Plasminogen, human-tvmh - Biologic Drug Details

Summary for plasminogen, human-tvmh

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
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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

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3. Patents from broad patent text search

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1) High Certainty: US Patents for plasminogen, human-tvmh Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for plasminogen, human-tvmh Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for plasminogen, human-tvmh Derived from Patent Text Search

No patents found based on company disclosures

Plasminogen, human-tvmh Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Plasminogen, Human-tvmh

Introduction to Plasminogen, Human-tvmh

Plasminogen, human-tvmh, marketed as Ryplazim, is a biologic drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with plasminogen deficiency type 1, also known as hypoplasminogenemia. This rare genetic disorder impairs the body's ability to break down fibrin clots, leading to the accumulation of fibrin and the development of lesions that can impair tissue and organ function, and potentially cause blindness[2].

Market Size and Growth

The global market for biologic therapeutic drugs, which includes plasminogen, is experiencing significant growth. Here are some key metrics:

• The global biologic therapeutic drugs market is projected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, with a CAGR of 12.7% during the forecast period[3].

Specific Market for Plasminogen

While the broader biologics market provides a context, the specific market for plasminogen is smaller but growing rapidly:

• The plasminogen market was valued at US$ 9 million in 2024 and is expected to reach US$ 64 million by 2030, with a CAGR of 39.5% during the forecast period 2024-2030[4].

Drivers of Market Growth

Several factors are driving the growth of the plasminogen market:

Increasing Awareness and Initiatives

• Growing awareness and initiatives related to rare genetic disorders like plasminogen deficiency type 1 are driving demand for treatments. The FDA's approval of Ryplazim in 2021 marked a significant milestone, addressing an unmet medical need for individuals affected by this rare disease[2].

Regulatory Approvals

• Regulatory approvals play a crucial role. The FDA's approval of Ryplazim, along with designations such as Orphan Drug, Fast Track, Priority Review, and a Rare Pediatric Disease Priority Review Voucher, have incentivized further research and development in this area[2].

Technological Advancements

• Advances in recombinant technology and plasma-derived human plasminogen production are enhancing the efficacy and safety of plasminogen treatments. For instance, Ryplazim is derived from human plasma and has shown significant clinical efficacy in reducing or resolving lesions in patients with plasminogen deficiency type 1[2][5].

Regional Analysis

The global tissue plasminogen activator market, which includes plasminogen, shows regional variations in market share and growth:

• North America is estimated to hold a dominant position in the global tissue plasminogen activator market, with 40.1% of the market share in 2023. This is driven by rising product approvals by regulatory authorities in the U.S., such as the FDA approval of Ryplazim[1].

Competitive Landscape

The market for plasminogen and related biologic drugs is competitive, with several key players:

• Companies like ProMetic Biotherapeutics Inc., F. Hoffmann-La Roche AG, Boehringer Ingelheim GmbH, CHIESI Farmaceutici S.p.A., Gennova Biopharmaceuticals Ltd, Abbott Laboratories, and Reliance Life Sciences are major players in the global tissue plasminogen activator market[1].

Challenges and Restraints

Despite the growth potential, there are challenges to consider:

• High development costs and the need for significant research and development investments are major restraints. Key players must focus on securing funds to advance their R&D activities[1].

• The risk of infectious disease transmission, although remote due to effective donor screening and manufacturing processes, is a concern for plasma-derived products like Ryplazim[2].

Clinical Efficacy and Safety

The clinical efficacy and safety of plasminogen treatments are critical factors:

• Ryplazim has demonstrated significant clinical efficacy in improving or resolving lesions in patients with plasminogen deficiency type 1. The treatment involves administering the drug every two to four days, with a notable reduction in lesions and prevention of new or recurrent lesions[2].

• Common side effects reported include abdominal pain, bloating, nausea, bleeding, limb pain, fatigue, and other symptoms. However, these are generally manageable with appropriate medical supervision[2].

Financial Projections

The financial trajectory for plasminogen, human-tvmh, is promising:

• The plasminogen market is expected to grow from US$ 9 million in 2024 to US$ 64 million by 2030, indicating a substantial increase in revenue over the forecast period[4].

• This growth is part of the broader trend in biologic therapeutic drugs, which are becoming increasingly important in treating rare and complex diseases.

Key Takeaways

• Market Growth: The plasminogen market is expected to grow significantly, driven by increasing awareness, regulatory approvals, and technological advancements.
• Regional Dominance: North America is a key region, driven by regulatory approvals and a strong healthcare infrastructure.
• Competitive Landscape: Major pharmaceutical and biotechnology companies are active in this market, with a focus on R&D and securing regulatory approvals.
• Clinical Efficacy: Plasminogen treatments have shown strong clinical efficacy in treating plasminogen deficiency type 1.
• Financial Projections: The market is projected to grow substantially, with a CAGR of 39.5% from 2024 to 2030.

Frequently Asked Questions (FAQs)

1. What is plasminogen, human-tvmh, and what is it used for?

Plasminogen, human-tvmh, marketed as Ryplazim, is a biologic drug used to treat patients with plasminogen deficiency type 1, a rare genetic disorder that impairs the body's ability to break down fibrin clots.

2. What are the key drivers of the plasminogen market growth?

Key drivers include increasing awareness and initiatives related to rare genetic disorders, regulatory approvals, and technological advancements in production.

3. Which region dominates the global tissue plasminogen activator market?

North America, particularly the U.S., dominates the market due to rising product approvals by regulatory authorities.

4. What are the common side effects of Ryplazim?

Common side effects include abdominal pain, bloating, nausea, bleeding, limb pain, fatigue, and other symptoms.

5. What is the projected growth rate of the plasminogen market from 2024 to 2030?

The plasminogen market is expected to grow at a CAGR of 39.5% from 2024 to 2030.

Cited Sources

1. Coherent Market Insights: Tissue Plasminogen Activator Market Size by 2030[1].
2. FDA: FDA Approves First Treatment for Patients with Plasminogen Deficiency[2].
3. BCC Research: Biologic Therapeutic Drugs: Technologies and Global Markets[3].
4. Valuates Reports: Plasminogen Market, Report Size, Worth, Revenue, Growth, Industry[4].