Introduction
Sklice, a lotion containing 0.5% ivermectin, has been a significant player in the treatment of head lice infestations. Initially approved as a prescription drug in 2012, it has recently transitioned to over-the-counter (OTC) status, expanding its accessibility to a broader population.
Clinical Trials and Approval
Sklice was first approved by the FDA in February 2012 as a prescription drug for the treatment of head lice infestations in patients 6 months of age and older. The transition to OTC status was granted in October 2020, following a rigorous evaluation process to ensure the drug's safety and effectiveness when used without the supervision of a healthcare professional[1].
Rx-to-OTC Switch Process
The FDA's Rx-to-OTC switch process involves a thorough review of data to confirm that the drug can be safely and effectively used by consumers based on the proposed labeling. This process is typically initiated by the drug's manufacturer and requires demonstrating that consumers can understand and follow the instructions without medical supervision[1].
Market Analysis
Global Lice Treatment Market
The global lice treatment market is projected to experience significant growth. By 2031, the market is expected to reach USD 1730.08 million, with a Compound Annual Growth Rate (CAGR) of 6.40% from 2023 to 2031. North America dominates this market, largely due to the high prevalence of head lice infestations and the presence of a large and growing population of children[2].
Distribution Channels
The retail pharmacies segment is the major contributor to the lice treatment market, expected to exhibit a CAGR of 6.35% during the forecast period. This growth is driven by the increasing trend of consumers purchasing medications from retail pharmacies rather than hospitals, especially in the wake of the COVID-19 pandemic[2].
Key Drivers
- Increasing Prevalence of Head Lice Infestation: Especially among school children, the prevalence of head lice is a significant driver of the market. According to various studies, the number of children aged below 14 years is expected to increase, contributing to the market growth[5].
- Easy Availability of Lice Treatment Products: The widespread availability of lice treatment products, including Sklice, has boosted market growth. The transition of Sklice to OTC status has further increased its accessibility[5].
Market Projections
Regional Dominance
North America, particularly the United States, is expected to continue dominating the lice treatment market. The region's large infestation pool and growing number of children contribute to this dominance. By 2050, the number of children in the United States is projected to increase, further propelling market growth[5].
Growth Statistics
- The global lice treatment market is projected to grow from USD 989.90 million in 2022 to USD 1730.08 million by 2031.
- The market is expected to grow at a CAGR of 6.40% during the forecast period from 2023 to 2031[2].
Impact of OTC Status on Market Growth
The approval of Sklice for OTC use has significantly expanded its market potential. Here are some key points:
Increased Accessibility
- The OTC status allows consumers to purchase Sklice without a prescription, making it more accessible to a broader audience. This increased accessibility is expected to drive sales and market growth[1].
Consumer Convenience
- Consumers can now purchase and use Sklice based on the Drug Facts label, reducing the need for healthcare professional supervision. This convenience is likely to increase consumer adoption and satisfaction[1].
Expert Insights and Statistics
FDA Perspective
“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”[1].
Prevalence of Head Lice
- In the United States, it is estimated that between 6 and 12 million cases of head lice infestation occur each year in children aged 3 to 11 years[1].
Key Takeaways
- Clinical Trials and Approval: Sklice transitioned from prescription to OTC status after rigorous clinical trials and FDA approval.
- Market Growth: The global lice treatment market is projected to reach USD 1730.08 million by 2031, driven by increasing prevalence and easy availability of treatments.
- Regional Dominance: North America, particularly the United States, dominates the market due to a large infestation pool and growing child population.
- Impact of OTC Status: Increased accessibility and consumer convenience are expected to drive market growth.
FAQs
What is Sklice used for?
Sklice is used for the topical treatment of head lice infestations in patients 6 months of age and older.
What is the active ingredient in Sklice?
The active ingredient in Sklice is ivermectin 0.5%.
When was Sklice approved for OTC use?
Sklice was approved for OTC use by the FDA in October 2020.
What is the projected market size of the global lice treatment market by 2031?
The global lice treatment market is projected to reach USD 1730.08 million by 2031.
Which region dominates the lice treatment market?
North America, particularly the United States, dominates the lice treatment market.
Sources
- FDA Approves Lotion for Nonprescription Use to Treat Head Lice - FDA News Release, October 27, 2020.
- Lice Treatment Market Size, Share and Forecast to 2031 - Straits Research.
- In Silico Clinical Trials Market Report 2023-2033 - GlobeNewswire.
- Clinical Policy: Ivermectin (Sklice) - Ambetter Health.
- Global Lice Treatment Market (2020 to 2025) - Growth, Trends, and Forecast - ResearchAndMarkets.com.
