Seasonal Influenza Therapeutics in Asia-Pacific Markets to 2022 – Growth Driven by Rising Elderly Population, Growing Awareness and Launch of Quadrivalent Therapies

Influenza, often referred to as the flu, is an acute infection caused by one of the three closely related viruses, designated as influenza Type A, B, and C. The infection’s rapid onset and potential for high morbidity and mortality, particularly in high-risk patient populations such as the elderly and young children, make prompt and effective treatment with antiviral medication very difficult. For these reasons, prophylactic vaccination is the preferred intervention for seasonal influenza.

In the recent years it was observed that demand for seasonal influenza vaccines have increased due to changed perception of patient population. APAC region is an attractive market for seasonal influenza vaccine manufacturers. Continuous improvements in the formulation of vaccines has occurred over the years, with the market currently transitioning from trivalent to quadrivalent formulations, which offer protection against an additional B strain of the virus. Traditional egg based manufacturing of seasonal influenza vaccines is being replaced with cell culture vaccines. Cell culture based production of vaccines is expected to reduce the problems associated with the production and use of seasonal influenza vaccines which will further increase the vaccination coverage in the APAC region.

GBI Research’s analysis shows that the R&D pipeline for seasonal influenza vaccines comprises a high number of vaccines in early-stage development, many of which are new formulations or those that have been developed using the cell culture method. Late-stage vaccines are either quadrivalent vaccines or pediatric versions of those that have already been approved. GBI Research expects that quadrivalent seasonal influenza vaccines will replace their trivalent vaccines forerunner by the end of the forecast period.

Scope

The seasonal influenza Asia-Pacific market will be valued at $1.71 billion in 2022, growing from $1.24 billion in 2015 at a CAGR of 4.7%.

Trivalent and quadrivalent vaccines dominate the seasonal influenza market, but unmet needs exist in terms of safety and efficacy.

– Will the drugs under development fulfill the unmet needs of the seasonal influenza market?

– Do quadrivalent therapies show continuous growth, and are they facing any competition from trivalent therapies?

– How will available therapies be affected by upcoming pipeline therapies?

The pipeline contains a range of molecule types and molecular targets, including those that are well established in seasonal influenza.

– Which molecular targets appear most frequently in the pipeline?

– Will the pipeline drugs fulfill the unmet needs of seasonal influenza market?

Market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value, due to the emergence of quadrivalent therapies.

– How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?

Various drivers and barriers will influence the market over the forecast period.

– What barriers limit the uptake of premium-priced vaccines in the assessed countries?

– What factors are most likely to drive the market in these countries?

Reasons to buy

This report will allow you to -

- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.

- Visualize the composition of the seasonal influenza market in terms of dominant therapies, with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the current market.

- Analyze the seasonal influenza pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.

- Understand the potential of late-stage therapies, with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.

- Predict seasonal influenza market growth in the five Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as analysis of the contributions of promising late-stage molecules to market growth.

- Identify commercial opportunities in the seasonal influenza deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Introduction 10

2.2 Epidemiology 10

2.3 Symptoms 12

2.4 Etiology and Pathophysiology 13

2.4.1 Pathophysiology 14

2.5 Diagnosis 14

2.6 Prognosis 16

2.7 Treatment Options 17

2.7.1 Treatment Algorithm 17

2.7.2 Pharmacological Treatments 19

2.7.3 Non-pharmacological Treatments 21

2.7.4 Exercise 21

2.7.5 Dietary Interventions 22

3 Marketed Products 23

3.1 Overview 23

3.2 Fluarix Tetra - GlaxoSmithKline 23

3.3 FluQuadri - Sanofi Pasteur 25

3.4 Vaxigrip - Sanofi Pasteur 25

3.5 Agrippal - CSL 26

3.6 Fluad - CSL 27

3.7 Fluvax/Afluria - CSL 27

3.8 Optaflu - CSL 28

3.9 Influvac - Abbott 29

3.10 GC Flu - Green Cross Corporation 29

3.11 Intanza/IDflu - Sanofi Pasteur 30

3.12 SkyCellflu - SK Chemicals 31

3.13 Nasovac-S - Serum Institute of India 31

3.14 Comparative Efficacy and Safety of Marketed Products 32

4 Pipeline Analysis 34

4.1 Overview 34

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 35

4.3 Pipeline by Molecular Target 37

4.4 Promising Pipeline Candidates 39

4.4.1 VN-100 - Daiichi Sankyo 39

4.4.2 ASP7374 (UMN-0502) - UMN Pharma 41

4.4.3 MEDI3250 (VN-0107) - Daiichi Sankyo 43

4.5 Comparative Efficacy and Safety of Pipeline Products 45

4.6 Product Competitiveness Framework 45

5 Clinical Trial Analysis 47

5.1 Failure Rate 47

5.1.1 Overall Failure Rate 47

5.1.2 Failure Rate by Phase and Molecule Type 48

5.1.3 Failure Rate by Phase and Molecular Target 49

5.2 Clinical Trial Duration 51

5.2.1 Clinical Trial Duration by Molecule Type 51

5.2.2 Clinical Trial Duration by Molecular Target 52

5.3 Clinical Trial Size 53

5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 53

5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 55

5.4 Competitive Clinical Trials Metrics Analysis 57

6 Multi-scenario Forecast 59

6.1 Geographical Markets 59

6.2 Asia-Pacific Market 59

6.3 India 61

6.3.1 Treatment Usage Patterns 61

6.3.2 Annual Cost of Therapy 62

6.3.3 Market Size 63

6.4 China 64

6.4.1 Treatment Usage Patterns 64

6.4.2 Annual Cost of Therapy 65

6.4.3 Market Size 66

6.5 Australia 67

6.5.1 Treatment Usage Patterns 67

6.5.2 Annual Cost of Therapy 68

6.5.3 Market Size 69

6.6 South Korea 70

6.6.1 Treatment Usage Patterns 70

6.6.2 Annual Cost of Therapy 71

6.6.3 Market Size 72

6.7 Japan 73

6.7.1 Treatment Usage Patterns 73

6.7.2 Annual Cost of Therapy 74

6.7.3 Market Size 75

7 Drivers and Barriers 77

7.1 Drivers 77

7.1.1 Increasing Awareness and Affordability of Seasonal Influenza Vaccines 77

7.1.2 Launch of Quadrivalent Influenza Vaccines 77

7.1.3 Growing Elderly Population 78

7.1.4 Expansion of Cell-Cultured Vaccines 78

7.2 Barriers 78

7.2.1 Limited Awareness of Influenza’s Threat 78

7.2.2 Unpredictable Vaccine Demand 78

7.2.3 Influenza Vaccine Safety Concerns 79

7.2.4 Decentralized Vaccine Policy and Reimbursement System 79

8 Deals and Strategic Consolidations 80

8.1 Licensing Deals 80

8.1.1 Deals by Region and Value 80

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 81

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 82

8.1.4 Key Licensing Deals 85

8.2 Co-Development Deals 86

8.2.1 Deals by Region and Value 86

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 87

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 88

8.2.4 Key Co-Development Deals 91

9 Appendix 92

9.1 All Pipeline Drugs by Stage of Development 92

9.1.1 Discovery 92

9.1.2 Preclinical 92

9.1.3 Phase I 93

9.1.4 Phase II 94

9.1.5 Phase III 94

9.1.6 Pre-registration 95

9.2 Market Forecasts to 2022 95

9.2.1 Asia-Pacific 95

9.2.2 India 95

9.2.3 China 96

9.2.4 Australia 96

9.2.5 South Korea 97

9.2.6 Japan 97

9.3 Bibliography 98

9.4 Abbreviations 104

9.5 Research Methodology 105

9.5.1 Secondary Research 105

9.5.2 Marketed Product Profiles 105

9.5.3 Late-Stage Pipeline Candidates 105

9.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products 106

9.5.5 Product Competitiveness Framework 106

9.5.6 Pipeline Analysis 106

9.5.7 Forecasting Model 107

9.5.8 Deals Data Analysis 108

9.6 Contact Us 108

9.7 Disclaimer 108

List of Tables

1.1 List of Tables

Table 1: Symptoms of Influenza 12

Table 2: Influenza Testing Methods 16

Table 3: Influenza Vaccination Recommendation Committees by Country 17

Table 4: Seasonal Influenza Therapeutics Market, Asia-Pacific, Most Administered Influenza Vaccines by Country 19

Table 5: Available Antiviral Drugs for Seasonal Influenza 20

Table 6: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 92

Table 7: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 92

Table 8: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 93

Table 9: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 94

Table 10: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 94

Table 11: Seasonal Influenza Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2016 95

Table 12: Seasonal influenza Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022 95

Table 13: Seasonal Influenza Therapeutics Market, India, Market Forecast, 2015-2022 95

Table 14: Seasonal Influenza Therapeutics Market, China, Market Forecast, 2015-2022 96

Table 15: Seasonal Influenza Therapeutics Market, Australia, Market Forecast, 2015-2022 96

Table 16: Seasonal Influenza Therapeutics Market, South Korea, Market Forecast, 2015-2022 97

Table 17: Seasonal Influenza Therapeutics Market, Japan, Market Forecast, 2015-2022 97

List of Figures

1.2 List of Figures

Figure 1: Notifications of Laboratory-Confirmed Influenza, Australia, 2012-July 2016 11

Figure 2: Seasonal Influenza Therapeutics Market, Treatment Algorithm of Seasonal Influenza 19

Figure 3: Seasonal Influenza Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Treatment of Seasonal Influenza 33

Figure 4: Pipeline for Seasonal Influenza Therapeutics by Molecular Type, Global, 2016 36

Figure 5: Pipeline for Seasonal Influenza Therapeutics by Molecular Target, Global, 2016 39

Figure 6: Seasonal Influenza Therapeutics Market, Asia-Pacific, VN-100 ($m), 2017-2022 41

Figure 7: Seasonal Influenza Therapeutics Market, Asia-Pacific, ASP7374 ($m), 2017-2022 43

Figure 8: Seasonal Influenza Therapeutics Market, Asia-Pacific, MEDI3250 ($m), 2017-2022 44

Figure 9: Seasonal Influenza Therapeutics Market, Comparative Efficacy Heatmap for Pipeline Products 45

Figure 10: Seasonal Influenza Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2016 46

Figure 11: Seasonal Influenza Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 48

Figure 12: Seasonal Influenza Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 49

Figure 13: Seasonal Influenza Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 50

Figure 14: Seasonal Influenza Therapeutics, Global, Clinical Trial Duration by Molecule Type, 2006-2016 52

Figure 15: Seasonal Influenza Therapeutics, Global, Clinical Trial Duration by Molecular Target, 2006-2016 53

Figure 16: Seasonal Influenza Therapeutics, Global, Clinical Trial Size per Product by Molecule Type, 2006-2016 54

Figure 17: Seasonal Influenza Therapeutics, Global, Clinical Trial Size per Product by Molecular Target, 2006-2016 55

Figure 18: Seasonal Influenza Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type, 2006-2016 56

Figure 19: Seasonal Influenza Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target, 2006-2016 57

Figure 20: Seasonal Influenza Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 58

Figure 21: Seasonal Influenza Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 58

Figure 22: Seasonal Influenza Therapeutics Market, Asia-Pacific, Treatment Patterns (million), 2015-2022 60

Figure 23: Seasonal Influenza Therapeutics Market, Asia-Pacific, Market Size ($bn), 2015-2022 61

Figure 24: Seasonal Influenza Therapeutics Market, India, Treatment Patterns (million), 2015-2022 62

Figure 25: Seasonal Influenza Therapeutics Market, India, Annual Cost of Therapy ($), 2015-2022 63

Figure 26: Seasonal Influenza Therapeutics Market, India, Market Size ($m), 2015-2022 64

Figure 27: Seasonal Influenza Therapeutics Market, China, Treatment Patterns (million), 2015-2022 65

Figure 28: Seasonal Influenza Therapeutics Market, China, Annual Cost of Therapy ($), 2015-2022 66

Figure 29: Seasonal Influenza Therapeutics Market, China, Market Size ($m), 2015-2022 67

Figure 30: Seasonal Influenza Therapeutics Market, Australia, Treatment Patterns (million), 2015-2022 68

Figure 31: Seasonal Influenza Therapeutics Market, Australia, Annual Cost of Therapy ($), 2015-2022 69

Figure 32: Seasonal Influenza Therapeutics Market, Australia, Market Size ($m), 2015-2022 70

Figure 33: Seasonal Influenza Therapeutics Market, South Korea, Treatment Patterns (million), 2015-2022 71

Figure 34: Seasonal Influenza Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022 72

Figure 35: Seasonal Influenza Therapeutics Market, South Korea, Market Size ($m), 2015-2022 73

Figure 36: Seasonal Influenza Therapeutics Market, Japan, Treatment Patterns (million), 2015-2022 74

Figure 37: Seasonal Influenza Therapeutics Market, Japan, Annual Cost of Therapy ($), 2015-2022 75

Figure 38: Seasonal Influenza Therapeutics Market, Japan, Market Size ($m), 2015-2022 76

Figure 39: Seasonal Influenza Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 81

Figure 40: Seasonal Influenza Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 82

Figure 41: Seasonal Influenza Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 83

Figure 42: Seasonal Influenza Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 84

Figure 43: Seasonal Influenza Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016 85

Figure 44: Seasonal Influenza Therapeutics Market, Global, Co-development Deals by Region, 2006-2016 87

Figure 45: Seasonal Influenza Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 88

Figure 46: Seasonal Influenza Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 89

Figure 47: Seasonal Influenza Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2016 90

Figure 48: Seasonal Influenza Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 90

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