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Hemophilia A and B Therapeutics in Asia-Pacific Markets to 2022 - Growth Driven by Increasing Treatment-Receiving Pool, Launch of Long-Acting Replacement Therapies and Non-factor Therapy

Hemophilia A and B Therapeutics in Asia-Pacific Markets to 2022 - Growth Driven by Increasing Treatment-Receiving Pool, Launch of Long-Acting Replacement Therapies and Non-factor Therapy

Summary

Hemophilia is a rare disease affecting more than 400,000 people worldwide. Hemophilia A is four times as common as hemophilia B, and more than half of patients with hemophilia A have a severe form of hemophilia. Males have a much higher chance of developing hemophilia because they only receive one copy of the X chromosome from their mother.

The mainstay of treatment for hemophilia is to replace the missing factor VIII or factor IX, produced using plasma-derived or recombinant methods. Some patients develop inhibitors to factor VIII or factor IX treatment and need a bypassing agent, such as factor VIIa, to resolve bleeds. Patients of hemophilia A or B often require lifelong treatment to prevent and control bleeding episodes, and this therefore represents a lucrative market opportunity.

The current marketed products landscape comprises replacement factor therapies, such as recombinant therapies and new long-acting recombinant products. The current pipeline shows strong promise, as it shows a gradual shift from short-acting recombinant factor VIII or factor IX to long-acting recombinant factor VIII, and from factor replacement therapies to non-factor therapies. Nevertheless, significant unmet need remains for products that can avoid the development of inhibitors in patients with hemophilia.

Though late-stage pipeline for treatment of hemophilia seems promising, the main market restraint is likely to be low penetration of new long-acting recombinant therapies in India and China, owing to their high expected prices.

Scope

The Hemophilia A and B Asia-Pacific market will be valued at $699.1m and $112.9m respectively in 2022, growing from $444.9m and $76.3m in 2015, at compound annual growth rates of 6.7% and 5.8%.

  • How will non-factor therapies contribute to the growth?
  • What will be the impact of the new long-acting recombinant factor VIII and recombinant factor IX products in the hemophilia A and B market sales?
The pipeline contains a range of molecule types and molecular targets, including both those that are well established in hemophilia A and B, and novel targeted therapies.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Introduction
2.2 Epidemiology
2.3 Symptoms
2.4 Etiology and Pathophysiology
2.4.1 Hemophilia A
2.4.2 Hemophilia B
2.5 Diagnosis
2.6 Diagnosis of Inhibitors
2.7 Disease stages
2.8 Prognosis
2.9 Treatment Options
2.9.1 Management of Bleeding with Factor Replacement Therapy
2.9.2 Antifibrinolytic Medication
2.9.3 Treatment of Inhibitors
2.9.4 Gene Therapy
2.9.5 Hemophilia A
2.9.6 Hemophilia B
3 Marketed Products
3.1 Overview
3.2 Marketed Products - Hemophilia A
3.2.1 Advate (octacog alfa) - Baxalta
3.2.2 Adynovate (rurioctocog alfa pegol) - Baxalta
3.2.3 Xyntha/ReFacto AF (moroctocog alfa) - Pfizer
3.2.4 Kogenate FS (octacog alfa) - Bayer
3.2.5 Kovaltry (octacog alfa) - Bayer
3.2.6 Eloctate (efmoroctocog Alfa) - Biogen
3.2.7 Nuwiq (simoctocog alfa) - Octapharma
3.2.8 NovoEight (turoctocog alfa) - Novo Nordisk
3.2.9 GreenGene F (Beroctocog Alfa) - Green Cross
3.3 Marketed Products - Hemophilia B
3.3.1 Alprolix (Eftrenonacog alfa) - Biogen
3.3.2 BeneFix (nonacog alfa) - Pfizer
3.3.3 Rixubis (nonacog gamma) - Baxter
3.3.4 Idelvion (albutrepenonacog alfa) - CSL Behring
3.4 Marketed Products - Hemophilia A and B
3.4.1 Feiba NF (anti-inhibitor coagulant complex) - Baxter
3.4.2 Byclot (freeze-dried-activated human blood coagulation factor VII concentrate containing factor X) - Kaketsuken
3.5 Comparative Efficacy and Safety of Marketed Products
4 Pipeline Analysis
4.1 Overview
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type
4.3 Pipeline by Molecular Target
4.4 Promising Pipeline Candidates - Hemophilia A
4.4.1 BAX-801 (susoctocog alfa) - Baxalta
4.4.2 CSL-627/NBP-601 (Lonoctocog alfa) - CSL Behring
4.4.3 Emicizumab (ACE-910/RG6013) - Roche
4.4.4 N8-GP (turoctocog Alfa Pegol) - Novo Nordisk
4.4.5 BAY94-9027 (damoctocog alfa pegol) - Bayer
4.5 Promising Pipeline Candidates -Hemophilia B
4.5.1 N9-GP/NN-7999 (nonacog beta pegol) - Novo Nordisk
4.6 Promising Pipeline Candidates -Hemophilia A and B
4.6.1 BAX-817 (recombinant activated factor VII BI) - Baxalta
4.6.2 CSL-689 (recombinant activated VII-FP) - CSL Behring
4.7 Comparative Efficacy and Safety of Pipeline Products
4.8 Product Competitiveness Framework
5 Clinical Trial Analysis
5.1 Failure Rate
5.1.1 Overall Failure Rate
5.1.2 Failure Rate by Phase and Molecule Type
5.1.3 Failure Rate by Phase and Molecular Target
5.2 Clinical Trial Duration
5.2.1 Clinical Trial Duration by Molecule Type
5.2.2 Clinical Trial Duration by Molecular Target
5.3 Clinical Trial Size
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development
5.4 Competitive Clinical Trials Metrics Analysis
6 Multi-scenario Forecast
6.1 Geographical Markets
6.2 Asia-Pacific Market
6.3 India
6.3.1 Treatment Usage Patterns
6.3.2 Annual Cost of Therapy
6.3.3 Market Size
6.4 China
6.4.1 Treatment Usage Patterns
6.4.2 Annual Cost of Therapy
6.4.3 Market Size
6.5 Australia
6.5.1 Treatment Usage Patterns
6.5.2 Annual Cost of Therapy
6.5.3 Market Size
6.6 South Korea
6.6.1 Treatment Usage Patterns
6.6.2 Annual Cost of Therapy
6.6.3 Market Size
6.7 Japan
6.7.1 Treatment Usage Patterns
6.7.2 Annual Cost of Therapy
6.7.3 Market Size
7 Drivers and Barriers
7.1 Drivers
7.1.1 Increasing Awareness
7.1.2 Promising Late-Stage Pipeline Products with Potential to Change Treatment Paradigm
7.1.3 Continued Uptake of Recently Approved Therapies
7.1.4 Increasing Usage of Prophylactic Therapies
7.2 Barriers
7.2.1 Low Diagnosis and Low Treatment Rate
7.2.2 Low Access to Factor Replacement Therapies
7.2.3 Limitation of Premium Pricing
8 Deals and Strategic Consolidations
8.1 Licensing Deals
8.1.1 Deals by Region and Value
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target
8.1.4 Key Licensing Deals
8.2 Co-development Deals
8.2.1 Deals by Region and Value
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target
8.2.4 Key Co-development Deals
9 Appendix
9.1 All Pipeline Drugs by Stage of Development
9.1.1 Discovery
9.1.2 Preclinical
9.1.3 Phase I
9.1.4 Phase II
9.1.5 Phase III
9.1.6 Pre-registration
9.2 Market Forecasts to 2021
9.2.1 Asia-Pacific
9.2.2 India
9.2.3 China
9.2.4 Australia
9.2.5 South Korea
9.2.6 Japan
9.3 Bibliography
9.4 Abbreviations
9.5 Research Methodology
9.5.1 Secondary Research
9.5.2 Marketed Product Profiles
9.5.3 Late-Stage Pipeline Candidates
9.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products
9.5.5 Product Competitiveness Framework
9.5.6 Pipeline Analysis
9.5.7 Forecasting Model
9.5.8 Deals Data Analysis
9.6 Contact Us
9.7 Disclaimer
1.1 List of Tables
Table 1: Hemophilia Therapeutics Market, APAC, Frequency of Bleeding at Various Sites of Body
Table 2: Diagnosis and Classification of Hemophilia Based on Clotting Factor Level and Bleeding Severity
Table 3: Hemophilia Therapeutics, APAC, Management of Bleeding Episodes
Table 4: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Discovery, 2016
Table 5: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016
Table 6: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase I, 2016
Table 7: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase II, 2016
Table 8: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase III, 2016
Table 9: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2016
Table 10: Hemophilia A Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022
Table 11: Hemophilia B Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022
Table 12: Hemophilia A Therapeutics Market, India, Market Forecast, 2015-2022
Table 13: Hemophilia B Therapeutics Market, India, Market Forecast, 2015-2022
Table 14: Hemophilia A Therapeutics Market, China, Market Forecast, 2015-2022
Table 15: Hemophilia B Therapeutics Market, China, Market Forecast, 2015-2022
Table 16: Hemophilia A Therapeutics Market, Australia, Market Forecast, 2015-2022
Table 17: Hemophilia B Therapeutics Market, Australia, Market Forecast, 2015-2022
Table 18: Hemophilia A Therapeutics Market, South Korea, Market Forecast, 2015-2022
Table 19: Hemophilia B Therapeutics Market, South Korea, Market Forecast, 2015-2022
Table 20: Hemophilia A Therapeutics Market, Japan, Market Forecast, 2015-2022
Table 21: Hemophilia B Therapeutics Market, Japan, Market Forecast, 2015-2022
1.2 List of Figures
Figure 1: Hemophilia A and B Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Treatment of Hemophilia A
Figure 2: Hemophilia A and B Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for the Treatment of Hemophilia B
Figure 3: Pipeline for Hemophilia A and B Therapeutics, Global, 2016
Figure 4: Pipeline for Hemophilia A and B Therapeutics by Molecular Target, Global, 2016
Figure 5: Hemophilia A and B Therapeutics Market, APAC, BAX-801 Market ($m), 2017-2022
Figure 6: Hemophilia A and B Therapeutics Market, APAC, CSL-627 Market ($m), 2016-2022
Figure 7: Hemophilia A and B Therapeutics Market, APAC, Emicizumab Market ($m), 2019-2022
Figure 8: Hemophilia A and B Therapeutics Market, APAC, N8-GP Market ($m), 2020-2022
Figure 9: Hemophilia A and B Therapeutics Market, APAC, BAY94-9027 Market ($m), 2020-2022
Figure 10: Hemophilia A and B Therapeutics Market, APAC, N9-GP Market ($m), 2018-2022
Figure 11: Hemophilia A and B Therapeutics Market, APAC, BAX-817 Market ($m), 2017-2022
Figure 12: Hemophilia A and B Therapeutics Market, APAC, CSL-689 Market ($m), 2018-2022
Figure 13: Hemophilia A and B Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Treatment of Hemophilia A
Figure 14: Hemophilia A and B Therapeutics Market, Competitor Matrix for Hemophilia A Marketed and Pipeline Products, 2016
Figure 15: Hemophilia A and B Therapeutics Market, Competitor Matrix for Hemophilia B Marketed and Pipeline Products, 2016
Figure 16: Hemophilia A and B Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016
Figure 17: Hemophilia A and B Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016
Figure 18: Hemophilia A and B Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016
Figure 19: Hemophilia A and B Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016
Figure 20: Hemophilia A and B Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016
Figure 21: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016
Figure 22: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016
Figure 23: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016
Figure 24: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016
Figure 25: Hemophilia A and B Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 26: Hemophilia A and B Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target
Figure 27: Hemophilia A and B Therapeutics Market, APAC, Treatment Patterns (000’), 2015-2022
Figure 28: Hemophilia A and B Therapeutics Market, APAC, Market Size ($m), 2015-2022
Figure 29: Hemophilia A and B Therapeutics Market, India, Treatment Patterns (000’), 2015-2022
Figure 30: Hemophilia A and B Therapeutics Market, India, Annual Cost of Therapy ($), 2015-2022
Figure 31: Hemophilia A and B Therapeutics Market, India, Market Size ($m), 2015-2022
Figure 32: Hemophilia A and B Therapeutics Market, China, Treatment Patterns (million), 2015-2022
Figure 33: Hemophilia A and B Therapeutics Market, China, Annual Cost of Therapy ($), 2015-2022
Figure 34: Hemophilia A and B Therapeutics Market, China, Market Size ($m), 2015-2022
Figure 35: Hemophilia A and B Therapeutics Market, Australia, Treatment Patterns (‘000), 2015-2022
Figure 36: Hemophilia A and B Therapeutics Market, Australia, Annual Cost of Therapy ($), 2015-2022
Figure 37: Hemophilia A and B Therapeutics Market, Australia, Market Size ($m), 2015-2022
Figure 38: Hemophilia A and B Therapeutics Market, South Korea, Treatment Patterns (‘000), 2015-2022
Figure 39: Hemophilia A and B Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022
Figure 40: Hemophilia A and B Therapeutics Market, South Korea, Market Size ($m), 2015-2022
Figure 41: Hemophilia A and B Therapeutics Market, Japan, Treatment Patterns (‘000), 2015-2022
Figure 42: Hemophilia A and B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2015-2022
Figure 43: Hemophilia A and B Therapeutics Market, Japan, Market Size ($m), 2015-2022
Figure 44: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2015
Figure 45: Hemophilia A and B Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015
Figure 46: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2015
Figure 47: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2015
Figure 48: Hemophilia A and B Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2015
Figure 49: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2015
Figure 50: Hemophilia A and B Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015
Figure 51: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2015
Figure 52: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2015
Figure 53: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015

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