Neuropathic pain (NP) is a prominent form of pain associated with a wide variety of common diseases and conditions, including cancer, diabetes, herpes zoster, chronic back pain, stroke, and multiple sclerosis. The NP market is one of moderate commercial opportunity, with a more favorable outlook for developers of drugs with novel mechanisms of action. The current and forthcoming availability of multiple generic first-line analgesics as well as the entrenchment of available treatment options in current medical practice presents notable barriers to market penetration of new drugs. Nevertheless, interviewed thought leaders tell us that many NP patients do not adequately respond to current treatment. Furthermore, unmet need for novel analgesics continues to be driven by the growing prevalence of the NP patient population and the significant percentage of patients refractory to or unable to tolerate current treatment options.
Questions Answered in This Report:
Neuropathic pain (NP) is associated with a wide variety of common disorders, including cancer, diabetes, herpes zoster, chronic back pain, stroke, and multiple sclerosis. What is the NP market size of these indications? Which type of NP patients do experts consider the most difficult to treat and/or least responsive to therapy? What influence do comorbidities have on choice of drug therapy? Which forms of NP do experts consider the best to target in clinical trials?
Despite the availability of a wide variety of products and formulations to treat NP, no one agent or class of agents provides the optimal balance of safety, tolerability, and efficacy. As a result, treatment of NP is characterized by a high rate of polypharmacy and switching from one agent to another. Which drugs/drug classes are commonly used in combination? What are the therapeutic advantages and disadvantages offered by current therapies? What are the specific unmet needs in the treatment of NP according to interviewed thought leaders?
Because of the heterogeneous clinical presentation of NP across and within various etiologies, physicians often initially segment patients by pain phenotype and severity rather than the specific etiology of the NP condition. What have been the recent advances in segmenting NP patients by pain phenotype and correlating phenotype with response to therapy? Where do physicians expect this field of research to progress in the near future? How important is establishing a mechanism-based approach to NP treatment, according to interviewed experts? What impact will current and forthcoming advances in this research have on medical practice and drug development for NP?
We forecast that, by 2022, generic equivalents of the 2012 major-market sales-leading agents, pregabalin (Pfizer’s Lyrica), duloxetine (Eli Lilly/Shionogi’s Cymbalta/Xeristar), and the 5% lidocaine patch (Endo/Grünenthal’s Lidoderm/Versatis), will be available in the United States and Europe. How will generic entry of these agents impact sales in the NP market? How can emerging therapies differentiate themselves from the growing number of low-cost generic versions of well-established agents? Will the sales of emerging products that penetrate the NP market (either with labeling specifically for NP or prescribed off label) through 2022 overcome sales lost due to the generic erosion of these key therapies?
Many agents in late-stage development for NP are reformulations of marketed drugs (e.g., Acorda Therapeutics’ capsaicin topical solution, BioDelivery Sciences’ topical clonidine gel, Pfizer’s once-daily pregabalin CR). Several other products with unique mechanisms of action will penetrate the NP market, even without regulatory approval for any NP indication (e.g., Pfizer/Eli Lilly’s tanezumab, Eisai’s perampanel [Fycompa]). How well do these emerging therapies address the remaining unmet clinical need in NP treatment? How do interviewed physicians expect these drugs to impact the treatment of NP? Which of these new products offers the greatest market potential? In which patient populations will these drugs be used?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 31 country-specific interviews with thought leaders, neuropathic pain experts, pain specialists, and neurologists.
Epidemiology: Prevalence of neuropathic back pain, painful diabetic neuropathy, neuropathic cancer pain, and HIV/AIDS-related NP in the major pharmaceutical markets under study. Diagnosed prevalence of postherpetic neuralgia in the major pharmaceutical markets under study. Other types of NP, including trigeminal neuralgia, central NP, postoperative NP, carpal tunnel syndrome, and complex regional pain syndrome, were also part of our research.
Emerging therapies: Phase II: 36 drugs; Phase II/III and Phase III: 6 drugs; coverage of 34 select preclinical and Phase I products.
Market forecast features: We present market segmentation of select NP populations in the base year of our forecast (2012); we provide an in-depth examination of current and future NP drug-treatment trends and market performance over a ten-year forecast period (2012-2022) and forecast major-market NP drug sales, by country for key therapies for the treatment of NP through 2022.