MarketVue® Report
Idiopathic Inflammatory Myopathies (U.S.), 2023

Syndicated market assessment report driven by primary market research

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Idiopathic Inflammatory Myopathies (U.S.), January 2023

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The MarketVue®: Idiopathic inflammatory myopathies market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
 
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
 
Topics covered in this report:
  • Disease overview: Review the disease pathophysiology and potential druggable targets
  • Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
  • Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
  • Unmet needs: Identify opportunities to address treatment or disease management gaps
  • Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
  • Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
 
Methodology:
Research for the MarketVue®: Idiopathic inflammatory myopathies report is supported by 5 qualitative interviews with key opinion leaders, a quantitative survey with 26 U.S. physicians and secondary research.
 
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
 
Key companies mentioned:
  • Priovant
  • CSL Behring
  • Janssen
  • argenx
  • Alexion/AstraZeneca
  • Pfizer
  • Horizon Therapeutics
  • Paean Biotechnology
  • EMD Serono
 
Key drugs mentioned:
  • IVIg (Octagam)
  • Rituximab
  • Azathioprine
  • Methotrexate
  • Mycophenolate mofetil
  • Tofacitinib (Xeljanz)
  • Etanercept (Enbrel)
  • Adalimumab (Humira)
  • Brepocitinib
  • IgPro20
  • Nipocalimab
  • Efgartigimod (Vyvgart)
  • Ravulizumab (Ultomiris)
  • Zilucoplan (Zilbrysq)
  • PF-06823859
  • Daxdilimab
  • PN-101
  • M5049
1. DISEASE OVERVIEW
A heterogenous group of chronic, autoimmune disorders marked by inflammation and weakness of the skeletal muscle
Figure 1.1. Immune system involvement and druggable therapeutic targets in IIM
There are no standardized classification criteria for IIMs
Figure 1.2. Clinical manifestations in the IIM sub-types
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Diagnosed prevalent cases of DM, ASyS, and IMNM by region
Table 2.1. Diagnosed prevalent and drug-treated patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Referral and diagnostic pathway for IIM patients
Autoantibody testing is useful in predicting the severity and disease course of IIM patients
Table 3.1. Clinical presentation of IIM subtypes and associated antibodies
All IIM patients need to be on drug therapy during the course of their disease
Table 3.2. Treatment goals for DM, ASyS, and IMNM patients
Figure 3.2. Physician-reported percentage of IIM patients receiving some form of drug therapy
Treatment flow for DM, ASyS, and IMNM
Immune suppression is the current backbone of IIM treatment
Figure 3.3. Current treatment share for DM, IMNM, and ASyS patients
Figure 3.4. Physician-reported rating of current therapy effectiveness in DM, IMNM, and ASyS
Upsides and downsides of current IIM treatments
Physicians’ perspectives on current treatment use in DM, ASyS, and IMNM
Octagam 10% is the only FDA-approved treatment for DM; there are no approved therapies for other subtypes
Table 3.3. Summary of the PRODERM trial results
IIMs are characterized by frequent occurrences of remission and relapse
Key treatment dynamics that will shape disease management and drug use in DM, ASyS, and IMNM
Figure 3.5. Important dynamics of IIM market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in DM, IMNM, and ASyS
Figure 4.2. Physician-reported unmet needs in DM, IMNM, and ASyS
There is a high unmet need for FDA-approved treatments with fewer insurance barriers
Figure 4.3. Neurologist-reported proportion of DM, IMNM, and ASyS who are not well-managed with current therapy options
Figure 4.4. Physician-reported proportion of DM, IMNM, and ASyS patients who encounter these barriers to receiving drug therapy
Physician perspectives on unmet needs in the diagnosis and treatment of IIM
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Percentage of rheumatologists and neurologists (n=26) rating target as “promising” for DM, IMNM, and ASyS (score of 6 or 7)
The pipeline for IIM is limited with three treatments in Phase 2/3 clinical development
Table 5.1. Comparison of ongoing Phase 3 and Phase 2/3 trials of therapies for IIM
The pipeline for DM is active; currently there are no industry-funded Phase 1 trials for IIM
Table 5.2. Comparison of ongoing Phase 2 therapies for IIM
Physician perspectives on novel, upcoming therapies are largely positive
6. VALUE & ACCESS
Overview
Table 6.1. Current IIM therapy pricing, U.S.
Table 6.2. Typical U.S. commercial payer coverage of Octagam 10%
Key market access dynamics that will continue to shape treatment use
Table 6.1. IIM patients by insurance type
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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