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

Key Highlights:

• In 2023, the total Androgenetic Alopecia market size in the 7MM was approximately USD 6 million, out of which the US accounted for approximately USD 3 million.
• With an aging population globally, various factors like exposure to pollutants, toxins, and other environmental stressors could worsen hair loss. Additionally, sedentary lifestyles marked by stress, unhealthy eating habits, and lack of physical activity might foster hair loss during the forecast period (2024-2034).
• Changes in hormonal levels due to factors such as puberty, pregnancy, or hormonal disorders can trigger or exacerbate androgenetic alopecia. Moreover, the growing awareness and enhanced knowledge of androgenetic alopecia among individuals who suffer from hair loss-related issues encourage them to visit experts and understand the potential causes and existing treatments. This leads to improved diagnosis and treatment rates for the condition.
• Another challenge in addressing androgenetic alopecia is the development of interventions that effectively mitigate the impaired psychological quality of life and financial burden experienced by individuals with this condition.
• Furthermore, the launch of promising treatments like Kintor Pharmaceutical's KX-826, Cosmo Pharmaceutical's BREEZULA/CB-03-01, and others are anticipated to positively influence the market size of Androgenetic Alopecia during the forecast period [2024-2034].

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

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

Androgenetic Alopecia Treatment Market

Androgenetic alopecia overview

Androgenetic alopecia, commonly known as male or female pattern baldness, is a prevalent form of hair loss characterized by a gradual reduction in hair density and thickness, typically in a specific pattern. It affects both men and women, although the presentation and progression may differ between the sexes. In men, androgenetic alopecia often begins with a receding hairline and thinning at the crown, eventually leading to partial or complete baldness. Women with androgenetic alopecia typically experience diffuse thinning over the crown of the scalp, while maintaining the frontal hairline. The condition is primarily driven by genetic and hormonal factors. It is associated with sensitivity to dihydrotestosterone (DHT), a derivative of testosterone, which can shrink hair follicles, shorten the hair growth cycle, and eventually lead to hair miniaturization and loss. While androgenetic alopecia does not typically cause serious medical problems, it can have significant psychological and emotional impacts, affecting self-esteem and quality of life.

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Androgenetic alopecia Diagnosis

To diagnose androgenetic alopecia, doctors typically combine a medical history assessment, a thorough scalp and hair examination, and sometimes additional tests. During the examination, they assess the pattern and extent of hair loss, examining remaining hair quality and checking for signs like inflammation or scarring. They may also conduct a pull test, gently tugging on hair strands to gauge shedding. Increased shedding may suggest active hair loss. In some cases, a scalp biopsy is performed to analyze a small tissue sample under a microscope, confirming the diagnosis and ruling out other conditions like alopecia areata or scarring alopecia. While not usually required, blood tests may be ordered to check for underlying medical conditions such as thyroid disorders or hormonal imbalances contributing to hair loss.

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Androgenetic alopecia Treatment

Treatment for androgenetic alopecia focuses on mitigating hair loss, stimulating hair growth, and addressing associated symptoms. Common treatments encompass medications like minoxidil and finasteride, which are effective in slowing down hair loss and encouraging regrowth. Additionally, options like hair transplantation or cosmetic methods to mask thinning areas may be pursued. Given the multifaceted nature of androgenetic alopecia, management typically involves a personalized blend of medical and cosmetic interventions, tailored to each individual's requirements. For those disinclined towards medical or surgical solutions, cosmetic alternatives such as wigs, hairpieces, or styling techniques can serve to camouflage hair loss and bolster self-assurance.

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Androgenetic Alopecia Epidemiology

As the Androgenetic Alopecia market is derived using a patient-based model, the androgenetic alopecia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalence of androgenetic alopecia, total prevalence of androgenetic alopecia in males, total prevalence of androgenetic alopecia in females, total diagnosed prevalence of androgenetic alopecia in males, total diagnosed prevalence of androgenetic alopecia in females in the 7MM covering the US, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• As per DelveInsight's analysis, in 2023, the total prevalent cases of androgenetic alopecia in the 7MM accounted for approximately 195 thousand million, out of which the US accounted for nearly 83 thousand million cases in 2023. These numbers are projected to increase by 2034 due to sedentary lifestyles, which contribute to hormonal changes and subsequently lead to androgenetic alopecia.
• In 2023, there were nearly 23 thousand million, and 20 thousand million diagnosed prevalent male cases of androgenic alopecia in the US. Indicating more males are affected with the disease than females.
• Among the EU4 and the UK, Germany had the highest prevalent population of androgenetic alopecia with approximately 22 thousand million cases, followed by the UK with around 17 thousand million cases in 2023.
• Japan accounted for nearly 28 thousand million prevalent cases of androgenic alopecia. These cases are expected to increase during the forecast period with the increased aging population in Japan.

Androgenetic Alopecia Drug Chapters

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

Emerging Androgenetic Alopecia Drugs

KX-826 (pyrilutamide): Kintor Pharmaceutical

KX-826 is a locally administered tincture and a potential first-in-class topical drug for the treatment of androgenetic alopecia. KX-826 is a topical AR antagonist with a specific target and can inhibit the combination of AR and androgen in hair follicle sebaceous glands, thereby treating androgenetic alopecia. KX-826 demonstrated a preliminary positive safety, pharmacokinetics, and tolerability profile in Phase I and Phase Ib clinical trials in the US. Furthermore, KX-826 has shown good efficacy and safety profile in Phase II clinical trials in China for treating androgenetic alopecia male patients and has completed patient enrollment for Phase III clinical trial.

Currently, the drug candidate is being investigated in a Phase III clinical trial for androgenic alopecia (male) in the US.

BREEZULA (clascoterone solution): Cosmo Pharmaceuticals

BREEZULA/CB-03-01 is a novel topical AR inhibitor that directly inhibits testosterone and DHT binding to local hair follicle androgen receptors. It is quickly metabolized to cortexolone, a metabolite with a known safety profile. Due to its rapid metabolism and local activity, there appears to be limited systemic exposure to BREEZULA; potential systemic side effects are likely minimized. BREEZULA depicted positive results in two Phase II trials, based on which the company plans to conduct Phase III trials.

Currently, clascoterone 5 % solution is being investigated in two Phase III clinical trials (SCALP1, SCALP2) to assess its safety and effectiveness in treating androgenic alopecia.

Androgenetic Alopecia Drug Class Insights

Androgenetic alopecia treatment typically involves a treatment landscape for androgenetic alopecia that encompasses various modalities, each with its unique mechanisms and considerations, aimed at addressing hair loss and promoting regrowth to enhance patient satisfaction and quality of life. The use of vasodilators like Minoxidil, can be obtained over-the-counter in various strengths. Minoxidil functions by extending the anagen (growth) phase of the hair follicle cycle, thus enhancing hair growth. It is commonly administered as a topical solution or foam applied directly to the scalp and is often recommended as a primary treatment option due to its effectiveness, particularly in the vertex and crown regions. Additionally, 5-alpha reductase inhibitors such as Finasteride, available by prescription, are utilized. Finasteride works by inhibiting the enzyme 5-alpha reductase, which reduces the conversion of testosterone to dihydrotestosterone (DHT), a hormone linked to hair follicle miniaturization in androgenetic alopecia. Finasteride is typically taken orally and has demonstrated effectiveness in slowing hair loss and promoting regrowth, especially in the crown and frontal scalp areas, although it may lead to sexual dysfunction in some individuals. Other therapies, including Low-Level Laser Therapy and Platelet-Rich Plasma (PRP) Therapy, aim to increase cellular activity and improve blood flow to the scalp, thereby enhancing hair follicle function. These treatments are believed to complement traditional approaches and may be used in conjunction with them.

Moreover, surgical options such as hair transplantation involve the extraction and relocation of hair follicles from donor sites, commonly the back or sides of the scalp, to areas affected by hair loss. Techniques such as follicular unit transplantation and follicular unit extraction are employed to achieve natural-looking results. While hair transplantation is considered a permanent solution for androgenetic alopecia, it necessitates careful patient selection and surgical expertise.

Androgenetic Alopecia Market Outlook

Current treatments for androgenetic alopecia involve the use of medications or dietary adjustments that can induce and sustain symptom relief. Minoxidil and finasteride are the sole treatments approved by the US FDA for this condition. Additionally, in Japan, dutasteride (marketed as ZAGALLO) has been utilized for androgenetic alopecia treatment in men since its approval in 2015. Minoxidil is available in 2% and 5% concentrations, administered topically to the scalp in either liquid or foam form. Both concentrations are approved by the US FDA for use in both men and women. While the precise mechanism by which minoxidil promotes hair growth during the anagen phase is not entirely understood, it is generally considered safe. However, some users may experience side effects, with irritant contact dermatitis being the most common, characterized by symptoms such as itching and scaling.

Finasteride specifically inhibits the Type II 5a-reductase enzyme, which converts testosterone to dihydrotestosterone (DHT), the androgen responsible for developing male pattern hair loss in genetically predisposed men. Oral finasteride 1 mg/day significantly reduced serum DHT levels by a median of 68.4% in men with male pattern hair loss treated for 1 year. A corresponding 9.1% (median) increase in testosterone levels from baseline was reported, but these levels remained within the normal physiological range. No current data support the use of finasteride in women with androgenetic alopecia. Moreover, pregnant women should not be directly exposed to finasteride by using or handling crushed tablets because of the risk of hypospadias developing in a male fetus.

Dutasteride, is a selective and competitive inhibitor of both Type I and Type II isoenzymes of 5-a-reductase. Dutasteride has been demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia. Research indicated that 0.5 mg dutasteride was found to be better than finasteride with comparable adverse effects. The common side effects associated with dutasteride include decreased sex drive, erectile dysfunction, and a decrease in semen. Dutasteride is considered to be potentially more effective at treating hair loss but also shows the same rate and types of side effects as finasteride.

Therefore, the shortcomings associated with the current treatment regime in the androgenetic alopecia landscape warrant the development of new therapies. As per our analysis, the emerging treatment landscape consists of KX-826 (Kintor Pharmaceutical) and BREEZULA (Cosmo Pharmaceuticals), and others are anticipated to positively influence the market size of Androgenetic Alopecia during the forecast period [2024-2034] owing to the increasing awareness among healthcare providers and patients, coupled with advancements in diagnostic techniques, is expected to contribute to a growing pool of diagnosed cases. Moreover, factors such as stress, poor diet, and environmental pollution can contribute to hair loss, and as lifestyles change, more people may experience hair thinning or baldness, thereby driving demand for treatment options for androgenetic alopecia.

• In 2023, the total Androgenetic Alopecia market size in the 7MM was approximately USD 6 million, out of which the US accounted for approximately USD 3 million.
• Among the EU4 and the UK, Germany holds the highest Androgenetic Alopecia market size of around USD 450 thousand followed by the UK, and France with approximately USD 350 thousand, and USD 340 thousand million respectively. These numbers are expected to change during the forecast period (2024-2034) driven by the ongoing research and development efforts that may lead to the discovery of more effective medications and therapies for treating androgenetic alopecia.
• The androgenetic alopecia market size in Japan accounted for nearly 10% of the total 7MM Androgenetic Alopecia market size in 2023, these numbers are expected to change by 2034

Androgenetic Alopecia Uptake

This section focuses on the uptake rate of potential Androgenetic Alopecia drugs expected to be launched in the market during 2020-2034. For example, Kintor Pharmaceutical's KX-826, is a locally administered tincture and a potential first-in-class topical drug for the treatment of androgenetic alopecia. In clinical findings, the drug proved to be efficacious in Chinese participants. However, the drug is associated with AEs like pruritus, and skin irritation that might cause discomfort to the patients and may require additional therapies.

Androgenetic Alopecia Pipeline Development Activities

The Androgenetic Alopecia market 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 Androgenetic Alopecia market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for androgenetic alopecia.

KOL Views

To keep up with current Androgenetic Alopecia 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 Androgenetic Alopecia 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 Long Island University, Clinical Research Center, Tennessee, and Center for Clinical and Cosmetic Research, Florida, Ablon Skin Institute and Research Center, University of Cambridge, and University Hospital Zurich, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or androgenetic alopecia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Androgenetic Alopecia market and the unmet needs.

Physician's View

According to physicians, a primary challenge in androgenetic alopecia treatment lies in the long-term maintenance of treatment efficacy and patient satisfaction. Even with effective treatment, the underlying hormonal and genetic factors driving hair thinning may continue to exert their influence, necessitating continuous management to sustain results. Managing these expectations through comprehensive patient education and counseling is essential for promoting realistic treatment goals and enhancing satisfaction with treatment outcomes.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Attribute 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.

Attribute 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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in Androgenetic Alopecia trials, one of the most important primary outcome measures is complete eschar removal.

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.

Androgenetic Alopecia Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The reimbursement challenges related to medical care and treatment for individuals with androgenetic alopecia can be significant as they often require specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Moreover, health insurance plans may not fully cover limited coverage of some medical treatments, and therapies specific to androgenetic alopecia. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

Scope of the Androgenetic Alopecia Market Report

• The Androgenetic Alopecia market report covers a segment of key events, an executive summary, descriptive overview of androgenetic alopecia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the androgenetic alopecia 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 Androgenetic Alopecia market 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 androgenetic alopecia market.

Androgenetic Alopecia Market Report Insights

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

Androgenetic Alopecia Market Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Androgenetic Alopecia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Androgenetic Alopecia Drugs Uptake
• Key Androgenetic Alopecia Market Forecast Assumptions

Androgenetic Alopecia Market Report Assessment

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

Key Questions:

Androgenetic Alopecia Market Insights

• What was the androgenetic alopecia market share (%) distribution in 2020 and what it would look like in 2034?
• What was the total Androgenetic Alopecia market size 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 KX-826, and BREEZULA/CB-03-01 affect the treatment paradigm of androgenetic alopecia?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed Androgenetic Alopecia therapies?
• How would future opportunities affect the Androgenetic Alopecia market dynamics and subsequent analysis of the associated trends?

Androgenetic Alopecia Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of androgenetic alopecia? What will be the growth opportunities across the 7MM concerning the patient population with androgenetic alopecia?
• What is the historical and forecasted androgenetic alopecia patient pool in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Out of the above-mentioned countries, which country would have the highest diagnosed prevalent androgenetic alopecia population during the forecast period (2023-2034)?
• What factors are factors contributing to the growth of androgenetic alopecia cases

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of androgenetic alopecia? What are the current guidelines for treating androgenetic alopecia in the US and Europe?
• How many Androgenetic Alopecia companies are developing therapies for the treatment of androgenetic alopecia?
• How many emerging Androgenetic Alopecia therapies are in the mid-stage and late stage of development for treating androgenetic alopecia?
• 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 country-specific accessibility issues of approved Androgenetic Alopecia therapies?
• What is the 7MM historical and forecasted Androgenetic Alopecia market?

Reasons to Buy:

• The Androgenetic Alopecia market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the androgenetic alopecia 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 Androgenetic Alopecia market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current Androgenetic Alopecia patient share based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming Androgenetic Alopecia companies 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 androgenetic alopecia, 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 Androgenetic Alopecia market so that the upcoming Androgenetic Alopecia companies can strengthen their development and launch strategy.