This Market Spotlight report covers the Fibromyalgia market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming events, probability of success, patent information, and prevalence data, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• The approved drugs in the fibromyalgia space target dopamine reuptake, norepinephrine (noradrenaline) reuptake, and serotonin reuptake transporters, as well as voltage-gated calcium channels. All of the marketed drugs for fibromyalgia are administered via the oral route.
• The majority of industry-sponsored drugs in active clinical development for fibromyalgia are in Phase II, with two drugs in Phase III.
• Therapies in mid-to-late-stage development for fibromyalgia focus on a wide variety of targets. All of the pipeline drugs in midand late-stage development are administered orally.
• Topline Phase IIa trial results for ASP0819 is the only high-impact upcoming event in the fibromyalgia space. The overall likelihood of approval of a Phase I pain asset is 8.7%, and the average probability a drug advances from Phase III is 60.2%. Drugs, on average, take 9.3 years from Phase I to approval, compared to 9.7 years in the overall neurology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for fibromyalgia have been in the late phases of development, with 69% of trials in Phase III–IV, and 31% in Phase I–II.
• The US has a substantial lead in the number of fibromyalgia clinical trials globally, while Germany, Spain, and the UK lead the major EU markets with 16 trials each.
• Clinical trial activity in the fibromyalgia space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for fibromyalgia, with 23 trials.
• Pfizer leads industry sponsors with the highest overall number of clinical trials for fibromyalgia, followed by Allergan.