Asia-Pacific Hereditary Angioedema (HAE) Therapeutics Markets 2016-2018 & 2023

DUBLIN, May 30, 2018 /PRNewswire/ --

The "HAE Therapeutics in Asia-Pacific Markets to 2023 - Growth Driven by Ongoing Shift towards Plasma-Derivative Products and Expected Launch of Premium Therapies" report has been added to ResearchAndMarkets.com's offering.

The approval of revolutionary plasma derivatives including Cinryze and Berinert for the treatment of HAE patients that are refractory to generic drugs triggered unparalleled growth in the market. Though the treatment options are limited to acute and prophylaxis patients, the HAE treatment patient pool is expected to increase over forecast period in APAC countries assessed in this report. However, competition is intensifying as governments in Australia, South Korea and Japan are looking for more affordable treatment options due to the very high treatment costs.

In 2018, two re-formulations of existing plasma derivative products will be launched one each in Japan and Australia. Despite the superior efficacy of recently marketed therapies over traditional generic therapies, there are still unmet needs in the therapeutic landscape. These include improved safety, the need to create products with more convenient and less invasive drug-delivery methods, and improved access to treatment. The difficulty of managing HAE is also compounded by poor patient adherence, a particular problem in countries where large segments of the population have limited access to healthcare.

Most significantly, the HAE market lacks curative treatments, as current therapies aim to alleviate symptoms and reduce disease progression. This major unmet need is not expected to be addressed directly by any of the pipeline agents. Additionally, any pipeline candidates that will be successfully approved and launched will compete for the same patient populations although late-stage drugs are likely to address the need for a more convenient route of administration, as the pipeline contains potential kallikrein inhibitors that can be administered orally. Products with novel mechanisms of action and safer and more efficacious profiles will be welcome additions to the market.

Scope

• The current Asia-Pacific HAE market contains premium therapies such as Berinert, Cinryze, Ruconest and Firazyr.
• What are the competitive advantages of the existing premium therapies?
• There are 24 active pipeline molecules, and the late-stage investigational drug candidates feature improved administration routes compared with currently marketed products.
• Which classes of re-formulation drugs are most prominent in the pipeline?
• What is the potential for pipeline products to address unmet needs in the HAE market?
• Analysis of clinical trials since 2006 identified that the failure rates of HAE molecules were highest in Phase III, at 14.3%.
• How do failure rates vary by stage of development, molecule type, and molecular target?
• How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?
• Over the 2016-2023 forecast period, the Asia-Pacific HAE therapeutics market is expected to grow at a CAGR of 9.6%, from $54.5m to over $103.5m.
• Which markets make the most significant contribution to the current market size?
• What are the epidemiology trends in these markets?
• Will new market entrants lead to substantial changes to annual therapy costs?
• How will different treatment usage patterns impact growth in the five assessed Asia-Pacific markets?
• The rising HAE prevalence population and the uptake of newer therapies will lead to significant market growth over the forecast period.
• Will the launch of emerging pipeline molecules threaten the commercial success of existing drugs?
• Licensing deals are the most common form of strategic alliance in the HAE therapeutics market, with deal values ranging from $2.7m to over $83m.
• How do deal frequency and value compare between target families and molecule types?
• What were the terms and conditions of key licensing deals?

Key Topics Covered:

1 Table of Contents

2 Introduction
2.1 Disease Introduction
2.2 Epidemiology
2.3 Symptoms
2.4 Etiology and Pathophysiology
2.5 Diagnosis
2.6 Prognosis
2.7 Treatment Algorithm and Treatment Options
2.7.1 On-demand Treatment (Acute Attacks)
2.7.2 Short-term Prophylaxis
2.7.3 Long-term Prophylaxis
2.7.4 Special Considerations for Children and Women
2.8 Expert involvement and Checkups
2.9 Orphan Drug Policies in APAC Countries

3 Marketed Products
3.1 Overview
3.1.1 Berinert (C1 esterase inhibitor-human) - CSL
3.1.2 Cinryze (C1 esterase inhibitor (human)) - Shire
3.1.3 Ruconest (Conestat alfa (Ruconest/Rhucin)) - Pharming Group NV
3.1.4 Firazyr (Icatibant acetate) - Shire
3.1.5 Kalbitor (Ecallantide) - Shire
3.1.6 Neurabol (Stanozolol)
3.1.7 Danazol
3.1.8 Cyklokapron (tranexamic acid) - Pfizer
3.2 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
4.4.1 SHP-616/Cinryze (C1 esterase inhibitor-human) - Shire
4.4.2 CSL-830/Berinert (C1 esterase inhibitor (human)) - CSL Behring
4.4.3 DX-2930 (Lanadelumab) - Shire
4.4.4 BCX 7353 - BioCryst
4.5 Comparative Efficacy and Safety of Pipeline Products
4.6 Product Competitiveness Framework

5 Clinical Trial Analysis
5.1 Failure Rate
5.1.1 Overall Failure Rate
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 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 Trial Duration by Molecule Type and Stage of Development
5.3.2 Trial Duration by Molecular Target and Stage of Development
5.4 Summary of Clinical Trial Metrics

6 Multi-scenario Forecast
6.1 Geographical Markets
6.2 Asia-Pacific Market
6.2.1 Treatment Usage Patterns
6.2.2 Market Size
6.3 India
6.4 China
6.5 Australia
6.6 South Korea
6.7 Japan

7 Market Dynamics (Drivers and Barriers) of HAE Market
7.1 Drivers
7.1.1 Increasing Awareness
7.1.2 Orphan Drug Assistance in APAC Countries
7.1.3 Promising Late-Stage Pipeline Products and Treatment Advancements
7.1.4 Advancements in Diagnosis
7.2 Barriers
7.2.1 HAE - An Under-researched Disease
7.2.2 No Curative Treatment Therapy
7.2.3 Delayed/Low Diagnosis and Treatment Rates
7.2.4 Steep Prices of HAE Therapeutics to Slow Down Market Growth

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
8.2.2 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
9.2 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

For more information about this report visit https://www.researchandmarkets.com/research/l2hdqx/asiapacific?w=5

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