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Hemlibra (Emicizumab-kxwh) - Drug Insight and Market Forecast - 2030

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    Report

  • 80 Pages
  • August 2020
  • Region: Global
  • DelveInsight
  • ID: 5135476
Overview

Hemlibra - Drug Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product based on routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with Hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. A detailed picture of the Hemlibra in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, United Kingdom), and Japan, for the study period 2017-2030 is provided in this report. The report contains a detailed description of the product covering mechanism of action, dosage and administration, route of synthesis and pharmacological studies, also including product marketed details, regulatory milestones and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly, every two weeks or every four weeks. Hemlibra was created by Chugai Pharmaceutical and is being co-developed globally by Chugai, Roche and Genentech. Hemlibra was approved by the FDA in November 2017 for adults and children with haemophilia A with factor VIII inhibitors. In April 2018, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Hemlibra (emicizumab-kxwh) for people with hemophilia A without factor VIII inhibitors. In October 2018, the US Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors.

Scope of the report

The report provides insights into:
  • A comprehensive product overview including the product description, mechanism of action, dosage and administration, route of synthesis, pharmacological studies (pharmacodynamics and pharmacokinetics) and adverse reactions.
  • Elaborated details on regulatory milestones and other development activities have been provided in this report.
  • The report also highlights the drug marketed details across the United States, Europe and Japan.
  • The report also covers the patent's information with expiry timeline around Hemlibra (emicizumab-kxwh).
  • The report contains historical and forecasted sales for Hemlibra (emicizumab-kxwh) till 2030.
  • Comprehensive coverage of the late-stage emerging therapies (Phase III) in the space with a brief snapshot of the details.
  • The report also features the SWOT analysis with analyst insights and key findings of Hemlibra (emicizumab-kxwh).

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Hemlibra (emicizumab-kxwh) Analytical Perspective

In-depth Hemlibra (emicizumab-kxwh) Market Assessment

This report provides a detailed market assessment of Hemlibra (emicizumab-kxwh) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides historical and forecasted sales data from 2017 to 2030.

Hemlibra (emicizumab-kxwh) Clinical Assessment

The report provides the clinical trials information of Hemlibra (emicizumab-kxwh) covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights
  • In the coming years, the market scenario for Hemlibra (emicizumab-kxwh) is set to change due to the extensive research in the treatment of the indicated condition and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Hemlibra (emicizumab-kxwh) dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Other approved products for the disease are giving market competition to Hemlibra (emicizumab-kxwh) and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, development activities, and some key findings provide the current market scenario of Hemlibra (emicizumab-kxwh).
  • Our in-depth analysis of the sales data of Hemlibra (emicizumab-kxwh) from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Hemlibra (emicizumab-kxwh) in the market.

Key Questions Answered
  • What is the prescribed dosage and strengths of Hemlibra (emicizumab-kxwh) are available in the market?
  • What are the common adverse reactions or side effects of Hemlibra (emicizumab-kxwh)?
  • What is the product type, route of administration and mechanism of action of Hemlibra (emicizumab-kxwh)?
  • What are the chemical specifications of Hemlibra (emicizumab-kxwh)?
  • How are the clinical trials diversified on the basis of the trial status?
  • What is the history of Hemlibra (emicizumab-kxwh), and what is its future?
  • What are the marketed details of Hemlibra (emicizumab-kxwh) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
  • How many patents have been granted to Hemlibra (emicizumab-kxwh) and when these patents will get expire?
  • What are the pros (benefits) and cons (disadvantages) of Hemlibra (emicizumab-kxwh)?
  • In which countries Hemlibra (emicizumab-kxwh) got approval and when it gets launched?
  • What are the clinical trials are currently ongoing for Hemlibra (emicizumab-kxwh)?
  • How the safety and efficacy results determined the approval of Hemlibra (emicizumab-kxwh)?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Hemlibra (emicizumab-kxwh) development?
  • What are the key designations that have been granted to Hemlibra (emicizumab-kxwh)?
  • What is the historical and forecasted market scenario of Hemlibra (emicizumab-kxwh)?
  • How is the market trend of Hemlibra (emicizumab-kxwh) is different in the Seven Major Markets (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan)?
  • What are the other approved products available and how these are giving competition to Hemlibra (emicizumab-kxwh)?
  • Which are the late-stage emerging therapies under development for the treatment of the indicated condition?

Table of Contents

1. Product Overview
1.1. Indication
1.2. Mechanism of Action
1.3. Dosage and Administration
1.4. Dosage Forms and Strengths
1.4.1 Route of Synthesis
1.5. Pharmacology
1.5.1 Pharmacodynamics
1.5.2 Pharmacokinetics
1.6. Adverse Reactions
1.7. Product Snapshot
1.8. Development Milestones of Hemlibra (emicizumab-kxwh)
1.9. Marketed Details
1.9.1 United States
1.9.2 Europe
1.9.3 Japan
1.10. Patent Details
2. SWOT Analysis
2.1. Analyst Views
3. Regulatory Milestones
3.1. Approvals
3.2. Research and Development
3.3. Clinical Trials Information
3.4. Safety and Efficacy
3.5. Product Developmental Activities
4. Market Assessment
4.1. 7MM Market Analysis
4.2. United States
4.3. Europe
4.4. Japan
4.5. Key Findings
5. Market Competitors6. Emerging Therapies
7. Appendix
7.1. Report Purchase Options
List of Tables
Table 1 Hemlibra (emicizumab-kxwh), Description
Table 2 Hemlibra (emicizumab-kxwh), Trial Diversification
Table 3 Hemlibra (emicizumab-kxwh), Marketed Details United States
Table 4 Hemlibra (emicizumab-kxwh), Marketed Details Europe
Table 5 Hemlibra (emicizumab-kxwh), Marketed Details Japan
Table 6 Patent Details: Hemlibra (emicizumab-kxwh)
Table 7 Hemlibra (emicizumab-kxwh), Clinical Trial Description, 2020
Table 8 Safety and Efficacy Results for Hemlibra (emicizumab-kxwh)
Table 9 Hemlibra (emicizumab-kxwh), 7MM Market Size from 2017 to 2030 (in Million USD)
Table 10 Hemlibra (emicizumab-kxwh), US Market Size from 2017 to 2030 (in Million USD)
Table 11 Hemlibra (emicizumab-kxwh), EU Market Size from 2017 to 2030 (in Million USD)
Table 12 Hemlibra (emicizumab-kxwh), EU5 Market Size from 2017 to 2030 (in Millions USD)
Table 13 Hemlibra (emicizumab-kxwh), Japan Market Size from 2017 to 2030 (in Million USD)
Table 14 Market Competitors
Table 15 Emerging Therapies
List of Figures
Figure 1 The Development Timeline of Hemlibra (emicizumab-kxwh)
Figure 2 Patent Details, Hemlibra (emicizumab-kxwh)
Figure 3 Hemlibra (emicizumab-kxwh), 7MM Market Size from 2017 to 2030 (in Million USD)
Figure 4 Hemlibra (emicizumab-kxwh), US Market Size from 2017 to 2030 (in Millions USD)
Figure 5 Hemlibra (emicizumab-kxwh), EU Market Size from 2017 to 2030 (in Millions USD)
Figure 6 Hemlibra (emicizumab-kxwh), EU5 Market Size from 2017 to 2030 (in Millions USD)
Figure 7 Hemlibra (emicizumab-kxwh), Japan Market Size from 2017 to 2030 (in Millions USD)