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Therapies and Biomarkers for Inflammatory Bowel Disease

  • January 2013
  • -
  • BCC Research
  • -
  • 115 pages

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This BCC Research report, Therapies and Biomarkers for Inflammatory Bowel Disease, provides a detailed analysis of the products and technologies that define the market space and summarizes the composition and dynamics of individual companies in the competitive environment. The study also includes an overview of the relevant regulatory issues, patent landscapes and strategic partnerships that will play substantial roles in shaping the market in the future.

REASONS FOR DOING THE STUDY

Inflammatory bowel diseases (IBDs), notably Crohn’s disease (CD) and ulcerative colitis (UC), are estimated to affect more than four million people globally. The precise etiology of these diseases is under active investigation, but the clinical observation that many IBD patients respond to anti-inflammatory medications with concomitant U.S. Food and Drug Administration (FDA) approval for alternative indications (e.g., infliximab [Remicade], a chimeric IgG1k monoclonal antibody targeted against TNF-alpha) makes IBD a disease class with broad market appeal to the pharmaceutical and biotechnology industries. In addition, the clinical removal of biopsy samples from IBD patients is a routine part of the standard of care in many cases, and thus the widespread availability of tissue samples from the site of active disease makes IBD a disease class in which the potential for disease and therapeutic biomarker discovery has a practical basis. Clinical biomarkers, whether used to assess IBD disease severity or to inform treatment regimens, represent a significant market segment in IBD management.

Despite the existence of diagnostics and therapeutics for IBD, the pharmaceutical, medical and payor market sectors are keeping up the demand for the development of better technologies. With the upcoming patent expiry of the biologic drug Remicade, the most efficacious treatment for Crohn’s and UC, the recent approval of several other biologic therapies for IBD, along with a shift in the clinical setting to toward treating with biologic therapies earlier in the course of disease, the market for IBD therapeutics is in a state of heavy flux.

SCOPE OF REPORT

The study scope of this report includes commercialized products used in the diagnosis and treatment of IBD, as well as novel products and technologies that may be commercially viable by 2017. Important IBD disease mechanisms, technologies for biomarker discovery, industry structure, and key players and factors influencing demand for IBD therapeutics are discussed. Suppliers of IBD diagnostic and therapeutic products are discussed, with the market for IBD therapeutics analyzed based on product types and regions. In addition to an in-depth analysis of the intellectual property landscape for major industry players, this report highlights recent industrial shifts (e.g., strategic alliances, mergers and acquisitions, major venture capital deals) in the IBD diagnostic and therapeutic space. Forecasted market growth from 2012 through 2017 is presented.

In addition to examining larger and more-established producers in IBD diagnostic and therapeutic product market segments, BCC Research profiled numerous smaller specialized market players in this report. Market segmentation within the areas of therapeutic class and geographical areas are highlighted. Each technology is analyzed by application type and in the context of relevant technological and regulatory forces to determine its current market status and forecasted growth through 2017.

Recent industrial alliances and acquisitions affecting producer market penetration and dominance are also discussed.

Topics that are specifically excludedfrom this study, as they are considered beyond the scope of this report, include a detailed market analysis for IBD diagnostic procedures (e.g., colonoscopy, endoscopy, radiology) and IBD classes with lower incidence and prevalence rates (e.g., ischemic, diversionary, Bechet’s). A detailed market analysis for products used for the palliative care of IBD and non-laboratory diagnostics for IBD detection were also excluded from this study.

INTENDED AUDIENCE

This report will be of general interest to business professionals in the pharmaceutical, biotechnology and investment fields. Both producers and consumers of IBD diagnostics and therapeutics will benefit from the comprehensive summary of relevant technologies and industrial profiles contained within this study.
Consultants, strategic and market analysts, and investors working within the pharmaceutical, clinical and biotechnology industries will also find this report particularly useful. In addition, business development professionals, as well as those in sales, marketing, information sciences and competitive intelligence fields of biotechnology, will benefit from the information contained in this report.

METHODOLOGY AND INFORMATION SOURCES

The market assessments presented in this report were derived from publicly available information up to and including September 2012 in conjunction with primary source interviews. Using 2010 as the base year, forecast data are provided through 2017. In cases where data for 2012 were incomplete or not readily available, figures were extrapolated from 2011 statistics, half-year figures for 2012 and historical trends between 2010 and 2012. Market figures are based on current U.S. dollars with no adjustments for inflation made in the projections.

The information contained in this report has been assembled from both primary and secondary data sources. Primary research was conducted via telephone or e-mail correspondence with industry professionals, research scientists, physicians, researchers and laboratory heads to discover the most recent developments in their fields of interest. Secondary data were collected via a comprehensive search of the scientific, peer-reviewed literature; clinical trial reports and databases; industry trade media; company websites; annual reports; intellectual-property databases; and industry press releases.

ANALYST CREDENTIALS

Dr. Willem Westra brings more than a decade of experience as an analyst in diverse areas of biomedical science, including basic research, intellectual property and investor relations, to BCC Research. He is the author of several peer-reviewed scientific articles and book chapters, and he actively works with major domestic and international pharmaceutical and biotechnology companies to evaluate potential biomarkers for autoimmune diseases. In addition to his pharmaceutical industry experience, Dr. Westra has served as an intellectual property/patent consultant, held visiting faculty positions in academia and has worked as a professional ski instructor. Dr. Westra has earned both a B.S. in Pharmacological Chemistry and a Ph.D. in Biomedical Science from the University of California, San Diego.

REPORT HIGHLIGHTS

This report provides:
- An overview of the global market for therapies and biomarkers for inflammatory bowel disease (IBD)
- Analyses of global market trends, with data from 2011, estimates for 2012, and projections of compound annual growth rates (CAGRs) through 2017
- Discussion of the types of IBD, including Crohn's disease, ulcerative colitis, and other (ischemic, diversionary, Bechet's)
- Examination of the types of IBD diagnostics, such as stool cultures, blood tests, and colonoscopy, endoscopy and radiology; and therapies, such as clinical guidelines for managing the disease, drugs, and surgery
- A breakdown of research and development, the current drugs approved for treatment, and current clinical trials of drugs
- Industry structure, key competitive factors, and growth drivers and obstacles
- Comprehensive company profiles of key players.

Table Of Contents

Therapies and Biomarkers for Inflammatory Bowel Disease
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 1
INTENDED AUDIENCE 2
METHODOLOGY AND INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
RELATED REPORTS 3
BCC ON-LINE SERVICES 3
DISCLAIMER 3

CHAPTER 2 SUMMARY 5
SUMMARY TABLE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET,
THROUGH 2017 ($ MILLIONS) 5
SUMMARY FIGURE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, BY
REGION, 2010-2017 ($ MILLIONS) 5

CHAPTER 3 OVERVIEW 7
INFLAMMATORY BOWEL DISEASE 7
DEFINITION OF INFLAMMATORY BOWEL DISEASE 7
Crohn's Disease 7
Ulcerative Colitis 7
EPIDEMIOLOGY OF INFLAMMATORY BOWEL DISEASE 8
Incidence and Prevalence of Inflammatory Bowel Disease 9
TABLE 1 GLOBAL INCIDENCE RANGES FOR CROHN'S DISEASE AND ULCERATIVE COLITIS
(PER 100,000) 9
TABLE 2 GLOBAL PREVALENCE OF CROHN'S DISEASE AND ULCERATIVE COLITIS 10
TABLE 3 GLOBAL INCIDENCE FOR CROHN'S DISEASE 11
TABLE 4 GLOBAL PREVALENCE FOR CROHN'S DISEASE 12
TABLE 5 GLOBAL INCIDENCE FOR ULCERATIVE COLITIS 13
TABLE 6 GLOBAL PREVALENCE FOR ULCERATIVE COLITIS 14
CURRENT TREATMENTS FOR INFLAMMATORY BOWEL DISEASE 15
TABLE 7 THERAPEUTIC OPTIONS FOR INFLAMMATORY BOWEL DISEASE 15
Symptom Management 16
Inflammation Reduction 16
Surgery 16
Surgery for Ulcerative Colitis 16
Surgery for Crohn's Disease 17
Alternative Therapies 17
Fecal Bacteriotherapy 17
Pre- and Probiotic Supplementation 17
Helminth Therapy 17
BIOMARKER DEFINITION 18
Biomarkers Types 18
Diagnostic Biomarkers 18
TABLE 8 DIAGNOSTIC BIOMARKER EXAMPLES 19
Prognostic Biomarkers 19
Predictive Biomarkers 19
TABLE 9 PREDICTIVE BIOMARKER EXAMPLES 20
Target-Engagement Biomarkers 20
Biomarkers for Inflammatory Bowel Disease 20
TABLE 10 BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE 21
TABLE 11 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS REGARDING INFLAMMATORY
BOWEL DISEASE BIOMARKERS, 2002-2012 21
TABLE 12 OPEN CLINICAL TRIALS FOR CROHN'S DISEASE THERAPEUTICS BY LOCATION,
2012 (NUMBER OF TRIALS) 22
TABLE 13 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION,
2012 (NUMBER OF TRIALS) 23

CHAPTER 4 INFLAMMATORY BOWEL DISEASE PHYSIOLOGY 25
OVERVIEW 25
ANATOMY OF THE INTESTINES 25
Small Intestine 25
Large Intestine 25
BIOLOGICAL FUNCTION OF THE INTESTINES 26
INFLAMMATORY BOWEL DISEASE TYPES 26
Crohn's Disease 26
Epidemiology 26
Risk Factors 27
Symptoms 27
Classification 27
Physiology 27
Causes 27
Ulcerative Colitis 27
Epidemiology 27
Risk Factors 28
Symptoms 28
Classification 28
Severity 28
Other Inflammatory Bowel Disease Types 28
INFLAMMATORY BOWEL DISEASE DIAGNOSIS 29
Signs and Symptoms 29
Clinical Aspects of Inflammatory Bowel Disease 29
TABLE 14 CLINICAL ASPECTS OF INFLAMMATORY BOWEL DISEASE SUBTYPES 30
Clinical Conditions Associated with inflammatory Bowel Disease 30
Pyoderma Gangrenosum 30
Primary Sclerosing Cholangitis 31
Malnutrition, Limited Nutrient Absorption and Stunting 31
CLINICAL CALCULATION OF CROHN'S DISEASE ACTIVITY INDEX SCORE 31
TABLE 15 FACTORS FOR CALCULATING THE CROHN'S DISEASE ACTIVITY INDEX SCORE 32
CLINICAL CALCULATION OF HARVEY-BRADSHAW INDEX 33
TABLE 16 FACTORS FOR CALCULATING THE HARVEY-BRADSHAW INDEX 33
CLINICAL CALCULATION OF THE CROHN'S DISEASE ENDOSCOPIC INDEX SEVERITY 34
CALCULATION OF THE MAYO SCORE 34
TABLE 17 FACTORS FOR CALCULATING THE MAYO SCORE 34
INFLAMMATORY BOWEL DISEASE SEROLOGIES 35
TABLE 18 INFLAMMATORY BOWEL DISEASE SEROLOGIES TO INFORM CLINICAL
DIAGNOSES 35
CAUSES OF INFLAMMATORY BOWEL DISEASE 36
Genetics of Inflammatory Bowel Disease 36
TABLE 19 GENETIC LOCI IMPLICATED IN INFLAMMATORY BOWEL DISEASE 36
NOD2 37
NOD2 Mutations 37
Environmental Risk Factors for Inflammatory Bowel Disease 38
TABLE 20 ENVIRONMENTAL RISK FACTORS FOR INFLAMMATORY BOWEL DISEASE 38
Stress as a Risk Factor for Inflammatory Bowel Disease 39

CHAPTER 5 INFLAMMATORY BOWEL DISEASE PRODUCT SEGMENTS 41
TABLE 21 INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET SEGMENTATION 41
NON-BIOLOGIC DRUGS FOR INFLAMMATORY BOWEL DISEASE 41
TABLE 22 COMPETITOR ASSESSMENT OF THE MAJOR MARKETED INFLAMMATORY BOWEL
DISEASE THERAPEUTICS, 2012 41
TABLE 23 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
NON-BIOLOGIC DRUGS, THROUGH 2017 ($ MILLIONS) 42
TABLE 24 GLOBAL MARKET SHARES FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
NON-BIOLOGIC DRUGS, 2011 ($ MILLIONS/%) 43
ASACOL 43
PENTASA 44
ENTOCORT 44
LIALDA 45
SALOFALK 45
BIOLOGIC DRUGS FOR INFLAMMATORY BOWEL DISEASE 46
TABLE 25 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE BIOLOGIC DRUGS,
THROUGH 2017 ($ MILLIONS) 46
TABLE 26 GLOBAL MARKET SHARE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
BIOLOGIC DRUGS, 2011 ($ MILLIONS) 46
REMICADE 46
HUMIRA 47
CIMZIA 48
TYSABRI 48
GLOBAL MARKETS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS 49
TABLE 27 LEADING INTERNATIONAL MARKETS FOR INFLAMMATORY BOWEL DISEASE
THERAPEUTICS, THROUGH 2017 ($ MILLIONS) 49
GLOBAL MARKETS 49
U.S. 49
TABLE 28 U.S. MARKET FOR INFLAMMATORY BOWEL DISEASE DRUGS, THROUGH 2017 ($
MILLIONS) 50
Japan 50
TABLE 29 JAPANESE INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($
MILLIONS) 50
EU5 51
TABLE 30 EU5 INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($
MILLIONS) 51
Rest of the World 51
TABLE 31 REST OF THE WORLD INFLAMMATORY BOWEL DISEASE DRUG MARKET,
THROUGH 2017 ($ MILLIONS) 52
EMERGING THERAPIES FOR INFLAMMATORY BOWEL DISEASE 52
CROHN'S DISEASE 52
TABLE 32 THERAPEUTIC PIPELINE FOR CROHN'S DISEASE THERAPIES 52
TABLE 33 CLINICAL TRIAL RESULTS FOR EMERGING THERAPIES FOR CROHN'S DISEASE 53
TXCell 54
Centocor Ortho Biotech 54
Enzo 54
ChemoCentryx 55
Osiris Therapeutics 55
Schering 55
Protein Design Labs BioPharma 56
NPS Pharmaceuticals 56
ULCERATIVE COLITIS 56
TABLE 34 THERAPEUTIC PIPELINE FOR ULCERATIVE COLITIS THERAPIES 57
TABLE 35 CLINICAL TRIAL RESULTS FOR EMERGING ULCERATIVE COLITIS THERAPIES,
2007-2012 58
Millennium/Takeda 58
Lipid Therapeutics 58
Abbott 58
Santarus and Cosmo Pharmaceuticals 59
Hutchison Medipharma 59
SUMMARY OF PROMISING INFLAMMATORY BOWEL DISEASE DRUGS IN
DEVELOPMENT 60
Monoclonal Antibodies 60
HuZAF (fontolizumab): Biogen Idec 60
Stelara (Ustekinumab): Johnson and Johnson 61
Vedolizumab (MLN02): Takeda 61
Simponi (Golimumab): Johnson and Johnson 61
Small Molecules 61
Tetomilast: Otsuka 61
Firategrast: GlaxoSmithKline 62
Other Therapies 62
Alicaforsen: Isis Pharmaceuticals 62
Alequel: Enzo 62
Nicotine and Bupropion 63
Mycobacterium Avium Subspecies Paratuberculosis Vaccine 63
EMERGING TECHNOLOGIES FOR INFLAMMATORY BOWEL DISEASE 63

CHAPTER 6 INFLAMMATORY BOWEL DISEASE RESEARCH AND DEVELOPMENT 66
CLINICAL GUIDELINES FOR MANAGING INFLAMMATORY BOWEL DISEASE 66
RECOMMENDATIONS FOR INITIAL TREATMENT OF CROHN'S DISEASE 66
RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN CROHN'S DISEASE 66
RECOMMENDATIONS FOR INITIAL TREATMENT OF ULCERATIVE COLITIS 67
RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS 67
CURRENT THERAPIES FOR INFLAMMATORY BOWEL DISEASE 68
CROHN'S DISEASE TREATMENT 68
ULCERATIVE COLITIS TREATMENT 68
TABLE 36 THERAPIES FOR INFLAMMATORY BOWEL DISEASE 68
Anti-Diarrheals 69
TABLE 37 ANTI-DIARRHEAL THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69
Class Description and Mechanism of Action 69
Dosing 69
Efficacy 69
Antibiotics 69
TABLE 38 ANTIBIOTIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69
Class Description and Mechanism of Action 70
Dosing 70
Efficacy 70
Aminosalicylates 70
TABLE 39 AMINOSALICYLATE THERAPIES FOR INFLAMMATORY BOWEL DISEASE 70
Class Description and Mechanism of Action 70
Dosing 71
Efficacy 71
Corticosteroids 71
TABLE 40 CORTICOSTEROID THERAPIES FOR INFLAMMATORY BOWEL DISEASE 72
Class Description and Mechanism of Action 72
Dosing 72
Efficacy 73
Immunosuppressants 73
TABLE 41 IMMUNOSUPPRESSANT THERAPIES FOR INFLAMMATORY BOWEL DISEASE 73
Class Description and Mechanism of Action 73
Dosing 74
Biologics 74
TABLE 42 BIOLOGIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 75
Class Description and Mechanism of Action 75
Dosing 76
Efficacy 76
Clinical Trials for Inflammatory Bowel Disease Therapies 77
TABLE 43 OPEN CLINICAL TRIALS FOR CROHN'S DISEASE THERAPEUTICS BY LOCATION,
2012 (TRIALS) 77
TABLE 44 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION,
2012 (TRIALS) 78

CHAPTER 7 BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE 80
TABLE 45 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS FOR INFLAMMATORY BOWEL
DISEASE BIOMARKERS, 2002-2012 80
INFLAMMATORY BOWEL DISEASE BIOMARKERS 80
SERUM BIOMARKERS 81
C-Reactive Protein 81
C-Reactive Protein in the Diagnosis of Inflammatory Bowel Disease 82
C-Reactive Protein in the Evaluation of Inflammatory Bowel Disease 82
Antibodies and Auto-Antibodies 82
TABLE 46 SERUM INFLAMMATORY BOWEL DISEASE BIOMARKERS 83
FECAL BIOMARKERS 83
TABLE 47 FECAL INFLAMMATORY BOWEL DISEASE BIOMARKERS 84
EMERGING BIOMARKERS 84
TABLE 48 NOVEL INFLAMMATORY BOWEL DISEASE BIOMARKERS 85
Metabolomic Inflammatory Bowel Disease Biomarkers 85
Gene-Expression Inflammatory Bowel Disease Biomarkers 86

CHAPTER 8 PATENT LANDSCAPE 88
INFLAMMATORY BOWEL DISEASE DIAGNOSTICS AND THERAPEUTICS INDUSTRY 88
IMPORTANT CONCEPTS 88
Priority Dates 88
Patent Cooperation Treaty 88
International Classification Codes 89
METHODOLOGY 89
NOTABLE PATENTS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTIC
MARKET 89
TABLE 49 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE
DIAGNOSTICS SPACE 89
Prometheus Laboratories 90
TABLE 50 PUBLISHED PATENTS FOR PROMETHUES LABORATORIES IN INFLAMMATORY
BOWEL DISEASE, 2005-2012 90
Exagen Diagnostics 90
TABLE 51 PUBLISHED PATENTS FOR EXAGEN DIAGNOSTICS IN INFLAMMATORY BOWEL
DISEASE, 2005-2012 90
TABLE 52 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE
THERAPEUTICS SPACE 91
TABLE 53 PUBLISHED PATENTS FOR PFIZER IN INFLAMMATORY BOWEL DISEASE,
2005-2012 91
TABLE 54 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE,
2005-2012 92
TABLE 55 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE,
2005-2012 93

CHAPTER 9 COMPANY PROFILES 95
COMPANIES IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTICS SPACE 95
TABLE 56 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES 95
REVENUE PER EMPLOYEE 95
TABLE 57 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER
EMPLOYEE, 2011 96
EXAGEN LABORATORIES INC. 96
GENETIC ANALYSIS SA 97
GLYCOMINDS LTD. 98
INDEX PHARMACEUTICALS AB 98
PROMETHEUS LABORATORIES INC. 99
QUEST DIAGNOSTICS 100
SYNEXA LIFE SCIENCES 101
COMPANIES IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTICS SPACE 101
TABLE 58 INFLAMMATORY BOWEL DISEASE THERAPEUTIC COMPANIES 101
TABLE 59 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER
EMPLOYEE, 2011 102
ABBOTT LABORATORIES 103
ASTRAZENECA PLC 103
BIOGEN IDEC 104
FERRING PHARMACEUTICALS 105
HUTCHISON MEDIPHARM 105
IRONWOOD PHARMACEUTICALS 106
JANSSEN BIOTECH INC 106
KYORIN PHARMACEUTICAL 107
MILLENNIUM PHARMACEUTICALS 107
MYLAN INC. 108
NEOVACS AG 109
NOVARTIS AG 110
OSIRIS THERAPEUTICS 110
PFIZER 111
SHIRE PHARMACEUTICALS 112
UNION CHIMIQUE BELGE, S.A. 112
WARNER CHILCOTT 113
MERGERS AND ACQUISITIONS: DIAGNOSTICS 113
TABLE 60 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL
DISEASE DIAGNOSTIC MARKET, 2008-2012 113
TABLE 61 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL
DISEASE DIAGNOSTIC MARKET, 2004-2012 ($ MILLIONS) 114
TABLE 62 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE
DIAGNOSTIC MARKET, 2008-2012 115
MERGERS AND ACQUISITIONS: THERAPEUTICS 115
TABLE 63 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL
DISEASE THERAPEUTIC MARKET, 2008-2012 115
TABLE 64 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL
DISEASE THERAPEUTIC MARKET, 2008-2012 ($ MILLIONS) 116
TABLE 65 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE
THERAPEUTIC MARKET, 2008-2012 116

CHAPTER 10 MARKET FACTORS 118
STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS 118
TABLE 66 STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS FOR THE
GLOBAL INFLAMMATORY BOWEL DISEASE MARKET 118
MARKET FACTORS 118
Market Drivers 119
Increasing Disease Incidence 119
Chronic Nature of the Disease 119
Increased Diagnostic Sensitivity 119
Novel Therapeutics 119
Market Restrictors 120
Cure for Inflammatory Bowel Disease 120
Murky Disease Etiology 120
Limitations of Novel Therapies 120

CHAPTER 11 APPENDIX DEFINITIONS 122
ANTIBODY 122
AUTOIMMUNE DISEASE 122
BIOLOGIC THERAPY 122
BOWEL 122
COMPANION DIAGNOSTIC 122
CLINICAL LABORATORY IMPROVEMENT AMENDMENT 123
CROHN'S DISEASE 123
CURRENT PROCEDURAL TERMINOLOGY 123
DIAGNOSTIC SENSITIVITY 123
DIAGNOSTIC SPECIFICITY 123
ILEUM 123
INCIDENCE 123
INFLAMMATORY BOWEL DISEASE 124
MICROBIOTA AND MICROBIOME 124
NUCLEOTIDE 124
PREVALENCE 124
SEROLOGY 124
SINGLE-NUCLEOTIDE POLYMORPHISM 124
TUMOR NECROSIS FACTOR ALPHA 124
ULCERATIVE COLITIS 125



LIST OF TABLES

SUMMARY TABLE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET,
THROUGH 2017 ($ MILLIONS) 5
TABLE 1 GLOBAL INCIDENCE RANGES FOR CROHN'S DISEASE AND ULCERATIVE COLITIS
(PER 100,000) 9
TABLE 2 GLOBAL PREVALENCE OF CROHN'S DISEASE AND ULCERATIVE COLITIS 10
TABLE 3 GLOBAL INCIDENCE FOR CROHN'S DISEASE 11
TABLE 4 GLOBAL PREVALENCE FOR CROHN'S DISEASE 12
TABLE 5 GLOBAL INCIDENCE FOR ULCERATIVE COLITIS 13
TABLE 6 GLOBAL PREVALENCE FOR ULCERATIVE COLITIS 14
TABLE 7 THERAPEUTIC OPTIONS FOR INFLAMMATORY BOWEL DISEASE 15
TABLE 8 DIAGNOSTIC BIOMARKER EXAMPLES 19
TABLE 9 PREDICTIVE BIOMARKER EXAMPLES 20
TABLE 10 BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE 21
TABLE 11 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS REGARDING INFLAMMATORY
BOWEL DISEASE BIOMARKERS, 2002-2012 21
TABLE 12 OPEN CLINICAL TRIALS FOR CROHN'S DISEASE THERAPEUTICS BY LOCATION,
2012 (NUMBER OF TRIALS) 22
TABLE 13 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION,
2012 (NUMBER OF TRIALS) 23
TABLE 14 CLINICAL ASPECTS OF INFLAMMATORY BOWEL DISEASE SUBTYPES 30
TABLE 15 FACTORS FOR CALCULATING THE CROHN'S DISEASE ACTIVITY INDEX SCORE 32
TABLE 16 FACTORS FOR CALCULATING THE HARVEY-BRADSHAW INDEX 33
TABLE 17 FACTORS FOR CALCULATING THE MAYO SCORE 34
TABLE 18 INFLAMMATORY BOWEL DISEASE SEROLOGIES TO INFORM CLINICAL DIAGNOSES 35
TABLE 19 GENETIC LOCI IMPLICATED IN INFLAMMATORY BOWEL DISEASE 36
TABLE 20 ENVIRONMENTAL RISK FACTORS FOR INFLAMMATORY BOWEL DISEASE 38
TABLE 21 INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET SEGMENTATION 41
TABLE 22 COMPETITOR ASSESSMENT OF THE MAJOR MARKETED INFLAMMATORY BOWEL
DISEASE THERAPEUTICS, 2012 41
TABLE 23 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
NON-BIOLOGIC DRUGS, THROUGH 2017 ($ MILLIONS) 42
TABLE 24 GLOBAL MARKET SHARES FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
NON-BIOLOGIC DRUGS, 2011 ($ MILLIONS/%) 43
TABLE 25 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE BIOLOGIC DRUGS,
THROUGH 2017 ($ MILLIONS) 46
TABLE 26 GLOBAL MARKET SHARE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC
BIOLOGIC DRUGS, 2011 ($ MILLIONS) 46
TABLE 27 LEADING INTERNATIONAL MARKETS FOR INFLAMMATORY BOWEL DISEASE
THERAPEUTICS, THROUGH 2017 ($ MILLIONS) 49
TABLE 28 U.S. MARKET FOR INFLAMMATORY BOWEL DISEASE DRUGS, THROUGH 2017 ($
MILLIONS) 50
TABLE 29 JAPANESE INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($
MILLIONS) 50
TABLE 30 EU5 INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($
MILLIONS) 51
TABLE 31 REST OF THE WORLD INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH
2017 ($ MILLIONS) 52
TABLE 32 THERAPEUTIC PIPELINE FOR CROHN'S DISEASE THERAPIES 52
TABLE 33 CLINICAL TRIAL RESULTS FOR EMERGING THERAPIES FOR CROHN'S DISEASE 53
TABLE 34 THERAPEUTIC PIPELINE FOR ULCERATIVE COLITIS THERAPIES 57
TABLE 35 CLINICAL TRIAL RESULTS FOR EMERGING ULCERATIVE COLITIS THERAPIES,
2007-2012 58
TABLE 36 THERAPIES FOR INFLAMMATORY BOWEL DISEASE 68
TABLE 37 ANTI-DIARRHEAL THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69
TABLE 38 ANTIBIOTIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69
TABLE 39 AMINOSALICYLATE THERAPIES FOR INFLAMMATORY BOWEL DISEASE 70
TABLE 40 CORTICOSTEROID THERAPIES FOR INFLAMMATORY BOWEL DISEASE 72
TABLE 41 IMMUNOSUPPRESSANT THERAPIES FOR INFLAMMATORY BOWEL DISEASE 73
TABLE 42 BIOLOGIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 75
TABLE 43 OPEN CLINICAL TRIALS FOR CROHN'S DISEASE THERAPEUTICS BY LOCATION,
2012 (TRIALS) 77
TABLE 44 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION,
2012 (TRIALS) 78
TABLE 45 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS FOR INFLAMMATORY BOWEL
DISEASE BIOMARKERS, 2002-2012 80
TABLE 46 SERUM INFLAMMATORY BOWEL DISEASE BIOMARKERS 83
TABLE 47 FECAL INFLAMMATORY BOWEL DISEASE BIOMARKERS 84
TABLE 48 NOVEL INFLAMMATORY BOWEL DISEASE BIOMARKERS 85
TABLE 49 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTICS
SPACE 89
TABLE 50 PUBLISHED PATENTS FOR PROMETHUES LABORATORIES IN INFLAMMATORY
BOWEL DISEASE, 2005-2012 90
TABLE 51 PUBLISHED PATENTS FOR EXAGEN DIAGNOSTICS IN INFLAMMATORY BOWEL
DISEASE, 2005-2012 90
TABLE 52 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE
THERAPEUTICS SPACE 91
TABLE 53 PUBLISHED PATENTS FOR PFIZER IN INFLAMMATORY BOWEL DISEASE,
2005-2012 91
TABLE 54 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE,
2005-2012 92
TABLE 55 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE,
2005-2012 93
TABLE 56 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES 95
TABLE 57 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER
EMPLOYEE, 2011 96
TABLE 58 INFLAMMATORY BOWEL DISEASE THERAPEUTIC COMPANIES 101
TABLE 59 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER
EMPLOYEE, 2011 102
TABLE 60 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL
DISEASE DIAGNOSTIC MARKET, 2008-2012 113
TABLE 61 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL DISEASE
DIAGNOSTIC MARKET, 2004-2012 ($ MILLIONS) 114
TABLE 62 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE
DIAGNOSTIC MARKET, 2008-2012 115
TABLE 63 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL
DISEASE THERAPEUTIC MARKET, 2008-2012 115
TABLE 64 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL DISEASE
THERAPEUTIC MARKET, 2008-2012 ($ MILLIONS) 116
TABLE 65 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE
THERAPEUTIC MARKET, 2008-2012 116
TABLE 66 STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS FOR THE GLOBAL
INFLAMMATORY BOWEL DISEASE MARKET 118



LIST OF FIGURES

SUMMARY FIGURE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, BY
REGION, 2010-2017 ($ MILLIONS) 5

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