A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2026 Update for Clinicians and Scientists

Authors

Simone Tunesi^1,2, Graham Bothamley^3-5, Gunar Günther^6,7, Yousra Kherabi^8,9, Liga Kuksa¹⁰, Berit Lange^11,12, Christoph Lange^13-16, Natalie Lorent^17,18, Francesca Saluzzo^19,20, Martina Sester^21,22, Xenia Emilie Sinding Iversen²³, Marc Tebruegge^24-26, Conor Tweed²⁷, Anca Vasiliu ^13,16, Lorenzo Guglielmetti²⁸, for the Tuberculosis Network European Trials group (TBnet)

Affiliated Institutions

¹Infectious Diseases Unit, AOU SS Antonio e Biagio e C. Arrigo, Alessandria, Italy
²Department of Public Health and Pediatric Sciences, University of Turin, Italy
³Homerton University Hospital, London, United Kingdom
⁴Queen Mary University of London, London, United Kingdom
⁵London School of Hygiene and Tropical Medicine, London, United Kingdom
⁶Department of Pulmonology, Allergology and Clinical Immunology, Inselspital Bern, Bern University Hospital, Bern, Switzerland
⁷Department of Clinical Sciences, School of Medicine, University of Namibia, Windhoek, Namibia
⁸Infectious and Tropical Diseases Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France
⁹Université Paris Cité, Inserm, IAME, Paris, France
¹⁰Tuberculosis and Lung Disease clinic, Riga East University hospital, Riga, Latvia
¹¹Department of Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany
¹²German Center for Infection Research, TI BBD, Braunschweig, Germany
¹³Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany
¹⁴Clinical Tuberculosis Unit, German Center for Infection Research (DZIF), Hamburg-Lübeck- Borstel-Riems, Germany
¹⁵Respiratory Medicine and International Health, University of Lübeck, Germany
¹⁶Baylor College of Medicine and Texas Children´s Hospital, Global TB Program, Houston, Texas
¹⁷Department of Respiratory Diseases, University Hospital Leuven, Leuven, Belgium
¹⁸Department of Chronic Diseases, Metabolism and Aging, Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), KU Leuven, Leuven, Belgium
¹⁹IRCCS San Raffaele Scientific Institute, Milan, Italy
²⁰Vita salute San Raffaele University, Milan, Italy
²¹Department of Transplant and Infection Immunology, Saarland University, Homburg, Germany
²²Centre for Gender-specific Biology and Medicine (CGBM), Saarland University, Homburg, Germany
²³International Reference Laboratory of Mycobacteriology, Statens Serum Institut, Copenhagen, Denmark
²⁴Department of Child and Adolescent Medicine & Austrian National Reference Centre for Childhood Tuberculosis, Klinik Ottakring, Vienna Healthcare Group, Vienna, Austria
²⁵Infectious Diseases Network, Vienna Healthcare Group, Vienna, Austria
²⁶Department of Pediatrics, University of Melbourne, Parkville, Australia
²⁷MRC Clinical Trials Unit, University College London, London, United Kingdom
²⁸Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy

Corresponding Author

Simone Tunesi
simonetunesi88@gmail.com

Suggested Citation

Tunesi S, Bothamley G, Günther G, Kherabi Y, Kuksa L, Lange B, Lange C, Lorent N, Saluzzo F, Sester M, Iversen XES, Tebruegge M, Tweed C, Vasiliu, A, Guglielmetti L. A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2026 Update for Clinicians and Scientists. Pathogens and Immunity. 2026;11(1):154–190. doi: 10.20411/pai.v11i1.970

DOI

10.20411/pai.v11i1.970

Abstract

Background: Tuberculosis (TB) remains a major cause of morbidity and mortality worldwide, while infections from non-tuberculous mycobacteria (NTM) represent a growing public health threat. In its 20^th year of activity, the Tuberculosis Network European Trials group (TBnet; www.tbnet.eu) is one of the leading research networks in Europe. In this review, we summarize the main advances in TB and NTM that occurred in 2025.

Methods: We conducted a non-systematic review of articles published in 2025, with a strong emphasis on research with current or potential impact on clinical practice. We also selected the most impactful papers regarding the management of adult TB, pediatric TB, and NTM infections.

Results: Members of the TBnet Steering Committee summarize the main advances in their areas of interest, including epidemiology, pathogenesis, prevention, diagnosis, treatment, pediatric TB, and NTM infections. We also include a summary of future research priorities.

Conclusions: The year 2025 presented many exciting advancements in almost all fields of mycobacterial science. This article provides an expert-based, clinically orientated summary of the main new findings in the TB and NTM fields and aims to provide an updated overview of the state of the art in those areas.

Keywords

NTM; TB; TBnet; pediatric TB

Introduction

Tuberculosis (TB) still ranks as the leading cause of death from a single infectious pathogen, while other mycobacterial diseases are recognized as increasingly important. Recent World Health Organization (WHO) estimates indicate that the global number of people affected by TB remains at historically high levels, while the epidemiology of the disease shows pronounced global disparities [1]. At the same time, the spectrum of mycobacterial infections is undergoing a notable shift in countries with low TB incidence, where non-tuberculous mycobacteria (NTM) have emerged as an increasingly important cause of pulmonary and extrapulmonary disease. Despite chronically insufficient research and development resources, in addition to relevant funding cuts in the last year, significant progress has been made in the development of novel tools and interventions to tackle mycobacterial infections. These include advanced diagnostic, prevention, and treatment strategies, including new antimycobacterial agents currently undergoing clinical evaluation. This review integrates key findings from studies published in 2025, providing a comprehensive overview of advances in epidemiology, pathogenesis, prevention, diagnosis, and treatment of TB and NTM disease, including post-treatment sequelae, in both adult and pediatric populations.

Epidemiology

In 2024, an estimated 10.7 million people developed TB and 1.23 million died from the disease worldwide (Figure 1) [1]. This corresponds to a global incidence rate of 131 per 100,000 population and a case fatality rate of 11.5%. TB mortality declined for the third consecutive year, by 29% compared with 2015. Among all people globally who developed TB in 2024, 5.8% were living with HIV, continuing a long-term downward trend from a peak observed in 2000 [1].

Although many indicators have rebounded following the disruptions caused by the COVID-19 pandemic, overall progress remains insufficient [2]. The 12% reduction in TB incidence between 2015 and 2024 falls far short of the End TB Strategy milestone of a 50% reduction by 2025. The importance of this missed step is huge, considering that this checkpoint has been completely missed [3]. This is further complicated by the expected impacts of funding disruptions on initiatives for TB programs. The actual effect of these funding cuts is not yet clear; however, current projections assume that the additional burden of disease might lead to more than 0.5 million additional TB deaths, even if not accounting for cascading effects by disruption to antiretroviral therapy (ART) [4].

The burden of disease remains highly concentrated geographically. Thirty high-TB-burden countries accounted for 87% of all incident cases, and 8 countries—India, Indonesia, the Philippines, China, Pakistan, Nigeria, the Democratic Republic of the Congo, and Bangladesh—accounted for 67% of the global burden (Figure 1) [1]. Regionally, the largest proportions of incident cases occurred in the WHO South-East Asia (34%), the Western Pacific (27%), and Africa (25%). Trends varied substantially by region: between 2015 and 2024, the WHO European Region achieved a 39% reduction in incidence, and the African Region achieved a 28% reduction, with both regions surpassing the first End TB Strategy milestone [5]. TB affects all age groups, but incidence worldwide is highest among adult men (≥15 years), who accounted for 54% of cases, compared with 35% among adult women and 11% among children in 2024.

Drug-resistant TB (DR-TB), particularly multidrug-resistant or rifampicin-resistant TB (MDR/RR-TB), continues to pose a major public health challenge. In 2024, an estimated 390,000 people developed MDR/RR-TB. India, China, the Philippines, and the Russian Federation together accounted for more than half of all estimated MDR/RR-TB cases globally [6]. Emerging resistance to Group A WHO medicines (fluoroquinolones, bedaquiline, linezolid), observed in 2025 in Moldova and Ukraine, will likely challenge efforts to control drug-resistant tuberculosis in Europe a WHO high-burden country of MDR/RR-TB.\nMETHODS: A retrospective cohort study analysed national tuberculosis surveillance data (2021-2022) [7, 8].

Figure 1. Estimated TB incidence rates, 2024 (WHO Global TB Report 2025, permission obtained to publish). TB incidence rates remain alarmingly high in low income countries in sub-Saharan Africa and south-east Asia.

Comorbidities

In 2025, evidence reaffirmed that both communicable and non-communicable comorbidities continue to influence the global burden and clinical course of TB. Recent evidence highlights their persistent epidemiological impact and describes emerging approaches, such as integrated care pathways and predictive tools, to enable earlier diagnosis and coordinated management.

Overall, comorbidities remain insufficiently addressed by national TB programs. A review of high-burden country guidelines shows that recommendations for systematic screening, referral, and coordinated management are often missing [9]. Most guidelines still follow a vertical, single-disease framework that does not reflect the multi-morbidity encountered in practice, limiting early detection and continuity of care. Guideline developers and National TB Program leadership should consider how they might provide more specificity around comorbidity and risk factor screening, diagnosis, and treatment in subsequent iterations of country guidelines [9]. A clinical review reinforces how a broad range of comorbidities, from HIV and diabetes to chronic lung diseases, silicosis, malignancy, and other immunosuppressive states, shape TB presentation and outcomes. These conditions alter immune responses, contribute to atypical clinical features and delays in diagnosis, and are associated with more severe disease and poorer treatment results [10].

Malnutrition

Malnutrition negatively affects TB outcomes worldwide. A recent study sought to detail the role of body mass index (BMI), confirming that a low BMI is strongly correlated with mortality among patients with TB [11]. An interesting new approach describes how climate change is driving the increase in food prices in low-resource countries, consequently reducing access to food in high TB-prevalence settings [12]. Standardization of the application of nutritional scores in standard clinical management remains an unmet need [13].

Silicosis

Silicosis and occupational silica exposure are strong risk factors for TB, with studies consistently showing a 2- to 4-fold higher risk of active TB among individuals with silicosis compared with unexposed populations. Silica particles impair alveolar macrophages, disrupt dendritic cell activity, and induce chronic fibrotic and immunomodulatory changes. Elevated TB incidence is also reported among individuals with substantial silica exposure but no diagnosed silicosis, with risk further increased in settings where HIV prevalence is high. The burden is concentrated in industries such as mining, quarrying, construction, and foundry work, underscoring the need for occupational health surveillance, routine TB screening, and dust-control measures in high-risk workplaces [14].

HIV

HIV remains a major comorbidity influencing TB epidemiology and outcomes, accounting for approximately 6% to 8% of global TB cases and a substantially higher proportion of TB-related mortality. Recent publications describe declines in TB incidence among people receiving timely HIV diagnosis and antiretroviral therapy, yet TB continues to cause substantial mortality. Data from different regions show marked heterogeneity in TB–HIV coinfection patterns. Common challenges include late presentation, the limited sensitivity of smear microscopy in immunosuppressed individuals, and gaps in service integration, particularly for adolescents, older adults, and populations with poor access to care. These findings support efforts to expand rapid testing, improve coordination between HIV and TB services, and promote earlier initiation of ART and TB treatment [15, 16].

Diabetes Mellitus

Diabetes impacts both TB risk and outcomes, with meta-analyses indicating a 2- to 3-fold increased risk of developing active TB among individuals with diabetes compared to those without. Experimental and clinical evidence show that chronic hyperglycemia impairs immune function, including macrophage activity, cytokine responses, and immune-metabolic pathways, leading to higher mycobacterial burden and slower treatment responses [17]. Genetic analyses using Mendelian randomization strengthen the likelihood of a causal link between diabetes and TB and support the need for bidirectional screening in high-burden settings [18]. Advances in predictive modeling also show potential for identifying individuals at early risk of diabetes–TB comorbidity, enabling more targeted prevention and clinical management [19].

Other Comorbidities

TB and cancer increasingly intersect clinically and epidemiologically. Chronic TB-related inflammation and fibrosis may contribute to carcinogenesis, while cancer-associated immune suppression can facilitate the persistence or reactivation of Mycobacterium tuberculosis (MTB). Diagnostic overlaps are common, and individuals with cancer, particularly those with lung or hematologic malignancies, have 2- to 6-fold higher rates of active and fatal TB. These findings emphasize the need for integrated diagnostic pathways within oncology care [20, 21].

Mental health is also gaining attention. Depression is highly prevalent among individuals with TB, affecting approximately 30% to 50% of patients in many settings, yet it remains under-detected and is associated with poorer treatment adherence and recovery. A co-design approach in a low-resource context demonstrated that incorporating depression screening and basic psychosocial support into TB services delivered by non-specialist staff, is feasible and acceptable [22].

Pathogenesis and Prevention

Pathogenesis

Among the 4 main human-adapted MTB complex lineages, lineage 1 is increasingly recognized as a strain with lower virulence but prolonged infectiousness [23]. Its frequency in several high-burden countries, such as the Philippines and India, makes this lineage the most common in people affected by TB [24]. In general, variabilities in strains may affect drug resistance, diagnostics, and transmissibility. Reduced expression of RD1 antigens affects virulence and makes contact tracing more difficult. In addition, strains with increased sulfolipid metabolism seem to stimulate cough, which may make transmission more likely [25].

Prevention by Identification of TB Infection

Active case finding in contact tracing is key to prevention, but is complicated by a high rate of asymptomatic cases [26]. A recent study confirmed that more than 80% of prevalent cases among household contacts were asymptomatic, and chest X-rays missed >40% of those cases. Thus, symptom-based screening in combination with chest X-rays achieved a sensitivity of only 64% in identifying prevalent cases [27]. In a large population-based study in China, elderly individuals with abnormal chest X-rays were found to have a higher risk of developing TB within 2 years, highlighting that chest X-ray abnormalities may identify a high-risk group [28]. When chest X-ray was used in combination with Xpert MTB/RIF Ultra as an initial screening test through event-based and door-to-door screening in Uganda, even trace-positive sputum results enabled prediction of TB disease during 2 years of follow-up, especially when combined with atypical chest X-rays [29]. In 2 cohorts from Brazil and India, an immune signature of interleukin (IL)-8, IL-10, and C-C motif chemokine ligand 3 (CCL3) reliably predicted progression to active TB among QuantiFERON-positive close contacts with a sensitivity and specificity ≥80% [30]. Several single-gene blood RNA transcripts allowed detection of subclinical TB with accuracy comparable to multi-gene signatures, suggesting the possibility of simplified biomarker approaches [31]. A prospective TBnet European multicenter study performed among 5 groups of immunocompromised individuals found that the QuantiFERON-TB Gold Plus assay had limited predictive value for progression to active TB, except among people living with HIV with uncontrolled viral replication and low CD4 T-cell counts. The study emphasizes the need for risk-stratified strategies in low-incidence settings [32]. Another TBnet study specifically addressing progression in transplant recipients found that the highest incidence occurred in patients with positive TB skin test (TST)/interferon-gamma release assay (IGRA) screening who did not receive tuberculosis preventive treatment (TPT). TB cases mainly occurred >2 years after transplantation, which suggests an important role of de novo infection in transplant recipients in Europe [33]. Finally, the long-held dogma to delay IGRA testing after live-attenuated vaccination was challenged by data showing that live-virus vaccines (MMR, polio, or varicella) do not cause false-negative TST/IGRA results. This suggests that immediate testing is reliable, could reduce delays in risk assessment, and enable timely TB prevention measures [34].

Prevention by Vaccination

TB vaccine trials that use disease as the primary outcome are challenging, as progression to active TB is relatively rare. To overcome this, sustained IGRA conversion is increasingly being explored as a surrogate endpoint. Evidence of success from Bacille Calmette-Guérin (BCG) vaccination has been mixed. The efficacy of BCG revaccination to protect against TB infection was tested among HIV-negative adolescents in a phase 2b, double-blind, randomized, placebo-controlled trial that did not show any benefit compared to placebo [35]. A recent phase 2b trial tested the H56:IC31 vaccine for prevention of recurrence or reinfection in HIV-negative adults after more than 5 months of successful treatment for drug-susceptible pulmonary TB. This study even raised concern about possibly inducing relapse, as vaccinated individuals had a slightly higher risk of recurrence as compared to those treated with placebo [36]. In contrast, the M72/AS01E–4 vaccine, which reduced progression to pulmonary TB by about 50% in individuals with TB infection in an earlier phase 2b study, also showed promise in people living with HIV [37], which led to inclusion of people living with HIV in the ongoing phase 3 trial (NCT06062238).

Diagnostics

TB diagnostics are undergoing rapid innovation, with 2025 marking several key advances. Progress has been driven by the dual priorities of simplifying specimen collection and integrating molecular and genomic technologies within streamlined diagnostic algorithms (Figure 2).

Simplified and Decentralized Molecular Testing

The simplification of specimen collection remains a key goal. Swab-based near-point-of-care (POC) molecular assays such as Truenat MTB Ultima (MTB Ultima) and MiniDock MTB Test (MiniDock MTB) have demonstrated diagnostic performance comparable to standard sputum testing in adults [38]. These assays, which can use tongue or sputum swabs, reduce biosafety risks and enable testing in decentralized settings. Another interesting innovation is the lab-in-a-tube assay, a portable, low-cost molecular platform that integrates sample preparation, amplification, and detection within a single, closed device [39]. Among other non-sputum-based tools, stool testing with Xpert MTB/RIF Ultra has shown potential for TB detection among adults living with HIV, addressing a recognized diagnostic gap in this population [40]. Together, these studies indicate that the diagnostic landscape is moving toward less invasive, more adaptable sampling strategies.

New evidence finally suggests that urinary and sputum LAM could be a useful diagnostic tool, fitting WHO target product profile for the diagnosis of TB, even in HIV-negative patients [41, 42].

Integration into Diagnostic Algorithms

Since the WHO endorsed targeted next-generation sequencing (tNGS) for drug-resistant TB diagnosis in 2024, attention in 2025 has shifted to its implementation and integration into diagnostic algorithms [43]. Ongoing work focuses on bacterial-load thresholds, workflow adaptation, and algorithm placement. At the systems level, the European Reference Laboratory Network for Tuberculosis (ERLTB-Net) has outlined a new algorithmic framework for the EU/EEA incorporating rapid molecular assays, sequencing, and selective phenotypic confirmation [44] (Figure 2).

Advances in Non-Microbiological Screening Tools

Several advances have occurred in non-microbiological diagnostics. The 2025 WHO policy statement on computer-aided detection (CAD) software endorsed 6 tools for the artificial-intelligence (AI)-based interpretation of chest X-rays. This follows growing evidence that automated imaging analysis can standardize screening quality and increase access to diagnosis in high-burden, resource-limited settings [45].

Complementary progress has been reported in the development of cough-based diagnostic algorithms. Results from the CODA TB DREAM Challenge demonstrated that machine-learning models trained on cough acoustics and minimal clinical data could differentiate pulmonary TB from other respiratory conditions with high accuracy [46]. These findings indicate the potential of digital phenotyping for large-scale, non-invasive screening, especially where access to radiography or microbiological testing remains limited.

Diagnostic Challenges in Immunocompromised Hosts

Despite these advances, diagnostic gaps remain among immunocompromised individuals. The aforementioned TBnet study reiterated that the QuantiFERON-TB Gold Plus assay has limited predictive value for progression to active disease [32], underscoring the need for more specific biomarkers that can distinguish TB infection from disease [47].

Figure 2. Early TB diagnosis is a strong priority for WHO and major public health authorities worldwide. AI-based technologies are playing a key role in the very next future. Adapted from: Lange C, et al. [47]

Treatment

The year 2025 saw eagerly awaited results for phase 2 and phase 3 trials in the treatment of TB disease. Novel agents continue to show promise in early-phase studies; additional results from studies on treatment shortening and treatment intensification were released; and some advances were seen in the management of rifampin- and fluoroquinolone-resistant disease. At the time of this review, there are also multiple studies underway and planned to investigate the treatment effect of host-directed therapies in TB disease, which is an important emerging focus in TB research, but there were no published results for 2025.

New Drugs Assessed in Early-Phase Trials

Figure 3 illustrates the pipeline of novel TB drugs, and identifying new oxazolidinones with improved safety profiles is among the main priorities in clinical research. The phase 2B PanACEA-DECODE-01 trial investigated the efficacy, safety, and optimal dosing of 16 weeks of delpazolid treatment in combination with bedaquiline (B), delamanid (D), and moxifloxacin (M) for pulmonary tuberculosis [48]. Pharmacokinetic-pharmacodynamic modeling estimated that once-daily 1,200 mg delpazolid resulted in 38% (95% CI 4-83%) faster decline in time-to-positivity (TTP) than without delpazolid. No significant oxazolidinone-class toxicities occurred except for one serious adverse event of anemia with delpazolid 800 mg twice daily. Delpazolid is planned for inclusion in Wave II of phase 2B in the PARADIGM4TB trial.

Figure 3. Global New TB Drug Pipeline showing new compounds being developed for the treatment of tuberculosis (courtesy of Tejaswini Dharmapuri Vachaspathi et al., Treatment Action Group 2025 - TB Treatment Pipeline Report). Host-directed interventions are not included.

Treatment-shortening and Treatment-intensifying in Drug-susceptible Disease

In 2023, the TRUNCATE-TB trial demonstrated that an 8-week regimen containing bedaquiline- linezolid was non-inferior to standard treatment for drug-susceptible disease when part of a strategy of treatment followed by intensive monitoring and re-treatment as necessary [49]. In 2025, an analysis of the safety and efficacy of the 8-week treatment arms in TRUNCATE-TB was published [50]. With the possibility of re-treatment excluded, 7 of 181 (4%) participants had an unfavorable outcome with standard care, compared to 46 of 184 (25%) in the high-dose rifampicin-linezolid arm and 26 of 189 (14%) in the bedaquiline-linezolid arm. These findings call into question the role of the bedaquiline-linezolid arm in settings where intensive monitoring is not feasible.

The phase 2C Clo-Fast study randomized participants to either a 3-month regimen of rifapentine-isoniazid-ethambutol-clofazimine (with pyrazinamide for the first 8 weeks) or standard of care for drug-susceptible disease [51]. Despite similar 12-week culture conversion rates in the experimental and control arms, respectively, the probability of an unfavorable outcome at week 65 was 52% (95% CI 37-69) and 27% (95% CI 14-50), and the trial was stopped early due to lack of clinical efficacy. The safety profile was undesirable in the clofazimine-containing arm, with 45% experiencing a grade 3 or higher adverse event compared to 16% in the control arm.

The HARVEST trial was a randomized, blinded, placebo-controlled trial of oral first-line TB treatment for TB meningitis with high-dose rifampin (35 mg/kg) for the first 8 weeks compared to standard therapy with 10 mg/kg rifampin throughout a 9- to 12-month treatment course [52]. Of 499 participants, 60.9% were HIV-infected. There was no significant difference in the primary outcome of mortality at 6 months post-randomization between the intervention and control groups, and no significant differences across subgroups. Treatment-emergent adverse events were reported by approximately 50% of participants on both arms, with 8.0% experiencing a grade 3 or 4 drug-induced liver injury in the experimental arm and 4.4% in the control arm. Overall, the potential for a harmful effect could not be ruled out.

New Regimens for Drug-resistant Tuberculosis

The endTB study investigated the efficacy of five 9-month oral regimens containing bedaquiline, delamanid, linezolid (L), levofloxacin (Lfx) or moxifloxacin, clofazimine (C), and pyrazinamide (Z) in rifampicin-resistant, fluoroquinolone-susceptible disease [53]. Non-inferiority, based on a 12 percentage points margin, was demonstrated by 3 experimental arms compared to the WHO-recommended standard therapy in both populations for the primary analysis (BCLLfxZ, BLMZ, and BDLLfxZ). Safety profiles were comparable across the non-inferior experimental arms and standard of care, except for increased hepatotoxicity in the BCLLfxZ and BLMZ arms. This study further expanded the armamentarium for rifampin-resistant TB. There is now growing pressure to ensure access to these life-saving drugs globally.

In parallel, the endTB-Q study randomized participants with rifampicin- and fluoroquinolone-resistant TB to receive either bedaquiline-delamanid-linezolid-clofazimine (BDLC) for 39 weeks or 24 weeks (based on disease severity and treatment response) [54] or the WHO-recommended longer regimen. BDLC was not non-inferior in the modified intention-to-treat but not in the per-protocol analysis. The authors conclude that a longer treatment course may be required in severe disease with rifampicin- and fluoroquinolone-resistance. These results also highlight the importance of ongoing work to clearly and reproducibly define disease severity for both clinical research and practice.

These exciting new developments are counterbalanced by sobering outcomes of treatment in people affected by bedaquiline-resistant and extensively drug-resistant TB (XDR-TB), where treatment success rates are similar to those of the pre-antibiotic era [55, 56].

Post-TB Disease

The first definition of post-tuberculosis lung disease (PTLD) stems from 2019, describing the condition as “Evidence of chronic respiratory abnormality, with or without symptoms, attributable at least in part to previous tuberculosis.” [57]. A more precise, but still broad research definition was published in 2025, including (a) a history of pulmonary or pleural TB without signs of active disease, (b) abnormalities in at least two out of three domains (lung function, imaging and respiratory symptoms) and (c) attributability of radiological, functional or symptomatic impairment at least in part to previous TB [58]. The authors stress the fact that very limited evidence was available to create this definition, but together with the reporting framework, it should be a basis for harmonizing PTLD research.

Among the attempts to gain more insight into the pathogenesis of PTLD, 2 studies should be highlighted. An analysis of immune, metabolic, anatomical and functional features of PTLD within 6 months post-TB treatment documents the complexity and variability of the condition. While inflammation in PET-CT correlated well with lung function impairment, it did not correlate with exercise tolerance, symptoms, and quality of life [59]. The study was conducted in human lungs post-TB and employed single-cell sequencing, demonstrating gene expression patterns associated with senescence, inflammation, fibrosis, and apoptosis. Further, the study demonstrated low levels of FOXO3, a protective longevity gene and NF-κB-driven thrombo-inflammatory post-TB vascular injury [60].

The proceedings from the Third International Post-Tuberculosis Symposium 2025 summarize the current state of discussion and knowledge around PTLD and other TB sequelae, based on input from different working groups covering the following topics: patient engagement; epidemiology and modelling; pathogenesis; post TB lung disease; cardiovascular and pulmonary vascular; central nervous system and musculoskeletal; pediatrics; economic, social and psychosocial aspects; advocacy, policy and stakeholder engagement [61].

To date, existing data on PTLD in children remain very limited, as highlighted by a recent systematic review. The authors found that approximately 40% of children aged 5 to 10 years exhibited abnormal lung function after TB treatment, rising to 65% in patients aged >10 years. Further data are urgently needed to generate a more detailed picture of associated growth and developmental issues [62].

Pediatrics

Recent TB incidence figures in children and adolescents in the EU/EEA give cause for concern. A study using data from 2015-2023 from TESSy at ECDC, found that following a nadir of 1,142 cases in 2021, numbers rose for 2 consecutive years to 1,689 cases in 2023, which was an astonishing increase of 47.9% [63]. Only a minority (28.7%) of cases were microbiologically confirmed. Several factors may have influenced this increase, including improved diagnosis and reporting of pediatric TB, modifications in population movements, and the impact of the COVID-19 pandemic on healthcare services.

In a study from South Africa, 154 (35.8%) of 430 TB-exposed children had TB, and 55 (35.7%) cases were asymptomatic. Unexpectedly, of the children with confirmed TB overall, 17 of 21 (81.0%) were asymptomatic, and only 4 of 21 (19.0%) were symptomatic. The authors concluded that asymptomatic children with TB need to be considered in future treatment-decision algorithms [64].

A multicenter study by the Pediatric TB Network European Trials Group (ptbnet) that focused on congenital (cTB) and postnatal (pTB) TB in the European setting found that cTB was associated with premature birth and low birth weight [65]. Most patients were microbiologically confirmed, but immune-based tests (TST and IGRAs) had poor sensitivity in both groups. Fatal outcome and long-term sequelae were observed in a substantial proportion of patients (8.7%, each), despite the high-resource setting.

A large multicenter study from the Spanish Pediatric TB Research Network (pTBred), which included children with TB in Spain and Mozambique, showed that chest X-rays, even when interpreted by expert readers, have limited sensitivity for detecting TB. Interestingly, lateral X-rays increased the overall sensitivity substantially [66].

A secondary analysis of data from the RaPaed-TB study illustrated that molecular testing cannot yet fully replace mycobacterial cultures [67]. Of 239 children with microbiologically confirmed TB, 110 (46%) were detected by both Xpert MTB/RIF Ultra and culture, 86 (36%) by Xpert MTB/RIF Ultra alone, and 43 (18%) by culture alone. The study also found that analyzing more than one clinical sample increases the diagnostic yield substantially (from 20% to 29%).

Microbiological confirmation of TB disease in children remains challenging, partly due to the inability of young children to generate sputum samples. Several studies have investigated alternative clinical samples that are easier to obtain, including oral swabs, nasopharyngeal aspirates (NPAs), and stool (68–74) by gastric aspiration or sputum induction, has a low diagnostic yield. In this study, we aimed to evaluate the diagnostic performance and additive yield of a novel stool-based assay in children diagnosed with tuberculosis in sub-Saharan Africa.\nMETHODS: We conducted a prospective case-control study from October 2020 to June 2023 in Eswatini, Mozambique, and Tanzania. Children under 15 years newly diagnosed with tuberculosis completed clinical examination, chest radiography, culture, sputum Xpert Ultra, stool Xpert Ultra, and stool-based quantitative polymerase chain reaction (stool qPCR [68–74].

A study in children aged <5 years, using 2 oral swabs analyzed with Xpert MTB/RIF Ultra assays, found that the sensitivity of this approach was only 6.9% against a microbiological reference standard and 1.8% against a composite reference standard [66]. A large multi-country study in children aged <15 years evaluating NPAs and stool reported that both sample types had suboptimal sensitivity [73]. Two recent studies investigated whether improvements in stool processing can increase the diagnostic yield. One assessed 3 centrifuge-free processing methods, comprising a simple one-step method, a stool processing kit, and an optimized sucrose flotation method, and found that each achieved similar sensitivity [74]. Another study in children in India, South Africa, and Uganda confirmed these findings [69]. Taken together, current evidence shows that, in children, respiratory samples (ie, sputum or gastric aspirates) remain superior to samples that are more easily obtained.

Table 1. Highlighted 2025 Publications in Pediatric TB According to TBnet Steering Committee Members

In parallel, the search for better biomarkers continues. A study investigated plasma metabolic signatures in children with TB, identifying a nine-metabolite signature that achieved an area under the curve (AUC) value of 0.72 for distinguishing confirmed TB from unlikely TB [75]. Another study used high-throughput proteomics, which identified 4 biosignatures (comprising 3-6 proteins) AUCs of 0.87-0.88 [76]. A third study used a CRISPR-based approach to detect MTB DNA in blood from children with TB; although the sample size was small (n=27), the results indicated that the assay used had greater sensitivity than Xpert MTB/RIF assays performed on respiratory samples from the same patients [39]. Those studies are encouraging, but their findings require further validation in independent cohorts, especially considering that previous proteomic studies in adults have found different sets of proteins to be characteristic markers of TB [77, 78].

A systematic review, which included data from ptbnet, provided insights regarding the treatment and outcomes of children and adolescents with rifampicin- and multidrug-resistant TB. The findings were sobering – it showed that, out of 23,369 children and adolescents with rifampicin- and multidrug-resistant TB, only 72.0% had treatment success, while 12.2% died, 3.1% experienced treatment failure, and 12.7% were lost to follow-up [79]. Table 1 summarizes the most important new evidence in Pediatric TB.

Nontuberculous Mycobacterial Disease

In 2025, epidemiologic and translational advances continued to shape understanding of nontuberculous mycobacterial (NTM) disease (Table 2). A Danish registry study of all NTM isolates from 1991–2022 analyzed 4,123 first-time positive individuals and observed increasing pulmonary NTM isolation rates, particularly among older females: in 2008–2022 vs 1991–2007, the incidence rate ratio for females was 1.9 (95% CI, 1.7–2.1) and for males 1.3 (95% CI, 1.1–1.4) (81). Geographic heterogeneity was evident, with age- and sex–adjusted rates 10% to 40% higher in rural and provincial municipalities vs the capital region [81].

Environmental risk associations were reinforced. In U.S. cohorts, higher molybdenum and vanadium concentrations in drinking water, and chloramine disinfectant use have been correlated with increased pulmonary NTM, with effects varying by geographic region [82].

Persons with underlying lung disease and suppressed immunity remain particularly vulnerable to NTM infection [83]. In a multinational matched case–control study of 85 solid organ transplant recipients diagnosed with NTM disease (2008–2018), the median time to diagnosis was 1.8 years post-transplant; 34% were lung recipients. One-year mortality was 20%, higher than matched uninfected controls, and lack of NTM therapy worsened outcomes [84]. These findings emphasize the need for surveillance in high-risk populations and for effective, well-tolerated regimens.

Preclinical drug development for M. abscessus showed notable advances. In an engineered C25-modified model, rifabutin analogs (UMN-120, UMN-121) have been shown to evade intrabacterial ADP-ribosylation, avoid CYP3A4 induction, and retain potent bactericidal activity. In murine lung models, these compounds cleared M. abscessus as effectively as standard 4-drug therapy, highlighting their potential as oral backbone agents [85]. A new all-oral, bactericidal triple-drug regimen (tebipenem + avibactam, moxifloxacin, and rifabutin) has been presented, which potentiated killing against both replicating and non-replicating, drug-tolerant bacteria, including in surrogate caseum models [86].

Meanwhile, dual β-lactam (or β-lactam/β-lactamase inhibitor) strategies also received renewed attention. M. abscessus cell-wall synthesis seems to involve DD and LD transpeptidases, which can be differentially targeted by β-lactam combinations. In vitro synergy was observed with cefoxitin/imipenem, ceftaroline/imipenem, ceftazidime/ceftaroline, and ceftazidime/imipenem, even without β-lactamase inhibitors [87, 88]. Although clinical evidence is limited, case reports support translational potential.

In M. avium complex (MAC) pulmonary disease, retrospective East Asian data suggest that dual regimens (macrolide + ethambutol) may be effective in select patients, though resistance and relapse remain a concern [89, 90]. Results from ongoing trials comparing 2- vs 3-drug regimens (NCT03672630, NCT04677569) are pending.

Host-directed strategies, including inhaled nitric oxide, GM-CSF, autophagy modulation, and interferon-gamma-driven macrophage activation, continue to attract interest [91], but no major breakthroughs occurred in 2025. Mechanistic and early-phase translational studies are ongoing [92, 93], though large-scale clinical translation remains aspirational.

Table 2. Highlighted 2025 Publications in NTM Disease According to TBnet Steering Committee Members

s

The field of mycobacterial diseases is undergoing rapid development. The year 2025 has been one of overturning long-held and cherished beliefs, with important benefits for those being treated for TB (Table 3). Higher rifampicin doses have been promoted on the basis of improved bactericidal activity. However, adverse events have been higher than expected, especially when including grades 1 and 2 adverse events [97], with no improvement in treatment outcome of severe TB disease, such as meningitis (50,52,98,99)multi-stage, open-label, randomised controlled trial in which participants aged 18-65 years with rifampicin-susceptible pulmonary tuberculosis were randomly assigned via a web-based system, using permuted blocks, to 24-week standard treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol [50, 52, 98, 99].

Biomarkers have been sought to assess the likelihood of an outcome. However, the best indices for relapses, using data gathered from RIFASHORT [100] and TRUNCATE-TB [50], now appear to be Xpert cycle threshold at the start of treatment and the return of symptoms. The latter is especially interesting in view of the lack of sensitivity and specificity of symptoms in TB diagnosis. Overall, these and other markers, such as the radiologic extent of TB disease, may pave the way to promising new approaches of stratified medicine for TB treatment [53] .

Never before in the history of TB have there been more anti-tuberculosis compounds in phases 1-3 clinical evaluation. However, current first-line regimens are still based on rifamycin, while MDR/RR-TB regimens include both bedaquiline and linezolid, the latter burdened by substantial toxicity. The increasing burden of bedaquiline-resistant and XDR-TB, for which no shorter and effective regimen exists, is deeply concerning. Pre-approval access to new compounds in late-stage development is a priority to treat patients with bedaquiline-resistant TB [101].

A plethora of novel diagnostic tools is “close-to-clinical application” with the potential to improve TB diagnostics. Promising approaches include the detection of MTB DNA at lower thresholds in serum, extracellular vesicles, and exosomes using CRISPR technology [39], and the rapid detection of T-cell responses in a point-of-care test that may potentially replace the current IGRAs [102]. This new technique holds the promise for broader applicability to understanding the immune response to MTB and translating the single-cell RNA sequencing studies of granulomas into a diagnostic test of clinical value [103–105]. Finally, in the 2025 Global Tuberculosis Report, WHO lists 18 TB vaccines in clinical development, including 6 in phase 3 trials, which will hopefully improve TB prevention compared to the more than 100-year-old BCG vaccine.

Despite these developments, the incidence of TB is still at a historical peak of more than 10 million estimated persons being newly affected in 2024 [1]. Although antituberculosis medicines are on the WHO’s list of essential medicines [106], stock-outs of these medicines are not infrequent, for instance in the Philippines [107] and even in Europe [108]. Rifapentine, a medicine recommended to shorten the duration of TB preventive therapy and TB treatment, is unavailable in almost all EU/EEA countries, as the drug has never been licensed by the European Medicines Agency [109]. The implementation of new, shorter treatments for drug-resistant TB happens with substantial delays in some countries due to problems in the roll-out of pretomanid [110]. Antimicrobial stewardship strategies for TB are urgently needed, as MDR/RR-TB was identified in 2024 as one of 4 antimicrobial-resistant organisms with the highest risk to threaten human health [111] (Table 5).

Decisions on resources made in 2025 are threatening TB control globally. Despite all innovations in research and development, forecasts predict that withdrawal of international donors from funding TB programs may lead to a substantial increase in the global TB incidence and attributed deaths in the next 10 years [112]. The growing field of NTM diseases is still largely ruled by eminence-based medicine, with a large need to fill the knowledge gap in all areas, from prevention to diagnosis and treatment.

In conclusion, we can assume that despite 2025 being a fruitful year across almost all TB research fields (Table 4), many research priorities still need to be addressed by authorities and stakeholders. Rapid, affordable, and cheaper diagnostic tools are mandatory to grant early diagnosis, especially in specific populations such as children or people living in low-resource, high-prevalence countries. TB and especially NTM treatments remain long, but new evidence is adding strength, year after year, to shorter and more tolerable schemes. Patient management evidence, finally, needs to be enforced not only for TB active disease, but also for long-term sequelae and concomitant diseases (Table 5).

Table 3. Key Recommendations for Tuberculosis Prevention, Diagnosis, and Treatment by the World Health Organization (WHO) Issued in 2025

Table 4. Highlighted 2025 Publications in Adult TB According to TBnet Steering Committee Members

Table 5: Future Priorities

Acknowledgments

The authors thank Mrs. Anne Oleischeck and Mrs. Margarita Abasheeva, Research Center Borstel, Germany, for administrative support.

Funding

CL is supported by the German Center for Infection Research (DZIF) under grant agreement TTU-TB 02.716

Potential Conflicts of Interest

All authors are members of the steering committee of the Tuberculosis network European Trials group (TBnet; www.tbnet.eu). CL has received honoraria for speaking at symposia sponsored by Astra Zeneca, INSMED, Gilead, GSK, medUpdate, and medUpdateEurope where the sponsor did not have influence on the content of the presentations. MT is currently receiving an honorarium for PI work from bioMérieux via his institutions and has previously received support from Cepheid and Cellestis/Qiagen for diagnostic tuberculosis studies. MS has received grant support from Astellas, Biotest, and Takeda to the organization Saarland University outside the submitted work, is PI of a TBnet study where Qiagen provided test kits free of charge, and has received honoraria for lectures from Biotest, MSD, and Moderna, and for advisory boards from Moderna, Biotest, MSD, and Takeda. NL has received honoraria to her institution for lectures and/or advisory board meetings from Insmed. All other authors declare no conflict of interest related to the contents of this manuscript.

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Footnotes

Submitted January 25, 2026 | Accepted May 12, 2026 | Published May 31, 2026

Copyright

Copyright © 2026 The Authors. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License.