Osteoarthritis (OA): Opportunity Assessments, Epidemiology Forecast, Market Dynamics, Pipeline Analysis, H2 2018

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Osteoarthritis (OA): Opportunity Assessments, Epidemiology Forecast, Market Dynamics, Pipeline Analysis, H2 2018

  • 227 Pages | 11-Jan-19 | Format:PDF | Last Updated: 11-Jan-19
  • GervanoRA’s pipeline analysis and opportunity assessment report “Osteoarthritis (OA): Opportunity Assessments, Epidemiology Forecast, Market Dynamics, Pipeline Analysis, H2 2018” analyzed and assessed Osteoarthritis (OA) pipeline molecules for the opportunities in the competitive space by covering all the pipeline molecules in different stages of development and all the companies which are actively involved in Osteoarthritis (OA) industry. To provide systematic pipeline analytics, we have segregated total pipeline molecules into different segments like Pipeline Molecules by Geography, Pipeline Molecules by Drug Class, Pipeline Molecules by Mechanism of Action and Pipeline Molecules by Stage of development. Report is more focused to provide competitive opportunities by assessing and providing in-depth analytics on
    • Unmet needs and Opportunities
    • Epidemiology and Epidemiology forecast 2018 – 2025
    • Market Dynamics with Coverage of Deals (Mergers, Acquisitions, Partnering, Collaborations etc.)
    • Patent Analysis of Pipeline Molecules
    • Pipeline Analysis and Estimated Pipeline Drug Approval Time lines
    • Clinical Trials Summary
    • Current and Future Competitive Landscape
    • Key Company Profiles with SWOT Analysis
    • Emerging Company Profiles with Opportunity Assessments
    • Pipeline Drug Descriptions along with Development milestones (Past and Future)
    Report helps clients to refine the commercial opportunities from the existing treatment armamentarium to pipeline assets, deals, and deal comparables. Even it helps in identifying the most relevant actors in the field for partnering deals.

  • TABLE OF CONTENTS
    1. INTRODUCTION
    1.1. REPORT DESCRIPTION
    1.2. METHODOLOGY
    1.3. UPCOMING AND OTHER AVAILABLE PIPELINE ANALYSIS REPORTS
    1.4. ABOUT US: GERVANORA DATA SERVICES
    2. EXECUTIVE SUMMARY
    2.1. REPORT MAJOR FINDINGS
    2.2. KEY EVENTS IN OSTEOARTHRITIS COMPETITIVE SPACE
    3. DISEASE OVERVIEW
    3.1. DISEASE DEFINITION AND SYMPTOMS
    3.2. DISEASE CAUSE AND CLASSIFICATION
    3.3. DISEASE DIAGNOSIS
    3.4. TREATMENT ALGORITHM & GUIDELINES
    3.5. EPIDEMIOLOGY AND DISEASE BURDEN
    3.6. EPIDEMIOLOGY FORECAST
    3.6.1. FORECAST METHODOLOGY AND ASSUMPTION
    3.6.2. PROBABILISTIC EPIDEMIOLOGY FORECAST
    4. MARKET OVERVIEW
    4.1. DEALS (MERGERS/ ACQUISITIONS / COLLABORATIONS)
    4.2. NEW PRODUCT APPROVAL IN THE US (FDA) SINCE 2000
    4.3. NEW PRODUCT APPROVAL INTERNATIONAL (EX. US) SINCE 2010
    4.4. PATENT ANALYSIS (EXPIRES AND GENERICIZATION)
    5. PIPELINE ANALYSIS
    5.1. PIPELINE ANALYSIS BY STAGE OF DEVELOPMENT
    5.1.1. PHASE 3 MOLECULES
    5.1.2. PHASE 2 MOLECULES
    5.1.3. PHASE 1 MOLECULES
    5.1.4. PRECLINICAL MOLECULES
    5.1.5. EARLY R&D (DISCOVERY) MOLECULES
    5.1.6. TERMINATED AND INACTIVE MOLECULES
    5.2. PIPELINE ANALYSIS BY GEOGRAPHY
    5.2.1. UNMET NEEDS AND OPPORTUNITIES
    5.3. PIPELINE ANALYSIS BY ROUTE OF ADMINISTRATION
    5.3.1. UNMET NEEDS AND OPPORTUNITIES
    5.4. PIPELINE ANALYSIS BY DRUG CLASS
    5.4.1. UNMET NEEDS AND OPPORTUNITIES
    5.5. PIPELINE ANALYSIS BY MECHANISM OF ACTION
    5.5.1. UNMET NEEDS AND OPPORTUNITIES
    6. ESTIMATED DRUG APPROVAL TIMELINES
    6.1. METHODOLOGY
    6.1.1. ESTIMATED APPROVAL TIMELINES US & EX-US
    7. OSTEOARTHRITIS CLINICAL TRIALS SUMMARY
    7.1. OSTEOARTHRITIS PIPELINE ANALYSIS BY CLINICAL TRIAL RESULTS
    7.1.1. KEY PHASE III RESULTS
    7.1.2. KEY PHASE II RESULTS
    7.2. ONGOING CLINICAL TRIALS SUMMARY
    7.2.1. PHASE III ONGOING CLINICAL TRIALS
    7.2.2. PHASE II/III ONGOING CLINICAL TRIALS
    7.2.3. PHASE II ONGOING CLINICAL TRIALS
    7.2.4. PHASE I ONGOING CLINICAL TRIALS
    7.3. PLANNED CLINICAL TRIALS SUMMARY
    7.3.1. PHASE III PLANNED CLINICAL TRIALS
    7.3.2. PHASE II PLANNED CLINICAL TRIALS
    7.3.3. PHASE I PLANNED CLINICAL TRIALS
    7.4. RECENTLY COMPLETED CLINICAL TRIALS SUMMARY
    7.4.1. RECENTLY COMPLETED PHASE III CLINICAL TRIALS (2015-2018)
    7.4.2. RECENTLY COMPLETED PHASE II/III CLINICAL TRIALS (2015-2018)
    7.4.3. RECENTLY COMPLETED PHASE II CLINICAL TRIALS (2015-2018)
    7.4.4. RECENTLY COMPLETED PHASE II/I CLINICAL TRIALS (2015-2018)
    7.4.5. RECENTLY COMPLETED PHASE I CLINICAL TRIALS (2015-2018)
    7.5. POST-MARKETING SURVEILLANCE (PMS) STUDIES
    8. CURRENT AND FUTURE COMPETITIVE LANDSCAPE
    8.1. COMPANIES
    8.1.1. ESTABLISHED COMPANIES
    8.1.2. KEY COMPANY PROFILES AND SWOT
    8.1.2.1. ASTRAZENECA PLC
    8.1.2.2. ELI LILLY AND COMPANY
    8.1.2.3. PFIZER PHARMACEUTICALS
    8.1.2.4. FLEXION THERAPEUTICS
    8.1.2.5. VERICEL CORPORATION
    8.1.2.6. IROKO PHARMACEUTICALS
    8.1.2.7. ANIKA THERAPEUTICS
    8.1.2.8. HORIZON PHARMA, PLC
    8.1.2.9. NUVO PHARMACEUTICALS, INC
    8.1.3. EMERGING COMPANIES
    8.1.3.1. KITOV PHARMACEUTICALS
    8.1.3.2. KOLON TISSUEGENE, INC.
    8.1.3.3. SAMUMED, LLC
    8.1.3.4. OLATEC THERAPEUTICS LLC
    8.1.3.5. ORTHOTROPHIX, INC
    8.1.3.6. CALOSYN PHARMA, INC.
    8.1.3.7. TECHFIELDS PHARMA CO. LTD
    8.1.3.8. EMBER THERAPEUTICS
    8.1.3.9. ZYNERBA PHARMACEUTICALS
    8.1.3.10. BONE THERAPEUTICS SA
    8.1.3.11. LEVOLTA PHARMACEUTICALS INC.
    8.1.3.12. CENTREXION THERAPEUTICS CORPORATION
    8.1.3.13. AMPIO PHARMACEUTICALS
    8.1.3.14. SYMIC BIOMEDICAL
    8.1.3.15. PARADIGM BIOPHARMA LTD
    9. ABBREVIATIONS

    LIST OF TABLES
    TABLE 01: OA GLOBAL EPIDEMIOLOGY (2017) AND FORECAST (2018-2025)
    TABLE 02: OA US EPIDEMIOLOGY (2017) AND FORECAST (2018-2025)
    TABLE 03: TOP 11 OSTEOARTHRITIS DEALS RANKED BY TOTAL DEAL VALUE ($ M)
    TABLE 04: TOTAL DEALS IN CHRONOLOGICAL ORDER (2018-2004)
    TABLE 05: FDA APPROVED DRUGS FOR OSTEOARTHITIS (2000-2018)
    TABLE 06: FDA APPROVED DRUGS FOR OSTEOARTHRITIS (PATENT ANALYSIS)
    TABLE 07: ZILRETTA US GRANTED PATENTS, FLEXION
    TABLE 08: ZILRETTA US PATENT APPLICATIONS, FLEXION
    TABLE 09: DUEXIS US GRANTED PATENTS, HORZON PHARMA
    TABLE 10: DUEXIS US PATENT APPLICATIONS, HORIZON PHARMA
    TABLE 11: PENNSAID 2% US GRANTED PATENTS, NUVO PHARMACEUTICALS
    TABLE 12: PENNSAID 2% US PATENT APPLICATIONS, NUVO PHARMACEUTICALS
    TABLE 13: VIVLODEX US GRANTED PATENTS, IROKO PHARMCEUTICALS
    TABLE 14: VIVLODEX US APPLICATION PATENTS, IROKO PHARMACEUTICALS
    TABLE 15: ZORVOLEX US GRANTED PATENTS, IROKO PHARMACEUTICALS
    TABLE 16: ZORVOLEX US PATENT APPLICATIONS, IROKO PHARMCEUTICALS
    TABLE 17: MONOVISC US PATENT APPLICATIONS, ANIKA THERAPEUTICS
    TABLE 18: PHASE III MOLECULES IN THE OSTEOARTHRITIS PIPELINE
    TABLE 19: PHASE 2 MOLECULES IN THE OSTEOARTHRITIS PIPELINE
    TABLE 20: PHASE 1 MOLECULES IN THE OSTEOARTHRITIS PIPELINE
    TABLE 21: PRECLINICAL STAGE MOLECULES IN THE OSTEOARTHRITIS PIPELINE
    TABLE 22: EARLY R&D STAGE MOLECULES IN THE OSTEOARTHRITIS PIPELINE
    TABLE 23: OSTEOARTHRITIS INACTIVE AND DISCONTINUED MOLECULES
    TABLE 24: OSTEOARTHRITIS PIPELINE ANALYSIS BY INJECTABLE ROA
    TABLE 25: OSTEOARTHRITIS PIPELINE ANALYSIS BY TOPICAL ROA
    TABLE 26: OSTEOARTHRITIS PIPELINE ANALYSIS BY ORAL ROA
    TABLE 27: OSTEOARTHRITIS PIPELINE ANALYSIS, ANTI-INFLAMMATORY DRUG CLASS
    TABLE 28: ESTIMATED APPROVAL TIMELINES OF OSTEOARTHRITIS PIPELINE DRUGS
    TABLE 29: AMPION PIVOTAL PHASE III TRIALS DESIGN
    TABLE 30: RESULTS OF NEO6860
    TABLE 31: KEY PHASE III ONGOING CLINICAL TRIALS
    TABLE 32: PHASE II/III ONGOING CLINICAL TRIAL RESULT
    TABLE 33: PHASE II ONGOING CLINICAL TRIALS
    TABLE 34: PHASE I ONGOING CLINICAL TRIALS
    TABLE 35: PHASE III PLANNED CLINICAL TRIALS
    TABLE 36: PHASE II PLANNED CLINICAL TRIALS
    TABLE 37: PHASE I PLANNED CLINICAL TRIALS
    TABLE 38: RECENTLY COMPLETED PHASE III CLINICAL TRIALS (2015-2018)
    TABLE 39: RECENTLY COMPLETED PHASE II/III CLINICAL TRIALS (2015-2018)
    TABLE 40: RECENTLY COMPLETED PHASE II CLINICAL TRIALS (2015-2018)
    TABLE 41: RECENTLY COMPLETED PHASE II/I CLINICAL TRIALS (2015-2018)
    TABLE 42: RECENTLY COMPLETED PHASE I CLINICAL TRIALS (2015-2018)
    TABLE 43: ONGOING POST-MARKETING SURVEILLANCE (PMS) STUDIES
    TABLE 44: COMPLETED POST-MARKETING SURVEILLANCE (PMS) STUDIES (2015-2018)
    TABLE 45: ASTRAZENECA PRODUCT PORTFOLIO
    TABLE 46: R&D ACTIVITIES OF ASTRAZENECA
    TABLE 47: CONFERENCES/EVENTS ATTENDED BY ASTRAZENECA
    TABLE 48: RECENT DEVELOPMENTS MADE BY ASTRAZENECA
    TABLE 49: ELI LILLY & COMPANY PRODUCT PORTFOLIO
    TABLE 50: OTHER PHASE 2 AND PHASE 1 PROGRAM, ENDOCRINOLOGY THERAPY AREA
    TABLE 51: OTHER PHASE 2 AND PHASE 1 PROGRAM, IMMUNOLOGY THERAPY AREA
    TABLE 52: OTHER PHASE 2 AND PHASE 1 PROGRAM, NEURODEGENERATION AREA
    TABLE 53: OTHER PHASE 2 AND PHASE 1 PROGRAM, ONCOLOGY THERAPY AREA
    TABLE 54: R&D ACTIVITIES OF ELI LILLY & COMPANY
    TABLE 55: CONFERENCES/EVENTS ATTENDED BY ELI LILLY & COMPANY
    TABLE 56: RECENT DEVELOPMENTS MADE BY ELI LILLY & COMPANY
    TABLE 57: PFIZER PRODUCT PORTFOLIO
    TABLE 58: PHASE 2 AND PHASE 1 PROGRAM, INFLAMMATION AND IMMUNOLOGY AREA
    TABLE 59: PHASE 2 AND PHASE 1 PROGRAM, INTERNAL MEDICINE
    TABLE 60: PHASE 2 AND PHASE 1 PROGRAM, ONCOLOGY THERAPY AREA
    TABLE 61: PRODUCTS UNDER DEVELOPMENT, RARE DISEASES
    TABLE 62: VACCINES UNDER DEVELOPMENT
    TABLE 63: BIOSIMILARS UNDER DEVELOPMENT
    TABLE 64: DRUGS UNDER DEVELOPMENT IN OTHER AREAS OF FOCUS
    TABLE 65: R&D ACTIVITIES OF PFIZER
    TABLE 66: CONFERENCES/EVENTS ATTENDED BY PFIZER
    TABLE 67: RECENT DEVELOPMENTS MADE BY PFIZER
    TABLE 68: R&D ACTIVITIES OF FLEXION
    TABLE 69: CONFERENCES/EVENTS ATTENDED BY FLEXION
    TABLE 70: RECENT DEVELOPMENTS MADE BY FLEXION
    TABLE 71: R&D ACTIVITIES OF VERICEL
    TABLE 72: CONFERENCES/EVENTS ATTENDED BY VERICEL
    TABLE 73: RECENT DEVELOPMENTS MADE BY VERICEL
    TABLE 74: R&D ACTIVITIES OF IROKO
    TABLE 75: CONFERENCES/EVENTS ATTENDED BY IROKO
    TABLE 76: RECENT DEVELOPMENTS MADE BY IROKO
    TABLE 77: R&D ACTIVITIES OF ANIKA THERAPEUTICS
    TABLE 78: CONFERENCES/EVENTS ATTENDED BY ANIKA THERAPEUTICS
    TABLE 79: RECENT DEVELOPMENTS MADE BY ANIKA THERAPEUTICS
    TABLE 80: HORIZON PHARMA PRODUCT PORTFOLIO
    TABLE 81: R&D ACTIVITIES OF HORIZON PHARMA
    TABLE 82: CONFERENCES/EVENTS ATTENDED BY HORIZON PHARMA
    TABLE 83: RECENT DEVELOPMENTS MADE BY HORIZON PHARMA
    TABLE 84: COMMERCIAL OPPORTUNITES, NUVO PHARMACEUTICALS
    TABLE 85: R&D ACTIVITIES OF NUVO PHARMACEUTICALS
    TABLE 86: RECENT DEVELOPMENTS MADE BY NUVO PHARMACEUTICALS
    TABLE 87: R&D ACTIVITIES OF KITOV PHARMACEUTICALS
    TABLE 88: CONFERENCES/EVENTS ATTENDED BY KITOV PHARMACEUTICALS
    TABLE 89: RECENT DEVELOPMENTS MADE BY KITOV PHARMACEUTICALS
    TABLE 90: RECENT DEVELOPMENTS OF KOLON TISSUEGENE
    TABLE 91: OTHER PHASE 1 AND PRECLINICAL PROGRAMS UNDER PIPELINE
    TABLE 92: R&D ACTIVITIES OF SAMUMED
    TABLE 93: RECENT DEVELOPMENTS MADE BY SAMUMED
    TABLE 94: CONFERENCES/EVENTS ATTENDED BY SAMUMED
    TABLE 95: RECENT DEVELOPMENTS MADE BY OLATEC
    TABLE 96: R&D ACTIVITIES OF ORTHOTROPHIX
    TABLE 97: CONFERENCES/EVENTS ATTENDED BY ORTHOTROPHIX
    TABLE 98: DRUG PIPELINE, TECHFIELDS
    TABLE 99: RECENT DEVELOPMENTS MADE BY TECHFIELDS
    TABLE 100: ACQUISITIONS MADE BY EMBER THERAPEUTICS
    TABLE 101: FUTURE MILESTONES OF ZYNERBA PHARMCEUTICALS
    TABLE 102: RECENT DEVELOPMENTS MADE BY ZYNERBA PHARMACEUTICALS
    TABLE 103: RECENT DEVELOPMENTS AND MILESTONES, BONE THERAPEUTICS
    TABLE 104: RECENT DEVELOPMENTS AND MILESTONES OF LEVOLTA PHARMACEUTICALS
    TABLE 105: RECENT DEVELOPMENTS AND MILESTONES OF CENTREXION THERAPEUTICS
    TABLE 106: RECENT DEVELOPMENTS AND MILESTONES OF AMPIO PHARMACEUTICALS
    TABLE 107: RECENT DEVELOPMENTS AND MILESTONES OF SYMIC BIO
    TABLE 108: RECENT DEVELOPMENTS AND MILESTONES OF PARADIGM BIOPHARMA
    TABLE 109: FUTURE MILESTONES OF PARADIGM BIOPHARMA

    LIST OF FIGURES
    FIGURE 01: KEY PIPELINE EVENTS, 2020-2035
    FIGURE 02: OA GLOBAL EPIDEMIOLOGY FORECAST 2018-2025
    FIGURE 03: US EPIDEMIOLOGY FORECAST 2018-2025
    FIGURE 04: OSTEOARTHRITIS MERGERS & ACQUISITIONS BY DEAL TYPE (2004 – 2018)
    FIGURE 05: GEOGRAPHY-WISE BREAKUP, DEAL MAKERS IN OSTEOARTHRITIS (2004 -2018)
    FIGURE 06: ZILRETTA, US AND EX-US GRANTED PATENTS
    FIGURE 07: ZILRETTA US AND EX-US APPLICATION PATENTS
    FIGURE 08: DUEXIS, US AND EX-US GRANTED PATENTS
    FIGURE 09: DUEXIS US AND EX-US PATENT APPLICATIONS
    FIGURE 10: PENNSAID 2%, US AND EX-US GRANTED PATENTS
    FIGURE 11: VIVLODEX, US AND EX-US GRANTED PATENTS
    FIGURE 12: VIVLODEX US AND EX-US APPLICATION PATENTS
    FIGURE 13: ZOVOLEX, US AND EX-US GRANTED PATENTS
    FIGURE 14: MONOVISC US AND EX-US APPLICATION PATENTS
    FIGURE 15: OSTEOARTHITIS PIPELINE ANALYSIS BY STAGES OF DEVELOPMENT
    FIGURE 16: OSTEOARTHITIS PIPELINE ANALYSIS BY GEOGRAPHY
    FIGURE 17: HSD COMPARISON, US V/S EU
    FIGURE 18: OSTEOARTHITIS DRUG PIPELINE SPLIT BY ROA
    FIGURE 19: OSTEOARTHITIS DRUGS PIPELINE, ROA V/S HSD
    FIGURE 20: PIPELINE ANALYSIS BY INJECTABLES, SPLIT BY TECHNIQUE USED
    FIGURE 21: INJECTABLES BY HSD SPLIT-UP
    FIGURE 22: ORALS BY HSD SPLIT-UP
    FIGURE 23: OSTEOARTHITIS DRUGS PIPELINE BY DIFFERENT DRUG CLASSES
    FIGURE 24: ANTI-INFLAMMATORY DRUGS SPLIT BY HSD
    FIGURE 25: AMPION PHASE III AP-003-A TRIAL RESULT
    FIGURE 26: AMPION PHASE III AP-003-C TRIAL RESULT
    FIGURE 27: TANEZUMAB PHASE III TRIAL EFFICACY RESULTS
    FIGURE 28: WOMAC PAIN AND FUNCTION RESPONDERS TO SM04690 & PBO
    FIGURE 29: UNILATERAL SYMPTOMATIC
    FIGURE 30: UNILATERAL SYMPTOMATIC WITHOUT WIDESPREAD PAIN
    FIGURE 31: PHASE III ONGOING TRIAL COMPLETION YEAR V/S OA TYPE
    FIGURE 32: PHASE II/III ONGOING TRIAL COMPLETION YEAR V/S OA TYPE
    FIGURE 33: PHASE II ONGOING TRIAL COMPLETION YEAR V/S OA TYPE
    FIGURE 34: PHASE I ONGOING TRIAL COMPLETION YEAR V/S OA TYPE
    FIGURE 35: KEY PHASE III PLANNED TRIAL COMPLETION YEAR V/S OA TYPE
    FIGURE 36: RECENTLY COMPLETED PHASE III CLINICAL TRIALS (2015-2018)
    FIGURE 37: RECENTLY COMPLETED PHASE II/III CLINICAL TRIALS (2015-2018)
    FIGURE 38: RECENTLY COMPLETED PHASE II CLINICAL TRIALS (2015-2018)
    FIGURE 39: RECENTLY COMPLETED PHASE II/I CLINICAL TRIALS (2015-2018)
    FIGURE 40: RECENTLY COMPLETED PHASE I CLINICAL TRIALS (2015-2018)
    FIGURE 41: ONGOING POST-MARKETING SURVEILLANCE (PMS) STUDIES
    FIGURE 42: ONGOING POST-MARKETING SURVEILLANCE (PMS) STUDIES
    FIGURE 43: FINANCIAL INFORMATION OF ASTRAZENECA
    FIGURE 44: SWOT ANALYSIS OF ASTRAZENECA
    FIGURE 45: FINANCIAL INFORMATION OF ELI LILLY & COMPANY
    FIGURE 46: SWOT ANALYSIS OF ELI LILLY & COMPANY
    FIGURE 47: FINANCIAL INFORMATION OF PFIZER
    FIGURE 48: SWOT ANALYSIS OF PFIZER
    FIGURE 49: FINANCIAL INFORMATION OF FLEXION
    FIGURE 50: SWOT ANALYSIS OF FLEXION
    FIGURE 51: FINANCIAL INFORMATION OF VERICEL
    FIGURE 52: SWOT ANALYSIS OF VERICEL
    FIGURE 53: SWOT ANALYSIS OF IROKO
    FIGURE 54: FINANCIAL INFORMATION OF ANIKA THERAPEUTICS
    FIGURE 55: SWOT ANALYSIS OF ANIKA THERAPEUTICS
    FIGURE 56: FINANCIAL INFORMATION OF HORIZON PHARMA
    FIGURE 57: SWOT ANALYSIS OF HORIZON PHARMA
    FIGURE 58: FINANCIAL INFORMATION OF NUVO PHARMACEUTICALS
    FIGURE 59: SWOT ANALYSIS OF NUVO PHARMACEUTICAL.

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