATENTS ISSUED FOR MULTIPLE SCLEROSIS BIOMARKERS,
2012 TO JAN. 22, 2013 134
U.S. PATENTS ISSUED FOR PARKINSON'S DISEASE BIOMARKERS 136
TABLE 37 U.S. PATENTS ISSUED FOR PARKINSON'S DISEASE BIOMARKERS,
2008 TO FEB. 14, 2012 136
U.S. PATENTS ISSUED FOR ALS DISEASE BIOMARKERS 137
TABLE 38 U.S. PATENTS ISSUED FOR ALS DISEASE BIOMARKERS, 2012 TO
JAN. 15, 2013 137
WIPO PATENTS FOR BIOMARKERS AND ASSAYS FOR CNS DISEASES 138
TABLE 39 WIPO PATENTS FOR BIOMARKERS AND ASSAYS FOR CNS
DISEASES, 2011 TO JAN. 24, 2013 139
TABLE 40 NUMBER OF PATENT APPLICATIONS, 2012 140

CHAPTER 12 MERGERS AND ACQUISITIONS, LICENSING AND PARTNERSHIP

ACTIVITY IN 2012 142
MAJOR PHARMACEUTICAL BIOMARKER ACQUISITIONS 143
TABLE 41 MAJOR PHARMACEUTICAL BIOMARKER TRANSACTIONS, 2012 143

CHAPTER 13 COMPANY PROFILES 146

ABASTAR MDX INC. 146
ABIANT INC. 146
ACUMEN PHARMACEUTICALS INC. 147
ADLYFE INC. 147
ALSERES PHARMACEUTICALS INC. 148
APITOPE INTERNATIONAL 148
PRODUCTS 149
TABLE 42 APIOTOPE PRODUCTS 149
APOSENSE 149
APPLIED NEUROSOLUTIONS INC. 150
AVACTA GROUP PLC 150
CURIDIUM LTD. 150
AVID RADIOPHARMACEUTICALS INC. 151
BANYAN BIOMARKERS 151
DIAGENIC ASA 152
PRODUCTS 153
TABLE 43 DIAGENIC PRODUCTS 153
EXONHIT THERAPEUTICS 153
PRODUCTS 154
TABLE 44 EXONHIT PRODUCTS 154
GENENEWS LTD. 154
GLYCOMINDS LTD. 155
PRODUCTS 155
TABLE 45 GLYCOMINDS PRODUCTS 155
GREAT LAKES NEUROTECHNOLOGIES 155
INNOGENETICS BIOLOGICALS (SOLVAY SUBSIDIARY) 156
INNOVATIVE NEUROTECHNOLOGIES INC. 157
PRODUCTS 157
TABLE 46 INNOVATIVE NEUROTECHNOLOGIES PRODUCTS 157
MEMORY DX LLC (PREVIOUSLY PROVISTA LIFE SCIENCES) 157
METABOLON INC. 158
MYRIAD RBM INC. 159
OLIGOMERIX INC. 159
PRODUCTS 160
TABLE 47 OLIGOMERIX PRODUCTS 160
OPKO HEALTH INC. 160
OSTA BIOTECHNOLOGIES INC. 161
PRODUCTS 161
TABLE 48 OSTA BIOTECHNOLOGIES' PRODUCT 161
PROTEOME SCIENCES PLC 161
PRODUCTS 162
TABLE 49 PROTEOME SCIENCES PRODUCTS 162
PSYNOVA NEUROTECH LTD. 162
PXBIOVISION GMBH 163
RIDGE DIAGNOSTICS 163
PRODUCTS 164
TABLE 50 RIDGE DIAGNOSTICS PRODUCTS 164
SATORI PHARMACEUTICALS INC. 164
PRODUCTS 165
TABLE 51 SATORI PHARMACEUTICALS PRODUCTS 165
SABIOSCIENCES (SUBSIDIARY OF QIAGEN INC.) 165
PRODUCTS 166
TABLE 52 SABIOSCIENCES CNS ASSAY PRODUCTS 166
THERMO FISHER SCIENTIFIC (BRAHMS BIOMARKERS) 166



LIST OF TABLES

SUMMARY TABLE GLOBAL CNS BIOMARKER MARKET BY APPLICATION,
THROUGH 2017 ($ MILLIONS) 8
TABLE 1 FDA REGULATORY REQUIREMENTS FOR BIOMARKER DIAGNOSTIC
TESTS 22
TABLE 2 ADVANTAGES AND DISADVANTAGES OF EACH TECHNOLOGY FOR
BIOMARKER STUDY 36
TABLE 3 COMPANION DIAGNOSTIC BIOMARKERS WITH FDA PMA APPROVAL 39
TABLE 4 EXAMPLES OF PHARMACEUTICAL/DIAGNOSTIC COMPANY
PARTNERSHIPS TO DEVELOP COMPANION DIAGNOSTIC BIOMARKERS 47
TABLE 5 ESTABLISHED BIOMARKERS FOR ALZHEIMER'S DISEASE 62
TABLE 6 PREDICTIVE VALUE OF CURRENT AD BIOMARKERS 63
TABLE 7 POTENTIAL BIOMARKERS FOR PARKINSON'S DISEASE 66
TABLE 8 POTENTIAL BIOMARKERS FOR MULTIPLE SCLEROSIS 71
TABLE 9 ALS DRUGS IN CLINICAL TRIALS 73
TABLE 10 RECENT ALS DRUGS THAT FAILED IN PHASE III CLINICAL TRIALS 74
TABLE 11 POTENTIAL ALS BIOMARKERS 74
TABLE 12 PROTEINS IDENTIFIED IN NEXTGEN SCIENCES ASSAY 19-PLEX ALS
TEST 76
TABLE 13 PROTEINS IDENTIFIED IN NEXTGEN SCIENCES' ASSAY 26-PLEX ALS
TEST 76
TABLE 14 MAJOR POTENTIAL BIOMARKERS FOR SCHIZOPHRENIA 83
TABLE 15 POTENTIAL BIOMARKERS FOR BIPOLAR DISEASE 85
TABLE 16 POTENTIAL BIOMARKERS FOR ADHD 87
TABLE 17 GLOBAL PHARMACEUTICAL REVENUES, 2012 ($ BILLIONS/%) 90
TABLE 18 PERCENTAGE OF DRUGS THAT ACHIEVE FDA APPROVAL BY
DISEASE CATEGORY (%) 91
TABLE 19 BRIC PHARMACEUTICAL REVENUES BY COUNTRY, THROUGH 2017
($ MILLIONS) 93
TABLE 20 ALZHEIMER'S SCHIZOPHRENIA AND DEPRESSION DRUGS IN
CLINICAL TRIALS 99
TABLE 21 GLOBAL CNS BIOMARKER MARKET BY APPLICATION, THROUGH
2017 ($ MILLIONS) 100
TABLE 22 GLOBAL CNS BIOMARKER MARKET BY TECHNOLOGY, THROUGH
2017 ($ MILLIONS) 105
TABLE 23 CNS DIAGNOSTICS COMPANIES AND DISEASE INDICATION 107
TABLE 24 CNS DIAGNOSTIC BIOMARKERS IN DEVELOPMENT BY INDICATION
(NO.) 108
TABLE 25 GLOBAL CNS BIOMARKER MARKET BY REGION, 2010-2017 ($
MILLIONS/%) 109
TABLE 26 DISTRIBUTION OF REVENUES AMONG CNS DISEASES, 2012 ($
MILLIONS/%) 110
TABLE 27 PERCENTAGE OF CNS REVENUE FROM EACH MAJOR CNS DISEASE
SEGMENT AS OF 2012 (%) 112
TABLE 28 CNS DISEASE BIOMARKERS IN COMPANY PIPELINES 113
TABLE 29 SWOT ANALYSIS 119
TABLE 30 CLINICAL TRIALS ON MAJOR CNS DISEASES (NO.) 123
TABLE 31 ONGOING CLINICAL TRIALS ON DRUG BIOMARKERS IN MAJOR CNS
DISEASES 124
TABLE 32 ONGOING CLINICAL TRIALS ON DIAGNOSTIC TEST BIOMARKERS IN
MAJOR CNS DISEASES 125
TABLE 33 CLINICAL TRIALS ON DRUG BIOMARKERS IN MAJOR CNS DISEASES
BEGINNING RECRUITMENT 126
TABLE 34 CLINICAL TRIALS ON CNS DIAGNOSTIC BIOMARKER TESTS
BEGINNING RECRUITMENT 129
TABLE 35 U.S. PATENTS ISSUED FOR ALZHEIMER'S DISEASE BIOMARKERS,
2009-2013 133
TABLE 36 U.S. PATENTS ISSUED FOR MULTIPLE SCLEROSIS BIOMARKERS,
2012 TO JAN. 22, 2013 134
TABLE 37 U.S. PATENTS ISSUED FOR PARKINSON'S DISEASE BIOMARKERS,
2008 TO FEB. 14, 2012 136
TABLE 38 U.S. PATENTS ISSUED FOR ALS DISEASE BIOMARKERS, 2012 TO JAN.
15, 2013 137
TABLE 39 WIPO PATENTS FOR BIOMARKERS AND ASSAYS FOR CNS DISEASES,
2011 TO JAN. 24, 2013 139
TABLE 40 NUMBER OF PATENT APPLICATIONS, 2012 140
TABLE 41 MAJOR PHARMACEUTICAL BIOMARKER TRANSACTIONS, 2012 143
TABLE 42 APIOTOPE PRODUCTS 149
TABLE 43 DIAGENIC PRODUCTS 153
TABLE 44 EXONHIT PRODUCTS 154
TABLE 45 GLYCOMINDS PRODUCTS 155
TABLE 46 INNOVATIVE NEUROTECHNOLOGIES PRODUCTS 157
TABLE 47 OLIGOMERIX PRODUCTS 160
TABLE 48 OSTA BIOTECHNOLOGIES' PRODUCT 161
TABLE 49 PROTEOME SCIENCES PRODUCTS 162
TABLE 50 RIDGE DIAGNOSTICS PRODUCTS 164
TABLE 51 SATORI PHARMACEUTICALS PRODUCTS 165
TABLE 52 SABIOSCIENCES CNS ASSAY PRODUCTS 166



LIST OF FIGURES

SUMMARY FIGURE GLOBAL CNS BIOMARKER MARKET BY APPLICATION,
2010-2017 ($ MILLIONS) 8

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