Therapies and Biomarkers for Inflammatory Bowel Disease


January 1, 2013
140 Pages - SKU: WA4938430
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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.


Additional Information

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.
CHAPTER 1 INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED REPORTS
BCC ON-LINE SERVICES
DISCLAIMER
CHAPTER 2 SUMMARY
SUMMARY TABLE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, THROUGH 2017 ($ MILLIONS)
SUMMARY FIGURE GLOBAL INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, BY REGION, 2010-2017 ($ MILLIONS)
CHAPTER 3 OVERVIEW
INFLAMMATORY BOWEL DISEASE
DEFINITION OF INFLAMMATORY BOWEL DISEASE
Crohn's Disease
Ulcerative Colitis
EPIDEMIOLOGY OF INFLAMMATORY BOWEL DISEASE
Incidence and Prevalence of Inflammatory Bowel Disease
TABLE 1 GLOBAL INCIDENCE RANGES FOR CROHN’S DISEASE AND ULCERATIVE COLITIS (PER 100,000)
TABLE 2 GLOBAL PREVALENCE OF CROHN’S DISEASE AND ULCERATIVE COLITIS
TABLE 3 GLOBAL INCIDENCE FOR CROHN’S DISEASE
TABLE 4 GLOBAL PREVALENCE FOR CROHN’S DISEASE
TABLE 5 GLOBAL INCIDENCE FOR ULCERATIVE COLITIS
TABLE 6 GLOBAL PREVALENCE FOR ULCERATIVE COLITIS
CURRENT TREATMENTS FOR INFLAMMATORY BOWEL DISEASE
TABLE 7 THERAPEUTIC OPTIONS FOR INFLAMMATORY BOWEL DISEASE
Symptom Management
Inflammation Reduction
Surgery
Surgery for Ulcerative Colitis
Surgery for Crohn's Disease
Alternative Therapies
Fecal Bacteriotherapy
Pre- and Probiotic Supplementation
Helminth Therapy
BIOMARKER DEFINITION
Biomarkers Types
Diagnostic Biomarkers
TABLE 8 DIAGNOSTIC BIOMARKER EXAMPLES
Prognostic Biomarkers
Predictive Biomarkers
TABLE 9 PREDICTIVE BIOMARKER EXAMPLES
Target-Engagement Biomarkers
Biomarkers for Inflammatory Bowel Disease
TABLE 10 BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE
TABLE 11 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS REGARDING INFLAMMATORY
BOWEL DISEASE BIOMARKERS, 2002-2012
TABLE 12 OPEN CLINICAL TRIALS FOR CROHN’S DISEASE THERAPEUTICS BY LOCATION, 2012 (NUMBER OF TRIALS)
TABLE 13 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION, 2012 (NUMBER OF TRIALS)
CHAPTER 4 INFLAMMATORY BOWEL DISEASE PHYSIOLOGY
OVERVIEW
ANATOMY OF THE INTESTINES
Small Intestine
Large Intestine
BIOLOGICAL FUNCTION OF THE INTESTINES
INFLAMMATORY BOWEL DISEASE TYPES
Crohn's Disease
Epidemiology
Risk Factors
Symptoms
Classification
Physiology
Causes
Ulcerative Colitis
Epidemiology
Risk Factors
Symptoms
Classification
Severity
Other Inflammatory Bowel Disease Types
INFLAMMATORY BOWEL DISEASE DIAGNOSIS
Signs and Symptoms
Clinical Aspects of Inflammatory Bowel Disease
TABLE 14 CLINICAL ASPECTS OF INFLAMMATORY BOWEL DISEASE SUBTYPES
Clinical Conditions Associated with inflammatory Bowel Disease
Pyoderma Gangrenosum
Primary Sclerosing Cholangitis
Malnutrition, Limited Nutrient Absorption and Stunting
CLINICAL CALCULATION OF CROHN'S DISEASE ACTIVITY INDEX SCORE
TABLE 15 FACTORS FOR CALCULATING THE CROHN’S DISEASE ACTIVITY INDEX SCORE
CLINICAL CALCULATION OF HARVEY-BRADSHAW INDEX
TABLE 16 FACTORS FOR CALCULATING THE HARVEY–BRADSHAW INDEX
CLINICAL CALCULATION OF THE CROHN'S DISEASE ENDOSCOPIC INDEX SEVERITY
CALCULATION OF THE MAYO SCORE
TABLE 17 FACTORS FOR CALCULATING THE MAYO SCORE
INFLAMMATORY BOWEL DISEASE SEROLOGIES
TABLE 18 INFLAMMATORY BOWEL DISEASE SEROLOGIES TO INFORM CLINICAL
DIAGNOSES
CAUSES OF INFLAMMATORY BOWEL DISEASE
Genetics of Inflammatory Bowel Disease
TABLE 19 GENETIC LOCI IMPLICATED IN INFLAMMATORY BOWEL DISEASE
NOD2
NOD2 Mutations
Environmental Risk Factors for Inflammatory Bowel Disease
TABLE 20 ENVIRONMENTAL RISK FACTORS FOR INFLAMMATORY BOWEL DISEASE
Stress as a Risk Factor for Inflammatory Bowel Disease
CHAPTER 5 INFLAMMATORY BOWEL DISEASE PRODUCT SEGMENTS
TABLE 21 INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET SEGMENTATION NON-BIOLOGIC DRUGS FOR INFLAMMATORY BOWEL DISEASE
TABLE 22 COMPETITOR ASSESSMENT OF THE MAJOR MARKETED INFLAMMATORY BOWEL DISEASE THERAPEUTICS, 2012
TABLE 23 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC NON-BIOLOGIC DRUGS, THROUGH 2017 ($ MILLIONS)
TABLE 24 GLOBAL MARKET SHARES FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC NON-BIOLOGIC DRUGS, 2011 ($ MILLIONS/%)
ASACOL
PENTASA
ENTOCORT
LIALDA
SALOFALK
BIOLOGIC DRUGS FOR INFLAMMATORY BOWEL DISEASE
TABLE 25 GLOBAL REVENUE FOR INFLAMMATORY BOWEL DISEASE BIOLOGIC DRUGS, THROUGH 2017 ($ MILLIONS)
TABLE 26 GLOBAL MARKET SHARE FOR INFLAMMATORY BOWEL DISEASE-SPECIFIC BIOLOGIC DRUGS, 2011 ($ MILLIONS)
REMICADE
HUMIRA
CIMZIA
TYSABRI
GLOBAL MARKETS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS
TABLE 27 LEADING INTERNATIONAL MARKETS FOR INFLAMMATORY BOWEL DISEASE THERAPEUTICS, THROUGH 2017 ($ MILLIONS)
GLOBAL MARKETS
U.S.
TABLE 28 U.S. MARKET FOR INFLAMMATORY BOWEL DISEASE DRUGS, THROUGH 2017 ($ MILLIONS)
Japan
TABLE 29 JAPANESE INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($ MILLIONS)
EU5
TABLE 30 EU5 INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($ MILLIONS)
Rest of the World
TABLE 31 REST OF THE WORLD INFLAMMATORY BOWEL DISEASE DRUG MARKET, THROUGH 2017 ($ MILLIONS)
EMERGING THERAPIES FOR INFLAMMATORY BOWEL DISEASE
CROHN'S DISEASE
TABLE 32 THERAPEUTIC PIPELINE FOR CROHN’S DISEASE THERAPIES
TABLE 33 CLINICAL TRIAL RESULTS FOR EMERGING THERAPIES FOR CROHN’S DISEASE
TXCell
Centocor Ortho Biotech
Enzo
ChemoCentryx
Osiris Therapeutics
Schering
Protein Design Labs BioPharma
NPS Pharmaceuticals
ULCERATIVE COLITIS
TABLE 34 THERAPEUTIC PIPELINE FOR ULCERATIVE COLITIS THERAPIES
TABLE 35 CLINICAL TRIAL RESULTS FOR EMERGING ULCERATIVE COLITIS THERAPIES, 2007-2012
Millennium/Takeda
Lipid Therapeutics
Abbott
Santarus and Cosmo Pharmaceuticals
Hutchison Medipharma
SUMMARY OF PROMISING INFLAMMATORY BOWEL DISEASE DRUGS IN
DEVELOPMENT
Monoclonal Antibodies
HuZAF (fontolizumab): Biogen Idec
Stelara (Ustekinumab): Johnson and Johnson
Vedolizumab (MLN02): Takeda
Simponi (Golimumab): Johnson and Johnson
Small Molecules
Tetomilast: Otsuka
Firategrast: GlaxoSmithKline
Other Therapies
Alicaforsen: Isis Pharmaceuticals
Alequel: Enzo
Nicotine and Bupropion
Mycobacterium Avium Subspecies Paratuberculosis Vaccine
EMERGING TECHNOLOGIES FOR INFLAMMATORY BOWEL DISEASE
CHAPTER 6 INFLAMMATORY BOWEL DISEASE RESEARCH AND DEVELOPMENT
CLINICAL GUIDELINES FOR MANAGING INFLAMMATORY BOWEL DISEASE
RECOMMENDATIONS FOR INITIAL TREATMENT OF CROHN'S DISEASE
RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN CROHN'S DISEASE
RECOMMENDATIONS FOR INITIAL TREATMENT OF ULCERATIVE COLITIS
RECOMMENDATIONS FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS
CURRENT THERAPIES FOR INFLAMMATORY BOWEL DISEASE
CROHN'S DISEASE TREATMENT
ULCERATIVE COLITIS TREATMENT
TABLE 36 THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Anti-Diarrheals
TABLE 37 ANTI-DIARRHEAL THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Efficacy
Antibiotics
TABLE 38 ANTIBIOTIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Efficacy
Aminosalicylates
TABLE 39 AMINOSALICYLATE THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Efficacy
Corticosteroids
TABLE 40 CORTICOSTEROID THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Efficacy
Immunosuppressants
TABLE 41 IMMUNOSUPPRESSANT THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Biologics
TABLE 42 BIOLOGIC THERAPIES FOR INFLAMMATORY BOWEL DISEASE
Class Description and Mechanism of Action
Dosing
Efficacy
Clinical Trials for Inflammatory Bowel Disease Therapies
TABLE 43 OPEN CLINICAL TRIALS FOR CROHN’S DISEASE THERAPEUTICS BY LOCATION, 2012 (TRIALS)
TABLE 44 OPEN CLINICAL TRIALS FOR ULCERATIVE COLITIS THERAPEUTICS BY LOCATION, 2012 (TRIALS)
CHAPTER 7 BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE
TABLE 45 PUBMED-INDEXED SCIENTIFIC PUBLICATIONS FOR INFLAMMATORY BOWEL DISEASE BIOMARKERS, 2002-2012
INFLAMMATORY BOWEL DISEASE BIOMARKERS
SERUM BIOMARKERS
C-Reactive Protein
C-Reactive Protein in the Diagnosis of Inflammatory Bowel Disease
C-Reactive Protein in the Evaluation of Inflammatory Bowel Disease
Antibodies and Auto-Antibodies
TABLE 46 SERUM INFLAMMATORY BOWEL DISEASE BIOMARKERS
FECAL BIOMARKERS
TABLE 47 FECAL INFLAMMATORY BOWEL DISEASE BIOMARKERS
EMERGING BIOMARKERS
TABLE 48 NOVEL INFLAMMATORY BOWEL DISEASE BIOMARKERS
Metabolomic Inflammatory Bowel Disease Biomarkers
Gene-Expression Inflammatory Bowel Disease Biomarkers
CHAPTER 8 PATENT LANDSCAPE
INFLAMMATORY BOWEL DISEASE DIAGNOSTICS AND THERAPEUTICS INDUSTRY
IMPORTANT CONCEPTS
Priority Dates
Patent Cooperation Treaty
International Classification Codes
METHODOLOGY
NOTABLE PATENTS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTIC
MARKET
TABLE 49 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTICS SPACE
Prometheus Laboratories
TABLE 50 PUBLISHED PATENTS FOR PROMETHUES LABORATORIES IN INFLAMMATORY BOWEL DISEASE, 2005–2012
Exagen Diagnostics
TABLE 51 PUBLISHED PATENTS FOR EXAGEN DIAGNOSTICS IN INFLAMMATORY BOWEL DISEASE, 2005–2012
TABLE 52 MAJOR PATENT HOLDERS IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTICS SPACE
TABLE 53 PUBLISHED PATENTS FOR PFIZER IN INFLAMMATORY BOWEL DISEASE, 2005–2012
TABLE 54 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE, 2005–2012
TABLE 55 PUBLISHED PATENTS FOR NOVARTIS IN INFLAMMATORY BOWEL DISEASE, 2005–2012
CHAPTER 9 COMPANY PROFILES
COMPANIES IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTICS SPACE
TABLE 56 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES
REVENUE PER EMPLOYEE
TABLE 57 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER EMPLOYEE, 2011
EXAGEN LABORATORIES INC.
GENETIC ANALYSIS SA
GLYCOMINDS LTD.
INDEX PHARMACEUTICALS AB
PROMETHEUS LABORATORIES INC.
QUEST DIAGNOSTICS
SYNEXA LIFE SCIENCES
COMPANIES IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTICS SPACE
TABLE 58 INFLAMMATORY BOWEL DISEASE THERAPEUTIC COMPANIES
TABLE 59 INFLAMMATORY BOWEL DISEASE DIAGNOSTIC COMPANIES BY REVENUE PER EMPLOYEE, 2011
ABBOTT LABORATORIES
ASTRAZENECA PLC
BIOGEN IDEC
FERRING PHARMACEUTICALS
HUTCHISON MEDIPHARM
IRONWOOD PHARMACEUTICALS
JANSSEN BIOTECH INC
KYORIN PHARMACEUTICAL
MILLENNIUM PHARMACEUTICALS
MYLAN INC.
NEOVACS AG
NOVARTIS AG
OSIRIS THERAPEUTICS
PFIZER
SHIRE PHARMACEUTICALS
UNION CHIMIQUE BELGE, S.A.
WARNER CHILCOTT
MERGERS AND ACQUISITIONS: DIAGNOSTICS
TABLE 60 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTIC MARKET, 2008–2012
TABLE 61 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTIC MARKET, 2004–2012 ($ MILLIONS)
TABLE 62 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE DIAGNOSTIC MARKET, 2008–2012
MERGERS AND ACQUISITIONS: THERAPEUTICS
TABLE 63 SIGNIFICANT MERGERS AND ACQUISITIONS IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, 2008–2012
TABLE 64 SIGNIFICANT VENTURE-CAPITAL DEALS IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, 2008–2012 ($ MILLIONS)
TABLE 65 SIGNIFICANT STRATEGIC ALLIANCES IN THE INFLAMMATORY BOWEL DISEASE THERAPEUTIC MARKET, 2008-2012
CHAPTER 10 MARKET FACTORS
STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS
TABLE 66 STRENGTH, WEAKNESS, OPPORTUNITY AND THREAT ANALYSIS FOR THE GLOBAL INFLAMMATORY BOWEL DISEASE MARKET
MARKET FACTORS
Market Drivers
Increasing Disease Incidence
Chronic Nature of the Disease
Increased Diagnostic Sensitivity
Novel Therapeutics
Market Restrictors
Cure for Inflammatory Bowel Disease
Murky Disease Etiology
Limitations of Novel Therapies
CHAPTER 11 APPENDIX DEFINITIONS
ANTIBODY
AUTOIMMUNE DISEASE
BIOLOGIC THERAPY
BOWEL
COMPANION DIAGNOSTIC
CLINICAL LABORATORY IMPROVEMENT AMENDMENT
CROHN'S DISEASE
CURRENT PROCEDURAL TERMINOLOGY
DIAGNOSTIC SENSITIVITY
DIAGNOSTIC SPECIFICITY
ILEUM
INCIDENCE
INFLAMMATORY BOWEL DISEASE
MICROBIOTA AND MICROBIOME
NUCLEOTIDE
PREVALENCE
SEROLOGY
SINGLE-NUCLEOTIDE POLYMORPHISM
TUMOR NECROSIS FACTOR ALPHA
ULCERATIVE COLITIS

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