FABRAZYME Drug Profile

Summary for Tradename: FABRAZYME

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

Recent Clinical Trials for FABRAZYME

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bio Sidus SA	Phase 3
Sanofi	Phase 4
Idorsia Pharmaceuticals Ltd.	Phase 1

See all FABRAZYME clinical trials

Pharmacology for FABRAZYME

Established Pharmacologic Class	Hydrolytic Lysosomal Neutral Glycosphingolipid-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 FABRAZYME Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FABRAZYME 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	FABRAZYME	agalsidase beta	For Injection	103979	5,356,804	2039-02-26	Company disclosures

3) Low Certainty: US Patents for FABRAZYME 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	FABRAZYME	agalsidase beta	For Injection	103979	10,016,338	2033-03-11	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10,111,968	2032-02-15	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10,182,561	2024-12-29	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10,280,414	2029-11-17	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10,543,204	2028-06-26	Patent claims search
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10,577,154	2029-05-13	Patent claims search

International Patents for FABRAZYME

Country	Patent Number	Estimated Expiration
Luxembourg	91704
Sweden	2210947
Luxembourg	91703
Japan	3598302
European Patent Office	1375665
Australia	8954791

Supplementary Protection Certificates for FABRAZYME

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132010901851583	Italy
C02210947/01	Switzerland		PRODUCT NAME: AGALSIDASE BETA; NAT. REGISTRATION NO/DATE: SWISSMEDIC 56261 20030725
C300627	Netherlands		PRODUCT NAME: METHOD FOR PRODUCING SECRETED PROTIENS; REGISTRATION NO/DATE: EU/1/01/188/001-006 20010803
SPC/GB10/030	United Kingdom		PRODUCT NAME: AGALSIDASE ALFA; REGISTERED: UK EU/1/01/189/001 20010807
122010000028	Germany		PRODUCT NAME: AGALSIDASE ALFA IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/01/189/001 20010803
20/2010	Austria		PRODUCT NAME: AGALSIDASE ALPHA; REGISTRATION NO/DATE: EU/1/01/189/001 20010803

FABRAZYME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: FABRAZYME

Introduction to FABRAZYME

FABRAZYME, also known as agalsidase beta, is a biologic drug used to treat Fabry disease, a rare genetic disorder caused by the accumulation of a specific type of fatty substance in various bodily tissues. Here, we will delve into the market dynamics and financial trajectory of FABRAZYME, highlighting key trends, drivers, and forecasts.

Market Size and Forecast

The global market for FABRAZYME has been experiencing significant growth. As of 2023, the fabrazyme agalsidase beta market size is substantial and is projected to continue its upward trend from 2023 to 2031. This growth is driven by increasing demand for effective treatments for Fabry disease, coupled with extensive research and incremental healthcare spending worldwide[1][3].

Segmentation and Geographic Distribution

The FABRAZYME market is segmented based on application (hospitals, drug stores), product types (5mg/vial, 35mg/vial), and geographical regions (North America, Europe, Asia-Pacific, South America, and the Middle East and Africa). The report highlights that the market is poised for significant growth across these segments, with particular emphasis on regions where penetration rates are lower, such as the Rest of World category[1].

Drivers of Market Growth

Several factors are driving the growth of the FABRAZYME market:

• Increasing Prevalence of Fabry Disease: The number of individuals diagnosed with Fabry disease is rising, which increases the demand for effective treatments like FABRAZYME[5].
• Advancements in Healthcare: Incremental healthcare spending and advancements in medical research are expanding the market size and enabling drug manufacturers to penetrate deeper into the market[3].
• Regulatory Approvals and Pipeline Development: Continuous regulatory approvals and the development of new therapies are crucial for the market's growth. For instance, Sanofi's robust pipeline and recent approvals for other biologic medicines indicate a strong focus on innovative treatments[2].

Financial Performance

Recent Sales Data

In the second quarter of 2024, FABRAZYME sales showed a significant increase. According to Sanofi's Q2 2024 report, FABRAZYME sales grew by 12.4%, driven primarily by growth in the Rest of World region where penetration rates are lower. This growth is part of a broader trend where FABRAZYME has seen consistent sales increases, with a 7.7% growth in Q1 2024 as well[2][4].

Revenue Projections

The market forecast for FABRAZYME indicates sustained significant expansion from 2023 to 2031. The report projects that the market will continue to grow, driven by the increasing demand for treatments and the expanding healthcare expenditure. The global fabry disease treatment market, which includes FABRAZYME, is projected to grow at a CAGR of 9.9% from 2024 to 2030, reaching a substantial market size[1][5].

Competitive Landscape

The competitive landscape for FABRAZYME is dynamic, with several emerging therapies expected to impact the market. Other biologic and innovative treatments for Fabry disease are being developed, which could pose competition to FABRAZYME. However, FABRAZYME's established presence and ongoing research and development activities position it strongly in the market[3].

Regulatory and Developmental Activities

Regulatory milestones and developmental activities play a crucial role in the market trajectory of FABRAZYME. The drug has undergone extensive research, and its mechanism of action, dosage, and administration are well-documented. Ongoing regulatory approvals and the launch of late-stage emerging therapies will continue to shape the market dynamics[3].

Challenges and Opportunities

Challenges

• Competition from Emerging Therapies: The launch of new therapies for Fabry disease could challenge FABRAZYME's market dominance.
• Generic Competition: As seen with other Sanofi products, generic competition can impact sales negatively[2].

Opportunities

• Increasing Healthcare Spending: Incremental healthcare spending across the world presents a significant opportunity for market expansion.
• Growing Awareness and Diagnosis: Increased awareness and diagnosis of Fabry disease can drive demand for treatments like FABRAZYME[3][5].

Key Players and Market Share

Genzyme Corporation, a subsidiary of Sanofi, is a key player in the FABRAZYME market. The company's strong performance in the biopharma sector, including the success of other biologic medicines like Dupixent, underscores its capability to drive growth in the FABRAZYME market[1][2].

Regional Performance

The performance of FABRAZYME varies across different regions. In the Rest of World category, FABRAZYME has seen significant growth due to lower penetration rates. In Europe and the US, the drug has also shown strong sales, although regional dynamics such as competition and regulatory environments can impact sales[2][4].

Conclusion

The market dynamics and financial trajectory for FABRAZYME are characterized by strong growth driven by increasing demand, advancements in healthcare, and robust pipeline development. Despite potential challenges from emerging therapies and generic competition, FABRAZYME is well-positioned for continued success.

Key Takeaways

• Strong Market Growth: FABRAZYME is expected to continue its upward trend from 2023 to 2031.
• Increasing Demand: Rising prevalence of Fabry disease and incremental healthcare spending drive market growth.
• Regulatory and Developmental Activities: Ongoing research and regulatory approvals are crucial for market dominance.
• Competitive Landscape: Emerging therapies pose competition, but FABRAZYME's established presence is a significant advantage.
• Regional Performance: Growth is notable in the Rest of World region, with varying performance in Europe and the US.

FAQs

Q1: What is FABRAZYME used for? FABRAZYME is used to treat Fabry disease, a rare genetic disorder caused by the accumulation of a specific type of fatty substance in various bodily tissues.

Q2: Who is the key player in the FABRAZYME market? Genzyme Corporation, a subsidiary of Sanofi, is the key player in the FABRAZYME market.

Q3: What are the main drivers of the FABRAZYME market growth? The main drivers include increasing prevalence of Fabry disease, advancements in healthcare, and robust pipeline development.

Q4: How is the competitive landscape for FABRAZYME? The competitive landscape is dynamic with emerging therapies posing competition, but FABRAZYME's established presence and ongoing research activities position it strongly.

Q5: What is the projected growth rate for the FABRAZYME market? The global fabry disease treatment market, which includes FABRAZYME, is projected to grow at a CAGR of 9.9% from 2024 to 2030.

Sources

1. Market Research Intellect: Global fabrazyme agalsidase beta market size and forecast.
2. Sanofi: Q2 2024 sales growth and business EPS report.
3. Research and Markets: FABRAZYME, Drug Insight and Market Forecast - 2032.
4. Sanofi: Q1 2024 sales growth and business EPS report.
5. Grand View Research: Fabry Disease Treatment Market Size & Share Report, 2030.