Coagulation, also known as blood clotting, is a vital physiological process that helps prevent excessive bleeding and maintain hemostasis. It involves a complex mechanism of action where various clotting factors and platelets work together to form a clot, sealing off damaged blood vessels. Coagulation is used to treat a range of disease indications, including hemophilia, von Willebrand disease, deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. According to the World Health Organization (WHO), hemophilia affects approximately 1 in 10,000 people in Europe, with more than 400,000 individuals diagnosed worldwide. In the United States, around 20,000 people are estimated to have hemophilia, as reported by the Centers for Disease Control and Prevention (CDC). Deep vein thrombosis and pulmonary embolism collectively affect around 1 to 2 per 1,000 individuals per year in Europe, as per statistics from the European Society of Cardiology.
The growth drivers of the Coagulation market include increasing awareness about coagulation disorders, a growing geriatric population, and rising incidences of cardiovascular diseases. Technological advancements in diagnostic tools and treatment options, such as point-of-care testing devices and novel anticoagulants, further fuel market growth. Companies such as Takeda, ISU Abxis, Pfizer, Chiesi, AstraZeneca, United Therapeutics Corp, Octapharma, Sanofi, Regeneron, UCB, Roche, Idorsia, ImmunityBio, uniQure, Apellis, SZGIMI, Ligand, Bayer, Ultragenyx, Ascension Healthcare, and CSL Behring cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, UCB is currently conducting a clinical trial of the drug RA101495 for the treatment of paroxysmal nocturnal hemoglobinuria.
Key Developments
- In June 2023, FDA approved an IND application for Clopidogrel nano-emulsion in coronary artery disease (CAD)
- In June 2023, AstraZeneca got Preregistration Soliris in Myasthenia gravis (In children, In adolescents, Treatment-experienced) in European Union
Approved Coagulation molecules
- Clopidogrel
- Ticagrelor
- Prasugrel
- Cilostazol
- Soliris (eculizumab)
- NovoSeven (eptacog alfa)
- Advate (octocog alfa)
- Clotinab (abciximab)
- Treprostinil
- Xyntha (moroctocog alfa)
- Kengreal (cangrelor)
- Ultomiris IV (ravulizumab-cwvz IV)
- BeneFix (nonacog alfa)
- Tyvaso (treprostinil)
- Kogenate FS (octocog alfa sucrose formulation)
- Eloctate (efraloctocog alfa)
- NovoEight (turoctocog alfa)
- Adynovate (rurioctocog alfa pegol)
- Rupex (rupatadine)
- Feiba (human plasma derived anti-inhibitor coagulant complex)
- Gohibic (vilobelimab)
- Nuwiq (simoctocog alfa)
- Cablivi (caplacizumab)
- Empaveli (pegcetacoplan SC)
- bezafibrate
- Alprolix (eftrenonacog alfa)
- Jivi (damoctocog alfa pegol)
- Esperoct (turoctocog alfa pegol)
- NovoThirteen (catridecacog)
- Wilate (human factor VIII)
- Rebinyn (nonacog beta pegol)
- Coversin SC (nomacopan SC)
- Kovaltry (octocog alfa)
- Rixubis (nonacog gamma)
- Biostate (factor VIII)
- Haemate-P (human plasma derived von Willebrand factor
- Ixinity (trenonacog alfa)
- Optivate (factor VIII)
- Tavneos (avacopan)
- Zimura (avacincaptad pegol)
- Idelvion (albutrepenonacog alfa)
- Obizur (susoctocog alfa)
- Octanate (human Factor VIII
- Vonvendi (vonicog alfa)
- Alphanate (human plasma derived von Willebrand factor)
- Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
- Disgren (triflusal)
Coagulation Pipeline Molecules
- Danicopan (ALXN2040)
- Milvexian (BMS-986177)
- Vemircopan (ALXN2050)
- Pozelimab (REGN3918)
- Zilucoplan (RA101495)
- Cemdisiran (ALN-CC5)
- Mim8
- Crovalimab (RG6107)
- Selatogrel (ACT-246475)
- Tesidolumab (LFG316)
- Abelacimab (MAA868)
- Egaptivon pegol (ARC1779)
- asundexian (BAY 2433334)
- Lampalizumab (RG7417)
- SHR2285
- Avdoralimab (IPH5401)
- Fidanacogene elaparvovec (PF-06838435)
- Pelecopan (BCX9930)
- KP104
- MK-2060
- PPY988
- STSA-1002
- TB-402
- Bentracimab (PB2452)
- Elinogrel (PRT-060128)
- Marzeptacog alfa (CB 813d)
- Treprostinil palmitil inhalation (INS1009)
- AMY-101
- Beraprost 314d (esuberaprost)
- FRSW107
- JNJ-81201887
Clinical Activity and Development of Coagulation
In the Coagulation space, more than 20 companies are conducting more than 400 clinical trials in this category of drugs. For instance,
- In June 2023, AstraZeneca released Updated adverse events data from a phase III trial of Soliris in Myasthenia gravis
- In June 2023, the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended expanded use of eculizumab for Myasthenia gravis (In children, In adolescents, Treatment experienced) in the European Union
|
Product Name |
Total Studies |
|
Danicopan (ALXN2040) |
29 |
|
Milvexian (BMS-986177) |
26 |
|
Vemircopan (ALXN2050) |
18 |
|
Pozelimab (REGN3918) |
14 |
|
Zilucoplan (RA101495) |
14 |
|
Cemdisiran (ALN-CC5) |
13 |
|
Mim8 |
9 |
|
Crovalimab (RG6107) |
9 |
|
Selatogrel (ACT-246475) |
9 |
|
Tesidolumab (LFG316) |
9 |
|
Abelacimab (MAA868) |
8 |
|
Egaptivon pegol (ARC1779) |
8 |
|
Asundexian (BAY 2433334) |
7 |
|
Lampalizumab (RG7417) |
7 |
|
SHR2285 |
6 |
|
Avdoralimab (IPH5401) |
6 |
|
Fidanacogene elaparvovec (PF-06838435) |
6 |
|
Pelecopan (BCX9930) |
6 |
|
KP104 |
5 |
|
MK-2060 |
5 |
Target Indication Analysis of Coagulation
The target indication for coagulation encompasses a range of medical conditions, including hemophilia, von Willebrand disease, deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. Coagulation disorders can lead to life-threatening complications such as uncontrolled bleeding or thrombosis. Accurate diagnosis and monitoring of coagulation parameters, such as prothrombin time, activated partial thromboplastin time, and fibrinogen levels, are essential for effective management and personalized treatment strategies. Coagulation therapies involve the administration of clotting factors, anticoagulants, or antiplatelet drugs to restore or regulate the coagulation process, thereby preventing or resolving coagulation-related abnormalities and improving patient outcomes.
Regional Analysis of Coagulation
Coagulation Market
The global Coagulation market is segmented into the United States, United Kingdom, Germany, Spain, France, Italy, and Japan. The US regional market analysis of Coagulation reveals a strong and mature market characterized by advanced healthcare infrastructure, favorable reimbursement policies, and a high prevalence of coagulation disorders. The market is dominated by key players, including Takeda, Pfizer, AstraZeneca, and Roche, who have a significant presence and extensive product portfolios. Growing awareness about coagulation disorders, the increasing geriatric population, and rising incidences of cardiovascular diseases contribute to the market's steady growth. Moreover, technological advancements in diagnostic tools and treatment options, such as point-of-care testing devices and novel anticoagulants, are driving the market further. Additionally, ongoing research and development activities focused on improving therapeutic outcomes and personalized treatments are expected to fuel market expansion in the coming years. Canada, on the other hand, is known for its well-established healthcare system and supportive regulatory framework, making it an attractive market for Coagulations. These countries are increasingly adopting Coagulations due to their efficacy and potential to improve patient outcomes. On the other hand, the Coagulation market in Europe has witnessed significant growth in recent years. Major countries driving this market include Germany, France, Italy, and Spain. These countries have a robust pharmaceutical industry, which is a key driver for the Coagulation market.
Latin America
Europe
Asia Pacific
Middle East
North America
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
- The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
- The report tracks recent innovations, key developments, and start-up details that are actively working in the market
- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
Frequently Asked Questions
Coagulation drugs are used in the management of hemophilia, von Willebrand disease, deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation.
The growth drivers of the Coagulation market include increasing awareness about coagulation disorders, a growing geriatric population, and rising incidences of cardiovascular diseases. Technological advancements in diagnostic tools and treatment options, such as point-of-care testing devices and novel anticoagulants, further fuel market growth.
The major players in this space are Takeda, ISU Abxis, Pfizer, Chiesi, AstraZeneca, United Therapeutics Corp, Octapharma, Sanofi, Regeneron, UCB, Roche, Idorsia, ImmunityBio, uniQure, Apellis, SZGIMI, Ligand, Bayer, Ultragenyx, Ascension Healthcare, and CSL Behring.
The coagulation market faces restraints due to increasing competition among manufacturers and the availability of alternative treatment options. Additionally, stringent regulatory requirements and the high cost associated with coagulation testing devices pose challenges to market growth.