Pegaspargase - Biologic Drug Details

Summary for pegaspargase

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

Recent Clinical Trials for pegaspargase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ruijin Hospital	N/A
CStone Pharmaceuticals	Phase 3
The First Affiliated Hospital with Nanjing Medical University	Phase 2

See all pegaspargase clinical trials

Recent Litigation for pegaspargase

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Ravgen, Inc. v. Quest Diagnostics Incorporated	2021-11-17
TwinStrand Biosciences, Inc. v. Guardant Health, Inc.	2021-08-03

See all pegaspargase litigation

PTAB Litigation

Petitioner	Date
Illumina, Inc. et al.	2021-07-20
Laboratory Corporation of America Holdings et al.	2021-05-28
Quest Diagnostics Incorporated	2021-04-15

See all pegaspargase litigation

Pharmacology for pegaspargase

Established Pharmacologic Class	Asparagine-specific Enzyme
Chemical Structure	Asparaginase

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 pegaspargase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Pegaspargase

Introduction to Pegaspargase

Pegaspargase is a pegylated form of the enzyme asparaginase, used primarily in the treatment of acute lymphoblastic leukemia (ALL), a common type of cancer affecting children and adults. This drug has gained significant attention due to its improved clinical profile, including reduced hypersensitivity reactions compared to traditional L-asparaginase treatments.

Market Size and Growth Projections

The global market for pegaspargase is experiencing robust growth. As of 2023, the market was valued at approximately $284 million and is forecasted to reach $505.9 million by 2030, with a compound annual growth rate (CAGR) of 8.2% during the forecast period from 2024 to 2030[1][4].

Drivers of Market Growth

Several factors are driving the growth of the pegaspargase market:

Increasing Incidence of ALL

The rising incidence of acute lymphoblastic leukemia (ALL) is a primary driver. ALL is one of the most common types of cancer in children, and pegaspargase is an essential component of its treatment regimen. The increasing prevalence of ALL, particularly in regions with high pediatric cancer rates, is leading to higher demand for pegaspargase globally[4].

Advancements in Oncology Treatment

The combination of pegaspargase with other chemotherapy agents has proven effective in treating ALL, leading to higher survival rates. As oncologists continue to refine treatment protocols, the role of pegaspargase in achieving better outcomes for leukemia patients is becoming increasingly important, driving market growth[4].

Improvements in Healthcare Infrastructure

The increasing availability of pegaspargase across various regions, driven by improved healthcare infrastructure and access to cancer treatments, is propelling the market forward. Governments and healthcare organizations in emerging economies are investing in improving access to oncology drugs, including pegaspargase[4].

Regional Market Dynamics

The pegaspargase market demonstrates varied growth patterns across different regions:

North America

North America leads the pegaspargase market due to its well-established healthcare infrastructure and the high incidence of ALL, particularly in pediatric patients. Advanced medical technology and a strong focus on cancer research contribute to the region's robust growth[4].

Europe

Europe follows closely, with stringent healthcare policies and initiatives aimed at improving cancer treatment accessibility. European markets are characterized by high standards of healthcare and significant investment in oncology research[4].

Asia-Pacific

The Asia-Pacific region is emerging as a lucrative market for pegaspargase due to its expanding healthcare systems and growing awareness of cancer treatment options. This region is expected to experience significant growth as healthcare improvements continue[4].

Middle East & Africa

Although facing challenges in terms of access and affordability, the Middle East & Africa region is seeing gradual adoption of pegaspargase as healthcare improvements are made. Government initiatives and increasing awareness about cancer treatments are driving market growth in this region[4].

Financial Trajectory and Cost Implications

Budget Impact Analysis

A budget impact analysis conducted in Greece revealed that the introduction of pegaspargase as a treatment option for ALL resulted in considerable cost-savings. Over a 5-year period, the inclusion of pegaspargase led to a budget impact of -€1,644,357 (-19%), with the highest total cost-savings observed in the final year of analysis[2].

Drug Acquisition Costs

The unit cost of pegaspargase is significantly higher than that of L-asparaginase, but its longer half-life and reduced administration frequency contribute to overall cost savings. For example, the drug acquisition cost for pegaspargase is approximately €1,540 per vial, compared to €339 for L-asparaginase[2].

Market Share and Cost Savings

The gradual increase in market share of pegaspargase treatment sequences is associated with increasing cost-savings for public payers. This trend indicates that while the initial costs of pegaspargase may be higher, its long-term benefits and reduced administration needs lead to significant financial savings[2].

Market Trends and Future Outlook

Focus on Pediatric Oncology

Pegaspargase is critical in pediatric cancer treatment, particularly for ALL. The growing emphasis on pediatric oncology is driving its demand, as survival rates for children with ALL continue to improve due to advancements in chemotherapy regimens[4].

Development of Biosimilars and Generics

As patents for original drugs expire, pharmaceutical companies are investing in the development of cost-effective biosimilars and generic versions of pegaspargase. This is expected to increase competition, making pegaspargase more affordable and accessible to a broader range of patients, especially in emerging economies[4].

Personalized Medicine and Targeted Therapies

The increasing focus on personalized medicine and targeted cancer therapies is expected to open new opportunities for pegaspargase. Healthcare providers are seeking more effective treatment options, and ongoing research and development efforts are expected to expand the application scope of pegaspargase[4].

Challenges and Limitations

Drug Shortages

Historically, asparaginase and its derivatives, including pegaspargase, have faced shortages that impact patient care. These shortages can lead to significant changes in patient utilization and service charges, highlighting the need for stable supply chains and alternative treatment options[5].

Key Takeaways

• The global pegaspargase market is projected to grow from $284 million in 2023 to $505.9 million by 2030, with a CAGR of 8.2%.
• The increasing incidence of ALL, advancements in oncology treatment, and improvements in healthcare infrastructure are key drivers of market growth.
• Regional dynamics vary, with North America and Europe leading the market, and the Asia-Pacific region emerging as a significant growth area.
• The introduction of pegaspargase can lead to considerable cost-savings due to its longer half-life and reduced administration frequency.
• The development of biosimilars and generics, along with a focus on personalized medicine, will continue to shape the market.

FAQs

What is the forecasted market size of pegaspargase by 2030?

The global market for pegaspargase is forecasted to reach $505.9 million by 2030[1][4].

What is the CAGR of the pegaspargase market from 2024 to 2030?

The compound annual growth rate (CAGR) of the pegaspargase market from 2024 to 2030 is 8.2%[1][4].

What are the primary drivers of the pegaspargase market growth?

The primary drivers include the increasing incidence of ALL, advancements in oncology treatment, and improvements in healthcare infrastructure[4].

How does the cost of pegaspargase compare to L-asparaginase?

While the unit cost of pegaspargase is higher, its longer half-life and reduced administration frequency lead to overall cost savings[2].

What are the potential future trends in the pegaspargase market?

Future trends include the development of biosimilars and generics, a focus on personalized medicine, and the increasing emphasis on pediatric oncology[4].

Cited Sources

1. Valuates Reports: Pegaspargase - Market Size[1]
2. ISPOR: Budget impact analysis of pegaspargase for the treatment of ALL[2]
3. Cognitive Market Research: Pegaspargase Drugs Market Report 2024[3]
4. Global Growth Insights: Pegaspargase Drugs Market Share, Forecast [2032][4]
5. ASPE: Impact of Drug Shortage on Cancer[5]

Last updated: 2024-12-18