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Pegfilgrastim Biosimilars Market to Reach USD 1.22M by 2035

12-26-2025 11:30 AM CET | Health & Medicine

Press release from: Expert Market Research

Pegfilgrastim Biosimilars Market to Reach USD 1.22M by 2035

Can Pegfilgrastim Biosimilars Redefine Supportive Cancer Care Worldwide?

Pegfilgrastim Biosimilars Market: Global Overview, Trends, and Future Outlook

The Pegfilgrastim Biosimilars Market is emerging as a critical component of modern oncology care, driven by the rising global burden of cancer-particularly leukaemia-and the need to reduce the cost of biologic therapies. Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), plays a vital role in preventing chemotherapy-induced neutropenia, a potentially life-threatening complication that increases infection risk and disrupts cancer treatment schedules.

With the number of leukaemia cases reaching 0.62 million in 2025, demand for cost-effective alternatives to branded pegfilgrastim products has accelerated. As patents expire and healthcare systems push for affordability without compromising efficacy, biosimilars are gaining strong traction across developed and emerging markets alike.

According to current estimates, the global Pegfilgrastim biosimilars market is expected to grow at a CAGR of 7.00% during 2026-2035, reaching a forecast value of USD 1.22 million by 2035.

Market Overview: Understanding Pegfilgrastim Biosimilars

Pegfilgrastim is a pegylated form of filgrastim designed to stimulate neutrophil production and reduce infection risk following chemotherapy. Biosimilars are highly similar versions of the reference biologic, offering comparable safety, purity, and efficacy at a lower cost.

Why Pegfilgrastim Biosimilars Matter

Reduce healthcare expenditure on oncology supportive care

Improve access to biologics in cost-sensitive markets

Support uninterrupted chemotherapy regimens

Encourage competition and price stabilization

As oncology treatment volumes increase globally, supportive care drugs like pegfilgrastim are no longer optional-they are essential.

Get a Free Sample Report with Table of Contents - https://www.expertmarketresearch.com/reports/pegfilgrastim-biosimilars-market/requestsample.

Key Market Drivers

Rising Prevalence of Leukaemia and Other Cancers

The increasing incidence of leukaemia and solid tumors requiring myelosuppressive chemotherapy is a primary growth driver. Chemotherapy-induced neutropenia remains a major cause of dose delays and treatment discontinuation.

Patent Expiry of Originator Biologics

The expiration of patents for branded pegfilgrastim products has opened the door for biosimilar manufacturers, intensifying competition and lowering entry barriers.

Cost Containment Pressures in Healthcare

Governments, insurers, and hospitals are actively promoting biosimilar adoption to control escalating oncology costs without sacrificing patient outcomes.

Growing Acceptance of Biosimilars

Clinical evidence, physician education, and regulatory support have significantly improved confidence in biosimilars, especially in Europe and increasingly in North America and Asia Pacific.

Market Trends Shaping the Industry

Shift Toward Long-Acting G-CSF Products

Pegylated formulations are preferred over daily injections due to better patient compliance and reduced hospital visits.

Hospital-Driven Biosimilar Adoption

Large oncology centers and hospital networks are leading biosimilar uptake through formulary inclusion and bulk procurement strategies.

Emergence of Asia Pacific Manufacturers

Companies from India, China, and South Korea are playing a growing role, offering competitively priced biosimilars with expanding global regulatory approvals.

Real-World Evidence (RWE) Utilization

Post-marketing surveillance and real-world data are increasingly used to demonstrate biosimilar effectiveness and build physician trust.

Market Segmentation Analysis

By Indication Type

Neutropenia

This segment dominates the market, as pegfilgrastim biosimilars are primarily prescribed to prevent chemotherapy-induced neutropenia in cancer patients.

Hematopoietic Subsyndrome

Used in radiation exposure and bone marrow suppression scenarios, though representing a smaller share.

Others

Includes off-label and emerging therapeutic uses.

By Product Type

The market features a diverse pipeline of pegfilgrastim and G-CSF biosimilars, including:

MK-6302

Peg G-CSF

PEG Neutrogena

Grasustek

LA-EP2006

R-TPR-029

Filgrastim / PEG-GCSF variants

Others

Product differentiation is based on pricing, delivery devices, regulatory approvals, and supply reliability.

By Application

Chemotherapy-Induced Neutropenia

The largest application segment, driven by the increasing use of aggressive chemotherapy regimens.

Transplantation

Used in hematopoietic stem cell transplantation to accelerate neutrophil recovery.

Others

Includes investigational and specialized clinical settings.

Read the Full Report with the Table of Contents - https://www.expertmarketresearch.com/reports/pegfilgrastim-biosimilars-market.

By Distribution Channel

Hospital-Based Pharmacies

The dominant channel due to centralized procurement, physician oversight, and inpatient oncology care.

Retail Pharmacies

Growing role in outpatient oncology management, particularly in developed markets.

Online Pharmacies

An emerging channel, especially in regions with strong digital health infrastructure.

Regional Analysis

North America

North America remains a key market due to:

High cancer prevalence

Advanced oncology infrastructure

Gradual but steady biosimilar adoption

While the U.S. has been slower than Europe in biosimilar uptake, payer-driven policies and oncology guidelines are accelerating acceptance.

Europe

Europe leads the global Pegfilgrastim biosimilars market, supported by:

Strong regulatory frameworks

Early biosimilar adoption

National tender systems favoring cost-effective therapies

Countries such as Germany, the UK, and France have established biosimilars as standard supportive care options.

Asia Pacific

Asia Pacific is the fastest-growing region, driven by:

Expanding cancer patient pool

Cost-sensitive healthcare systems

Strong domestic manufacturing base

India and China are emerging as both major consumers and producers of pegfilgrastim biosimilars.

Latin America

Market growth is supported by:

Rising cancer incidence

Gradual regulatory alignment with global standards

Increasing hospital procurement of biosimilars

Middle East and Africa

Though still nascent, this region offers long-term potential as oncology infrastructure improves and access to affordable biologics expands.

Competitive Landscape

The Pegfilgrastim biosimilars market is moderately competitive, featuring both global pharmaceutical leaders and regional biosimilar specialists.

Key Companies Covered

Merck & Co., Inc.

Zydus Lifesciences Limited

Ratiopharm GmbH

Jiangsu Hengrui Pharmaceuticals Co. Ltd

Biocon Limited

Dr. Reddy's Laboratories Ltd

Pfizer Inc.

Emcure Pharmaceuticals Limited

USV Private Limited

Apotex Pty Ltd

Kyowa Kirin Co., Ltd.

Lupin Limited

Strategic partnerships, regulatory approvals, and geographic expansion remain key competitive strategies.

Challenges Facing the Market

Regulatory Complexity

Biosimilar approval requires extensive analytical and clinical comparability data, increasing development time and cost.

Physician Hesitancy

Despite growing acceptance, some clinicians remain cautious about switching stable patients from reference biologics.

Pricing Pressures

Intense competition can compress margins, particularly in tender-based procurement systems.

Pharmacovigilance Requirements

Post-marketing surveillance adds operational complexity for manufacturers.

Future Outlook: 2026-2035

The Pegfilgrastim Biosimilars Market is expected to witness steady, sustainable growth over the next decade. Key future developments include:

Broader interchangeability approvals

Increased use in outpatient oncology settings

Expansion into emerging markets

Continued price erosion benefiting healthcare systems

As leukaemia and cancer incidence continue to rise globally, pegfilgrastim biosimilars will play an increasingly vital role in ensuring affordable, high-quality supportive cancer care.

View More Reports

Radiopharmaceuticals Market - https://bit.ly/47DIVVK.

Neurotechnology Market - https://bit.ly/4r7bGBE.

Oxygen Therapy Market - https://www.linkedin.com/pulse/oxygen-therapy-market-outlook-industry-analysis-2035-roshan-kumar-hgytc.

North America Laboratory Informatics Market - https://www.linkedin.com/pulse/north-america-laboratory-informatics-market-analysis-roshan-kumar-whncc.

Media Contact

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Contact Person: Roshan Kumar, Business Consultant
Email: sales@expertmarketresearch.com
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Address: 30 North Gould Street, Sheridan, WY 82801, USA
Website: www.expertmarketresearch.com

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