Asia-Pacific Hemophilia A Market Will Be Valued At $1,499.2m In 2023, At A CAGR Of 8.6%

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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.

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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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Table of Contents

1 Table of Contents 41.1 List of Tables 7
1.2 List of Figures 8

2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 11
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 12
2.4.1 Hemophilia A 12
2.4.2 Hemophilia B 13
2.5 Diagnosis 13
2.6 Diagnosis of Inhibitors 13
2.7 Disease stages 14
2.8 Prognosis 14
2.9 Treatment Options 14
2.9.1 Management of Bleeding with Factor Replacement Therapy 15
2.9.2 Antifibrinolytic Medication 17
2.9.3 Treatment of Inhibitors 17
2.9.4 Gene Therapy 17
2.9.5 Hemophilia A 18
2.9.6 Hemophilia B 18

3 Marketed Products 20
3.1 Overview 20
3.2 Marketed Products - Hemophilia A 20
3.2.1 Advate (octacog alfa) - Shire 20
3.2.2 Adynovate (rurioctocog alfa pegol) - Shire 22
3.2.3 Xyntha/ReFacto AF (moroctocog alfa) - Pfizer 23
3.2.4 Kogenate FS (octacog alfa) - Bayer 24
3.2.5 Kovaltry (octacog alfa) - Bayer 25
3.2.6 Eloctate (efmoroctocog alfa) - Bioverativ 27
3.2.7 Nuwiq (simoctocog alfa) - Octapharma 29
3.2.8 NovoEight (turoctocog alfa) - Novo Nordisk 30
3.2.9 GreenGene F (beroctocog alfa) - Green Cross 31
3.2.10 Obizur (susoctocog alfa) - Shire 32
3.2.11 Afstyla (lonoctocog alfa) - CSL Behring 33
3.3 Marketed Products - Hemophilia B 34
3.3.1 Alprolix (eftrenonacog alfa) - Bioverativ 34
3.3.2 BeneFix (nonacog alfa) - Pfizer 36
3.3.3 Rixubis (nonacog gamma) - Shire 37
3.3.4 Idelvion (albutrepenonacog alfa) - CSL Behring 38
3.4 Marketed Products - Hemophilia A and B 40
3.4.1 Feiba NF (anti-inhibitor coagulant complex) - Baxter 40
3.4.2 Byclot (freeze-dried-activated human blood coagulation factor VII concentrate containing factor X) - Kaketsuken 40
3.5 Comparative Efficacy and Safety of Marketed Products 41

4 Pipeline Analysis 44
4.1 Overview 44
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 44
4.3 Pipeline by Molecular Target 45
4.4 Promising Pipeline Candidates - Hemophilia A 47
4.4.1 Emicizumab (ACE-910/RG6013) - Roche and Chugai Pharma 47
4.4.2 N8-GP (turoctocog alfa pegol) - Novo Nordisk 50
4.4.3 BAY94-9027 (damoctocog alfa pegol) - Bayer 52
4.5 Promising Pipeline Candidates -Hemophilia B 54
4.5.1 N9-GP/NN-7999 (nonacog beta pegol) - Novo Nordisk 54
4.5.2 Ixinity (trenonacog alfa) - Aptevo Therapeutics 56
4.6 Promising Pipeline Candidates - Hemophilia A and B 57
4.6.1 CSL-689 (recombinant activated VII-FP) - CSL Behring 57
4.7 Comparative Efficacy and Safety of Pipeline Products 59
4.8 Product Competitiveness Framework 62

5 Clinical Trial Analysis 65
5.1 Failure Rate 65
5.1.1 Overall Failure Rate 65
5.1.2 Failure Rate by Phase and Molecule Type 67
5.1.3 Failure Rate by Phase and Molecular Target 67
5.2 Clinical Trial Size 68
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 68
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 69
5.2.3 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 70
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 71
5.3 Clinical Trial Duration 72
5.3.1 Clinical Trial Duration by Molecule Type 72
5.3.2 Clinical Trial Duration by Molecular Target 73
5.4 Competitive Clinical Trials Metrics Analysis 74

6 Multi-scenario Forecast 76
6.1 Geographical Markets 76
6.2 Asia-Pacific Market 76
6.3 India 79
6.3.1 Treatment Usage Patterns 79
6.3.2 Annual Cost of Therapy 80
6.3.3 Market Size 82
6.4 China 83
6.4.1 Treatment Usage Patterns 83
6.4.2 Annual Cost of Therapy 84
6.4.3 Market Size 86
6.5 Australia 87
6.5.1 Treatment Usage Patterns 87
6.5.2 Annual Cost of Therapy 88
6.5.3 Market Size 89
6.6 South Korea 90
6.6.1 Treatment Usage Patterns 90
6.6.2 Annual Cost of Therapy 91
6.6.3 Market Size 92
6.7 Japan 94
6.7.1 Treatment Usage Patterns 94
6.7.2 Annual Cost of Therapy 95
6.7.3 Market Size 96

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