Von willebrand factor/coagulation factor viii complex (human) - Biologic Drug Details

Summary for von willebrand factor/coagulation factor viii complex (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for von willebrand factor/coagulation factor viii complex (human)

Recent Clinical Trials for von willebrand factor/coagulation factor viii complex (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Swedish Orphan Biovitrum	Phase 3
Syneos Health	Phase 3
Zagazig University	N/A

See all von willebrand factor/coagulation factor viii complex (human) clinical trials

Pharmacology for von willebrand factor/coagulation factor viii complex (human)

Physiological Effect	Increased Coagulation Activity Increased Platelet Aggregation
Established Pharmacologic Class	Human Antihemophilic Factor Human Blood Coagulation Factor
Chemical Structure	Blood Coagulation Factors Factor VIII von Willebrand Factor

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1) High Certainty: US Patents for von willebrand factor/coagulation factor viii complex (human) Derived from Brand-Side Litigation

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Market Dynamics and Financial Trajectory for Von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Market Overview

The market for von Willebrand factor (VWF)/coagulation factor VIII complex (human) is experiencing significant growth, driven by several key factors. This market is part of the broader Von Willebrand Disease (VWD) treatment landscape, which is anticipated to expand substantially in the coming years.

Market Size and Growth

The global Von Willebrand Disease market, which includes the VWF/coagulation factor VIII complex, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.99% from 2022 to 2029. The market size is expected to increase from USD 491 million in 2021 to USD 781.99 million by 2029[1].

Drivers of Market Growth

Increasing Prevalence of Von Willebrand Disease

The rising prevalence of VWD is a primary driver of market growth. VWD affects up to 1% of the U.S. population, with many cases remaining undiagnosed, which suggests a significant potential market[3].

Increasing Healthcare Infrastructure Investment

Investments in healthcare infrastructure are improving the availability and accessibility of treatments for VWD. This includes better-equipped hospitals, specialty clinics, and homecare services, all of which contribute to the market's expansion[1].

Patient Support Programs

Initiatives by public and private organizations to support patients with VWD, such as the PAN Foundation's patient aid program, are also driving market growth. These programs provide financial assistance, which helps in increasing the adoption of VWF/coagulation factor VIII complex treatments[1].

Awareness and New Therapies

Rising awareness campaigns and the launch of new therapies are further boosting the market. For instance, the FDA's orphan drug designation for products like wilate, which is the first VWF concentrate for prophylactic treatment across all forms of VWD, is a significant milestone[3].

Market Segmentation

By Type

The VWD market is segmented into three main types: Type 1, Type 2, and Type 3. Each type has different treatment requirements, with Type 3 being the most severe and requiring more intensive treatment regimens[1].

By Drugs

The market is also segmented by drugs, including Antihemophilic Factor/Von Willebrand Factor Complex, Von Willebrand Factor/Coagulation Factor VIII Complex, Von Willebrand factor (Recombinant), Desmopressin Acetate, and others. The Von Willebrand Factor/Coagulation Factor VIII Complex is a key product in this segment[1].

By End-Users

The end-users of these treatments include hospitals, specialty clinics, homecare, and others. The shift towards homecare and specialty clinics is increasing due to the need for long-term prophylaxis and better patient outcomes[1].

By Distribution Channel

The distribution channels include hospital pharmacy, retail pharmacy, online pharmacy, and others. The convenience and accessibility of online pharmacies are expected to grow in importance[1].

Key Products and Innovations

Wilate

Wilate, a Von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution, has been granted orphan drug exclusivity by the FDA for routine prophylaxis in adults and children with VWD. This product is significant as it is the first VWF concentrate indicated for prophylactic treatment across all forms of VWD[3].

Regulatory Framework

The FDA's orphan drug designation program provides significant benefits to manufacturers, including up to seven years of market exclusivity, tax credits for qualified clinical trials, and exemption from user fees. This framework encourages innovation and investment in rare disease treatments like VWD[3].

Opportunities

Research and Development

The market is fueled by an increase in research and development activities. New therapies and advanced technologies are being developed to improve treatment outcomes and patient quality of life. This includes recombinant forms of VWF, such as vonicog alfa, which aim to enhance production and reduce the risk of pathogen transmission from plasma donors[1][4].

Emerging Markets

Rising investment in emerging markets is another opportunity for growth. As healthcare infrastructure improves in these regions, the demand for VWF/coagulation factor VIII complex treatments is expected to increase[1].

Challenges

High Treatment Costs

The high cost associated with the treatment of VWD is a significant challenge. This can limit access to these treatments, especially in developing economies where healthcare infrastructure and financial resources are limited[1].

Side Effects and Lack of Awareness

Side effects linked with the treatment and a lack of awareness among people about VWD and its treatments are additional challenges. These factors can impede the growth rate of the market during the forecast period[1].

Dearth of Skilled Professionals

The lack of skilled professionals in managing VWD treatments is another challenge, particularly in developing economies. This can affect the quality of care and treatment outcomes[1].

Mechanism of Action and Clinical Significance

Von Willebrand factor (VWF) serves as a carrier protein for coagulation factor VIII (FVIII), stabilizing it in the circulation and preventing its premature clearance. The VWF/FVIII complex is crucial for hemostasis, mediating platelet adhesion and aggregation at the site of vascular injury and supporting the formation of the intrinsic tenase complex necessary for blood clotting[4][5].

Market Players

Major market players are investing heavily in research and development to improve existing treatments and develop new ones. Companies like Octapharma USA are at the forefront of these efforts, with products like wilate receiving significant regulatory approvals and market exclusivity[3].

Financial Trajectory

The financial trajectory of the VWF/coagulation factor VIII complex market is positive, driven by increasing demand, improving healthcare infrastructure, and supportive regulatory frameworks. Here are some key financial highlights:

• Market Size: Expected to reach USD 781.99 million by 2029 from USD 491 million in 2021.
• CAGR: 5.99% during the forecast period of 2022 to 2029.
• Revenue Streams: Primarily from hospital pharmacies, retail pharmacies, and increasingly from online pharmacies.
• Cost Savings: Patient support programs and tax credits from FDA orphan drug designations can help reduce costs for manufacturers and patients.

Key Takeaways

• The VWF/coagulation factor VIII complex market is growing rapidly due to increasing prevalence of VWD, improving healthcare infrastructure, and supportive patient programs.
• New therapies and innovations, such as wilate, are driving market growth.
• Regulatory frameworks like the FDA's orphan drug designation program are crucial for market expansion.
• High treatment costs, side effects, and lack of awareness are significant challenges.
• The market is expected to reach USD 781.99 million by 2029, growing at a CAGR of 5.99%.

FAQs

Q: What is the expected market size of the Von Willebrand Disease market by 2029? A: The market is expected to reach USD 781.99 million by 2029[1].

Q: What is the role of von Willebrand factor in the body? A: Von Willebrand factor (VWF) mediates platelet adhesion and aggregation at the site of vascular injury and serves as a carrier protein for coagulation factor VIII (FVIII)[4][5].

Q: What is wilate, and what is its significance in VWD treatment? A: Wilate is a Von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution, granted orphan drug exclusivity by the FDA for routine prophylaxis in adults and children with VWD. It is the first VWF concentrate indicated for prophylactic treatment across all forms of VWD[3].

Q: What are the main challenges facing the VWF/coagulation factor VIII complex market? A: High treatment costs, side effects linked with the treatment, lack of awareness, and the dearth of skilled professionals are significant challenges[1].

Q: How does the FDA's orphan drug designation program benefit manufacturers of VWD treatments? A: The program provides up to seven years of market exclusivity, tax credits for qualified clinical trials, and exemption from user fees, encouraging innovation and investment in rare disease treatments[3].

Sources

1. Data Bridge Market Research - Global Von Willebrand Disease (Factor VIII Deficiency) Market.
2. Frontiers in Immunology - Structure of Blood Coagulation Factor VIII in Complex With an Anti.
3. Octapharma USA - FDA Grants Orphan Drug Exclusivity to wilate.
4. DrugBank - Von Willebrand factor human: Uses, Interactions, Mechanism of Action.
5. Blood - von Willebrand factor biosynthesis, secretion, and clearance.