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Market Research Report

Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders

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Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders
Published: October 5, 2017 Content info: 72 Pages
Description

Summary

Rx-to-OTC switching is the process of transferring Rx pharmaceuticals to non-prescription OTC status for the same dosage form, population, and route of administration. OTC drugs are defined as those that are safe and effective for use by the general public without requiring intervention from a healthcare professional to obtain the product. Therefore, OTC medicines are available through a far wider range of channels than Rx drugs, including pharmacies, department stores and E-commerce.

Drug switches can therefore make access to treatments much easier for patients. This offers the added benefit of freeing general practitioners from spending office time on minor issues or chronic conditions that patients can manage on their own.

For pharmaceutical companies, Rx-to-OTC switches allow lifecycle extension of an off-patent drug, moving it from an environment in which healthcare providers drive sales to one in which patients select their own medications and will often demonstrate brand loyalty towards the original drug. In general, the broadened availability of OTC products can often mean that sales of the drug will increase, in spite of the lower price point at which such drugs are sold.

Based on overall revenue, the OTC pharmaceutical market has been dominated by four main categories: cough, cold, and allergy; analgesics; dermatologicals; and gastrointestinals. These categories have led the OTC drugs market over the last two decades in revenue and volume.

Key barriers to switching include the potential for misuse and abuse of drugs, particularly for analgesics, and the resultant need to demonstrate safety and clear labelling to regulatory agencies. A lack of harmonization in OTC approval processes between different countries also increases the burden for companies that want to launch their products across multiple territories.

The report "Current and Future Trends in Rx-to-OTC Switching with Insight from Key Industry Opinion Leaders" analyzes contemporary trends in Rx-to-OTC switching, a process in which a drug which has formerly been marketed as a prescription-only Rx drug is authorized for sale to the general public, without the need for a prescription.

Companies mentioned in this report: Teva Pharmaceutical Industries, Novartis, Bayer, GlaxoSmithKline, Mylan, GlaxoSmithKline, Perrigo Company, Valeant, Pharmaceuticals International Inc, Grifols, Mallinckrodt.

Scope

  • What are the characteristics of an ideal Rx-to-OTC switching candidate?
  • How well have recent Rx-to-OTC switches performed, and into which therapeutic categories do they fall?
  • What are the key drivers and barriers of the global OTC market?
  • What are the key future trends that will influence the OTC market and Rx-to-OTC switches worldwide?
  • Which disease areas do industry professionals believe to hold the most opportunity for switches?
  • Which geographies hold the most potential for an OTC product, and which are the most amenable to Rx-to-OTC switching?

Key Reasons to Purchase

  • Gain a thorough understanding of Rx-to-OTC switching, including key concepts, the regulatory environment and geographic variations.
  • Understand the competitive environment of key disease areas in the OTC product space.
  • Identify the drug classes and indications which pharmaceutical professionals around the world believe hold the most opportunity for Rx-to-OTC switching.
  • Understand in depth the key trends driving and holding back the OTC market, both globally and within specific geographies.
  • Identify the geographies that are poised for growth, and those at the highest risk of experiencing reverse switching of products from OTC-to-Rx.
  • Understand which companies have been the most active in pursuing mergers and acquisitions in the OTC space.
Table of Contents
Product Code: GBI084CBR

Table of Contents

1 Table of Contents 3

  • 1.1 List of Tables 5
  • 1.2 List of Figures 5

2 Rx-to-OTC Switching Overview 7

  • 2.1 What is Rx-to-OTC switching? 7

3 Leading Product Categories in the OTC Drugs Market 10

  • 3.1 Cough, Cold and Allergy OTC Drugs 10
    • 3.1.1 Overview 10
    • 3.1.2 Market Analysis 11
  • 3.2 Analgesics 12
    • 3.2.1 Overview 12
    • 3.2.2 Internal Analgesics 12
    • 3.2.3 External Analgesics 12
    • 3.2.4 Market Analysis 12
  • 3.3 Dermatology 13
    • 3.3.1 Overview 13
    • 3.3.2 Market Analysis 14
  • 3.4 Gastrointestinal 14
    • 3.4.1 Overview 14
    • 3.4.2 Market Analysis 15
  • 3.5 Erectile Dysfunction and Premature Ejaculation as Potential Future Segments 15
    • 3.5.1 Erectile Dysfunction 15
    • 3.5.2 Premature Ejaculation 17
  • 3.6 Which are the Fastest Growing Segments According to Industry Professionals? 18
  • 3.7 Which Treatment Segments are Most Likely to Experience Future Rx-to-OTC Switches? 19
  • 3.8 Which Indications are Most Likely to Experience Future Rx-to-OTC Switches? 20

4 Rx-to-OTC Switch Case Studies 23

  • 4.1 Xyzal Allergy 24HR 23
    • 4.1.1 Overview 23
    • 4.1.2 Switch Benefits 23
    • 4.1.3 Financial Impact of Switch 23
  • 4.2 Differin Gel, 0.1% 23
    • 4.2.1 Overview 23
    • 4.2.2 Switch Benefits 24
    • 4.2.3 Financial Impact of Switch 24
  • 4.3 Nexium 24HR 24
    • 4.3.1 Overview 24
    • 4.3.2 Switch Benefits 25
    • 4.3.3 Financial and Economic Impact of Switch 25
  • 4.4 Nasacort Allergy 24HR 25
    • 4.4.1 Overview 25
    • 4.4.2 Switch Benefits 25
    • 4.4.3 Financial Impact of Switch 26
  • 4.5 Oxytrol For Women 26
    • 4.5.1 Overview 26
    • 4.5.2 Switch Benefits 26
    • 4.5.3 Financial Impact of Switch 27

5 OTC Market Drivers and Barriers 28

  • 5.1 Market Drivers 28
  • 5.2 Market Barriers 28

6 Future Trends in the OTC Drugs Market and Rx-to-OTC Switches 30

  • 6.1 Growing Global Market for OTC Products 30
  • 6.2 Growing Consumer Interest in OTC Products 30
  • 6.3 Will there be an Increase in Rx-to-OTC Switching? 31
  • 6.4 Opinions as to the Benefits of Rx-to-OTC Switching for Healthcare Systems are Mixed 32
  • 6.5 Changes to the US Healthcare System will Increase Demand for OTC Products 33
  • 6.6 The Importance of Marketing 34
  • 6.7 Personalized Therapy an Attractive Concept 34
  • 6.8 Industry Professionals Believe Motivation of Patients to Self-Treat Disease and Clear Label Instructions to be Strong Criteria for Successful Rx-to-OTC Switching 36
  • 6.9 Impact of Smart Healthcare 37
    • 6.9.1 Self-Diagnosis 38
    • 6.9.2 Health Management 39
  • 6.10 Impact of E-Commerce 40
    • 6.10.1 Online Pharmacies 40
  • 6.11 Other Trends to Consider 43
    • 6.11.1 Increasing Elderly Population 43
    • 6.11.2 Increasing Industrialization and Pollutants 43
    • 6.11.3 Sedentary Working Environments 43
    • 6.11.4 Fast-Paced and Stressful Lifestyles 43

7 Current Regulations and Recent Developments in Key Markets 44

  • 7.1 US 44
    • 7.1.1 OTC Drug Regulations in the US 44
    • 7.1.2 FDA Principles and Requirements for Rx-to-OTC Switches 45
    • 7.1.3 US Regulations for Rx-to-OTC Switches: Approval Process 45
    • 7.1.4 FDA-Approved OTC Switches 1976-2016: Trends and Developments 46
    • 7.1.5 Will Switching Improve Patient Care? 47
    • 7.1.6 List of Rx-to-OTC Switched Products from 2012 to August 2017 48
  • 7.2 Europe 49
    • 7.2.1 European Regulatory Guidelines for OTC Drugs 49
    • 7.2.2 Need for Increased Harmonization of Regulatory Process in Europe 50
    • 7.2.3 Further Regulatory Requirements for OTC Switches in Europe 50
    • 7.2.4 Will Switching Improve Patient Care in the EU? 51
    • 7.2.5 Brexit, Boots and the UK 52
  • 7.3 Asia-Pacific 53
    • 7.3.1 Key Historical Developments in Japan 53
    • 7.3.2 India 53
    • 7.3.3 China 55

8 Other Geographic Trends and Insights 56

  • 8.1 Australia 56
  • 8.2 Canada 56
  • 8.3 China 57
  • 8.4 Germany 58
  • 8.5 Poland 58
  • 8.6 South Korea 59
  • 8.7 Sweden 59
  • 8.8 Russia 60
  • 8.9 Greatest Revenue-Generating OTC Markets 60
  • 8.10 In Which Countries is Reverse Switching a Possibility? 61

9 Mergers and Acquisitions: Trends in the OTC Drugs Market 62

  • 9.1 OTC Mergers and Acquisition Trends 62
    • 9.1.1 Almost Half of Deals Had an Undisclosed Value 62
    • 9.1.2 Companies Focus on Acquisitions and Asset Transactions 64
    • 9.1.3 Leading Companies Continue to Consolidate Market Position 65
  • 9.2 Companies with Multiple M&A Deals in Recent Years 65

10 Appendix 66

  • 10.1 Abbreviations 66
  • 10.2 References 67
  • 10.3 Report Methodology 71
  • 10.4 About GBI Research 71
  • 10.5 Disclaimer 71

1.1 List of Tables

  • Table 1: Criteria for Rx-to-OTC Switching Candidates 8
  • Table 2: Rx-to-OTC Switching, Selected Key Brands in the OTC Cough, Cold and Allergy Market 10
  • Table 3: Rx-to-OTC Switching, Selected Key Brands in the OTC Analgesics Market 12
  • Table 4: Rx-to-OTC Switching, Selected Key Brands in the OTC Dermatology Market 13
  • Table 5: Rx-to-OTC Switching, Selected Key Brands in the OTC Gastrointestinal Market 14
  • Table 6: Rx-to-OTC Switch, FDA Approved OTC Switches, 2012-2017 48
  • Table 7: Rx-to-OTC Switching, Countries of Residence of Survey Respondents that Unanimously Answered with Either Agree or Disagree, GBI Research Survey, 2017 51
  • Table 8: Criteria for Rx-to-OTC Switching Candidates 53
  • Table 9: Rx-to-OTC Switching, Major Companies with Recent OTC M&A Activity, 2013-2016 65
  • Table 10: Rx-to-OTC Switching, Major Companies with Recent OTC M&A Activity, 2012-2017 65

1.2 List of Figures

  • Figure 1: Key Considerations When Switching Products from Rx to OTC Status 8
  • Figure 2: Rx-to-OTC Switching, Leading OTC Product Categories and Examples, 2017 10
  • Figure 3: Rx-to-OTC Switching, Cough and Cold OTC Products, Market Size ($bn), 2016 11
  • Figure 4: Rx-to-OTC Switching, Analgesics OTC Products, Key Markets, Market Size ($bn), 2016 13
  • Figure 5: Rx-to-OTC Switching, Dermatology OTC Products, Key Markets, Market Size ($bn), 2016 14
  • Figure 6: Rx-to-OTC Switching, Gastrointestinal OTC Products, Key Markets, Market Size ($bn), 2016 15
  • Figure 7: Rx-to-OTC Switching, Likelihood of Faster than Average Growth of OTC Segments, GBI Research Survey, Global, 2017 18
  • Figure 8: Rx-to-OTC Switching, Likelihood of OTC Segments Experiencing Rx-to-OTC Switches Within the Next Five Years, GBI Research Survey, Global, 2017 19
  • Figure 9: Rx-to-OTC Switching, Likelihood of Specific Indications Experiencing Rx-to-OTC Switches Within the Next Five Years, GBI Research Survey, Global, 2017 20
  • Figure 10: Rx-to-OTC Switching, Likelihood of Specific Indications Experiencing Rx-to-OTC Switches Within the Next Five Years, GBI Research Survey, US, 2017 20
  • Figure 11: Rx-to-OTC Switching, Likelihood of Specific Indications Experiencing Rx-to-OTC Switches Within the Next Five Years, GBI Research Survey, EU, 2017 21
  • Figure 12: Rx-to-OTC Switching, Likelihood of Specific Indications Experiencing Rx-to-OTC Switches Within the Next Five Years, GBI Research Survey by Professional Group, Global, 2017 22
  • Figure 13: Rx-to-OTC Switching, Percentage of US and EU Respondents that Believe there will be an Increase in Interest in Rx-to-OTC switching, GBI Research Survey 2017 31
  • Figure 14: Rx-to-OTC Switching, Percentage of Survey Respondents that Believe that Rx-to-OTC Switching will Substantially Relieve Pressures on Healthcare Systems, Global, GBI Research Survey 2017 32
  • Figure 15: Rx-to-OTC Switching, Percentage of US and EU Survey Respondents that Believe that Rx-to-OTC Switching will Substantially Relieve Pressures on their National Healthcare System, Global, GBI Research Survey 2017 32
  • Figure 16: Rx-to-OTC Switching, Trends in Consumer Attitude Towards Personal Healthcare 34
  • Figure 17: Rx-to-OTC Switching, Trends in Consumer Appeal of OTC Concepts 35
  • Figure 18: Rx-to-OTC Switching, Perceived Key Strategies for a Successful Rx-to-OTC Switch, 2017 36
  • Figure 19: Rx-to-OTC Switching, Most Popular Healthcare Apps, 2017 38
  • Figure 20: Rx-to-OTC Switching, Trends in Consumer Self-Diagnosis, 2017 39
  • Figure 21: Rx-to-OTC Switching, Trends in Consumer use of Smart Healthcare, 2017 40
  • Figure 22: Rx-to-OTC Switching, GBI Research Survey Respondent Opinion on Whether E-commerce has a Significant Effect on Rx-to-OTC Switching Prospects, Global, 2017 42
  • Figure 23: Rx-to-OTC Switching, GBI Research Survey Respondent Opinion on Whether E-commerce has a Significant Effect on Rx-to-OTC Switching Prospects, Global, 2017 42
  • Figure 24: Rx-to-OTC Switching, General Overview of OTC Drug Applications to Regulatory Bodies 44
  • Figure 25: Rx-to-OTC Switching, US Rx-to-OTC Switch Regulatory Process, Flow Diagram 46
  • Figure 26: Rx-to-OTC Switching, FDA-Approved OTC Switches, 1976-2016 47
  • Figure 27: Rx-to-OTC Switching, Survey Respondent Level of Agreement with the Statement 'Rx-to-OTC Switching Will Improve Patient Care in Your Country, US, 2017 47
  • Figure 28: Rx-to-OTC Switching, Survey Respondent Level of Agreement with the Statement 'Rx-to-OTC Switching Will Improve Patient Care in Your Country, EU, 2017 51
  • Figure 29: Rx-to-OTC Switching, Frequency of OTC Drug Consumers by Condition, India, 2017 54
  • Figure 30: Rx-to-OTC Switching, Countries that Represent the Greatest OTC Revenue-Generating Potential, GBI Research Survey, 2017 60
  • Figure 31: Rx-to-OTC Switching, Survey Respondent Opinion on the Likelihood of Reverse Switching within Their Country Within the Next Five Years, GBI Research Survey, US, 2017 61
  • Figure 32: Rx-to-OTC Switching, OTC M&A Deals, Number of Deals, 2010-2017 62
  • Figure 33: Rx-to-OTC Switching, OTC M&A Deals, Aggregate and Average Disclosed Deal Values and Share of Disclosed and Undisclosed Deal Values, 2010-2017 63
  • Figure 34: Rx-to-OTC Switching, OTC M&A Deals, Share of Disclosed Deals by Subtype, 2010-2017 64
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