The rheumatoid arthritis (RA) market is mature—there are many drug options available and all of them work relatively well. However, even though patients may have an abundance of choices, there is still a great deal of room for the treatment of RA to improve. The unmet needs for RA include: earlier diagnosis and treatment, need for cost-effective therapies, personalised treatment strategies, improved guidance on treating RA patients in remission, and new treatment options for patients with refractory disease.

RA is very treatable for the majority of patients, however, there are risks with delayed diagnosis and delay in treatment, which could lead to irreversible joint damage. However, RA is managed by a rheumatologist and referral is often not quick enough or such specialists are not readily available to patients in rural areas. In the future, it is hoped that patients could be identified in the earliest and even pre-clinical stages of RA. Another reason that patients may not have great access to treatment is the lack of cost-effective therapies. Biologics form the mainstay of treatment but are priced between $21,000 and $73,000 per year in the US, and small molecule Janus kinase (JAK) inhibitors were new arrivals less than a decade ago and are priced similarly. While many stakeholders had hoped that biosimilars would change the field, these drugs remain a high-cost treatment and are only listed at a 20%–30% discount to originators. Therefore, there are high hopes for generics within the JAK inhibitor class, the first of which is likely to be for tofacitinib upon patent expiry of Pfizer’s Xeljanz (tofacitinib) between 2025 and 2028 throughout the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan).

With a wealth of options to treat RA, there are a few important clinical unmet needs relating to situations in which the best treatment regimen is less clear. Specifically, while oncology has entered the realm of precision medicine, rheumatology is lagging behind. Key opinion leaders (KOLs) interviewed by GlobalData revealed that this wish-list item would allow them to improve patient treatment by directing the right patient to the right therapy, without the need for trial-and-error. In addition, there are two groups of patients with higher need, those who achieve remission and those with refractory disease, despite treatment. For patients with sustained remission, the ultimate goal would be to taper treatment down to a minimal maintenance dose, or to remove treatment altogether. However, more research is needed to determine whether this would be possible, and if so, what type of monitoring would be necessary. This would benefit patients as RA treatments are typically immunosuppressive, which come with higher risks for infection, among other safety signals. Finally, the highest needs are within the refractory population, as a small percentage of patients have cycled through multiple drug classes, but active disease remains. These patients are at the highest risk for irreversible joint damage and may ultimately require joint replacement.

Important unmet needs for RA are summarised in Figure 1 and are rated according to their level of attainment in the current and future RA market (1 = low attainment and 5 = high attainment). Each unmet need is also ranked by level of importance (High, Moderate, or Low) and includes a gap analysis of drugs or initiatives that are poised to meet the need over the next decade.

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