This Market Spotlight report covers the Osteoarthritis and Osteoarthritis Pain market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways The analyst estimates that in 2019, there were 320.7 million prevalent cases of osteoarthritis (knee or hip) in adults aged 30 years and older worldwide, and forecasts that number to increase to 367.7 million prevalent cases by 2028.
The global prevalence of osteoarthritis in adults aged 30 years and older is estimated to be 8.2%. The approved drugs in the osteoarthritis space focus on a wide variety of targets. The majority of these therapies are administered via the oral route, with the remainder being topical, intraarticular, and transdermal formulations.
The majority of industry-sponsored drugs in active clinical development for osteoarthritis are in Phase II, with only one drug in the NDA/BLA phase.
Therapies in development for osteoarthritis focus on a wide variety of targets. The largest proportion of pipeline drugs are administered via the intraarticular route.
High-impact upcoming events for drugs in the osteoarthritis space comprise topline Phase II trial results for AKL4; topline Phase IIb trial results for MM-II; topline Phase III trial results for CNTX-4975, TLC599, and Zilosul; an expected decentralized approval in the EU for Pennsaid 2%; and an expected CHMP opinion, PDUFA date, and FDA advisory panel meeting for tanezumab.
The overall likelihood of approval of a Phase I osteoarthritis and osteoarthritis pain asset is 9.7%, and the average probability a drug advances from Phase III is 50%. Drugs, on average, take 12.9 years from Phase I to approval in the osteoarthritis and osteoarthritis pain space, as well as in the overall rheumatology (non autoimmune) space.
The distribution of clinical trials across Phase I–IV indicates that the majority of trials for osteoarthritis have been in the early and mid-phases of development, with 58% of trials in Phase I–II, and 42% in Phase III–IV.
The US has a substantial lead in the number of osteoarthritis clinical trials globally. The UK leads the major European markets, while South Korea has the top spot in Asia.
Clinical trial activity in the osteoarthritis space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for osteoarthritis, with 124 trials.
Pfizer leads industry sponsors with the highest overall number of clinical trials for osteoarthritis.
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