The Human Tuberculosis Vaccine Market, estimated at USD 68.1 Mn in 2025, is expected to exhibit a CAGR of 6% and reach USD 102.4 Mn by 2032.
The market growth is driven by increasing demand for innovative and effective drugs across diverse therapeutic areas. Advances in drug discovery, biopharmaceuticals, and digital technologies are improving treatment outcomes and operational efficiency. Supportive regulations, rising R&D investments, and a strong focus on patient-centric care are creating new opportunities for pharmaceutical companies.
Market Dynamics:
The growth of the human tuberculosis vaccine market is driven by the rising burden of tuberculosis infections globally and increasing R&D investments for the development of novel and effective vaccines. In 2022, according to the WHO, around 10 million people fell ill with tuberculosis in 2021. This massive patient pool requires effective prevention and vaccination against the disease which is increasing the focus on R&D and clinical trials of new TB vaccines. Additionally, various government and private organizations are investing heavily in TB vaccine development.
Growing Government Support and Funding for TB Vaccine Research and Development
Governments and global health organizations have increasingly prioritized efforts and allocated more funding towards developing new tools to combat the global TB epidemic. For instance, the WHO’s End TB Strategy aims to reduce TB deaths by 95% and cut new cases by 90% between 2015 and 2035. The National Institutes of Health (NIH) alone provided over US$ 250 million in funding for TB research in 2020. With strong commitment and financing from public sectors, private companies have more incentives to invest in developing novel TB vaccines which can potentially generate huge returns if successfully developed and commercialized on a global scale.
Evolving BCG Vaccine Shortcomings and Need for More Effective Alternatives
The only currently available TB vaccine – Bacille Calmette-Guérin (BCG) – has significant limitations in terms of efficacy as well as safety. BCG provides variable and often low levels of protection against pulmonary TB in adolescents and adults, the groups most at risk. It is also not recommended for individuals who are HIV positive due to safety concerns. With the shortcomings of BCG becoming increasingly apparent, researchers have accelerated efforts into developing new TB vaccine candidates with improved efficacy, safety, and immunogenicity profiles to replace or boost BCG. This growing realization of the need for BCG alternatives presents major opportunities for new vaccine entrants.
Stringent Regulatory Standards and Lengthy Clinical Trials Process
Developing new vaccines is an extremely long, risky and costly endeavor that takes over 10-15 years on average. Tuberculosis vaccine candidates must undergo extensive preclinical testing followed by multi-year Phase I, II and III clinical trials involving thousands of human subjects to establish safety, immunogenicity and protective efficacy profile against TB infection/disease. Stringent review and approval are also required by regulatory bodies such as the Food and Drug Administration (FDA) in the U.S. before any new vaccine can be commercially available. The protracted and expensive product development process deters many companies away from TB vaccine R&D.
Competing Health Priorities and Budget Constraints
Amid competing global health priorities such as cancer, cardiovascular diseases and COVID-19, governments and international donors often face difficult choices in allocating already stretched healthcare budgets. Though TB causes millions of deaths annually, it does not garner as much public attention or fundraising dollars compared to higher profile diseases. Furthermore, the largest TB burden disproportionately impacts low and middle-income countries with constrained economic capabilities. This budget prioritization challenge results in fewer resources allocated towards TB vaccine R&D when alternatives for preventable diseases exist as well.
Fragmented IP Landscape and Licensing Barriers
Developing new TB vaccines involves technologies and findings patented by multiple different institutions, biotechs, and universities worldwide. However, navigating the complex web of IP ownership and agreeing on fair licensing terms have proven difficulty for TB vaccine developers in the past. Lengthy negotiations delays progress and hinders coalition-building needed to pool resources and expertise. This fragmented IP landscape disincentivizes potential entrants and deters partnership/collaboration opportunities critical for advancing cutting-edge vaccine candidates through clinical milestones.
Entry of Large Pharma Companies and Follow-on Booster Market Potential
While the human tuberculosis vaccine market alone may not be lucrative enough to attract mega pharmaceutical companies, opportunities exists when a new vaccine is developed. Large pharmaceutical companies with global infrastructure are well-positioned to manufacture and distribute primary vaccines approved on a massive scale recommended by WHO. Additionally, the follow-on market for booster vaccines represents a major revenue stream as immunity wanes over time for high-risk populations. Successful phase III trial data and endorsement of a novel vaccine's protective value could galvanize Big Pharma's downstream participation in manufacturing and selling booster doses globally for decades to come.
Link: https://www.coherentmarketinsights.com/market-insight/human-tuberculosis-vaccine-market-5209
Key Developments
- On March 24, 2024, Bharat Biotech, a biotechnology company, announced the initiation of clinical trials for the tuberculosis vaccine MTBVAC on adults in India. MTBVAC is a live attenuated vaccine derived from a human strain of Mycobacterium tuberculosis. Unlike the existing BCG vaccine, MTBVAC contains all the antigens present in strains that infect humans, potentially offering broader protection against tuberculosis.
- In May 2023, Biofabri, a subsidiary of Zendal, and IAVI, an international non-profit research organization focused on developing vaccines and antibodies against infectious and neglected diseases, announced an agreement for the end-to-end development of the tuberculosis (TB) vaccine candidate MTBVAC. Under the agreement, IAVI is supporting development, global regulatory strategy, resource mobilization, and access planning for the adolescent/adult MTBVAC program.
- In January 2023, the World Health Organization (WHO) announced the establishment of a TB Vaccine Accelerator Council aimed at expediting the development and deployment of effective tuberculosis (TB) vaccines
Key Players
GSK plc., Serum Institute of India Pvt. Ltd., Valneva SE, Archivel Farma, BIOFABRI (Zendal), Japan BCG Laboratory, CSL Seqirus, GreenSignal Bio Pharma Private Limited (GSBPL), AJ Vaccines A/S, Taj Pharmaceuticals Ltd., Merck & Co., Inc., Bharat Biotech, Moderna, Inc., and BioNTech SE
Contact Us