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

Rx-to-OTC switching is the 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. For patients and healthcare providers, OTC products can reduce the cost of medical treatment and allow easier access of drugs to patients, and for pharmaceutical companies, they allow lifecycle extension of an off-patent drug by transferring it to the consumer environment, and facilitate renewed revenue growth.

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.

GBI Research conducted a targeted industry survey of experts and key opinion leaders (KOL) in the field of Rx-to-OTC switching to gather insight and opinions on the trends and commercial prospects of switching pharmaceuticals. The majority of these respondents believe that there will be an increase in Rx-to-OTC switching in the next five years, particularly in the weight control, dermatological and cough, cold and allergy segments.

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.

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.

Reasons to buy

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

Summary

Rx-to-OTC switching is the 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. For patients and healthcare providers, OTC products can reduce the cost of medical treatment and allow easier access of drugs to patients, and for pharmaceutical companies, they allow lifecycle extension of an off-patent drug by transferring it to the consumer environment, and facilitate renewed revenue growth.

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.

GBI Research conducted a targeted industry survey of experts and key opinion leaders (KOL) in the field of Rx-to-OTC switching to gather insight and opinions on the trends and commercial prospects of switching pharmaceuticals. The majority of these respondents believe that there will be an increase in Rx-to-OTC switching in the next five years, particularly in the weight control, dermatological and cough, cold and allergy segments.

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.

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

1 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

List of Tables

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

List of Figures

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

    Pricing

Quick Buy
Add to basket Request sample pages

Discounts available for multiple purchases.

reportstore@marketline.com
+44 20 7947 2960

Saved reports