In 2013, total sales for pain therapies in the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) were estimated to be $36.5 billion. Well-established opioid analgesics and NSAIDs dominate the current pain market, but they are fraught with safety and tolerability concerns and are not sufficiently effective in all patients—leaving substantial commercial opportunity for pain therapies that offer improvements over current therapeutic options, in particular products that feature novel mechanisms of action. In this report we provide detailed analysis on emerging analgesic therapies that represent 13 new drug classes; these agents were individually selected from hundreds of development programs based on their clinical promise according to interviewed experts and their market potential over the next 15 years.

Questions Answered in This Report:

  • The first biologic pain therapies—the anti-nerve growth factor monoclonal antibodies—are poised to resume pivotal clinical trials in chronic non-cancer pain patient populations following a clinical hold placed on the class in 2010 due to safety risks. How do interviewed physicians now view the clinical potential of these agents? What impact will the successful development and launch of these agents have on sales of pain therapies across the seven major pharmaceutical markets?

  • Many promising drug targets identified in vivo using animal models of inflammatory, nociceptive, and neuropathic pain ultimately fail proof-of-concept studies when moved into human subjects. What novel drug classes are viewed as having the greatest clinical and commercial potential by pain specialists and researchers interviewed? Which of these classes will reach the market by 2028? What challenges remain for drug developers pursuing new molecular targets?

  • The pain market is served by dozens of companies and a plethora of inexpensive generic products. How will emerging therapies be differentiated from the large number of existing well-established, low-cost agents? Which companies’ drugs and drug classes will be the most threatened by novel therapies?

  • Because the etiology and pathophysiology of pain syndromes varies so widely, physicians often rely on the practice of polypharmacy to maximize relief for their patients. Will novel pain therapies be broadly effective enough to be administered as monotherapies? Which novel agents will likely be used as adjunct treatments?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 56 country-specific interviews with PCPs, pain specialists, anesthesiologists, neurologists, and oncologists.

Epidemiology: Prevalence of chronic low back pain, fibromyalgia, cancer pain, migraine, osteoarthritic pain, painful diabetic neuropathy, postherpetic neuralgia, and postoperative pain.

Emerging therapies: Phase II: 44 drugs; Phase III: 4 drugs. Coverage of 57 select preclinical and Phase I products.

Market forecast features: Forecast of the entire pain market from 2013 to 2028, considering sales data, prescription and diagnosis drug audit data, patent expiry data, forecast market launch dates for emerging therapies, and primary market research.

Author(s): Natalie C. Taylor, Ph.D.
Catherine Vasilakis-Scaramozza, Ph.D., M.P.H.