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.
- It is estimated 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 topical and intravenous formulations.
- The greatest proportion of industry-sponsored drugs in active clinical development for TB are in Phase II. Therapies in mid-to-late-stage development for TB focus on a wide variety of targets. The majority of pipeline drugs are administered via the oral route, with the remainder being tested in intramuscular and intradermal formulations.
- High-impact upcoming events for drugs in the TB space comprise CHMP supplemental filing results for Sirturo, CHMP opinion for Pretomanid, and topline Phase II trial results for GSK3036656.
- The overall likelihood of approval of a Phase I antibacterial, mycobacterial, or fungal asset is 25%, and the average probability a drug advances from Phase III is 64.2%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
- There have been 23 licensing and asset acquisition deals involving TB drugs during 2014–19. The largest deal was the $74.5m transaction agreement in 2018 between Evotec and Sanofi, pursuant to which Evotec will integrate Sanofi’s infectious disease unit into its organization and in-license the majority of Sanofi’s infectious disease research portfolio, including TB.
- 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 75% of trials in Phase I–II, and only 25% in Phase III–IV.
- South Africa has a substantial lead in the number of TB clinical trials globally. The UK leads the major EU 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.
- Disease definition
- Patient subtypes
- Risk factors
- Anti-tuberculosis drugs
RECENT EVENTS AND ANALYST OPINION
Pretomanid for tuberculosis (June 6, 2019)
Pretomanid for tuberculosis (June 4, 2019)
Pretomanid for tuberculosis (April 18, 2019)
Pretomanid for tuberculosis (October 26, 2018)
M72/AS01E for tuberculosis (September 25, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions
Pretomanid Gets Panel Endorsement As Part Of Regimen, Not Individual Molecule, For Treatment-Resistant Tuberculosis
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
BioNTech Gets Gates Foundation Funding For HIV, TB Drug Discovery
Deals Shaping The Medical Industry, December 2018
Deals Shaping The Medical Industry, October 2018
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
LIST OF FIGURES
Figure 1: Global trends in incident cases of tuberculosis, 2018–27
Figure 2: Overview of pipeline drugs for tuberculosis in the US
Figure 3: Pipeline drugs for tuberculosis, by company
Figure 4: Pipeline drugs for tuberculosis, by drug type
Figure 5: Pipeline drugs for tuberculosis, by classification
Figure 6: Pretomanid for tuberculosis (October 26, 2018): Phase III – NIX-TB
Figure 7: M72/AS01E for tuberculosis (September 25, 2018): Phase IIb – South Africa
Figure 8: Key upcoming events in tuberculosis
Figure 9: Probability of success in the tuberculosis pipeline
Figure 10: Licensing and asset acquisition deals in tuberculosis, 2014–19
Figure 11: Parent patents in tuberculosis
Figure 12: Clinical trials in tuberculosis
Figure 13: Top 10 drugs for clinical trials in tuberculosis
Figure 14: Top 10 companies for clinical trials in tuberculosis
Figure 15: Trial locations in tuberculosis
Figure 16: Tuberculosis trials status
Figure 17: Tuberculosis trials sponsors, by phase
LIST OF TABLES
Table 1: Global incident cases of tuberculosis, 2018–27
Table 2: Global incident cases of tuberculosis with HIV, 2018
Table 3: Global incident cases of MDR/RR tuberculosis, 2018
Table 4: Marketed drugs for tuberculosis
Table 5: Pipeline drugs for tuberculosis in the US
Table 6: Pretomanid for tuberculosis (June 6, 2019)
Table 7: Pretomanid for tuberculosis (June 4, 2019)
Table 8: Pretomanid for tuberculosis (April 18, 2019)
Table 9: Pretomanid for tuberculosis (October 26, 2018)
Table 10: M72/AS01E for tuberculosis (September 25, 2018)