Alopecia Areata Market
- A complicated, polygenic, autoimmune condition called alopecia areata causes non-scarring alopecia patches on the scalp and body hair, which can be emotionally distressing. Clinically diverse, alopecia areata has an erratic course, with 80% of patients seeing spontaneous hair growth within the first year and the possibility of rapid recurrence at any time. Instances that start in childhood are more severe than instances that start as adults.
- Usually, the pattern of hair loss and the patient's medical history can be used to diagnose alopecia areata. To confirm the diagnosis, a biopsy may be required in some circumstances. Dermoscopy (trichoscopy) has recently become a useful auxiliary tool. Dermoscopic observations that indicate early regrowth include yellow and black spots, broken hairs, exclamation point hairs, and short vellus hairs.
- As per DelveInsight’s analysis, the largest market size was observed the US, approximately 47% which is further expected to increase by 2032.
- Topical, locally injected, or systemic steroids, contact immunotherapy, topical minoxidil, topical irritants like anthralin, and systemic immunosuppressants like cyclosporine or methotrexate are among the treatments for alopecia areata. JAK inhibitors, platelet-rich plasma, recombinant IL-2, hydroxychloroquine, simvastatin with ezetimibe, and excimer laser are examples of current and effective experimental therapies.
- Recently, OLUMIANT was approved by the US FDA for the treatment of alopecia areata. The therapy is expected to generate a decent market share of approximately 300 million by 2032.
- As per Alopecia Areata Consensus of Experts (ACE) Study, when full regrowth has been attained and maintained for six months, or when regrowth is adequate to be controlled topically, systemic therapy should be stopped.
- OLUMIANT being the only approved therapy leaves patients with limited options for the management of their condition. When taken in dermatology, rheumatology, or gastroenterology, JAK inhibitors—promising therapy alternatives for alopecia areata—are listed by the US FDA's "black box warning" for an elevated risk of severe infection, mortality, malignancy, and significant CVS events.
- The emerging therapies in the market for include Concert Pharmaceuticals’ (CTP-543), Pfizer’s (PF-06651600), Legacy Healthcare’s (LH 8) and others have the potential to create a significant positive shift in the market size.
- Considering the current treatment landscape, minoxidil is widely used among the patients of alopecia areata but a high relapse rate is observed that needs to be addressed and shape the future market.
DelveInsight’s “Alopecia Areata – Market Insights, Epidemiology and Market Forecast – 2032” report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends of in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. The report also provides in-depth analysis of alopecia areata, current diagnostic algorithms and unmet medical needs and SWOT analysis emerging drugs, market share of individual therapies, current and forecasted 7MM market size to better analyze and visualize the market and curate the best opportunities and assess the market’s potential.
Alopecia Areata report highlights the major types of alopecia areata observed in different population and the preferred therapeutic approaches. It also provides in depth analysis of market including the recently approved OLUMIANT and off label therapies (corticosteroids, minoxidil, etc.) for the management.
- Key players such as Concert Pharmaceuticals’ (CTP-543), Pfizer’s’ (PF-06651600), Legacy HealthCare’s’ (LH 8) and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of alopecia areata.
- In 2022, the US captured the highest market share (64%) out of all the 7MM countries.
- EU4 and the UK accounted for nearly (21%) market share, and Germany accounted for the highest share in Europe in 2022.
- In Japan, the alopecia areata accounted for approximately 15% of the market share. It is expected to increase at a CAGR of ~18% during the forecast period (2023–2032).
The alopecia areata report's drugs chapter includes an in depth assessment of both late-stage (Phase III and Phase II) pipeline therapeutics as well as treatments that have been marketed for the treatment. Alopecia areata expressive pharmacological action, agreements and collaborations, approval and patent information, benefits and drawbacks of each featured therapy, and the most recent news and press releases are also included.
Additionally, the information related to the safety and efficacy is also highlighted based on which OLUMIANT is approved. Also, the pivotal trials are mentioned based on which the companies (Concert Pharmaceuticals, Pfizer, Legacy Healthcare and others) are seeking approvals.
OLUMIANT (baricitinib): Eli Lilly and Company/Incyte Corporation
OLUMIANT is a Janus kinase (JAK) inhibitor which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. The results of clinical study demonstrated the efficacy of OLUMIANT in the alopecia areata patients. Moreover, there has been a significant unmet medical need for people with alopecia areata until the approval of OLUMIANT.
The drug is already approved in multiple indications like atopic dermatitis and rheumatoid arthritis, but the drug is also associated with severe adverse events. Hence, OLUMIANT carries a black box warning regarding serious infections, malignancy, and mortality.
CTP-543 (deuruxolitinib): Concert Pharmaceuticals
Concert Pharmaceuticals’ CTP-543 is an oral inhibitor of JAK1 and JAK2 designed to target the immunological basis of alopecia areata. The drug received breakthrough designation and orphan designation from the US FDA for the treatment of alopecia areata. The company reported positive results from late phase clinical studies demonstrating its efficacy in the patients.
When compared with Pfizer’s PF-06651600, Concerts’ CTP-543 demonstrated nearly 10% better primary endpoint of SALT score <20. Hence, the drug can prove itself an asset for the company and target the unmet needs of the patients.
PF-06651600 (ritlecitinib): Pfizer
PF-06651600 is 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. Currently, the company is in preregistration phase for the treatment of alopecia areata.
The drug is expected to enter the market ahead of other therapies. Moreover with least side effects and a better dosing frequency of once daily, it can offer a better compliance over other therapies, and can attain a decent market share.
Alopecia areata is the second most common form after androgenetic alopecia. It often appears during childhood and can be different for everyone. Therapy efficacy is difficult to estimate due to the unpredictable course of the disease, and spontaneous remission is often observed within the first year. The current therapies focus on immunosuppression that does not influence the long-term course of the disease, creating an unmet need for novel therapies. 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.
Other therapies involved in the treatment of alopecia areata are methotrexate in combination with oral corticosteroids is more effective; cyclosporine A monotherapy or combined with oral corticosteroids has a moderate effect in severe alopecia areata. Furthermore, topical minoxidil and tacrolimus are frequently used for the patchy alopecia areata and on the eyebrows.
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. As 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 (2023–2032).
Drug Class Insights
For the treatment of alopecia areata, corticosteroids are considered as the first line treatment for the patients due to low side effects associated. They are available in broad spectrum such as solutions, shampoos, foams etc.
Intralesional injection of corticosteroids are recommended for the patchy alopecia, combined with topical corticosteroids.
Systemic corticosteroids have been used in the treatment of alopecia areata as oral pulse therapy (PT), intravenous (IV) PT, intramuscularly (IM), or continuously (CT). Oral corticosteroids are considered an appropriate first-line treatment for moderate to severe alopecia areata in adults (SALT > 30%), alone or combined with topical corticosteroids.
In daily practice, minoxidil is frequently used to manage patchy alopecia areata. However, it should be noted that topical minoxidil has no anti-inflammatory effect. It is mainly used to enhance hair growth as a co-medication with other treatments which can stop or reverse the inflammatory infiltrate.
Alopecia Areata Drugs Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019–2032. For instance, for PF-06651600 which is expected to be launched in the US in 2023, the drug uptake is expected to be medium, with a probability-adjusted peak patient share of ~10% in the US, expected to peak at 9 years from the year of launch.
Further detailed analysis of emerging therapies drug uptake in the report…
Alopecia Areata Epidemiology
As the market is derived using a patient-based model, the alopecia areata disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Alopecia Areata, Total Diagnosed Cases of Alopecia Areata, Type-Specific Cases of Alopecia Areata, Cases of Alopecia Areata Based on Age of Onset, Severity-Specific Cases of Alopecia Areata, and Comorbidities Associated With Alopecia Areata in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.
- In 2022, the total prevalent cases of alopecia areata in the United States were approximately 704,000 cases which is projected to increase during the forecast period (2023–2032).
- The total prevalent cases of alopecia areata in EU4 and the UK were approximately 447,000 in 2022. The cases are projected to increase during the forecast period (2023–2032).
- The total prevalent population of alopecia areata in Japan were approximately 334,000 cases in 2022.
- In 2022, for severity specific cases, ~10% of the patient share were estimated for the mild, ~60% moderate, and ~30% cases for severe in the US.
Alopecia Areata Pipeline Development Activities
The report provides insights into different therapeutic candidates in late as well as early stage (Phase III, Phase II, and Phase I) of development. 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 alopecia areata emerging therapies. The reports covers the assets with advancements in drug delivery systems and targeted approaches aid in discovering novel therapeutics that promise better medication for alopecia areata in the future
Alopecia Areata Disease Understanding and Treatment
Alopecia Areata Overview
People of all ages, both sexes, and all ethnic groups can develop alopecia areata, a common autoimmune skin condition that causes hair loss on the scalp, face, and occasionally other regions of the body.
Over time, there has been significant drift in the etiology of alopecia areata, and several research have proposed various etiologies for the disorder. Most alopecia areata research makes a compelling argument for the involvement of genetic, autoimmune, and environmental variables in the etiology.
Alopecia Areata Diagnosis
An extensive medical and family history should be obtained from an alopecia areata patient, and their entire body, including their nails, should be thoroughly examined. A hair pull test and dermatoscopy should always be added to this. Additional tests, such as a scalp biopsy, a fungal culture, or serology for other autoimmune illnesses or infectious diseases (like syphilis), may be required when clinical findings do not allow for a certain diagnosis.
Further details related to country-based variations are provided in the report…
Alopecia Areata Treatment
With largely unsatisfactory results and significant recurrence rates, particularly in more severe instances, current medications for alopecia areata attempt to immunosuppress or immunomodulate the activity of the illness. Due to its modest side-effect profile when administered carefully, topical corticosteroids are frequently utilized in the treatment of restricted patchy alopecia areata and as first-line therapy for children. In more severe instances, they are also suggested as an adjuvant treatment. First-line recommendations for treating limited patchy alopecia areata include intralesional injections of corticosteroids, either alone or in combination with topical corticosteroids. Alopecia areata has been treated with systemic corticosteroids administered orally, intravenously, intramuscularly, or continuously (CT). In everyday practice, patchy alopecia areata is usually treated with minoxidil.
The treatment landscape of alopecia areata is expected to change substantially and experience growth. The upcoming launch of innovative therapies such as CTP-543 (Concert Pharmaceuticals), PF-06651600 (Pfizer), LH 8 (Legacy Healthcare) and others are expected to drive the market further.
To keep up with current market trends, we take KOLs and ’SME’s 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’s therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers and Professors from renowned universities in the US, Europe, the UK, and Japan.
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Dermatology and Laser Center, Yale University School of Medicine, University of Sheffield etc., were contacted. Their opinion helped understand and validate current and emerging therapy treatment patterns of 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.
As per the expert opinion “Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia areata. So, in my opinion the approval of OLUMIANT will help to fulfill a significant unmet need for patients with severe alopecia areata.”
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, 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 is percentage of patients achieving an absolute severity of alopecia tool, and relative change in SALT scores from baseline. 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 in comparison 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.
Scope of Report
- The report includes a section on key events, an executive summary, and a comprehensive overview of alopecia areata, outlining its diagnosis, types, risk factors, pathophysiology, and treatment guidelines, market outlook.
- The epidemiological segments and forecast, as well as the future growth potential of diagnostic rate, illness progression, and therapy recommendations, have all been covered in detail.
- Current market and emerging therapies are covered, description regarding their stages, and their impact on the current treatment landscape is covered
- The report also covers a thorough analysis of the alopecia areata market, historical and projected market size, market share by therapy, in-depth assumptions, and rationale behind our approach.
- What were the market sizes for alopecia areata overall, by therapy, in terms of market share (%) in 2019, and what would they be in 2032? What are the underlying causes of this expansion?
- What kind of the uptake the new therapies are going to witness in coming years in alopecia areata patients?
- Being the only approved therapy, will OLUMIANT emerge as largest revenue generating therapy?
- Which therapy is going to be the major revenue generating by 2032?
- What are the differences in price between regions for the treatments?
- How will market dynamics and associated trends be impacted by market drivers, obstacles, and potential future opportunities?
- What diseases, costs, and unmet needs are associated with alopecia areata? What will the patient population for alopecia areata patients' growth possibilities be across the 7MM?
- What is the historical and projected patient population for alopecia areata in the US, the EU4 (Germany, France, Italy, Spain), the UK, and Japan?
- What factors will have an impact on the rise in alopecia areata diagnoses?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
- What alternatives are there for treating alopecia areata? What are the recommended treatments for alopecia areata in the US, Europe, the UK, and Japan right now?
- How many companies are working to treat alopecia areata?
- What novel therapies, targets, mechanisms of action, and technologies have recently been created to get around the shortcomings of present therapies?
- What financial burden do approved therapies place on the patient?
- What are the problems with pricing, recently approved therapies' accessibility that vary by nation?