Reportlinker Adds Central Nervous System (CNS) Biomarkers: Technologies and Global Markets

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

http://www.reportlinker.com/p0326190/Central-Nervous-System-CNS-Biomarkers-Technologies-and-Global-Markets.html

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

To order this report:

Biotechnology Industry: Central Nervous System (CNS) Biomarkers: Technologies and Global Markets

Biotechnology Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas Bombourg

Reportlinker

Email: [email protected]

US: (805)652-2626

Intl: +1 805-652-2626



SOURCE Reportlinker

Suggested Articles

The profit margins and management of Community Health Group raise questions about oversight of managed care insurers.

Financial experts are warning practices about the pitfalls of promoting medical credit cards to their patients.

A proposed rule issued by HHS on Tuesday would expand short-term coverage, a move Seema Verma said will have "virtually no impact" on ACA premiums.