Pegfilgrastim biosimilars are medications that stimulate the production of white blood cells (neutrophils) in patients who have received cancer treatment such as chemotherapy. They work similarly to existing biological drugs called filgrastim but with lower costs. The need for pegfilgrastim biosimilars is increasing as they provide an effective and affordable alternative to costly biologic drugs for cancer patients undergoing chemotherapy.
Global pegfilgrastim biosimilars market is estimated to be valued at USD 1.84 Bn in 2025 and is expected to reach USD 3.39 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 9.1% from 2025 to 2032.
Key Takeaways:
Key players operating in the pegfilgrastim biosimilars market are Coherus BioSciences,
Mylan N.V., Biocon, Sandoz (a Novartis division), copyright Inc., Apotex Inc., Cinfa Biotech,
Gedeon Richter, Stada Arzneimittel AG, Mundipharma, Aurobindo Pharma, Glenmark Pharmaceuticals, Dr. Reddy's Laboratories, Intas Pharmaceuticals, Biocad, Genor Biopharma, Qilu Pharmaceutical, Henlius Biotech.
Pegfilgrastim Biosimilars Market opportunities include increasing focus on the development of cost-effective biosimilar drugs for cancer treatment and rising patent expiries of blockbuster biologics creating opportunities for biosimilar manufacturers. Technological advancements such as continuous manufacturing processes, antibody-drug conjugates, and biosimilar interchangeability are further fueling market growth.
Market drivers:
The rising cancer prevalence worldwide is expected to increase the demand for affordable biosimilar drugs for cancer treatment. According to the World Health Organization, cancer burden is projected to grow to 27.5 million new cancer cases and 16.3 million cancer deaths by 2040. In addition, favorable policies and regulations by regulatory bodies to approve biosimilars will provide the necessary impetus for market growth over the forecast period.
Challenges in Pegfilgrastim Biosimilars Market:
the rising prevalence of cancer and growing demand for supportive cancer care drugs, which have bolstered the market. However, high development costs and pricing pressures have challenged pharmaceutical companies in investing in and commercializing biosimilars. Additionally, ensuring product interchangeability and substitutability with reference drugs is a key regulatory hurdle. Manufacturers must demonstrate biosimilarity through extensive analytical, animal, and clinical studies. This entails significant financial investments and time for regulatory approvals. Intellectual property barriers from patents on reference drugs have also delayed biosimilar approvals and market entries.
SWOT Analysis:
Strength: High unmet needs in oncology provide a large commercial opportunity. Biosimilars offer more affordable treatment options for cancer patients.
Weakness: Pegfilgrastim is a complex biologic to manufacture at commercial scale. Ensuring consistent quality and performance is challenging.
Opportunity: Patent expiries of reference drugs in major markets will stimulate biosimilar competition. Developing markets offer significant future growth potential.
Threats: Aggressive pricing strategies by reference drug makers can limit biosimilar uptake. Long-term immunogenicity and interchangeability data is still lacking versus originators.
Geographical Regions:
North America currently dominates the pegfilgrastim biosimilars market in terms of value, attributed to high adoption within the US. The large oncology patient pool and increasing affordability through biosimilars are major regional growth drivers. Europe is another major revenue generator, led by countries like Germany and United Kingdom.
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