The acute pain market continues to be characterized by numerous low-cost, early-line, and reasonably effective generic analgesics competing against many reformulated brands that incorporate conventional analgesics (e.g., opioid analgesics, NSAIDs, acetaminophen, local anesthetics) into more patient-friendly, safer and more tolerable, and/or more conveniently delivered products. Physicians’ comfort with mainstay therapies, many of which are generically available and well entrenched in treatment, presents a notable barrier to market penetration of new drugs. Furthermore, the failure to develop and commercialize truly novel agents, in addition to ever-tightening healthcare budgets in all the markets under study, has created an intensely competitive marketplace for branded therapies, where product differentiation is often subtle and frequently based on incremental improvement in delivery technologies and where reformulations struggle to capture meaningful shares of the market. Nevertheless, niche opportunities remain for drug developers that can address key areas of unmet need, the most significant of which are for safer and better tolerated analgesics; effective analgesics for opioid-refractory severe pain and/or acute neuropathic pain; effective analgesics able to prevent progression to chronic pain; and more-potent, opioid-sparing analgesics for postoperative pain.

Questions Answered in This Report:

  • Nearly all recently launched and late-stage pipeline products for the treatment of acute pain are reformulations of existing agents or drugs that have mechanisms of action similar to those of mainstay current therapies. How have/will physicians incorporate these therapies into the treatment algorithm? Do interviewed thought leaders believe that these reformulated products will have truly differentiated clinical profiles; if yes, which agents show the most commercial potential?

  • Although the efficacy of NSAIDs and opioid analgesics used to treat acute pain is reasonably satisfactory, these drugs’ side-effect and safety profiles are undesirable and can preclude use or be dose-limiting. Will any emerging therapies offer improved tolerability? Will the benefits (efficacy and/or safety) of such agents be sufficient to steal significant patient share from existing first-line therapies?

  • Two novel, noninvasive, opioid-based, patient-controlled analgesia (PCA) drug/device combination products are forecasted to launch in the United States and Europe during our ten-year forecast period. How will these agents compete with one another for market share? What do interviewed thought leaders identify as advantages and disadvantages with each agent? How will hospital formulary access and third-party payer reimbursement affect uptake?

  • The launch of multiple opioid-sparing analgesics from several drug classes—NSAIDs, simple analgesics, local anesthetics—targeted for postoperative pain in the U.S. market has not only driven growth within this sector but has also sparked a cultural shift in medical practice in this region. How have physicians integrated these agents into clinical practice, and how have these agents fared relative to one another? What impact has their launch had on the prescribing of strong opioids in the postoperative pain setting? To what extent will emerging non-opioid therapies be able to fulfill the lingering unmet need for additional, more-potent opioid-sparing analgesics?

Scope:

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

Primary research: 56 country-specific interviews with though leaders, including anesthesiologists, oncologists, primary care physicians, pain specialists, and surgeons.

Epidemiology: Prevalent cases of breakthrough cancer pain; number of diagnosed events of select inpatient surgical procedures; number of diagnosed events of select inpatient and outpatient bunionectomy, dental, hernia, and other orthopedic procedures (United States only); prevalent cases of acute/subacute musculoskeletal pain (by number of involved sites); prevalent cases of acute low back pain; prevalent cases of acute neck pain.

Population segments in market forecast: U.S. 2013 acute pain market, segmented into breakthrough cancer pain, postoperative pain, musculoskeletal pain, and other acute pains.

Emerging therapies: Phase II: 27 drugs; Phase II/III: 13 drugs; preregistration: 4 drugs.

Author(s): Andrea Buurma
Catherine Vasilakis-Scaramozza, Ph.D., M.P.H.