The prothrombin complex concentrates (PCC) market demonstrates steady growth between 2025 and 2035 because the global bleeding disorders prevalence rises together with increased anticoagulant utilization and faster emergency care reversal agent adoption.
PCCs provide essential treatment to stop bleeding and protect the blood of patients who have either haemophilia B or acquired coagulation factor deficiency and serve to cancel out the effects of warfarin and similar vitamin K antagonist medications. The market projection shows that it will expand to reach USD 1,286.8 million in 2035 from its initial value of USD 836.6 million in 2025 while demonstrating a 4.4% annual growth rate.
The use of PCCs represents superior therapy compared to plasma-based methods because they require speedier delivery and a reduced volume along with lower risks of fluid volume-related complications. The medical field actively expands its use of these compounds in trauma facilities and surgical procedures and anticoagulant bleeding cases within critical care units and emergency departments.
The implementation of PCC-friendly clinical recommendations along with rising availability of recombinant products and 4-factor drugs makes PCC therapies more accessible and effective. Investments and research in coagulation studies drive the creation of improved PCC formulations featuring better safety features and expanded treatment ability.
Key Market Metrics
| Metric | Value |
|---|---|
| Industry Size (2025E) | USD 836.6 million |
| Industry Value (2035F) | USD 1,286.8 million |
| CAGR (2025 to 2035) | 4.4% |
Explore FMI!
Book a free demo
North America dominates the PCC market on account of wide acceptance of anticoagulant therapies and strong emergency care infrastructure. Expanding use in the USA and Canada of PCCs for warfarin reversal and bleeding management in trauma and surgical patients is illustrated by the integration of clinical guidelines and hospital protocols.
Europe is consistently growing with countries like Germany, France, and the UK, where hospitals and critical care units are increasingly adopting PCCs. The region benefits from good haemophilia treatment programs, strong regulatory support for advanced blood products, and increased usage in perioperative care.
Asia-Pacific is an emerging market with rapid demand for haemostatic agents and knowledge of complications owing to anticoagulants. There is an expansion in the access to PCCs from countries like China, India, and Japan with the support of modernization in the health system and improvement in blood dis-orders management to tertiary hospitals and trauma centers.
Thrombosis Risk and Limited Use in Non-Emergency Settings
This specific segment of prothrombin concentrate products suffers from a few challenges due to the thromboembolic complications they may impose, especially in patients who have already compromised cardiovascular conditions. While obviously a very effective agent for reversing vitamin K-antagonant, generally warfarin, PCCs are limited primarily to emergency or surgical settings for reasons of safety and cost.
Conflicting clinical guidelines between regions across the world and low awareness among general practitioners are additional barriers to their widespread use. Also, in low-resource settings, availability of PCCs is a limiting factor, with fresh frozen plasma (FFP) being more commonly used in its place, acting slower and creating a higher volume problem.
Growing Demand for Rapid Anticoagulant Reversal
The prothrombin complex concentrates market is gaining momentum, with better acceptance for use in oral anticoagulants, growing incidences of urgent surgical needs, and major bleeding events along its pathway. PCCs are being offered as a rapid, low-volume method for reversing anticoagulation in settings such as trauma, neurosurgical, and emergency settings, standing in contrast to FFP.
There is much development of the 4-factor prothrombin complex concentrate formulations, along with an increased range in clinical guidelines and pharmacoeconomic support, all helping to increase acceptance of the use of the PCC. As health systems keep focusing on possibilities for rapid bleeding control and perioperative management, the prothrombin complex concentrate concept will become pivotal in hospital and out-of-hospital emergency protocols.
Between the years 2020 to 2024, the use of PCC has increased in emergency departments and surgical facilities, primarily for indications of warfarin reversal and trauma-induced bleeding. The 4F-PCCs became standard to use in many high-income countries.
Market will see changes during 2025 to 2035 market favour more indications, including the reversal of DOACs, with accompanying real-world studies and increased clinical consensus. Further innovations in lyophilized formulations, lower thrombosis risk profiles, and point-of-care administration models will continue to improve access to emergency care both in hospitals and in the ambulatory setting.
Market Shifts: Comparative Analysis (2020 to 2024 vs. 2025 to 2035)
| Market Factor | 2020 to 2024 |
|---|---|
| Regulatory Landscape | Approved primarily for vitamin K antagonist reversal. |
| Technological Advancements | 3F- and 4F-PCC formulations with manual dosing calculations. |
| Sustainability Trends | Limited focus on cold-chain logistics and single-use efficiency. |
| Market Competition | Led by plasma-derived product manufacturers and hematology firms. |
| Industry Adoption | Used in trauma, neurosurgery, and warfarin-related bleeding. |
| Consumer Preferences | Focused on speed of reversal and minimal infusion volume. |
| Market Growth Drivers | Boosted by anticoagulant use and trauma-related bleeding cases. |
| Market Factor | 2025 to 2035 |
|---|---|
| Regulatory Landscape | Expansion to off-label DOAC reversal and global harmonization of bleeding management protocols. |
| Technological Advancements | Rise of lyophilized, pre-filled, and AI-assisted dose prediction platforms. |
| Sustainability Trends | Shift to shelf-stable packaging, low-waste reconstitution, and streamlined emergency kits. |
| Market Competition | Entry of biosimilar PCCs, trauma care solution providers, and perioperative biotech innovators. |
| Industry Adoption | Expands to DOAC reversal, outpatient settings, and pre-hospital emergency services. |
| Consumer Preferences | Shift to broader safety profile, ease of administration, and inclusion in hospital rapid-response kits. |
| Market Growth Drivers | Accelerated by DOAC prevalence, aging demographics, and evolution of global bleeding management guidelines. |
The PCC market in the United States is showing a consistent growth pattern, thanks to the increasing use of anticoagulants such as warfarin and the requirement for fast reversal in trauma or surgical casualties. The USA trauma centers and cardiac surgery units have recently been turning to PCCs for timely action and low risk when compared to the alternatives derived from blood plasma.
The 4-factor PCCs approved by the FDA for clinical usage found high penetration into healthcare institutions with their articulate orientations in guideline-modulated protocols of the hospitals regarding the reversal management of Vitamin K antagonist and DOAC related bleeding.
| Country | CAGR (2025 to 2035) |
|---|---|
| USA | 4.2% |
The PCC market in the UK has been increasing only at a moderate pace since the incorporation of PCC guidelines in the NHS which would give preference to PCC over fresh frozen plasma in warfarin reversal. Administration of PCC has also increased in the areas of stroke units, emergency departments, as well as during perioperative settings.
Both hospital formularies and national procurement policies assist in streamlining access to PCCs in acute care settings, especially to older persons and persons with very high cardiovascular risks.
| Country | CAGR (2025 to 2035) |
|---|---|
| UK | 4.1% |
The European Union is still a significant market for PCCs as in Germany, France, and the Netherlands, which were already known for advanced clinical practices in emergency hematology and yet further demanded by such EU guidelines that propagated 3-and 4-factor PCCs for treatment of huge hemorrhagic events and perioperative reversal of anticoagulation.
Regional manufacturers are increasingly focusing on recombinant and virus-inactivated formulations to improve safety and supply chain stability across European hospitals.
| Region | CAGR (2025 to 2035) |
|---|---|
| European Union | 4.4% |
The PCC market of Japan is developing steadily, considering the factor that there is an aging population that depends on long-term anticoagulant therapy and the increased number of cardiovascular surgeries. Institutions are adopting the use of PCCs into their guidelines in rapidly correcting haemostasis in emergency and interventional care settings.
Cost-effectiveness with sound clinical proof will encourage the local market in the uptake of PCC products approved by government regulation.
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 4.3% |
The PCC market of South Korea is showing steady growth with modernization of the emergency department and cardiovascular care. PCCs are fast gaining acceptance as the preferred drug over plasma for urgent reversal of all anticoagulants with a very high uptake in tertiary hospitals.
Pharmaceutical companies based in Korea are also working on internal manufacturing and obtaining regulatory approval for lower-cost PCC alternatives to improve the national supply chain.
| Country | CAGR (2025 to 2035) |
|---|---|
| South Korea | 4.7% |
The prothrombin complex concentrates (PCCs) are accelerating at a rapid pace due to the growing incidence of anticoagulation therapy, aging population, and incidence of acute transfusion of life-threatening bleeding in emergency rooms. PCCs are pivotal for urgent reversal of vitamin K antagonist anticoagulants and the substitution of clotting factors.
Its most paramount domain is the management of life-threatening bleeding associated with warfarin. To further explain this fact, with the widespread therapy of warfarin comes great urgency in treating its adverse effects. The overt criticism by hospital pharmacies of PCCs is not unfounded, considering their importance in emergency departments, intensive care units, and perioperative settings.
These segments together provide much insight into the life-saving potential for PCCs amidst growing demand in high-acuity medical environments, where survival is dependent on every second.
| Treatment Type | Market Share (2025) |
|---|---|
| Warfarin-Associated Acute Life-Threatening Bleeding | 46.8% |
Warfarin-associated acute life-threatening bleeding is the predominant segment of the PCC market for therapeutic medical types because the inconvenience of high frequency related to complications on the foundation of anticoagulants and the most urgent need for rapid reversal. Warfarin is the clinically most common and established oral anticoagulant that prevents thromboembolic events.
Although it is the most common anticoagulant, it has a high risk of bleeding and particularly is present in the elderly and the financially disabled undergoing an invasive procedure. In an emergency, PCCs serve as the most preferred reversal agent, rapidly restoring clotting factor levels and minimizing the requirement of transfusion with plasma.
Currently, clinical guidelines recommend PCCs for warp of membrane rather than fresh blood. They have a faster onset and lower volume loading, thus making them the gold standard for managing warfarin-related hemorrhages.
Healthcare institutions in the emergency departments and surgical units use PCCs against uncontrolled gastrointestinal bleeding, intracranial hemorrhage, or trauma in the anticoagulated population.
All of these cases require a rapid reversal from anticoagulation to prevent an irreversible organ parade or possibly death. An ever-increasing demand for effective warfarin reversal is bound to put in place as the world continues to age and has higher rates of anticoagulant usage. The continued emergence of four-factor PCCs and next-generation formulations only solidifies the position of this segment as the mainstay of bleeding control in a warfarin-treated population.
| End User Type | Market Share (2025) |
|---|---|
| Hospital Pharmacies | 58.2% |
The rightmost segment of end users in the prothrombin complex concentrates market that falls under hospital pharmacies mostly serves as an access point for PCCs in acute care settings. It functions most significantly through emergency departments, operating rooms, and critical care units, allowing rapid administration during trauma, urgent surgery, or hemorrhagic episodes.
Relying on hospital inventory, pharmacists and clinicians provide timely coagulation support, especially in cases of anticoagulant reversal or bleeding disorders such as hemophilia B and acquired coagulopathy. Ready availability of PCCs in hospitals improves survival rates and decreases transfusion-related complications.
It would also help in hospitals achieving safe and evidence-based use of PCCs by controlling their use through acceptable doses, adverse effects monitoring, and documenting treatments in electronic medical records.
As the realization regarding the inadequacies of older plasma products rises and as its approval in treatment guidelines worldwide to be used in patients grows, hospitals prioritize stocking and use of PCCs fairly well.
Their positioning as centralized treatment hubs for acute bleeding will ensure that hospital pharmacies stay the premier channel-to-patient distribution and administration for PCCs in critical care across the globe.
The PCC market remains essential to both hematology and emergency medicine since it provides fast antagonizing of vitamin K blockers and treats patients with haemophilia B and manages surgical and traumatic major bleeding manifestations.
Three-factor or four-factor PCCs emerge from plasma derivation processes which yield products containing Factor II VII IX and X. The main benefits that PCC offers over the alternative product FFP consist of an accelerated onset of action and small volume requirements and a lower chance of fluid retention.
The market grows because medical institutions worldwide increase their anticoagulant prescriptions while physicians seek urgent reversal agents across all areas and expand their use of these drugs within cardiac surgery units and intensive care units. Competing companies focus on developing product factors and pathogen inactivation systems and rapid infusion systems as well as obtaining regulatory approvals like FDA and EMA.
Market Share Analysis by Company
| Company Name | Estimated Market Share (%) |
|---|---|
| CSL Behring GmbH | 32-36% |
| Octapharma AG | 24-28% |
| Grifols, S.A. | 17-21% |
| Kedrion Biopharma Inc. | 7-11% |
| Takeda Pharmaceutical Company Limited | 6-9% |
| Other Companies (combined) | 10-15% |
| Company Name | Key Offerings/Activities |
|---|---|
| CSL Behring GmbH | Markets Beriplex®/Kcentra® (4-factor PCC) for urgent reversal of acquired coagulation factor deficiency due to warfarin therapy in 2025. |
| Octapharma AG | Provides Octaplex®, a 4-factor PCC widely used in Europe and Asia for emergency anticoagulant reversal and surgical bleeding control in 2024. |
| Grifols, S.A. | Supplies Profilnine® (3-factor PCC) primarily indicated for hemophilia B treatment and perioperative bleeding in hereditary factor IX deficiency in 2025. |
| Kedrion Biopharma | Offers 3-factor PCCs for use in coagulation disorders and distributes PCC formulations across Europe, Latin America, and the Middle East in 2024. |
| Takeda Pharmaceuticals | Develops specialized plasma-derived products and supports PCC-related hemostatic therapies through partnerships and R&D initiatives in 2024. |
Key Company Insights
CSL Behring GmbH
This company has taken over the PCC market with Kcentra® (called Beriplex® outside the USA), the only FDA-approved 4-factor PCC for urgent vitamin K antagonist reversal. It is used in the majority of emergency departments and surgical ICUs, and has an amazing safety and efficacy profile.
Octapharma AG
There are many more suppliers for 4-factor PCC, the most important being Octapharma, with its Octaplex®, extremely popular in Europe, Australia, and Asia." Its drug boasts about uniform potency, viral inactivation steps, and applicability in warfarin reversal and trauma surgery.
Grifols, S.A.
Grifols sells Profilnine®, which is a 3-factor PCC for hereditary factor IX deficiency (hemophilia B). This narrow focus encourages a large loyalty of hematologists and rare disease institutes worldwide.
Kedrion Biopharma Inc.
Kedrion also plays a role in providing worldwide access to PCCs through plasma-derived therapies and regional distribution channels. Its products are most often utilized in areas where the affordability and availability of reversal agents are important.
Takeda Pharmaceutical Company Limited
Takeda supports bleeding disorder care with a diversified portfolio that includes factor concentrates and plasma derivatives. Though not a dominant PCC player, its influence in global hemostasis and bleeding control markets positions it well for future collaboration.
Other Key Players (10-15% Combined)
Several regional biopharma firms and blood product organizations contribute to the PCC market with specialized manufacturing, national tenders, and emergency care programs:
The overall market size for the prothrombin complex concentrates market was USD 836.6 million in 2025.
The prothrombin complex concentrates market is expected to reach USD 1,286.8 million in 2035.
The increasing incidence of anticoagulant-related bleeding, rising clinical preference for rapid reversal agents, and growing administration through hospital pharmacies for warfarin-associated bleeding fuel the prothrombin complex concentrates market during the forecast period.
The top 5 countries driving the development of the prothrombin complex concentrates market are the USA, UK, European Union, Japan, and South Korea.
Warfarin-associated bleeding and hospital pharmacies lead market growth to command a significant share over the assessment period.
Prothrombin Complex Concentrates Market
Thank you!
You will receive an email from our Business Development Manager. Please be sure to check your SPAM/JUNK folder too.
