Which of the Blockbuster Drugs on the Autoimmune Drug Market Will Show the Glory that Humira Had?(4)

Rheumatoid Arthritis (RA) Drug

TNFα inhibitors have been occupying most of the rheumatoid arthritis (RA) drug market owing to their quick acting clinically, significant effect in inhibiting bone destruction, and overall good patient tolerance.

However, most anti-TNF drugs need to be used in combination with methotrexate to achieve better efficacy, but some patients are intolerant to methotrexate, resulting in the failure to significantly improve patients’ symptoms.

As anti-IL-6 monoclonal antibodies and JAK inhibitors have achieved clear advantages in the efficacy, patients’ reliance on TNF-α agonists will gradually decrease, and impacts from generic drugs will further compress the market share of anti-TNFα monoclonal antibodies, which is expected to decline to 53% in 2022.

Tocilizumab of Roche approved for marketing in 2010 was first approved to treat adult patients with moderate to severe RA who had poor treatment responses to one or more TNFα agonists, and then has been gradually expanded the indications. In terms of administration, it has extended from the earliest intravenous injection to subcutaneous injection. Its sales reached CHF 1.926 billion in 2017 and are expected to keep good growth before patent expiration.

BMS’ Orencia is a soluble fusion protein that consists of 2 extracellular domains of cytotoxic T-lymphocyte-antigen-4 (CTLA-4) linked to the Fc portion of human IgG1, belongs to T cell inhibitors, and is used for RA patients with inadequate treatment responses to TNFα inhibitors. Its market sales reached USD 2.6 billion in 2017, however, the growth has slowed down in recent two years due to challenges from Pfizer’s Xeljanz.

As the world’s first JAK inhibitor launched by Pfizer, Xeljanz was approved by FDA in November 2012 to treat patients with moderate to severe RA who did not receive good effect or were intolerant after methotrexate treatment. The biggest advantage of Xeljanz is that it can be taken orally, and it has a price advantage, to enable it to have a place on the intensely competitive RA drug market, with 2017 sales reaching USD 1.345 billion. Xeljanz is expected to maintain rapid growth and exceed USD 2 billion, as it was approved for marketing in European region and its extended-release tablets were approved successively in 2017.

The Olumiant (the world’s second JAK inhibitor) of Eli Lilly was approved on February 9, 2017, which was also the first JAK inhibitor that beat Humira in the head-to-head study. It has the potential of becoming a blockbuster drug upon clinical advantages and oral small molecule drug advantage. Its sales reached USD 46 million in 2017, and its market share is expected to further increase as it will be soon marketed in the U.S.

Up-rising Stars on the RA Drug Market

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