Sections
Title | Starting Page | Number of Pages |
---|
1 Table of Contents | 4 | 4 |
1.1 List of Tables | 7 | 1 |
1.2 List of Figures | 7 | 1 |
2 Introduction | 8 | 10 |
2.1 Disease Introduction | 8 | 1 |
2.2 Epidemiology | 8 | 2 |
2.3 Etiology and Pathophysiology | 10 | 1 |
2.3.1 Viral Genome | 10 | 1 |
2.3.1.1 Surface22T Gene | 11 | 1 |
2.3.1.2 22TCore Gene | 11 | 1 |
2.3.1.3 22TX Gene | 11 | 1 |
2.3.1.4 P Gene | 11 | 1 |
2.3.2 Viral life cycle | 11 | 1 |
2.3.3 Genotypes and Global Distribution | 12 | 1 |
2.4 Symptoms | 13 | 1 |
2.5 Diagnosis | 13 | 1 |
2.6 Prognosis | 14 | 1 |
2.7 Treatment and Management | 14 | 1 |
2.7.1 First-Line Treatment | 15 | 1 |
2.7.2 Second-Line Treatment | 16 | 1 |
2.8 Co-infection | 17 | 1 |
2.8.1 HBV-HIV Co-infection | 17 | 1 |
2.8.2 HBV-HDV Co-infection | 17 | 1 |
2.8.3 HBV HCV Co-infection | 17 | 1 |
3 Marketed Products | 18 | 8 |
3.1 Viread | 18 | 1 |
3.1.1 Study 0102 | 18 | 1 |
3.1.2 Study 0103 | 18 | 1 |
3.2 Entecavir | 19 | 1 |
3.2.1 Study AI463022 (HBeAg-Positive Subjects) | 19 | 1 |
3.2.2 Study AI463027 (HBeAg-Negative Subjects) | 19 | 1 |
3.2.3 Study AI463026 | 20 | 1 |
3.2.4 Study AI463048 | 20 | 1 |
| 21 | 1 |
3.4 Adefovir dipivoxil | 22 | 1 |
3.4.1 Study 437 (HBeAg-Positive) | 22 | 1 |
3.4.2 Study 438 (HBeAg-Negative) | 22 | 1 |
3.4.3 Adefovir Treatment beyond 48 Weeks | 22 | 1 |
3.4.4 Study 435 | 23 | 1 |
3.4.5 Study 461 | 23 | 1 |
3.5 Tyzeka/Sebivo | 23 | 1 |
3.5.1 NV-02B-007 GLOBE Trial | 23 | 1 |
3.5.2 HBeAg-Positive Subjects | 24 | 1 |
3.5.3 HBeAg-Negative Subjects | 24 | 1 |
3.6 Comparative Efficacy and Safety | 24 | 2 |
4 Pipeline Analysis | 26 | 11 |
4.1 Overview | 26 | 1 |
4.2 Pipeline Analysis of Therapeutic Vaccines | 27 | 2 |
4.3 Clinical Trials | 29 | 1 |
4.3.1 Failure Rate | 29 | 2 |
4.3.2 Clinical Trial Duration | 31 | 1 |
4.3.3 Clinical Trial Size | 32 | 1 |
4.4 Competitive Clinical Trials Metrics Analysis | 33 | 1 |
4.5 Promising Drug Candidates in Pipeline | 33 | 1 |
4.5.1 Tenofovir Alafenamide Fumarate (GS-7340) | 33 | 1 |
4.6 Therapeutic Vaccines in Pipeline | 34 | 1 |
4.6.1 GS-4774 Therapeutic Vaccine with Oral Antiviral Therapy | 34 | 1 |
4.6.2 ABX203 Therapeutic Vaccine with Nucleos(t)ide Analogs against HBeAg-Negative Chronic Hepatitis B | 34 | 1 |
4.6.3 HB-110E Therapeutic DNA Vaccine | 34 | 1 |
4.6.4 INO-1800 with or without INO-9112 in Entecavir/Tenofovir-Treated HBeAg-Positive Chronic Hepatitis B Patients | 35 | 1 |
4.6.5 TG1050 Therapeutic Vaccine | 36 | 1 |
5 Market Forecast to 2021 | 37 | 12 |
5.1 Geographical Markets | 37 | 1 |
5.2 Global Market | 37 | 1 |
5.3 North America | 38 | 1 |
5.3.1 Treatment Usage Patterns | 38 | 1 |
5.3.2 Annual Cost of Therapy | 39 | 1 |
5.3.3 Market Size | 40 | 1 |
5.4 Top Five EU Markets | 41 | 1 |
5.4.1 Treatment Usage Patterns | 41 | 1 |
5.4.2 Annual Cost of Therapy | 42 | 1 |
5.4.3 Market Size | 43 | 1 |
5.5 Japan | 44 | 1 |
5.5.1 Treatment Usage Patterns | 44 | 1 |
5.5.2 Annual Cost of Therapy | 45 | 1 |
5.5.3 Market Size | 46 | 1 |
5.6 Drivers and Barriers in the Disease Market | 46 | 1 |
5.6.1 Drivers | 46 | 1 |
5.6.1.1 Increasing Immigration and Overseas Travel | 46 | 1 |
5.6.1.2 Expected Launch of GS-7340 (tenofovir alafenamide fumarate) | 47 | 1 |
5.6.2 Barriers | 47 | 1 |
5.6.2.1 Universal Prophylactic Vaccination | 47 | 1 |
5.6.2.2 Patent Expiries and Weak Late-Stage Pipeline | 48 | 1 |
5.6.2.3 Social Stigma and Asymptomatic Nature of the disease | 48 | 1 |
6 Deals and Strategic Consolidations | 49 | 6 |
6.1 Licensing Deals | 49 | 3 |
6.1.1 OnCore Enters into Licensing Agreement with NeuroVive | 52 | 1 |
6.1.2 Ligand Enters into Licensing Agreement with Chiva for Pradefovir and MB01733 | 52 | 1 |
6.1.3 Cytos Biotech Enters into Licensing Agreement with OnCore Biopharma | 52 | 1 |
6.1.4 NeuroVive Pharma Enters into Licensing Agreement with OnCore Biopharma for NVP018 | 52 | 1 |
6.2 Co-development Deals | 53 | 1 |
6.2.1 Research agreement between OnCore Biopharma and Baruch S. Blumberg | 53 | 1 |
6.2.2 Vaccine Development Agreement between Artes Biotech and Bio Farma | 54 | 1 |
7 Appendix | 55 | 18 |
7.1 All Pipeline Drugs by Phase of Development | 55 | 4 |
7.1.1 Discovery | 55 | 1 |
7.1.2 Preclinical | 56 | 1 |
7.1.3 Phase I | 57 | 1 |
7.1.4 Phase II | 58 | 1 |
7.1.5 Phase III | 58 | 1 |
7.2 Market Forecasts to 2021 | 59 | 5 |
7.2.1 Global | 59 | 1 |
7.2.2 US | 59 | 1 |
7.2.3 Canada | 60 | 1 |
7.2.4 UK | 60 | 1 |
7.2.5 France | 61 | 1 |
7.2.6 Germany | 61 | 1 |
7.2.7 Italy | 62 | 1 |
7.2.8 Spain | 62 | 1 |
7.2.9 Japan | 63 | 1 |
7.3 Bibliography | 63 | 4 |
7.4 Abbreviations | 67 | 1 |
7.5 Research Methodology | 67 | 5 |
7.5.1 Secondary Research | 68 | 1 |
7.5.2 Marketed Product Profiles | 68 | 1 |
7.5.3 Late-Stage Pipeline Candidates | 69 | 1 |
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products | 69 | 1 |
7.5.4.1 Overall Pipeline | 69 | 1 |
7.5.4.2 Clinical Trials | 70 | 1 |
7.5.4.2.1 Failure Rate | 70 | 1 |
7.5.4.2.2 Clinical Trial Size | 70 | 1 |
7.5.4.2.3 Clinical Trial Duration | 70 | 1 |
7.5.4.2.4 Clinical trial Endpoint Analysis | 70 | 1 |
7.5.5 Forecasting Model | 70 | 1 |
7.5.6 Deals Data Analysis | 71 | 1 |
7.6 Contact Us | 72 | 1 |
7.7 Disclaimer | 72 | 1 |