Stakeholder Opinions: Back Pain - Gain competitive edge by targeting subpopulations

Content

• ABOUT DATAMONITOR HEALTHCARE
  • About the Central Nervous System pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of analysis
  • Datamonitor insight into the back pain market
  • Contributing experts
  • Related reports
• CHAPTER 2 CONDITION OVERVIEW AND PATIENT POTENTIAL
  • Introduction
  • Anatomy of the back
  • Definition of back pain
  • Back pain classification
  • Location
  • Duration
  • Etiology
  • Mechanism
  • Etiology of back pain
  • Back pain is a condition of many possible etiologies
  • Risk factors
  • Risk factors for back pain are multi-factorial
  • Genetic risk factors
  • Individual risk factors
  • Environmental risk factors
  • Epidemiology of back pain
  • Assessing the prevalence of back pain is fraught with methodological difficulties
  • Acute and chronic back pain is estimated to affect a total of 129 million adults in the seven major markets in 2009
  • Acute back pain is estimated to affect over 79 million adults across the seven major markets
  • Chronic back pain is estimated to affect 49 million adults across the seven major markets
  • Back pain prevalence increases with age
  • The prevalence rate of back pain during school age approaches that seen in adults
  • Back pain prevalence peaks among adults of working age
  • Epidemiological studies report only small gender differences in back pain prevalence
  • International studies lack consensus on the longitudinal prevalence of back pain
  • Reports of increased prevalence of back pain in recent years may be attributable to cultural factors
  • Although highly prevalent, key opinion leaders believe the patient presentation rate for back pain to be low
• CHAPTER 3 DIAGNOSIS AND TREATMENT OF BACK PAIN
  • Diagnosis of back pain
  • Guidelines discourage routine use of diagnostic imaging
  • However, some physicians continue to order unnecessary and costly imaging tests
  • The majority of back pain cases are classified as non-specific
  • Key treating physicians
  • Primary care physicians are key prescribers of pharmacological treatments for back pain
  • Beyond primary care physicians, the management of back pain lacks a well-defined referral pathway
  • Overview of current treatment options
  • Pharmacotherapy
  • The key pharmacological drug classes prescribed for the treatment of back pain are discussed in further detail below
  • Non-steroidal anti-inflammatory drugs: the cornerstone of pharmacological treatment of back pain
  • Opioids
  • Skeletal muscle relaxants
  • Non-traditional analgesics
  • Medical devices
  • Implantable systems
  • Transcutaneous electrical nerve stimulation (TENS)
  • Surgery
  • Complementary and alternative medicine
  • Treatment guidelines for back pain
  • The American College of Physicians and the American Pain Society Joint Clinical Practice Guideline
  • Clinical guidelines for use of chronic opioid therapy in chronic non-cancer pain
  • European guidelines for the management of chronic non-specific low back pain
  • UK: NICE is expected to publish clinical guidelines in May 2009
  • Unmet needs
  • Unmet need 1: More targeted treatments
  • Greater investment in basic science research is needed in order for treatments to become more targeted
  • Unmet need 2: Improved pain relief and control
  • Unmet need 3: Improved side effect and safety profile
  • Unmet need 4: Therapies that carry a lower risk of tolerance and dependence than opioid analgesics
• CHAPTER 4 COMMERCIAL OPPORTUNITIES IN THE BACK PAIN MARKET
  • Introduction
  • The pain market is highly mature and dominated by non-branded drugs
  • Seeking back pain as a sole indication represents a high risk strategy
  • No marketed pharmacological product possesses an indication specifically for back pain
  • Gaining an indication for the treatment of back pain will serve as a key product differentiator
  • Gaining a back pain indication will enable marketing messages to become more targeted
  • Commitment to one condition was a winning strategy for UCB's Keppra
  • The US market offers the greatest commercial opportunity to drugs with a back pain indication due to the presence of direct-to-consumer (DTC) advertising
  • Hurdles lie in the path to securing a back pain indication
  • Difficulties of establishing efficacy in back pain clinical trials
  • Tougher post-Vioxx regulatory environment in the US
  • Targeting the neuropathic back pain population represents a more viable strategy
  • Key opinion leaders concur that targeting treatments towards back pain subpopulations would be of benefit
  • However, identifying subgroups of non-specific back pain patients amenable to specific drug treatments would require substantial research
  • Seeking a neuropathic back pain indication represents a viable strategy to companies marketing non-traditional analgesics
  • Pfizer's Lyrica has benefited from targeting neuropathic pain subtypes
  • At present no drug is approved for the treatment of neuropathic back pain
  • Newron's ralfinamide has the potential to become the first drug approved for the treatment of neuropathic low back pain
  • Topical formulations
  • Topical treatments account for a minority of pain-drug prescriptions
  • Development of further injectable formulations and medical devices is unlikely to be met with commercial success
  • There remains room in the market for further topical formulations
  • Three prescription topical formulations are presently available for the treatment of pain conditions
  • Key opinion leaders concur that topical is the preferred drug delivery method among back pain patients
  • The US will be the most receptive market to topical treatments for back pain
• BIBLIOGRAPHY
  • Books and journal papers
  • Websites
  • Datamonitor reports
• APPENDIX
  • Contributing experts
  • About Datamonitor
  • About Datamonitor Healthcare
  • About the CNS analysis team
  • Disclaimer
• List of Tables
  • Table 1: Epidemiology surveys of back pain, published between 1994 and 2007
  • Table 2: Prevalence of acute back pain in adults in the seven major markets, 2009
  • Table 3: Prevalence of chronic back pain in adults in the seven major markets, 2009
  • Table 4: Epidemiology surveys of neuropathic pain among patients with chronic back pain
  • Table 5: Prevalence of neuropathic pain among adult patients with chronic back pain across the seven major markets, 2009
  • Table 6: Epidemiology surveys of back pain among men and women, published between 1995 and 2007
  • Table 7: Studies examining the longitudinal prevalence of back pain
  • Table 8: Advantages and disadvantages of two implantable systems in the treatment of back pain
  • Table 9: Key recommendations on the use of pharmacological treatments from the European guidelines for the management of chronic non-specific low back pain
  • Table 10: Side effects and risks associated with key drug classes prescribed for back pain, 2009
  • Table 11: Approved indications of the top 10 pain brands, 2007
  • Table 12: Key drugs in clinical trials for back pain, 2009
  • Table 13: Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain
• List of Figures
  • Figure 1: Key regions of the spine
  • Figure 2: Key classifications of back pain
  • Figure 3: Key risk factors for developing back pain
  • Figure 4: Prevalence of back pain in the adult population across the seven major markets in 2009
  • Figure 5: Age distribution of 1-month and lifetime prevalence of back pain lasting more than 24 hours
  • Figure 6: Red flags associated with a higher risk of serious disorders as a cause of back pain
  • Figure 7: Use of lumbar magnetic resonance imaging (MRI) among US Medicare patients, 1994-2005
  • Figure 8: Current drug treatment for chronic back pain, according to treating physicians in Germany, 2006
  • Figure 9: Key recommendations of the clinical guideline for the use of chronic opioid therapy on chronic non-cancer pain
  • Figure 10: Key unmet needs in the treatment of back pain
  • Figure 11: Branded and unbranded sales value of the pain market across the seven major markets ($ billion), 2004-07
  • Figure 12: Pros and cons of key strategies to penetrate the back pain market
  • Figure 13: SWOT analysis for seeking a back pain indication
  • Figure 14: SWOT analysis: Ralfinamide in the treatment of neuropathic low back pain
  • Figure 15: Pain market sales volume (IMS standard units sold) by delivery method in the seven major markets, 2007
  • Figure 16: Seven major market pain market sales value dynamics by delivery method, 2007
  • Figure 17: Clinical advantages and disadvantages of topical administration of back pain treatments