Psoriatic arthritis (PsA) is a disease hallmarked by psoriatic skin lesions and erosive joint damage that remains poorly understood, underdiagnosed, and undertreated. Nevertheless, tumor necrosis-alpha (TNF-α) inhibitors have revolutionized treatment of the disease and expanded the PsA therapy market to a multibillion-dollar entity. Several novel therapies with alternative mechanisms of action are expected to launch for PsA during the 2013-2023 study period, and thought-leading physicians describe a dynamic patient-management environment with a growing need for additional novel therapies.
The recent launches of the interleukin-12/-23 (IL-12/23) inhibitor ustekinumab (Janssen’s Stelara) and the oral phosphodiesterase-4 (PDE-4) inhibitor apremilast (Celgene’s Otezla) have heralded the post-TNF-α inhibitor era in the PsA market. In this report, we analyze physician perception and anticipated positioning of these agents and the implications for the market-leading TNF-α inhibitor class.
Questions Answered in This Report:
- Etanercept (Amgen/Pfizer/Takeda’s Enbrel), infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade), and adalimumab (AbbVie/Eisai’s Humira) are the established agents in the TNF-α inhibitor drug class and contributed the majority of sales in the DMARD-treated PsA market in 2013. What are key opinion leaders’ perception of the comparative clinical advantages and disadvantages of these agents? Have golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi) and certolizumab pegol (UCB/Astellas’s Cimzia) been able to infiltrate early lines of biological therapy and weaken the dominance of the established agents? How have third-party payer restrictions affected TNF-α inhibitors’ move into earlier stages of the PsA treatment algorithm?
- Lower-cost biosimilar formulations of several biologics will launch beginning in 2015 and will erode biologics’ sales through 2023. Are rheumatologists and dermatologists comfortable prescribing biosimilars for PsA if those products are approved based on data in other indications? How fast will uptake of biosimilars be in the PsA market? Which agents will suffer the greatest erosion in sales?
- The PsA market has been dominated by genericized conventional agents that have only low to modest efficacy and the highly effective, premium-priced TNF-α inhibitors. In which PsA segments have recently launched non-TNF-α inhibitors ustekinumab (Janssen’s Stelara) and apremilast (Celgene’s Otezla) found the greatest uptake? What are the commercial and patient-share potentials for the emerging IL-17 inhibitors, JAK inhibitors, and selective costimulation modulators?
- PsA is a market characterized by relatively modest sales and population size. What events will influence the indication’s diagnosis and drug treatment during our forecast period? Will novel PsA agents expand the market or cannibalize share from current therapies?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 19 country-specific interviews with rheumatologists and dermatologists.
Epidemiology: The number of total, diagnosed, and drug-treated prevalent cases of PsA; the number of diagnosed prevalent cases of PsA by joint involvement.
Emerging therapies: Phase II: 2 drugs; Phase III: 5 drugs; preregistration: 1 drug.
Market forecast features: We forecast population sizes and drug sales of conventional and biological disease-modifying drugs to treat PsA from 2013 through 2023.
Courtney Walls, M.P.H.