ACTIVASE Drug Profile

Summary for Tradename: ACTIVASE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ACTIVASE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTIVASE

Recent Clinical Trials for ACTIVASE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 3
South West Sydney Local Health District	Phase 2
Memorial Healthcare System	Phase 4

See all ACTIVASE clinical trials

Recent Litigation for ACTIVASE

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.	2023-02-28
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Impossible Foods Inc. v. Motif Foodworks, Inc.	2022-03-09

See all ACTIVASE litigation

PTAB Litigation

Petitioner	Date
	2014-04-17
	2013-12-02

See all ACTIVASE 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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 ACTIVASE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2033-03-11	Patent claims search
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2024-07-05	Patent claims search
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2035-03-12	Patent claims search
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2033-08-02	Patent claims search
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2036-01-14	Patent claims search
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172		2024-12-29	Patent claims search

ACTIVASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Alteplase (Activase)

Introduction

Alteplase, marketed under the brand name Activase, is a biologic drug used primarily for the treatment of acute ischemic stroke and myocardial infarction. It is a recombinant tissue plasminogen activator (rtPA) that works by dissolving blood clots. Here, we delve into the market dynamics and financial trajectory of Alteplase.

Global Market Size and Forecast

The global Alteplase market is substantial and growing. As of 2024, the market size is estimated to be around USD 1352.2 million[1][4].

• This market is projected to expand at a compound annual growth rate (CAGR) of 5.20% from 2024 to 2031, reaching approximately USD 1892.62 million by 2031[1][4].

Regional Market Analysis

North America

North America dominates the Alteplase market, accounting for around 40% of the global revenue in 2024, with a market size of USD 540.88 million.

• The region's sophisticated healthcare system, high incidence of cardiovascular illnesses, and active research and development in thrombolytic therapies are key drivers of this market.
• The CAGR for North America is expected to be around 3.4% from 2024 to 2031[1].

Europe

Europe is another significant market for Alteplase, with a market size of USD 405.66 million in 2024.

• The growth in Europe is driven by the increasing incidence of cardiovascular disorders, improved healthcare infrastructure, and greater awareness of thrombolytic therapy.
• The CAGR for Europe is anticipated to be around 3.7% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region is experiencing rapid growth in the Alteplase market, with a market size of USD 311.01 million in 2024.

• This region is expected to grow at the highest CAGR of 7.2% from 2024 to 2031, driven by rising cardiovascular disease rates and investments in healthcare infrastructure[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases such as acute ischemic stroke and myocardial infarction is a major driver of the Alteplase market. As populations age and lifestyle factors contribute to higher disease rates, the demand for effective thrombolytic treatments like Alteplase increases[1][4].

Advanced Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in regions like North America and Europe, facilitate better access to Alteplase therapy. In the Asia Pacific, investments in healthcare are also expanding access to modern medical treatments[1][4].

Research and Development

Active research and development in thrombolytic therapies continue to enhance the efficacy and safety of Alteplase, making it a preferred treatment option for critical cardiovascular conditions[1].

Market Challenges

High Cost of Treatment

Alteplase is a costly treatment, which can be a barrier to access in many regions. This high cost is a significant challenge, especially in areas with limited healthcare resources[1][4].

Regulatory Approvals

While regulatory approvals are crucial for the market growth of Alteplase, the process can be lengthy and stringent. Any delays or changes in regulatory environments can impact market dynamics[1].

Competitive Landscape

The Alteplase market is relatively concentrated, with a few major players dominating the landscape. These companies invest heavily in research and development to maintain their market position and expand their product offerings[1].

Financial Performance and Projections

Revenue Growth

The revenue from Alteplase sales is expected to grow steadily over the forecast period, driven by increasing demand and expanding market reach. The CAGR of 5.20% from 2024 to 2031 indicates a robust financial trajectory[1][4].

Regional Revenue Contributions

North America and Europe will continue to be significant contributors to the global revenue, while the Asia Pacific region is expected to show the highest growth rate due to its large and growing patient population[1].

Impact of Healthcare Policies and Reimbursement

Reimbursement Policies

Favorable reimbursement policies in regions like North America and Europe support the market growth of Alteplase by ensuring that patients have access to this life-saving treatment. In other regions, government initiatives to improve healthcare access also play a crucial role[1].

Healthcare Infrastructure Investments

Investments in healthcare infrastructure, particularly in emerging markets, are critical for expanding access to Alteplase therapy. These investments include both public and private sector contributions[1][4].

Conclusion

The Alteplase market is poised for significant growth driven by increasing demand for thrombolytic treatments, advancements in healthcare infrastructure, and ongoing research and development. Despite challenges such as high treatment costs and regulatory hurdles, the market is expected to expand at a CAGR of 5.20% from 2024 to 2031.

Key Takeaways

• Global Market Size: The global Alteplase market size was estimated at USD 1352.2 million in 2024.
• Growth Rate: The market is expected to grow at a CAGR of 5.20% from 2024 to 2031.
• Regional Dominance: North America dominates the market, followed by Europe and the Asia Pacific.
• Key Drivers: Increasing prevalence of cardiovascular diseases, advanced healthcare infrastructure, and ongoing research and development.
• Challenges: High cost of treatment and regulatory approvals.

FAQs

What is Alteplase (Activase)?

Alteplase, marketed under the brand name Activase, is a biologic drug used primarily for the treatment of acute ischemic stroke and myocardial infarction.

What is the current market size of Alteplase?

The global Alteplase market size was estimated at USD 1352.2 million in 2024.

What is the expected growth rate of the Alteplase market?

The market is expected to grow at a CAGR of 5.20% from 2024 to 2031.

Which region dominates the Alteplase market?

North America dominates the Alteplase market, accounting for around 40% of the global revenue.

What are the key drivers of the Alteplase market growth?

The key drivers include the increasing prevalence of cardiovascular diseases, advanced healthcare infrastructure, and ongoing research and development.

Sources

1. Cognitive Market Research: Alteplase Market Report 2024.
2. Federal Reserve: The Shift from Active to Passive Investing: Potential Risks to Financial Stability.
3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032.
4. Verified Market Research: In-Depth Industry Outlook: Alteplase Market Size & Forecast.