Scleroderma (Systemic Sclerosis) – Unmet Need – Detailed, Expanded Analysis (US & EU)

The systemic sclerosis (SSc) pipeline is replete with therapies targeting pathways underlying autoimmunity, inflammation, and fibrosis, particularly in the early phases of development. Currently, patients are managed on an individualized basis, depending on the severity of the patient’s disease and the organs or organ systems involved. Boehringer Ingelheim’s Ofev, which was approved in 2019, is a potent tyrosine kinase inhibitor that slows the rate of decline in pulmonary function in adults with interstitial lung disease (ILD) associated with SSc. Two novel therapies are in late-phase development: Corbus’s CB2 agonist lenabasum and Reata’s bardoxolone methyl (for pulmonary arterial hypertension [PAH]). We will assess the commercial opportunity in SSc through a comprehensive look at the key efficacy, safety, and delivery attributes driving prescribing choices; the gaps in treatment left by current therapies; and the interplay of clinical and nonclinical attributes in determining the appeal of potential SSc products in the patient population.


  • What are the treatment drivers and goals for SSc?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for SSc?
  • What are the prevailing areas of unmet need and opportunity in SSc?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European rheumatologists for a hypothetical new SSc drug?

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 30 European rheumatologists fielded in February 2020

Key companies: Boehringer Ingelheim, Genentech, Roche, Teva

Key drugs: Ofev (nintedanib), Rituxan/MabThera (rituximab), methotrexate, cyclophosphamide, mycophenolate mofetil


  • Target Product Profile (TPP) simulator based on conjoint analysis methodology.
  • Stated versus derived importance of product attributes on prescribing behavior.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet needs in the indication and related indications.
  • Drug development opportunities.


Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

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