Tuberculosis Market Insight, Epidemiology and Market Forecast

Tuberculosis Key Takeaways

• Tuberculosis Market size projection: As per DelveInsight’s analysis, the total market size of tuberculosis in the 7MM is expected to surge significantly by 2032, driven by increasing awareness of the disease and more effective interventions being developed.

• Tuberculosis Patient population data: The report provides the total tuberculosis potential pool across the United States, EU4 countries (Germany, Spain, Italy, and France), the United Kingdom, and Japan from 2019 to 2032, with comprehensive epidemiological segmentation covering diagnosed patient pool and forecasted trends.

• Key Tuberculosis companies: Leading tuberculosis companies, such as Biofabri S.L., GlaxoSmithKline, Otsuka Pharmaceutical, Global Alliance for TB Drug Development, Spero Therapeutics, Sequella Inc., Aeras, LegoChem Biosciences, Quratis Inc., Vaxil Biotherapeutics, Faron Pharmaceuticals, and others are actively developing innovative therapeutic solutions.

• Tuberculosis Pipeline assets: Some of the key tuberculosis therapies in the pipeline include MTBVAC (Biofabri), GSK3036656 (GlaxoSmithKline), RUTI (Archivel Farma), GC3107A (GC Biopharma), BNT164 (BioNTech), and others across various development phases.

• Recent developments:

  • On January 7, 2025, the U.S. Centers for Disease Control and Prevention (CDC) issued updated guidelines endorsing a six-month BPaL regimen—bedaquiline, pretomanid, and linezolid—for people aged 14 years and older with drug-susceptible pulmonary TB, shortening therapy while maintaining efficacy.

  • In January 2025, IntelliGenome’s CRISPR-TB blood test, which uses CRISPR-based PCR to detect Mycobacterium tuberculosis cell-free DNA in blood, received FDA Breakthrough Device Designation.

  • In January 2025, the New England Journal of Medicine published the endTB trial findings, demonstrating that multiple all-oral, nine-month regimens for multidrug- and rifampicin-resistant TB achieved high cure rates, offering shorter and more tolerable alternatives to the traditional 18-month therapies.

  • In February 2025, Revvity’s Auto-Pure 2400 liquid handling platform integrated with the T-SPOT.TB assay received FDA approval for high-throughput, automated detection of latent TB infection, enhancing laboratory productivity and accuracy in TB screening.

  • In April 2025, the UNITE4TB consortium reported completion of the DECISION phase 2B dose-finding study of BTZ-043 with bedaquiline and delamanid, with post-study analysis expected soon.

  • In May 2025, the FDA withdrew its January 2025 final guidances on tuberculosis and sepsis, reissuing both as draft guidances, reflecting evolving regulatory considerations for TB testing and management.

Discover more recent advancements in the Tuberculosis landscape @ Tuberculosis Recent Developments.

Tuberculosis Market Dynamics

The tuberculosis treatment market has evolved significantly with innovations in diagnostics, treatment regimens, and vaccines offering hope for millions affected by this devastating disease. According to DelveInsight’s comprehensive Tuberculosis Market Insight, Epidemiology and Market Forecast report, the market is positioned for substantial growth through 2032, driven by increasing research and development investments and rising incidence rates across the seven major markets. Market momentum continues to build as awareness of tuberculosis increases globally, creating expanded opportunities for pharmaceutical manufacturers to penetrate deeper into previously underserved markets.

The scientific rationale behind current therapeutic development focuses on addressing the complex pathophysiology of Mycobacterium tuberculosis infections, which primarily target the lungs but can affect various organ systems including respiratory, gastrointestinal, and musculoskeletal systems. Current pipeline candidates employ diverse mechanisms of action, from traditional antimicrobial approaches to innovative vaccine strategies and immunomodulatory interventions designed to overcome existing treatment limitations.

The tuberculosis clinical development activity remains robust across Phase II and Phase III stages, with companies pursuing novel approaches to treat and improve disease outcomes. The competitive landscape features established pharmaceutical giants alongside specialized biotechnology companies, each contributing unique strategic approaches to address different aspects of tuberculosis treatment. Major players are investing heavily in collaborative research, acquisition strategies, and licensing arrangements to strengthen their tuberculosis portfolios.

Significant challenges persist in the tuberculosis treatment landscape, particularly regarding high pricing of second-line treatments and inadequate diagnostic capabilities in resource-limited settings. Despite these barriers, market opportunities continue to expand as global health initiatives prioritize infectious disease elimination and sustained investment in research and development drives innovation. The market outlook through 2032 remains optimistic, supported by increasing healthcare spending, improved diagnostic technologies, and growing pipeline diversity that addresses both drug-sensitive and drug-resistant tuberculosis variants.

Download the Tuberculosis Market report to understand which factors are driving the therapeutic market @ Tuberculosis Market Trends.

Tuberculosis Epidemiology

The tuberculosis epidemiology landscape across the seven major markets encompasses comprehensive historical and forecasted patient data from 2019 to 2032, providing critical insights into disease burden and treatment opportunities. The epidemiological analysis covers the United States, EU5 countries including Germany, Spain, Italy, France, and the United Kingdom, along with Japan, representing the world’s largest pharmaceutical markets and most advanced healthcare systems.

Epidemiology segmentation within the report includes detailed breakdowns of diagnosed patient populations, treatment-eligible cohorts, and forecasted trends that account for various demographic and clinical factors influencing tuberculosis prevalence. The total cases across selected indications reflect both pulmonary and extrapulmonary manifestations of tuberculosis, with particular attention to drug-sensitive and drug-resistant variants that require different therapeutic approaches.

The total eligible patient pool analysis incorporates patients suitable for current and emerging therapeutic interventions, considering factors such as disease severity, treatment history, and contraindications that influence treatment selection. Geographic segmentation reveals significant variation in tuberculosis burden across the seven major markets, with some regions experiencing higher incidence rates due to socioeconomic factors, healthcare infrastructure differences, and varying levels of disease awareness and screening programs.

Forecasted epidemiological trends through 2032 suggest evolving patient demographics and treatment patterns, influenced by improved diagnostic capabilities, enhanced public health interventions, and increased access to effective therapies. The comprehensive epidemiological framework supports market sizing calculations and treatment uptake projections essential for strategic planning across the tuberculosis treatment landscape.

Discover evolving trends in the Tuberculosis epidemiology forecasts @ Tuberculosis Patient Pool Analysis.

Key Tuberculosis Companies and Treatment Market Context

The tuberculosis clinical and regulatory landscape for tuberculosis treatment encompasses both established therapeutic options and innovative pipeline candidates addressing significant unmet medical needs. Current treatment practices include standard antimicrobial regimens, though challenges with drug resistance, treatment duration, and patient compliance create opportunities for next-generation therapeutic approaches.

The tuberculosis clinical pipeline activity spans multiple development phases, with key players pursuing diverse therapeutic strategies from novel antimicrobials to innovative vaccine platforms. Key players include Biofabri (MTBVAC), GlaxoSmithKline (GSK3036656), Archivel Farma (RUTI), GC Biopharma (GC3107A), BioNTech (BNT164), Otsuka Pharmaceutical, Global Alliance for TB Drug Development, Spero Therapeutics, Sequella Inc., Aeras, LegoChem Biosciences, and Quratis Inc., each contributing specialized expertise and resources to advance tuberculosis treatment options.

Market positioning within the current treatment paradigms reflects the critical need for improved therapeutic alternatives that address drug resistance, reduce treatment duration, and enhance patient outcomes. Drug profiles across the pipeline demonstrate varied mechanisms of action, from traditional antimicrobial approaches to innovative immunotherapeutic strategies designed to boost host immune responses against Mycobacterium tuberculosis infections.

Development milestones include recent phase transitions, regulatory designations, and strategic partnerships that accelerate clinical progress and commercial preparation. Commercial arrangements encompass licensing deals, collaborative research agreements, and acquisition strategies that strengthen company positions within the competitive tuberculosis treatment landscape. These strategic initiatives support continued innovation while addressing the substantial global health burden posed by tuberculosis infections.

Delve deeper into the major and specialised companies in the Tuberculosis market @ Tuberculosis Competitive Landscape.

Conclusion

DelveInsight’s comprehensive tuberculosis market analysis through 2032 reveals significant growth potential driven by innovative therapeutic development, increasing disease awareness, and substantial unmet medical needs. The convergence of robust pipeline activity, strategic industry collaboration, and evolving epidemiological understanding positions the tuberculosis treatment market for meaningful expansion across the seven major markets.

Scope of the Tuberculosis Market Report

• Comprehensive descriptive overview of tuberculosis, explaining causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies

• Complete insight into tuberculosis epidemiology and treatment landscape across the 7MM (United States, EU5 countries, and Japan)

• All-inclusive assessment of current and emerging tuberculosis therapies, with evaluation of new treatments impacting the current treatment landscape

• Detailed historical and forecasted tuberculosis market review covering drug outreach across the 7MM

• Patient-based tuberculosis market forecasting providing strategic business development insights through trend analysis

• 10-year tuberculosis market forecast from 2019-2032 with comprehensive market size projections

• Tuberculosis Epidemiology segmentation across seven major markets with detailed patient pool analysis

• Key cross-competition analysis and highly analyzed market dynamics

• Tuberculosis Pipeline drug uptake analysis and development activity assessment

• Current Tuberculosis treatment practices, unmet needs, and market attractiveness evaluation

• Tuberculosis Pipeline product profiles with detailed clinical trial information and regulatory milestones

• Tuberculosis Market drivers, barriers, and opportunities assessment

• Reimbursement scenario analysis and key opinion leader insights

• Collaborative activities, licensing deals, patent details, and merger/acquisition information for emerging tuberculosis therapies.

Table of Contents

1. Key Insights

2. Executive Summary of Tuberculosis

3. Competitive Intelligence Analysis for Tuberculosis

4. Tuberculosis Market Overview at a Glance

5. Tuberculosis: Disease Background and Overview

6. Tuberculosis Patient Journey

7. Tuberculosis Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Tuberculosis Unmet Needs

10. Key Endpoints of Tuberculosis Treatment

11. Tuberculosis Marketed Products

12. Tuberculosis Emerging Therapies

13. Tuberculosis: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Tuberculosis

17. KOL Views

18. Tuberculosis Market Drivers

19. Tuberculosis Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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