Pegfilgrastim - Biologic Drug Details

Summary for pegfilgrastim

Tradenames:	2
High Confidence Patents:	3
Applicants:	7
BLAs:	7
Suppliers: see list	8
Recent Clinical Trials:	See clinical trials for pegfilgrastim

Recent Clinical Trials for pegfilgrastim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Cancer Center, Korea	Phase 2
Seoul National University Hospital	Phase 2
Apobiologix.	Phase 3

See all pegfilgrastim clinical trials

Pharmacology for pegfilgrastim

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte 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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	5,580,755	2013-12-03	Company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	5,582,823	2013-12-10	Company disclosures
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	5,824,784	2039-02-26	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,580,755	2013-12-03	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,582,823	2013-12-10	Company disclosures
Amgen Inc.	NEULASTA ONPRO	pegfilgrastim	Injection	125031	5,824,784	2039-02-26	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,338	2033-03-11	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,016,412	2021-05-01	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,092,706	2031-04-20	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,105,389	2036-04-01	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,117,943	2039-02-26	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,195,188	2036-06-13	Patent claims search
Amgen Inc.	NEULASTA	pegfilgrastim	Injection	125031	10,383,876	2031-04-05	Patent claims search

International Patents for pegfilgrastim

Country	Patent Number	Estimated Expiration
China	1896103
Denmark	0733067
Germany	69533556
Norway	314902
Spain	2131811
World Intellectual Property Organization (WIPO)	8701132
World Intellectual Property Organization (WIPO)	9611953

Supplementary Protection Certificates for pegfilgrastim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3/2014	Austria		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 (MITTEILUNG) 20130725
14C0007	France		PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
2014/005	Ireland		PRODUCT NAME: LONQUEX-LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725
132014902227609	Italy		PRODUCT NAME: LIPEGFILGRASTIM(LONQUEX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/856/001-002, 20130725
92359	Luxembourg		PRODUCT NAME: LIPEGFILGRASTIM
C300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; NAT. REGISTRATION NO/DATE: EU/1/02/228/001 20020822; FIRST REGISTRATION: EU/1/02/228/001 20020822
SPC/GB14/009	United Kingdom		PRODUCT NAME: LIPEGFILGRASTIM; REGISTERED: UK EU/1/13/856/001 20130729

Market Dynamics and Financial Trajectory for Pegfilgrastim

Introduction

Pegfilgrastim, a biologic drug used to reduce the risk of infection in patients undergoing chemotherapy by boosting white blood cell counts, is experiencing significant growth in the global market. Here, we delve into the market dynamics and financial trajectory of pegfilgrastim, including its current market size, growth projections, regional performance, and key drivers.

Current Market Size and Growth Projections

As of 2024, the global pegfilgrastim market size is estimated to be USD 1,654.2 million[1].

• This market is expected to expand at a compound annual growth rate (CAGR) of 11.5% from 2024 to 2031, reaching USD 3,544.1 million by 2031[1].

Regional Performance

North America

North America dominates the global pegfilgrastim market, holding more than 40% of the global revenue with a market size of USD 661.68 million in 2024. The region is projected to grow at a CAGR of 9.7% from 2024 to 2031[1].

Europe

Europe accounts for over 30% of the global revenue, with a market size of USD 496.26 million in 2024. The European market is expected to grow at a CAGR of 10.0% during the forecast period[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 380.47 million in 2024. This region is projected to grow at a CAGR of 13.5% from 2024 to 2031, making it one of the fastest-growing markets[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, with market sizes of USD 82.71 million and USD 33.08 million in 2024, respectively. These regions are expected to grow at CAGRs of 10.9% and 11.2%, respectively, from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Cancer

The rising incidence of cancer is a significant driver for the pegfilgrastim market. Cancer cases have seen an increase globally, leading to a higher demand for supportive treatments like pegfilgrastim to manage chemotherapy-induced neutropenia[2][3].

Cost Savings and Biosimilar Adoption

Biosimilars of pegfilgrastim offer significant cost savings compared to the reference biologic drugs. The expiry of patents for major pegfilgrastim brands, such as Neulasta, has paved the way for the commercialization of biosimilars, which are 30-50% cheaper than the originator versions. This has boosted the adoption of pegfilgrastim biosimilars by hospitals and cancer care centers[3].

Regulatory Incentives

Regulatory bodies in key regions like Europe and Asia Pacific have implemented policies to incentivize the uptake of biosimilars. These regulations help in expanding the market by making biosimilars more accessible and affordable[3].

Research and Development

Substantial investments in research and development are driving the creation of effective and innovative biologics. Strategic partnerships and merger and acquisition strategies are also enhancing the market's growth by expanding the customer base and geographic markets[2][4].

Competitive Landscape

The pegfilgrastim biosimilars market is competitive, with major players such as Mylan, Biocon, Sandoz, Coherus BioSciences, and Intas Biopharmaceuticals. These companies are focusing on product differentiation, strategic partnerships, and expanding their distribution networks to capture a larger market share[2][3].

Financial Performance and Projections

Global Pegfilgrastim Biosimilars Market

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, growing at a CAGR of 8.9% from 2024 to 2031[3].

Regional Financial Projections

• North America: Expected to grow at a CAGR of 9.7% from 2024 to 2031, with the U.S. market alone accounting for over 40% of the regional share[1].
• Asia Pacific: Projected to grow at a CAGR of 13.5% from 2024 to 2031, driven by growing cancer patient pools and significant investments in local manufacturing capabilities[1][3].

Challenges and Opportunities

High Entry Barriers

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

Emerging Markets

Emerging markets like China and India are expected to adopt pegfilgrastim biosimilars faster, driven by cost reductions and government initiatives. For example, China's "Made in China 2025" program is boosting the development of a strong biosimilars industry[3].

Product Differentiation

Investments in novel drug delivery systems can help differentiate products and appeal to a wider patient base. Collaborations with regional distributors will also aid in market penetration in select territories[3].

"The expiry of patents of major reference biologic drugs enables the commercialization of various novel biosimilars in the market. This can expand treatment access to more patients," - Coherent Market Insights[3].

Key Takeaways

• The global pegfilgrastim market is expected to grow significantly, driven by the increasing prevalence of cancer and the adoption of biosimilars.
• North America and Europe are major contributors to the global market, but the Asia Pacific region is emerging as the fastest-growing market.
• Cost savings from biosimilars and regulatory incentives are key drivers of market growth.
• Major players are focusing on product differentiation, strategic partnerships, and expanding distribution networks.

FAQs

What is the current global market size for pegfilgrastim?

The global pegfilgrastim market size is estimated to be USD 1,654.2 million in 2024[1].

What is the projected growth rate for the pegfilgrastim market from 2024 to 2031?

The pegfilgrastim market is expected to grow at a compound annual growth rate (CAGR) of 11.5% from 2024 to 2031[1].

Which region dominates the global pegfilgrastim market?

North America dominates the global pegfilgrastim market, holding more than 40% of the global revenue[1].

What are the key drivers of the pegfilgrastim biosimilars market?

Key drivers include the increasing prevalence of cancer, cost savings from biosimilars, and regulatory incentives[2][3].

Who are the major players in the pegfilgrastim biosimilars market?

Major players include Mylan, Biocon, Sandoz, Coherus BioSciences, and Intas Biopharmaceuticals[2][3].

Sources

1. Cognitive Market Research: Global Pegfilgrastim Market Report 2024.
2. Research and Markets: Pegfilgrastim Biosimilars Global Market Size & Competitors.
3. Coherent Market Insights: Pegfilgrastim Biosimilars Market - Price, Size, Share & Growth.
4. The Business Research Company: Global Pegfilgrastim Biosimilars Market Report 2024.