Market Spotlight: Axial Spondyloarthritis (axSpA)
This Market Spotlight report covers the Axial Spondyloarthritis (axSpA) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
Datamonitor Healthcare estimates that in 2018, there were 5.9 million prevalent cases of ankylosing spondylitis in adults aged 20 years and older worldwide, and forecasts that number to increase to 6.4 million prevalent cases by 2027.
The approved drugs in the axial spondyloarthritis (axSpA) space target tumor necrosis factor-alpha, prostaglandin E receptor 1, prostaglandin E receptor 2, interleukin 17, IL-17 receptor, and JAK/STAT. These are commonly administered via the subcutaneous route, with the remainder being intravenous, oral, and percutaneous catheter/injection formulations.
The greatest proportion of industry-sponsored drugs in active clinical development for axSpA are in the NDA/BLA phase. Therapies in development for axSpA focus on targets such as JAK/STAT, interleukin 17, and granulocyte-macrophage colonystimulating factor. These drugs are administered via the oral, intravenous, subcutaneous, and topical routes.
High-impact upcoming events in the axSpA space comprise topline Phase III trial results for bimekizumab, Cosentyx, and Rinvoq; and expected PDUFA dates for Rinvoq and Xeljanz/Xeljanz XR.
The overall likelihood of approval of a Phase I arthritis asset is 8.4%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.2 years in the overall autoimmune/immunology space.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for ankylosing spondylitis have been in the late phases of development, with 82% of trials in Phase III-IV, and only 18% in Phase I-II.
Germany has a significant lead in the number of ankylosing spondylitis clinical trials globally, while South Korea has the top spot in Asia.
Clinical trial activity in the ankylosing spondylitis space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for ankylosing spondylitis, with 28 trials.
Pfizer leads industry sponsors with the highest overall number of clinical trials for ankylosing spondylitis, followed by AbbVie