Keywords : opioid, Drug, analgesic, oxycodone, Pregabalin, Cymbalta, Lidocaine, Tapentadol, Hydrocodone bitartrate, Fentanyl, Quinidine, Naproxen
Pain Therapy Drugs Market As the market evolves over the next decade current market leaders will lose patent expiry and become subject to generic competition. What’s in the pipeline and which companies and products will prosper? Pain affects around 1.5 billion people worldwide. In most cases, pain is temporary and easily treated with commonly available analgesics. For some people, however, pain is a debilitating, chronic condit...
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Pain Therapy Drugs Market
As the market evolves over the next decade current market leaders will lose patent expiry and become subject to generic competition. What’s in the pipeline and which companies and products will prosper?
Pain affects around 1.5 billion people worldwide. In most cases, pain is temporary and easily treated with commonly available analgesics. For some people, however, pain is a debilitating, chronic condition. In Europe, an estimated 20% of the population suffers from chronic pain. As the population ages, the number of people with chronic pain is increasing, particularly from conditions such as osteoarthritis. Chronic pain is also associated with cancer. An estimated 30% of all cancer patients are in pain with the proportion more than doubling among people with late-stage cancer. In recent years, drug development in pain therapy has been focused mainly on reformulations of existing therapies and alternative modes of drug delivery in order to improve the safety and efficacy of existing drug groups.
Drugs of the future
This report identifies 75 agents in clinical development for pain indications, of which 26 are in development for neuropathic pain. Among these, six are specifically targeting postherpetic neuralgia. Other indications specified, include: diabetic peripheral neuropathy, central neuropathic pain due to spinal cord injury or multiple sclerosis (MS), neuropathic pain in cancer, lumbosacral radiculopathy, and painful neuropathies affecting AIDS patients. Nociceptive pain indications being targeted by developers,
include: osteoarthritis pain and chronic low back pain.
This report answers key questions on:
What is the current clinical understanding of pain?
What is the status of, and commercial prospects for, currently available pain therapies?
What drugs are in the pipeline and what is their status?
Which companies are set to win, and which to lose, as the pain sector develops over the next 5 years?
While highly competitive, pain remains a sector of high unmet clinical need with excellent opportunities in niche markets
While the pain market is fragmented and highly competitive, it remains an area of high unmet need as current therapies are often less than effective and/or have undesirable side-effects. A number of new drugs are poised to take market share, with Palexia/Nucynta (tapentadol) widely tipped to be among the up and coming market leaders. As the market continues to evolve over the next decade, the current market leaders will lose patent expiry and become subject to generic competition and consequent price erosion. It is generally agreed that sales of novel treatments are unlikely to entirely replace the revenue lost following patent expiry of the current top five. However, there will be opportunities in underserved niche market segments, particularly neuropathic pain, which typically fails to respond adequately to conventional analgesics.
Lessons in OTC switching
The pain sector is ideal for OTC switching and is a means of mitigating the effects of generic competition. A good example is Novartis’ former blockbuster, Voltaren (diclofenac), which was re-launched as an OTC product in 1999 and is now the company’s leading OTC brand. The prescription product still maintains relatively strong sales, however, due to long-term trust in the brand in markets in Latin America, the Middle East, Africa and Asia. In 2010, sales of Voltaren (excluding OTC) amounted to US$791 million.
Tackling Opioid Abuse
Opioid abuse is a widely known problem, particularly in the US. Prescription drug abuse in the US is the country’s fastest growing drug abuse problem and has been directly correlated to a dramatic increase in the number of prescriptions filled for opioids. According to the Office of National Drug Control Policy, between 1997 and 2007, the milligram-per-person use of prescription opioids in the US increased from 74mg to 369mg while the number of prescriptions for opioids dispensed by retail pharmacies rose from 174 million in 2000 to 257 million in 2009. In 2007, the number of deaths from unintentional overdose of opioids in the US was 11,499, compared with just 2,901 in 1999. Despite the potential for abuse, however, opioids remain important in the treatment of moderate to severe chronic pain and several companies such as Acura and Collegium are developing formulations aimed at deterring abuse.
"...Who are the players, and what are the products, that will shape this US$46 billion sector over the next 5 years...?"
Questions answered
To what extent will generic competition affect Lilly’s leading pain drug Cymbalta from 2013 onwards?
What legal challenges must Pfizer overcome if Lyrica is to achieve its forecast sales of US$4.2 billion in 2017?
What clinical benefits does GW Pharmaceuticals’ Sativex offer in the MS market and does the product have new indication opportunities?
Grünenthal’s Palexia/Nucynta (also marketed by Johnson & Johnson in the US) is widely tipped for rapid growth due to its dual action and better tolerability profile over its opioid competitors. But will these benefits be enough to challenge the lower price of generically available competitors in the future?
How did Pfizer improve its market share in 2011 in the pain sector?
What techniques are being employed to overcome opioid abuse?
Who is developing products that target cancer-related pain?
What do the market leaders have in their Phase I/II pipelines?
Drug And Medication Industry in the United States
Contents
FOREWORD 1
EXECUTIVE SUMMARY 3
MARKET ANALYSIS 4
CURRENT MARKET 4
Leading Pain Therapies 5
Opioid Analgesics 6
FDA Risk Evaluation and Mitigation Strategy for Opioids 7
Leading Companies 8
Endo Pharmaceuticals 8
Eli Lilly 8
Grünenthal 8
Johnson & Johnson 9
Pfizer 9
Purdue Pharma/Mundipharma/NappPharmaceuticals 9
TYPES OF PAIN 9
Acute and Chronic Pain 9
Nociceptive and Neuropathic Pain 10
Psychogenic Pain 10
CURRENT GUIDANCE AND TREATMENT OPTIONS 11
Cancer Pain 11
The World Health Organization’s Pain Ladder 11
Cancer Pain Complexity and a Case for Change 11
Neuropathic Pain 12
FUTURE MARKET 14
What’s in the Pipeline? 14
Opioid Abuse Deterrents 17
Acura Pharmaceuticals’ Aversion Technology 18
Collegium Pharmaceutical’s DETERx Technology 18
Durect’s Oradur Technology 19
Grünenthal’s Tamper Resistant Formulation 19
COMPETITOR RATIO ANALYSIS 20
PRODUCT ANALYSIS 22
NEUROPATHIC PAIN 22
Cymbalta (duloxetine) 22
Mode of Action 22
Approvals 22
Lifecycle Development 23
Proof of Concept/Clinical Data 23
Diabetic Peripheral Neuropathic Pain 23
Chronic Low Back Pain 24
Fibromyalgia 24
Development Risks 24
Company Expertise 24
Competition within the Marketplace 24
Patents 25
Generic Company Activity 25
Competitor Ratio Analysis 26
Sales Forecast 26
Lyrica (pregabalin) 28
Mode of Action 28
Approvals 28
Lifecycle Development 28
Proof of Concept/Clinical Data 29
Central neuropathic pain following spinal cord injury 29
Postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy 29
Fibromyalgia 29
Development Risks 29
Company Expertise 30
Competition within the Marketplace 30
Patents 30
Generic Company Activity 30
Competitor Ratio Analysis 31
Sales Forecast 31
Lidoderm/Versatis (lidocaine) 33
Mode of Action 33
Approvals 33
Lifecycle Development 33
Proof of Concept/Clinical Data 33
Development Risks 34
Company Expertise 34
Competition within the Marketplace 34
Patents 34
Generic Company Activity 35
Watson Pharmaceuticals 35
Mylan 35
Endo’s Citizen Petition Regarding Bioequivalence 36
Competitor Ratio Analysis 36
Sales Forecast 36
Qutenza/NGX-1998 (capsaicin) 38
Mode of Action 38
Approvals 38
Lifecycle Development 38
Qutenza 38
NGX-1998 38
Proof of Concept/Clinical Data 39
Development Risks 39
Company Expertise 39
Competition within the Marketplace 40
Patents 40
Competitor Ratio Analysis 40
Sativex (nabiximols) 41
Mode of Action 41
Approvals 41
Development 41
Proof of Concept/Clinical Data 41
Development Risks 42
Company Expertise 42
Competition within the Marketplace 43
Competitor Ratio Analysis 43
IN DEVELOPMENT FOR NEUROPATHIC PAIN 44
Horizant (gabapentin enacarbil) 44
Mode of Action 44
Approvals 44
Lifecycle Development 44
Proof of Concept/Clinical Data 44
Development Risks 45
Company Expertise 45
Competition within the Marketplace 45
Patents 45
Competitor Ratio Analysis 46
Nuedexta (dextromethorphan+quinidine) 47
Mode of Action 47
Approvals 47
Lifecycle Development 47
Proof of Concept/Clinical Data 47
Development Risks 48
Company Expertise 48
Competition within the Marketplace 48
Patents 48
Generic Company Activity 49
Competitor Ratio Analysis 49
Zebinix (eslicarbazepine acetate) 50
Mode of Action 50
Approvals 50
Lifecycle Development 50
Proof of Concept/Clinical Data 50
Development Risks 50
Company Expertise 51
Competition within the Marketplace 51
Competitor Ratio Analysis 51
AGN-214868 52
Mode of Action 52
Current Status 52
Proof of Concept/Clinical Data 52
Development Risks 52
Company Expertise 52
Competition within the Marketplace 53
Competitor Ratio Analysis 53
ARA290 54
Mode of Action 54
Current Status 54
Proof of Concept/Clinical Data 54
Development Risks 54
Company Expertise 54
Competition within the Marketplace 54
Competitor Ratio Analysis 55
AZD2066 56
Mode of Action 56
Current Status 56
Proof of Concept/Clinical Data 56
Development Risks 56
Company Expertise 56
Competition within the Marketplace 56
Competitor Ratio Analysis 57
AZD2423 58
Mode of Action 58
Current Status 58
Proof of Concept/Clinical Data 58
Development Risks 58
Company Expertise 58
Competition within the Marketplace 59
Competitor Ratio Analysis 59
E2007 (perampanel) 60
Mode of Action 60
Current Status 60
Proof of Concept/Clinical Data 60
Development Risks 60
Company Expertise 61
Competition within the Marketplace 61
Competitor Ratio Analysis 61
EMA401 62
Mode of Action 62
Current Status 62
Proof of Concept/Clinical Data 62
Development Risks 62
Company Expertise 62
Competition within the Marketplace 62
Competitor Ratio Analysis 63
KRN5500 64
Mode of Action 64
Current Status 64
Proof of Concept/Clinical Data 64
Development Risks 64
Company Expertise 64
Competition within the Marketplace 65
Competitor Ratio Analysis 65
NT-11624 (dimiracetam) 66
Mode of Action 66
Current Status 66
Proof of Concept/Clinical Data 66
Development Risks 66
Company Expertise 67
Competition within the Marketplace 67
Competitor Ratio Analysis 67
CNV1014802 68
Mode of Action 68
Current Status 68
Proof of Concept/Clinical Data 68
Development Risks 68
Company Expertise 68
Competition within the Marketplace 68
Competitor Ratio Analysis 69
NOCICEPTIVE PAIN 70
Celebrex (celecoxib) 70
Mode of Action 70
Approvals 70
Lifecycle Development 71
Proof of Concept/Clinical Data 71
Gastrointestinal Events 71
Development Risks 71
Cardiovascular and Gastrointestinal Risks 71
Company Expertise 72
Competition within the Marketplace 72
Patents 72
Generic Company Activity 73
Competitor Ratio Analysis 73
Sales Forecast 73
Duragesic (fentanyl) 75
Mode of Action 75
Approvals 75
Proof of Concept/Clinical Data 75
Development Risks 75
Company Expertise 76
Competition within the Marketplace 76
Competitor Ratio Analysis 76
Sales Forecast 76
OxyContin (oxycodone) 78
Mode of Action 78
Approvals 78
Proof of Concept/Clinical Data 78
Development Risks 78
Company Expertise 79
Competition within the Marketplace 79
Patents 79
Generic Company Activity 79
Competitor Ratio Analysis 80
Sales Forecast 80
Oxecta (oxycodone) 82
Mode of Action 82
Approvals 82
Lifecycle Development 82
Proof of Concept/Clinical Data 82
Development Risks 82
Company Expertise 83
Competition within the Marketplace 83
Patents 83
Competitor Ratio Analysis 84
Opana/Opana ER (oxymorphone) 85
Mode of Action 85
Approvals 85
Lifecycle Development 85
Proof of Concept/Clinical Data 86
Development Risks 86
Company Expertise 86
Competition within the Marketplace 86
Patents 86
Generic Company Activity 87
Competitor Ratio Analysis 88
Sales Forecast 88
Palexia/Nucynta (tapentadol) 90
Mode of Action 90
Approvals 90
Lifecycle Development 90
Proof of Concept/Clinical Data 91
Development Risks 91
Company Expertise 91
Competition within the Marketplace 92
Patents 92
Competitor Ratio Analysis 92
Sales Forecast 93
Vimovo (naproxen+esomeprazole) 94
Mode of Action 94
Approvals 94
Proof of Concept/Clinical Data 94
Development Risks 95
Company Expertise 95
Competition within the Marketplace 95
Patents 95
GenericCompany Activity 96
Competitor Ratio Analysis 97
Sales Forecast 97
BuTrans/Norspan (buprenorphine) 99
Mode of Action 99
Approvals 99
Lifecycle Development 99
Proof of Concept/Clinical Data 99
Development Risks 100
Company Expertise 100
Competition within the Marketplace 101
Patents 101
Competitor Ratio Analysis 101
IN DEVELOPMENT FOR NOCICEPTIVE PAIN 102
Remoxy (oxycodone) 102
Mode of Action 102
Current Status 102
Proof of Concept/Clinical Data 102
Development Risks 103
Company Expertise 103
Competition within the Marketplace 103
Competitor Ratio Analysis 104
MoxDuo IR (morphine+oxycodone) 105
Mode of Action 105
Current Status 105
Proof of Concept/Clinical Data 105
Development Risks 105
Company Expertise 105
Competition within the Marketplace 106
Competitor Ratio Analysis 106
ALO-02 (oxycodone+naltrexone) 107
Mode of Action 107
Current Status 107
Proof of Concept/Clinical Data 107
Development Risks 108
Company Expertise 108
Competition within the Marketplace 108
Competitor Ratio Analysis 108
COL-003 (oxycodone) 109
Mode of Action 109
Current Status 109
Proof of Concept/Clinical Data 109
Development Risks 109
Company Expertise 110
Competition within the Marketplace 110
Competitor Ratio Analysis 110
Eladur (bupivacaine) 111
Mode of Action 111
Current Status 111
Proof of Concept/Clinical Data 111
Development Risks 111
Company Expertise 111
Competition within the Marketplace 112
Competitor Ratio Analysis 112
Zohydro (hydrocodone bitartrate) 113
Mode of Action 113
Current Status 113
Proof of Concept/Clinical Data 113
Development Risks 113
Company Expertise 114
Competition within the Marketplace 114
Competitor Ratio Analysis 114
NP2 Enkephalin 115
Mode of Action 115
Current Status 115
Proof of Concept/Clinical Data 115
Development Risks 115
Company Expertise 115
Competition within the Marketplace 116
Competitor Ratio Analysis 116
Tanezumab 117
Mode of Action 117
Current Status 117
Proof of Concept/Clinical Data 117
Development Risks 118
Company Expertise 118
Competition within the Marketplace 118
Competitor Ratio Analysis 118
ARRY-797 119
Mode of Action 119
Current Status 119
Proof of Concept/Clinical Data 119
Development Risks 119
Company Expertise 119
Competition within the Marketplace 119
Competitor Ratio Analysis 120
SOURCES 121
Others 121
INDEX 122
List of Tables
Global Sales of Branded Drugs Used in Pain Management, 2010 (US$ Million) 5
Drugs Approved for Neuropathic Pain in the US and EU 13
Drugs in Development for Pain 14
Competitor Ratio Analysis Summary 21
Cymbalta US Patents 25
FDA Tentative ANDA Approvals for Duloxetine 26
Cymbalta Sales, 2010-2017 (US$ Million) 26
Lyrica US Patents 30
FDA Tentative ANDA Approvals for Pregabalin 31
Lyrica Sales, 2010-2017 (US$ Million) 31
Lidoderm US Patents 35
Lidoderm/Versatis Sales by Company, 2010-2017 (EUR & US$ Million) 37
Qutenza US Patents 40
Horizant US Patents 45
Nuedexta US Patents 49
Celebrex US Patents 72
Celebrex/Celecox Sales by Company, 2010-2017 (¥ & US$ Million) 74
Duragesic Sales, 2010-2017 (US$ Million) 76
OxyContin US Patents 79
OxyContin Sales, 2010-2017 (US$ Million) 80
Oxecta US Patents 83
Opana ER US Patents 87
FDA ANDA Approvals for Oxymorphone ER 87
Opana/Opana ER Sales, 2010-2017 (US$ Million) 88
Nucynta US Patents 92
Palexia/Nucynta Sales, 2010-2017 (US$ Million) 93
Vimovo US Patents 96
Vimovo Sales, 2011-2017 (US$ Million) 97
BuTrans US Patents 101
List of Figures
Global Pain Market by Country, 2011 (%) 4
NHS Opioid Analgesic Prescriptions by Volume, 2010 (%) 6
NHS Opioid Analgesic Prescriptions by Cost, 2010 (%) 7
Leading Companies in Pain Management by Revenue (%) 8
Cymbalta Sales Trend, 2007-2017 27
Lyrica Sales Trend, 2007-2017 32
Lidoderm/Versatis Sales Trend, 2008-2017 37
Celebrex/Celecox Sales Trend, 2007-2017 74
Duragesic Sales Trend, 2007-2017 77
OxyContin Sales Estimate, 2010-2017 81
Opana/Opana ER Sales Trend, 2007-2017 89
Palexia/Nucynta Sales Trend, 2009-2017 93
Vimovo Sales, 2011-2017 98
