PEGASYS Drug Profile

Summary for Tradename: PEGASYS

High Confidence Patents:	1
Applicants:	2
BLAs:	2
Drug Prices:	Drug price information for PEGASYS
Recent Clinical Trials:	See clinical trials for PEGASYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEGASYS

See drug prices for PEGASYS

Recent Clinical Trials for PEGASYS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Regeneron Pharmaceuticals	Phase 1
Baptist Health South Florida	Phase 1

See all PEGASYS clinical trials

Pharmacology for PEGASYS

Established Pharmacologic Class	Interferon alpha
Chemical Structure	Interferon-alpha

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 PEGASYS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964		2003-12-13	Company disclosures

3) Low Certainty: US Patents for PEGASYS 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
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964		2033-09-11	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964		2034-01-16	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964		2029-10-27	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964		2035-03-19	Patent claims search

International Patents for PEGASYS

Country	Patent Number	Estimated Expiration
Canada	1341607
Lithuania	4012
Portugal	81213
World Intellectual Property Organization (WIPO)	8502610

PEGASYS: Market Dynamics and Financial Trajectory

Introduction

PEGASYS, a PEGylated form of interferon alfa-2a, is a biologic drug used primarily in the treatment of chronic hepatitis B and C, as well as other conditions. To understand the market dynamics and financial trajectory of PEGASYS, it is crucial to delve into the broader context of the PEGylated drugs market and the specific factors influencing its growth.

Global PEGylated Drugs Market Overview

The global PEGylated drugs market has been experiencing significant growth driven by several key factors. The market size was valued at USD 7,003.6 million in 2019 and is projected to reach USD 10,074.85 million by 2032, growing at a CAGR of 2.8%[3].

Key Drivers of the Market

Growing Incidence of Chronic Diseases

The increasing prevalence of chronic diseases such as cancer, hepatitis C, and rheumatoid arthritis is a major driver of the PEGylated drugs market. These conditions require advanced therapeutic options, and PEGylated drugs offer enhanced efficacy and reduced side effects[3][4].

Advancements in Biopharmaceuticals

Advancements in biotechnology and pharmaceutical research have led to the development of more effective PEGylated drugs. Innovations in drug delivery mechanisms, such as those seen in mRNA vaccines during the COVID-19 pandemic, further boost the market[1][4].

Market Segmentation

By Type

The PEGylated drugs market is segmented into macromolecular drugs, small molecular drugs, and nanoparticles. Macromolecular drugs, which include proteins like PEGASYS, are a significant segment due to their widespread use in treating chronic conditions[3].

By Application

The market is also segmented by application, with cancer, hepatitis C, leukemia, and rheumatoid arthritis being key areas. The cancer segment, in particular, holds a substantial market share due to the high demand for effective treatments[4].

Financial Trajectory of PEGASYS

Historical Performance

PEGASYS, being a part of the PEGylated proteins market, has benefited from the overall growth trends in this sector. The global PEGylated proteins market size was valued at USD 1.14 billion in 2021 and is expected to grow at a CAGR of 11.71% from 2022 to 2030, reaching USD 3.06 billion by 2030[1].

Revenue Contribution

The hepatitis segment, where PEGASYS is primarily used, was valued at USD 156 million in 2017. Although this segment is anticipated to follow a declining trend due to the emergence of new treatments, the launch of PEGASYS and similar drugs continues to contribute to market growth[4].

Regional Dynamics

North America and Europe

North America and Europe are significant regions for the PEGylated drugs market, driven by high R&D investments, advanced healthcare infrastructure, and a high prevalence of chronic diseases. These regions are expected to continue driving the market growth, with North America dominating the industry due to its developed infrastructure and economic conditions[1][4].

Competitive Landscape

The market for PEGylated drugs, including PEGASYS, is highly competitive with several major pharmaceutical and biotechnology companies involved. The patent expiry of novel PEGylated therapeutics has led to increased competition and industry consolidation. Companies like Roche, which markets PEGASYS, continue to invest heavily in R&D to maintain market share[1].

Challenges and Opportunities

Side Effects and Drug Failure

Despite the benefits, PEGylated drugs, including PEGASYS, face challenges such as side effects and drug failure. These issues can impede market growth but also drive innovation towards safer and more effective treatments[4].

Continuous Research and Development

The continuous need for better drug-delivery mechanisms and the development of novel therapeutics provide significant opportunities for growth. The COVID-19 pandemic has accelerated research activities, leading to increased spending by governments and key players, which positively impacts the market[1].

Key Takeaways

• The global PEGylated drugs market is driven by the growing incidence of chronic diseases and advancements in biopharmaceuticals.
• PEGASYS, used primarily for hepatitis B and C, benefits from the overall growth trends in the PEGylated proteins market.
• The market is expected to grow significantly, with North America and Europe being key regions.
• Despite challenges like side effects, the continuous R&D activities and industry consolidation present opportunities for growth.

FAQs

What is the projected market size of the global PEGylated drugs market by 2032?

The global PEGylated drugs market is expected to reach USD 10,074.85 million by 2032[3].

What is the CAGR of the PEGylated drugs market from 2019 to 2032?

The PEGylated drugs market is expected to exhibit a CAGR of 2.8% from 2019 to 2032[3].

Which segment dominates the PEGylated proteins market?

The consumables segment, including kits and reagents, dominates the PEGylated proteins market with a share of 63.21% in 2021[1].

What are the primary applications of PEGylated drugs?

The primary applications include cancer, hepatitis C, leukemia, severe combined immunodeficiency disease, rheumatoid arthritis, and Crohn's disease[3].

How does the COVID-19 pandemic impact the PEGylated proteins market?

The COVID-19 pandemic had a positive impact on the industry, with increased spending by governments and key players for the development of novel drug candidates, including PEGylated proteins[1].

Sources

1. Grand View Research: PEGylated Proteins Market Size, Share & Trends Report, 2030
2. General Services Administration: Pegasys PIA
3. Business Research Insights: PEGylated Drugs Market Size, Revenue, Forecast [2032]
4. Global Market Insights: PEGylated Drugs Market in Europe and North America to exceed $10.5 bn by 2024
5. General Services Administration: Pegasys Financial Services

Last updated: 2024-12-16