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Last Updated: May 16, 2025

PEGASYS Drug Profile


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Recent Clinical Trials for PEGASYS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Bristol-Myers SquibbPhase 1
Regeneron PharmaceuticalsPhase 1
Baptist Health South FloridaPhase 1

See all PEGASYS clinical trials

Pharmacology for PEGASYS
Established Pharmacologic ClassInterferon alpha
Chemical StructureInterferon-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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ⤷  Try for Free 2003-12-13 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for PEGASYS Derived from Patent Text Search

These patents were obtained by searching patent claims

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

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