Hyaluronidase - Biologic Drug Details

Summary for hyaluronidase

Tradenames:	3
High Confidence Patents:	4
Applicants:	4
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for hyaluronidase
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hyaluronidase

Recent Clinical Trials for hyaluronidase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Nebraska	Early Phase 1
Adrienne G. Waks	Phase 2
Gilead Sciences	Phase 2

See all hyaluronidase clinical trials

Recent Litigation for hyaluronidase

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Northwestern University v. Moderna, Inc.	2024-10-16
Promosome LLC v. Moderna, Inc.	2023-06-06
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all hyaluronidase litigation

PTAB Litigation

Petitioner	Date
	2017-05-30
	2017-01-31

See all hyaluronidase litigation

Pharmacology for hyaluronidase

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hyaluronidase 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 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
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2030-09-29	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2033-03-11	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2023-03-05	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2027-04-03	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2033-12-05	Patent claims search

Hyaluronidase Market: Dynamics and Financial Trajectory

Introduction to Hyaluronidase

Hyaluronidase is an enzyme that breaks down hyaluronic acid, a substance found in the body that can accumulate in tissues due to various chronic diseases, leading to symptoms such as pain, inflammation, and swelling. The market for hyaluronidase is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The hyaluronidase market is anticipated to grow substantially over the next few years. By 2036, the market size is expected to reach USD 12 billion, with a compound annual growth rate (CAGR) of around 9% from 2023 to 2036[1].

In 2023, the market size was valued at approximately USD 1.01 billion and is projected to increase to USD 1.16 billion in 2024. By 2030, the market is expected to reach USD 2.62 billion, growing at a CAGR of 14.43%[5].

Regional Market Dynamics

North America

North America is expected to dominate the hyaluronidase market, accounting for the largest revenue share. This is due to the region's advanced healthcare infrastructure, high adoption rates of innovative therapies, and favorable government regulations. The market in this region is particularly driven by the increasing demand for dermatology and cosmetic treatments, such as facial injectables with hyaluronidase[1][4].

Asia Pacific

The Asia Pacific region is also expected to witness significant growth, primarily driven by the expanding medical tourism sector. Countries like India are becoming key players in this region, contributing to the market's expansion[1].

Europe

Europe follows closely behind North America, driven by a large patient population and a strong focus on research and development. The region's advanced healthcare system and supportive government initiatives further contribute to the market's growth[3][4].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as cancer and diabetes is a major driver of the hyaluronidase market. These diseases can lead to the accumulation of hyaluronic acid, necessitating the use of hyaluronidase to alleviate symptoms[1].

Technological Advancements

Technological advancements in enzyme engineering and gene editing are leading to the development of more efficient and versatile hyaluronidases. This includes the emergence of synthetic hyaluronidase, which is gaining popularity due to its consistent quality, purity, and reduced risk of immunogenicity[3][4].

Demand for Minimally Invasive Procedures

The increasing demand for minimally invasive procedures and targeted drug delivery is another significant factor driving the adoption of hyaluronidase in various medical applications[3].

Market Segmentation

Type of Hyaluronidase

The market is segmented into animal-derived and synthetic hyaluronidase. Animal-derived hyaluronidase currently holds the largest market share due to its proven efficacy and availability. However, synthetic hyaluronidase is expected to register the fastest CAGR due to its superior purity and reduced potential for allergic reactions[3][4].

Applications

Hyaluronidase finds applications in various fields, including:

• Chemotherapy: Used to enhance the delivery of chemotherapeutic agents.
• In Vitro Fertilization: Helps in improving the success rates of IVF procedures.
• Ophthalmology: Used in ophthalmic therapeutic solutions.
• Dermatology: Commonly used in cosmetic treatments such as facial injectables[3][4].

Financial Performance and Key Players

Halozyme Therapeutics

Halozyme Therapeutics, a key player in the biopharmaceutical sector, has reported significant financial growth driven by its ENHANZE drug delivery technology, which includes the use of hyaluronidase. The company's third-quarter revenue for 2024 increased by 34% year-over-year, with royalty revenues growing to $155.1 million. Halozyme has raised its full-year guidance, anticipating high double-digit revenue growth and impressive adjusted EBITDA growth[2].

Challenges and Restraints

Despite the positive outlook, the hyaluronidase market faces several challenges:

• Regulatory Barriers: Stringent approval processes and regulatory barriers can hinder market growth.
• Potential Side Effects: Concerns over potential side effects and immunogenicity, particularly with animal-derived hyaluronidase.
• Competition: Competition from alternative products and high production costs of synthetic hyaluronidase[3].

Emerging Trends

Development of Thermostable and pH-Stable Hyaluronidases

Research is focused on developing thermostable and pH-stable hyaluronidases to enhance their stability and efficacy.

Use of Nanoparticles and Targeted Delivery Systems

The use of nanoparticles and targeted delivery systems is emerging as a trend to improve the delivery and effectiveness of hyaluronidase.

Combination Therapies

Combination therapies with other drugs and biologics are being explored to enhance the therapeutic outcomes of hyaluronidase[3].

Growth Catalysts

Increased Investment in R&D

Increased investment in research and development is driving innovation and the development of new products.

Strategic Partnerships and Collaborations

Strategic partnerships and collaborations among key players are expanding the market reach and improving product offerings.

Expansion into Emerging Markets

Expansion into emerging markets, particularly in the Asia Pacific region, is providing new growth opportunities[3].

Key Takeaways

• The hyaluronidase market is expected to reach USD 12 billion by 2036, growing at a CAGR of around 9%.
• North America dominates the market due to advanced healthcare infrastructure and high adoption of innovative therapies.
• Technological advancements and the increasing demand for minimally invasive procedures are key drivers of market growth.
• Synthetic hyaluronidase is gaining popularity due to its superior quality and reduced risk of immunogenicity.
• Key players like Halozyme Therapeutics are driving growth through innovative technologies and strategic partnerships.

Frequently Asked Questions (FAQs)

Q: What is the primary use of hyaluronidase in medical applications? A: Hyaluronidase is primarily used to break down hyaluronic acid, which accumulates in tissues due to chronic diseases, leading to symptoms such as pain, inflammation, and swelling.

Q: Which region is expected to dominate the hyaluronidase market? A: North America is expected to dominate the hyaluronidase market due to its advanced healthcare infrastructure and high adoption rates of innovative therapies.

Q: What are the key drivers of the hyaluronidase market growth? A: The key drivers include the increasing prevalence of chronic diseases, technological advancements in enzyme engineering, and the growing demand for minimally invasive procedures.

Q: What is the difference between animal-derived and synthetic hyaluronidase? A: Synthetic hyaluronidase is preferred due to its consistent quality, purity, and reduced risk of immunogenicity compared to animal-derived hyaluronidase.

Q: Which company is a significant player in the hyaluronidase market? A: Halozyme Therapeutics is a key player, with significant financial growth driven by its ENHANZE drug delivery technology.

Cited Sources:

1. Research Nester: Hyaluronidase Market Size & Share, Growth Analysis 2036.
2. Investing.com: Earnings call: Halozyme raises full-year guidance on strong Q3 performance.
3. Data Insights Market: Hyaluronidase Industry 2024 Market Trends and 2032 Forecasts.
4. Grand View Research: Hyaluronidase Market Size & Share Analysis Report, 2030.
5. GII Research: Hyaluronidase Market by Type, Route of Administration, Application.