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.
Authors:
Mariam Faizullabhoy, Gauri Wani
Frequently Asked Questions (FAQ) :
The global prothrombin complex concentrate industry was valued at approximately USD 2.1 billion in 2023 and is estimated to grow at a 9.4% CAGR from 2024 to 2032, driven by the increased incidence of coagulation disorders and growing demand for plasma-related therapies.
The 4-factor PCC segment dominated the market in 2023, accounting for USD 1.2 billion, due to its quicker onset of action and broader applications, such as for direct oral anticoagulant (DOAC) reversal.
North America's prothrombin complex concentrate industry recorded USD 788.3 million in 2023 and is anticipated to reach USD 1.7 billion by 2032, driven by the increasing prevalence of coagulation disorders, particularly among the aging population.
Key players in the industry include CSL, Baxter, Emergent BioSolutions, Grifols Biologicals, Intas Pharmaceuticals, Kedrion Biopharma, LFB Group, Octapharma, Pfizer, and Prothya Biosolutions.