Press release
Pegfilgrastim Biosimilars Market to Reach USD 1.22M by 2035
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.
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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.
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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.
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