Abstract
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?
About the Author:
The report has been researched and written by Espicom's Senior Analyst, Karen
Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis
experience.
Table of Contents
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
- Grunenthal
- 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
- 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
- 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
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
