Urokinase Market Size, Share and Industry Analysis, By Product Type (High Molecular Weight and Low Molecular Weight), By Form (Injection and Infusion), By Indication (Deep Vein Thrombosis & Pulmonary Embolism, Heart Attacks, Catheter Occlusion, and Others), By Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2025-2032

The global urokinase market is witnessing significant growth due to the increasing prevalence of thromboembolic disorders such as pulmonary embolism and deep vein thrombosis, increasing clinical applications in the management of cardiovascular diseases, and regulatory approvals over the past few years. Urokinase plays a critical role in the management of such diseases. Its effectiveness, combined with a relatively low risk of severe complications, makes it a valuable option in the treatment of these serious conditions.

• For instance, as per an article published by the American Lung Association in January 2024, an estimated 900,000 individuals in the U.S. are affected by pulmonary embolism.

Urokinase Market Driver

Rising Incidence of Thromboembolic Disorders Coupled with Several Risk Factors Boosts Urokinase Market Growth

Over the recent years, there has been a surge in the cases of thromboembolic disorders such as pulmonary embolism and deep vein thrombosis among the global population. These conditions are becoming more common due to risk factors such as recent surgery, prolonged immobility, cancer, pregnancy, and certain genetic conditions. Moreover, in several cases, deep vein thrombosis (DVT) can lead to the pulmonary embolism development. Such factors are expected to increase the demand for treatment with urokinase to avoid further complications, which is anticipated to boost the market growth.

• For instance, an article published by the American Lung Association in January 2024 stated deep vein thrombosis, in most cases, leads to pulmonary embolism development.

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In 2023, the U.S. accounted for an estimated 895,241 cases of venous thromboembolism, accounting for 0.3% of the country’s population in 2023.

Urokinase Market Restraint

Complications Associated with Urokinase May Limit Market Growth

The complications associated with urokinase can significantly hinder their widespread adoption in clinical settings. The administration of urokinase carries a significant risk of bleeding complications, necessitating careful monitoring and limiting its use to hospital settings under strict medical supervision. This requirement can deter its use in outpatient settings or patients with a higher risk of bleeding, thereby hampering the market growth.

• For instance, as of July 2024, Eazymed Technologies Pvt Ltd reported that the urokinase use can lead to significant bleeding, which may be life-threatening for some patients.

Urokinase Market Opportunity

Research and Development Initiatives for Urokinase Presents Lucrative Prospects

Continuous research into the efficacy and safety of urokinase is projected to open new opportunities for its use, potentially expanding its applications beyond current therapeutic areas. This ongoing development can lead to innovative formulations and delivery methods, further increasing its market presence.

• For instance, according to an article published by the National Center for Biotechnology Information (NCBI) in June 2023, recent studies have explored the efficacy of urokinase in combination with ultrasound-accelerated thrombolysis (USAT) for the treatment of pulmonary embolism.

Key Insights

The report covers the following key insights:

• Prevalence of Key Diseases, By Key Countries/Region, 2023
• Overview: Regulatory & Reimbursement Scenario, By Key Countries/Regions
• Pipeline Analysis, By Key Players
• Key Industry Developments (Mergers, Acquisitions, and Partnerships) 
• Impact of COVID-19 on the Market

Segmentation

Analysis by Product Type

Based on product type, the market is divided into high molecular weight and low molecular weight.

The low molecular weight segment is expected to hold a major share of the global market. Low molecular weight urokinase is used more frequently than high molecular weight urokinase in clinical settings due to its higher efficacy, safety profile, and specific activity. These factors make LMW-UK the preferred choice for thrombolytic therapy in various medical conditions, which is anticipated to boost the segment growth.

• For instance, according to the National Center for Biotechnology Information (NCBI), LMW-UK has a higher specific activity than HMW-UK, making it more efficient in clinical applications.

Analysis by Form

By form, the market is fragmented into injection and infusion.

The infusion segment accounts for a substantial proportion of the urokinase market. Urokinase infusion is the approved and preferred method for administering this thrombolytic agent to treat conditions caused by blood clots safely and effectively. The continuous infusion allows for optimal dosing and therapeutic effect. Moreover, the urokinase injection is contraindicated in certain situations due to several complications. This is expected to boost the adoption of urokinase infusion over injection, driving the segment growth over the forthcoming years.

• For instance, as of August 2022, RxList Inc. stated that the use of Kinlytic (urokinase injection) is contraindicated in certain situations due to the increased bleeding risk, such as recent surgery, trauma, or stroke.

Analysis by Indication

By indication, the market is segmented into deep vein thrombosis & pulmonary embolism, heart attacks, catheter occlusion, and others.

The deep vein thrombosis & pulmonary embolism segment is expected to hold a major share of the urokinase market. Urokinase is primarily used in the treatment of pulmonary embolism (PE) & deep vein thrombosis (DVT), with a notable emphasis on its application for PE due to its effectiveness and the clinical urgency often associated with this condition.

• For instance, as per the Public Assessment Report published by COLLEGE TER BEOORDELING VAN GENEESMIDDELEN in March 2023, urokinase is used in unblocking fibrin clots from intravascular catheters and cannulae and thromboembolic occlusive vascular disease.

Analysis by Distribution Channel

Based on distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, online pharmacies, and others.

The online pharmacies segment is expected to grow at a substantial CAGR during the forecast period. Online pharmacies are offering urokinase injections at discounted prices and significant offers globally, which is expected to boost its sales through online pharmacies, driving segment growth over the coming years.

• For instance, as of July 2024, PharmEasy is offering urokinase injections from several manufacturers at the discounted prices.

Regional Analysis

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By region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for the largest share of the global urokinase market in 2023. The growth of the market in the region is attributed to the high burden of coronary heart disease in the region, which is expected to result in heart attacks in the end. This is driving the recommendation of Urokinase, which is anticipated to spur regional market growth.

• For instance, as of July 2024, the New York State Department of Health reports that around 805,000 people in the U.S. have a heart attack every year.

Europe is the second-largest market based on the demand for urokinase. There is a growing demand for Urokinase in end-stage renal disease patients on hemodialysis in the region. This is expected to increase the number of launches and product approvals with an expanded indication, driving the regional market growth.

• For instance, as per the Public Assessment Report published by COLLEGE TER BEOORDELING VAN GENEESMIDDELEN in March 2023, the national applicant provided evidence of a demand for Urokinase in the U.K., mainly for use in end-stage renal disease patients on hemodialysis.

The Asia Pacific is expected to grow moderately over the forthcoming years. The growing awareness of thromboembolic and cardiovascular disorders in the region is anticipated to fuel the demand for Urokinase, thereby driving the market growth during the projection period.

Key Players Covered

The global urokinase market is consolidated, with a limited number of companies offering various types of urokinase.

The report includes the profiles of the following key players:

• Syner-Med (Pharmaceutical Products) Ltd. (U.K.)
• Microbix Biosystems Inc. (Canada)
• Abbott (U.S.)
• Midas Pharma GmbH (Germany)
• Cerbios-Pharma SA (Switzerland)
• Aidea Pharma (China)

Key Industry Developments

• In July 2024, Microbix Biosystems Inc.’s Kinlytic (Urokinase), a biologic to treat a biologic thrombolytic drug used to treat blood clots, was reported to be under clinical development for additional applications.
• In November 2023, Microbix Biosystems Inc. announced the reconfirmation of its agreement with Sequel Pharma, LLC to return Kinlytic (Urokinase) to the U.S. market and other geographies.