Pegademase bovine - Biologic Drug Details

Summary for pegademase bovine

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

Recent Clinical Trials for pegademase bovine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Great Ormond Street Hospital for Children NHS Foundation Trust	Phase 1/Phase 2
California Institute for Regenerative Medicine (CIRM)	Phase 1/Phase 2
Orchard Therapeutics	Phase 1/Phase 2

See all pegademase bovine clinical trials

Recent Litigation for pegademase bovine

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Glaxo Group Limited v. Genentech, Inc.	2010-02-17
BIOGEN IDEC MA INC. v. DOLL	2009-04-30
Human Genome Sciences Inc. v. Immunex Corp.	2007-11-30

See all pegademase bovine 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 pegademase bovine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Pegademase Bovine

Introduction

Pegademase bovine, an enzyme replacement therapy, is used to treat adenosine deaminase severe combined immune deficiency (ADA-SCID), a rare and inherited disorder that severely impacts the immune system. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Size and Forecast

The global market for pegademase bovine is projected to grow significantly over the coming years. As of 2023, the market was estimated to be worth US$ 79 million and is forecasted to reach US$ 103.7 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period of 2024-2030[1][4].

Key Players

The market for pegademase bovine is dominated by Leadiant Biosciences, a company that has been instrumental in developing and marketing enzyme replacement therapies for rare genetic disorders. Leadiant's commitment to bringing innovative treatments to market has been pivotal in advancing the care for patients with ADA-SCID[2][4].

Applications and Product Types

The pegademase bovine market is segmented by application and product type. The primary applications include hospitals and pharmacies, where the drug is administered to patients. The product types are categorized into pre-filled and vial forms, catering to different clinical needs and preferences[1][4].

Geographical Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics, influenced by factors such as healthcare infrastructure, regulatory environments, and patient demographics[4].

Mechanism of Action and Clinical Significance

Pegademase bovine works by replacing the deficient adenosine deaminase enzyme, which is crucial for purine metabolism and the proper functioning of immune cells. This therapy reduces the risk of severe and recurrent infections and helps patients with ADA-SCID to thrive[2].

FDA Approval and Regulatory Landscape

The FDA approved Revcovi (elapegademase-lvlr), a newer form of pegademase bovine, in 2018 for the treatment of ADA-SCID in pediatric and adult patients. This approval, along with the Orphan Drug Act, provides seven years of marketing exclusivity in the United States, which significantly impacts the market dynamics and financial projections[2][3].

Financial Trajectory

The financial trajectory of pegademase bovine is influenced by several factors, including the growing demand for rare disease treatments, advancements in enzyme replacement therapies, and the expanding reach of Leadiant Biosciences. Here are some key financial indicators:

• Market Growth: The market is expected to grow from US$ 79 million in 2023 to US$ 103.7 million by 2030, indicating a steady increase in revenue.
• CAGR: A CAGR of 4.2% during the forecast period suggests a stable and predictable growth trajectory.
• Revenue Streams: The revenue is primarily generated from the sales of pre-filled and vial forms of the drug, with hospitals and pharmacies being the main distribution channels[1][4].

Competitive Landscape

The competitive landscape for pegademase bovine is relatively niche due to the rare nature of the disease it treats. Leadiant Biosciences holds a significant market share, and the company's efforts in disease state education, reimbursement navigation, and patient assistance programs further solidify its position[2][4].

Clinical Studies and Post-Marketing Commitments

Leadiant Biosciences is committed to ongoing clinical studies to monitor the health status of patients using elapegademase-lvlr. These studies help in understanding the efficacy and safety of the drug, particularly in newly diagnosed patients, and provide critical data for future improvements[2].

Market Trends and Drivers

Several trends and drivers are influencing the market for pegademase bovine:

• Increasing Awareness: Growing awareness about rare genetic disorders and the availability of treatments is driving demand.
• Advancements in Technology: Improvements in enzyme replacement therapies and the development of new formulations like Revcovi are enhancing treatment outcomes.
• Regulatory Support: The Orphan Drug Act and FDA approvals provide a favorable regulatory environment, encouraging investment and innovation in this sector[2][3].

Challenges and Opportunities

Despite the positive growth trajectory, there are challenges and opportunities to consider:

• High Development Costs: Developing biologic drugs like pegademase bovine is costly, which can be a barrier to entry for new players.
• Market Exclusivity: The seven years of marketing exclusivity provided by the Orphan Drug Act can limit competition but also incentivizes innovation.
• Global Expansion: Expanding into new geographical regions presents opportunities for growth but also requires navigating different regulatory and healthcare landscapes[3][4].

Conclusion

The market for pegademase bovine is poised for steady growth, driven by increasing demand for rare disease treatments, advancements in enzyme replacement therapies, and the dominant position of Leadiant Biosciences. With a forecasted market size of US$ 103.7 million by 2030 and a CAGR of 4.2%, this market offers significant opportunities for both patients and investors.

Key Takeaways

• The global pegademase bovine market is expected to reach US$ 103.7 million by 2030.
• Leadiant Biosciences is the main player in this market.
• The drug is primarily used in hospitals and pharmacies.
• The market is segmented into pre-filled and vial forms.
• Regulatory support, such as the Orphan Drug Act, plays a crucial role in market dynamics.

FAQs

Q: What is the forecasted market size of pegademase bovine by 2030? A: The forecasted market size of pegademase bovine by 2030 is US$ 103.7 million[1].

Q: Who is the main player in the pegademase bovine market? A: Leadiant Biosciences is the main player in the pegademase bovine market[1][2].

Q: What are the primary applications of pegademase bovine? A: The primary applications of pegademase bovine include hospitals and pharmacies[1][4].

Q: What are the different product types of pegademase bovine? A: The different product types of pegademase bovine are pre-filled and vial forms[1][4].

Q: What is the mechanism of action of pegademase bovine? A: Pegademase bovine works by replacing the deficient adenosine deaminase enzyme, which is crucial for purine metabolism and the proper functioning of immune cells[2].

Sources

1. Valuates Reports: Pegademase Bovine - Global Market Share and Ranking, Overall ...
2. Pharmacy Times: Revcovi: A New Treatment Option for ADA-SCID
3. Enzon Pharmaceuticals, Inc.: Annual Reports
4. Market Research Intellect: Pegademase Bovine Market Size and Forecast