Hyaluronidase human - Biologic Drug Details

Summary for hyaluronidase human

Tradenames:	1
High Confidence Patents:	4
Applicants:	1
BLAs:	1
Suppliers: see list	3

Pharmacology for hyaluronidase human

Established Pharmacologic Class	Endoglycosidase
Chemical Structure	Glycoside Hydrolases

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 hyaluronidase human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2039-09-22	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2023-03-05	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2023-03-05	Company disclosures
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2023-03-05	Company disclosures

3) Low Certainty: US Patents for hyaluronidase human 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
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859			Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2017-05-29	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2028-03-05	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2039-02-26	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2032-10-16	Patent claims search
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859		2031-10-25	Patent claims search

International Patents for hyaluronidase human

Country	Patent Number	Estimated Expiration
Singapore	178799
South Korea	20120094493
Japan	5366407
Hong Kong	1109162
Spain	2526536
South Korea	20080004473

Supplementary Protection Certificates for hyaluronidase human

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016C/036	Belgium		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/98/067 20140328
C201530049	Spain		PRODUCT NAME: TRASTUZUMAB Y HIALURONIDASA HUMANA RECOMBINANTE; NATIONAL AUTHORISATION NUMBER: EU/1/100/145/002; DATE OF AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/100/145/002; DATE OF FIRST AUTHORISATION IN EEA: 20130826
PA2016022	Lithuania		PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321
132016000070123	Italy		PRODUCT NAME: RITUXIMAB IN ASSOCIAZIONE CON IALURONIDASI RICOMBINANTE UMANA - SOLUZIONE PER INIEZIONE SOTTOCUTANEA(MABTHERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/98/067/001-003, 20140326
2015C/044	Belgium		PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828
93138	Luxembourg		PRODUCT NAME: RITUXIMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; FIRST REGISTRATION DATE: 20140326

Hyaluronidase human Market Analysis and Financial Projection Experimental

Hyaluronidase Market Dynamics and Financial Trajectory

Introduction to Hyaluronidase

Hyaluronidase is an enzyme that breaks down hyaluronic acid, a naturally occurring substance in the human body that maintains tissue moisture and elasticity. This enzyme has versatile applications in both medical and aesthetic fields, making it a significant player in the healthcare and beauty industries.

Market Size and Growth Projections

The global hyaluronidase market was valued at USD 909.5 million in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030, reaching USD 1,734.6 million by 2030[1][2].

Key Drivers of Market Growth

Several factors are driving the growth of the hyaluronidase market:

• Increasing Demand for Aesthetic Procedures: The rising awareness and demand for cosmetic treatments, particularly non-invasive procedures, are significantly boosting the market. Hyaluronidase is used to dissolve unwanted dermal fillers and correct aesthetic treatments, making it a crucial tool in cosmetic dermatology[1][2].
• Advancements in Medical Applications: Hyaluronidase is increasingly used in chemotherapy to enhance the absorption of chemotherapeutic drugs and in ophthalmic treatments. Its role in cancer therapy, particularly in noninvasive tumor imaging, is also a key growth driver[1][2].
• Technological Innovations: Improvements in drug delivery systems, such as microneedling and advanced injection techniques, are enhancing the effectiveness of hyaluronidase, leading to better patient outcomes and reduced side effects[2].

Application Segments

The hyaluronidase market is segmented into several application areas:

• Dermatology: This segment held the largest revenue share of approximately 44.6% in 2022. The increasing use of hyaluronidase in dermatology for correcting fillers and treating skin disorders is driving this segment[1].
• Chemotherapy: Expected to register the fastest CAGR of 10.5% over the forecast period, this segment benefits from hyaluronidase's role in enhancing tumor response to chemotherapeutic drugs[1].
• Ophthalmology and Plastic Surgery: These segments also contribute significantly to the market, with hyaluronidase being used in various therapeutic solutions[1].

Type of Hyaluronidase

The market is divided based on the type of hyaluronidase:

• Animal-Derived Hyaluronidase: Held the largest revenue share of 67.0% in 2022. However, it is expected to face competition from synthetic products due to limitations associated with animal-derived sources[1].
• Synthetic Hyaluronidase: Anticipated to register the fastest CAGR of 9.4% over the forecast period. Recombinant human hyaluronidase is gaining preference due to its high efficacy, consistency, and purity[1].

Regional Outlook

Geographically, the hyaluronidase market is segmented as follows:

• North America: Dominated the market in 2022 with the largest revenue share of 38.0%, driven by the presence of major players, high adoption of advanced treatments, and a substantial number of dermatology clinics[1].
• Asia Pacific: Expected to grow at the fastest CAGR of 9.3% during the forecast period, driven by medical tourism, the presence of suppliers, and technological advancements in countries like South Korea[1].
• Europe and Other Regions: Europe, particularly countries like Germany, France, and the UK, and regions like Latin America and the Middle East & Africa, also contribute significantly to the market growth[4].

Market Competitiveness and Strategies

The hyaluronidase market is highly competitive, with players engaging in strategies such as mergers & acquisitions, product launches, and collaborations to increase market penetration. For example, Alteogen Inc. announced an exclusive license arrangement with Sandoz AG in January 2023 to commercialize a unique hyaluronidase product[1].

Investment Opportunities

The growing demand for hyaluronidase presents lucrative investment opportunities in research and development, product development, and strategic partnerships. Companies are exploring new applications and formulations, and collaborations between research institutions and biotech firms are expected to yield innovative products[2].

Technological Advancements

Technological innovations are revolutionizing the application of hyaluronidase. Advances in drug delivery systems and the development of recombinant human hyaluronidase are enhancing the efficacy and safety of treatments. For instance, the conversion of intravenous dosing to subcutaneous dosing using recombinant human hyaluronidase is improving treatment outcomes[5].

Impact on Patient Care

The use of hyaluronidase has led to significant improvements in patient care. In aesthetic procedures, it allows for immediate results and greater flexibility in achieving desired outcomes. In medical applications, it enhances the absorption of medications, increasing the effectiveness of treatments.

"Hyaluronidase is primarily used to break down hyaluronic acid in various applications, including dissolving unwanted dermal fillers, enhancing drug absorption, and treating localized edema"[2].

Key Takeaways

• The global hyaluronidase market is projected to grow at a CAGR of 8.4% from 2023 to 2030.
• Dermatology and chemotherapy segments are key drivers of market growth.
• Synthetic hyaluronidase is gaining preference due to its high efficacy and purity.
• North America and Asia Pacific are significant regions driving market growth.
• Technological advancements and strategic partnerships are crucial for market expansion.

Frequently Asked Questions

Q: What is the current market size of the hyaluronidase market? A: The global hyaluronidase market size was estimated at USD 909.5 million in 2022[1].

Q: What is the projected growth rate of the hyaluronidase market? A: The market is anticipated to grow at a CAGR of 8.4% from 2023 to 2030[1].

Q: Which segment holds the largest revenue share in the hyaluronidase market? A: The dermatology segment held the largest revenue share of approximately 44.6% in 2022[1].

Q: What are the primary applications of hyaluronidase? A: Hyaluronidase is used in dermatology, chemotherapy, ophthalmology, and plastic surgery, among other applications[1].

Q: Which region is expected to grow the fastest in the hyaluronidase market? A: The Asia Pacific region is anticipated to grow at the fastest CAGR of 9.3% during the forecast period[1].

Sources:

1. Grand View Research - Hyaluronidase Market Size & Share Analysis Report, 2030
2. Market Research Intellect - Hyaluronidase Market Size And Projection
3. Federal Trade Commission - Emerging Health Care Issues: Follow-on Biologic Drug Competition
4. Verified Market Research - Hyaluronidase Market Size, Trends, & Forecast
5. PharmTech - Converting Intravenous Dosing to Subcutaneous Dosing with Recombinant Human Hyaluronidase