CLINICAL TRIALS PROFILE FOR HYALURONIDASE

Biosimilar Clinical Trials for hyaluronidase

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Gilead Sciences	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Adrienne G. Waks	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug

All Clinical Trials for hyaluronidase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000493 ↗	Multicenter Investigation of Limitation of Infarct Size (MILIS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1977-09-01	To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
NCT00198419 ↗	Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)	Completed	Bausch & Lomb Incorporated	Phase 1	2004-03-01	The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.
NCT00198458 ↗	Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)	Completed	Bausch & Lomb Incorporated	Phase 1	2004-07-01	The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
NCT00198471 ↗	Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment	Completed	Bausch & Lomb Incorporated	Phase 2	2005-07-01	The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.

Clinical Trial Conditions for hyaluronidase

Condition Name

Condition Name for hyaluronidase
Intervention	Trials
Healthy	6
Type 1 Diabetes Mellitus	6
Multiple Myeloma	5
Dehydration	5

Condition MeSH

Condition MeSH for hyaluronidase
Intervention	Trials
Diabetes Mellitus	12
Neoplasms, Plasma Cell	10
Multiple Myeloma	10
Diabetes Mellitus, Type 1	9

Clinical Trial Locations for hyaluronidase

Trials by Country

Trials by Country for hyaluronidase
Location	Trials
United States	436
United Kingdom	17
Spain	15
France	15
Canada	14

Trials by US State

Trials by US State for hyaluronidase
Location	Trials
California	36
New York	22
Texas	20
Washington	19
North Carolina	18

Clinical Trial Progress for hyaluronidase

Clinical Trial Phase

Clinical Trial Phase for hyaluronidase
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for hyaluronidase
Clinical Trial Phase	Trials
Completed	60
Recruiting	26
Not yet recruiting	17

Clinical Trial Sponsors for hyaluronidase

Sponsor Name

Sponsor Name for hyaluronidase
Sponsor	Trials
Halozyme Therapeutics	36
National Cancer Institute (NCI)	10
Baxter Healthcare Corporation	7

Sponsor Type

Sponsor Type for hyaluronidase
Sponsor	Trials
Other	90
Industry	82
NIH	12

Hyaluronidase Market Analysis and Financial Projection

Hyaluronidase: Clinical Trials, Market Analysis, and Projections

Introduction to Hyaluronidase

Hyaluronidase is an enzyme that breaks down hyaluronic acid, a key component of the extracellular matrix. This enzyme has diverse applications, including cosmetic treatments, cancer therapy, and ophthalmic therapeutic solutions. Here, we will delve into recent clinical trials, market analysis, and projections for hyaluronidase.

Clinical Trials and Approvals

Multiple Myeloma Treatment

A significant recent development involves the FDA approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of newly diagnosed multiple myeloma in patients eligible for a stem cell transplant. This approval was based on the PERSEUS clinical trial, which showed a 60% lower risk of disease progression or death in the experimental arm compared to the control arm[1].

Subcutaneous Administration in Solid Tumors

Another notable approval is for nivolumab and hyaluronidase-nvhy, a PD-1 inhibitor co-formulated with recombinant human hyaluronidase (rHuPH20) for subcutaneous administration in patients with solid tumors. This formulation offers a faster and more convenient alternative to intravenous infusions, with consistent efficacy and comparable safety profiles[4].

Market Analysis

Current Market Size

The global hyaluronidase market was estimated at USD 909.5 million in 2022 and is projected to grow significantly over the next few years. By 2030, the market is expected to reach USD 2.62 billion at a CAGR of 14.43%[5].

Growth Drivers

Several factors are driving the growth of the hyaluronidase market:

• Increasing Prevalence of Chronic Diseases: Conditions like cancer and diabetes lead to the accumulation of hyaluronic acid, making hyaluronidase a valuable treatment option[3].
• Technological Advancements: The development of recombinant hyaluronidase has reduced the risk of allergic reactions, making the enzyme safer and more effective[3].
• Strategic Collaborations: Partnerships between healthcare providers and biotech firms are fueling innovation in the hyaluronidase market[5].

Market Segments

• Dermatology: This segment held the largest revenue share in 2022, with approximately 44.6% of the market. The increasing significance of hyaluronidase in dermatology is driving this segment's growth[2].
• Chemotherapy: The chemotherapy segment is expected to register the fastest CAGR, driven by the enzyme's role in enhancing tumor response to chemotherapeutic drugs[2].

Market Projections

Forecasted Growth

By 2036, the hyaluronidase market is expected to reach USD 12 billion, growing at a CAGR of around 9% from 2023 to 2036[3].

Regional and Application-Specific Growth

• Ophthalmology: There is a growing trend for hyaluronidase in ophthalmology, particularly for improved surgical outcomes[5].
• Orthopedics and Veterinary Medicine: Emerging applications in orthopedics for post-operative recovery and in veterinary medicine for animal care are also anticipated to drive market growth[5].

Challenges and Opportunities

Regulatory Challenges

Stringent approval processes and regional disparities in the availability and distribution of hyaluronidase products are significant challenges affecting market growth[5].

Market Opportunities

• Identifying Growth Trends: Investigating hyaluronidase applications in ophthalmology, orthopedics, and veterinary medicine presents lucrative opportunities for market expansion[5].
• Efficient Pricing Strategies: Achieving efficient pricing strategies amid variability in insurance coverage is crucial for market growth[5].

Conclusion

Hyaluronidase is a versatile enzyme with expanding applications across various medical fields. Recent clinical trials and FDA approvals highlight its efficacy in cancer treatment, particularly in multiple myeloma and solid tumors. The market is poised for significant growth, driven by technological advancements, increasing prevalence of chronic diseases, and strategic collaborations.

Key Takeaways

• Hyaluronidase has been approved for new indications in multiple myeloma and solid tumors.
• The global hyaluronidase market is expected to grow substantially, reaching USD 2.62 billion by 2030.
• Key growth drivers include the increasing prevalence of chronic diseases and technological advancements.
• Dermatology and chemotherapy segments are significant contributors to the market.
• Regulatory challenges and regional disparities need to be addressed for sustained market growth.

FAQs

What is hyaluronidase used for in medical treatments?

Hyaluronidase is used to break down hyaluronic acid, a component of the extracellular matrix, and has applications in cosmetic treatments, cancer therapy, ophthalmic solutions, and more.

What is the current market size of the hyaluronidase market?

The global hyaluronidase market was estimated at USD 909.5 million in 2022[2].

What are the key growth drivers for the hyaluronidase market?

Key growth drivers include the increasing prevalence of chronic diseases, technological advancements, and strategic collaborations between healthcare providers and biotech firms[3][5].

What are the main segments driving the hyaluronidase market?

The main segments include dermatology, chemotherapy, and emerging applications in ophthalmology and orthopedics[2][5].

What are the challenges facing the hyaluronidase market?

Challenges include regulatory hurdles, regional disparities in product availability, and inadequate reimbursement policies[5].

Sources

1. American Association for Cancer Research. A New Multiple Myeloma Indication for Daratumumab and Hyaluronidase-fihj.
2. Grand View Research. Hyaluronidase Market Size & Share Analysis Report, 2030.
3. Research Nester. Hyaluronidase Market Size & Share, Growth Analysis 2036.
4. Pharmacy Times. FDA Approves Nivolumab and Hyaluronidase-nvhy for Subcutaneous Use in Patients With Solid Tumors.
5. 360iResearch. Hyaluronidase Market Size & Share 2025-2030.