Prothrombin Complex Concentrate Market – By Product Type, By Application, By End Use & Global Forecast, 2024 – 2032

Prothrombin Complex Concentrate Market Size

The global prothrombin complex concentrate market size was valued at around USD 2.1 billion in 2023 and is estimated to grow at 9.4% CAGR from 2024 to 2032. The increased incidence of coagulation disorders and growing demand for plasma-related therapies are driving the growth of the market.
 

The increased incidence of coagulation disorders is significantly driving the growth of the prothrombin complex concentrate (PCC) market globally. As the prevalence of bleeding disorders such as Hemophilia B and acquired coagulation disorders rises, the demand for effective and rapid treatments like PCC has surged. Conditions such as Vitamin K deficiency, liver disease, and the widespread use of anticoagulant therapies like warfarin, which require swift reversal in emergency situations, are also contributing to this market expansion.
 

According to the World Federation of Hemophilia (WFH) Annual Global Survey, hemophilia affects approximately 400,000 people worldwide, and about 75% of these individuals are under-treated, particularly in developing regions where access to treatment is limited. In addition, the aging global population and the rising usage of anticoagulants among elderly individuals with cardiovascular conditions are further fueling the need for PCC. With the increasing diagnosis and awareness of these disorders, the market for PCC is expected to experience robust growth in the coming years.
 

Prothrombin complex concentrate (PCC) is a medication that contains a combination of blood clotting factors. These include clotting factors II, VII, IX, and X, along with proteins C and S in some formulations. PCC is primarily used to treat or prevent bleeding in individuals with deficiencies in these factors, such as in the case of Hemophilia B (Factor IX deficiency) or for the rapid reversal of anticoagulant therapy, such as warfarin.
 

Prothrombin Complex Concentrate Market Trends

Several key technological advancements are driving innovation and improving patient outcomes.
 

• Newer formulations of PCCs have been developed with better pharmacokinetics and safety profiles, enhancing their efficacy in managing bleeding events. For example, the development of non-activated PCCs (for routine prophylaxis) and activated PCCs for emergency situations are streamlining treatment pathways.
   
• Advances in purification processes and recombinant technologies are enabling the production of more consistent and higher-purity concentrates, reducing the risk of adverse reactions, such as thrombosis, while maintaining hemostatic efficacy.
   
• Additionally, technology-enabled monitoring systems, such as thromboelastography (TEG) and rotational thromboelastometry (ROTEM), are being used to optimize PCC administration by providing real-time information on a patient's coagulation status. These technologies allow for more precise and tailored dosing, improving patient safety.
   
• Moreover, ongoing clinical research is expanding the use of PCC beyond traditional hemophilia treatment and warfarin reversal to other acquired bleeding disorders testing, including trauma-induced coagulopathy and direct oral anticoagulant (DOAC) reversal, increasing the utility of these products.
   

Prothrombin Complex Concentrate Market Analysis

Based on product type, the market is segmented into 4-factor PCC, and 3-factor PCC. The 4-factor PCC segment dominated the market in 2023 and accounted for USD 1.2 billion.
 

• 4-factor PCC is preferred in critical care settings due to its quicker onset of action and broader applications, such as for direct oral anticoagulant (DOAC) reversal, making it more versatile and widely used across various medical emergencies. Clinical guidelines from various health organizations also recommend 4-factor PCC over 3-factor PCC in most coagulation-related treatments, further driving its market dominance.
   
• Additionally, 4-factor PCC offers a quicker onset of action compared to alternatives, making it crucial in time-sensitive medical situations. Its ability to rapidly restore hemostasis is preferred in life-threatening emergencies, contributing to higher demand and its market leadership.
   

Based on application, the prothrombin complex concentrate market is segmented into acquired coagulation factor deficiency, congenital coagulation factor deficiency, and other applications. The acquired coagulation factor deficiency segment dominated the market in 2023 with a market share of 49%.
 

• Acquired coagulation disorders, such as those caused by vitamin K deficiency, liver disease, or the use of anticoagulant medications, are more common than congenital disorders. This higher prevalence leads to increased demand for PCC products in clinical settings to manage these conditions effectively.
   
• Additionally, acquired coagulation factor deficiencies often present in acute care settings, such as during surgeries or trauma, where immediate intervention is crucial. PCC is frequently used in emergencies to restore hemostasis quickly, further driving its usage in this segment. Hospitals prioritize treatment for acquired conditions due to their immediate life-threatening nature, leading to higher market growth in this area compared to congenital deficiencies, which may require ongoing management rather than acute interventions.
   

Based on end use, the prothrombin complex concentrate market is segmented into hospital, ambulatory surgical centers, and other end-users. The hospitals segment is anticipated to reach USD 2.3 billion by 2032.
 

• Hospitals are often the first point of care for patients experiencing severe bleeding or requiring urgent reversal of anticoagulants. The presence of emergency departments allows for rapid intervention using PCC, particularly in critical situations such as trauma cases, surgeries, or complications from anticoagulant therapy.
   
• Additionally, hospitals have the necessary infrastructure, including specialized staff and equipment, to provide comprehensive care for patients with complex medical conditions. This capability facilitates not only the administration of PCC but also the monitoring and management of potential side effects or complications associated with its use.
   

North America dominated the global prothrombin complex concentrate market in 2023 with a revenue of USD 788.3 million and is anticipated to reach USD 1.7 billion by 2032.
 

• The increasing prevalence of coagulation disorders, particularly among the aging population, is driving demand for prothrombin complex concentrates (PCCs). According to the Centers for Disease Control and Prevention (CDC), conditions such as hemophilia and vitamin K deficiency are becoming more common, necessitating effective treatment options.
   
• The advanced healthcare infrastructure in the U.S. and Canada facilitates the effective administration and monitoring of PCCs. Hospitals and specialized clinics are increasingly equipped with technologies that enhance patient outcomes.
   

U.S. prothrombin complex concentrate market was valued at USD 720.5 million in 2023.
 

• The U.S. healthcare system has seen advancements in treatment protocols for managing anticoagulation and bleeding disorders. The Food and Drug Administration (FDA) has approved various PCC formulations, improving patient outcomes and safety profiles. This regulatory support encourages healthcare providers to adopt PCCs more widely, contributing to market growth.
   
• The U.S. is experiencing a significant rise in healthcare spending, including investments in biotechnology and innovative treatments for coagulation disorders. This financial commitment allows for improved research and development of prothrombin complex concentrates, leading to advanced formulations and improved efficacy.
   

UK is anticipated to witness robust growth in the global prothrombin complex concentrate market.
 

• There is increasing awareness and improved diagnostic capabilities for coagulation disorders in the UK, leading to higher rates of diagnosis and subsequent treatment with PCCs. The National Health Service (NHS) has emphasized early diagnosis, contributing to an increased patient population requiring these treatments.
   
• The UK's regulatory environment, including guidelines from the National Institute for Health and Care Excellence (NICE), encourages the use of PCCs for treating bleeding disorders and managing anticoagulant reversal, thereby driving market growth.
   

Japan is anticipated to witness high growth in prothrombin complex concentrate market, during the forecast period.
 

• Japan has one of the world's oldest populations, leading to a higher incidence of age-related health issues, including coagulation disorders. The increasing demand for effective treatments, such as PCCs, is directly correlated with the aging demographic.
   
• There is a growing trend towards adopting innovative treatment approaches for managing anticoagulation and bleeding disorders in Japan. Pharmaceutical companies are actively investing in research and development to enhance PCC formulations and delivery methods.
   

Prothrombin Complex Concentrate Market Share

The competition in the market is marked by intense rivalry, driven by the increasing demand for prothrombin complex concentrates. In addition to global leaders, advanced formulations tailored to specific advantages or accurate results are emerging, particularly in regions like North America, where technological advancements are highly emphasized. New innovations in prothrombin complex concentrates are a key competitive factor, with companies partnering with other manufacturers or research organizations to create high-quality prothrombin complex concentrates that provide efficient results. Thus, continuous innovation and advancements are vital for staying competitive in this fast-evolving industry.
 

Prothrombin Complex Concentrate Market Companies

Prominent players operating in the prothrombin complex concentrate industry include:

• CSL
• Baxter
• Emergent BioSolutions
• Grifols Biologicals
• Intas Pharmaceuticals
• Kedrion Biopharma
• LFB Group
• Octapharma
• Pfizer
• Prothya Biosolutions
• Takeda Pharmaceuticals
   

Prothrombin Complex Concentrate Industry News:

• In July 2023, Octapharma U.S. announced that Balfaxar, a prothrombin complex concentrate, received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients. This approval enhanced the company's competitiveness in the market.
   

Prothrombin complex concentrate market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Product Type

• 4-factor PCC
• 3-factor PCC

Market, By Application

• Acquired coagulation factor deficiency
• Congenital coagulation factor deficiency
• Other applications

Market, By End Use

• Hospitals
• Ambulatory surgical centers
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE