Last Updated 14 December 2015
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 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, biosimilars of infliximab have launched in Japan and the EU5 countries, 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 tofacitinib (Xeljanz) is mainly prescribed to RA patients failing treatment with biologics, but as rheumatologists gain more experience with the agent’s safety profile, tofacitinib and emerging Jak inhibitors, such as baricitinib, could increasingly be used in earlier lines of therapy. This report offers a detailed analysis and an annualized ten-year forecast of the RA therapy market in the major pharmaceutical markets during the 2014-2024 study period.

Questions Answered in This Report:

  • The TNF-α inhibitors—etanercept (Amgen/Pfizer/Takeda’s Enbrel), infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade), adalimumab (AbbVie/Eisai’s Humira), golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi/Simponi Aria), and certolizumab pegol (UCB/Astellas’s Cimzia—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 anticipated to launch during the forecast period. What will be the impact of the entry of 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, biosimilar versions of the other TNF-α inhibitors—etanercept and adalimumab—are 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: 38 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: Phase II: 15 drugs; Phase III: 5 drugs; coverage of 3 select preclinical? and Phase I products.

Author(s): Ronnie Yoo, Ph.D.
Lade Ayodele, M.B.B.S., M.P.H.
Wouter van der Pluijm, M.P.H.

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