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Market Research Reports: Rx-to-OTC Switch

Rx-to-OTC Switch USA: New Paradigm for Growth
Published January 2014
Base Year: 2013
Forecasts Through: 2018

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  • Description
  • Regional Coverage: United States
    DESCRIPTION Download

    This report provides subscribers with a comprehensive, objective assessment of the Rx-to-OTC switch landscape including analysis of recently approved switches and forecasts of future switches in the United States. This analysis provides forecasts of future switches in existing OTC categories and projections for new OTC or BTC categories. The study provides:

    • Assessment of recently approved switch brands including coverage of:
      – Comparison of Rx and OTC sales and share
      – Review of switch application and approval
      – OTC market exclusivity
      – OTC market performance to date
      – Branded and private-label OTC competition
      – Marketing and advertising strategy
      – Pricing
      – Sales and share projections
    • Analysis of regulatory and retail paradigm shifts and implications for future switches
    • Broad assessment of “switchable” OTC and BTC categories
    • Specific analysis and forecasts of most likely switch categories.
    Featuring: Kline’s Interactive FutureView Forecasting Model.
  • Contents
  • Introduction

    Executive Summary
    An executive briefing including regulatory criteria for switches, review of recent switches, overview of expected switch paradigm shifts, forecasts for categories that have potential to switch in the future, and impacts of key trends and switches on the OTC market in the future.

    Recently Approved Switch Brands
    Assessment of brands shown in Table 1 below including overview of the condition, overview of the drug, Rx and OTC comparison, review of switch application/approval, market exclusivity, market performance, branded and private-label competition, marketing and advertising strategy, pricing, and projections.

    Future Switch Categories
    Specific forecasts for future switches for the categories shown in Table 2 below, including overview of the condition, comparative analysis of Rx and OTC markets (where applicable), regulatory issues, including patent expiration data, safety/efficacy, potential OTC indications and claims, likelihood of switch and expected timing, sales forecasts, expected competitive response from both branded and private-label products.
    FutureView Forecasting Model

    Table 1: Recently Approved Switch Brands
    Allegra (Sanofi), Zyrtec (Johnson & Johnson)
    Prevacid 24 Hour (Novartis), Zegerid OTC (Merck)
    Plan B (Teva Pharmaceuticals)
    Zaditor (Novartis)
    Miralax (Merck)
    Oxytrol (Merck)
    Alli (GlaxoSmithKline)

    Table 2: Future Switch Forecasts
    Acne (topical retinoids)
    Analgesics (COX2 inhibitors and muscle relaxants)
    Digestives/GI (PPIs)
    Digestives/GI (IBS)
    Benign prostatic hyperplasia (BPH)
    Cholesterol add (statins and blockers)
    Sleeping aids
    Topical skin rash products (eczema and psoriasis)
    Upper respiratory (oral and nasal allergy medications)
    Upper respiratory (leukotriene inhibitors)
    Upper respiratory (codeine cough syrups)
  • Scope
  • Rx-to-OTC Switch USA: New Paradigm for Growth is an extensive industry resource used by sales, marketing, and business development executives in the pharmaceutical industry for competitive analysis, market investigation, acquisition screening, business planning, and strategic purposes. This is the 10th edition in Kline’s long running series of reports on Rx-to-OTC switch and seeks to understand how paradigm shifts in regulations, retail, and technology may be game changers and open up new opportunities for medications to move along the prescription to OTC continuum.

    Recently, there have been meetings in the industry exploring new paradigms for switch which could involve post marketing surveillance, use of Rx data, cooperative efforts between drug manufacturers and retailers, technology to aid consumers when making purchase decisions and using switch medications, and more emphasis on consumer and healthcare professional education of switch medications. This report provides analysis of the future paradigm changes in switch and uncover opportunities for future switches as a result. The recent approval of the Rx-to-OTC switch of Merck's Oxytrol for Women OAB treatment after one advisory panel vote signals a willingness on the part of FDA to switch more products and create entirely new nonprescription categories. The FDA also approved the first nasal steroid for allergy treatments as an OTC with Sanofi's Nasacort Allergy 24HR.

    Subscribers also have access to Kline’s Interactive FutureView Forecasting Model. With Rx-to-OTC switches, a variety of factors are at play in each market that can affect the timing of switches. Competitive pressures, regulatory hurdles, and patent expirations each play significant roles in switch timing. Therefore, each drug is analyzed on a case-by-case basis, and the forecast time horizon may differ for each. Most forecasts are through 2018; however, this may vary depending on various variables and will be noted as such.

  • Key Benefits
  • For pharmaceutical marketers, Rx-to-OTC Switch USA: New Paradigm for Growth examines key issues and implications that switches can have on the existing OTC business and identifies opportunities for future growth from switches. Accurately predicting Rx-to-OTC switches and assessing their impact is crucial for maximizing business opportunities, minimizing threats, and successfully constructing long term strategic plans. Specifically, the report provides subscribers with the following key deliverables:

    • Up-to-date primary research on switches conducted with knowledgeable industry participants
    • An objective perspective on future switches
    • Realistic assessment of paradigm shifts and future implications
    • An understanding of implications of future switches for existing OTC or BTC categories
    • Identification of future opportunities by identifying categories with high likelihood of switch, with what timing, and forecasting sales potential

    Forecasts in this report are generated with Kline's interactive, web-based FutureView Forecasting Model. With enhanced forecasts, subscribers can see Kline’s assumptions and can make adjustments to the assumptions to see how the changes impact sales forecasts.

  • Methodology
  • As the leading consultancy on Rx-to-OTC switches, Kline has developed a program based heavily on primary research (field and phone interviews) that has proven to be most effective and reliable in preparing switch forecasts. The forecasts, data, and insights provided in this report are based on both primary and secondary sources, building on Kline & Company's extensive database of OTC industry information. Rx-to-OTC Switch USA: New Paradigm for Growth leverages our contacts in the industry and employs the use of primary research to capture insights and information available from a wide range of industry experts and opinion leaders. Kline's seasoned consultants conducted detailed in-person and telephone interviews with the following knowledgeable stakeholders: executives in the OTC and Rx industry, regulators, retailers, pharmacists, trade associations, consultants, attorneys, and others.

    In addition to primary research, the study draws upon relevant secondary data, including regulatory information obtained from the FDA and trade associations and patent searches. In forecasting Rx-to-OTC switches, a variety of factors are at play in each market that can affect the timing of switches. Competitive pressures, regulatory hurdles, and patent expirations each play significant roles in switch timing. Therefore, each category is analyzed on a case-by-case basis, and the forecast time horizon may differ for each, though most forecasts are through 2018.

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