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

Key Takeaways

• Datamonitor Healthcare estimates that in 2018, there were 13.9 million incident cases of tuberculosis (TB) worldwide, and forecasts that number to increase to 15.3 million incident cases by 2027.
• 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 largest proportion 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. The majority of pipeline drugs are administered via the oral route, with two drugs being tested in an intramuscular formulation.
• The only high-impact upcoming event for drugs in the TB space is topline Phase II trial results for GSK3036656. The overall likelihood of approval of a Phase I antibacterial, mycobacterial, or fungal asset is 19.8%, and the average probability a drug advances from Phase III is 62%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.0 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 74% of trials in Phase I–II, and only 26% in Phase III–IV.
• South Africa has a substantial lead in the number of TB clinical trials globally. The UK leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the TB space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for TB, with 17 trials.
• GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for TB.