Pegfilgrastim Biosimilars Market By Product Type (Primary Biosimilars, Secondary Biosimilars), By Application (Cancer Treatment, Bone Marrow Disorders), By End-User (Hospitals & Clinics, Oncology Centers), By Distribution Channel (Direct Sales, Distributors), and By Region; Global Insights & Forecast (2023 – 2030)

As per Intent Market Research, the Pegfilgrastim Biosimilars Market was valued at USD 3.9 billion in 2024-e and will surpass USD 6.2 billion by 2030; growing at a CAGR of 7.8% during 2025 - 2030.

The Pegfilgrastim biosimilars market has been witnessing significant growth due to the increasing demand for cost-effective alternatives to the reference biologic, Pegfilgrastim, used primarily to manage chemotherapy-induced neutropenia. Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) that stimulates the production of white blood cells to help reduce the risk of infection in patients undergoing cancer treatment. Biosimilars of Pegfilgrastim are gaining traction as they offer a more affordable treatment option while maintaining similar efficacy and safety profiles to the originator biologic.

The growing adoption of biosimilars is driven by increasing pressure to reduce healthcare costs, particularly in oncology treatments, and the expiration of patents for many reference biologics. With the rise in the incidence of cancer worldwide, the demand for Pegfilgrastim biosimilars is expected to surge, particularly in emerging markets where cost considerations play a significant role in healthcare decisions. Additionally, regulatory approvals for biosimilars in multiple regions are enhancing market access, fueling competition and broadening patient access to these treatments.

Primary Biosimilars Segment is Largest Owing to Their Broad Clinical Adoption

The primary biosimilars segment is the largest in the Pegfilgrastim biosimilars market, driven by the extensive clinical adoption of these products in cancer treatment. Primary biosimilars are the direct alternatives to the reference biologic and have been the focus of most regulatory approvals and market entry. With their proven efficacy and safety, primary biosimilars have become a critical part of oncology care, particularly for patients undergoing chemotherapy who are at risk of neutropenia.

The increasing focus on reducing healthcare costs and improving patient outcomes has further solidified the position of primary Pegfilgrastim biosimilars in the market. As these biosimilars gain acceptance among healthcare providers, their use is expected to grow rapidly, making them the dominant product type in the market. Furthermore, ongoing clinical studies and real-world data supporting their use continue to boost the confidence of physicians and patients in these affordable alternatives.

Oncology Centers Segment is Largest End-User Owing to High Demand for Cancer Treatments

Oncology centers are the largest end-users of Pegfilgrastim biosimilars, owing to the high demand for effective treatments to manage chemotherapy-induced neutropenia in cancer patients. Pegfilgrastim biosimilars are widely used in oncology centers to help reduce the risk of infection and support the administration of chemotherapy without the delay caused by low white blood cell counts. Oncology centers, with their specialized staff and infrastructure, are the primary healthcare providers for cancer patients and, therefore, the key consumers of Pegfilgrastim biosimilars.

As cancer treatment regimens become more aggressive and prevalent, the need for biosimilars to manage side effects like neutropenia will continue to grow. The shift toward cost-effective, high-quality biosimilars in oncology centers is expected to drive further growth in this segment. Additionally, oncology centers are increasingly looking for solutions that can improve patient outcomes while reducing treatment costs, making Pegfilgrastim biosimilars a vital tool in cancer care.

Direct Sales Segment is Fastest Growing Owing to Streamlined Distribution and Lower Costs

The direct sales distribution channel is the fastest growing in the Pegfilgrastim biosimilars market, driven by the increasing preference for more streamlined and cost-effective supply chains. Direct sales allow manufacturers to reach healthcare providers and end-users more efficiently, reducing the markup costs typically associated with third-party distributors. As the market for Pegfilgrastim biosimilars expands, direct sales are becoming an increasingly attractive option for biosimilar manufacturers, enabling them to maintain competitive pricing while ensuring product availability across different regions.

With the growing emphasis on cost reduction in healthcare systems worldwide, direct sales are becoming the preferred method for distributing biosimilars, particularly in markets where cost containment is crucial. This distribution channel offers manufacturers greater control over pricing and logistics, contributing to the rapid growth of Pegfilgrastim biosimilars in the market.

North America is Largest Region Owing to Advanced Healthcare Infrastructure and High Cancer Incidence

North America holds the largest market share in the Pegfilgrastim biosimilars market, owing to its advanced healthcare infrastructure, high rates of cancer incidence, and early adoption of biosimilars. The region's well-established healthcare system, combined with a growing oncology patient population, has led to the widespread use of Pegfilgrastim biosimilars. Additionally, regulatory bodies in North America, such as the U.S. Food and Drug Administration (FDA), have been proactive in approving biosimilars, providing a clear pathway for market entry and adoption.

The high cost of biologics in the U.S. and the growing focus on cost-effective treatment options are driving the demand for biosimilars, further enhancing the region's dominance in the market. As healthcare providers increasingly recognize the cost-effectiveness and safety of Pegfilgrastim biosimilars, the demand in North America is expected to continue to rise, solidifying its position as the largest region in the market.

Competitive Landscape

The Pegfilgrastim biosimilars market is highly competitive, with several global and regional players vying for market share. Major companies in the market include Sandoz (Novartis), Amgen, and Teva Pharmaceuticals, which offer Pegfilgrastim biosimilars with similar efficacy to the reference biologic, Neulasta. These companies are actively involved in the development, manufacturing, and distribution of Pegfilgrastim biosimilars to meet the growing demand in oncology centers and hospitals.

Competition in the Pegfilgrastim biosimilars market is intensifying as more players enter the market, particularly with the ongoing patent expirations of reference biologics. This competitive landscape is expected to foster innovation and lower prices, benefiting healthcare providers and patients alike. Additionally, regulatory approvals and partnerships between biosimilar manufacturers and healthcare providers will continue to shape the dynamics of this market, as players seek to expand their reach and improve access to these essential cancer treatments.

List of Leading Companies:

• Amgen Inc.
• Sandoz (Novartis)
• Celltrion Healthcare
• Teva Pharmaceutical Industries
• Mylan N.V. (Viatris)
• Biocon
• Samsung Biologics
• Coherus BioSciences
• Dr. Reddy’s Laboratories
• Biogen
• Pfizer
• Kyowa Kirin Co., Ltd.
• Eli Lilly and Company
• Fresenius Kabi
• Apotex

Recent Developments:

• In December 2024, Biocon announced the launch of its pegfilgrastim biosimilar in emerging markets to expand its global footprint.
• In November 2024, Sandoz received FDA approval for its pegfilgrastim biosimilar to be marketed in the U.S.
• In October 2024, Mylan collaborated with a leading healthcare provider to promote pegfilgrastim biosimilars in European markets.
• In September 2024, Coherus BioSciences introduced an advanced delivery system for its pegfilgrastim biosimilar to enhance patient convenience.
• In August 2024, Pfizer announced the expansion of its biosimilar manufacturing facilities to meet the growing demand for pegfilgrastim biosimilars globally.

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