US Alopecia (Hair Loss) Therapeutics Market Analysis

US Alopecia Therapeutics Market Analysis: Executive Summary

The US Alopecia (Hair Loss) Therapeutics Market is at around US $3.44 Bn in 2022 and is projected to reach US $5.28 Bn in 2030, exhibiting a CAGR of 5.50% during the forecast period.

Alopecia, characterized by the occurrence of patchy hair loss, affects a considerable number of individuals. It may manifest as localized or diffuse, temporary or permanent, affecting individuals of all ages and genders. Alopecia, a manifestation of diverse causes, can lead to significant distress among patients, impacting their quality of life. Common symptoms include hair loss, thinning hair, and bald patches on the scalp. Treatment options encompass the use of topical medications like Minoxidil or corticosteroids directly applied to the scalp, as well as injections and oral medications offering more potent immunosuppressive effects. Light therapy and hair transplantation are also viable alternatives. Leading companies like Eli Lilly, with their JAK inhibitor Baricitinib, and Bayer, with Rogaine (Minoxidil), are actively pioneering advancements in the treatment of this condition.

The prevalence of alopecia in the US is estimated to be approximately 2%, and around 7,00,000 individuals are expected to be currently living with alopecia. The market is propelled by significant factors such as the growing aging population at a risk of developing alopecia, technological advancements, and the growing accessibility of the therapeutics industry. However, high treatment costs like JAK inhibitors, transplantation, and a lack of specialists are a few factors that limit the market's potential.

Market Dynamics

Market Growth Drivers

Surge in the prevalence of Alopecia: The estimated prevalence of alopecia in US is approximately 2%. It is reported that around 6.5 million individuals in US have had Alopecia areata, and currently 7,00,000 people are living with it. Additionally, it is estimated that about 30 million women and 50 million men in the US suffer from androgenetic alopecia. Risk factors like elevated stress levels, environmental influences, and shifts in lifestyle are contributing to a rise in alopecia cases, especially among young adults and women. The expanding patient demographic enhances the market potential for diverse treatment alternatives.

Technological advancement: The recent FDA clearance of Baricitinib (Olumiant) and encouraging other late-stage trials present novel oral medication choices that could potentially increase effectiveness and enhance convenience in comparison to traditional treatments. Ongoing research into the development pipeline is exploring innovative therapies directed at various pathways associated with alopecia, and advancements such as hair follicle cloning and gene therapy raise expectations for more effective and personalized treatment alternatives in the future

Growing Market Accessibility: Market dynamics are shifting with the increasing prominence of specialty pharmacies. These pharmacies specialize in addressing specific conditions, such as alopecia, providing patient support services, and facilitating streamlined access to medications. This shift has the potential to enhance treatment adherence and contribute to market growth. Furthermore, pharmaceutical companies are increasingly utilizing digital platforms for direct-to-consumer marketing. This approach allows them to reach patients directly, raising awareness about alopecia and the various treatment options available.

Market Restraints

High costs of medications: JAK inhibitors such as Baricitinib and Xeljanz often surpass typical insurance coverage thresholds, resulting in considerable expenses for many patients. Even topical treatments and procedures contribute to the financial burden, posing challenges for individuals with limited income to access these therapies.

Limited coverage: While insurance plans may cover certain treatments for alopecia, particular medications or hair transplantation procedures might be excluded or entail significant co-payments, affecting affordability and influencing decisions about care. This situation may result in patients having to bear co-payments, which results in treatment non-compliance in many patients, which restricts market growth.

Lack of specialists: Rural or underserved communities face challenges in accessing dermatologists or specialists with expertise in treating alopecia, resulting in geographical disparities in healthcare.

Notable Updates

June 2023, LITFULO™ (ritlecitinib), a dual JAK3/TEC inhibitor from Pfizer, received approval from the US FDA for the treatment of severe Alopecia areata in adults and adolescents aged 12 and above.

June 2022, The US FDA granted approval to Olumiant (baricitinib), an oral tablet manufactured by Eli Lilly, as a systemic treatment for severe alopecia areata in adult patients.

Healthcare Policies and Regulatory Landscape

In the United States, the healthcare policy and regulatory landscape are characterized by the involvement of various governmental bodies, each playing a distinct role in overseeing different aspects of the healthcare system. The primary regulatory authorities include the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Department of Health and Human Services (HHS).

The FDA, as a central regulatory agency, is tasked with ensuring the safety and effectiveness of a wide range of healthcare products, including pharmaceuticals and medical devices. Before these products can be licensed for use, they undergo a rigorous approval process. This process involves multiple stages, starting with pre-clinical research, followed by clinical trials to assess safety and efficacy in human subjects. Subsequently, companies submit their findings to the FDA for evaluation and approval. Post-approval surveillance is then conducted to monitor the ongoing safety and effectiveness of these products in real-world settings. The governance and procedures established by these regulatory bodies significantly influence the framework of healthcare policy in the United States.

Competitive Landscape

Key Players

• Eli Lilly
• Pfizer
• Johnson & Johnson
• Merck & Co
• Cipla Limited
• Sun Pharmaceuticals
• GlaxoSmithKline plc
• Mylan N.V
• iRestore Hair Growth system
• Theradome