Safety and caution characterize the next frontier of Rx-to-OTC switches

Rx-to-OTC Switch Forecasts
Rx-to-OTC Switch Forecasts

Companies are being more selective in the Rx-to-OTC switches they pursue, according to new research just published by Kline & Company in the 13th study in its venerable syndicated series, Rx-to-OTC Switch Forecasts USA: Next Frontier.

Safety is paramount, and the sophistication of clinical studies required to gain approval has increased the cost burden and risk to switch sponsors. Most future switches will depend on a combination of market-driven forces and safety, as determined by regulators. Many future switches will be characterized by the sponsor needing to overcome safety concerns with well-designed and well-executed trials that prove consumers can safely use the medication without the intervention of a healthcare professional.

Therefore, future switches are likely to be fewer in number and pursued by the largest companies that have the resources and multi-faceted management teams needed to gain approval, lead a successful OTC launch, and sustain commercially successful switch brands.

Categories with future switch potential analyzed in Kline’s latest study, Rx-to-OTC Switch Forecasts USA: Next Frontier, include:

  • Acne medications
  • Allergy medications
  • Benign prostatic hyperplasia
  • Digestives (PPIs)
  • Erectile dysfunction
  • Migraine
  • Overactive bladder
  • Skin rash/eczema/psoriasis
  • Sleeping aids
  • Topical pain relievers

Rx-to-OTC Switch Forecasts USA: Next Frontier provides a comprehensive, objective assessment of the Rx-to-OTC switch landscape, including forecasts of future switches in the United States. This report provides forecasts of switches in existing OTC categories and projections for new OTC categories. The study presents a broad assessment of “switchable” OTC categories, a specific analysis and forecasts of most likely switch categories and drugs, and an analysis of regulatory and retail paradigm shifts and implications for future switches.