Hypofibrinogenemia - Market Insights, Epidemiology, and Market Forecast - 2030

DelveInsight’s ‘Hypofibrinogenemia – Market Insights, Epidemiology, and Market Forecast—2030’ report deliver an in-depth understanding of the Hypofibrinogenemia, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Hypofibrinogenemia market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted Hypofibrinogenemia market size from 2017 to 2030 segmented by seven major markets. The Report also covers current Hypofibrinogenemia treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geographies Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017–2030
Hypofibrinogenemia: Disease Understanding and Treatment Algorithm
Hypofibrinogenemia Overview
Hypofibrinogenemia is a rare disorder characterized by low fibrinogen levels (<1.5 g/L), normal plasma fibrinogen levels ranging from 1.5 g/L to 4.5 g/L. It is broadly classified into two types, i.e., Congenital Hypofibrinogenemia and Acquired Hypofibrinogenemia.
Fibrinogen is a critical protein for clot formation, providing a matrix and mesh network essential for clot strength. Maintaining fibrinogen levels is an essential therapeutic target in bleeding patients, particularly in perioperative settings. Low fibrinogen levels are associated with reduced clot strength and are strongly associated with severe bleeding.
Congenital fibrinogen disorders are caused by genetic variants occurring within all three fibrinogen genes. However, each gene (FGA, FGB, FGG) differently shows specific variants, wherein “nonsense” variants are mostly found within FGA, while FGG variants are prevalently responsible for missense changes.
In congenital hypofibrinogenemia, genes responsible for producing fibrinogen (a critical blood clotting factor) are unable to make a functional fibrinogen glycoprotein because of an inherited mutation. In contrast, acquired hypofibrinogenemia can result from either severe hepatic disease or disseminated intravascular coagulation (DIC), cardiac surgery, etc.
Several genetic variants have been identified in individuals with fibrinogen disorders. The complexity of the fibrinogen molecules, formed by three non-identical chains and with a trinodal organization, renders the identification of molecular causes and clinical and biochemical phenotypes very challenging. However, the acknowledgment of the type of molecular defect is crucial for a safer therapy as it can help improve the clinical management of patients.
Hypofibrinogenemia Diagnosis and Treatment
It covers the details of conventional and current medical therapies and diagnosis available in the Hypofibrinogenemia market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
The DelveInsight Hypofibrinogenemia market report gives a thorough understanding of Hypofibrinogenemia by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides Hypofibrinogenemia treatment algorithms and treatment guidelines for Hypofibrinogenemia in the US, Europe, and Japan.
Hypofibrinogenemia Epidemiology
Hypofibrinogenemia epidemiology division provides insights about the historical and current patient pool along with the 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
The disease epidemiology covered in the report provides historical as well as forecasted Hypofibrinogenemia epidemiology segmented as the Total Cases of Hypofibrinogenemia, Type-Specific Cases of Hypofibrinogenemia (as congenital and acquired), and Acquired Hypofibrinogenemia cases. The report includes the prevalent scenario of Hypofibrinogenemia in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Country Wise- Hypofibrinogenemia Epidemiology
The epidemiology segment also provides the Hypofibrinogenemia epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The total prevalent population of Hypofibrinogenemia in 7MM countries was estimated to be 11,084 cases in 2017.
Hypofibrinogenemia Drug Chapters
The drug chapter segment of the Hypofibrinogenemia report encloses the detailed analysis of Hypofibrinogenemia marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Hypofibrinogenemia clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Fibrinogen replacement therapy is currently indicated as prophylaxis and therapy of hemorrhage in congenital and acquired fibrinogen deficiency, the latter being associated with liver failure, disseminated intravascular coagulation, massive transfusion, and cardiac surgery. Fibrinogen supplementation can be provided by transfusion of fresh-frozen plasma (FFP), cryoprecipitate, and fibrinogen concentrate.
Products detail in the report…
Hypofibrinogenemia Emerging Drugs
BT-524 (Biotest)
A novel fibrinogen concentrate purified from human plasma developed by Biotest. The company investigated the product clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency and for the acquired fibrinogen deficiency. Biotest is conducting a phase III study in multiple European countries in patients with high blood loss during spine surgery. The results of both studies will serve as a basis for the marketing authorization of fibrinogen concentrate BT524 for the treatment of patients with congenital and acquired fibrinogen deficiency.
Products detail in the report…
Hypofibrinogenemia Market Outlook
The Hypofibrinogenemia market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Hypofibrinogenemia market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.
This segment gives a thorough detail of Hypofibrinogenemia market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on an annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the Hypofibrinogenemia market in 7MM is expected to change in the study period 2017–2030.
Key Findings
This section includes a glimpse of the Hypofibrinogenemia market in 7MM. The market size of Hypofibrinogenemia in the seven major markets was found to be USD 161.5 Million in 2017.
The United States Market Outlook
This section provides a total of Hypofibrinogenemia market size and market size by therapies in the United States.
The United States accounts for the highest market size of Hypofibrinogenemia in comparison to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
Fresh frozen plasma also contains fibrinogen and is available in all hospital settings and is comparatively cheap but requires the administration of large quantities of fluid to achieve a reasonable fibrinogen dose. Although, FFP has several limitations including a low fibrinogen content, which means that large volumes must be given, and the risk of transfusion-related complications (e.g., transfusion-related acute lung injury [TRALI] and viral transmission), cryoprecipitate and fibrinogen concentrate has the major role.

Fibrinogen concentrate preparation includes safety steps for inactivation/removal of viruses, so concentrates are safer than cryoprecipitate or FFP. Furthermore, more precise dosing can be accomplished with fibrinogen concentrates because their potency is known, in contrast to FFP or cryoprecipitates. However, these products are still useful when no concentrates are available. Fibrinogen concentrates available for the treatment of Hypofibrinogenemia include Clottafact from LFB, RiaStap (CSL Behring), Fibryna (Octapharma).

EU-5 Countries: Market Outlook
Cryoprecipitate appear to be more cost-effective in the UK. The cost advantage, however, is lost in patients born after January 1996, as the national recommendation is to use methylene blue-treated non-UK-plasma products. Particularly, before these patients constitute the majority of blood recipients, it is a major challenge to keep sufficient stock of MB-treated cryoprecipitate of the optimal blood group without causing wastage due to expiry, and there is a stringent requirement to infuse this within 4 h of thawing. MF plasma products are approximately 5× as expensive as UK-based plasma products. Also, although cryoprecipitate is cheaper than fibrinogen concentrate, a recent cost-effective analysis showed that the overall costs (i.e., including compatibility testing, thawing, and administration) of cryoprecipitate and fibrinogen concentrate are quite similar.
Japan Market Outlook
The total of Hypofibrinogenemia market size and market size by therapies in Japan are also mentioned.
Hypofibrinogenemia Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017–2030. The analysis covers Hypofibrinogenemia market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
Hypofibrinogenemia Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Hypofibrinogenemia key players involved in developing targeted therapeutics.
BT-524 (Biotest) is the only emerging therapy in the developmental phase for the treatment of Congenital and Acquired Hypofibrinogenemia.

Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Hypofibrinogenemia emerging therapies.
Reimbursement Scenario in Hypofibrinogenemia
Cryoprecipitate preparation is the only available source of fibrinogen for therapeutic purposes in some countries. Despite increasing interest in the use of fibrinogen concentrates, cryoprecipitate remains the major source of fibrinogen in England. In the UK, the cryoprecipitate is provided as single units of standard cryoprecipitate or methylene-blue (MB)-treated non-UK sourced cryoprecipitate or pools of 5 units.
KOL- Views
To keep up with current market trends, we take KOLs and SME’s opinion working in Hypofibrinogenemia 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 the Hypofibrinogenemia market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform Competitive & Market Intelligence analysis of the Hypofibrinogenemia Market by using various Competitive Intelligence tools that includes – 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.
Scope of the Report
• The report covers the descriptive overview of Hypofibrinogenemia, explaining its causes, signs and symptoms, pathophysiology and currently available therapies
• Comprehensive insight has been provided into the Hypofibrinogenemia epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Hypofibrinogenemia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of Hypofibrinogenemia market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Hypofibrinogenemia market
Report Highlights
• In the coming years, Hypofibrinogenemia market is set to change due to the rising awareness of the disease, 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 Hypofibrinogenemia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Hypofibrinogenemia. Launch of emerging therapies will significantly impact the Hypofibrinogenemia market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Hypofibrinogenemia.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Hypofibrinogenemia Report Insights
• Patient Population
• Therapeutic Approaches
• Hypofibrinogenemia Pipeline Analysis
• Hypofibrinogenemia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Hypofibrinogenemia Report Key Strengths
• 11 Years Forecast
• 7MM Coverage
• Hypofibrinogenemia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hypofibrinogenemia Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
Key Questions
Market Insights:
• What were the Hypofibrinogenemia Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Hypofibrinogenemia total market Size as well as market Size by therapies across the 7MM during the forecast period (2017–2030)?
• What are the key findings of the market across 7MM and which country will have the largest Hypofibrinogenemia market Size during the forecast period (2017–2030)?
• At what CAGR, the Hypofibrinogenemia market is expected to grow in 7MM during the forecast period (2017–2030)?
• What would be the Hypofibrinogenemia market outlook across the 7MM during the forecast period (2017–2030)?
• What would be the Hypofibrinogenemia market growth till 2030 and what will be the resultant market Size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
• What are the disease risk, burden, and unmet needs of the Hypofibrinogenemia?
• What is the historical Hypofibrinogenemia patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan?
• What would be the forecasted patient pool of Hypofibrinogenemia in 7 major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan?
• What will be the growth opportunities in the 7MM concerning the patient population about Hypofibrinogenemia?
• Out of all 7MM countries, which country would have the highest prevalent population of Hypofibrinogenemia during the forecast period (2017–2030)?
• At what CAGR the population is expected to grow in 7MM during the forecast period (2017–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of Hypofibrinogenemia?
• What are the current treatment guidelines for the treatment of Hypofibrinogenemia in the USA, Europe, and Japan?
• What are the Hypofibrinogenemia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Hypofibrinogenemia?
• How many therapies are developed by each company for the treatment of Hypofibrinogenemia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Hypofibrinogenemia?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hypofibrinogenemia therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hypofibrinogenemia and their status?
• What are the key designations that have been granted for the emerging therapies for Hypofibrinogenemia?
• What are the global historical and forecasted market of Hypofibrinogenemia?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the Hypofibrinogenemia market
• To understand the future market competition in the Hypofibrinogenemia market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for Hypofibrinogenemia in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for Hypofibrinogenemia market
• To understand the future market competition in the Hypofibrinogenemia market