Rasburicase - Biologic Drug Details

Summary for rasburicase

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for rasburicase
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rasburicase

Recent Clinical Trials for rasburicase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 4
M.D. Anderson Cancer Center	Phase 4
AVM Biotechnology LLC	Phase 1/Phase 2

See all rasburicase clinical trials

Recent Litigation for rasburicase

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2018-04-30

See all rasburicase 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 rasburicase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Rasburicase

Introduction

Rasburicase, a recombinant urate oxidase enzyme, is a crucial biologic drug used to treat elevated uric acid levels in patients undergoing chemotherapy for cancers such as leukemia, lymphoma, and solid tumors. This article delves into the market dynamics and financial trajectory of rasburicase, highlighting its indications, market segments, competitive landscape, and future outlook.

Rasburicase Market Fundamentals

Rasburicase is produced from a cDNA coding for a modified Aspergillus flavus strain and expressed in a modified yeast strain of Saccharomyces cerevisiae. It converts uric acid into allantoin, a compound 5-10 times more soluble in urine than uric acid, thereby reducing the risk of tumor lysis syndrome (TLS), a potentially fatal side effect of chemotherapy[1].

Market Indications

Leukemia and Other Hematologic Malignancies

The primary indication for rasburicase is the treatment of hyperuricemia in patients with hematologic malignancies, such as leukemia and lymphoma. The rising prevalence of leukemia, particularly acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL), is a significant driver of the rasburicase market. For instance, in Europe, AML affects 5 per 100,000 people annually, contributing to the market's growth[1].

Patient Type

The market is segmented into adult and pediatric patients. The adult segment dominates the market due to the higher incidence of hematologic malignancies in this age group. Rasburicase has been approved for use in adult cancer patients, offering an effective alternative to traditional treatments like allopurinol[1].

Market Dynamics

Regional Market

The global rasburicase market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Europe and Asia-Pacific are expected to account for a significant portion of the global market during the forecast period. High awareness and treatment rates for leukemia in Europe, particularly in countries like Lithuania and Belgium, drive market growth in this region[1].

Competitive Landscape

Key players in the rasburicase market include Sanofi S.A., Manus Aktteva Biopharma LLP, and Trumac Healthcare. Sanofi, with its strong pharmaceutical portfolio, plays a significant role in the market. The company's financial performance, driven by its Specialty Care and Oncology segments, indicates a robust capacity for investment in research and development, which can further enhance the market position of rasburicase[1][2].

Financial Trajectory

Revenue Growth

The global rasburicase market is projected to register a revenue CAGR of 6.5% from 2023 to 2031. This growth is driven by the increasing prevalence of leukemia and the effectiveness of rasburicase in managing hyperuricemia associated with tumor lysis syndrome[1].

Cost-Effectiveness

Rasburicase has been shown to be cost-effective compared to standard of care (SOC) for preventing and treating TLS in pediatric patients with hematologic malignancies. A cost-effectiveness analysis from the Chinese healthcare system perspective revealed that rasburicase offers favorable incremental cost-effectiveness ratios (ICERs) for patients with AML, ALL, and NHL, making it a viable economic option[4].

Market Segments

Indication

The market is segmented based on indication, with the leukemia segment expected to grow significantly due to the rising prevalence of this disease. Rasburicase's ability to rapidly reduce plasma uric acid levels makes it an essential treatment for patients at high risk of TLS[1].

Patient Type

The adult patient segment dominates the market, but the pediatric segment is also significant due to the need for effective management of hyperuricemia in children undergoing chemotherapy for hematologic malignancies[1].

Strategic Developments

Product Innovations

Rasburicase's unique mechanism of action, which involves converting uric acid to allantoin, sets it apart from other treatments like allopurinol. This innovation has made rasburicase a preferred choice for managing hyperuricemia in cancer patients[1].

Regulatory Approvals

Rasburicase has been approved for use in adult cancer patients, and its efficacy in pediatric patients has also been established through various clinical studies. These approvals have expanded the market reach and acceptance of the drug[1].

Challenges and Limitations

Safety Concerns

Rasburicase can cause serious side effects, such as hemolysis in patients with G-6-PD deficiency and methemoglobinemia. These risks necessitate careful patient screening and monitoring before and during treatment[1].

Market Competition

The biologic therapeutic drugs market is highly competitive, with other treatments and emerging therapies vying for market share. However, rasburicase's specific indication and efficacy profile help it maintain a strong market position[3].

Future Outlook

Market Growth

The global rasburicase market is expected to continue growing, driven by the increasing incidence of hematologic malignancies and the drug's proven efficacy. The Asia-Pacific region, in particular, is anticipated to contribute significantly to this growth due to rising healthcare awareness and investments in cancer treatment[1].

Research and Development

Ongoing research and development in biologic therapeutic drugs, including rasburicase, are expected to enhance treatment outcomes and expand the drug's indications. This could further boost the market's financial trajectory[3].

Key Takeaways

• Rising Prevalence of Leukemia: The increasing incidence of leukemia and other hematologic malignancies drives the demand for rasburicase.
• Cost-Effectiveness: Rasburicase is a cost-effective alternative to standard of care for preventing and treating TLS.
• Regional Growth: Europe and Asia-Pacific are key regions driving the market growth.
• Competitive Landscape: Sanofi S.A. and other players are significant in the market, with ongoing investments in R&D.
• Safety Concerns: Careful patient screening is necessary due to potential side effects like hemolysis and methemoglobinemia.

FAQs

What is rasburicase used for?

Rasburicase is used to treat elevated uric acid levels in patients undergoing chemotherapy for cancers such as leukemia, lymphoma, and solid tumors.

How does rasburicase work?

Rasburicase converts uric acid into allantoin, a compound more soluble in urine, thereby reducing the risk of tumor lysis syndrome (TLS).

What are the potential side effects of rasburicase?

Rasburicase can cause serious side effects such as hemolysis in patients with G-6-PD deficiency and methemoglobinemia.

Which regions are expected to drive the growth of the rasburicase market?

Europe and Asia-Pacific are anticipated to be significant drivers of the rasburicase market growth.

Is rasburicase cost-effective compared to standard of care?

Yes, rasburicase has been shown to be cost-effective compared to standard of care for preventing and treating TLS in pediatric patients with hematologic malignancies.

Sources

1. Growth Plus Reports: Rasburicase Market Forecast 2031 - CAGR of 6.5% | GPR
2. Sanofi: Press Release: Strong 2021 sales and business EPS growth enabling increased investment in R&D
3. BCC Research: Biologic Therapeutic Drugs: Technologies and Global Markets
4. PubMed: Cost-effectiveness analysis of rasburicase over standard of care for tumor lysis syndrome in children with hematologic malignancies.

Last updated: 2024-12-18