ELAPRASE Drug Profile

Summary for Tradename: ELAPRASE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ELAPRASE

Recent Clinical Trials for ELAPRASE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda	Phase 2/Phase 3
Takeda Development Center Americas, Inc.	Phase 4
Takeda	Phase 4

See all ELAPRASE clinical trials

Pharmacology for ELAPRASE

Established Pharmacologic Class	Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Chemical Structure	alpha-Glucosidases

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 ELAPRASE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for ELAPRASE 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
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2033-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2029-05-13	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2029-01-29	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2033-05-03	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2036-08-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2038-07-09	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ELAPRASE	idursulfase	Injection	125151		2038-09-17	Patent claims search

ELAPRASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ELAPRASE

Introduction to ELAPRASE

ELAPRASE, also known as idursulfase, is a biologic drug used for the treatment of Hunter syndrome, a rare genetic disorder classified under lysosomal storage diseases. It is an enzyme replacement therapy (ERT) that helps replace the deficient iduronate-2-sulfatase enzyme in patients.

Market Dominance and Monopoly

ELAPRASE is currently the dominant treatment for Hunter syndrome, with its manufacturer, Shire (now part of Takeda Pharmaceutical Company Limited), holding a significant market share. The drug's efficiency and indispensability in key markets have been crucial factors in Shire's leading position in the global Hunter syndrome treatment market[1][4].

Financial Performance of ELAPRASE

Historically, ELAPRASE has contributed substantially to Shire's revenue. In 2011, for example, ELAPRASE sales were up 17% to $124 million in the fourth quarter, reflecting strong growth across Shire's product portfolio[5].

Quarterly and Annual Sales

• In the fourth quarter of 2011, ELAPRASE sales were $124 million, part of Shire's overall product sales growth of 23% to $1,049 million[5].
• By 2015, the sales of ELAPRASE continued to grow, though they were somewhat impacted by foreign exchange headwinds, particularly from the strong US dollar[2].

Revenue Contribution

ELAPRASE is one of the key products driving Shire's revenue. The company's strong financial performance, including record full-year revenues and double-digit growth in non-GAAP diluted earnings per ADS, has been partly attributed to the success of ELAPRASE and other rare disease treatments[2][5].

Market Growth Drivers

Several factors drive the market growth for ELAPRASE and other Hunter syndrome treatments:

Unmet Clinical Needs

The lack of multiple therapeutic options for Hunter syndrome patients and the high cost of existing treatments like ELAPRASE and Hunterase create significant unmet clinical needs. This gap is expected to fuel the demand for more affordable and effective treatments[1].

Regulatory and Reimbursement Factors

Regions like North America have higher diagnosis and treatment rates for rare conditions, coupled with adequate reimbursement policies. These factors contribute to the dominant market share of ELAPRASE in these regions[1].

Clinical Trials and Emerging Therapies

The increasing number of clinical trials involving hematopoietic stem cell transplantation (HSCT) and gene therapy is expected to drive market growth. These emerging therapies could potentially offer alternative or complementary treatments to ERTs like ELAPRASE[1].

Geographical Market Dynamics

The market for ELAPRASE varies significantly across different regions:

North America

North America dominates the market share due to higher diagnosis and treatment rates, as well as favorable reimbursement policies. The U.S., in particular, has a strong focus on orphan drug development, supported by government initiatives[1][4].

Europe and Asia-Pacific

Europe and the Asia-Pacific region are expected to register higher CAGRs during the forecast period. The presence of key products, increasing awareness, and improving healthcare infrastructure in countries like Japan and China are driving this growth[1][4].

Rest of the World

The rest of the world, including Latin America and the Middle East & Africa, is currently in a nascent stage but is expected to grow due to developing healthcare infrastructure and increasing awareness of orphan disorders[1].

Challenges and Opportunities

Despite its market dominance, ELAPRASE faces several challenges:

Cost and Accessibility

The high cost of ELAPRASE makes it inaccessible to many patients in emerging countries, leading to a significant need for more affordable treatment options[1].

Competition from Emerging Therapies

The introduction of new therapies, such as gene therapy and HSCT, could potentially challenge ELAPRASE's market position. However, these therapies also present opportunities for combination treatments and improved patient outcomes[1].

Future Outlook

The global Hunter syndrome treatment market, driven by ELAPRASE, is projected to grow significantly:

• The market size is expected to reach USD 1,599.5 million by 2032, exhibiting a CAGR of 6.0% from 2019 to 2026[1].
• The Asia-Pacific region is anticipated to grow at the fastest CAGR, driven by rising awareness and improved medical education[4].

Key Takeaways

• ELAPRASE dominates the Hunter syndrome treatment market due to its efficacy and the lack of alternative treatments.
• The high cost and limited accessibility of ELAPRASE in emerging countries create significant unmet clinical needs.
• Emerging therapies such as HSCT and gene therapy are expected to drive market growth and potentially offer alternative or complementary treatments.
• North America currently dominates the market, but the Asia-Pacific region is expected to grow rapidly.

FAQs

What is ELAPRASE used for?

ELAPRASE (idursulfase) is used for the treatment of Hunter syndrome, a rare genetic disorder caused by the deficiency of the iduronate-2-sulfatase enzyme.

Who manufactures ELAPRASE?

ELAPRASE is manufactured by Shire, which is now part of Takeda Pharmaceutical Company Limited.

Why is ELAPRASE expensive?

ELAPRASE is expensive due to its complex production process and the high cost associated with developing and maintaining rare disease treatments.

Are there any alternative treatments to ELAPRASE?

Currently, the only other approved therapeutic for Hunter syndrome is Hunterase, which is approved in some countries. However, clinical trials involving HSCT and gene therapy are underway and may offer alternative or complementary treatments in the future.

What regions dominate the market for ELAPRASE?

North America currently dominates the market for ELAPRASE due to higher diagnosis and treatment rates, as well as favorable reimbursement policies. However, the Asia-Pacific region is expected to grow rapidly in the coming years.

Cited Sources:

1. Fortune Business Insights - Hunter Syndrome Treatment Market Size, Share & Industry Report
2. PR Newswire - Shire Delivers Record Full-year Revenue and Strong Double Digit Growth
3. Biospace - Biologics Market Size to Reach USD 699.5 Billion by 2032
4. Grand View Research - Hunter Syndrome Treatment Market Size, Share Report 2030
5. PR Newswire - Another Strong Year for Shire With Revenues Exceeding $4 Billion