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Adalimumab, Infliximab and Etanercept Biosimilars Global Market Report 2021: COVID-19 Growth And Change To 2030

Adalimumab, Infliximab and Etanercept Biosimilars Global Market Report 2021: COVID-19 Growth And Change To 2030

  • September 2021
  • 175 pages
  • ID: 6151690
  • Format: PDF
  • The Business Research Company


Table of Contents

Major players in the adalimumab, infliximab and etanercept biosimilars market are Zydus Cadila, Sandoz (Novartis), Samsung Bioepis, AbbVie, Amgen, Boehringer Ingelheim, Pfizer, Celltrion, and Mylan.

The global adalimumab, infliximab and etanercept biosimilars market is expected to grow from $2.21 billion in 2020 to $3.02 billion in 2021 at a compound annual growth rate (CAGR) of 36.7%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $12.2 billion in 2025 at a CAGR of 42%.

The adalimumab, infliximab and etanercept biosimilars market consists of sales of adalimumab, infliximab and etanercept biosimilar drugs by the companies that manufacture these biosimilars. Adalimumab, infliximab and etanercept biosimilar molecules are bioequivalent to original reference molecules such as Humira, Remicade and Enbrel, respectively.

The adalimumab, infliximab and etanercept biosimilars market covered in this report is segmented by product into adalimumab biosimilars (exemptia, mabura, hyrimoz, hadlima, abrilada, others), infliximab biosimilars (inflectra, renflexis, ixifi, avsola), cipleumab (erelzi, eticovo). It is also segmented by application into crohn’s disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, others and by distribution channel into hospital pharmacies, retail pharmacies, online pharmacies.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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.

In November 2019, Biogen Inc, a US-based multinational biotechnology company based in Cambridge, Massachusetts had acquired Samsung Bioepis Co., Ltd. to get the exclusive powers to market two new ophthalmology biosimilars, SB11 referencing Lucentis 1 and SB15 referencing Eylea 2, in major markets globally, including the U.S., Canada, Europe, Japan, and Australia. The deal provides Biogen an excuse to increase the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars – BENEPALI (etanercept), FLIXABI (infliximab), and IMRALDI (adalimumab) in Europe. Samsung Bioepis is a biopharmaceutical company. It produces biosimilars medicines and other related products.

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 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.

The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

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