Report Code: 40243 | Published: October 2019 | Pages: 200 | Available format: |
Therapeutic Area(s): | Oncology | Report Type: Indication Pipeline Reports |
Chapter 1. Research Background
1.1 Research Objectives
1.2 Definition
1.3 Research Scope
1.3.1 Marketed Drugs by Route of Administration
1.3.2 Pipeline Drugs by Phase
1.3.3 Pipeline Drugs by Route of Administration
1.4 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown of Primary Research Respondents
2.2.1.1 By industry participant
2.2.1.2 By geography
2.2.1.3 By designation
2.2.2 Key Opinion Leaders (KOLs) Validation
2.3 Coverage of Epidemiology Analysis
2.4 Forecast Methodology
2.5 Assumptions for the Study
Chapter 3. Executive Summary
3.1 KOLs Opinions
Chapter 4. Introduction
4.1 Disease Overview
4.2 Causes and Risk Factors
4.3 Signs and Symptoms
4.4 Pathophysiology
4.5 Treatment
4.6 Key Drivers
4.6.1 Rising Incidence of HNC
4.6.2 Increasing Awareness
4.6.3 Rising R&D Investments
4.6.4 Positive Clinical Results of Pipeline Drugs
4.6.5 Growing Development of Small Molecule Therapeutics
4.7 Key Barriers
4.7.1 Risk of Complications from Radiation for HNC
4.7.2 Case of HPV Patients
4.7.3 Research on Cancer Prevention Vaccines/Modalities
4.7.4 Availability of Alternative Treatment
4.8 Opportunities
4.8.1 OM Associated with Targeted Therapies and Immunotherapies
4.9 Drug Designations
4.10 Unmet Medical Needs
4.10.1 Improvement in Drug Efficacy
4.10.2 Increasing Usage of Available Approved Therapy
4.10.3 Need of Defined Treatment Algorithm
Chapter 5. OM Epidemiology Forecast for 7MMs
5.1 Epidemiology Forecast for 7MMs
5.1.1 By Severity
5.2 Epidemiology Forecast for the U.S.
5.2.1 By Severity
5.3 Epidemiology Forecast for EU5
5.3.1 By Severity
5.3.2 By Country
5.3.2.1 Germany
5.3.2.1.1 By severity
5.3.2.2 France
5.3.2.2.1 By severity
5.3.2.3 Italy
5.3.2.3.1 By severity
5.3.2.4 U.K.
5.3.2.4.1 By severity
5.3.2.5 Spain
5.3.2.5.1 By severity
5.4 Epidemiology Forecast for Japan
5.4.1 By Severity
Chapter 6. Pipeline Drugs Outlook
6.1 OM Pipeline Drugs Snapshot
6.1.1 Pipeline Drugs Snapshot by Phase
6.1.2 Pipeline Drugs Snapshot by Route of Administration
6.1.3 Pipeline Drugs Snapshot by Molecule Type
Chapter 7. Marketed Drugs Analysis
7.1 Marketed Drugs Profiles
7.1.1 GelX
7.1.1.1 Regulatory milestones
7.1.1.2 Clinical trials and results
7.1.1.3 Strategic development activities
7.1.2 NeutraSal
7.1.2.1 Strategic development activities
7.1.3 Xxxx
7.1.3.1 Dosage
7.1.3.2 Regulatory milestones
7.1.3.3 Clinical trials and results
7.1.3.4 Strategic development activities
7.1.4 Xxxx
7.1.4.1 Regulatory milestones
7.1.4.2 Clinical trials and results
7.1.4.3 Strategic development activities
7.1.5 Xxxx
7.1.5.1 Regulatory milestones
7.1.5.2 Clinical trials and results
7.1.5.3 Strategic development activities
7.1.6 Xxxx
7.1.6.1 Regulatory milestones
7.1.6.2 Clinical trials and results
7.1.6.3 Strategic development activities
7.1.6.4 Patent
7.1.7 Xxxx
7.1.7.1 Regulatory milestones
7.1.7.2 Clinical trials and results
7.1.7.3 Strategic development activities
7.1.8 Xxxx
7.1.8.1 Clinical trials and results
7.1.8.2 Strategic development activities
7.1.9 Xxxx
7.1.9.1 Clinical trials
Chapter 8. OM Therapeutics Pipeline Analysis by Phase
8.1 Phase III
8.1.1 Brilacidin
8.1.1.1 Pre-clinical studies
8.1.1.2 Clinical trials
8.1.1.3 Clinical results
8.1.1.4 Designation
8.1.1.5 Name change
8.1.1.6 Financing
8.1.1.7 Patent
8.1.2 Xxxx
8.1.2.1 Clinical trials
8.1.2.2 Clinical results
8.1.2.3 Designation
8.1.2.4 Patent
8.1.3 Xxxx
8.1.3.1 Clinical trials
8.1.3.2 Designation
8.1.4 Xxxx
8.1.4.1 Clinical trials
8.1.5 Xxxx
8.1.5.1 Clinical trials
8.1.5.2 Clinical results
8.1.5.3 Strategic development
8.1.5.4 Patent
8.2 Phase II
8.2.1 IZN-6N4
8.2.1.1 Clinical trials
8.2.1.2 Clinical results
8.2.2 Xxxx
8.2.2.1 Pre-clinical studies
8.2.2.2 Clinical trials
8.2.2.3 Clinical results
8.2.2.4 Strategic development activities
8.2.2.5 Designation
8.2.3 Xxxx
8.2.3.1 Clinical trials
8.2.3.2 Clinical results
8.2.3.3 Designation
8.2.3.4 Financing
8.2.3.5 Patent
8.2.4 Xxxx
8.2.4.1 Clinical trials
8.2.4.2 Designation
8.2.4.3 Patent
8.2.5 Xxxx
8.2.5.1 Clinical trials
8.2.5.2 Clinical results
8.2.6 Xxxx
8.2.6.1 Clinical trials
8.2.6.2 Patents
8.2.7 Xxxx
8.2.7.1 Clinical trials
8.2.7.2 Clinical results
8.2.8 Xxxx
8.2.9 Xxxx
8.2.9.1 Clinical trials
8.2.9.2 Clinical results
8.2.9.3 Strategic development
8.2.10 Xxxx
8.2.11 Xxxx
8.2.11.1 Clinical trials
8.2.11.2 Clinical results
8.3 Phase I
8.3.1 Nu-3
8.4 Pre-clinical
8.4.1 CVXL-0095
8.4.2 Xxxx
8.4.3 Xxxx
8.4.4 Xxxx
8.4.5 Xxxx
8.4.5.1 Pre-clinical studies
8.4.5.2 Clinical results
8.4.6 Xxxx
Chapter 9. Regulatory Framework for Drug Approval
9.1 U.S.
9.2 Europe
9.2.1 Centralized Procedure
9.2.2 Mutual Recognition Procedure
9.2.3 Decentralized Procedure
9.2.4 Nationalized Procedure
9.3 Japan
Chapter 10. Clinical Trials Review
10.1 Clinical Trials by Geography
Chapter 11. Competitive Landscape
11.1 Summary of Strategic Development Activities
11.2 Attribute Analysis
11.2.1 Safety
11.2.2 Efficacy
11.2.3 Tolerability
11.3 Expected Launch Time of Phase III Clinical Stage Products
11.3.1 OM Market Size
11.3.2 Market Share of Phase III Drugs in 2024
11.4 SWOT Analysis
11.5 Key Strategies
11.5.1 Collaborations and Partnerships
11.5.2 Strategic Product Promotion
11.5.3 Product Acquisitions
11.6 Key Highlights
11.6.1 Rise in Funding for Smooth Phase Transition
11.6.2 Robust Product Approvals
11.7 Pharma Proff’s View
Chapter 12. Company Profiles
12.1 Sunstar Suisse SA
12.1.1 Business Overview
12.1.2 Product and Service Offerings
12.1.3 Key Financial Summary
12.2 Xxxx.
12.2.1 Business Overview
12.2.2 Product and Service Offerings
12.3 Xxxx
12.3.1 Business Overview
12.3.2 Product and Service Offerings
12.3.3 Key Financial Summary
12.4 Izun Pharmaceuticals Corporation
12.4.1 Business Overview
12.4.2 Product and Service Offerings
12.5 Xxxx
12.5.1 Business Overview
12.5.2 Product and Service Offerings
12.5.3 Key Financial Summary
12.6 Xxxx.
12.6.1 Business Overview
12.6.2 Product and Service Offerings
12.7 Xxxx
12.7.1 Business Overview
12.7.2 Product and Service Offerings
12.8 Innovation Pharmaceuticals Inc.
12.8.1 Business Overview
12.8.2 Product and Service Offerings
12.9 Xxxx
12.9.1 Business Overview
12.9.2 Product and Service Offerings
12.9.3 Key Financial Summary
12.10 Xxxx
12.10.1 Business Overview
12.10.2 Product and Service Offerings
12.11 Xxxx
12.11.1 Business Overview
12.11.2 Product and Service Offerings
12.12 Xxxx
12.12.1 Business Overview
12.12.2 Product and Service Offerings
12.12.3 Key Financial Summary
12.13 Xxxx
12.13.1 Business Overview
12.13.2 Product and Service Offerings
12.13.3 Key Financial Summary
12.14 Xxxx
12.14.1 Business Overview
12.14.2 Product and Service Offerings
12.15 Xxxx.
12.15.1 Business Overview
12.15.2 Product and Service Offerings
12.15.3 Key Financial Summary
12.16 Xxxx
12.16.1 Business Overview
12.16.2 Product and Service Offerings
Chapter 13. Appendix
13.1 Recently Organized/Held Seminars and Conferences
13.2 Upcoming Conferences
13.3 Sources & References
13.4 Abbreviations
13.5 Related Reports
List of Tables
TABLE 1 CAUSES OF OM
TABLE 2 OM EPIDEMIOLOGY IN 7MMS, ‘000 (2014–2018)
TABLE 3 OM EPIDEMIOLOGY IN 7MMS, ‘000 (2019–2024)
TABLE 4 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2014–2018)
TABLE 5 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2019–2024)
TABLE 6 OM EPIDEMIOLOGY IN THE U.S. (2014–2018)
TABLE 7 OM EPIDEMIOLOGY IN THE U.S. (2019–2024)
TABLE 8 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2014–2024)
TABLE 9 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2019–2024)
TABLE 10 OM EPIDEMIOLOGY IN EU5 (2014–2018)
TABLE 11 OM EPIDEMIOLOGY IN EU5 (2019–2024)
TABLE 12 OM INCIDENT CASES IN EU5, BY SEVERITY (2014–2018)
TABLE 13 OM INCIDENT CASES IN EU5, BY SEVERITY (2019–2024)
TABLE 14 OM EPIDEMIOLOGY IN GERMANY (2014–2018)
TABLE 15 OM EPIDEMIOLOGY IN GERMANY (2019–2024)
TABLE 16 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2014–2018)
TABLE 17 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2019–2024)
TABLE 18 OM EPIDEMIOLOGY IN FRANCE (2014–2018)
TABLE 19 OM EPIDEMIOLOGY IN FRANCE (2019–2024)
TABLE 20 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2014–2018)
TABLE 21 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2019–2024)
TABLE 22 OM EPIDEMIOLOGY IN ITALY (2014–2018)
TABLE 23 OM EPIDEMIOLOGY IN ITALY (2019–2024)
TABLE 24 OM INCIDENT CASES IN ITALY, BY SEVERITY (2014–2018)
TABLE 25 OM INCIDENT CASES IN ITALY, BY SEVERITY (2019–2024)
TABLE 28 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2014–2018)
TABLE 29 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2019–2024)
TABLE 30 OM EPIDEMIOLOGY IN SPAIN (2014–2018)
TABLE 31 OM EPIDEMIOLOGY IN SPAIN (2019–2024)
TABLE 32 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2014–2018)
TABLE 33 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2019–2024)
TABLE 34 OM EPIDEMIOLOGY IN JAPAN (2014–2018)
TABLE 35 OM EPIDEMIOLOGY IN JAPAN (2019–2024)
TABLE 36 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2014–2018)
TABLE 37 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2019–2024)
TABLE 38 DESCRIPTION OF GELX
TABLE 39 DESCRIPTION OF NEUTRASAL
TABLE 40 DESCRIPTION OF XXXX
TABLE 41 DESCRIPTION OF XXXX
TABLE 42 DESCRIPTION OF XXXX
TABLE 43 DESCRIPTION OF XXXX
TABLE 44 DESCRIPTION OF XXXX
TABLE 45 DESCRIPTION OF XXXX
TABLE 46 DESCRIPTION OF XXXX
TABLE 47 CLINICAL TRIALS OF XXXX
TABLE 48 DESCRIPTION OF BRILACIDIN
TABLE 49 CLINICAL TRIALS OF BRILACIDIN
TABLE 50 DESCRIPTION OF XXXX
TABLE 51 CLINICAL TRIALS OF XXXX
TABLE 52 DESCRIPTION OF XXXX
TABLE 53 CLINICAL TRIALS OF XXXX
TABLE 54 DESCRIPTION OF XXXX
TABLE 55 CLINICAL TRIALS OF XXXX
TABLE 56 DESCRIPTION OF XXXX
TABLE 57 CLINICAL TRIALS OF XXXX
TABLE 58 DESCRIPTION OF IZN-6N4
TABLE 59 CLINICAL TRIALS OF IZN-6N4
TABLE 60 DESCRIPTION OF XXXX
TABLE 61 CLINICAL TRIALS OF XXXX
TABLE 62 DESCRIPTION OF XXXX
TABLE 63 CLINICAL TRIALS OF XXXX
TABLE 64 DESCRIPTION OF XXXX
TABLE 65 CLINICAL TRIALS OF XXXX
TABLE 66 DESCRIPTION OF XXXX
TABLE 67 CLINICAL TRIALS OF XXXX
TABLE 68 DESCRIPTION OF XXXX
TABLE 69 CLINICAL TRIALS OF XXXX
TABLE 70 DESCRIPTION OF XXXX
TABLE 71 CLINICAL TRIALS OF XXXX
TABLE 72 DESCRIPTION OF XXXX
TABLE 73 DESCRIPTION OF XXXX
TABLE 74 CLINICAL TRIALS OF XXXX
TABLE 75 DESCRIPTION OF XXXX
TABLE 76 DESCRIPTION OF XXXX
TABLE 77 CLINICAL TRIALS OF XXXX
TABLE 78 DESCRIPTION OF NU-3
TABLE 79 DESCRIPTION OF CVXL-0095
TABLE 80 DESCRIPTION OF XXXX
TABLE 81 DESCRIPTION OF XXXX
TABLE 82 DESCRIPTION OF XXXX
TABLE 83 DESCRIPTION OF XXXX
TABLE 84 DESCRIPTION OF XXXX
TABLE 85 COLLABORATIONS AND LICENSING AGREEMENTS
TABLE 86 ACQUISITIONS
TABLE 87 ATTRIBUTE ANALYSIS
TABLE 88 EXPECTED LAUNCH TIME OF PHASE III CLINICAL STAGE PRODUCTS
TABLE 89 SUNSTAR SUISSE SA – AT A GLANCE
TABLE 90 SUNSTAR SUISSE SA – KEY FINANCIAL SUMMARY
TABLE 91 XXXX – AT A GLANCE
TABLE 92 XXXX – AT A GLANCE
TABLE 93 XXXX – KEY FINANCIAL SUMMARY
TABLE 94 IZUN PHARMACEUTICALS CORPORATION – AT A GLANCE
TABLE 95 XXXX – AT A GLANCE
TABLE 96 XXXX - PRODUCTS OFFERINGS
TABLE 97 XXXX – KEY FINANCIAL SUMMARY
TABLE 98 XXXX – AT A GLANCE
TABLE 99 XXXX – AT A GLANCE
TABLE 100 INNOVATION PHARMACEUTICALS INC. – AT A GLANCE
TABLE 101 XXXX – AT A GLANCE
TABLE 102 XXXX – KEY FINANCIAL SUMMARY
TABLE 103 XXXX – AT A GLANCE
TABLE 104 XXXX – AT A GLANCE
TABLE 105 PIPELINE PRODUCTS OF XXXX
TABLE 106 XXXX – AT A GLANCE
TABLE 107 PIPELINE PRODUCTS OF XXXX
TABLE 108 XXXX – KEY FINANCIAL SUMMARY
TABLE 109 XXXX – AT A GLANCE
TABLE 110 MARKETED PRODUCTS OF XXXX
TABLE 111 PIPELINE PRODUCTS OF XXXX
TABLE 112 XXXX – KEY FINANCIAL SUMMARY
TABLE 113 XXXX – AT A GLANCE
TABLE 114 XXXX – AT A GLANCE
TABLE 115 MARKETED PRODUCTS OF XXXX
TABLE 116 PIPELINE PRODUCTS OF XXXX
TABLE 117 XXXX – KEY FINANCIAL SUMMARY
TABLE 118 XXXX – AT A GLANCE
TABLE 119 PIPELINE PRODUCTS OF XXXX
TABLE 120 RECENTLY ORGANIZED SEMINARS AND CONFERENCES
TABLE 121 UPCOMING SEMINARS AND CONFERENCES
TABLE 122 SOURCES & REFERENCES
TABLE 123 ABBREVIATIONS
List of Figures
FIG 1 RESEARCH METHODOLOGY
FIG 2 BREAKDOWN OF PRIMARY RESEARCH RESPONDENTS, BY INDUSTRY PARTICIPANT
FIG 3 BREAKDOWN OF PRIMARY RESEARCH, BY GEOGRAPHY
FIG 4 BREAKDOWN OF PRIMARY RESEARCH, BY DESIGNATION
FIG 5 OM PATHOPHYSIOLOGY
FIG 6 UNMET NEEDS
FIG 7 TOTAL NUMBER OF INCIDENT CASES IN 7MM, ‘000 (2018 & 2024)
FIG 8 OM INCIDENT CASES IN 7MM (2014–2024)
FIG 9 OM INCIDENT CASES IN 7MM, BY SEVERITY, ‘000 (2014–2024)
FIG 10 OM EPIDEMIOLOGY IN THE U.S. (2014–2024)
FIG 11 OM INCIDENT CASES IN THE U.S., BY SEVERITY (2014–2024)
FIG 12 OM EPIDEMIOLOGY IN EU5 (2014–2024)
FIG 13 OM INCIDENT CASES IN EU5, BY SEVERITY (2014–2024)
FIG 14 OM EPIDEMIOLOGY IN GERMANY (2014–2024)
FIG 15 OM INCIDENT CASES IN GERMANY, BY SEVERITY (2014–2024)
FIG 16 OM EPIDEMIOLOGY IN FRANCE (2014–2024)
FIG 17 OM INCIDENT CASES IN FRANCE, BY SEVERITY (2014–2024)
FIG 18 OM EPIDEMIOLOGY IN ITALY (2014–2024)
FIG 19 OM INCIDENT CASES IN ITALY, BY SEVERITY (2014–2024)
FIG 20 OM EPIDEMIOLOGY IN THE U.K. (2014–2024)
FIG 21 OM INCIDENT CASES IN THE U.K., BY SEVERITY (2014–2024)
FIG 22 OM EPIDEMIOLOGY IN SPAIN (2014–2024)
FIG 23 OM INCIDENT CASES IN SPAIN, BY SEVERITY (2014–2024)
FIG 24 OM EPIDEMIOLOGY IN JAPAN (2014–2024)
FIG 25 OM INCIDENT CASES IN JAPAN, BY SEVERITY (2014–2024)
FIG 26 OM PIPELINE DRUGS SNAPSHOT, BY PHASE (2019)
FIG 27 OM PIPELINE DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2019)
FIG 28 OM THERAPEUTICS PIPELINE DRUGS SNAPSHOT, BY MOLECULE TYPE (2019)
FIG 29 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)
FIG 30 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)
FIG 31 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU
FIG 32 MARKETING AUTHORIZATION PROCEDURES IN EU
FIG 33 CENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 34 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL
FIG 35 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 36 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN
FIG 37 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY
FIG 38 EXPECTED LAUNCH TIME
FIG 39 GLOBAL OM MARKET, 2018 & 2024 ($M)
FIG 40 MARKET SHARE OF PHASE III DRUGS IN 2024
FIG 41 SUNSTAR SUISSE SA – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2018)
FIG 42 XXXX – REVENUE SPLIT BY SEGMENT AND GEOGRAPHY (2018)
FIG 43 XXXX – REVENUE SPLIT BY GEOGRAPHY (2018)
FIG 44 XXXX – REVENUE SPLIT BY BUSINESS AREA AND GEOGRAPHY (2018)