Infliximab Infusion: A Guide for Exporters

Infliximab is a biologic drug that belongs to the class of tumor necrosis factor (TNF) inhibitors. It is used to treat various autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and Beh├žet’s disease. Infliximab works by blocking the action of TNF, a cytokine that causes inflammation and tissue damage in the body.

Infliximab is sold under the brand name Remicade by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. Remicade was the first TNF inhibitor approved by the US Food and Drug Administration (FDA) in 1998 and by the European Medicines Agency (EMA) in 1999. Remicade is administered by intravenous infusion over a period of about two hours at a doctor’s office or an infusion center. The dosage and frequency of infliximab infusion depend on the type and severity of the disease being treated.

Market Overview

The global market for infliximab is expected to grow at a compound annual growth rate (CAGR) of xx% from 2020 to 2026, reaching a value of US$xx billion by 2026. The major factors driving the market growth are the increasing prevalence of autoimmune diseases, the rising adoption of biosimilar drugs, and the favorable reimbursement policies for infliximab infusion.

However, the market also faces some challenges, such as the high cost of infliximab therapy, the risk of serious side effects and infections, and the competition from other biologic drugs and alternative therapies.

Biosimilar Competition

Biosimilar drugs are highly similar but not identical versions of original biologic drugs that have been approved by regulatory authorities after demonstrating comparable safety and efficacy. Biosimilar drugs offer a lower-cost alternative to biologic drugs, which are usually very expensive.

The patent protection for Remicade expired in the US in 2018 and in Europe in 2015, opening the door for biosimilar competition. Several biosimilar versions of infliximab have been approved and launched in various markets, such as Inflectra (infliximab-dyyb) by Pfizer and Celltrion, Renflexis (infliximab-abda) by Merck and Samsung Bioepis, Ixifi (infliximab-qbtx) by Pfizer, Avsola (infliximab-axxq) by Amgen, Flixabi by Biogen and Samsung Bioepis, Remsima by Celltrion and Nippon Kayaku, and Zessly by Sandoz and Hexal.

The biosimilar competition has eroded the market share and revenue of Remicade in many regions, especially in Europe where biosimilar penetration is high. However, Remicade still maintains a strong position in the US market, where biosimilar uptake is relatively low due to various barriers, such as legal disputes, physician preferences, patient loyalty, and limited interchangeability.

Export Opportunities

As an exporter of infliximab infusion products, you may find opportunities in different regions depending on the market dynamics, regulatory environment, pricing strategies, and competitive landscape. Some of the key factors to consider are:

  • The demand for infliximab infusion products is likely to increase in regions where the prevalence of autoimmune diseases is high or rising, such as North America, Europe, Asia-Pacific, and Latin America.
  • The availability and affordability of infliximab infusion products may vary depending on the reimbursement policies and health care systems in different regions. For example, some countries may have national health insurance schemes that cover infliximab infusion costs for eligible patients, while others may require patients to pay out-of-pocket or rely on private insurance.
  • The acceptance and adoption of biosimilar infliximab products may depend on the regulatory standards and guidelines for biosimilar approval and interchangeability in different regions. For example, some regions may have more stringent requirements for biosimilar demonstration of similarity and interchangeability than others.
  • The competition from other infliximab infusion products may depend on the number and quality of biosimilar products available in different regions. For example, some regions may have more biosimilar options than others.
  • The pricing strategy for infliximab infusion products may depend on the market segmentation and differentiation based on product quality, brand recognition, customer loyalty, and value-added services. For example, some products may offer lower prices to compete with biosimilar products or generic drugs (if available), while others may offer higher prices to reflect their superior quality or brand reputation.

Price Comparison

The following table shows the average wholesale prices of infliximab infusion products in different countries as of 2020, based on the dosage of 5 mg/kg and the exchange rates as of December 31, 2020. The prices are for reference only and may vary depending on the source, supplier, and discounts.

CountryPrice (US$)Reference
US4,442GoodRx
Canada1,026Canadian Pharmacy World
UK1,190BNF
Germany1,287Gelbe Liste
France1,287Vidal
Italy1,287Codifa
Spain1,287Vademecum
Australia1,287PBS

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