Hemophilia A and B Therapeutics in Asia-Pacific Markets to 2023 - Growth Driven by Increasing Treatment-Receiving Pool, Launch of Long-Acting Replacement Therapies and Non-factor Therapy

  • ID: 4432751
  • Report
  • 133 Pages
  • GBI Research
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Asia-Pacific Hemophilia A Market will be Valued at $1,499.2m in 2023, Growing from $838.9m in 2016, at a CAGR of 8.6%

FEATURED COMPANIES

  • Aptevo Therapeutics
  • Baxter
  • Bayer
  • Bioverativ
  • CSL Behring
  • Green Cross
  • MORE

Summary

Hemophilia is a rare disease affecting more than 400,000 people worldwide. Hemophilia A is four to six times as common as hemophilia B, and more than half of hemophilia A patients have a severe form of hemophilia. 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 with hemophilia A or B often require lifelong treatment to prevent and control bleeding episodes, and they therefore represent a strong market opportunity. The current marketed products landscape comprises replacement factor therapies, including recombinant therapies and new long-acting recombinant products. The pipeline shows strong promise, and highlights 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. Although the late-stage pipeline for hemophilia treatment seems promising, the main market restraint is likely to be low penetration of new long-acting recombinant therapies - particularly in India and China - owing to their high expected prices.

Scope

The Asia-Pacific hemophilia A market will be valued at $1,499.2m in 2023, growing from $838.9m in 2016, at a compound annual growth rate of 8.6%.

  • How will the market value of hemophilia B compare?
  • How will non-factor therapies contribute to growth?
  • What will be the impact of the new long-acting recombinant factor VIII and recombinant factor IX products?

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.

  • Which molecular targets appear most frequently in the pipeline?
  • Will the pipeline address unmet needs such as less frequently administered therapies and risk of inhibitor development for hemophilia A and B patients?
  • What are the most promising first-in-class targets?
  • Will the current first-in-class targets have broader therapeutic potential across the Asia-Pacific markets?

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

  • What are the barriers that will limit the uptake of premium-priced recombinant factor VIII and recombinant factor IX therapies in the assessed countries?
  • Which factors are most likely to drive the market in these countries?

Co-development deals are the most common form of strategic alliance in hemophilia A and B, with deal values ranging from under $10m to over $280m.

  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key co-development deals?

Reasons to buy

  • 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 hemophilia A and B market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the hemophilia A and B pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel treatment approaches.
  • 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.
  • Anticipate levels of hemophilia A and B 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 coverage of the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the hemophilia A and B deals landscape by analyzing trends in licensing and co-development deals.
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FEATURED COMPANIES

  • Aptevo Therapeutics
  • Baxter
  • Bayer
  • Bioverativ
  • CSL Behring
  • Green Cross
  • MORE

1 Table of Contents

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) - Shire
3.2.2 Adynovate (rurioctocog alfa pegol) - Shire
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) - Bioverativ
3.2.7 Nuwiq (simoctocog alfa) - Octapharma
3.2.8 NovoEight (turoctocog alfa) - Novo Nordisk
3.2.9 GreenGene F (beroctocog alfa) - Green Cross
3.2.10 Obizur (susoctocog alfa) - Shire
3.2.11 Afstyla (lonoctocog alfa) - CSL Behring
3.3 Marketed Products - Hemophilia B
3.3.1 Alprolix (eftrenonacog alfa) - Bioverativ
3.3.2 BeneFix (nonacog alfa) - Pfizer
3.3.3 Rixubis (nonacog gamma) - Shire
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 Emicizumab (ACE-910/RG6013) - Roche and Chugai Pharma
4.4.2 N8-GP (turoctocog alfa pegol) - Novo Nordisk
4.4.3 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
4.5.2 Ixinity (trenonacog alfa) - Aptevo Therapeutics
4.6 Promising Pipeline Candidates - Hemophilia A and B
4.6.1 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 Size
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development
5.2.3 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development
5.3 Clinical Trial Duration
5.3.1 Clinical Trial Duration by Molecule Type
5.3.2 Clinical Trial Duration by Molecular Target
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 IND/CTA-filed
9.1.4 Phase I
9.1.5 Phase II
9.1.6 Phase III
9.1.7 Pre-registration
9.2 Market Forecasts to 2023
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

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, Licensing Deals Valued Above $10m, 2006-2017
Table 5: Hemophilia A and B Therapeutics Market, Global, Co-development Deals with Disclosed Deal Value, 2006-2017
Table 6: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Discovery, 2017
Table 7: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017
Table 8: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2017
Table 9: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase I, 2017
Table 10: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase II, 2017
Table 11: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Phase III, 2017
Table 12: Hemophilia A and B Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017
Table 13: Hemophilia A Therapeutics Market, Asia-Pacific, Market Forecast, 2016-2023
Table 14: Hemophilia B Therapeutics Market, Asia-Pacific, Market Forecast, 2016-2023
Table 15: Hemophilia A Therapeutics Market, India, Market Forecast, 2016-2023
Table 16: Hemophilia B Therapeutics Market, India, Market Forecast, 2016-2023
Table 17: Hemophilia A Therapeutics Market, China, Market Forecast, 2016-2023
Table 18: Hemophilia B Therapeutics Market, China, Market Forecast, 2016-2023
Table 19: Hemophilia A Therapeutics Market, Australia, Market Forecast, 2016-2023
Table 20: Hemophilia B Therapeutics Market, Australia, Market Forecast, 2016-2023
Table 21: Hemophilia A Therapeutics Market, South Korea, Market Forecast, 2016-2023
Table 22: Hemophilia B Therapeutics Market, South Korea, Market Forecast, 2016-2023
Table 23: Hemophilia A Therapeutics Market, Japan, Market Forecast, 2016-2023
Table 24: Hemophilia B Therapeutics Market, Japan, Market Forecast, 2016-2023

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, 2017
Figure 4: Pipeline for Hemophilia A and B Therapeutics by Molecular Target, Global, 2017
Figure 5: Hemophilia A and B Therapeutics Market, APAC, Emicizumab Market ($m), 2018-2023
Figure 6: Hemophilia A and B Therapeutics Market, APAC, N8-GP Market ($m), 2020-2023
Figure 7: Hemophilia A and B Therapeutics Market, APAC, BAY94-9027 Market ($m), 2019-2023
Figure 8: Hemophilia A and B Therapeutics Market, APAC, N9-GP Market ($m), 2018-2023
Figure 9: Hemophilia A and B Therapeutics Market, APAC, CSL-689 Market ($m), 2021-2023
Figure 10: Hemophilia A and B Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Treatment of Hemophilia A
Figure 11: Hemophilia A and B Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Treatment of Hemophilia B
Figure 12: Hemophilia A and B Therapeutics Market, Competitor Matrix for Hemophilia A Marketed and Pipeline Products, 2017
Figure 13: Hemophilia A and B Therapeutics Market, Competitor Matrix for Hemophilia B Marketed and Pipeline Products, 2017
Figure 14: Hemophilia A and B Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016
Figure 15: Hemophilia A and B Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016
Figure 16: Hemophilia A and B Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016
Figure 17: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016
Figure 18: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016
Figure 19: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016
Figure 20: Hemophilia A and B Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016
Figure 21: Hemophilia A and B Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016
Figure 22: Hemophilia A and B Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016
Figure 23: Hemophilia A and B Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 24: Hemophilia A and B Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target
Figure 25: Hemophilia A and B Therapeutics Market, APAC, Treatment Patterns (000’), 2016-2023
Figure 26: Hemophilia A and B Therapeutics Market, APAC, Market Size ($m), 2016-2023
Figure 27: Hemophilia A and B Therapeutics Market, India, Treatment Patterns (000’), 2016-2023
Figure 28: Hemophilia A and B Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023
Figure 29: Hemophilia A and B Therapeutics Market, India, Market Size ($m), 2016-2023
Figure 30: Hemophilia A and B Therapeutics Market, China, Treatment Patterns (000’), 2016-2023
Figure 31: Hemophilia A and B Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023
Figure 32: Hemophilia A and B Therapeutics Market, China, Market Size ($m), 2016-2023
Figure 33: Hemophilia A and B Therapeutics Market, Australia, Treatment Patterns (‘000), 2016-2023
Figure 34: Hemophilia A and B Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023
Figure 35: Hemophilia A and B Therapeutics Market, Australia, Market Size ($m), 2016-2023
Figure 36: Hemophilia A and B Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016-2023
Figure 37: Hemophilia A and B Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023
Figure 38: Hemophilia A and B Therapeutics Market, South Korea, Market Size ($m), 2016-2023
Figure 39: Hemophilia A and B Therapeutics Market, Japan, Treatment Patterns (‘000), 2016-2023
Figure 40: Hemophilia A and B Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023
Figure 41: Hemophilia A and B Therapeutics Market, Japan, Market Size ($m), 2016-2023
Figure 42: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017
Figure 43: Hemophilia A and B Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017
Figure 44: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017
Figure 45: Hemophilia A and B Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017
Figure 46: Hemophilia A and B Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2017
Figure 47: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2017
Figure 48: 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, 2006-2017
Figure 49: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017
Figure 50: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2017
Figure 51: Hemophilia A and B Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2017

Note: Product cover images may vary from those shown
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  • Aptevo Therapeutics
  • Baxter
  • Bayer
  • Bioverativ
  • CSL Behring
  • Green Cross
  • Novo Nordisk
  • Octapharma
  • Pfizer
  • Roche and Chugai Pharma
  • Shire
Note: Product cover images may vary from those shown
5 of 5
Note: Product cover images may vary from those shown
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