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

Date: January 5, 2012
Pages: 126
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
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Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development
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?
FOREWORD

EXECUTIVE SUMMARY

MARKET ANALYSIS

CURRENT MARKET

Leading Pain Therapies
Opioid Analgesics
FDA Risk Evaluation and Mitigation Strategy for Opioids
Leading Companies
Endo Pharmaceuticals
Eli Lilly
Grünenthal
Johnson & Johnson
Pfizer
Purdue Pharma/Mundipharma/Napp Pharmaceuticals

TYPES OF PAIN

Acute and Chronic Pain
Nociceptive and Neuropathic Pain
Psychogenic Pain

CURRENT GUIDANCE AND TREATMENT OPTIONS

Cancer Pain
The World Health Organization’s Pain Ladder
Cancer Pain Complexity and a Case for Change
Neuropathic Pain

FUTURE MARKET

What’s in the Pipeline?
Opioid Abuse Deterrents
Acura Pharmaceuticals’ Aversion Technology
Collegium Pharmaceutical’s DETERx Technology
Durect’s Oradur Technology
Grünenthal’s Tamper Resistant Formulation

COMPETITOR RATIO ANALYSIS

PRODUCT ANALYSIS

NEUROPATHIC PAIN

Cymbalta (duloxetine)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Diabetic Peripheral Neuropathic Pain
Chronic Low Back Pain
Fibromyalgia
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
Lyrica (pregabalin)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Central neuropathic pain following spinal cord injury
Postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy
Fibromyalgia
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
Lidoderm/Versatis (lidocaine)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Watson Pharmaceuticals
Mylan
Endo’s Citizen Petition Regarding Bioequivalence
Competitor Ratio Analysis
Sales Forecast
Qutenza/NGX-1998 (capsaicin)
Mode of Action
Approvals
Lifecycle Development
Qutenza
NGX-1998
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Competitor Ratio Analysis
Sativex (nabiximols)
Mode of Action
Approvals
Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
IN DEVELOPMENT FOR NEUROPATHIC PAIN
Horizant (gabapentin enacarbil)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Competitor Ratio Analysis
Nuedexta (dextromethorphan+quinidine)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Zebinix (eslicarbazepine acetate)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
AGN-214868
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
ARA290
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
AZD2066
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
AZD2423
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
E2007 (perampanel)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
EMA401
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
KRN5500
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
NT-11624 (dimiracetam)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
CNV1014802
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
NOCICEPTIVE PAIN
Celebrex (celecoxib)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Gastrointestinal Events
Development Risks
Cardiovascular and Gastrointestinal Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
Duragesic (fentanyl)
Mode of Action
Approvals
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
Sales Forecast
OxyContin (oxycodone)
Mode of Action
Approvals
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
Oxecta (oxycodone)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Competitor Ratio Analysis
Opana/Opana ER (oxymorphone)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
Palexia/Nucynta (tapentadol)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Competitor Ratio Analysis
Sales Forecast
Vimovo (naproxen+esomeprazole)
Mode of Action
Approvals
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Generic Company Activity
Competitor Ratio Analysis
Sales Forecast
BuTrans/Norspan (buprenorphine)
Mode of Action
Approvals
Lifecycle Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Patents
Competitor Ratio Analysis
IN DEVELOPMENT FOR NOCICEPTIVE PAIN
Remoxy (oxycodone)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
MoxDuo IR (morphine+oxycodone)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
ALO-02 (oxycodone+naltrexone)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
COL-003 (oxycodone)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
Eladur (bupivacaine)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
Zohydro (hydrocodone bitartrate)
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
NP2 Enkephalin
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
Tanezumab
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis
ARRY-797
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Marketplace
Competitor Ratio Analysis

SOURCES

Espicom Sources
Others

INDEX

LIST OF TABLES

Global Sales of Branded Drugs Used in Pain Management, 2010 (US$ Million)
Drugs Approved for Neuropathic Pain in the US and EU
Drugs in Development for Pain
Competitor Ratio Analysis Summary
Cymbalta US Patents
FDA Tentative ANDA Approvals for Duloxetine
Cymbalta Sales, 2010-2017 (US$ Million)
Lyrica US Patents
FDA Tentative ANDA Approvals for Pregabalin
Lyrica Sales, 2010-2017 (US$ Million)
Lidoderm US Patents
Lidoderm/Versatis Sales by Company, 2010-2017 (EUR & US$ Million)
Qutenza US Patents
Horizant US Patents
Nuedexta US Patents
Celebrex US Patents
Celebrex/Celecox Sales by Company, 2010-2017 (¥ & US$ Million)
Duragesic Sales, 2010-2017 (US$ Million)
OxyContin US Patents
OxyContin Sales, 2010-2017 (US$ Million)
Oxecta US Patents
Opana ER US Patents
FDA ANDA Approvals for Oxymorphone ER
Opana/Opana ER Sales, 2010-2017 (US$ Million)
Nucynta US Patents
Palexia/Nucynta Sales, 2010-2017 (US$ Million)
Vimovo US Patents
Vimovo Sales, 2011-2017 (US$ Million)
BuTrans US Patents

LIST OF FIGURES

Global Pain Market by Country, 2011 (%)
NHS Opioid Analgesic Prescriptions by Volume, 2010 (%)
NHS Opioid Analgesic Prescriptions by Cost, 2010 (%)
Leading Companies in Pain Management by Revenue (%)
Cymbalta Sales Trend, 2007-2017
Lyrica Sales Trend, 2007-2017
Lidoderm/Versatis Sales Trend, 2008-2017
Celebrex/Celecox Sales Trend, 2007-2017
Duragesic Sales Trend, 2007-2017
OxyContin Sales Estimate, 2010-2017
Opana/Opana ER Sales Trend, 2007-2017
Palexia/Nucynta Sales Trend, 2009-2017
Vimovo Sales, 2011-2017
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