US Atopic Dermatitis Therapeutics Market Analysis

US Atopic Dermatitis Therapeutics Market Analysis: Executive Summary

The US Atopic Dermatitis Therapeutics Market is at around US $5.166 Bn in 2022 and is projected to reach US $8.744 Bn in 2030, exhibiting a CAGR of 6.8% during the forecast period.

Atopic dermatitis, commonly known as eczema, is a persistent skin condition characterized by inflammation, redness, and irritation. It is non-contagious and can affect individuals of all age groups, although it frequently initiates in childhood. Key risk factors involve a history of eczema, allergies, hay fever, or asthma, and a familial predisposition to these conditions. Common symptoms encompass intense itchiness, redness, swelling, cracking, clear fluid discharge, crusting, and scaling. Treatment strategies for AD may involve routine moisturizing and other self-care practices, the application of medicated creams to manage itching and aid in skin repair, the administration of topical or oral medications, and additional therapies such as phototherapy or immunosuppressants. Several companies, including Sanofi, Pfizer, AbbVie, Leo Pharma, Eli Lilly, and Teva Pharmaceutical, produce therapeutic options for AD. Their product lines encompass topical corticosteroids, calcineurin inhibitors, and other medications aimed at alleviating the symptoms of atopic dermatitis.

It is estimated that currently, around 31 million Americans are living with AD, with an estimated prevalence of around 7.3%. The market is propelled by significant factors such as the surge in the prevalence of AD, a strong pipeline of innovative drugs, the evolving healthcare landscape, and consumer knowledge of the therapeutics industry. However, conditions such as poor adherence and treatment effectiveness, high cost of treatments like JAK inhibitors, market saturation, and others can restrict the growth and potential of the market.

The top market player, Sanofi, has recently obtained approval from the US FDA for its therapeutic Dupixent for the treatment of AD in children. It is followed by its close competitor, Pfizer.

Market Dynamics

Market Growth Drivers

Surge in the prevalence of AD: It is estimated that approximately 31.6 million Americans are currently living with some form of AD accounting to around 10% of US population. The overall prevalence of AD is 7.3% in the US. It is estimated that every 1 in 10 children in US will develop eczema in their life. The significant and expanding number of patients forms a robust demand for efficient therapeutic solutions. Elements such as urbanization, shifts in hygiene practices, and heightened exposure to allergens could play a role in the escalating prevalence.

Pipeline of Innovative Drugs: Pharmaceutical firms are proactively creating novel medications, particularly biologics with precise mechanisms of action, providing enhanced effectiveness and the potential for more extended periods of remission. This continual innovation is anticipated to attract a growing number of patients seeking treatment and generate enthusiasm within the market.

Evolving healthcare landscape: The rise of telemedicine and direct-to-consumer models is expanding access to specialized care and medications, potentially reaching populations that have been underserved. These changes in healthcare delivery have the potential to strengthen the market further by creating new pathways for patients to obtain AD therapeutics.

Market Restraints

Poor Adherence and Treatment Effectiveness: Although treatments address symptoms, they rarely provide a cure, necessitating prolonged usage and potentially resulting in medication fatigue and non-compliance. Regarding side effects, specific medications, especially systemic therapies, may pose potential adverse effects that could deter patients from following the prescribed treatment regimen.

High cost and low affordability: Innovative, focused treatments such as biologics are associated with substantial costs, restricting access for individuals with low incomes and potentially straining healthcare systems. Certain insurance plans may not include coverage for newer or specialized treatments, leaving patients with significant out-of-pocket expenses.

Market saturation: The greater prevalence of generic alternatives for older topical steroids and immunosuppressants may exert downward pressure on the prices of newer, more costly therapies. The market for topical corticosteroids and emollients is already saturated, posing a challenge for new entrants to distinguish themselves.

Notable Recent Updates

June 2022, The FDA has granted approval for Dupixent® (dupilumab) from Sanofi, marking it as the initial biologic medication authorized for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

January 2022, Pfizer Inc. reported that the U.S. Food and Drug Administration (FDA) has granted approval for CIBINQO® (Abrocitinib), an oral, once-daily Janus kinase 1 (JAK1) inhibitor, designed for treating adults with refractory, moderate-to-severe atopic dermatitis (AD).

Healthcare Policies and Regulatory Landscape

The regulatory framework in the United States is overseen by the Food and Drug Administration (FDA), the primary health authority responsible for ensuring the safety and effectiveness of drugs and medical devices. The process of obtaining a license or drug approval in the U.S. involves several stages, including preclinical testing, clinical trials, FDA review, FDA approval, and post-market surveillance. The FDA thoroughly assesses the safety, efficacy, and quality data of the drug and may request additional information or studies. Following the review, the FDA makes a regulatory decision regarding the drug's approval, which is communicated to the manufacturer or sponsor. Post-approval, the FDA continues monitoring the safety and effectiveness of the drug through post-market surveillance activities.

This comprehensive process ensures that drugs marketed in the U.S. adhere to the necessary standards for safety, effectiveness, and quality. The regulatory environment for new therapeutics in the United States is evolving to accommodate the development and approval of novel treatments

Competitive Landscape

Key Players

• Sanofi
• Pfizer
• AbbVie
• Leo Pharma
• Eli Lilly
• Novartis
• Teva Pharmaceuticals
• Galderma
• Regeneron Pharmaceuticals
• Astellas Pharma