Market Spotlight: Tuberculosis (TB)
Market Spotlight: Tuberculosis (TB)
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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 topical and intravenous formulations.
- The majority 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 an expected CHMP opinion for pretomanid, a meeting with the FDA for SPR720, and topline Phase II trial results for GSK3036656.
- The overall likelihood of approval of a Phase I antibacterial, mycobacterial, or fungal asset is 24.9%, and the average probability a drug advances from Phase III is 62.8%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.
- There have been 17 licensing and asset acquisition deals involving TB drugs during 2015–20. 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.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Disease definition
8 Patient subtypes
9 Symptoms
9 Risk factors
9 Diagnosis
10 TREATMENT
10 Anti-tuberculosis drugs
11 Surgery
12 EPIDEMIOLOGY
17 MARKETED DRUGS
19 PIPELINE DRUGS
25 RECENT EVENTS AND ANALYST OPINION
25 Pretomanid for tuberculosis (June 6, 2019)
27 Pretomanid for tuberculosis (June 4, 2019)
29 Pretomanid for tuberculosis (April 18, 2019)
30 Pretomanid for tuberculosis (October 26, 2018)
31 M72/AS01E for tuberculosis (September 25, 2018)
34 KEY UPCOMING EVENTS
35 KEY REGULATORY EVENTS
35 Global Approvals Snapshot: November 2019
35 Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions
35 Pretomanid Gets Panel Endorsement As Part Of Regimen, Not Individual Molecule, For Treatment-Resistant TB
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Pfizer Deal Covers Sutezolid For TB
37 Deals Shaping The Medical Industry, December 2019
38 Shionogi, Hsiri Expand Mycobacterial R&D Pact
38 BioNTech Gets Gates Foundation Funding For HIV, TB Drug Discovery
39 PARENT PATENTS
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
44 BIBLIOGRAPHY
44 Prescription information
45 APPENDIX
LIST OF FIGURES
14 Figure 1: Global trends in incident cases of tuberculosis, 2018–27
19 Figure 2: Overview of pipeline drugs for tuberculosis in the US
20 Figure 3: Pipeline drugs for tuberculosis, by company
20 Figure 4: Pipeline drugs for tuberculosis, by drug type
20 Figure 5: Pipeline drugs for tuberculosis, by classification
31 Figure 6: Pretomanid for tuberculosis (October 26, 2018): Phase III – NIX-TB
33 Figure 7: M72/AS01E for tuberculosis (September 25, 2018): Phase IIb – South Africa
34 Figure 8: Key upcoming events in tuberculosis
36 Figure 9: Probability of success in the tuberculosis pipeline
37 Figure 10: Licensing and asset acquisition deals in tuberculosis, 2015–20
39 Figure 11: Parent patents in tuberculosis
40 Figure 12: Clinical trials in tuberculosis
40 Figure 13: Top 10 drugs for clinical trials in tuberculosis
41 Figure 14: Top 10 companies for clinical trials in tuberculosis
41 Figure 15: Trial locations in tuberculosis
42 Figure 16: Tuberculosis trials status
43 Figure 17: Tuberculosis trials sponsors, by phase
LIST OF TABLES
13 Table 1: Global incident cases of tuberculosis, 2018–27
15 Table 2: Global incident cases of tuberculosis with HIV, 2018
16 Table 3: Global incident cases of MDR/RR tuberculosis, 2018
18 Table 4: Marketed drugs for tuberculosis
22 Table 5: Pipeline drugs for tuberculosis in the US
25 Table 6: Pretomanid for tuberculosis (June 6, 2019)
28 Table 7: Pretomanid for tuberculosis (June 4, 2019)
29 Table 8: Pretomanid for tuberculosis (April 18, 2019)
30 Table 9: Pretomanid for tuberculosis (October 26, 2018)
32 Table 10: M72/AS01E for tuberculosis (September 25, 2018)
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