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Last Updated: May 22, 2025

NYVEPRIA Drug Profile


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Summary for Tradename: NYVEPRIA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for NYVEPRIA
Recent Clinical Trials for NYVEPRIA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
Children's Oncology GroupPhase 2
University of WashingtonPhase 2

See all NYVEPRIA clinical trials

Pharmacology for NYVEPRIA
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 NYVEPRIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NYVEPRIA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for NYVEPRIA Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for NYVEPRIA (Pegfilgrastim Biosimilar)

Introduction to NYVEPRIA and Pegfilgrastim Biosimilars

NYVEPRIA is a biosimilar version of the biologic drug pegfilgrastim, which is used to treat chemotherapy-induced neutropenia, a common side effect of cancer treatment. Pegfilgrastim biosimilars, including NYVEPRIA, have been gaining traction in the healthcare market due to their cost-effectiveness and comparable efficacy to the reference biologic drugs.

Market Growth Drivers

Increasing Demand for Biosimilars

The global pegfilgrastim biosimilars market is driven by the rising demand for cheaper biosimilar alternatives to reference biologic drugs. Patients and healthcare systems are seeking cost-effective treatments, and biosimilars offer significant cost savings, often ranging from 30-50% compared to the reference products[3].

Rising Incidence of Cancer

The increasing incidence of cancer worldwide boosts the need for supportive care therapies such as pegfilgrastim. This trend is expected to continue, driving the demand for pegfilgrastim biosimilars like NYVEPRIA[3].

Patent Expiry and Regulatory Support

The expiry of patents for major reference biologic drugs, including Neulasta (the original pegfilgrastim product), has enabled the commercialization of various novel biosimilars. Regulatory bodies in regions like Europe and Asia Pacific have also laid down regulations to incentivize the uptake of biosimilars, further driving market growth[3].

Market Size and Financial Projections

Current Market Size

The global pegfilgrastim biosimilars market is estimated to be valued at USD 1.69 billion in 2024 and is expected to reach USD 3.07 billion by 2031, exhibiting a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031[3].

Regional Dominance

North America, particularly the U.S., dominates the global pegfilgrastim biosimilars market with an estimated market share of 41.3% in 2024. The U.S. market alone accounts for over 40% of the share due to high demand from healthcare facilities and favorable reimbursement policies[3].

Emerging Markets

Asia Pacific, including countries like China, India, South Korea, and Japan, is emerging as the fastest-growing market for pegfilgrastim biosimilars. These regions are witnessing increasing adoption due to growing cancer patient pools and significant investments in local manufacturing capabilities[3].

Cost Savings and Budget Impact

Cost Savings Analysis

A budget impact analysis conducted in France using real-world data showed that introducing NYVEPRIA resulted in significant cost savings. Over a 5-year period, the cumulative cost savings were estimated to be €3,518,669 using real-world data and €5,864,448 using clinical trial data[5].

Drug Acquisition and Administration Costs

The cost savings are primarily due to lower drug acquisition and administration costs compared to the reference biologic drugs. For instance, NYVEPRIA has been shown to reduce annual costs significantly, making it an attractive option for both private and public healthcare systems[5].

Market Share and Competition

Market Share Trends

As of Q3 2024, the biosimilar share of the pegfilgrastim market was 84%, with NYVEPRIA being one of the key players. The market is highly competitive, with multiple biosimilars vying for market share. Recent entrants, such as Ziextenzo and Nyvepria, are competing for market share, although established players like Fulphila and Udenyca still hold significant market shares[4].

Price Erosion

The introduction of multiple biosimilars has led to price erosion in the market. The average sales price (ASP) of pegfilgrastim biosimilars has decreased significantly, with biosimilars alone averaging an ASP that is 53% lower than the reference product's ASP at the time of the first biosimilar launch[4].

Regulatory and Reimbursement Challenges

High Entry Barriers

Despite the growth potential, the pegfilgrastim biosimilars market faces high entry barriers due to stringent regulatory pathways. Incumbent competition from current biologics and potential anti-substitution laws in some countries can also pose challenges[3].

Reimbursement Policies

Disparities in reimbursement policies can impact pricing and adoption scenarios. For example, while the U.S. has favorable reimbursement policies promoting biosimilar usage, other regions may face pricing pressures from government payers, which can temper future growth[3].

Key Players and Investments

Major Players

Tier-1 companies such as Coherus BioSciences, Biocon, Novartis AG, and Mylan hold the highest market share in the pegfilgrastim biosimilars market. These companies are investing heavily in research and development to improve accessibility and develop novel pegfilgrastim biologics[1].

Investments in R&D

Manufacturers are highly investing in developing novel pegfilgrastim biologics and improving accessibility with the help of real-time data. This investment is likely to accelerate the growth of the market by providing more affordable and effective treatment options[1].

Future Outlook

Expanding Patient Access

Expanding patient access through cost reductions is set to remain a priority area. Emerging markets like China and India are likely to adopt these products faster, buoying global revenues. Investments in novel drug delivery systems can help differentiate products and appeal to a wider patient base[3].

Collaborations and Market Penetration

Collaborations with regional distributors will aid market penetration in select territories. This strategic approach will help in ensuring reliable and affordable supply to meet domestic treatment needs, particularly in regions with growing cancer patient pools[3].

Key Takeaways

  • The global pegfilgrastim biosimilars market is expected to grow significantly, driven by rising demand for cost-effective treatments and increasing cancer cases.
  • NYVEPRIA and other pegfilgrastim biosimilars offer substantial cost savings, making them attractive options for healthcare systems.
  • North America, particularly the U.S., dominates the market, but Asia Pacific is emerging as a fast-growing region.
  • High entry barriers and regulatory challenges need to be navigated, but investments in R&D and collaborations with regional distributors are expected to drive market growth.

FAQs

What is NYVEPRIA?

NYVEPRIA is a biosimilar version of the biologic drug pegfilgrastim, used to treat chemotherapy-induced neutropenia.

How does NYVEPRIA impact healthcare costs?

NYVEPRIA and other pegfilgrastim biosimilars offer significant cost savings, often ranging from 30-50% compared to the reference biologic drugs, making them an affordable treatment option.

Which regions dominate the pegfilgrastim biosimilars market?

North America, particularly the U.S., currently dominates the market, but Asia Pacific is emerging as a fast-growing region due to increasing cancer cases and investments in local manufacturing.

What are the key challenges in the pegfilgrastim biosimilars market?

High entry barriers, stringent regulatory pathways, and disparities in reimbursement policies are some of the key challenges facing the pegfilgrastim biosimilars market.

How is the market expected to grow in the future?

The market is expected to grow at a CAGR of 8.9% from 2024 to 2031, driven by increasing demand for biosimilars, rising cancer cases, and investments in R&D and novel drug delivery systems.

Sources

  1. Fact.MR: Research on Developing Novel Pegfilgrastim Biosimilars to Elevate Sales[1]
  2. Pfizer: Financials - Quarterly Reports - Pfizer Inc.[2]
  3. Coherent Market Insights: Pegfilgrastim Biosimilars Market - Price, Size, Share & Growth[3]
  4. Samsung Bioepis: Biosimilar Market Dynamics[4]
  5. Open Health Group: Biosimilar pegfilgrastim may offer affordable treatment options for patients in France[5]
Last updated: 2024-12-23

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