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疼痛治療薬市場における発展:侵害受容性および神経因性疼痛治療薬の開発

Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development

発行 Espicom Business Intelligence 商品コード 227842
出版日 ページ情報 英文 126 Pages
納期: 即日から翌営業日
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疼痛治療薬市場における発展:侵害受容性および神経因性疼痛治療薬の開発 Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development
出版日: 2012年01月05日 ページ情報: 英文 126 Pages
概要

疼痛(痛み)は世界中で15億人の人々に影響を及ぼします。多くの場合、痛みは一時的なもので、一般的に入手可能な鎮痛薬で治療することができます。しかし、一部の人にとっては、疼痛は身体を衰弱させる慢性的な症状です。欧州では、人口のおよそ2割が慢性的な疼痛に苦しんでいます。人口の高齢化に伴い、特に骨関節炎などの症状による慢性的な疼痛を抱える人の数が増えつつあります。また、慢性的な疼痛は癌と関連付けられます。全ての癌患者のおよそ30%が疼痛の症状に見舞われており、その比率は末期癌患者では倍増します。近年、疼痛治療薬の開発は、既存薬品グループの安全性および効能の向上のため、既存治療薬の改質および薬物送達の代替モードの開発に主眼が置かれています。

当レポートでは、疼痛治療薬市場を取り上げ、市場概要、疼痛の種類、治療オプション、および将来の展望をまとめ、疼痛治療用に臨床開発中の75種類の薬剤を紹介するなど、概略下記の構成でお届けいたします。

序文

エグゼクティブサマリー

市場分析

  • 現在の市場
    • 主要な疼痛治療
    • 主要な企業
  • 疼痛の種類
    • 急性および慢性の疼痛
    • 侵害受容性疼痛および神経因性疼痛
    • 心因性疼痛
  • 現在の指導および治療オプション
    • 癌性疼痛
    • 神経因性疼痛
  • 将来の市場
  • 開発中の製品
  • オピオイド乱用抑止剤
    • Acura PharmaceuticalsのAversion技術
    • Collegium PharmaceuticalのDETERx技術
    • DurectのOradur技術
    • Grunenthalの不正開封防止処方
  • 競合他社比率の分析

製品分析

  • 神経因性疼痛
    • シンバルタ(デュロキセチン)
    • 概念実証/臨床データ
    • 開発リスク
    • Lyrica(pregabalin)
    • Lidoderm/Versatis(リドカイン)
    • Qutenza/NGX-1998(カプサイシン)
    • Sativex(nabiximols)
  • 神経因性疼痛用に開発中
    • Horizant(ガバペンチンエナカルビル)
    • Nuedexta(デキストロメトルファン+キニジン)
    • Zebinix(エスリカルバゼピン酢酸塩)
    • AGN-214868
    • ARA290
    • AZD2066
    • AZD2423
    • E2007(perampanel)
    • EMA401
    • KRN5500
    • NT-11624(ジミラセタム)
    • CNV1014802
  • 侵害受容性疼痛
    • セレブレックス(セレコキシブ)
    • Duragesic(フェンタニル)
    • オキシコンチン(オキシコドン)
    • Oxecta(オキシコドン)
    • Opana/Opana ER(オキシモルホン)
    • Palexia/Nucynta(タペンタドール)
    • Vimovo(ナプロキセン+エソメプラゾール)
    • BuTrans/Norspan(ブプレノルフィン)
  • 侵害受容性疼痛用に開発中
    • Remoxy(オキシコドン)
    • MoxDuo IR(モルヒネ+オキシコドン)
    • ALO-02(オキシコドン+ナルトレキソン)
    • COL-003(オキシコドン)
    • Eladur(ブピバカイン)
    • Zohydro(酒石酸水素ヒドロコドン)
    • NP2エンケファリン
    • Tanezumab
    • ARRY-797

情報源

  • Espicom情報源

索引

図表

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目次

Abstract

Summary

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.

Description

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?
  • Grunenthal'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?

Table of 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/Napp Pharmaceuticals 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
      • Generic Company 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

  • Espicom 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
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