Global Infliximab Drug Market Report and Forecast 2024-2032

Global Infliximab Drug Market Outlook

The growth of the global infliximab drug market is driven by the rising number of rheumatoid arthritis cases, which was close to 35.35 million in 2023. The prevalence of rheumatoid arthritis disease is likely to grow at a CAGR of 1.3% in the forecast period of 2024-2032 and the number of cases is likely to reach nearly 39.54 million by 2032.

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Key Company News

In September 2021, Sandoz announced a marketing agreement with Bio-Thera Solution for the Biosimilar Bat1706. This contract will improve the tumour portfolio of the company and will add further growth to the infliximab drug market expansion.

In July 2021, Biocon Ltd (Biocon Biologics), in collaboration with Viatris, obtained Food and Drug Administration approval for the first SEMGLEE biosimilar (insulin glargine injection) for the treatment of diabetes.

Introduction

Infliximab (Remicade) was the first monoclonal antibody produced by Janssen Biotech, Inc. Infliximab is the biosimilar version of Remicade. It was first approved by the United States Food and Drug Administration (FDA) in 1998 in collaboration with Merck & Company.

The drug is widely used in the treatment of active plaque psoriasis rheumatoid arthritis, ulcerative colitis, and Crohn's disease in children and adults.

Inflectra (infliximab dyyb) was launched under the brand name Remicade developed by Celltrion Healthcare and Pfizer Hospira in the European market after receiving an approval from EMA’s CHMP in June 2013.

Moreover, the United States Food and Drug Administration (FDA) has now released Remicade's biosimilar Inflectra.

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According to the global infliximab drug market research report, the market can be categorised into the following segments:

Market Breakup by Product Type

• Brands Drugs

• Generic Drugs

Market Breakup by Route of Administration

• Oral

• Parenteral

• Topical

• Transdermal

• Rectal

Market Breakup by Application

• Rheumatoid Arthritis

• Crohn’s Disease

• Ulcerative Colitis

• Psoriasis

Market Breakup by Distribution Channel

• Hospital-based Pharmacies

• Online Pharmacies

• Retail Pharmacies

Market Breakup by Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East and Africa

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Market Scenario

The increasing prevalence of rheumatoid arthritis has been driving the growth of the infliximab drug market. Infliximab (Remicade) biosimilar sales will grow further in the coming years due to the rising cases of rheumatoid arthritis and the early loss of patent exclusivity. A growing number of autoimmune diseases and a decline in the price of biosimilar Infliximab (Remicade) are driving the adoption and consumption of the drug in European market.

In the regional nodal countries, the development of FDA-approved manufacturing facilities and faster approval procedures are the contributing factors to the growth of the drugs market.

In addition, clear labelling and transparent labelling to ensure that medicines are accurately prescribed and dispensed and to improve post-market control will greatly contribute to the confidence of prescribers and lead the infliximab drug market in the coming years.

The availability of adequate FDA-approved manufacturing facilities in regional nodal countries and faster approval procedures are significantly aiding the market growth.

However, long-term adoption of infliximab biosimilars may be difficult due to safety concerns associated with manufacturing facilities and potential side effects of drug use.

Drivers and Restraints: Infliximab Drug Market

Infliximab biosimilars are driven by factors such as an increase in the prevalence of autoimmune diseases, especially rheumatoid arthritis and plaque psoriasis, the expiration of the branded version's patent early, a lower price in the European market and quicker response times.

The introduction of biosimilar versions could greatly improve access to essential drugs for patients and relieve the financial burden on the healthcare system.

There are also serious drug-related side effects associated with Infliximab biosimilars that can lead to hospitalisation or death. Tuberculosis, bacterial sepsis, and histoplasmosis are some of these infections.

To ensure that both healthcare professionals and patients are informed, pharmaceutical manufacturers must include "box alerts." Furthermore, infliximab's complex molecule and lack of FDA-approved manufacturing facilities also limit the market growth in developing countries.

North America is Dominating the Global Infliximab Drug Market

The North American market is dominated by infliximab due to the developed healthcare infrastructure. During the forecast period, the Asia Pacific region will witness high growth due to increased research and development activity.

Therapeutic Landscape

Infliximab Drugs: Mechanism of Action

The drug Infliximab is a potential treatment platform for many diseases. Infliximab is used clinically to treat a variety of conditions.

The chimeric IgG1 monoclonal antibody, infliximab (Remicade), targets tumor necrosis factor alpha (TNFa) in humans. A continuous infusion of recombinant cells produces infliximab. An injectable powder preparation is used for making intravenous injection solutions.

With high affinity, infliximab inhibits the binding of TNF to its receptor and neutralizes its biological activity.

Infliximab does not neutralize lymphotoxin-α, a related cytokine that uses the same TNFα receptor.

Among the biological effects of TNFa are the release of inflammatory cytokines such as interleukins (IL) 1 and 6, the activation of leukocytes, and increased endothelial layer permeability. Activation results in increased expression of adhesive molecules in leukocytes. In addition to acute contrast, other degrading enzymes of the tissues are produced by the liver proteins and cartilage cells.

The functional activity of TNF alpha is prevented by infliximab using neutrophils, endothelial cells, B lymphocytes, human fibroblasts and T lymphocytes.

Approved Biosimilars of infliximab

A few biosimilars are approved for therapeutic use by regulatory authorities. Inflectra, Renflexis and Ixifi are three FDA-approved biosimilars of infliximab for rheumatoid and Crohn’s disease indications. All these biosimilars are injected intravenously and are sold under different brands.

Inflectra will be Celltrion's first biosimilar monoclonal antibody (mAb) and the second biosimilar to be marketed in the United StatesThis drug is approved for the treatment of moderately to severely active Crohn's disease in adults and children.

The invention and development of new biosimilars is essential to provide robust and cost-effective treatments. These economic benefits, therefore, contribute to improving access to health services. New biosimilar therapeutics targeting infliximab will drive the development of the infliximab drug market in the coming year.

Clinical Trials

A biosimilar should be substantially similar to the original reference product in efficacy and safety. Conduct research and confirmatory clinical studies to confirm similarity to the reference product are ongoing.

Infliximab is primarily used to treat follicular lymphoma and rheumatoid arthritis. Therefore, infliximab biosimilar studies were primarily conducted in patients with signs of plaque psoriasis and rheumatoid arthritis disease.

Biosimilars undergo different clinical trials than their biological counterparts. In biosimilar trials, there is an exemption for in-vivo clinical studies. To ensure that the newly developed product is as effective and safe as the reference product, pharmacological and pharmacokinetic studies are performed.

The clinical trials for biosimilars are a bit different from their biological ones. The two approved infliximab biosimilars, that is, BCD 055 successfully passed the last phase of clinical trials. The Phase III study for CT-P10 is ongoing on patients with rheumatoid arthritis.

Apart from the three approved infliximab biosimilars, many more potential biosimilars are in the last stage of clinical development. The approval of these biosimilars will lead to the infliximab drug market expansion.

A proposed biosimilar of infliximab is in the final stage of clinical trials and under regulatory scrutiny. The invention of new infliximab biosimilars could help deliver better treatments at a lower cost.

These new targeted therapies are likely to attract the attention of major corporations and investors and will have a direct impact on the development of this field. This will enable patient access and accelerate the infliximab drug market in the coming year.

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the infliximab drug market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:

• Zydus Cadila

• Pfizer

• Samsung Bioepis

• Celltrion

• Sandoz

• AbbVie

• Hospira

• Epirus Biopharmaceuticals

• Janssen Biotech, Inc.

• NAPP Pharmaceuticals

• Nippon Kayaku

• Alvogen

Key Highlights of the Report