VITRASE Drug Profile

Summary for Tradename: VITRASE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for VITRASE
Recent Clinical Trials:	See clinical trials for VITRASE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITRASE

See drug prices for VITRASE

Recent Clinical Trials for VITRASE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Nebraska	Early Phase 1
Bausch & Lomb Incorporated	Phase 2
Bausch & Lomb Incorporated	Phase 3

See all VITRASE clinical trials

Recent Litigation for VITRASE

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 VITRASE litigation

PTAB Litigation

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

See all VITRASE litigation

Pharmacology for VITRASE

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 VITRASE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for VITRASE 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
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2028-04-22	Patent claims search
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640		2033-02-13	Patent claims search

VITRASE Market Analysis and Financial Projection Experimental

The Biologics Market: Understanding the Dynamics and Financial Trajectory

Introduction

The biologics market is experiencing unprecedented growth, driven by several key factors including the rising prevalence of chronic diseases, technological advancements, and the increasing adoption of biosimilars. This article will delve into the market dynamics and financial trajectory of biologic drugs, with a focus on the broader industry trends rather than a specific drug like VITRASE, as detailed data on VITRASE is not provided in the sources.

Market Size and Growth Projections

The global biologics market has seen significant expansion in recent years. As of 2023, the market size was valued at approximately USD 349.6 billion[1][3][4].

• Future Projections: The market is expected to reach USD 699.5 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.8% during the period of 2024-2032[1].
• Alternative Projections: Another forecast suggests the market could reach USD 823.4 billion by 2028, with a CAGR of 12.7% from 2023 to 2028[3].

Key Drivers of the Biologics Market

Increasing Burden of Chronic Diseases

The rising prevalence of chronic diseases such as cancer, autoimmune diseases, and genetic disorders is a major driver of the biologics market. These conditions require advanced and targeted therapies, which biologics can provide[1][3][4].

Technological Advancements

Continuous technological advancements in drug delivery systems, cell and gene therapy, and the development of personalized medicine are fueling the growth of the biologics market. These advancements enable more effective and targeted treatments[1][3][4].

Growing Adoption of Biosimilars

Biosimilars, which are biologic products that are highly similar to an already approved biologic drug, are gaining traction. They offer a more affordable alternative to original biologic drugs, increasing accessibility and driving market growth[1][4].

Regulatory Approvals

The escalating approvals of biologics by regulatory agencies are also a significant factor. These approvals validate the safety and efficacy of biologic drugs, boosting market confidence and adoption[1].

Regional Market Analysis

North America

North America holds the largest revenue share in the biologics market, primarily due to the high prevalence of chronic diseases, favorable reimbursement policies, and significant investments in research and development (R&D)[4].

Asia-Pacific

The Asia-Pacific region is expected to grow at a CAGR of 11.0% during the forecast period. This growth is driven by the increasing burden of diseases such as cancer, diabetes, and cardiovascular diseases, along with an expanding geriatric population[4].

Financial Performance and Trends

Revenue Growth

Companies in the biologics sector are experiencing robust revenue growth. For instance, the global biologics market grew from USD 461.74 billion in 2022 to an expected USD 699.5 billion by 2032[1][4].

Profit Margins and EBITDA

The financial performance of biologics companies is also marked by improving profit margins and EBITDA. For example, the gross profit margin and adjusted EBITDA of companies in related industries have shown significant increases, reflecting efficient cost management and strong pricing strategies[2][5].

Market Segmentation

By Product

The biologics market is segmented by product types, including therapeutic proteins, monoclonal antibodies, and cell and gene therapies. These segments are expected to dominate the market in the coming years due to their efficacy in treating various diseases[3][4].

By Application

Biologics are used in a wide range of applications, including cancer treatments, autoimmune diseases, and genetic disorders. The demand for biologics in these applications is driving market growth[3][4].

By Source

Biologics are produced from various sources, including fermented cells, transgenic plant cells, and human, animal, or micro-organism-derived materials. The diversity in production sources contributes to the market's growth and innovation[3].

Competitive Landscape

The biologics market is highly competitive, with several key players investing heavily in R&D and expanding their product portfolios. Companies are focusing on developing advanced biologic products and biosimilars to capture market share[3][4].

Challenges and Opportunities

Regulatory Challenges

Biologics face stringent regulatory requirements, which can be a challenge for new entrants and existing players. However, regulatory approvals also present opportunities for growth and market validation[1][3].

Cost and Accessibility

Despite the high efficacy of biologics, their cost remains a significant barrier to accessibility. The development of biosimilars and generic biologics is addressing this issue, making these treatments more affordable for a broader population[1][4].

Key Takeaways

• Market Growth: The biologics market is expected to grow significantly, reaching USD 699.5 billion by 2032.
• Key Drivers: The market is driven by the increasing burden of chronic diseases, technological advancements, and the growing adoption of biosimilars.
• Regional Dominance: North America currently holds the largest revenue share, while the Asia-Pacific region is expected to grow rapidly.
• Financial Performance: Companies in the sector are experiencing robust revenue growth, improved profit margins, and increased EBITDA.
• Market Segmentation: The market is segmented by product, application, and source, with therapeutic proteins and monoclonal antibodies being key segments.

FAQs

1. What is the projected market size of the biologics market by 2032?

   • The biologics market is expected to reach USD 699.5 billion by 2032[1].

2. What are the key drivers of the biologics market?

   • The key drivers include the increasing burden of chronic diseases, technological advancements, and the growing adoption of biosimilars[1][3][4].

3. Which region holds the largest revenue share in the biologics market?

   • North America currently holds the largest revenue share in the biologics market[4].

4. What role do biosimilars play in the biologics market?

   • Biosimilars offer a more affordable alternative to original biologic drugs, increasing accessibility and driving market growth[1][4].

5. How is the Asia-Pacific region contributing to the growth of the biologics market?

   • The Asia-Pacific region is expected to grow at a CAGR of 11.0% due to the increasing burden of diseases and an expanding geriatric population[4].

Sources

1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems - Biospace
2. Earnings call: VirTra reports record-breaking annual revenues in 2023 - Investing.com
3. Big Growth Ahead Biologic Drugs Market to Hit 823.4 Billion by 2028 - BCC Research
4. Biologics Market Size, Share & Growth Analysis Report, 2030 - Grand View Research
5. Vital Farms Reports Fourth Quarter and Fiscal Year 2023 Financial Results - Vital Farms Investors