미국의 원형 탈모증 시장 : 시장 인사이트, 역학, 시장 예측(2032년)

Key Highlights:

• Alopecia areata is a complex, polygenic, autoimmune disorder characterized by patches of non-scarring alopecia affecting the scalp and body hair that can be psychologically devastating. Alopecia areata is clinically heterogeneous, and the course of the disease is unpredictable, with spontaneous regrowth of hair occurring in 80% of patients within the first year and sudden relapse at any given time. Cases beginning during childhood are more severe than cases with an onset during adulthood.
• Typically, an alopecia areata diagnosis can be made based on the pattern of hair loss and the patient's medical history. In some cases, a biopsy is needed to confirm the diagnosis. Recently, dermoscopy (trichoscopy) has emerged as a helpful supporting tool.
• Treatment options for alopecia areata include topical, locally injected, or systemic steroids, contact immunotherapy, topical minoxidil, topical irritants such as anthralin, and systemic immunosuppressants such as cyclosporine or methotrexate. Current and promising investigational treatments include JAK inhibitors, platelet-rich plasma, recombinant IL-2, hydroxychloroquine, simvastatin with ezetimibe, and excimer laser.
• As per DelveInsight's estimates, the prevalent cases of alopecia areata in the US was found to be ~783,100 cases in 2022, which as per DelveInsight's analysts, is expected to increase by 2032.
• Despite limited evidence for the efficacy of therapeutic agents, intralesional and topical corticosteroids are considered first-line treatment for most patients with patchy alopecia areata. Patients with extensive disease, often defined as greater than 50% scalp hair loss, may be treated with topical immunotherapy. This approach avoids the large number of injections that would be otherwise required when using intralesional corticosteroids.

Report Summary:

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Aloecia Areata market, providing an in-depth examination of its historical and projected market size (2019-2032). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology.
• The report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journeys, and treatment preferences that help shape and drive the United States Alopecia Areata market.

The table given below further depicts the key segments provided in the report:

• Study Period: 2019-2032
• Forecast Period: 2023-2032
• Geographies Covered: United States

Epidemiology Segmented by:

• By Diagnosed Prevalent Cases of Alopecia Areata
• By Age Onset
• By Type-specific
• By Severity-specific
• Comorbidities Associated

Market Segmented by:

• Therapies

Market Analysis * KOL Views

• SWOT Analysis
• Unmet Needs

Market

Various key players currently leading the treatment landscape of Alopecia Areata include Eli Lilly and Company, Incyte Corporation, and Pfizer. Moreover, various key players are investigating their therapeutic candidates in the late phases of clinical development. Concert Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Pfizer, AnaptysBio, Horizon Therapeutics, Bristol Myers Squibb, Suzhou Zelgen Biopharmaceuticals, and Reistone Biopharma. The details of the country-wise and therapy-wise market size have been provided below.

• The market size of alopecia areata in the US was estimated to be around USD 200 million in 2022 and is estimated to increase by 2032 with a significant CAGR.
• Among the emerging and recently launched therapies, in the US, LITFULO is expected to capture the largest market share by 2032, followed by OLUMIANT and CTP-543 (deuruxolitinib).

Market Share 2022 Market Size (in USD million) (%)

• Topical steroids ~40%
• Systemic steroids ~15%
• Non-steroids ~10%
• Immunomodulators ~5%
• Iron Chelating agents ~10%
• OLUMIANT (baricitinib) ~5%
• Deuruxolitinib (CTP-543) ~15%

Alopecia Areata Drug Chapters

The section dedicated to drugs in the Alopecia Areata report provides an in-depth evaluation of marketed therapies and the late-stage pipeline drugs (Phase III and Phase II) related to Alopecia Areata.

The drug chapters section provides valuable information on various aspects related to clinical trials of Alopecia Areata, including specific details, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Alopecia Areata.

Marketed Therapies

OLUMIANT (baricitinib): Eli Lilly and Company/Incyte Corporation

OLUMIANT is an oral, selective, reversible inhibitor of JAK1 and JAK2 that works inside the body by disrupting the cytokine signaling pathway involved in the Alopecia areata by inhibiting the activation of ATPase on JAK and blocks the signal transmission to cells through STATs. Data from the two pivotal Phase III clinical trials showed that patients who received OLUMIANT achieved significant hair regrowth resulting in more scalp coverage and eyebrow and eyelash improvements. The recommended dose of OLUMIANT is 2 mg/day, increasing to 4 mg/day if treatment response is inadequate

LITFULO (ritlecitinib): Pfizer

PF-06651600 (ritlecitinib), a dual inhibitor of the TEC family of tyrosine kinases and JAK3, is an investigational oral once-daily treatment, i.e., the first in a new class of oral highly selective kinase inhibitors. The US FDA has granted BTD to PF-06651600 for the treatment of alopecia areata. Recently, the company has announced positive results from two Phase III studies (ALLEGRO-IIb/III, ALLEGRO-LT). Furthermore, the US FDA and EMA have accepted the New Drug Application (NDA) and Marketing Authorization Application (MAA) for ritlecitinib in alopecia areata

Emerging Therapies

CTP-543 (deuruxolitinib): Concert Pharmaceuticals

CTP-543 (deuruxolitinib), an oral inhibitor of JAK1 and JAK2, is an investigational JAK inhibitor designed to target the immunological basis of alopecia areata. The US FDA has granted BTD and Fast Track Designation (FTD) to CTP-543 for the treatment of alopecia areata. Recently, the company has presented the positive results from two Phase III studies (THRIVE-AA1, THRIVE-AA2) at the 31st European Academy of Dermatology and Venereology (EADV) Congress.

DUPIXENT (dupilumab): Regeneron Pharmaceuticals/Sanofi

Dupilumab is a human monoclonal IgG4 antibody that inhibits IL-4 and IL-13 signaling by binding to the IL-4Ra subunit shared by the IL-4 and IL-13 receptor complexes. It inhibits IL-4 signaling via the type I receptor and IL-4 and IL-13 signaling through the type II receptor. Currently, the drug is being evaluated in Phase II of the clinical trial to treat moderate-to-severe alopecia areata

Etrasimod: Pfizer

Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator developed by Pfizer. The company is evaluating the drug for moderate-to-severe alopecia areata

Therapy Name Company Phase RoA MoA

Rosnilimab AnaptysBio Phase II Subcutaneous Programmed cell death 1 receptor agonist

HZN-7734 (daxdilimab) Horizon Therapeutics Phase II Subcutaneous Dendritic cell inhibitor

SOTYKTU (deucravacitinib) Bristol Myers Squibb Phase II Oral TYK2 kinase inhibitor

Note: Detailed assessment will be provided in the final report of Alopecia Areata)…

Alopecia Areata Market Outlook

Alopecia areata is a common autoimmune skin disease that causes hair loss on the scalp, face, and sometimes on other body areas. It affects people of all ages, both sexes, and all ethnic groups. As per research, Alopecia areata affects 1 in every 500-1,000 people in the United States. It is one of many recognized forms of alopecia; Alopecia areata is the second most common form after androgenetic alopecia. It often appears during childhood and can be different for everyone.

Alopecia areata treatment involves corticosteroids, topical sensitization therapy, topical irritation therapy, and others. Topical corticosteroids possess fewer side effects and are widely used as a first-line treatment for Alopecia areata; available in different formulations, shampoos, and foams, it is generally well-tolerated with patient compliance for Alopecia areata treatment. Intralesional injection of corticosteroids alone or combined with topical corticosteroids is also recommended for patchy Alopecia areata.

Another drug, CTP-543 (Concert pharmaceuticals), an oral inhibitor of JAK1 and JAK2, is an investigational JAK inhibitor designed to target the immunological basis of Alopecia areata. The US FDA has granted BTD and FTD to CTP-543 for Alopecia areata treatment. Recently, the company has announced positive results from two Phase III studies.

The market presents a wide opportunity for these players to capitalize on the untapped market. However, continuous efforts are further needed to develop drugs treating Alopecia areata. Additionally, the goal of the therapy of Alopecia areata is not only to improve clinical symptoms but also to prevent disease progression and ensuing complications, for which both medical and dietary therapy can be useful. Henceforth, the critical area that must be further defined in this field is understanding the pathogenesis of the disease. Since the entire landscape consists of only a single approved drug and off-label therapies, any significant development in this direction is expected to create a tectonic impact on the existing market scenario during the forecast period.

Alopecia Areata Understanding and Treatment

Alopecia Areata Overview

According to the National Alopecia Areata Foundation (NAAF), alopecia areata is a common autoimmune skin disease, causing hair loss on the scalp, face, and sometimes on other areas of the body, affecting people of all ages, both sexes and all ethnic groups can develop alopecia areata. As per research, alopecia areata affects 1 in every 500-1,000 people in the United States. It is one of many recognized forms of alopecia; alopecia areata is the second most common form after androgenetic alopecia. It often first appears during childhood and can be different for everyone who has it.

There are different types of alopecia areata, among which the three main forms include: alopecia areata patchy, alopecia totalis, and alopecia universalis. Persistent patchy alopecia areata, diffuse alopecia areata, and ophiasis alopecia are alopecia areata's other observed clinical variants. Alopecia areata is known as "polygenic disease" due to its genetic predisposition; about 20% of people with alopecia areata have a family history. In alopecia areata, hair loss is mainly due to inflammation caused by an attack of hair follicles by the body's immune system, but the exact cause behind this autoimmune disorder is still unknown.

Alopecia Areata diagnosis

The evaluation of an alopecia areata patient should include a comprehensive medical and family history, and a thorough examination of the scalp, the face, and the entire body, including the nails. This should always be complemented by dermatoscopy and a hair pull test. When clinical findings do not allow a definite diagnosis, additional investigations may be necessary, such as a scalp biopsy, a fungal culture, or serology for other autoimmune diseases or infectious diseases

Further details related to country-based variations are provided in the report…

Alopecia Areata treatment

Current therapies for alopecia areata aim to immunosuppress or immunomodulate the activity of the disease, with generally unsatisfying responses and high relapse rates, especially in more severe cases. Due to the unpredictable course of the disease and the spontaneous remissions often observed within the first year, therapy efficacy is difficult to estimate. Additionally, the available therapeutic options do not influence the long-term course of the disease, and thus an urgent need remains for a novel, more effective therapies. New insights into the pathophysiologic mechanisms in alopecia areata are leading researchers to develop more targeted therapeutic approaches

Topical corticosteroids are widely used in the treatment of limited patchy alopecia areata and as first-line therapy for children because of their low side-effect profile when used discerningly. They are also recommended as adjunctive therapy in more severe forms.

Systemic corticosteroids have been used in the treatment of alopecia areata as oral pulse therapy (PT), intravenous (IV) PT, intramuscularly (IM), or continuously (CT). The reported therapeutic schemes vary between studies.

Further details related to treatment and management are provided in the report…

Alopecia Areata Epidemiology

The Alopecia Areata epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Alopecia Areata, Alopecia Areata Age Onset Cases in the US, Type-specific Cases of Alopecia Areata in the US, Severity-specific Cases of Alopecia Areata in the US and Comorbidities Associated with Alopecia Areata in the US from 2019 to 2032.

• As per DelveInsight's estimates, the prevalent cases of alopecia areata in the US were found to be ~783,100 cases in 2022, which as per DelveInsight's analysts, is expected to increase by 2032.
• The total alopecia areata age onset cases in the US for before 40 and after 40 was found to be ~657,800 cases and ~125,300 cases in 2022 respectively. As per DelveInsight's analysts, these cases are expected to increase by 2032.
• In 2019, there were ~741,600 cases of alopecia areata (patchy), ~16,100 cases of alopecia areata totalis and ~25,500 cases of alopecia areata universalis, which are expected to increase by 2032.

Further details related to epidemiology will be provided in the report…

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Alopecia Areata, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the United States.

Our team of analysts at DelveInsight connected with more than 10 KOLs in the United. We contacted institutions such as the Dermatology and Laser Center, Yale University School of Medicine and others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Alopecia Areata market, which will assist our clients in analyzing the overall epidemiology and market scenario.

The opinion of experts from various regions has been provided below:

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Alopecia Areata one of the most important primary endpoints was the proportion of subjects who have not experienced any severe vaso-occlusive crisis, frequency, and severity of collected adverse events (AEs). Based on these, the overall efficacy is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Alopecia Areata Report Insights

• Patient Population
• Therapeutic Approaches
• Alopecia Areata Market Size and Trends
• Existing Market Opportunity

Alopecia Areata Report Key Strengths

• Ten Year Forecast
• The United States Coverage
• Alopecia Areata Epidemiology Segmentation
• Key Cross Competition

Alopecia Areata Report Assessment

• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis)

Key Questions

• Would there be any changes in the treatment approach that can cater to the needs of old patients, too, as over 50% of Alopecia Areata patients belong to the older age group?
• Will there be any improvements in management recommendations for the pain in Alopecia Areata?
• Would research and development advances pave the way for future tests and therapies for Alopecia Areata?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Alopecia Areata?
• What kind of uptake will the new therapies witness in the coming years in Alopecia Areata patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Alopecia Areata Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Alopecia Areata by therapies in 2019
• 3.2. Market Share (%) Distribution of Alopecia Areata by therapies in 2032

4. Executive Summary of Alopecia Areata

5. Key Events

6. Disease Background and Overview

• 6.1. Introduction
• 6.2. Clinical Manifestation
• 6.3. Risk Factors
• 6.4. Prognosis
• 6.5. Diagnosis
  • 6.5.1. Differential diagnosis
• 6.6. Treatment
  • 6.6.1. Treatment guidelines

7. Epidemiology and Market Methodology

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale
• 8.3. Epidemiology Scenario: The United States
  • 8.3.1. Total Diagnosed Prevalent Cases of Alopecia Areata in the US
  • 8.3.2. Alopecia Areata Age Onset Cases in the US
  • 8.3.3. Type-specific Cases of Alopecia Areata in the US
  • 8.3.4. Severity-specific Cases of Alopecia Areata in the US
  • 8.3.5. Comorbidities Associated with Alopecia Areata in the US

9. Patient Journey

10. Marketed Therapies

• 10.1. OLUMIANT (baricitinib): Eli Lilly and Company/Incyte Corporation
  • 10.1.1. Product Description
  • 10.1.2. Regulatory milestone
  • 10.1.3. Other developmental activities
  • 10.1.4. Clinical Development
  • 10.1.5. Safety and efficacy
• 10.2. LITFULO (ritlecitinib): Pfizer
  • 10.2.1. Product Description
  • 10.2.2. Other developmental activities
  • 10.2.3. Clinical Development
  • 10.2.4. Safety and efficacy

11. Emerging Therapies

• 11.1. Key Cross of emerging therapies
• 11.2. CTP-543 (deuruxolitinib): Concert Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Other developmental activities
  • 11.2.3. Clinical development
  • 11.2.4. Safety and efficacy
• 11.3. DUPIXENT (dupilumab): Regeneron Pharmaceuticals/Sanofi
  • 11.3.1. Product Description
  • 11.3.2. Other developmental activities
  • 11.3.3. Clinical development
  • 11.3.4. Safety and efficacy
• 11.4. Etrasimod: Pfizer
  • 11.4.1. Product Description
  • 11.4.2. Other developmental activities
  • 11.4.3. Clinical development
• 11.5. Rosnilimab: AnaptysBio
  • 11.5.1. Product Description
  • 11.5.2. Other developmental activities
  • 11.5.3. Clinical development
  • 11.5.4. Safety and efficacy
• 11.6. HZN-7734 (daxdilimab): Horizon Therapeutics
  • 11.6.1. Product Description
  • 11.6.2. Clinical development
• 11.7. SOTYKTU (deucravacitinib): Bristol Myers Squibb
  • 11.7.1. Product Description
  • 11.7.2. Clinical development
• 11.8. ORENCIA (abatacept): Bristol Myers Squibb (BMS)
  • 11.8.1. Product Description
  • 11.8.2. Other developmental activities
  • 11.8.3. Clinical development
  • 11.8.4. Safety and efficacy
• 11.9. Jaktinib: Suzhou Zelgen Biopharmaceuticals
  • 11.9.1. Product Description
  • 11.9.2. Clinical development
• 11.10. SHR0302 (ivarmacitinib): Reistone Biopharma
  • 11.10.1. Product Description
  • 11.10.2. Other developmental activities
  • 11.10.3. Clinical development
  • 11.10.4. Safety and efficacy
• 11.11. SHR0302 (ivarmacitinib): Reistone Biopharma
  • 11.11.1. Product Description
  • 11.11.2. Other developmental activities
  • 11.11.3. Clinical development
  • 11.11.4. Safety and efficacy

12. Alopecia areata: The US Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Attribute Analysis
• 12.4. Key Market Forecast Assumptions
• 12.5. United States Market Size
  • 12.5.1. Total market size of Alopecia Areata in the US
  • 12.5.2. Market size of Alopecia Areata by therapies in the US

13. KOL Views

14. SWOT

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
  • 16.1.2. Patient access program and copay

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer