DelveInsight's "Hemophilia A Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Hemophilia A, historical and forecasted epidemiology as well as the Hemophilia A market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Hemophilia A market report provides current treatment practices, emerging drugs, Hemophilia A market share of the individual therapies, current and forecasted Hemophilia A market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Hemophilia A treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
Study Period: 2017-2030
Hemophilia A is an X chromosome-linked genetic disorder caused by the mutations in the genes for factor VIII (FVIII). This clotting factor is a part of the intrinsic pathway of blood coagula tion. Without enough factor VIII, the blood cannot clot properly to control bleeding. It is mainly a defect in the gene on chromosome X, females have two copies of the X chromosome. So, if the factor VIII gene on one chromosome does not work, the gene on the other chromosome can do the job of making enough factor VIII. On the other hand, males have only one X chromosome; if the factor VIII gene is missing on the male X chromosome, he will have hemophilia A that is why the most people with Hemophilia A are male.
The symptoms of Hemophilia A can vary greatly from one person to another, it ranges from mild to moderate to severe. The age of onset and frequency of bleeding episodes depend upon the amount of factor VIII protein and overall clotting ability of the blood. In most individuals, regardless of severity, bleeding episodes tend to be more frequent in childhood and adolescence than in adulthood.
Additionally, the diagnosis of Hemophilia A depends on the identification of characteristic symptoms, a detailed patient history, a thorough clinical evaluation, and a variety of specialized laboratory tests. The identification of a hemizygous F8 pathogenic variant on molecular genetic testing in a male proband confirms the diagnosis.
The treatment of Hemophilia A is mainly focused on the prophylaxis as there is no cure for hemophilia A. Treatment consists of replacing the missing clotting protein (factor VIII) and preventing the complications associated with the disorder. Replacement of this protein may be obtained through recombinant factor VIII, which is artificially created in a lab. Several recombinant forms of factor VII are also approved for the treatment of hemophilia A. In some cases, subjects with hemophilia A may develop ‘inhibitors’ against the replacement factor VIII. Inhibitors are antibodies, which are specialized proteins created by the body’s immune system to combat foreign or invading substances such as toxins or bacteria. The immune system may recognize replacement factor VIII as ‘foreign’ and create these antibodies (inhibitors), which target and destroy the replacement factor. For inhibitors treatment is mainly dependent on bypassing agents and immne tolerance therapy (ITI).
The Hemophilia A epidemiology division provide insights about historical and current Hemophilia A patient pool and forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
DelveInsight’s analysts have assessed that the total prevalent population of Hemophilia A in the 7MM was 42,458 in 2017. In addition to this, it was accessed that the total diagnosed and treated prevalent population of Hemophilia A in the 7MM was assessed to be 38,212 in 2017.
Country Wise- Hemophilia A Epidemiology
The epidemiology segment also provides the Hemophilia A epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Hemophilia A can be characterized by immediate or delayed bleeding or prolonged oozing after injuries, tooth extractions, or surgery or renewed bleeding after initial bleeding has stopped. Prolonged or delayed bleeding or wound hematoma formation after surgery is common. After circumcision, males with hemophilia A of any severity may have prolonged oozing, or they may heal normally without treatment. In severe hemophilia A, spontaneous joint bleeding is the most frequent symptom.
The treatment of hemophilia A is based upon the severity of disease if the disease is mild and moderate then on-demand (episodic) treatment will be given, and if the disease is severe, then continuous prophylaxis treatment is given. Some individuals with severe hemophilia A may receive periodic factor VIII infusions at regular intervals to prevent bleeding episodes and associated complications, such as joint damage. This is referred to as prophylactic therapy.
The treatment landscape of Hemophilia A comprises of recombinant or plasma derived Factor VIII (long and short acting) as well as antibody for non-inhibitors patients and for inhibitors Hemophilia A patients the treatment is mainly comprises of by passing agents and ITI.
The US Food and Drug Administration (FDA) has approved several recombinant forms of factor VIII for the treatment of hemophilia A, including HelixateFS (CSL Behring); Recombinate (Baxter); Kogenate FS (Bayer HealthCare); Advate (Baxter); ReFacto (Pfizer); Eloctate (Biogen-Idec), and Xyntha (Pfizer). Human plasma-derived preparations include Monarc-M (Baxter), Monoclate-P (CSL Behring), Hemofil M (Baxter), Koate-DVI (Kedrion), Nuwiq (Octapharma), Adynovate (Baxalta), and Jivi (Bayer). Individuals with mild or moderate hemophilia A may be treated with replacement therapy as needed (i.e., to treat specific bleeding episodes). This is referred to as ‘on-demand’ therapy.
Another breakthrough treatment for both Inhibitors and non-inhibitors patients is Hemlibra (Roche) which was approved by US FDA in 2017. It is a bispecific monoclonal antibody for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A.
The market size of Hemophilia A in seven major markets (7MM) is estimated to be USD 5,760 million in 2017. The United States accounts for the highest market size of Hemophilia A, i.e., USD 3,178 million, in comparison to the other major markets i.e., EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Among the EU5 countries, the United Kingdom had the highest market size in 2017, while Spain had the lowest market size of Hemophilia A in 2017.
Key Findings
This section includes a glimpse of the Hemophilia A market in 7MM.
The United States Market Outlook
This section provides the total Hemophilia A market size and market size by therapies in the United States.
EU-5 Countries: Market Outlook
The total Hemophilia A market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.
Japan Market Outlook
The total Hemophilia A market size and market size by therapies in Japan is also mentioned.
With the launch of emerging therapies like Valoctocogene Roxaparvovec (BMN 270, a product of Biomarin Pharmaceutical), which is a gene therapy based on the use of adeno-associated virus (AAV) vectors, Concizumab (NN7415, a product of Novo Nordisk), Fitusiran (Sanofi Genzyme/ Alnylam Pharmaceuticals), BIVV001 (Sanofi), Marstacimab (Pfizer), SPK-8011 (Spark Therapeutics) and others, the market of Hemophilia A is anticipated to change during the forecast period (2019–2030).
Products that are anticipated to be launched during the forecast period are in late clinical stages of development, while others are in ongoing late clinical development stages. Some of the above-mentioned drug candidates have shown very promising results and it has been anticipated by DelveInsight’s analysts that completion of clinical development and launch of these products in the market, might increase the market share of these companies, and besides this, patients of Hemophilia A will have better management practices.
According to our assessment, potential emerging candidates shall launch in the upcoming years of the forecast period [2019–2030], and with their anticipated launch, the market size of Hemophilia A will also experience significant growth.
The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Hemophilia A key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Hemophilia A emerging therapies.
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
To keep up with current market trends, we take KOLs and SME's opinion working in Hemophilia A domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Hemophilia A market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
We perform Competitive and Market Intelligence analysis of the Hemophilia A Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.
Market Insights:
Epidemiology Insights:
What is Hemophilia A?
Hemophilia A is a genetic bleeding disorder in which an individual lacks or has low levels of proteins named clotting factor VIII
What was the market size of Hemophilia A in 2017?
The market size for Hemophilia A was found to be USD 5,760 Million in 2017
What are the Hemophilia A market drivers?
Popularity of Gene Therapy, Development of Novel Treatments with extended half-life, and Increased Focus on Prophylactic Treatment are the Hemophilia A market drivers
What are the Hemophilia A market barriers?
High Cost of Treatment, Inconvenience and Scheduling Barriers, and Lack of Skilled Healthcare Professionals are the Hemophilia A market barriers
Which companies are developing drugs for Hemophilia A?
Biomarin Pharmaceutical, Novo Nordisk, Sanofi, Pfizer, Catalyst Biosciences, OPKO Biologics, Spark Therapeutics, Sangamo therapeutics are developing drugs for Hemophilia A
1. Key Insights
2. Executive Summary of Hemophilia A
3. Competitive Intelligence Analysis for Hemophilia A
4. Hemophilia A: Market Overview at a Glance
4.1. Hemophilia A Total Market Share (%) Distribution in 2017
4.2. Hemophilia A Total Market Share (%) Distribution in 2030
5. Hemophilia A: Disease Background and Overview
5.1. Introduction
5.2. Sign and Symptoms
5.3. Pathophysiology
5.4. Risk Factors
5.5. Diagnosis
6. Patient Journey
7. Hemophilia A Epidemiology and Patient Population
7.1. Epidemiology Key Findings
7.2. Assumptions and Rationale: 7MM
7.3. Epidemiology Scenario: 7MM
7.3.1. Hemophilia A Epidemiology Scenario in the 7MM (2017-2030)
7.4. United States Epidemiology
7.4.1. Hemophilia A Epidemiology Scenario in the United States (2017-2030)
7.5. EU-5 Country-wise Epidemiology
7.5.1. Germany Epidemiology
7.5.1.1. Hemophilia A Epidemiology Scenario in Germany (2017-2030)
7.5.2. France Epidemiology
7.5.2.1. Hemophilia A Epidemiology Scenario in France (2017-2030)
7.5.3. Italy Epidemiology
7.5.3.1. Hemophilia A Epidemiology Scenario in Italy (2017-2030)
7.5.4. Spain Epidemiology
7.5.4.1. Hemophilia A Epidemiology Scenario in Spain (2017-2030)
7.5.5. United Kingdom Epidemiology
7.5.5.1. Hemophilia A Epidemiology Scenario in the United Kingdom (2017-2030)
7.5.6. Japan Epidemiology
7.5.6.1. Hemophilia A Epidemiology Scenario in Japan (2017-2030)
8. Treatment Algorithm, Current Treatment, and Medical Practices
8.1. Hemophilia A Treatment and Management
8.2. Hemophilia A Treatment Algorithm
9. Unmet Needs
10. Key Endpoints of Hemophilia A Treatment
11. Marketed Products
11.1. List of Marketed Products in the 7MM
11.2. Drug Name: Company Name
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Pivotal Clinical Trials
11.2.5. Summary of Pivotal Clinical Trial
List to be continued in report
12. Emerging Therapies
12.1. Key Cross
12.2. Drug Name: Company Name
12.2.1. Product Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.4. Safety and Efficacy
12.2.5. Product Profile
List to be continued in report
13. Hemophilia A: Seven Major Market Analysis
13.1. Key Findings
13.2. Hemophilia A Market Size in 7MM
13.3. Hemophilia A Market Size by Therapies in the 7MM
14. Attribute analysis
15. 7MM: Market Outlook
15.1. United States: Market Size
15.1.1. Hemophilia A Total Market Size in the United States
15.1.2. Hemophilia A Market Size by Therapies in the United States
15.2. EU-5 countries: Market Size and Outlook
15.3. Germany Market Size
15.3.1. Hemophilia A Total Market Size in Germany
15.3.2. Hemophilia A Market Size by Therapies in Germany
15.4. France Market Size
15.4.1. Hemophilia A Total Market Size in France
15.4.2. Hemophilia A Market Size by Therapies in France
15.5. Italy Market Size
15.5.1. Hemophilia A Total Market Size in Italy
15.5.2. Hemophilia A Market Size by Therapies in Italy
15.6. Spain Market Size
15.6.1. Hemophilia A Total Market Size in Spain
15.6.2. Hemophilia A Market Size by Therapies in Spain
15.7. United Kingdom Market Size
15.7.1. Hemophilia A Total Market Size in the United Kingdom
15.7.2. Hemophilia A Market Size by Therapies in the United Kingdom
15.8. Japan Market Outlook
15.8.1. Japan Market Size
15.8.2. Hemophilia A Total Market Size in Japan
15.8.3. Hemophilia A Market Size by Therapies in Japan
16. Access and Reimbursement Overview of Hemophilia A
17. KOL Views
18. Market Drivers
19. Market Barriers
20. Appendix
20.1. Bibliography
20.2. Report Methodology
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
*The table of contents is not exhaustive; the final content may vary.
Table 1 : 7MM Hemophilia A Epidemiology (2017-2030)
Table 2 : 7MM Hemophilia A Diagnosed and Treatable Cases (2017-2030)
Table 3 : Disease% Epidemiology in the United States (2017-2030)
Table 4 : Hemophilia A Diagnosed and Treatable Cases in the United States (2017-2030)
Table 5 : Hemophilia A Epidemiology in Germany (2017-2030)
Table 6 : Hemophilia A Diagnosed and Treatable Cases in Germany (2017-2030)
Table 7 : Hemophilia A Epidemiology in France (2017-2030)
Table 8 : Hemophilia A Diagnosed and Treatable Cases in France (2017-2030)
Table 9 : Hemophilia A Epidemiology in Italy (2017-2030)
Table 10 : Hemophilia A Diagnosed and Treatable Cases in Italy (2017-2030)
Table 11 : Hemophilia A Epidemiology in Spain (2017-2030)
Table 12 : Hemophilia A Diagnosed and Treatable Cases in Spain (2017-2030)
Table 13 : Hemophilia A Epidemiology in the UK (2017-2030)
Table 14 : Hemophilia A Diagnosed and Treatable Cases in the UK (2017-2030)
Table 15 : Hemophilia A Epidemiology in Japan (2017-2030)
Table 16 : Hemophilia A Diagnosed and Treatable Cases in Japan (2017-2030)
Table 17 : Drug Name, Clinical Trials by Recruitment status
Table 18 : Drug Name, Clinical Trials by Zone
Table 19 : Total Seven Major Market Size in USD, Million (2017-2030)
Table 20 : Region-wise Market Size in USD, Million (2017-2030)
Table 21 : 7MM-Market Size by Therapy in USD, Million (2017-2030)
Table 22 : United States Market Size in USD, Million (2017-2030)
Table 23 : United States Market Size by Therapy in USD, Million (2017-2030)
Table 24 : Germany Market Size in USD, Million (2017-2030)
Table 25 : Germany Market Size by Therapy in USD, Million (2017-2030)
Table 26 : France Market Size in USD, Million (2017-2030)
Table 27 : France Market Size by Therapy in USD, Million (2017-2030)
Table 28 : Italy Market Size in USD, Million (2017-2030)
Table 29 : Italy Market Size by Therapy in USD, Million (2017-2030)
Table 30 : Spain Market Size in USD, Million (2017-2030)
Table 31 : Spain Market Size by Therapy in USD, Million (2017-2030)
Table 32 : United Kingdom Market Size in USD, Million (2017-2030)
Table 33 : United Kingdom Market Size by Therapy in USD, Million (2017-2030)
Table 34 : Japan Market Size in USD, Million (2017-2030)
Table 35 : Japan Market Size by Therapy in USD, Million (2017-2030)
*The list of tables is not exhaustive; the final content may vary
Figure 1 : 7MM Hemophilia A Epidemiology (2017-2030)
Figure 2 : 7MM Hemophilia A Diagnosed and Treatable Cases (2017-2030)
Figure 3 : Hemophilia A Epidemiology in the United States (2017-2030)
Figure 4 : Hemophilia A Diagnosed and Treatable Cases in the United States (2017-2030)
Figure 5 : Hemophilia A Epidemiology in Germany (2017-2030)
Figure 6 : Hemophilia A Diagnosed and Treatable Cases in Germany (2017-2030)
Figure 7 : Hemophilia A Epidemiology in France (2017-2030)
Figure 8 : Hemophilia A Diagnosed and Treatable Cases in France (2017-2030)
Figure 9 : Hemophilia A Epidemiology in Italy (2017-2030)
Figure 10 : Hemophilia A Diagnosed and Treatable Cases in Italy (2017-2030)
Figure 11 : Hemophilia A Epidemiology in Spain (2017-2030)
Figure 12 : Hemophilia A Diagnosed and Treatable Cases in Spain (2017-2030)
Figure 13 : Hemophilia A Epidemiology in the UK (2017-2030)
Figure 14 : Hemophilia A Diagnosed and Treatable Cases in the UK (2017-2030)
Figure 15 : Hemophilia A Epidemiology in Japan (2017-2030)
Figure 16 : Hemophilia A Diagnosed and Treatable Cases in Japan (2017-2030)
Figure 17 : Drug Name, Clinical Trials by Recruitment status
Figure 18 : Drug Name, Clinical Trials by Zone
Figure 19 : Total Seven Major Market Size in USD, Million (2017-2030)
Figure 20 : Region-wise Market Size in USD, Million (2017-2030)
Figure 21 : 7MM-Market Size by Therapy in USD, Million (2017-2030)
Figure 22 : United States Market Size in USD, Million (2017-2030)
Figure 23 : United States Market Size by Therapy in USD, Million (2017-2030)
Figure 24 : Germany Market Size in USD, Million (2017-2030)
Figure 25 : Germany Market Size by Therapy in USD, Million (2017-2030)
Figure 26 : France Market Size in USD, Million (2017-2030)
Figure 27 : France Market Size by Therapy in USD, Million (2017-2030)
Figure 28 : Italy Market Size in USD, Million (2017-2030)
Figure 29 : Italy Market Size by Therapy in USD, Million (2017-2030)
Figure 30 : Spain Market Size in USD, Million (2017-2030)
Figure 31 : Spain Market Size by Therapy in USD, Million (2017-2030)
Figure 32 : United Kingdom Market Size in USD, Million (2017-2030)
Figure 33 : United Kingdom Market Size by Therapy in USD, Million (2017-2030)
Figure 34 : Japan Market Size in USD, Million (2017-2030)
Figure 35 : Japan Market Size by Therapy in USD, Million (2017-2030)
*The list of figures is not exhaustive; the final content may vary.
