Rheumatoid Arthritis | Disease Landscape and Forecast | G7 | 2016

The rheumatoid arthritis (RA) therapy market has matured to the point that TNF-α inhibitors have become firmly established as first-line biological agents, leaving non-TNF-α inhibitor agents to largely compete for use in TNF-refractory patients. For emerging agents, the barrier to entry is high in the absence of clear advantages over marketed therapies. Moreover, biosimilar erosion has begun with the launch of biosimilar infliximab in 2015 (Japan/EU5) and biosimilar etanercept in 2016 (EU5), and biosimilars of other market-leading biologics will launch for RA over the next few years. Thus, competition in the RA market is becoming increasingly fierce. However, market opportunity remains for alternative biologics and oral compounds; in particular, oral Jak inhibitors could have a substantial impact on the current treatment algorithm for RA. Pfizer/Takeda’s Jak inhibitor Xeljanz is mainly prescribed to RA patients failing treatment with biologics, but as rheumatologists gain more experience with the agent’s safety profile, Xeljanz and the emerging Jak inhibitor baricitinib, which demonstrated robust efficacy data in clinical trials, could increasingly be used in earlier lines of therapy. This content offers a detailed analysis and an annualized ten-year forecast of the RA therapy market in the major pharmaceutical markets during the 2015-2025 study period.

Questions Answered:

  • The TNF-α inhibitors—etanercept (Amgen/Pfizer/Takeda’s Enbrel, biosimilars), infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade, biosimilars), Humira (AbbVie/Eisai), Simponi/Simponi Aria (Janssen/Merck/Mitsubishi Tanabe), and Cimzia (UCB/Astellas)—are entrenched as first-line biologics in RA. What are key opinion leaders’ perceptions of the advantages and disadvantages of these drugs? What factors influence the prescription of one TNF-α inhibitor over another?
  • In patients with inadequate responses to TNF-α inhibitors, the competition among non-TNF-α inhibitors is fierce and expected to intensify with the entry of emerging therapies. What are key opinion leaders’ perceptions of the currently marketed non-TNF-α inhibitor biologics and novel oral kinase inhibitors, and where do these agents fit in their current treatment approach? Which emerging agents are likely to be most successful in targeting the TNF-refractory patient segment and gaining uptake in the RA market?
  • Additional oral Jak inhibitors (e.g., Eli Lilly/Incyte’s baricitinib, AbbVie’s ABT-494, Galapagos’s filgotinib) are expected to launch during the forecast period. What will be the impact of the entry of additional novel oral therapies on the treatment algorithm for RA? In which patient segments and lines of treatment will these oral therapies most likely be used? What is this drug class’s market potential in RA?
  • Following the launch of biosimilar infliximab in Japan and Europe and biosimilar etanercept in Europe, biosimilar versions of adalimumab are also expected to enter the RA market during the first few years of the forecast period. Biosimilars of the non-TNF-α inhibitors abatacept, rituximab, and tocilizumab are also anticipated to launch during this time. How will the entry of biosimilars affect the market sales and patient share of currently marketed RA agents and the entry of emerging therapies?


Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 39 country-specific interviews with thought leaders.

Epidemiology: Number of total, diagnosed, and drug-treated prevalent cases of RA; number of diagnosed prevalent cases of RA by severity.

Emerging therapies: Preregistered: 4 drugs; Phase III: 4 drugs; Phase II: 13 drugs; coverage of 2 select preclinical and Phase I products.


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