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Last Updated: April 28, 2025

Urokinase - Biologic Drug Details


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Recent Clinical Trials for urokinase

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Shaare Zedek Medical CenterN/A
National University of MalaysiaN/A
Alexandria UniversityPhase 3

See all urokinase clinical trials

Recent Litigation for urokinase

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.2023-11-17
Genentech, Inc. v. Biogen MA Inc.2023-07-13
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.2023-02-28

See all urokinase litigation

PTAB Litigation
PetitionerDate
2016-11-22
2013-12-02
2012-09-25

See all urokinase litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for urokinase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for urokinase Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for urokinase Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Urokinase

Introduction to Urokinase

Urokinase, a thrombolytic enzyme, plays a crucial role in the dissolution of blood clots, making it a vital component in the treatment of various cardiovascular and thrombotic conditions. The market for urokinase is driven by several key factors, which are explored in detail below.

Market Size and Growth Projections

The global urokinase market has been experiencing significant growth. As of 2023, the market size was valued at approximately $1.8 billion and is projected to reach $3.1 billion by 2033, growing at a compound annual growth rate (CAGR) of 5.7% from 2024 to 2033[1][2][4].

Key Drivers of Market Growth

Increasing Geriatric Population

The rise in the geriatric population is a significant driver for the growth of the urokinase market. By 2050, 22% of the global population is expected to be aged above 60 years, according to the World Health Organization. This demographic shift increases the prevalence of age-related health conditions such as cardiovascular diseases, deep vein thrombosis, and pulmonary embolism, all of which require thrombolytic therapy[1].

Growing Burden of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases, including stroke, heart attacks, and heart failure, is another major driver. For instance, it is anticipated that cardiovascular disease rates will significantly increase, with stroke rates expected to rise from 33.8% to 15 million and heart failure rates from 33.4% to 13 million by the forecast period[2].

Advancements in Biotechnology and Healthcare Infrastructure

Advancements in biotechnology and significant investments in healthcare infrastructure are also driving the market. The integration of AI and digital health tools, as well as advancements in personalized medicine and drug delivery systems, are expected to further boost the market growth[2].

Market Segmentation

The urokinase market is segmented based on several criteria:

By Type

The market is divided into urokinase powder and urokinase solution. These forms cater to different clinical needs and preferences[1][2].

By Manufacturing Process

Urokinase can be produced through biotechnological methods or traditional extraction methods. Biotechnological methods are increasingly preferred due to their precision and efficiency[2].

By Indication

Urokinase is used for various indications, including catheter clearance, coronary artery thrombosis, deep vein thrombosis, and pulmonary embolism. The rising prevalence of these conditions is driving the demand for urokinase[2].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies dominate the market due to the critical nature of the treatments involved[2].

By End User

The primary end users are hospitals and clinics. These institutions are the main consumers of urokinase due to the need for immediate and effective thrombolytic therapy[1][2].

Regional Market Outlook

North America

North America has been the largest region in the urokinase market, driven by a well-established healthcare infrastructure, high prevalence of cardiovascular diseases, and robust research and development activities[1][2].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing region in the forecast period. This growth is propelled by increasing healthcare expenditure, a rising geriatric population, and the development of healthcare infrastructure and the pharmaceutical industry[1][2].

Industry Trends and Strategies

Personalized Medicine

There is a growing focus on personalized medicine, which includes tailored treatments based on individual patient profiles. This trend is expected to enhance the efficacy of urokinase treatments and drive market growth[2].

Technological Innovations

Advancements in drug delivery systems and the integration of AI and digital health tools are significant trends. These innovations improve the delivery and monitoring of urokinase, making treatments more effective and patient-friendly[2].

Regulatory Approvals

Regulatory approvals for critical indications and the development of initial formulations are also driving the market. Recent acquisitions, such as Eli Lilly's acquisition of DICE Therapeutics Inc., aim to bolster research and development capabilities in innovative therapies, including thrombolytic treatments[2].

Financial Trajectory

The financial trajectory of the urokinase market is robust, with a projected CAGR of 5.7% from 2024 to 2033. Here are some key financial highlights:

  • Market Size in 2023: $1.8 billion[1].
  • Projected Market Size by 2033: $3.1 billion[1].
  • CAGR: 5.7% from 2024 to 2033[1][2].

Key Market Players

The urokinase market is competitive, with several key players contributing to its growth. Some of the major players include:

  • Jiangxi Haoran Bio-Pharma
  • Jiangsu Aidea Pharmaceutical
  • TAJ Pharmaceuticals Limited
  • Microbix Biosystems Inc
  • NDpharm
  • Wanhua Biochem
  • Cadila Healthcare Limited
  • Livzon Pharmaceutical Group Inc.[1][5].

Impact of External Factors

COVID-19 Impact

The COVID-19 pandemic had a mixed impact on the urokinase market. While it disrupted supply chains and delayed some clinical trials, it also highlighted the importance of effective thrombolytic therapies in managing COVID-19-related complications[2].

Economic Factors

High inflation and geopolitical events, such as the Ukraine-Russia war, can impact the market by affecting the availability and pricing of raw materials and finished products. However, the essential nature of urokinase in healthcare ensures a relatively stable demand despite these challenges[2].

Conclusion

The urokinase market is poised for significant growth driven by demographic changes, advancements in biotechnology, and the increasing burden of cardiovascular diseases. As the market continues to evolve, it is expected to be shaped by trends in personalized medicine, technological innovations, and regulatory approvals.

Key Takeaways

  • The global urokinase market is projected to grow from $1.8 billion in 2023 to $3.1 billion by 2033.
  • The market is driven by the rising geriatric population and the increasing prevalence of cardiovascular diseases.
  • Advancements in biotechnology and healthcare infrastructure are key drivers.
  • North America currently dominates the market, but the Asia-Pacific region is expected to be the fastest-growing.
  • Personalized medicine and technological innovations are significant trends.

FAQs

What is the projected growth rate of the urokinase market from 2024 to 2033?

The urokinase market is expected to grow at a CAGR of 5.7% from 2024 to 2033[1][2].

Which region is expected to be the fastest-growing in the urokinase market?

The Asia-Pacific region is expected to be the fastest-growing region in the forecast period[1][2].

What are the primary indications for the use of urokinase?

Urokinase is used for catheter clearance, coronary artery thrombosis, deep vein thrombosis, and pulmonary embolism[2].

How has the COVID-19 pandemic impacted the urokinase market?

The COVID-19 pandemic had a mixed impact, disrupting supply chains but also highlighting the importance of effective thrombolytic therapies in managing COVID-19-related complications[2].

Who are some of the major players in the urokinase market?

Major players include Jiangxi Haoran Bio-Pharma, Jiangsu Aidea Pharmaceutical, TAJ Pharmaceuticals Limited, Microbix Biosystems Inc, and others[1][5].

Sources

  1. Allied Market Research: Urokinase Market Statistics, Segments Analysis| Forecast- 2033.
  2. The Business Research Company: Urokinase Market Report 2024, Overview And Insights By 2033.
  3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems.
  4. Business Wire: Global Urokinase Market (2023-2028) by Type, Dose Strength, Indication, Applications, and Geography, Competitive Analysis, Impact of Covid-19 and Ansoff Analysis.
  5. Market Research Intellect: Urokinase For Injection Market Size And Forecast.

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