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Last Updated: March 24, 2025

ASPARLAS Drug Profile


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Summary for Tradename: ASPARLAS
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for ASPARLAS
Recent Clinical Trials for ASPARLAS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Children's Oncology GroupPhase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 1
University of Colorado, DenverPhase 1

See all ASPARLAS clinical trials

Pharmacology for ASPARLAS
Established Pharmacologic ClassAsparagine-specific Enzyme
Chemical StructureAsparaginase
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 ASPARLAS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Asparlas

Introduction to Asparlas

Asparlas, also known as calaspargase pegol, is a biologic drug used in the treatment of acute lymphoblastic leukemia (ALL), a type of cancer that affects the bone marrow, blood, and other organs. It is a pegylated form of asparaginase, an enzyme that depletes the amino acid asparagine, which is essential for the survival of leukemia cells.

Market Size and Growth Projections

The global asparaginase market, which includes Asparlas, is projected to experience significant growth. By 2030, the market size is expected to reach USD 2,619.3 million, with a revenue CAGR of 16.7%[1][4].

Drivers of Market Growth

Several factors are driving the growth of the asparaginase market, including:

Growth of Pharmaceutical and Food Industries

The expansion of the pharmaceutical and food industries is a major driver. As these industries grow, the demand for asparaginase, including Asparlas, increases due to its use in both medical treatments and food processing[1][4].

Increasing Prevalence of ALL

In developing countries such as India, China, Malaysia, and Indonesia, there is an increasing prevalence of acute lymphoblastic leukemia and lymphoblastic lymphoma. This rise in disease incidence is expected to drive the revenue growth of the asparaginase market[1][4].

Research and Development

Market players are investing heavily in research and development to improve the production and efficacy of asparaginase. For instance, the Indian Institute of Technology (IIT) Indore developed a new asparaginase drug using protein engineering to treat ALL with fewer side effects[1][4].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region is expected to register a robust revenue CAGR throughout the forecast period. The increasing research and development activities, along with the growing prevalence of ALL, are key factors driving this growth[1][4].

Economic Implications

Cost Considerations

Asparlas is a costly treatment, with each patient's treatment course estimated to cost approximately $52,093 for 7 doses, according to the Children’s Oncology Group (COG) AALL07P4 trial protocol[5].

Health Economic Evidence

The Canadian Agency for Drugs and Technologies in Health (CADTH) has assessed that Asparlas does not represent good value to the health care system at the public list price. The committee determined that there is not enough evidence to justify a greater cost for Asparlas compared to pegaspargase[5].

Public Drug Plans

The public drug plans in Canada are estimated to incur costs of approximately $4.6 million over the next three years for Asparlas[5].

Regulatory and Reimbursement Landscape

Regulatory Approval

Asparlas has been recommended for reimbursement as a component of a multi-agent chemotherapy (MAC) regimen for the treatment of ALL in pediatric and young adult patients aged 1 to 21 years by the CADTH pan-Canadian Oncology Drug Review Expert Review Committee (pERC)[5].

Biosimilar Impact

While Asparlas is not a biosimilar itself, the introduction of biosimilars in the biologic drug market can influence pricing and reimbursement strategies. Biosimilars are expected to reduce drug costs, although to a lesser degree than small-molecule generic drugs[3].

Patient and Payer Perspectives

Patient Safety and Cost

For patients, safety is paramount, but out-of-pocket costs are also a significant concern. High-deductible health plans may incentivize patients to switch from branded agents like Asparlas to biosimilars or start treatment with a biosimilar[3].

Payer Considerations

Payers must carefully consider the economic implications and potential cost-effectiveness of Asparlas and other biologic drugs. Even a 15% to 30% price discount from biosimilars can be significant and may prompt reconsideration of plan design and formulary structure[3].

Key Takeaways

  • The global asparaginase market, including Asparlas, is expected to grow significantly, reaching USD 2,619.3 million by 2030.
  • Growth is driven by the expansion of pharmaceutical and food industries, increasing prevalence of ALL, and ongoing research and development.
  • The Asia-Pacific region is a key growth area due to increasing disease prevalence and R&D activities.
  • Asparlas is a costly treatment, with significant economic implications for health care systems and patients.
  • Regulatory approvals and reimbursement recommendations play a crucial role in the market dynamics of Asparlas.

FAQs

What is Asparlas used for?

Asparlas, or calaspargase pegol, is used in the treatment of acute lymphoblastic leukemia (ALL), a type of cancer affecting the bone marrow, blood, and other organs[5].

How much does Asparlas cost?

Treatment with Asparlas is estimated to cost approximately $52,093 per patient per treatment course (7 doses)[5].

What are the key drivers of the asparaginase market growth?

The key drivers include the growth of pharmaceutical and food industries, increasing prevalence of ALL, and ongoing research and development activities[1][4].

How does the Asia-Pacific region contribute to the asparaginase market?

The Asia-Pacific region is expected to register a robust revenue CAGR due to increasing research and development activities and the growing prevalence of ALL in countries like India, China, Malaysia, and Indonesia[1][4].

What is the regulatory status of Asparlas?

Asparlas has been recommended for reimbursement as a component of a MAC regimen for the treatment of ALL in pediatric and young adult patients aged 1 to 21 years by the CADTH pERC[5].

Sources

  1. BioSpace: Asparaginase Market Demand 2022-2030: Growth of Pharmaceutical and Food Industries Is Driving Industry Revenue Growth.
  2. ASPE: Antimicrobial Drugs Market Returns Analysis.
  3. AJMC: The Economic Implications of Biosimilars.
  4. BioSpace: Asparaginase Market Size 2022-2030- Growing Pharmaceutical Industry and Increasing Focus on Research and Development (R&D).
  5. CADTH: Calaspargase Pegol (Asparlas).

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