Major Trends and Emerging Patterns in the Prothrombin Complex Concentrate Market: Development Of Innovative Formulations In The Market
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What Is the Estimated Market Size of the Prothrombin Complex Concentrate Market In 2029?
In recent times, the market for prothrombin complex concentrate has seen substantial growth. It is projected to increase from a worth of $1.29 billion in 2024 to $1.39 billion in 2025, with a compound annual growth rate (CAGR) of 7.8%. This historical growth trend can be linked to a surge in bleeding disorders incidence, heightened usage for warfarin reversal, increased recognition of coagulation treatments, a rise in the number of surgical procedures, and an uptick in trauma cases.
Significant expansion is forecasted in the prothrombin complex concentrate market in the upcoming years, with its value predicted to rise to $1.86 billion by 2029, exhibiting a compound annual growth rate of 7.6%. The predicted growth during this period is primarily attributed to the escalating demand for rapid coagulation therapies, an increased occurrence of hemophilia and liver-related ailments, the widening use in emergency medical situations, the broadening applications in cardiovascular surgeries, and the growth in health care expenses. Key trends to watch during this forecast period encompass the incorporation of AI-led diagnostics, advancements in the development of recombinant coagulation factors, next-gen recombinant pccs, personalized dosing algorithms, and improvements in the realm of blood plasma products.
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What Are the Primary Drivers Supporting the Market Growth of the Prothrombin Complex Concentrate Market?
The escalating occurrence of blood clotting disorders is predicted to catalyze the expansion of the prothrombin complex concentrate market in the future. These disorders are health conditions in which blood fails to clot as it should, resulting in excessive bleeding due to defective or depleted clotting factors or platelets. Hemophilia, liver diseases, increased use of anticoagulant drugs, and Vitamin K deficiencies are some of the major contributors to the surge in such disorders. Prothrombin complex concentrate assists in controlling these disorders by promptly replenishing clotting factors which play a crucial role in ensuring efficient blood clotting and hemostasis. As per the information released in November 2023 by the National Library of Medicine, a medical library based in the U.S, a study in 2022 involving 10,276 patients suffering from hemophilia was conducted at 87 treatment centers in 40 countries. Nearly half (49%) of these patients suffered from severe hemophilia, a vast majority (99%) were men, and 85% were diagnosed with Hemophilia A. 67% of these patients were from countries with low to middle-income levels. Therefore, the rise in blood clotting disorders is accelerating the growth of the prothrombin complex concentrate market. Due to the rising instances of cardiovascular diseases, the prescription rate of anticoagulants has surged, promoting market growth. Anticoagulants are substances designed to prevent or minimize blood clot formation by disrupting coagulation factors or platelet aggregation. The heightened prescription of these substances is due to factors like increased cardiovascular diseases, aging population, growing clinical indications, enhanced screening methods, and progression in anticoagulant treatment. Prothrombin complex concentrate mitigates the effects of anticoagulants by promptly replenishing clotting factors and reinstating hemostasis in patients with excessive bleeding or those undergoing urgent surgical procedures. For example, as per the National Health Service, UK, in 2022 close to 460,000 people began taking anticoagulant medications and more than 24 million prescriptions were given out to patients. Consequently, an estimated 17,000 strokes and 4,000 deaths were prevented. This increased prescription rate of anticoagulants is thus propelling the prothrombin complex concentrate market.
Which Primary Segments of the Prothrombin Complex Concentrate Market Are Driving Growth and Industry Transformations?
The prothrombin complex concentrate market covered in this report is segmented –
1) By Product: 3-Factor Prothrombin Complex Concentrates, 4-Factor Prothrombin Complex Concentrates, Other Products
2) By Indication: Haemorrhagic Episodes In Factor IX Deficiency (Haemophilia B), Trauma, Life-Threatening Coagulopathy With Acute Bleeding, Warfarin-Associated Acute, Life-Threatening Bleeding, Non-Warfarin Anticoagulant Reversal With Acute Bleeding
3) By Route Of Administration: Intravenous, Subcutaneous, Intramuscular
4) By End-Use: Hospital And Ambulatory Surgical Centers, Specialty Clinics, Other End Users
Subsegments:
1) By Type: Low-Dose 3-Factor Prothrombin Complex Concentrates (PCC), High-Dose 3-Factor Prothrombin Complex Concentrates (PCC), Lyophilized 3-Factor Prothrombin Complex Concentrates (PCC)
2) By Type: Low-Dose 4-Factor Prothrombin Complex Concentrates (PCC), High-Dose 4-Factor Prothrombin Complex Concentrates (PCC), Activated 4-Factor Prothrombin Complex Concentrates (PCC)
3) By Type: Recombinant Coagulation Factor Complexes, Plasma-Derived Coagulation Factor Complexes, Combination Therapy Products
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Which Regions Are Key Players in the Growth of the Prothrombin Complex Concentrate Market?
North America was the largest region in the prothrombin complex concentrate market in 2024. The regions covered in the prothrombin complex concentrate market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
What Are the Most Significant Market Trends in the Prothrombin Complex Concentrate Market?
Leading players in the prothrombin complex concentrate market are pioneering new formulations such as lyophilized powders which bolster stability, augment storage, and ensure easier administration. The lyophilized powder is a freeze-dried formulation that extracts water to extend shelf life and preserve potency, enabling improved storage conditions and swift reconstitution in emergencies. For example, Octapharma USA Inc., an American biotech company, secured FDA’s nod for their four-factor prothrombin complex concentrate (4F-PCC), Balfaxar in July 2023, for immediate warfarin reversal during surgeries and invasive procedures. This approval was granted based on the findings of the LEX-209 trial, which demonstrated a 94.6% hemostatic efficacy, matching the effectiveness of Kcentra. This development highlights the sector’s commitment toward enhancing clotting therapies for improved patient outcomes in critical healthcare environments.
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What Parameters Are Used to Define the Prothrombin Complex Concentrate Market?
Prothrombin complex concentrate (PCC) is a medication containing clotting factors used to treat or prevent bleeding in patients with coagulation disorders. It is administered intravenously to rapidly restore clotting factor levels in conditions such as hemophilia, warfarin reversal, and severe bleeding episodes.
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