This Market Spotlight report covers the Tuberculosis (TB) market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease incidence forecast, as well as licensing and acquisition deals.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were 8.69 million incident cases of tuberculosis (TB) worldwide, and forecasts that number to increase to 9.62 million incident cases by 2029.
• Approved drugs in the TB space focus on a variety of targets. The majority of these drugs are administered via the oral route, with the remainder being intradermal, topical, and intravenous formulations.
• The majority of industry-sponsored drugs in active clinical development for TB are in Phase II. Therapies in development for TB focus on a wide variety of targets. All pipeline drugs with a known route of administration are administered via the oral route.
• High-impact upcoming events for drugs in the TB space comprise topline Phase II trial results for GSK3036656, and topline Phase I/II trial results for OPC-167832.
• The overall likelihood of approval of a Phase I antibacterial, mycobacterial, or fungal asset is 18.3%, and the average probability a drug advances from Phase III is 62.2%. Drugs, on average, take 9.8 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for TB have been in the early and midphases of development, with 80% of trials in Phase I–II, and only 20% in Phase III–IV.
• South Africa leads in terms of the number of TB clinical trials globally, while China has the top spot in Asia. Clinical trial activity in the TB space is dominated by completed trials. Aeras has the highest number of completed clinical trials for TB, with 36 trials.
• Aeras leads industry sponsors with the highest overall number of clinical trials for TB.