The U.S. Market for Rx to OTC Switches, 6th Edition

The U.S. market for Rx-to-OTC Switches encompasses a wide variety of products that have been determined safe and effective as over-the-counter products, once only available by prescription.   This report represents the six time that Kalorama Information has analyzed the market for drugs with switched ingredients in detail.  The market is fueled by several factors including an aging population; steady to increased incidences of conditions and diseases; new drug classes switched to OTC; product demand; economic conditions and several other factors.

The U.S. Market for Rx-to-OTC Switches focuses on several treatment segments in which Rx-to-OTC switches are available. These include:

• Allergy, Cough, Cold, and Sinus Products
• Analgesics, NSAIDs, and Pain Treatments
• Anti-Infectives
• Gastrointestinal Drugs
• Hair Loss Products
• Hormones
• Oral Care
• Rectal Ointments
• Sleep-aids
• Smoking Cessation
• Weight Loss

In addition to the areas with switches in place, Kalorama Information has identified other areas which may be open to Rx-to-OTC switches in the future. These include:

• Blood Products
• BPH Treatments
• Cholesterol-reducing Drugs
• Hormone Replacement Therapies
• Migraine Treatments
• Osteoporosis Treatments
• Overactive Bladder
• Sexual Dysfunction/ Erectile Dysfunction

The report covers OTC drugs that were once only available by prescription due to either the active ingredient or dosage of the drug. Current and historical revenues for product segments include both the switched brands and OTC drugs containing switched ingredients. Forecasted data includes current products and forecasted switches which are outlined in the report.

The report includes statistical information for conditions and diseases affecting the U.S. population, including detail discussions, tables and figures. Each segment provides an overview, descriptions of products on the market, market estimates and forecasts, and competitive analysis of leading providers. In addition to above-mentioned information, the report includes current issues and trends affecting the industry and identifies trends that may arise in the future.

All product areas contribute to the growth and development of the OTC market; however, new product development and additional regulatory review and approval of new OTC drug classifications, specifically in areas such as allergy treatments, cholesterol-reducing drugs, urinary disorders treatments and hormones treatments are expected to make the most impact.

There are several companies that compete heavily in this market and use the Rx-to-OTC switch as a major part of their life-cycle management arsenal. Companies involved in the Rx-to-OTC switched market include brand, generic, and private label manufacturers. Competition will likely continue to be moderate in the OTC market, especially with the patent expiration of key products nearing. Consolidation remains a major factor in this market. Most major players have made a significant acquisition or formed a strategic alliance to increase revenues and drive growth. Product innovation, line extensions and strong promotional support are a few of the top strategies for growth in this industry.

Leading competitors offering key brand products are provided in this report. These companies include:

• Bayer Healthcare
• Boehringer Ingelheim
• GlaxoSmithKline
• Insight Pharmaceuticals
• Johnson & Johnson
• Merck
• Novartis
• Pfizer
• Prestige Brands
• Procter & Gamble
• Reckitt Benckiser
• Sanofi (Chattem)
• TEVA

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Person-to-person, email and telephone interviews were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with approximately 50 industry officials, consultants, health providers, company representatives and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, business development managers, division managers, and product representatives.

All market data pertains to the U.S. market at the manufacturers’ level. The base year for data was 2012. Historical data are provided for 2007 through 2011, with forecast data provided for 2013 through 2017. Compound annual growth rates (CAGRs) are provided for the 2007-2012, 2012-2017 and 2007-2017 periods for each industry segment covered."