Therapies and Biomarkers for Inflammatory Bowel Disease

Jan 08, 2013, 08:49 ET from Reportlinker

NEW YORK, Jan. 8, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Therapies and Biomarkers for Inflammatory Bowel Disease

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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 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 5SUMMARY TABLE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET,THROUGH 2017 ($ MILLIONS) 5SUMMARY FIGURE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, BYREGION, 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 25OVERVIEW 25ANATOMY OF THE INTESTINES 25Small Intestine 25Large Intestine 25BIOLOGICAL FUNCTION OF THE INTESTINES 26INFLAMMATORY BOWEL DISEASE TYPES 26Crohn's Disease 26Epidemiology 26Risk Factors 27Symptoms 27Classification 27Physiology 27Causes 27Ulcerative Colitis 27Epidemiology 27Risk Factors 28Symptoms 28Classification 28Severity 28Other Inflammatory Bowel Disease Types 28INFLAMMATORY BOWEL DISEASE DIAGNOSIS 29Signs and Symptoms 29Clinical Aspects of Inflammatory Bowel Disease 29TABLE 14 CLINICAL ASPECTS OF INFLAMMATORY BOWEL DISEASE SUBTYPES 30Clinical Conditions Associated with inflammatory Bowel Disease 30Pyoderma Gangrenosum 30Primary Sclerosing Cholangitis 31Malnutrition, Limited Nutrient Absorption and Stunting 31CLINICAL CALCULATION OF CROHN'S DISEASE ACTIVITY INDEX SCORE 31TABLE 15 FACTORS FOR CALCULATING THE CROHN'S DISEASE ACTIVITY INDEX SCORE 32CLINICAL CALCULATION OF HARVEY-BRADSHAW INDEX 33TABLE 16 FACTORS FOR CALCULATING THE HARVEY–BRADSHAW INDEX 33CLINICAL CALCULATION OF THE CROHN'S DISEASE ENDOSCOPIC INDEX SEVERITY 34CALCULATION OF THE MAYO SCORE 34TABLE 17 FACTORS FOR CALCULATING THE MAYO SCORE 34INFLAMMATORY BOWEL DISEASE SEROLOGIES 35TABLE 18 INFLAMMATORY BOWEL DISEASE SEROLOGIES TO INFORM CLINICALDIAGNOSES 35CAUSES OF INFLAMMATORY BOWEL DISEASE 36Genetics of Inflammatory Bowel Disease 36TABLE 19 GENETIC LOCI IMPLICATED IN INFLAMMATORY BOWEL DISEASE 36NOD2 37NOD2 Mutations 37Environmental Risk Factors for Inflammatory Bowel Disease 38TABLE 20 ENVIRONMENTAL RISK FACTORS FOR INFLAMMATORY BOWEL DISEASE 38Stress 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 66CLINICAL GUIDELINES FOR MANAGING INFLAMMATORY BOWEL DISEASE 66RECOMMENDATIONS FOR INITIAL TREATMENT OF CROHN'S DISEASE 66RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN CROHN'S DISEASE 66RECOMMENDATIONS FOR INITIAL TREATMENT OF ULCERATIVE COLITIS 67RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS 67CURRENT THERAPIES FOR INFLAMMATORY BOWEL DISEASE 68CROHN'S DISEASE TREATMENT 68ULCERATIVE COLITIS TREATMENT 68TABLE 36 THERAPIES FOR INFLAMMATORY BOWEL DISEASE 68Anti-Diarrheals 69TABLE 37 ANTI-DIARRHEAL THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69Class Description and Mechanism of Action 69Dosing 69Efficacy 69Antibiotics 69TABLE 38 ANTIBIOTIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 69Class Description and Mechanism of Action 70Dosing 70Efficacy 70Aminosalicylates 70TABLE 39 AMINOSALICYLATE THERAPIES FOR INFLAMMATORY BOWEL DISEASE 70Class Description and Mechanism of Action 70Dosing 71Efficacy 71Corticosteroids 71TABLE 40 CORTICOSTEROID THERAPIES FOR INFLAMMATORY BOWEL DISEASE 72Class Description and Mechanism of Action 72Dosing 72Efficacy 73Immunosuppressants 73TABLE 41 IMMUNOSUPPRESSANT THERAPIES FOR INFLAMMATORY BOWEL DISEASE 73Class Description and Mechanism of Action 73Dosing 74Biologics 74TABLE 42 BIOLOGIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE 75Class Description and Mechanism of Action 75Dosing 76Efficacy 76Clinical Trials for Inflammatory Bowel Disease Therapies 77TABLE 43 OPEN CLINICAL TRIALS FOR CROHN'S DISEASE THERAPEUTICS BY LOCATION,2012 (TRIALS) 77TABLE 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 88INFLAMMATORY BOWEL DISEASE DIAGNOSTICS AND THERAPEUTICS INDUSTRY 88IMPORTANT CONCEPTS 88Priority Dates 88Patent Cooperation Treaty 88International Classification Codes 89METHODOLOGY 89NOTABLE PATENTS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTICMARKET 89TABLE 49 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASEDIAGNOSTICS SPACE 89Prometheus Laboratories 90TABLE 50 PUBLISHED PATENTS FOR PROMETHUES LABORATORIES IN INFLAMMATORYBOWEL DISEASE, 2005–2012 90Exagen Diagnostics 90TABLE 51 PUBLISHED PATENTS FOR EXAGEN DIAGNOSTICS IN INFLAMMATORY BOWELDISEASE, 2005–2012 90TABLE 52 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASETHERAPEUTICS SPACE 91TABLE 53 PUBLISHED PATENTS FOR PFIZER IN INFLAMMATORY BOWEL DISEASE,2005–2012 91TABLE 54 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE,2005–2012 92TABLE 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 118STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS 118TABLE 66 STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS FOR THEGLOBAL INFLAMMATORY BOWEL DISEASE MARKET 118MARKET FACTORS 118Market Drivers 119Increasing Disease Incidence 119Chronic Nature of the Disease 119Increased Diagnostic Sensitivity 119Novel Therapeutics 119Market Restrictors 120Cure for Inflammatory Bowel Disease 120Murky Disease Etiology 120Limitations 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

To order this report:Pathology Industry: Therapies and Biomarkers for Inflammatory Bowel Disease

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