In 2014, total sales for neuropathic pain (NP) in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) were estimated to be approximately $7.2 billion. Current treatment of NP involves the use of drugs from several drug classes, including antidepressants, antiepileptic drugs, local anesthetics, dual-acting opioid analgesics, and opioid analgesics. The current and forthcoming generic availability of early-line analgesics across several drug classes, as well as the entrenchment of available treatment options in current medical practice, present notable barriers to market penetration of new drugs. Nevertheless, commercial opportunity exists for drug developers that can address key areas of unmet need, the most significant of which are for more-effective and/or safer and better-tolerated analgesics.
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 are the current prevalence estimates for these patient populations and how will prevalence change over the 2014-2024 forecast period? What factors are driving or constraining growth of these patient populations? What is the current NP market size, in terms of dollars, of these populations?
- Despite the availability of a wide variety of products across several drug classes 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 continues to be characterized by a high rate of polypharmacy and switching from one agent to another. Which drugs/drug classes are commonly used first line and/or 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, and what emerging agents, if any, are poised to address these needs?
- In 2013, generic versions of duloxetine (Eli Lilly/Shionogi’s Cymbalta/Xeristar, generics) and the 5% lidocaine patch (Endo/Grünenthal’s Lidoderm/Versatis, generics) launched in the United States; generics of these agents began launching in Europe in 2015. Additionally, we forecast that, by 2019, generic equivalents of the 2014 major-market sales-leading agent, pregabalin (Pfizer’s Lyrica), will be available in the United States, throughout Europe, and in Japan. How will generic entry of these agents impact NP market sales in 2019 and 2024? What effect has/will generic availability have on physicians’ early-line use of these agents for NP? 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 2024 overcome sales lost due to the generic erosion of first-line agents?
- The first subtype-selective sodium-channel blockers—Teva/Xenon’s TV-45070 and Biogen’s raxatrigine (CNV-1014802 )—are poised to begin Phase III clinical trials in NP and are forecast to launch in the NP market in 2019 and 2020, respectively. How do interviewed physicians view the clinical potential (efficacy and safety/tolerability) of these agents? What impact will the successful development and launch of these agents have on sales of NP therapies across the seven major pharmaceutical markets? How do interviewed thought leaders anticipate incorporating these therapies into their treatment algorithm for NP?
- Most other agents in late-stage development for NP and forecast to launch in this market are reformulations of marketed drugs (e.g., BioDelivery Sciences’ topical clonidine gel, Pfizer’s once-daily pregabalin CR), or are products with unique mechanisms of action that will penetrate the NP market, without regulatory approval for any NP indication (e.g., Pfizer/Eli Lilly’s tanezumab). How well will these emerging therapies address the remaining unmet 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, and why? In which patient populations and for which lines of therapy will these drugs most likely be used?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 51 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 neuropathy 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.
Population segments in market forecast: Neuropathic cancer pain, neuropathic back pain, painful diabetic neuropathy, postherpetic neuralgia, postsurgical/post-traumatic neuropathic pain, central neuropathic pain, and ‘other’ neuropathic pain. ‘Other’ neuropathic pain includes HIV/AIDS-related neuropathic pain, trigeminal neuralgia, carpal tunnel syndrome, complex regional pain syndrome, and other mono- and poly-neuropathies.
Emerging therapies: Phase II: 20 drugs; Phase III: 7 drugs. Coverage of 14 select preclinical and Phase I products.
Seth Kuranz, M.P.H.