Therapies and Biomarkers for Inflammatory Bowel DiseaseBCC ResearchJanuary 1, 2013 140 Pages - SKU: WA4938430 |
Additional Information
INTRODUCTIONSTUDY 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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