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Last Updated: February 11, 2025

Etanercept - Biologic Drug Details


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Summary for etanercept
Recent Clinical Trials for etanercept

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaPhase 1
Medical Research Agency, PolandPhase 2/Phase 3
National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandPhase 2/Phase 3

See all etanercept clinical trials

Recent Litigation for etanercept

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Hetero USA, Inc.2024-08-08
AbbVie Inc. v. Hetero USA, Inc.2023-11-20
FENNEC PHARMACEUTICALS, INC. v. CIPLA LIMITED2023-01-10

See all etanercept litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Laboratories, Inc. et al.2018-08-03
2014-11-06
2013-08-15

See all etanercept litigation

Pharmacology for etanercept
Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic ClassTumor Necrosis Factor Blocker
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 etanercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Immunex Corporation ENBREL etanercept For Injection 103795 10,307,483 2036-10-21 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 11,491,223 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 5,395,760 2012-03-07 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 5,605,690 2014-02-25 Company disclosures
Immunex Corporation ENBREL etanercept For Injection 103795 5,712,155 2009-09-05 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for etanercept

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
10075011 Germany ⤷  Try for Free PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201
C300008 Netherlands ⤷  Try for Free PRODUCT: ETANERCEPTUM
0090011-8, 0091011-7 Sweden ⤷  Try for Free NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
132000900852970 Italy ⤷  Try for Free
15/2000 Austria ⤷  Try for Free PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Etanercept Market Dynamics and Financial Trajectory

Overview of Etanercept

Etanercept is a biologic medication that plays a crucial role in treating various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, plaque psoriasis, and Crohn's disease. It functions as a tumor necrosis factor (TNF)-alpha inhibitor, blocking the activity of TNF-alpha, a protein involved in inflammation.

Market Size and Growth

The global etanercept market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at approximately USD 17.6 billion and is projected to reach USD 27.0 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period from 2024 to 2033[2][4].

Regional Market Dynamics

North America

North America holds the largest market share, primarily due to a large patient population, advanced healthcare infrastructure, and high adoption rates of biologic medications. In 2022, North America accounted for 38.30% of the global etanercept market, with the U.S. contributing 62.70% of this share. The high prevalence of autoimmune diseases in the region, affecting between 5% and 8% of the U.S. population, drives this market growth[1][4].

Europe

Europe is another significant region, driven by the increasing prevalence of autoimmune diseases, favorable reimbursement policies, and well-established healthcare systems. The focus on personalized medicine and biologics further boosts market growth in this region[4].

Asia Pacific

The Asia Pacific region is experiencing rapid growth due to the rising incidence of autoimmune disorders, expanding healthcare access, and increasing awareness about biologic therapies. Countries like Japan, China, and India are witnessing notable market growth, supported by government initiatives to improve healthcare infrastructure and expand insurance coverage[2][4].

Driving Factors

Increasing Prevalence of Autoimmune Diseases

The growing prevalence of autoimmune diseases globally is a primary driver of the etanercept market. Conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis are becoming more common, increasing the demand for effective treatments like etanercept[1][2].

Expanding Indications

The approval of new indications for etanercept, such as non-radiographic axial spondyloarthritis, expands its potential patient population and contributes to market growth[4].

Emerging Markets

Increasing healthcare expenditure and rising prevalence of autoimmune diseases in emerging markets present significant growth opportunities for etanercept manufacturers. Strategic partnerships, expanded distribution networks, and regulatory approvals have facilitated market entry into these regions[2][4].

Technological Advancements

Technological innovations in drug delivery systems and formulation techniques enhance the convenience and effectiveness of etanercept therapy, contributing to market expansion. For instance, the development of self-administered biologic therapies and home-based treatment options is driving demand[4].

Challenges and Competitive Landscape

Competition from Biosimilars

The entry of biosimilar versions of etanercept into the market poses competitive challenges to branded products. This competition influences pricing strategies and market share dynamics, as biosimilars offer cost-effective alternatives to patients[4].

Regulatory Changes

Regulatory reforms and changes in market access policies, including biosimilar approval pathways and reimbursement policies, significantly influence market dynamics and the competitive positioning of etanercept. Uncertainty in reimbursement policies can deter market expansion by creating barriers to patient access[2][4].

Pricing Strategies

The pricing of etanercept, particularly under brands like Enbrel, has been a subject of scrutiny. Amgen, the manufacturer of Enbrel, has implemented significant price increases over the years, which have contributed to the company's profitability but also raised concerns about affordability and accessibility for patients. For example, the price of Enbrel has increased by 457% since its acquisition by Amgen, reaching $72,240 annually for a typical course[5].

Financial Performance

The financial performance of the etanercept market is robust, with major players like Amgen reporting substantial revenues. For instance, Amgen’s net U.S. revenue from Enbrel increased from $1.25 billion in 2003 to over $5 billion in 2019. The company’s net income has grown significantly, driven by price increases and strong market demand[5].

Key Players and Market Competition

The global etanercept market is highly competitive, with several large players and numerous small and medium-sized enterprises. Key players have strong research and development capabilities and a strong presence in the market through their extensive product portfolios and distribution networks. Companies are focusing on expanding their product offerings and increasing market revenue through mergers, acquisitions, and partnerships[1].

Market Opportunities

Increasing Investment in Healthcare Infrastructure

Governments and private entities worldwide are investing in enhancing healthcare infrastructure, which includes specialized treatment centers and infusion facilities. This investment facilitates the administration of biologics like etanercept, driving uptake among patients with autoimmune diseases[2].

Growing Adoption of Biologic Drugs

The growing adoption of biologic drugs for the treatment of chronic inflammatory conditions fuels market growth. The efficacy and favorable safety profiles of these drugs contribute to their increasing use[4].

Patient Preference for Self-Administration

Growing patient preference for self-administered biologic therapies drives demand for convenient drug delivery devices and home-based treatment options. This trend is expected to continue, influencing market dynamics and product development[4].

Key Takeaways

  • The global etanercept market is projected to grow significantly, driven by the increasing prevalence of autoimmune diseases and expanding healthcare access.
  • North America and Europe are key regions, with the Asia Pacific region showing rapid growth.
  • Technological advancements and expanding indications are crucial drivers of market growth.
  • Competition from biosimilars and regulatory changes pose significant challenges.
  • Pricing strategies and investment in healthcare infrastructure play critical roles in market dynamics.

FAQs

What is etanercept used for?

Etanercept is used to treat various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, plaque psoriasis, and Crohn's disease.

What is the projected market size of etanercept by 2033?

The global etanercept market is expected to reach USD 27.0 billion by 2033, with a CAGR of 4.5% during the forecast period from 2024 to 2033[2][4].

Which region dominates the etanercept market?

North America dominates the etanercept market, primarily due to a large patient population and advanced healthcare infrastructure[1][4].

What are the main challenges facing the etanercept market?

The main challenges include competition from biosimilars, regulatory changes, and uncertainty in reimbursement policies[2][4].

How has the pricing of etanercept impacted its market?

The pricing of etanercept, particularly under brands like Enbrel, has been a subject of scrutiny. Significant price increases have contributed to the company's profitability but raised concerns about affordability and accessibility for patients[5].

Sources

  1. Consegic Business Intelligence: Etanercept Market Size | Global Industry Report 2023-2031
  2. Marketresearch.biz: Etanercept Market Size, Share, Growth | CAGR of 4.5%
  3. ResearchGate: Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany
  4. PharmiWeb: Etanercept Market Projected to Grow at 4.5% CAGR, Crossing US$ 27.0 Billion by 2033, Reports Marketresearch.biz
  5. House Committee on Oversight and Reform: Drug Pricing Investigation

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.