Pegfilgrastim-apgf - Biologic Drug Details

Summary for pegfilgrastim-apgf

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for pegfilgrastim-apgf

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage Colony-Stimulating Factor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for pegfilgrastim-apgf Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pegfilgrastim-apgf Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for pegfilgrastim-apgf Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Pegfilgrastim Biosimilars

Introduction

Pegfilgrastim, a granulocyte-colony stimulating factor (G-CSF) used to prevent neutropenia in patients undergoing chemotherapy, has seen a significant shift in its market dynamics with the emergence of biosimilars. This article delves into the current market trends, financial projections, and the factors driving the growth of pegfilgrastim biosimilars.

Market Size and Growth

The global pegfilgrastim biosimilars market is projected to experience substantial growth. As of 2024, the market is estimated to be valued at USD 1.69 billion and is expected to reach USD 3.07 billion by 2031, with a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the pegfilgrastim biosimilars market:

Increasing Demand for Cost-Effective Alternatives

Biosimilars offer significant cost savings compared to their reference biologics, making them an attractive option for hospitals and cancer care centers. This cost-effectiveness is a major driver, as patients and healthcare systems seek to reduce healthcare expenditures[1].

Rising Incidence of Cancer

The increasing incidence of cancer worldwide has boosted the need for supportive care therapies like pegfilgrastim. Cancer patients often require chemotherapy, which can lead to neutropenia, making pegfilgrastim biosimilars a crucial component of their treatment[1].

Patent Expiry of Reference Biologics

The expiry of patents for major reference biologic drugs, such as Neulasta, has paved the way for the commercialization of biosimilar versions. Neulasta lost its exclusivity in the U.S. in 2018, allowing multiple biosimilar entrants into the market[1].

Market Share and Average Sales Price (ASP)

As of Q3 2023, biosimilars held a 75% share of the pegfilgrastim market. The average ASP of all pegfilgrastim products has significantly decreased, with biosimilars averaging $1,976 as of Q1 2024, representing a 56% reduction from the reference product's ASP at the time of the first biosimilar launch[3].

Regional Market Dynamics

North America

North America, particularly the U.S., dominates the global pegfilgrastim biosimilars market with an estimated market share of 41.3% in 2024. Favorable reimbursement policies and the presence of large regional pharmaceutical companies contribute to this dominance[1].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing market for pegfilgrastim biosimilars. Countries like China, India, South Korea, and Japan are witnessing increased adoption due to growing cancer patient pools and significant investments in local manufacturing capabilities. China's "Made in China 2025" program has further boosted the development of a strong biosimilars industry in the region[1].

Distribution Channels

Hospital pharmacies are expected to hold around 54% of the global market share for pegfilgrastim biosimilars. This is due to the high demand for these drugs in hospital settings where chemotherapy is commonly administered[4].

Financial Assistance and Reimbursement

To facilitate access to pegfilgrastim biosimilars, various financial assistance programs are available. For instance, Pfizer's patient support programs help patients understand their benefits, connect them with financial assistance resources, and assist with billing and coding, prior authorization, and appeals[2].

Challenges and Restraints

Despite the growth potential, several challenges exist:

Regulatory Barriers

High entry barriers and stringent regulatory pathways can initially hamper the uptake of pegfilgrastim biosimilars. Potential anti-substitution laws in some countries can also jeopardize automatic substitution of biosimilars[1].

Incumbent Competition

Competition from existing biologics and disparities in reimbursement policies can impact pricing and adoption scenarios[1].

Manufacturing Complexities

Resistance from biologic manufacturers and the complexities involved in manufacturing pegfilgrastim biosimilars can restrict market growth[4].

Future Outlook and Opportunities

Novel Drug Delivery Systems

Investments in novel drug delivery systems can help differentiate products and appeal to a wider patient base. Collaborations with regional distributors will also aid market penetration in select territories[1].

Emerging Markets

Emerging markets like China and India are likely to adopt these products faster, contributing to global revenues. The focus on expanding patient access through cost reductions will remain a priority area[1].

Research and Development

Increasing investment in research and development for novel pegfilgrastim biosimilars is expected to accelerate market growth. New indications and the patent expiry of biologic products will create growth opportunities for key players[4].

Key Takeaways

• The global pegfilgrastim biosimilars market is expected to grow significantly, driven by cost savings, rising cancer incidence, and patent expiry of reference biologics.
• North America and the Asia Pacific region are key markets, with hospital pharmacies playing a crucial role in distribution.
• Financial assistance programs and favorable reimbursement policies are critical for market growth.
• Regulatory barriers, incumbent competition, and manufacturing complexities are significant challenges.
• Investments in novel drug delivery systems and emerging markets will drive future growth.

FAQs

1. What is the projected market size of the pegfilgrastim biosimilars market by 2031? The global pegfilgrastim biosimilars market is expected to reach USD 3.07 billion by 2031[1].

2. What are the main drivers of the pegfilgrastim biosimilars market? The main drivers include the rising demand for cost-effective alternatives, increasing incidence of cancer, and the expiry of patents for reference biologics[1].

3. Which region dominates the pegfilgrastim biosimilars market? North America, particularly the U.S., dominates the global pegfilgrastim biosimilars market[1].

4. What is the average sales price (ASP) of pegfilgrastim biosimilars as of Q1 2024? The average ASP of pegfilgrastim biosimilars is $1,976 as of Q1 2024, representing a 56% reduction from the reference product's ASP[3].

5. What are the challenges facing the pegfilgrastim biosimilars market? Challenges include regulatory barriers, incumbent competition from existing biologics, and complexities in manufacturing biosimilars[1][4].

Sources

1. Coherent Market Insights - Pegfilgrastim Biosimilars Market - Price, Size, Share & Growth
2. Pfizer Biosimilars Resource - NYVEPRIA® (pegfilgrastim-apgf) Billing and Coding Guide
3. Samsung Bioepis - Biosimilar Market Report
4. Fact.MR - Research on Developing Novel Pegfilgrastim Biosimilars to Elevate Sales