Prothrombin Complex Concentrate Market

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 market is expanding due to greater incidences of bleeding issues such as hemophilia and acquired hemorrhagic disorders coupled with prothrombin complex concentrate requirement in aiding treatment for patients suffering from vitamin K insufficiency, liver ailments, and use of blood thinners like warfarin that require prompt intervention.

Coupled with these factors, global population data from The World Federation of Hemophilia (WFH) estimates around 400,000 people are afflicted with the condition while around 75% of patients are underserved, specifically in developing countries, resulting in a boost to the PCC market.

In addition, the growing geriatric population and increased use of blood thinners with patients suffering from heart diseases have also necessitated the demand for prothrombin complex concentrate (PCC). With models continuing to become aware of new illnesses on the horizon, the PCC market is expected to grow exponentially in years to come.

Prothrombin complex concentrate treats bleeding disorders and anticoagulant reversal, as it consists of clotting factors II, VII, IX, X, and, in certain PCC formulations, C and S proteins. 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.

• Non-activated and activated prothrombin complex concentrates are among the newer formulations which have proven to be more effective at routine set levels as well as more flexible in emergency usage, thus addressing the bleeding events more efficiently.
  
• There are several benefits obtained from purification techniques and recombinant technologies such as lower chances of thrombus and improved hemostatic efficacy as well as more consistent concentrations around the production.
  
• Rotational thromboelastometry (ROTEM) and thromboelastography (TEG) have become vital tools in patient monitoring and in coordinating treatment for patients which are tailored individually based on their coagulation levels since they provide physicians with real-time data.
  
• Furthermore, clinical studies are also broadening the scope of testing for PCC, which currently only fights against hemophilia and the complications caused by warfarin, to coagulopathy induced by trauma and the use of DOACs, making these remedies even more beneficial.
  

Prothrombin Complex Concentrate Market Analysis

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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.

• The 4-factor PCC is increasingly being recommended among various health organizations' clinical guidelines for most diagnostics who have problems with blood coagulability status, which loses its role in the treatment of bleeding hemophilia or hemophilia-like syndrome. It is also recommended for reversal of direct oral anticoagulants (DOACs) during critical situations improving survival.
  
• Moreover, owing to its more effectiveness compared to its alternatives and other agents, it makes PCC useful in life-threatening situations where quicker onset of action is of utmost importance, making it a market leader.
  

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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. The higher prevalence leads to greater need for supply of PCC products in clinical setups to meet the demand set by these conditions.
  
• Also, acquired coagulation factor deficiencies are mostly prevalent in surgeries and trauma, which require immediate attention. PCC is mostly used in these types of conditions during an emergency to augment hemostasis, which in turn increases the use of this type of PCC 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. Emergency departments being available facilitates the swift use of PCC during trauma, surgery, and even during medical problems associated with the use of anticoagulants.
  
• Additionally, hospitals have the necessary infrastructure, including skilled personnel and technologies, enabling them to take care of patients with complicated medical conditions. This ability helps not only the provision of PCC but also the assessment and handling of potential adverse effects as well as any complications from its use. These factors enhance the growth of this segment.
  

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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. As per reports presented by the Centers for Disease Control and Prevention, hemophilia and vitamin K deficiency are increasing rapidly, which needs to be treated properly.
  
• Moreover, the advanced healthcare infrastructure in the U.S. and Canada assists the effective administration and monitoring of PCCs. Hospitals and specialized clinics are progressively equipped with technologies that increase patient outcomes.
  

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

• In recent years, there have been changes in the guidelines for managing patients with anticoagulation and bleeding disorders. The FDA has already given approval for different formulations of PCC and that has contributed to better outcomes and safety profiles. Such supporting regulatory frameworks enhance the acceptance of PCCs among healthcare providers and subsequently facilitate market growth.
  
• There is noticeable growth in healthcare expenditure in the U.S. including biotechnology and new therapies for coagulation problems. This makes it possible to improve R&D of prothrombin complex concentrates and thus get better formulations and more efficient products.
  

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

• There is better awareness and 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.
  
• Furthermore, the UK's regulatory environment, including guidelines from the National Institute for Health and Care Excellence (NICE), drives the use of PCCs in the management of bleeding disorders and reversal of anticoagulants, hence boosting the market.  
  

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

• Japan is one of the countries in the world with a high number of older populations, which increases the chances of developing age-related medical conditions such as coagulation disorders. There is a huge surge in the need for better therapies such as PCCs owing to the aging population.
  
• Japan is increasingly shifting toward novel therapeutic strategies for the treatment of bleeding disorders and anticoagulation management. Pharmaceutical companies are actively investing in R&D to enhance PCC formulations and delivery methods.
  

Prothrombin Complex Concentrate Market Share

The demand for prothrombin complex concentrates is constantly on the rise which has led to an increase in the competition within the market. Apart from the global players, there is a growing trend among the advanced formulations that strive to achieve a specific advantage or result in various parts of North America where technology is highly favored. New innovations in prothrombin complex concentrates are a crucial competitive factor, with companies partnering with other manufacturers or research organizations to create premium prothrombin complex concentrates that provide efficient results. Therefore, continuous innovations and improvements of new technologies are the prerequisites for being competitive in this rapidly 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
  

USPs For the Top Players:

• Advanced manufacturing capabilities with a focus on innovation.
  
• Strong global distribution network for wide market access.
  
  
• Extensive experience in plasma fractionation and product development.
  

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.
  

The 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