This year has seen continued investment into the development of novel opioids, with a corresponding action plan from the FDA to curb the epidemic of abuse and addiction. This report summarizes the latest developments within pain, analyzing trends within regulatory approvals, clinical trials, and deal-making activities, gauging current physician perceptions, as well as looking forward to the catalysts set to change the future pain market.

Highlights

• Pain can be caused both by underlying nociceptive and neuropathic etiologies, while it is also typically segmented by onset of duration and the severity of symptoms. These distinctions are important to diagnose as they inform the decision-making process for appropriate treatments.
• Numerous professional bodies publish treatment guidelines, spanning the diagnosis and management of pain. These are typically at the level of nociceptive and neuropathic pain, although the abuse of prescription opioid analgesics has necessitated specific recommendations governing the use of this class in a range of patient populations.
• The $13bn US market for opioids is being very carefully regulated, with the US Food and Drug Administration attempting various approaches to reduce the amount of inappropriate prescriptions and the corresponding epidemic levels of abuse, misuse, and diversion. Industry is also reacting to a problem it helped to create by reformulating opioids with abuse-deterrent technology.
• With limited treatment options and comparatively few recent approvals, considerable unmet need remains for patients with neuropathic pain. Physician research indicates that polypharmacy is common and there is strong demand for novel drug classes, with strong uptake expected for successful new agents.
• Chronic pain and the opioid class in particular emerge as the most studied indication and drug class when it comes to the development of new analgesics, although there are clinical trials across the whole pain spectrum. Pfizer leads the industry for R&D involvement, although the majority of other players are considered “boutique” firms with a vested interest or specialty in pain therapeutics.
• The last five years have seen a high amount of deal activity within pain, with the highest-profile partnerships being for anti-nerve growth factor antibodies. Licensing opportunities are typically spread across the pain spectrum, with a large number being concluded at the commercialization stage.

Key questions answered

• How is pain typically segmented and how do these inform treatment practices and guidelines?
• What are the latest clinical and regulatory developments in the lucrative opioid market?
• To what extent are prescribers adopting abuse-deterrent opioids into their prescribing behaviors?
• What are the expectations surrounding new classes of neuropathic pain drugs?
• Where is industry concentrating its R&D efforts within pain?
• Who are the most active licensees and acquirers of pain therapeutics?

Best-in-class information sources

• Trialtrove – clinical trial landscape in pain and detailed patient segmentation
• Pharmaprojects – pipeline drug information, including stage of development and mechanisms of action
• Biomedtracker – approval timelines and expected market catalysts over 2017
• Medtrack and Strategic Transactions – the deals, partnerships and funding landscape in pain
• Pink Sheet – up-to-date tracking of opioid regulatory developments at the FDA
• Meddevicetracker – market sizing data for opioids and neuropathic pain drugs
• Primary research – two 30-respondent Pulse surveys and a US Key Opinion Leader interview were conducted to support this report

Like our report? Have any questions or feedback? Please let us know at askanalyst@sagientresearch.com.

For our disclosures, please read the Biomedtracker Research Standards.