Pegfilgrastim Biosimilar Market Revenue Insights: On-Body Injector Dominates with 51% Share | Fact.MR

The global pegfilgrastim biosimilar market is projected to increase from approximately USD 4.5 billion in 2025 to around USD 9.3 billion by 2035, representing a compound annual growth rate (CAGR) of about 7.5% over the forecast period. This expansion is driven by growing cancer-treatment demand, rising adoption of biosimilars, and escalating cost-containment initiatives in oncology supportive-care settings.

Pegfilgrastim biosimilars—used primarily to manage chemotherapy-induced neutropenia—are becoming increasingly important as healthcare providers shift toward value-based care models. With the loss of patent exclusivity of the reference biologic and increasing global oncology incidence, the biosimilar segment is poised for significant growth.

Key Market Insights at a Glance

• Market Value (2025): USD 4.5 billion
• Forecast Value (2035): USD 9.3 billion
• CAGR (2025–2035): ~7.5%
• Leading Administration Route: Subcutaneous prefilled systems (~82% share)
• Dominant Setting: Hospital / Oncology Clinics (~64% share)
• Rapid Growth Regions: North America, Europe and Asia-Pacific
• Major Players: Viatris/Biocon, Sandoz, Coherus, Fresenius Kabi, Pfizer, Teva

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Market Drivers / Growth Overview

Several key factors underpin the growth of the pegfilgrastim biosimilar market:

• Rising oncology treatment volumes: As cancer incidence increases globally, demand for supportive‐care drugs such as pegfilgrastim rises, driving related biosimilar uptake.
• Cost-containment pressures: Healthcare systems are prioritising biosimilars to reduce expenditures while maintaining treatment efficacy, thus favouring pegfilgrastim biosimilar adoption.
• Patent expiry and competitive entry: Expiry of reference biologic patents facilitates biosimilar market entry, increasing accessibility and competition in many regions.
• Convenience delivery formats: Subcutaneous prefilled and on-body injector delivery formats enhance patient compliance and broaden settings of use.
• Emerging market penetration: Growth in lower- and middle-income markets is increasing as biosimilar manufacturing expands and local adoption rises.

Some challenges temper growth, including regulatory complexity for biosimilar approvals, manufacturing and supply-chain demands, and slower uptake in regions where brand loyalty or physician familiarity remains strong.

Segmentation & Key Drivers

By Route:

• Subcutaneous prefilled systems dominate (~82% share) due to ease of use and clinician preference.
• Vials/others constitute the remaining share, often used in less standardised settings or by specialty pharmacies.

By Setting:

• Hospital / Oncology Clinics lead (~64%) as the primary point of administration for neutropenia support.
• Specialty Pharmacies and Other Settings follow, representing a growing share as outpatient and home-care delivery models expand.

By Product Format:

• On-body injector systems hold significant share (~51%) enabling autonomous or home-based administration.
• Standard prefilled syringes (PFS) continue to be widely used in clinics and hospitals.

Key segmentation drivers include convenience of administration, site of care trends (inpatient vs outpatient), regulatory frameworks, and evolving delivery technologies.

Regional & Country Insights

• North America: Leads in value share thanks to advanced oncology care infrastructure, strong biosimilar policies, and early market adoption.
• Europe: Mature biosimilar environment and clear regulatory pathways support steady growth, with significant uptake in key countries.
• Asia-Pacific: Rapid growth expected as healthcare spending rises, cancer incidence increases, and biosimilar access improves.
• Latin America & Middle East/Africa: Emerging demand as oncology infrastructure develops and biosimilar acceptance expands.

Regional growth is influenced by reimbursement frameworks, local manufacturing capabilities, clinician awareness, and the extent of biosimilar substitution policies.

Competitive Landscape

The pegfilgrastim biosimilar market is moderately competitive, with global biosimilar manufacturers and established pharma companies participating. Key players include Viatris/Biocon, Sandoz, Coherus, Fresenius Kabi, Pfizer, and Teva.

Primary strategic initiatives involve:

• Scaling biosimilar production while maintaining clinical equivalence.
• Launching advanced delivery systems and patient-friendly formats.
• Expanding geographic reach, particularly into emerging oncology markets.
• Forming partnerships with oncology providers, specialty pharmacies and supply-chain stakeholders to optimise roll-out and utilisation.

Market Outlook & Strategic Insights

Over the forecast period to 2035, the pegfilgrastim biosimilar market is expected to evolve from volume-driven uptake to value-driven innovation and delivery optimisation. Key strategic insights for stakeholders:

• Focus on manufacturing scale-up and cost-optimisation to enhance biosimilar competitiveness.
• Leverage delivery format innovations (on-body injectors, home care models) to meet shifting treatment patterns.
• Expand into emerging markets where biosimilar access is still developing.
• Partner with oncology providers and specialty pharmacies to embed biosimilar adoption early in care pathways.
• Monitor regulatory changes and reimbursement policy shifts influencing biosimilar substitution and pricing.

Companies that align along these strategic priorities—while maintaining therapeutic equivalence, strong market access and robust supply infrastructure—will be best positioned to capture value in a market projected to exceed USD 9.3 billion by 2035.

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