Tuberculosis (TB) is one of the oldest diseases affecting humankind, accounting for 10.8 million cases and killing approximately 1.25 million people in 2023.1 While preventable and curable, TB remains the deadliest infectious disease globally, surpassing COVID-19 and HIV-related deaths combined. More importantly, TB disproportionately affects the most vulnerable and impoverished populations, with an increasingly devastating impact in patients and communities due to comorbidities, drug resistance, pandemics, climate change, conflict, migration, and catastrophic out-of-pocket expenditures for those insufficiently covered by national health schemes.
Notable clinical developments in the last decade have renewed the TB landscape, but more and stronger action is needed to better diagnose, treat, and support people living with TB. In parallel, as deep changes are taking place in the global health architecture in 2025, particularly regarding governance, funding and priorities, it is relevant to review the state of the art of the TB response, reflecting on the most salient issues directly influencing the disease’s trajectory and the last-mile work of civil society and community-based actors.
The current pipeline of medicines and vaccines for tuberculosis
In terms of clinical development over the last decade, the optimization of rifamycins in drug-sensitive regimens is promising to shorten the treatment of TB from six to four months.2 For drug-resistant strains, after a stalemate in drug development for 40 years, bedaquiline was approved by the U.S. Food and Drug Administration in 2012,3 followed by several other new compounds such as delamanid and pretomanid in combination with linezolid and bedaquiline. These medicines have led to the recommendation of several all-oral, shorter six- to nine-month regimens.4 Many of these treatments are comprised of three to four drugs, markedly reducing the potential for toxicity and drug-drug interactions and making treatment more tolerable for patients. Likewise, advancements for TB infection have broadened options to shorten treatment from upwards of nine months of daily medications to three months of weekly treatment.5 Six new immunization products in the late phase of development could replace the Bacille Calmette-Guérin (BCG) vaccine, which provides insufficient protection and has been the only TB vaccine available for almost a century.6,7
Despite consequential discoveries in recent years, the microbiological features of Mycobacterium tuberculosis, the pathogen responsible for the disease, continue to pose challenges to drug and vaccine development. This bacillus can evade the host’s innate immunity, impede drug penetration due to its waxy cell walls, and prolong the amount of time required for drug efficacy and resistance testing due to its slow growth. Mycobacterium tuberculosis can also mutate and develop drug-resistant strains, which can extend treatment to 18 to 24 months, in contrast to the usual six to nine for drug-sensitive infections.
These steps forward are reassuring, but they are not entirely devoid of obstacles. IQVIA's experience on the ground shows several barriers to TB research and implementation:
- Despite the promising efficacy of bedaquiline-containing regimens, their high cost continues to limit widespread use, particularly in low-income settings. Recent access negotiations are fast-tracking generic alternatives since late 2024 with halved prices in some countries.
- There is a need to expand clinical trial infrastructure in sub-Saharan Africa to propel large-scale TB studies, especially in settings of high HIV co-infection.
- New TB vaccine candidates exist, but clinical validation and regulatory approvals take years, delaying impact.
- Current diagnostic tools still have limitations in rural and high-burden settings. Interferon-gamma release assay (IGRA), molecular bacterial load assay-based (MBLA) diagnostics, and nucleic acid amplification tests (NAAT), which are used to detect TB, can be very helpful but require further validation and/or investments to enable optimal use.
- Multidrug-resistant tuberculosis (MDR-TB) remains a significant challenge, requiring complex treatment regimens that pose adherence issues. Ensuring timely diagnosis and treatment initiation, as well as patient care through treatment, remains pivotal.
