Adalimumab, Infliximab and Etanercept Biosimilars Global Market to Reach $18.61 Billion by 2026 at a 40.6% CAGR

2022-11-29

上市批准专利到期生物类似药

DUBLIN, Nov. 29, 2022 /PRNewswire/ -- The "Adalimumab, Infliximab and Etanercept Biosimilars Global Market Report 2022: By Product, By Application, By Distribution" report has been added to

ResearchAndMarkets.com's offering.

The global adalimumab, infliximab and etanercept biosimilars market is expected to grow from $3.10 billion in 2021 to $4.76 billion in 2022 at a compound annual growth rate (CAGR) of 53.4%. The market is expected to reach $18.61 billion in 2026 at a CAGR of 40.6%.

The main types of products in adalimumab, infliximab and etanercept biosimilars are adalimumab biosimilars (exemptia, mabura, hyrimoz, hadlima, abrilada, others), infliximab biosimilars (inflectra, renflexis, ixifi, avsola) and cipleumab (erelzi, eticovo). Adalimumab is a biological drug that works on the immune system to lessen inflammation. The different applications include crohn's disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, others and is distributed through various channels such as hospital pharmacies, retail pharmacies, online pharmacies.

The patent expiry of branded drugs allows biosimilars to enter the market. For instance, In United States FDA approved inflectra, developed by Hospira (a Pfizer Inc company) for the treatment of various autoimmune diseases such as rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, after the patent expiry of branded drug Remicade.

Similarly, Amgen's Enbrel had its patent expired in the EU and with the expiry of the patent, Benepali (a biosimilar of Enmbrel) was approved by the European Commission. Humira's patent expired and its biosimilars were made available in the market. FDA has recently (July 2020) approved Hulio, the sixth biosimilar of Humira. Therefore, the patent expiry of branded biologic drugs such as Humira, Enbrel and Remicade will drive the biosimilar market.

The patent extension of Humira (adalimumab) will hamper the Humira biosimilar market. The patent extension is a strategy to compete with generic and biosimilar products after patent termination. For instance, the patents of Humira, the branded biologic drug manufactured by AbbVie, in the US and EU.

AbbVie obtained Supplementary Protection Certificates (SPCs) that provided protection in Europe. AbbVie received a patent extension for Humira till 2023 in the US. In pursuit of patent extension, AbbVie also had settlements with Amgen, Samsung Bioepis, and Mylan to protect Humira sales in the United States. The patent extension of Humira is anticipated to hinder its biosimilars market growth.

The brand versions of biosimilar drugs are of high costs, which are now being replaced with biosimilar versions upon their patent's expiry. The cost of branded biologic drugs almost doubled in recent years. For instance, the cost of Humira, the top-selling drug, increased to more than $72,000 in 2020.

The shift to low-cost biosimilar drugs is mainly because there are no clinically relevant differences in safety and efficacy between the biosimilars and originator biologics. The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication.

Scope

Markets Covered:

1) By Product: Adalimumab Biosimilars (Exemptia, Mabura, Hyrimoz, Hadlima, Abrilada, Others); Infliximab Biosimilars (Inflectra, Renflexis, Ixifi, Avsola); Cipleumab (Erelzi, Eticovo)