Commercial Insight: Pain Market Overview - Non-traditional analgesics and opioid reformulations to sustain sector growth

Published by: Datamonitor

Published: Oct. 24, 2008 - 128 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Central Nervous System pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION

Market definition for this report

Disease definition

Overview of pain-drug classes

M1A - Non-steroidal anti-inflammatory drugs (NSAIDs)

N1A - General anesthetics

N1B - Local anesthetics

N2A - Narcotic analgesics

N2B - Non-narcotic analgesics

Non-traditional analgesics

CHAPTER 3 MARKET OVERVIEW

Current market assessment

Sales by region

Pain market totaled $24.3 billion in 2007

5EU was the key growth market for pain in 2004-07

Pain market is a huge volume market

Despite recording negative sales value growth, the US pain market increased by volume

Sales by class

N2A Narcotic analgesic class accounts for the largest proportion of the pain market value

N2B Non-narcotic analgesic class accounts for over half of all pain market prescription volume

Sales by hospital or retail

France and Italy have the greatest proportion of sales originating from the hospital sector

General anesthetics sales originate predominantly from the hospital setting

Sales by branded and unbranded drugs

Unbranded drugs have accounted for the majority of the pain market value since 2005

Japan pain market is by far the least genericized

Unbranded products dominate the traditional analgesic classes

Sales by delivery method

Sales of solid oral products dominate pain-drug prescriptions

Higher priced parenteral and 'other' systemic formulations account for a greater proportion of the pain market sales value

Rest of World snapshot

Current market assessment

Rest of the world pain market is growing faster than the seven major markets

Rest of world is larger than the combined 5EU and Japan regions and accounts for one-third of total global pain market by value

Canada represents the largest of the small and emerging pain markets, Brazil is a close second

In South America, Brazil, Peru and Venezuela are all growing at over 20% a year

With retail sales only, China represents the strongest growing Pacific Rim pain market over 2004-07

Future market assessment

Sales by region

The US will be more susceptible to growth deviations as the 5EU market is expected to show steady yearly growth

Sales by class

Market to maintain recent positive turnaround in sales

Non-traditional analgesic class to claim a greater share of the pain market

CHAPTER 4 OPPORTUNITIES AND THREATS

Pain market opportunities

Underserved pain indications continue to provide significant opportunities

Fibromyalgia - FDA approvals further validate condition but misdiagnosis remains an issue

Neuropathic pain - improved efficacy rather than side-effect profile is key to driving commercial success

Cancer pain - variety of co-morbidities and types of pain experienced leave room for great treatment improvement

Breakthrough pain in non-malignant diseases

Back pain

Opportunities exist for reformulations in the mature opioids market

Requirement for anti-abuse technologies sees the US FDA designating two recently filed NDAs with priority reviews

Rapid-onset developments focus on fentanyl

Non-traditional analgesic classes

Physicians are now turning to alternative analgesics amid concerns over NSAID and opioid use

Pain market threats

Stigma attached to opioid abuse should not influence guidelines in such a way that restricts access

State pain policies must value opioid effectiveness

Pharmacovigilance requirements leads to more rigorous post-marketing regulations

Risk Evaluation and Mitigation Strategy (REMS) safety plan deemed essential for certain FDA approved fentanyl products

Cephalon asked to address Fentora risk management program before potential approval for non-cancer breakthrough pain

CHAPTER 5 BRAND DYNAMICS

Overview of competitive landscape

Leading 10 brands in the pain market

Celebrex and OxyContin - only pain brands to achieve blockbuster status in 2007

Duragesic and Actiq - two branded fentanyl formulations succumb to genericization

Lyrica and Cymbalta - non-traditional analgesic brands show strongest 4-year growth

Marketing strategies for the leading brands

Promotional spend

Sponsorship and public awareness campaigns

Direct-to-consumer advertising

M1A class leader: Celebrex (celecoxib, Pfizer)

Drug profile

Celebrex sales are largely derived from the US market

Increased promotional efforts in the US sees sales rebound

Celebrex reserved for second-line osteoarthritis therapy after acetaminophen or a topical NSAID

SWOT analysis

Strengths - broad indication coverage and US patent protection to drive mid-term sales growth

Weaknesses - cardiovascular warnings on label document potential risks with Celebrex use

Opportunities - Japanese launch opens up new market opportunities

Threats - pipeline drugs to provide major market threat

N1A class leader: Sevorane (sevoflurane, Abbott)

Drug profile

Availability of Baxter's generic sevoflurane versions results in declining yearly sales

SWOT analysis

Strengths - remains inhaled general anesthetic gold standard after more than 15 years on the market

Weaknesses - level of genericization will increase with major patents expired

N1B class leader: Lidoderm (lidocaine 5% patch, Endo)

Drug profile

2007 European roll-out comes 8 years after US launch

SWOT analysis

Strengths - remains first and only of its kind resulting in strong brand loyalty

Weaknesses - although rare and mild in nature Lidoderm can cause local allergic reactions

Opportunities - EU launch as Versatis should maintain strong historical sales growth

Threats - uncertainty over strength of US patents could see challengers emerge

N2A class leader: OxyContin (oxycodone HCl controlled-release, Purdue)

Drug profile

Extensive genericization has hit sales over the last 4 years

SWOT analysis

Strengths - Purdue has successfully reinstated OxyContin's key patents

Weaknesses - abuse potential limits OxyContin's patient potential

Opportunities - launch of new dosages provides more options for abuse-prone patients

Threats - imminent launch of abuse deterrent oxycodone formulations will pressurize OxyContin

N2B class leader: Efferalgan (acetaminophen, Bristol-Myers Squibb)

Drug profile

Non-traditional analgesic class leader: Lyrica (pregabalin, Pfizer)

Drug profile

Sales from pain indications accounted for over 60% of Lyrica's 2007 total

SWOT analysis

Strengths - broad neuropathic pain indications and most recent fibromyalgia approval to drive future growth

Weaknesses - Schedule V classification increases complexity of prescribing

Opportunities - Lyrica has yet to be launched in Japan

Threats - approval of additional drugs for fibromyalgia will provide stiff competition in this young and growing market

CHAPTER 6 KEY DEVELOPERS

Strategic overview

Despite a significant decline in its franchise, Pfizer continues be the driving force in the pain market

Generics companies have prospered in the pain market

Trends in corporate strategy

Only half of the leading 10 pain market companies are actively looking to further enhance their pain franchise offerings

Big Pharma seeks out novel developments while specialist companies focus on reformulations

Recent strategic partnerships/deals

Licensing deals will remain an important strategy to companies of all sizes in the pain market

Big Pharma market leader - Pfizer

Unearthing unchartered pain indications continues to reap rewards

Increased Celebrex investment set to drive future growth

Pfizer - the pioneer in neuropathic pain and now fibromyalgia

Pfizer identifies pain to be a 'high-potential disease area'

Late-stage developments show desire to maintain investment in well-established pain franchise

Specialist pain company - Endo

Endo prospers on Lidoderm's success

Recently established Opana franchise set for steady growth

Research and development review sees Endo discontinue development of two late-stage pain products

In-licensing remains key in Endo's refocused pipeline

Leading generics company presence - Teva

The exploitation of major pain brands proves a lucrative strategy for Teva

Reinstated OxyContin patent to hurt Teva from 2008

Challenges to Celebrex's patents appear to be unsuccessful

Key emerging companies - King Pharmaceuticals and Pain Therapeutics

Strategic alliance plays a significant part in King Pharmaceuticals and Pain Therapeutics emergence as key players in the pain market

Partnership marries drug development capabilities with commercial expertise

Remoxy's anti-abuse potential to fulfill a significant market opportunity

Potential Alpharma takeover shows King Pharmaceuticals's intention to further shift focus to the pain market

Oxytrex shows Pain Therapeutics' development strength and provides another strong out-licensing opportunity

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX A - MARKET ASSUMPTIONS

Data definitions, limitations and assumptions

Standard units

Japanese market data

Rest of World

Forecast methodology

Important information specifically for this report

APPENDIX B

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the central nervous system analysis team

Disclaimer

List of Tables

Table 1: Pain market sales value by region ($m) across the seven major markets (7MM), 2004-07

Table 2: Pain market sales volume by region ($m) across the seven major markets, 2004-07

Table 3: Pain market sales value by class across the seven major markets ($m), 2004-07

Table 4: Pain market sales volume by class across the seven major markets ($m), 2004-07

Table 5: Summary of opportunities and threats in the seven major market pain market, 2008

Table 6: Epidemiology surveys of cancer pain

Table 7: Epidemiology surveys of breakthrough pain in cancer patients

Table 8: Epidemiology surveys of low back pain

Table 9: Top 10 pain brands by seven major market revenues ($m), 2004-07

Table 10: Marketing strategies employed by the companies behind the top three pain market brands, 2008

Table 11: Celebrex - Drug profile, 2008

Table 12: Sevorane - Drug profile, 2008

Table 13: Lidoderm - Drug profile, 2008

Table 14: OxyContin - Drug profile, 2008

Table 15: Lyrica - Drug profile, 2008

Table 16: Top 10 pain market companies by seven major market revenues ($m), 2004-07

Table 17: Strategic importance of pain market drugs to the leading pain market companies, 2008

Table 18: Key strategic deals and events in the pain market, 2008

Table 19: Pfizer's pain market portfolio overview, 2004-07

Table 20: Pfizer's late-stage (Phase II onwards) pain pipeline, 2008

Table 21: Endo's pain market portfolio overview, 2004-07

Table 22: Endo's pain pipeline, 2008

Table 23: Teva's pain drug portfolio overview, 2004-07

List of Figures

Figure 1: Pain market sales value in the US, 5EU and Japan ($ billion), 2004-07

Figure 2: Sales value performance of the US, 5EU and Japan pain markets ($m), 2004-07

Figure 3: Pain market sales volume in the US, 5EU and Japan (IMS standard units [SUs] sold), 2004-07

Figure 4: Sales volume performance of the US, 5EU and Japan pain markets (IMS standard units [SUs] sold), 2004-07

Figure 5: Sales value performance of the seven major market pain market by class ($m), 2004-07

Figure 6: Sales volume (SUs m) performance of the seven major market pain market by class, 2004-07

Figure 7: Pain market volume and value sales by retail and hospital distribution channel in the US and 5EU countries, 2007

Figure 8: Pain market volume and value sales in terms of retail and hospital origin in the US and 5EU by class, 2007

Figure 9: Branded and unbranded sales value of the pain market across the seven major markets ($m), 2004-07

Figure 10: Branded and unbranded pain market volume and value sales in the US, 5EU and Japan, 2007

Figure 11: Branded and unbranded pain market volume and value sales in the seven major markets by class, 2007

Figure 12: Seven major market pain market sales volume (IMS standard units sold) by delivery method, 2007

Figure 13: Seven major market pain market sales value dynamics by delivery method, 2007

Figure 14: Pain market sales value ($ billion) and volume (IMS standard units [SUs]) in the rest of the world, 2004-07

Figure 15: Rest of World versus seven major market sales split in the pain market ($m), 2007

Figure 16: Sales value of the largest 10 small and emerging pain markets, 2004-07

Figure 17: Pain market sales value in South America ($m), 2004-07

Figure 18: Pain market sales value dynamics in the Pacific Rim ($m), 2004-07

Figure 19: Pain market historic (2004-07) and Datamonitor forecast (2008-2017) sales by region across the seven major markets

Figure 20: Pain market historic (2004-07) and Datamonitor forecast (2008-2017) sales by class across the seven major market

Figure 21: Market value share of pain market drug classes in the seven major markets ($ billion), 2007 versus 2017

Figure 22: Top 10 pain brands by seven major market revenues ($m), 2007

Figure 23: Sales value dynamics of the top 10 pain brands by seven major market revenues ($m), 2004-07

Figure 24: US and 5EU promotional spend for the top 10 pain market brands, 2007

Figure 25: Seven major market sales revenues for 2007's leading M1A - NSAID class brands, 2004-07

Figure 26: Celebrex seven major market revenues ($m), 2007

Figure 27: Sevorane seven major market sales revenue versus generics ($m), 2004-07

Figure 28: Seven major market Oxycodone HCl extended-release sales value ($m) by brand (OxyContin) and generics versus total molecule sales volume (SUs), 2004-07

Figure 29: Seven major market Lyrica sales split by sector - pain market versus total other sales, 2004-07

Figure 30: Sales value dynamics of the top 10 pain market companies by seven major market revenues ($m), 2004-07

Abstract

• Analysis of 200407 prescriptions for ATC classes M1A, N1A, N1B, N2A, N2B and non-traditional analgesics split by region, class, and delivery method
• Future market assessment, including pain market forecast by region and class level through to 2017
• Brand dynamics assessment, including the current competitive landscape, marketing strategies employed, and focus on leading brands within each class
• Strategic analysis of key players in the pain market and focus of corporate strategic trends and recent licensing deals

• Between 2004 and 2005, the seven major market pain market moved from a brand dominated market to one where unbranded products account for the majority of sales value. This trend strengthened over the last 2 years, with major genericization of the N2A narcotic analgesic and N2B non-narcotic analgesic classes creating this financially-driven shift.
• After 2 consecutive years of declining sales, 200607 saw positive market growth of 8.7%. The pain market is forecast to continue this annual growth through to 2011 to be worth approximately $31.5 billion, driven by non-traditional analgesic brand sales for neuropathic pain and fibromyalgia.
• In contrast to Pfizer's focus on in-house R&D, Johnson & Johnson has turned to collaborations with specialist companies to bolster its previously lackluster pain pipeline. Additionally, smaller pain companies are increasingly collaborating to combine drug development capabilities with commercial expertise in order to bring new products to market.

• Identify and understand the commercial characteristics of the pain market across the US, Japan, 5EU, and rest of world markets
• Understand the future pain market landscape to align R&D decisions and target the indications that offer the most opportunity to your company
• Quantify the key historical company and brand dynamics that have shaped the pain market

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