Pegfilgrastim - Biologic Drug Details

Summary for pegfilgrastim

Tradenames:	2
High Confidence Patents:	3
Applicants:	7
BLAs:	7
Suppliers: see list	9
Recent Clinical Trials:	See clinical trials for pegfilgrastim

Recent Clinical Trials for pegfilgrastim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda	PHASE2
University of Washington	PHASE2
Cancer League of Colorado	PHASE2

See all pegfilgrastim clinical trials

Pharmacology for pegfilgrastim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor

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. DrugPatentWatch analysis and 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 pegfilgrastim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,338	2036-12-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,039,808	2035-10-19	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,053,498	2035-11-20	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,087,175	2035-04-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pegfilgrastim 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
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,338	2036-12-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,412	2036-12-09	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,092,706	2032-04-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,105,389	2037-03-31	Patent claims search

International Patents for pegfilgrastim

Country	Patent Number	Estimated Expiration
Greece	3030526
Australia	2019200353
Japan	2004041242
Mexico	2011013417

Supplementary Protection Certificates for pegfilgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10299044	Germany		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
C300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; NAT. REGISTRATION NO/DATE: EU/1/02/228/001 20020822; FIRST REGISTRATION: EU/1/02/228/001 20020822
SZ 5/2003	Austria		PRODUCT NAME: PEGFILGRASTIM

Market Dynamics and Financial Trajectory for the Biologic Drug Pegfilgrastim

Last updated: July 27, 2025

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Introduction

Pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF), is pivotal in managing febrile neutropenia among cancer patients undergoing chemotherapy. Its unique pharmacokinetics allows for single-dose administration per chemotherapy cycle, improving compliance and patient outcomes. As the biologic landscape evolves, understanding market dynamics and financial trajectories surrounding pegfilgrastim is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Overview

The global pegfilgrastim market has demonstrated significant growth, driven by rising cancer prevalence, expanding indications for chemotherapy-induced neutropenia, and increasing adoption of biologic therapies. The market size was valued at approximately USD 4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2028 [1].

Key players include Amgen, Pfizer, Mylan, and novel entrants offering biosimilars, intensifying market competition. The latter notably impact pricing strategies and market share distribution, with biosimilar versions offering lower-cost alternatives that enhance access and affordability.

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Market Drivers

1. Rising Cancer Incidence and Aging Population

Global cancer cases are projected to reach 28.4 million by 2040, up from 19.3 million in 2020, according to WHO data [2]. An aging population in developed markets further amplifies this trend, as elderly individuals are more susceptible to cancers like lung, colorectal, and breast cancers, which require cytotoxic chemotherapy regimens that induce neutropenia.

2. Advancements in Chemotherapy Protocols

Modern chemotherapeutic agents have improved survival rates but often carry myelosuppressive side effects. Pegfilgrastim reduces the incidence of febrile neutropenia, supporting more aggressive and effective chemotherapy regimens, thereby increasing its utilization.

3. Expansion of Indications

Initially approved for reducing infection risk in chemotherapy-induced neutropenia, pegfilgrastim's indications now include stem cell mobilization and management in certain hematologic disorders, broadening its application scope.

4. Biosimilar Competition

Entry of biosimilars has challenged the market dominance of originator brands (e.g., Neulasta by Amgen). These biosimilars, approved in multiple regions including the U.S. and Europe, supply more cost-effective options, prompting price erosion and increased adoption.

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Market Challenges

1. Pricing Pressures and Healthcare Cost Containment

Healthcare payers seek to reduce expenditures via biosimilar uptake and enforcing reimbursement restrictions. Original biologic manufacturers respond through legal strategies, volume discounts, and patient assistance programs.

2. Regulatory Environment

Stringent biosimilar approval pathways and interchangeability standards influence market entry. Variations across regions cause uneven competition and market fragmentation [3].

3. Patent Expirations

Patent cliffs for original biologics like Neulasta have facilitated biosimilar market entry, significantly impacting revenue streams for incumbent firms.

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Financial Trajectory Analysis

Revenue Trends

Revenue growth for pegfilgrastim aligns with the increasing global cancer burden, particularly in emerging markets, which present significant opportunity due to lower drug penetration and affordability constraints. In 2022, Amgen reported approximately USD 3.8 billion in pegfilgrastim-related revenues, primarily from Neulasta sales, demonstrating resilience despite biosimilar competition [4].

Impact of Biosimilars on Profitability

The advent of biosimilars has led to price competition, with discounts of up to 30-50% compared to originators in some markets. These shifts have compressed profit margins but also expanded overall market volume due to increased access.

Forecasted Financial Performance

Analysts project that, while original biologics will experience revenue erosion, the overall pegfilgrastim market will sustain healthy growth due to rising demand and expanding indications. Revenue in the biosimilar segment is expected to surpass USD 1 billion by 2025, driven by regional approvals and increasing acceptance.

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Regional Market Dynamics

North America

The U.S. dominates with sophisticated healthcare infrastructure and high cancer prevalence. The originator's market share remains substantial but faces downward pressure from biosimilars, such as Mylan’s Fulphila and Sandoz’s Ziextenzo, introduced post-2018 [5].

Europe

European markets have embraced biosimilars due to cost-containment policies. The European Medicines Agency (EMA) has approved multiple biosimilar pegfilgrastims, leading to substantial price reductions and market penetration.

Asia-Pacific

Rapidly growing markets driven by expanding healthcare infrastructure, increasing cancer incidence, and government initiatives favor biologic adoption. Local biosimilar manufacturers are entering the market, challenging international players.

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Future Outlook

Innovation and Formulation Improvements

Next-generation pegfilgrastim formulations targeting improved delivery, reduced side effects, or combination therapies could revolutionize treatment paradigms, influencing financial trajectories positively.

Market Expansion and New Indications

Emerging therapies and expanded indications—such as in pediatric oncology and hematopoietic stem cell transplants—offer additional revenue streams. Strategic partnerships and licensing agreements will play vital roles.

Pricing Strategies and Market Penetration

Manufacturers will leverage value-based pricing, patient assistance programs, and flexible reimbursement strategies to maintain profitability amid biosimilar competition.

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Key Challenges and Opportunities

• Challenges: Patent expirations, biosimilar acceptance, regulatory hurdles, and price erosion require strategic navigation.

• Opportunities: Growing global cancer burden, new indications, pipeline innovations, and emerging markets present substantial growth avenues.

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Key Takeaways

• The pegfilgrastim market is expected to grow steadily, driven by rising cancer incidence and chemotherapy protocols.
• Biosimilar competition has significantly influenced pricing strategies, compressing margins but expanding market access.
• Regional variations, regulatory frameworks, and healthcare policies will shape market dynamics, with emerging markets offering substantial growth opportunities.
• Continued innovation, including next-generation formulations and expanded indications, can positively influence financial trajectories.
• Payers and providers prioritize cost-effective therapies, increasing focus on biosimilars and value-based pricing models.

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FAQs

1. What factors are driving the adoption of biosimilar pegfilgrastims?
   Cost savings, regulatory approvals, and increased healthcare expenditure pressures motivate payers and providers to favor biosimilars, which offer similar efficacy at reduced prices.

2. How will patent expirations impact the pegfilgrastim market?
   Patent expirations enable biosimilar entrants, intensify price competition, and potentially reduce revenues for originator manufacturers, while expanding access for patients.

3. What are the major challenges faced by manufacturers of pegfilgrastim?
   Key challenges include biosimilar approval pathways, regulatory hurdles, patent litigation, and downward pricing pressures due to market competition.

4. Which regions offer the most growth potential for pegfilgrastim?
   Emerging markets in Asia-Pacific and Latin America present significant growth due to expanding healthcare infrastructure and increasing cancer prevalence.

5. What innovations could influence the future financial trajectory of pegfilgrastim?
   Breakthroughs in sustained-release formulations, combination therapies, and expanded indications could enhance efficacy and market penetration, positively impacting revenues.

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References

1. MarketWatch. “Pegfilgrastim Market Size and Trends.” 2022.
2. WHO. “Cancer Facts & Figures 2022.”
3. EMA. “Guidelines on Biosimilar Medicines.” 2021.
4. Amgen. “Financial Reports 2022.”
5. IQVIA. “Global Biosimilar Market Data.” 2022.