Asparaginase erwinia chrysanthemi - Biologic Drug Details

Summary for asparaginase erwinia chrysanthemi

Tradenames:	1
High Confidence Patents:	2
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for asparaginase erwinia chrysanthemi

Recent Clinical Trials for asparaginase erwinia chrysanthemi

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Baxalta US Inc.	Phase 2/Phase 3
St. Jude Children's Research Hospital	Phase 2/Phase 3

See all asparaginase erwinia chrysanthemi clinical trials

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 asparaginase erwinia chrysanthemi Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for asparaginase erwinia chrysanthemi Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Jazz Pharmaceuticals Ireland Limited	RYLAZE	asparaginase erwinia chrysanthemi (recombinant)-rywn	Injection	761179	10,787,671	2037-10-27	Company disclosures
Jazz Pharmaceuticals Ireland Limited	RYLAZE	asparaginase erwinia chrysanthemi (recombinant)-rywn	Injection	761179	8,288,127	2029-07-30	Company disclosures

3) Low Certainty: US Patents for asparaginase erwinia chrysanthemi Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Jazz Pharmaceuticals, Inc.	ERWINAZE	asparaginase erwinia chrysanthemi	For Injection	125359	10,287,294	2035-07-08	Patent claims search
Jazz Pharmaceuticals, Inc.	ERWINAZE	asparaginase erwinia chrysanthemi	For Injection	125359	10,787,671	2037-10-27	Patent claims search
Jazz Pharmaceuticals, Inc.	ERWINAZE	asparaginase erwinia chrysanthemi	For Injection	125359	10,821,160	2037-03-01	Patent claims search

Market Dynamics and Financial Trajectory for Asparaginase Erwinia Chrysanthemi

Introduction

Asparaginase Erwinia chrysanthemi is a biologic drug that has garnered significant attention in recent years due to its critical role in the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma, particularly in patients who are allergic to E. coli-derived asparaginase. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global asparaginase market is projected to experience robust growth over the coming years. By 2030, the market is expected to reach USD 2,619.3 million, registering a revenue CAGR of 16.7%[1]. Similarly, another forecast indicates that the market will grow from USD 777.8 million in 2023 to USD 3,581.8 million by 2033, at a CAGR of 16.5%[3].

Key Drivers of Growth

Several factors are driving the growth of the asparaginase market:

Increasing Prevalence of Leukemia

The rising incidence of acute lymphoblastic leukemia and lymphoblastic lymphoma globally is a significant driver. This trend is particularly pronounced in developing countries such as India, China, Malaysia, and Indonesia[1].

Pharmaceutical and Food Industries

The growth of the pharmaceutical and food industries is another crucial factor. Asparaginase is used not only in cancer treatment but also in food processing to reduce the formation of carcinogenic compounds like acrylamide in starchy foods[1][3].

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].

Source Segmentation

The asparaginase market is segmented based on the source of the enzyme:

Erwinia Chrysanthemi

Asparaginase derived from Erwinia chrysanthemi is gaining traction due to its lower allergenic potential compared to E. coli-derived asparaginase. It was first approved by the FDA in 2011 for treating patients with ALL who are allergic to E. coli-derived asparaginase[1][2].

Escherichia Coli

Despite the growing demand for Erwinia chrysanthemi-derived asparaginase, the E. coli segment still dominates the market, holding a significant share due to its widespread use in cancer treatment and food processing[3][5].

Route of Administration

The route of administration plays a crucial role in the market dynamics:

Intramuscular and Intravenous

Intramuscular administration is common for asparaginase Erwinia chrysanthemi, with intravenous administration also being used. The intravenous route held a 61.2% share in 2023 and is projected to grow further[3].

Application Segmentation

The primary applications of asparaginase are:

Acute Lymphoblastic Leukemia (ALL)

ALL dominates the market share, with asparaginase being a critical component of multi-agent chemotherapy regimens for this condition[3].

Lymphoblastic Lymphoma

Lymphoblastic lymphoma is another key application area, where asparaginase Erwinia chrysanthemi is used to treat patients who are hypersensitive to E. coli-derived asparaginase[2].

Distribution Channels

The distribution channels for asparaginase include:

Hospital Pharmacies

Hospital pharmacies account for the largest revenue share, approximately 52.5%, due to the frequent prescriptions and diagnoses within hospital settings[3].

Online and Retail Pharmacies

Online pharmacies are expected to experience the highest compound annual growth rate due to their convenience, while retail pharmacies will also see substantial growth, especially in developing nations[3].

Regional Analysis

The market is geographically diverse, with:

North America

North America holds a dominant market share, approximately 45.1%, driven by advanced healthcare infrastructure and high demand for asparaginase treatments[3].

Asia-Pacific

The Asia-Pacific region, particularly countries like India, China, Malaysia, and Indonesia, is expected to register robust growth due to increasing prevalence of leukemia and growing healthcare awareness[1].

Emerging Markets and Opportunities

Emerging markets present significant growth opportunities:

Growing Emphasis on Orphan Drugs

The increasing interest in orphan drugs for rare diseases, such as certain forms of leukemia, offers additional incentives for manufacturers, including market exclusivity and tax credits, which can drive innovation and expand the application of asparaginase[3].

Untapped Regions

Regions with rising healthcare awareness and improving infrastructure, such as India and China, offer untapped opportunities for market expansion. Partnerships and strategic initiatives in these regions can help establish a strong market presence[3].

Financial Trajectory

The financial trajectory of the asparaginase market is promising:

Revenue Projections

By 2030, the global asparaginase market is expected to reach USD 2,619.3 million, and by 2033, it is projected to be worth around USD 3,581.8 million[1][3].

CAGR

The market is expected to grow at a CAGR of 16.7% from 2022 to 2030 and 16.5% from 2024 to 2033[1][3].

Technological Advancements

Technological advancements in asparaginase formulation and delivery are expected to shape the market. For instance, protein engineering approaches, like the one developed by IIT Indore, aim to reduce side effects and improve efficacy[1].

Key Takeaways

• Market Growth: The global asparaginase market is expected to grow significantly, driven by increasing prevalence of leukemia and advancements in pharmaceutical and food industries.
• Source Segmentation: Erwinia chrysanthemi-derived asparaginase is gaining traction due to lower allergenic potential.
• Application: Acute lymphoblastic leukemia dominates the market share.
• Distribution: Hospital pharmacies hold the largest revenue share.
• Regional Growth: North America and Asia-Pacific regions are key drivers of growth.
• Emerging Markets: Untapped opportunities exist in emerging economies with growing healthcare awareness.

FAQs

What is the primary use of asparaginase Erwinia chrysanthemi?

Asparaginase Erwinia chrysanthemi is primarily used as a component of multi-agent chemotherapy regimens for treating patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma who are allergic to E. coli-derived asparaginase[2].

Which region is expected to register the highest growth in the asparaginase market?

The Asia-Pacific region, particularly countries like India, China, Malaysia, and Indonesia, is expected to register robust growth due to increasing prevalence of leukemia and growing healthcare awareness[1].

What are the main distribution channels for asparaginase?

The main distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies, with hospital pharmacies accounting for the largest revenue share[3].

How does asparaginase Erwinia chrysanthemi work?

Asparaginase Erwinia chrysanthemi depletes the source of asparagine for leukemic cells by catalyzing the deamidation reaction of L-asparagine to aspartic acid and ammonia, leading to the death of leukemic cells[2].

What are the common adverse effects of asparaginase Erwinia chrysanthemi?

Common adverse effects include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity. Pancreatitis is a significant concern, especially in pediatric patients[2].

Sources

1. BioSpace: Asparaginase Market Demand 2022-2030: Growth of Pharmaceutical and Food Industries Is Driving Industry Revenue Growth.
2. DrugBank: Asparaginase Erwinia chrysanthemi: Uses, Interactions, Pharmacology.
3. Market.us: Asparaginase Market Outlook Analysis | CAGR of 16.5%.
4. Aetna: Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn (Rylaze).
5. GlobeNewswire: Asparaginase Market Size to Hit $1.57Bn, Globally, by 2028.

Last updated: 2024-12-18