Alopecia areata (AA) is an inflammatory autoimmune skin disease characterized by varying degrees of hair loss due to the targeting of anagen hair follicles by the host immune system. The primary goal of treatment is to stimulate hair growth through the alleviation of inflammation at sites of hair loss. Topical corticosteroids and topical contact allergens are commonly prescribed; however, tolerability issues, side effects, and the modest efficacy of these treatments underscore the substantial unmet clinical need in AA. The drug development pipeline is active and consists primarily of targeted immunomodulatory agents, with some investigational Janus-activated kinase (JAK) inhibitors (e.g., Pfizer’s ritlecitinib, Concert’s CTP-543) and one recently approved JAK inhibitor (Eli Lilly’s Olumiant [baricitinib]). This report provides an analysis of AA epidemiology, current disease management, unmet needs, and the clinical and commercial potential of emerging therapies.
QUESTIONS ANSWERED
How large is the diagnosed AA population, and how will its size change between 2021 and 2031? How large are the diagnosed alopecia totalis and universalis populations?
What are the key unmet clinical needs in AA and to what degree will they be fulfilled by 2031?
What is the current state of treatment in AA, and how will it evolve over time?
What emerging AA therapies are viewed by treating dermatologists as most promising, and what sales / uptake will they achieve in AA? How will JAK inhibitors fit into the AA treatment algorithm?
CONTENT HIGHLIGHTS
Geographies: United States, France, Germany, Italy, Spain, and the United Kingdom.
Primary research: Six country-specific interviews with thought-leading dermatologists supported by survey data collected for this study.
Epidemiology: Diagnosed and drug-treated prevalence of AA by country.
Forecast: Drug-level sales and patient share of key AA therapies in 2031.
Emerging therapies:
Phase II/III: 4 drugs.
Phase II: 7 drugs.
Coverage of select preclinical and Phase I products.
PRODUCT DESCRIPTION
Niche & Rare Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Regional sales of key therapies to treat alopecia: 2031
Alopecia areata SWOT analysis
Drivers and constraints
What factors are driving sales in alopecia areata?
What factors are constraining sales in alopecia areata?
Drug-class-specific trends
JAK inhibitors
Alternative market scenarios
Alternative market scenarios
Alternative scenarios for the alopecia market through 2031
Forecast
Sales of key therapies in alopecia
Etiology and pathophysiology
Disease overview
Key genetic susceptibility loci in alopecia areata
Key pathways and drug targets
Epidemiology
Key findings
Epidemiology populations
Disease definition, methods, and sources used
Diagnosed incident cases of alopecia areata: 2021-2031
Disease definition, methods, and sources used
Diagnosed incident cases of alopecia areata by severity: 2021-2031
Disease definition, methods, and sources used
Diagnosed lifetime prevalent cases of alopecia areata: 2021-2031
Drug-treated prevalent cases of alopecia areata: 2021-2031
Current Treatment
Key findings
Diagnosis
Treatment providers and referral patterns
Treatment goals
Key endpoints used in clinical trials for alopecia
Key current therapies
Overview
Mechanism of action of key current drug classes used for alopecia areata
Current treatments used for alopecia areata
Market events impacting the use of key current therapies in alopecia areata
Nonsteroidal topical agents
Clinical trial outcomes for nonsteroidal topical agents
Advantages and disadvantages of nonsteroidal topical agents
Corticosteroids
Clinical trial outcomes for corticosteroids
Advantages and disadvantages of corticosteroids
Topical / contact immunotherapy
Clinical trial outcomes for contact immunotherapy agents
Advantages and disadvantages of contact immunotherapy agents
Conventional immunosuppressants
Clinical trial outcomes for conventional immunosuppressants
Advantages and disadvantages of conventional immunosuppressants
Advantages and disadvantages of JAK inhibitors
Medical practice
Overview
Treatment guidelines
Generalized treatment decision tree for adult alopecia areata
Generalized treatment decision tree for adolescent alopecia areata
Generalized treatment decision tree for pediatric alopecia areata
Unmet need overview
Current and future attainment of unmet needs in alopecia areata
Top unmet needs in alopecia areata: current and future attainment
Expert insight: unmet need in alopecia areata
Drug pipeline
Pipeline
Regulatory Milestones
Indication Comparison
Emerging therapies
Key findings
Key emerging therapies
Notable developments among key emerging therapies for alopecia areata
Key therapies in development for alopecia areata
Estimated launch dates of key emerging therapies for the treatment of alopecia areata
CTP-543 profile
Key ongoing clinical trials of CTP-543 in the treatment of alopecia areata
Analysis of the clinical development program for CTP-543
Expert insight: CTP-543
Expectations for launch and sales opportunity of CTP-543 in alopecia areata
Ritlecitinib profile
Key ongoing clinical trials of ritlecitinib in the treatment of alopecia areata
Analysis of the clinical development program for ritlecitinib
Expert insight: ritlecitinib
Expectations for launch and sales opportunity of ritlecitinib in alopecia areata
Brepocitinib profile
Analysis of the clinical development program for brepocitinib
Expert insight: brepocitinib
Expectations for launch and sales opportunity of brepocitinib in alopecia areata
Botanical drugs
Key results from clinical trials of LH-8 / Coacillium in alopecia areata-related indications
Key ongoing clinical trials of LH-8 / Coacillium in the treatment of alopecia areata
Analysis of the clinical development program for LH-8 / Coacillium
Expert insight: LH-8 / Coacillium
Expectations for launch and sales opportunity of LH-8 / Coacillium in alopecia areata
Early-phase pipeline analysis
Notable developments in the early-phase pipeline for alopecia areata
Select compounds in early-phase development for alopecia areata
Key discontinuations and failures in alopecia
Key discontinuations and failures
Patient registries
Patient registries for alopecia
Access & reimbursement overview
Region-specific reimbursement practices
Key market access considerations in alopecia areata: United States
General reimbursement environment: United States
Key market access considerations in alopecia areata: EU5
General reimbursement environment: EU5
Appendix
Alopecia areata bibliography
Abbreviations
Naomi Lopez Caraballo
Naomi López Caraballo, Ph.D., Healthcare Research & Data Analyst, Infectious, Niche, and Rare Diseases. Dr. López Caraballo is a healthcare research and data analyst for the rare disorders therapy market. She holds a Ph.D. in neuroscience and physiology from the New York University School of Medicine and a B.S. in industrial biotechnology from the University of Puerto Rico in Mayaguez.
Bethany A. Kiernan, Ph.D.
Bethany A. Kiernan, Ph.D., Director, Healthcare Research & Data Analytics, Infectious, Niche, and Rare Diseases. Dr. Kiernan manages and supports a team of analysts and managers producing both syndicated and custom market research analyses in a range of niche / rare indications as well as infectious diseases. Dr. Kiernan has extensive experience in market forecasting and broad knowledge across a range of CNS disorders, rare diseases, and infectious diseases. Her previous experience includes eight years of scientific research conducted at Tufts University School of Medicine, Case Western Reserve University, and the College of the Holy Cross. She earned her doctorate in neurosciences from Case Western Reserve University.
Naorem Subhadra Devi
Naorem Subhadra Devi, M.P.H., Epidemiologist, Epidemiology. Ms. Devi holds a master’s degree in public health with epidemiology as a specialization from Manipal Academy of Higher Education. She also completed a bachelor’s degree in naturopathy and yogic sciences from SVYASA University in Bangalore, India. Her area of interests are lifestyle-related disorders and psychiatry.
Preeti Attri
Preeti Attri, M.Sc., Ph.D., is an associate analyst on the Infectious, Niche, and Rare Diseases team. Prior to joining Clarivate, she was a business analyst at Smart Analyst (India) Private Limited. She has experience in market assessment, competitive intelligence, primary market research, market forecasting, analogue and indication assessment, disease portfolio optimization, and database research. She received her Ph.D. in cancer epigenetics from the National Institute of Immunology in New Delhi.
Shilpa Verma
Shilpa Verma, B.Pharm., Manager, Healthcare Research & Data Analytics, Infectious, Niche, and Rare Diseases. She has more than 11 years of work experience in competitive intelligence and medical affairs. Her expertise is in infectious diseases and immuno-inflammatory diseases. She received her bachelor’s degree in pharmacy from the Indian Institute of Technology at Banaras Hindu University. She also has a postgraduate degree in business management from the Narsee Monjee Institute of Management Studies.
Prior to joining Clarivate, Ms. Verma worked for WNS and Evalueserve, where her clients included leading pharmaceutical companies. She is also an expert in HIV. She did her internship at AstraZeneca and has experience working in the quality control department.