Imiglucerase - Biologic Drug Details

Summary for imiglucerase

Tradenames:	1
High Confidence Patents:	2
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for imiglucerase
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for imiglucerase

Recent Clinical Trials for imiglucerase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AVROBIO	Phase 2/Phase 3
Sanofi	Phase 4
ISU Abxis Co., Ltd.	Phase 1

See all imiglucerase clinical trials

Recent Litigation for imiglucerase

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Juul Labs Inc v. EZfumes	2020-07-10

See all imiglucerase litigation

Pharmacology for imiglucerase

Established Pharmacologic Class	Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Chemical Structure	Glucosylceramidase

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 imiglucerase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2010-08-17	Company disclosures
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2013-08-27	Company disclosures

3) Low Certainty: US Patents for imiglucerase 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
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2033-03-11	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2027-09-17	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2029-10-19	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367		2028-06-26	Patent claims search

International Patents for imiglucerase

Country	Patent Number	Estimated Expiration
Canada	2006709
Japan	2893481
Spain	2093642
World Intellectual Property Organization (WIPO)	9007573

Market Dynamics and Financial Trajectory for the Biologic Drug: Imiglucerase

Introduction

Imiglucerase, a biologic drug used in the treatment of Gaucher disease, is a crucial component in the management of this rare genetic disorder. This article delves into the market dynamics and financial trajectory of imiglucerase, highlighting its current market size, growth prospects, and key factors influencing its financial performance.

Market Size and Growth Prospects

The imiglucerase market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at $1.69 billion and is projected to reach $2.57 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5%[1].

Prevalence and Awareness of Gaucher Disease

The rising prevalence of Gaucher disease and increasing awareness about enzyme replacement therapy (ERT) are primary drivers of the imiglucerase market. Gaucher disease, a rare genetic disorder, requires long-term treatment, which contributes to the sustained demand for imiglucerase[4].

Clinical Effectiveness and Safety

The clinical effectiveness and safety of imiglucerase have been extensively studied. Long-term data from registries like the Gaucher Outcome Survey (GOS) confirm the positive impact of imiglucerase on patients with Gaucher disease. These studies show significant improvements in clinical parameters such as hemoglobin concentrations, platelet counts, and liver and spleen volumes over the course of treatment[5].

Competitive Landscape

Imiglucerase competes with other ERTs such as velaglucerase and taliglucerase. The Life Saving Drugs Program (LSDP) review protocol compares these medicines in terms of clinical effectiveness, safety, and value for money. The competition among these drugs is intense, with each having its own market share and patient base[2].

Financial Performance of Key Players

Sanofi, one of the major players in the rare disease segment, has seen significant growth in its Specialty Care portfolio, which includes imiglucerase (marketed as Cerezyme). In 2021, the Rare Disease segment of Sanofi saw a 7.0% increase in sales, driven by strong performance in the Gaucher franchise. Cerezyme sales specifically increased by 3.9% globally, with notable growth in the Rest of the World region[3].

Sales and Revenue Trends

The sales of imiglucerase have been consistently strong, driven by increased patient demand and new patient accruals across different geographic regions. In the fourth quarter of 2021, the Gaucher franchise sales, which include Cerezyme and Cerdelga, increased by 12.8% to €248 million. This growth is attributed to switches and new patient accruals in Europe and the U.S.[3].

Market Drivers

Several factors drive the market for imiglucerase:

• Increasing Prevalence: The rising number of Gaucher disease cases globally contributes to the growing demand for imiglucerase.
• Awareness and Diagnosis: Improved diagnostic techniques and increased awareness about Gaucher disease lead to more patients being diagnosed and treated.
• Long-term Treatment: Gaucher disease requires lifelong treatment, ensuring a steady and predictable market demand.
• Regulatory Support: Programs like the LSDP provide subsidized access to these medicines, making them more accessible to patients[2][4].

Market Challenges

Despite the growth, the imiglucerase market faces several challenges:

• Competition: The presence of other ERTs like velaglucerase and taliglucerase creates competitive pressure.
• High Cost: Imiglucerase is a costly treatment, which can be a barrier to access in some regions.
• Storage and Dispensing: The drug requires specific storage and dispensing conditions, which can affect its availability and patient compliance[2].

Value for Money and Utilization

The value for money of imiglucerase is a critical aspect of its market dynamics. The LSDP review protocol includes an analysis of the value for money of these medicines under current funding arrangements. The utilization of imiglucerase, including storage, dispensing, and patient compliance, is also closely monitored to ensure optimal use and effectiveness[2].

Future Outlook

The future of the imiglucerase market looks promising, with continued growth expected due to the increasing prevalence of Gaucher disease and advancements in diagnostic and treatment technologies. Developing technologies that may impact future funded access are also being investigated, which could further expand the market[2].

Key Takeaways

• The imiglucerase market is projected to grow from $1.69 billion in 2023 to $2.57 billion by 2031.
• The market is driven by the rising prevalence of Gaucher disease and increasing awareness about ERT.
• Imiglucerase has shown significant clinical effectiveness and safety in long-term treatment.
• The competitive landscape includes other ERTs like velaglucerase and taliglucerase.
• Financial performance is strong, with notable growth in the Rare Disease segment of key players like Sanofi.
• Market challenges include competition, high cost, and specific storage and dispensing requirements.

FAQs

What is the current market size of the imiglucerase market?

The current market size of the imiglucerase market was valued at $1.69 billion in 2023[1].

What is the projected growth rate of the imiglucerase market?

The imiglucerase market is projected to grow at a CAGR of 6.5% from 2023 to 2031[1].

What are the key drivers of the imiglucerase market?

The key drivers include the rising prevalence of Gaucher disease, increased awareness about ERT, and long-term treatment requirements[4].

Which companies are major players in the imiglucerase market?

Sanofi is one of the major players, with its product Cerezyme being a significant contributor to the Rare Disease segment[3].

What are the main challenges faced by the imiglucerase market?

The main challenges include competition from other ERTs, high cost of treatment, and specific storage and dispensing requirements[2].

Sources

1. Verified Market Research: Imiglucerase Market Size, Share, Growth & Forecast.
2. Australian Government Department of Health: Life Saving Drugs Program – Gaucher disease (type 1) – Medicines Review Protocol.
3. Sanofi: Press Release: Strong 2021 sales and business EPS growth.
4. Dataintelo: Imiglucerase Market Research Report 2032.
5. MDPI: Twelve Years of the Gaucher Outcomes Survey (GOS).