Opioids Market to 2018 - Increasing Concentration of Abuse-Resistant Branded Generics Alter Competitive Dynamics in this Flat Market

Opioids Market to 2018 - Increasing Concentration of Abuse-Resistant Branded Generics Alter Competitive Dynamics in this Flat Market

Summary

Leading business intelligence provider GBI Research has released its latest research report, entitled “Opioids Market to 2018 - Increasing Concentration of Abuse-Resistant Branded Generics Alter Competitive Dynamics in this Flat Market”. The current opioids market is characterized by a very broad and highly diversified product portfolio. Patients experiencing moderate to severe pain for a range of underlying physiological reasons are virtually exclusively treated with opioid analgesics. As a result, most patient populations experiencing more severe levels of pain across most pain indications, with the exception of, for example, migraines, are heavily dominated by opioids. As a therapeutic drug class, opioids have virtually no competition from molecules with non-opioid receptor targets. However, although the competition is virtually exclusively limited to opioid compounds, the current environment within this therapeutic class is highly competitive and strongly diversified. The approved drugs are based on 16 different opioid compounds and are differentiated on a range of characteristics, which include dosage, route of administration and pharmacokinetic features, as well as increasingly on the basis of abuse-resistance technologies.

Whilst the prescription rates of opioid analgesic have seen a historically unprecedented increase over the last two decades, particularly in the US, this has resulted in a dramatic concomitant increase in opioid abuse and dependency. Over the last few years, the growing concern over opioid abuse has resulted in tighter regulations and increasingly vocal concerns by physicians. Due to these concerns from regulatory authorities and physicians about growing opioid abuse, there has been a seismic shift towards developing abuse-resistant formulations of extended-release opioid analgesics, including both novel products and reformulations of existing ones. Since the launch of the first abuse-resistant product, Embeda, in 2009, a whole range of novel products and reformulations of existing product ranges have been brought to the market. While abuse-resistant formulations do not confer any clinical benefits, they have become an essential differentiating factor in the current market environment in order ensure that products remain competitive for the future. There is a growing concentration and competition among abuse-resistant products, which is expected to be the primary driving factor in this largely stagnant market, particularly as the current developmental pipeline is very small and is characterized by a lack of innovation, with virtually no novel compounds and strong saturation across multiple pain indications.

Scope

- An overview of the current opioid product market.
- A brief discussion about the inconsistent prescription preferences among European physicians.
- A brief profile of the most important opioid products.
- A pipeline analysis of the opioid products currently in development and an overview of the developmental pipeline by phase, by the route of administration and a summary of the promising pipeline products.
- An overview of the M&A and licensing deals, as well as co-development deals, across multiple indications in which opioids are frequently used in patients suffering from moderate to severe pain.

Reasons to buy

- Identify trends in the developmental pipeline for opioid analgesics.
- Develop their awareness of the regulatory environment, physician concerns and inconsistency of prescription preferences among physicians.

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 7
2.1 Introduction 7
2.1.1 High Levels of Product Diversification in a Highly Competitive Market Environment 7
2.1.2 Inconsistent Clinician Prescribing Preferences 7
2.1.3 Ongoing Market Shift Towards Abuse-Resistant Product Formulations 8
2.1.4 Increasingly Vocal Physician Associations Raise Concerns About Extent of Opioid Abuse 9
2.1.5 Full Commercial Potential of Transdermal Patches May Have Yet to be Fully Exploited 9
3 Overview of Currently Marketed Products 10
3.1 Major Marketed Products 10
3.1.1 Oxycontin 10
3.1.2 Exalgo 10
3.1.3 Onsolis 10
3.1.4 Duragesic 11
3.1.5 Opana ER 11
3.1.6 Vicodin CR 11
3.1.7 Dolophine Hydrochloride 11
3.1.8 Oxecta 11
3.1.9 Actiq 12
3.1.10 Embeda 12
3.1.11 Kadian 12
3.1.12 Avinza 12
3.2 Market Drivers and Barriers 13
3.2.1 Drivers 14
3.2.2 Barriers 15
4 Pipeline Analysis 17
4.1 Introduction 17
4.2 Opioid Compounds in the Developmental Pipeline 20
4.3 Distribution by Route of Administration 23
4.4 Promising Pipeline Products 26
4.4.1 ARX-01, AcelRX Pharmaceuticals 26
4.4.2 ALO-02, Pfizer 26
4.4.3 Zohydro ER, Zogenix 26
4.4.4 ELI-216, Elite Pharmaceuticals 27
4.4.5 BEMA Buprenorphine 27
4.4.6 CEP-33237, Cephalon 27
5 Deals Analysis 28
5.1 Overview: 28
5.1.1 M&As by Year 28
5.1.2 M&As by Value 29
5.1.3 Major M&As 30
5.2 Licensing Agreements 33
5.2.1 Licensing Agreements by Year 33
5.2.2 Licensing Agreements by Value 34
5.2.3 Major Licensing Agreements 35
5.3 Co-Development Agreements 38
5.3.1 Deals by Year 38
5.3.2 Major Co-Development Deals 39
6 Appendix 40
6.1 Abbreviations 40
6.2 Bibliography 41
6.3 Research Methodology 41
6.3.1 Coverage 41
6.3.2 Secondary Research 42
6.3.3 Primary Research 42
6.3.4 Pipeline Analysis 42
6.3.5 Expert Panel Validation 42
6.4 Contact Us 43
6.5 Disclaimer 43

1.1 List of Tables
Table 1: Opioids Market, Global, R&D Pipeline Analysis by Phase, 2012 18

1.2 List of Figures
Figure 1: Opioids Market, Drivers and Barriers, 2012 13
Figure 2: Opioids Market, Global, R&D Pipeline by Phase (%), 2012 17
Figure 3: Opioids Market, Pipeline Analysis,,Opioid Compounds in Phase III 20
Figure 4: Opioids Market, Pipeline Analysis,,Opioid Compounds in Phase II 21
Figure 5: Opioids Market, Pipeline Analysis,,Opioid Compounds in Phase I 22
Figure 6: Opioids Market, Pipeline Analysis, Route of Administration for Pipeline Molecules Currently in Phase III 23
Figure 7: Opioids Market, Pipeline Analysis, Route of Administration for Pipeline Molecules Currently in Phase II 24
Figure 8: Opioids Market, Pipeline Analysis, Route of Administration for Pipeline Molecules Currently in Phase I 25
Figure 9: Opioids Market, M&As by Year, 2005–2012 28
Figure 10: Opioids Market, M&As by Value ($m), 2005–2012 29
Figure 11: Opioids Market, Licensing Agreements by Year, 2005–2012 33
Figure 12: Opioids Market, Licensing Agreements by Value ($m), 2005–2012 34
Figure 13: Opioids Market, Co-Development Agreements by Year, 2005–2012 38