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Last Updated: March 24, 2025

ELSPAR Drug Profile


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Recent Clinical Trials for ELSPAR

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University of WashingtonPhase 2
Jazz PharmaceuticalsPhase 2
Dana-Farber Cancer InstitutePhase 2

See all ELSPAR clinical trials

Recent Litigation for ELSPAR

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Highland Capital v. NexPoint Asset2023-09-06
Highland v. NexPoint2023-09-06
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.2023-01-19

See all ELSPAR litigation

PTAB Litigation
PetitionerDate
Illumina, Inc. et al.2021-07-20
Laboratory Corporation of America Holdings et al.2021-05-28
Quest Diagnostics Incorporated2021-04-15

See all ELSPAR 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
  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 ELSPAR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for the Biologic Drug: ELSPAR (Asparaginase)

Introduction to Asparaginase and ELSPAR

Asparaginase, marketed under the brand name ELSPAR among others, is a biologic drug used primarily in the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). This enzyme works by depleting the amino acid asparagine, which is essential for the survival of certain cancer cells.

Market Size and Growth

The global asparaginase market is projected to experience significant growth over the coming years. By 2033, the market is expected to reach approximately USD 3,581.8 million, up from USD 777.8 million in 2023, with a compound annual growth rate (CAGR) of 16.5% during the forecast period of 2024-2033[1].

Source Analysis

The asparaginase market is dominated by the Escherichia coli (E. coli) source segment, which held a 67.1% market share in 2023. This dominance is due to the high efficacy and widespread use of E. coli-derived asparaginase in clinical settings. The Erwinia chrysanthemi source is another significant segment, though it holds a smaller market share[1].

Route of Administration

In terms of the route of administration, intravenous drugs hold the largest share, accounting for 61.2% of the market. This method is preferred due to its direct delivery into the bloodstream, ensuring rapid and effective treatment. Intramuscular administration is another route, though it is less common compared to intravenous administration[1].

Application Analysis

The primary application of asparaginase is in the treatment of acute lymphoblastic leukemia (ALL), which accounts for 42.1% of the market share. Lymphoblastic lymphoma (LBL) and other rare forms of leukemia also contribute to the demand for this drug[1].

Distribution Channels

Hospital pharmacies are the leading distribution channels, accounting for 52.5% of the revenue share. This is due to the frequent diagnoses and treatments of leukemia and other related conditions within hospital settings. Online pharmacies are forecasted to experience the highest growth rate due to their convenience and ease of access, while retail pharmacies also play a significant role, especially in developing nations[1].

Regional Analysis

North America dominates the asparaginase market with a 45.1% market share, generating USD 350.7 million in revenue in 2023. The region's advanced healthcare infrastructure and high prevalence of leukemia contribute to this dominance. However, emerging markets such as India and China are expected to show significant growth due to increasing healthcare awareness and the affordability of asparaginase treatments[1].

Emerging Markets and Growth Potential

Regions like India and China present substantial growth opportunities for the asparaginase market. Increasing healthcare awareness, improving healthcare infrastructure, and rising affordability of treatments are key drivers in these emerging markets. For instance, research and development activities, such as the development of a new asparaginase drug by the Indian Institute of Technology (IIT) Indore using protein engineering, are expected to boost market growth in these regions[4].

Technological Advancements

Technological advancements in asparaginase formulation and delivery are expected to shape the market's future. Innovations such as protein engineering and biosensor technologies are enhancing the efficacy and safety of asparaginase treatments. For example, the use of molecular dynamics simulations and quantum mechanics to elucidate the reaction mechanism of human asparaginase III is contributing to better drug design and development[5].

Growing Emphasis on Orphan Drugs

The increasing interest in orphan drugs, which are designed to treat rare diseases, represents a significant opportunity for the asparaginase market. Asparaginase, commonly used to treat rare forms of leukemia, can benefit from orphan drug designation, which offers manufacturers incentives such as market exclusivity and tax credits. This can drive innovation and expand the application of asparaginase in treating rare disorders[1].

Financial Viability and Development Costs

The development and approval of asparaginase involve substantial costs. Clinical trials, especially those for oncology drugs like asparaginase, are costly and time-consuming. However, the financial returns can be significant. For instance, drugs with higher comparative added clinical benefit scores tend to have higher early market sales, indicating that markets reward drugs with substantial clinical benefits[2].

Market Players and Competitive Landscape

Key players in the asparaginase market include Jazz Pharmaceuticals, Medac GmbH, and Taj Pharmaceuticals Ltd. These companies are involved in various strategies such as partnerships, collaborations, and strategic initiatives to expand their market presence, especially in emerging regions[1].

Future Trends

The future of the asparaginase market is promising, driven by technological advancements, growing demand in emerging markets, and the increasing emphasis on orphan drugs. Here are some key trends to watch:

  • Technological Innovations: Advances in protein engineering, biosensor technologies, and formulation improvements will continue to enhance the efficacy and safety of asparaginase treatments.
  • Emerging Markets: Regions like India and China will see significant growth due to improving healthcare infrastructure and increasing awareness about effective therapies.
  • Orphan Drug Designation: The potential for asparaginase to be designated as an orphan drug will offer additional incentives for manufacturers, driving innovation and expanding its application in treating rare disorders.
"Markets do in fact reward comparative added clinical benefit within each therapy area... However, there are large variations in the magnitude of sales across different drug cohorts."[2]

Key Takeaways

  • The global asparaginase market is expected to grow to USD 3,581.8 million by 2033, with a CAGR of 16.5%.
  • Escherichia coli-derived asparaginase dominates the market with a 67.1% share.
  • Intravenous administration is the preferred route, accounting for 61.2% of the market.
  • Acute lymphoblastic leukemia (ALL) is the primary application, holding 42.1% of the market share.
  • Hospital pharmacies are the leading distribution channels, with online pharmacies expected to grow significantly.
  • North America leads the market, but emerging markets like India and China show promising growth potential.
  • Technological advancements and the emphasis on orphan drugs are key drivers for future growth.

FAQs

What is the expected market size of the asparaginase market by 2033?

The global asparaginase market is expected to reach approximately USD 3,581.8 million by 2033[1].

Which source segment dominates the asparaginase market?

The Escherichia coli (E. coli) source segment dominates the market with a 67.1% share[1].

What is the primary application of asparaginase?

The primary application of asparaginase is in the treatment of acute lymphoblastic leukemia (ALL), accounting for 42.1% of the market share[1].

Which distribution channel holds the largest revenue share in the asparaginase market?

Hospital pharmacies hold the largest revenue share, accounting for 52.5% of the market[1].

What are the key drivers for the growth of the asparaginase market in emerging regions?

Key drivers include improving healthcare infrastructure, increasing awareness about effective therapies, and rising affordability of treatments in regions like India and China[1][4].

References

  1. Market.us, "Asparaginase Market Outlook Analysis | CAGR of 16.5%," https://market.us/report/asparaginase-market/.
  2. ASPE, "Antimicrobial Drugs Market Returns Analysis Final," https://aspe.hhs.gov/sites/default/files/documents/b0962d8b3a6a3a825216485a4a988c76/antimicrobial-drugs-market-returns-analysis.pdf.
  3. PATh, "L-asparaginase production review: bioprocess design and optimization," https://path.web.ua.pt/publications/s00253-021-11359-y.pdf.
  4. BioSpace, "Asparaginase Market Demand 2022-2030: Growth of Pharmaceutical and Food Industries is Driving Industry Revenue Growth," https://www.biospace.com/asparaginase-market-demand-2022-2030-growth-of-pharmaceutical-and-food-industries-is-driving-industry-revenue-growth.
  5. ACS Publications, "Elucidation of the Active Form and Reaction Mechanism in Human Asparaginase III," https://pubs.acs.org/doi/10.1021/acs.jcim.3c00900.

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