Hypofibrinogenemia – Pipeline Insight, 2020
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DelveInsight’s, “Hypofibrinogenemia – Pipeline Insight, 2020,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Hypofibrinogenemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
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.
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.
Causes
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.
Signs and Symptoms
Individuals with congenital hypfibringenemia often lack any symptoms are detected by routine lab testing of fibrinogen or when tested for it because close relatives have symptomatic hypofibrinogenmeia. Indeed, studies indicate that, among family members with the identical congenital hypofibrinogenemia mutation, some never exhibit symptoms and those that are symptomatic develop symptoms only as adults.
Diagnosis
The diagnosis of hypofibrinogenemia is indicated in individuals who have low levels (<1.5 gram/liter) of plasma fibrinogen as determined by both immunological (e.g. immunoelectrophoresis and (i.e. able to be clotted) methods. The ratio of immunological to functional fibrinogen masses should be ~1.0 as assayed with partial thromboplastin time, activated partial thromboplastin time, thrombin time, and reptilase time tests. These tests are used to distinguish hypofibrinogenemia from hypodysfibrinogenemia, a typically more severe disorder in which plasma fibrinogen levels are low and this fibrinogen includes at least in part dysfunctional fibrinogen.
Treatment
Recommended treatment of asymptomatic congenital hypofibrinogenemia depends in part on the expectations of developing bleeding and/or thrombotic complications as indicated by the personal history of the afflicted individual and family members.
Hypofibrinogenemia Emerging Drugs Chapters
This segment of the Hypofibrinogenemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Hypofibrinogenemia Emerging Drugs
Further product details are provided in the report
Hypofibrinogenemia: Therapeutic Assessment
This segment of the report provides insights about the different Hypofibrinogenemia drugs segregated based on following parameters that define the scope of the report, such as:
Phases
DelveInsight’s report covers around 5+ products under different phases of clinical development like
Hypofibrinogenemia: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hypofibrinogenemia therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hypofibrinogenemia drugs.
Report Highlights
Current Treatment Scenario and Emerging Therapies:
DelveInsight’s, “Hypofibrinogenemia – Pipeline Insight, 2020,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Hypofibrinogenemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
- Global coverage
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.
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.
Causes
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.
Signs and Symptoms
Individuals with congenital hypfibringenemia often lack any symptoms are detected by routine lab testing of fibrinogen or when tested for it because close relatives have symptomatic hypofibrinogenmeia. Indeed, studies indicate that, among family members with the identical congenital hypofibrinogenemia mutation, some never exhibit symptoms and those that are symptomatic develop symptoms only as adults.
Diagnosis
The diagnosis of hypofibrinogenemia is indicated in individuals who have low levels (<1.5 gram/liter) of plasma fibrinogen as determined by both immunological (e.g. immunoelectrophoresis and (i.e. able to be clotted) methods. The ratio of immunological to functional fibrinogen masses should be ~1.0 as assayed with partial thromboplastin time, activated partial thromboplastin time, thrombin time, and reptilase time tests. These tests are used to distinguish hypofibrinogenemia from hypodysfibrinogenemia, a typically more severe disorder in which plasma fibrinogen levels are low and this fibrinogen includes at least in part dysfunctional fibrinogen.
Treatment
Recommended treatment of asymptomatic congenital hypofibrinogenemia depends in part on the expectations of developing bleeding and/or thrombotic complications as indicated by the personal history of the afflicted individual and family members.
Hypofibrinogenemia Emerging Drugs Chapters
This segment of the Hypofibrinogenemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Hypofibrinogenemia Emerging Drugs
- Fibrinogen concentrate: Biotest AG
Further product details are provided in the report
Hypofibrinogenemia: Therapeutic Assessment
This segment of the report provides insights about the different Hypofibrinogenemia drugs segregated based on following parameters that define the scope of the report, such as:
- Major Players in Hypofibrinogenemia
Phases
DelveInsight’s report covers around 5+ products under different phases of clinical development like
- Mid-stage products (Phase II and Phase I/II)
- Early-stage products (Phase I/II and Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
- Route of Administration
- Subcutaneous
- Intravenous
- Intramuscular
- Oral
- Molecule Type
- Small molecules
- Gene therapies
- Fibrinogen replacements
- Blood coagulation factors
- Coagulants
- Product Type
Hypofibrinogenemia: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hypofibrinogenemia therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hypofibrinogenemia drugs.
Report Highlights
- 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 Hypofibrinogenemia.
- Hypofibrinogenemia Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Hypofibrinogenemia drugs?
- How many Hypofibrinogenemia drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage 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 therapeutics?
- What are the recent trends, drug types and novel 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 to the emerging drugs?
- Biotest AG
- ICON PLC
- Octapharma
- CSL Behring
- BT524
- Human fibrinogen concentrate
- Octafibrin
Introduction
Executive Summary
Hypofibrinogenemia: Overview
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Disease Management
Pipeline Therapeutics
Comparative Analysis
Therapeutic Assessment
Assessment by Product Type
Assessment by Stage and Product Type
Assessment by Route of Administration
Assessment by Stage and Route of Administration
Assessment by Molecule Type
Assessment by Stage and Molecule Type
Hypofibrinogenemia – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
Hypofibrinogenemia companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Hypofibrinogenemia Collaboration Deals
Company-Company Collaborations (Licensing / Partnering) Analysis
Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
Comparative Analysis
BT524: Biotest
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
Comparative Analysis
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Hypofibrinogenemia Key Companies
Hypofibrinogenemia Key Products
Hypofibrinogenemia- Unmet Needs
Hypofibrinogenemia- Market Drivers and Barriers
Hypofibrinogenemia- Future Perspectives and Conclusion
Hypofibrinogenemia Analyst Views
Hypofibrinogenemia Key Companies
Appendix
Executive Summary
Hypofibrinogenemia: Overview
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Disease Management
Pipeline Therapeutics
Comparative Analysis
Therapeutic Assessment
Assessment by Product Type
Assessment by Stage and Product Type
Assessment by Route of Administration
Assessment by Stage and Route of Administration
Assessment by Molecule Type
Assessment by Stage and Molecule Type
Hypofibrinogenemia – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
Hypofibrinogenemia companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Hypofibrinogenemia Collaboration Deals
Company-Company Collaborations (Licensing / Partnering) Analysis
Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
Comparative Analysis
BT524: Biotest
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
Comparative Analysis
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Hypofibrinogenemia Key Companies
Hypofibrinogenemia Key Products
Hypofibrinogenemia- Unmet Needs
Hypofibrinogenemia- Market Drivers and Barriers
Hypofibrinogenemia- Future Perspectives and Conclusion
Hypofibrinogenemia Analyst Views
Hypofibrinogenemia Key Companies
Appendix
LIST OF TABLES
Table 1 Total Products for Hypofibrinogenemia
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
Table 1 Total Products for Hypofibrinogenemia
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
LIST OF FIGURES
Figure 1 Total Products for Hypofibrinogenemia
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
Figure 1 Total Products for Hypofibrinogenemia
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
