Infliximab - Biologic Drug Details

Summary for infliximab

Tradenames:	1
High Confidence Patents:	0
Applicants:	5
BLAs:	6
Suppliers: see list	5
Recent Clinical Trials:	See clinical trials for infliximab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for infliximab

Recent Clinical Trials for infliximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda France	Phase 4
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1
Kyungpook National University Hospital	N/A

See all infliximab clinical trials

Recent Litigation for infliximab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
United Therapeutics Corporation v. Liquidia Technologies, Inc.	2023-09-05

See all infliximab litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy's Laboratories, Inc. et al.	2018-08-03
	2017-12-20
	2014-11-06

See all infliximab litigation

Pharmacology for infliximab

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor 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

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 infliximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Infliximab

Introduction

Infliximab, a monoclonal antibody and tumor necrosis factor-alpha (TNF-α) inhibitor, has been a cornerstone in the treatment of various autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. The market dynamics and financial trajectory of infliximab are influenced by several key factors, including its efficacy, the rise of biosimilars, and changing healthcare landscapes.

Growing Demand for Infliximab

The demand for infliximab is driven by the increasing prevalence of inflammatory bowel diseases (IBD) and other autoimmune conditions. In the United States, for example, approximately 3 million people live with IBD, with about 70,000 new cases diagnosed annually[1].

Market Growth Projections

The global infliximab market is expected to grow at a Compound Annual Growth Rate (CAGR) of 11.3% from 2023 to 2033. This growth is attributed to the expanding patient base, the development of new formulations such as subcutaneous injections, and the increasing penetration into emerging markets like Asia Pacific and Latin America[1].

Impact of Biosimilars

Biosimilars have significantly altered the market landscape for infliximab. Biosimilars like Inflectra and Remsima have eroded the market share of the original product, Remicade. By 2019, Remicade's market share had decreased from 95% to nearly 80%, while Inflectra accounted for approximately 10% of the infliximab market[3].

Cost-Effectiveness of Biosimilars

Biosimilars offer a cost-effective alternative to the original biologic. A cost-effectiveness analysis revealed that infliximab biosimilars are more economically viable compared to other TNF-α inhibitors like adalimumab and certolizumab. For instance, infliximab biosimilars have been shown to provide the highest Quality-Adjusted Life Years (QALYs) at the lowest cost, staying below the $100,000/QALY threshold[2].

Price Dynamics

The launch of biosimilars has led to a significant reduction in prices. In regions like Canada and the Nordics, the prices of biosimilars such as Remsima were approximately 40% lower than the original product by 2019. This price difference has been a key factor in the adoption of infliximab biosimilars[3].

Regional Market Analysis

North America

North America is projected to account for the highest market share, driven by the high prevalence of chronic inflammatory diseases and the presence of advanced healthcare infrastructure. Favourable reimbursement policies for biologics in this region also contribute to the market growth[1].

Europe and Other Regions

In Europe, the EU5 and Nordic countries have shown greater receptivity to biosimilars, with significant market penetration. The Middle East and Africa (MEA) region also presents opportunities for growth, with biologics' value share increasing annually[3].

Clinical and Financial Outcomes

Switching patients from the original Remicade to an infliximab biosimilar has shown positive clinical and financial outcomes. A retrospective analysis indicated that 70% of patients maintained the same or improved dose, and the health plan savings were nearly $725,000, or $11,508 per transitioned patient[5].

New Formulations and Indications

The development of new formulations, such as subcutaneous injections, is expected to drive increased demand for infliximab. These formulations are more convenient for patients compared to intravenous infusions and could expand the market to include patients who were previously unwilling or unable to receive infusion-based treatment[1].

Expanding Indications

Infliximab is being used for new indications such as psoriasis and psoriatic arthritis, further expanding its market potential. This expansion into new treatment areas is a significant opportunity for growth[1].

Competitive Landscape

The infliximab market is highly competitive, with multiple biosimilars available. The availability of these biosimilars has increased competition, making the medication more accessible to patients and driving demand. Key players in the market are investing in research and development to improve the effectiveness and safety of infliximab[1].

Regulatory and Reimbursement Factors

Favourable reimbursement policies, especially in North America, are a significant driver for the market growth. Faster approval procedures and the presence of FDA-certified manufacturing facilities in regional nodes also contribute to the increased acceptance of infliximab and its biosimilars[4].

Future Outlook

The global infliximab market is poised for significant growth, driven by increasing demand, the rise of biosimilars, and the development of new formulations. As more biologic products lose their exclusivity, the market is expected to see further penetration of biosimilars, leading to increased accessibility and affordability for patients.

Key Takeaways

• The global infliximab market is expected to grow at a CAGR of 11.3% from 2023 to 2033.
• Biosimilars have significantly reduced the market share of the original product, Remicade, and offer a cost-effective alternative.
• New formulations and expanding indications are driving market growth.
• Favourable reimbursement policies and regulatory approvals are crucial for market expansion.
• The market is highly competitive, with multiple biosimilars available.

FAQs

What is the expected growth rate of the global infliximab market?

The global infliximab market is expected to grow at a CAGR of 11.3% from 2023 to 2033[1].

How have biosimilars impacted the infliximab market?

Biosimilars have significantly reduced the market share of the original product, Remicade, and offer a cost-effective alternative, making the medication more accessible to patients[3].

What are the key drivers for the growth of the infliximab market?

Key drivers include the increasing prevalence of inflammatory diseases, the development of new formulations, expanding indications, and favourable reimbursement policies[1].

Which regions are expected to contribute significantly to the infliximab market growth?

North America is projected to account for the highest market share, followed by Europe and emerging regions like Asia Pacific and Latin America[1].

What are the clinical and financial outcomes of switching to infliximab biosimilars?

Switching to infliximab biosimilars has shown positive clinical outcomes with 70% of patients maintaining the same or improved dose, and significant financial savings for health plans[5].

Sources:

1. Market Statsville Group, "Infliximab Market Size, Share and Trends Analysis by 2033".
2. ISPOR, "Cost-Effectiveness Analysis of Infliximab, Adalimumab, and Certolizumab for Crohn's Disease: A Markov Model Study".
3. IQVIA, "Realizing Biosimilar Potential in the Middle East & Africa".
4. Verified Market Research, "Infliximab And Biosimilar Market Size And Forecast".
5. AMCP Foundation, "A Retrospective Analysis of the Clinical and Financial Outcomes of Converting Patients from Originator Remicade to an Infliximab Biosimilar".