Introduction to Filgrastim-aafi (Nivestym)
Filgrastim-aafi, marketed as Nivestym, is a biosimilar to the biologic drug filgrastim (Neupogen), which is a recombinant DNA-derived granulocyte colony stimulating factor (G-CSF). It is used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever[2].
Market Share and Adoption
As of Q3 2024, the biosimilar share of the filgrastim market has reached an impressive 85%, indicating a significant shift towards biosimilars in this segment. Nivestym, along with other biosimilars like Zarxio and Releuko, dominates the market, with Nivestym holding a substantial portion of the market share[1][3].
Average Sales Price (ASP) Trends
The average ASP of all filgrastim products has seen a significant decline. As of Q1 2024, the average ASP of all products is $194, which is a 57% decrease from the reference product's ASP at the time of the first biosimilar launch. For biosimilars alone, the average ASP is $130, representing a 75% decrease. This price erosion is a result of the increasing competition in the biosimilar market[1][3].
Competitive Landscape
The filgrastim market is highly competitive, with multiple biosimilars available. Nivestym competes with other biosimilars such as Zarxio, Releuko, and Granix (which is not a biosimilar but approved under a new drug application pathway). The market share distribution shows that biosimilars have captured the majority of the market, with Neupogen, the reference product, holding a minor share[1][3].
Global Filgrastim Market Size and Growth
The global filgrastim market was valued at $562.50 million in 2020 and is projected to reach $745.90 million by 2030, growing at a CAGR of 2.80% from 2021 to 2030. This growth is driven by the increasing demand for cost-effective treatments, particularly in developing countries, and the surge in demand for biosimilars in treating neutropenia[4].
Segment Analysis
By Drug Type
The biosimilars segment dominates the filgrastim market and is expected to continue its lead over the forecast period. The low cost and easy availability of biosimilars in developing countries are key factors driving this segment's growth[4].
By Distribution Channel
Hospital pharmacies are the primary distribution channel for filgrastim, driven by the high demand in hospital settings. Retail and online pharmacies also play significant roles but to a lesser extent[4].
By Indication
The primary indication for filgrastim is chemotherapy-induced neutropenia, followed by chronic neutropenia. The rise in cancer prevalence, especially in developing countries like China and India, is a significant driver for the market growth in these indications[4].
Regional Market Analysis
Europe is projected to account for a major share of the global filgrastim market, driven by developed healthcare infrastructure, favorable reimbursement policies, and an increase in the prevalence of infectious diseases and cancer. North America and the Asia-Pacific region also contribute significantly to the market, with countries like the U.S., Germany, and China being key markets[4].
Financial Impact of Biosimilars
The introduction of biosimilars like Nivestym has significantly reduced healthcare expenditure on filgrastim treatments. The average ASP decline of 75% for biosimilars has made these treatments more accessible and cost-effective, thereby increasing their adoption rates. This cost-effectiveness is a crucial factor in the financial trajectory of the filgrastim market, as it allows for more patients to be treated without a substantial increase in overall healthcare costs[1][3].
Challenges and Opportunities
Challenges
Despite the growth, the filgrastim market faces challenges such as common adverse effects of the drug, including joint pain, chest pain, hair loss, and vomiting. These side effects can hinder market growth by affecting patient compliance and overall treatment outcomes[4].
Opportunities
The increasing investment in R&D activities for developing effective and innovative biosimilars presents significant opportunities for market growth. The strong pipeline of biosimilar drugs and ongoing research are expected to further boost the market during the forecast period[4].
Industry Expert Insights
" Biosimilars have revolutionized the treatment landscape for conditions like neutropenia by offering cost-effective alternatives without compromising on efficacy," says an industry expert. "The market dynamics are shifting rapidly, with biosimilars capturing a larger share of the market, which is expected to continue as more biosimilars enter the market and as healthcare systems seek to reduce costs without sacrificing patient care."
Key Statistics
- Market Value: The global filgrastim market was valued at $562.50 million in 2020 and is projected to reach $745.90 million by 2030[4].
- CAGR: The market is expected to grow at a CAGR of 2.80% from 2021 to 2030[4].
- ASP Decline: The average ASP of biosimilars has declined by 75% compared to the reference product[1][3].
- Market Share: Biosimilars hold around 85% of the filgrastim market share as of Q3 2024[1][3].
Conclusion
The market dynamics for filgrastim-aafi (Nivestym) are characterized by a strong shift towards biosimilars, driven by cost-effectiveness, ease of availability, and the need to reduce healthcare expenditure. The financial trajectory of the market is marked by significant price erosion, making treatments more accessible. Despite challenges such as adverse effects, the market is poised for growth, driven by ongoing R&D and the increasing demand for biosimilars.
Key Takeaways
- Biosimilar Dominance: Biosimilars dominate the filgrastim market, capturing around 85% of the market share.
- Price Erosion: The average ASP of biosimilars has declined significantly, making treatments more cost-effective.
- Market Growth: The global filgrastim market is projected to grow at a CAGR of 2.80% from 2021 to 2030.
- Regional Impact: Europe and North America are key regions driving market growth, with developing countries also showing significant potential.
- Challenges and Opportunities: While adverse effects are a challenge, ongoing R&D and the strong pipeline of biosimilars present significant opportunities for market growth.
FAQs
What is the current market share of biosimilars in the filgrastim market?
As of Q3 2024, biosimilars hold around 85% of the filgrastim market share[1][3].
How has the average sales price (ASP) of filgrastim products changed?
The average ASP of all filgrastim products has declined by 57%, and for biosimilars alone, it has declined by 75% compared to the reference product's ASP at the time of the first biosimilar launch[1][3].
What is the projected growth rate of the global filgrastim market?
The global filgrastim market is expected to grow at a CAGR of 2.80% from 2021 to 2030[4].
Which regions are driving the growth of the filgrastim market?
Europe and North America are key regions driving market growth, with developing countries like China and India also showing significant potential[4].
What are the main challenges facing the filgrastim market?
Common adverse effects of the drug, such as joint pain, chest pain, hair loss, and vomiting, are significant challenges facing the market[4].
Sources
- Samsung Bioepis. Biosimilar Market Dynamics - SAMSUNG BIOEPIS. Q3 2024.
- FDA. 761080Orig1s000 - accessdata.fda.gov. June 5, 2018.
- Samsung Bioepis. Biosimilar Market Report - SAMSUNG BIOEPIS. Q1 2024.
- Allied Market Research. Filgrastim Market Size, Share| Segment Analysis| Forecast- 2030.
