How are Pegfilgrastim biosimilars reshaping supportive oncology treatment worldwide?

The Pegfilgrastim biosimilars market is gaining steady traction as healthcare systems increasingly seek affordable and effective alternatives to branded biologics. Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is widely used to reduce the risk of chemotherapy-induced neutropenia in cancer patients. The growing burden of blood cancers, particularly leukaemia, has significantly contributed to the rising demand for Pegfilgrastim biosimilars. In 2025, the number of leukaemia cases reached approximately 0.62 million globally, highlighting the urgent need for accessible supportive therapies.

During the forecast period of 2026–2035, the global Pegfilgrastim biosimilars market is expected to grow at a CAGR of 7.00%, reaching a forecast value of USD 1.22 million by 2035.

Key Market Drivers

One of the primary drivers of the Pegfilgrastim biosimilars market is the increasing prevalence of cancer and the subsequent rise in chemotherapy treatments. Biosimilars offer comparable efficacy and safety to reference biologics at a lower cost, making them an attractive option for hospitals, oncology clinics, and payers aiming to manage rising treatment expenses.

Additionally, the growing acceptance of biosimilars among clinicians, supported by real-world evidence and regulatory approvals, is accelerating market penetration. Favorable government policies promoting biosimilar adoption and expanding reimbursement coverage further support market growth, especially in emerging economies.

Regulatory Landscape and Market Trends

Regulatory agencies across major markets are streamlining approval pathways for biosimilars while maintaining strict quality and safety standards. This has encouraged pharmaceutical manufacturers to expand their biosimilar portfolios and invest in advanced biologics manufacturing capabilities.

A notable trend in the market is the increasing focus on long-acting injectable formulations that reduce dosing frequency and improve patient adherence. Strategic partnerships, licensing agreements, and geographic expansion are also shaping the competitive dynamics of the Pegfilgrastim biosimilars market.

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Competitive Landscape

The market is moderately competitive, with several global and regional players actively involved in product development and commercialization. Key companies operating in the Pegfilgrastim biosimilars market include 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., and Lupin Limited.

These companies are leveraging strong R&D capabilities and global distribution networks to strengthen their market presence.

Market Outlook

Despite challenges such as pricing pressures and intense competition, the Pegfilgrastim biosimilars market is expected to witness sustained growth. Rising cancer incidence, increasing biosimilar acceptance, and ongoing efforts to improve affordability will continue to support market expansion through 2035.