Alopecia Areata - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 1.7 million diagnosed prevalent cases of alopecia areata in the 7MM. Of these, the United States accounted for 35% of the cases, while EU4 and the UK accounted for nearly 49% and Japan represented 16% of the cases, respectively.
• The alopecia areata market is poised for steady growth, with a strong compound annual growth rate (CAGR) projected from 2024 to 2034. This expansion across the 7MM will be driven by the launch of innovative therapies, including RINVOQ (upadacitinib), coacillium (LH-8), bempikibart, Rezpegaldesleukin (NKTR-358), among others.
• According to DelveInsight's analysis, the alopecia market in the 7MM was valued at approximately USD 379 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 21.2%.
• Eli Lilly and Company, Incyte Corporation, Pfizer, and Sun Pharmaceuticals have been leading players in the alopecia market, offering approved treatments like OLUMIANT in the (US, EU, and Japan), LITFULO in the (US, EU, and Japan), and LEQSELVI in the US.
• The demand for safer and more effective treatments creates opportunities to develop innovative therapies that achieve remission without requiring long-term use or carrying risks such as black box warnings.
• The emergence of new therapies in development could intensify competition, potentially diminishing the market share of established treatments such as LITFULO and OLUMIANT as more options become available to address the needs of patients and healthcare providers.

DelveInsight's "Alopecia Areata - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of alopecia areata, historical and forecasted epidemiology, as well as the alopecia areata market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The alopecia areata market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM alopecia areata market size from 2020 to 2034. The report also covers alopecia areata treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Alopecia Areata Understanding and Treatment Algorithm

Alopecia Areata overview

Alopecia areata is a prevalent autoimmune skin disorder that leads to hair loss on the scalp, face, and occasionally other parts of the body. It affects individuals of all ages, genders, and ethnic backgrounds, making it a widely inclusive condition in terms of its impact.

Alopecia areata has various forms, with the primary types being patchy alopecia areata, alopecia totalis, and alopecia universalis. Other clinical variants include persistent patchy, diffuse, and ophiasis alopecia areata. It is considered a "polygenic disease" due to its genetic predisposition and multifactorial inheritance pattern.

Alopecia areata is an autoimmune condition that targets hair follicles, causing sudden hair loss, often in small patches that can expand into larger bald areas. Hair loss may also affect other areas, such as eyelashes, eyebrows, or the beard (in men), typically occurring without accompanying redness, rashes, or scarring on the affected skin.

Alopecia areata is caused by various risk factors, including nutritional deficiencies, systemic illnesses like autoimmune or thyroid disorders, and stress, which disrupts immune function. Genetic predisposition, environmental triggers such as infections or allergens, and certain medications can also contribute, with family history often increasing susceptibility to the condition.

Alopecia Areata diagnosis

Alopecia areata's differential diagnosis includes non-scarring hair loss conditions like tinea capitis, trichotillomania, and telogen effluvium. Comorbidities may include autoimmune diseases, atopic conditions, and psychiatric disorders, with age influencing prevalence. Screening involves tests like hair pull, trichogram, dermatoscopy, and biopsy to assess symptoms and clinical signs.

Alopecia Areata treatment

Alopecia areata treatments range from mild options like topical corticosteroids to systemic corticosteroids for severe cases. Other therapies include topical immunotherapy, methotrexate, cyclosporine, OX40L, and JAK inhibitors. Adjuncts like minoxidil, vitamin D, and zinc offer variable results, while phototherapy and platelet-rich plasma show limited success with relapses.

Alopecia Areata Epidemiology

As the market is derived using a patient-based model, the alopecia areata epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Prevalent Cases of Alopecia Areata, Diagnosed Prevalent Cases of Alopecia Areata, Gender-specific Diagnosed Prevalent Cases of Alopecia Areata, Age Onset-based Diagnosed Prevalent Cases of Alopecia Areata, and Severity-specific Diagnosed Prevalent Cases of Alopecia Areata in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the US accounted for the highest prevalent cases of alopecia areata with approximately 764 thousand cases, which are expected to increase by 2034 at a CAGR of 1.4%.
• In 2023, the UK reported the highest number of diagnosed prevalent cases of alopecia areata among the EU4 and the UK, with approximately 323 thousand cases. Spain followed with around 170 thousand cases, while Italy recorded the lowest diagnosed prevalence, with nearly 100 thousand cases.
• In 2023, Japan reported approximately 167 thousand diagnosed prevalent cases of alopecia areata in females and 107 thousand cases in males, with numbers projected to rise by 2034.
• In 2023, females accounted for 63% of alopecia areata cases in the EU4 and the UK, while males represented 37%. These gender-specific patterns are expected to grow, with overall prevalence projected to increase by 2034.
• In Germany, approximately 89% of alopecia areata cases in 2023 occurred in individuals before 40 age group, while 11% were observed in those above 40 age group, indicating higher susceptibility among the before 40 age group.
• In 2023, around 14% of alopecia areata cases in the EU4 and the UK were mild, 45% moderate, and 41% severe. These severity patterns are expected to continue, with overall prevalence anticipated to increase by 2034.

Alopecia Areata Drug Chapters

The drug chapter segment of the alopecia areata report encloses a detailed analysis of alopecia areata marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the alopecia areata clinical trial details, expressive pharmacological action, agreements and collaborations and approval, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

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

OLUMIANT is a selective and reversible JAK inhibitor that targets the cytokine signaling pathway associated with alopecia areata. It works by inhibiting the activation of ATPase on JAK, blocking signal transmission to cells via the Signal Transducer and Activator of Transcription (STAT) pathway. This mechanism disrupts inflammation and immune responses involved in the condition. OLUMIANT, acting as a JAK inhibitor, has received regulatory approval in the US, EU, and Japan for the treatment of severe alopecia areata.

LITFULO (Ritlecitinib): Pfizer

LITFULO (ritlecitinib), developed by Pfizer, is an innovative FDA-approved oral treatment for severe alopecia areata, an autoimmune disorder causing significant hair loss. It works by targeting JAK3 and TEC inhibitors to disrupt immune pathways responsible for hair follicle destruction. LITFULO has been approved for use in the US, EU, and Japan, addressing the needs of individuals aged 12 and older with severe forms of the condition. It also received breakthrough designation, highlighting its potential to transform alopecia areata treatment.

LEQSELVI (Deuruxolitinib, CTP 543): Sun Pharmaceuticals

LEQSELVI (Deuruxolitinib), developed by Sun Pharmaceutical Industries, is an FDA-approved oral treatment for severe alopecia areata in adults. It works by inhibiting JAK1 and JAK2, targeting immune pathways that contribute to hair loss in the condition. LEQSELVI is taken once daily and has received breakthrough and fast track designation for alopecia areata. This approval provides a new treatment option for individuals with severe alopecia areata, offering hope for those affected by this autoimmune disorder.

Emerging Drugs

RINVOQ (Upadacitinib): AbbVie

RINVOQ (upadacitinib), a JAK1-specific oral inhibitor, shows promise for alopecia areata treatment, despite being primarily approved for rheumatoid arthritis and atopic dermatitis. Clinical studies indicate significant hair regrowth and improved quality of life. Currently in Phase III, RINVOQ is projected for alopecia areata approval by 2027.

Bempikibart (ADX-914): Q32 Bio

Bempikibart (ADX-914) is a fully human antibody that targets the IL-7 Receptor Alpha subunit (IL-7Ra) and Thymic Stromal Lymphopoietin (TSLP), aiming to regulate immune function in autoimmune diseases. Currently in Phase II trials for alopecia areata, both IL-7 and TSLP pathways are linked to T-cell-mediated processes in autoimmune conditions. Q32 Bio has completed enrollment for the Phase II trial.

Amlitelimab (SAR-445229): Sanofi

Amlitelimab (SAR-445229) is a monoclonal antibody targeting OX40L, a molecule that activates T cells driving autoimmune responses. By blocking the OX40-OX40L pathway, it reduces inflammation and regulates the immune system without widespread immunosuppression. Currently in Phase II trials for alopecia areata, it shows potential as a targeted, effective alternative to traditional immunosuppressive therapies.

Drug Class Insights

Alopecia areata treatment primarily involves corticosteroids as the first-line therapy, often combined with immunosuppressants like methotrexate or azathioprine for patients who do not respond adequately.

Emerging therapies include RINVOQ (Upadacitinib), coacillium (LH-8), and STS01.

RINVOQ (Upadacitinib) is developed by AbbVie, is an oral JAK1 selective inhibitor in Phase III trials for severe alopecia areata, with participant recruitment ongoing. The trial is expected to conclude by March 2028, targeting immune pathways involved in hair loss.

Coacillium (LH-8) is developed by Legacy Healthcare, is the only botanical drug candidate for alopecia areata. As a cutaneous solution, it modulates immune-inflammatory pathways and has completed Phase II/III trials under the RAAINBOW study, targeting hair loss mechanisms.

STS01 is developed by Soterios, is a small-molecule topical cream for mild-to-moderate alopecia areata. Completing Phase II trials, it targets cytokines to modulate immune responses, offering a non-steroidal, safe alternative to JAK inhibitors and potential standard treatment for patchy alopecia areata.

Market Outlook

Alopecia areata is a chronic autoimmune disorder causing non-scarring hair loss, often starting as patchy bald spots on the scalp but potentially affecting other hair-bearing areas. The immune system attacks hair follicles, disrupting growth cycles. The condition can range from localized patches to complete hair loss (alopecia totalis or universalis). Genetic and environmental factors contribute to its onset. Besides physical effects, alopecia areata significantly impacts emotional well-being and quality of life.

The treatment landscape for alopecia areata has evolved to incorporate a comprehensive approach, combining medications with supportive care. The market offers a range of therapies, including corticosteroids, immunosuppressants, immunomodulators, and topical sensitizers or irritants. Corticosteroids remain central for their anti-inflammatory properties, reducing immune attacks on hair follicles, while immunosuppressants and immunomodulators are used in more severe or resistant cases to regulate the immune system and prevent further hair loss.

Topical sensitization therapies, like diphencyprone, induce a mild allergic reaction to divert the immune response from hair follicles. Similarly, topical irritation therapies trigger irritation to stimulate hair regrowth. Minoxidil, a vasodilator, promotes blood flow to hair follicles and is often used off-label for alopecia areata. Dithranol, less commonly used, creates controlled inflammation to alter immune responses and encourage regrowth, primarily for patchy alopecia areata as part of sensitization therapy.

Some drugs are currently approved and available for the treatment of alopecia areata, reflecting the focus on immune modulation therapies. Key options include OLUMIANT, a small molecule co-developed by Eli Lilly and Company and Incyte Corporation, and LITFULO, a JAK3 and TEC kinase inhibitors offered by Pfizer. LEQSELVI, JAK1 and JAK2 inhibitors developed by Sun Pharmaceuticals.

There is a significant need for new treatments for alopecia areata, as existing therapies often fall short of fully managing the condition. Innovative drug development could provide more effective options for patients. Several promising drugs are currently in the pipeline, including RINVOQ (Upadacitinib), coacillium (LH-8), and STS01, among others.

• In 2023, the alopecia areata market size in the US was around USD 202 million, accounting for 53% of the total market. This figure is expected to grow significantly with the introduction of emerging therapies.
• The total market size of EU4 and the UK was estimated to be approximately USD 146 million in 2023, which was nearly 39% of the total market revenue for the 7MM.
• Among EU4 and the UK, the UK accounted for the highest market share with approximately USD 51 million in 2023, followed by Spain with approximately USD 28 million in the respective year, and France, capturing the least market with nearly USD 20 million in 2023.
• In 2023, the total market size of alopecia areata was approximately USD 31 million in Japan which is anticipated to increase during the forecast period (2024-2034).
• As per the estimates, among the current marketed drugs currently in use, OLUMIANT held the largest market share, generating approximately USD 180 million in revenue in 2023 across the 7MM.

Alopecia Areata Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Alopecia Areata Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for alopecia areata.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on alopecia areata evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Brigham and Women's Hospital, the US, Atrium Health Wake Forest Baptist, the US, Carver College of Medicine, the US, Charite - Universitatsmedizin Berlin, Germany, Centre hospitalier universitaire de Nantes, France, University of Bologna, Italy, International University of Catalonia (UIC Barcelona), Spain, University of Bradford, the UK, Kyorin University School of Medicine, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or alopecia areata market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, early detection is pivotal in improving patient outcomes and enhancing healthcare efficiency. It enables access to a broader range of treatment options, including less aggressive therapies, which greatly enhance a patient's quality of life. Timely diagnosis is strongly associated with higher survival rates, as it prevents the disease from advancing to more severe stages.

As per the KOLs from Germany, recent studies have highlighted the critical role of CD8+NKG2D+ T cells as key effectors in the pathogenesis of alopecia areata. Both mouse and human studies have shown gene expression profiles indicative of cytotoxic T cell infiltration, heightened IFN-? responses, and upregulation of ?-chain cytokines like IL-2 and IL-15, which support the activation and persistence of these effector T cells. Additionally, Vd1+ T cells with pro-inflammatory properties were significantly enriched in the supra bulbar and bulbar regions of affected hair follicles, providing further insight into the immunological mechanisms driving this disease.

As per the KOLs from Japan, the understanding of alopecia areata in Japan remains limited due to scarce epidemiological data. To address this gap, it is crucial to thoroughly investigate the prevalence and severity of the condition within the Japanese population. This insight will be pivotal in shaping future research initiatives and guiding the development of tailored treatment options for affected patients.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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 emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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

Eli Lilly OLUMIANT Support Services

Eli Lilly's OLUMIANT companion in care team collaborates with doctors, specialty pharmacies, and insurance providers to streamline the process of verifying coverage, exploring pharmacy options, and assisting with savings enrollment. Upon receiving the prescription, the insurance company evaluates coverage and cost, coordinating with the specialty pharmacy. The pharmacy handles insurance approval, medication preparation, and patient communication for payment and delivery. For eligible patients, the co-pay program offers the opportunity to pay as little as USD 5 for a 30-day supply, or USD 25 if insurance doesn't cover the medication, reducing out-of-pocket expenses.

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

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of alopecia areata, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the alopecia areata market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM alopecia areata market.

Alopecia Areata report insights

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

Alopecia Areata report key strengths

• 11 years Forecast
• The 7MM Coverage
• Alopecia Areata Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Alopecia Areata report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of alopecia areata, the market size of alopecia areata by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will RINVOQ (Upadacitinib) affect the treatment paradigm of alopecia areata?
• How will OLUMIANT compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of alopecia areata? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to alopecia areata?
• What is the historical and forecasted alopecia areata patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent alopecia areata population during the forecast period (2024-2034)?
• What factors are contributing to the growth of alopecia areata cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of alopecia areata? What are the current clinical and treatment guidelines for treating alopecia areata?
• How many companies are developing therapies for the treatment of alopecia areata?
• How many emerging therapies are in the mid-stage and late stage of development for treating alopecia areata?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of alopecia areata?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the alopecia areata market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for alopecia areata, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.