HUMAN TUBERCULOSIS VACCINE MARKET ANALYSIS

Human Tuberculosis Vaccine Market Size and Trends

The human tuberculosis vaccine market is estimated to be valued at USD 64.2 Mn in 2024 and is expected to reach USD 95.1 Mn by 2031, exhibiting a compound annual growth rate (CAGR) of 5.8% from 2024 to 2031.

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The human tuberculosis vaccine market has been experiencing steady growth, driven by the increasing prevalence of tuberculosis worldwide and enhanced vaccination initiatives by governments and non-profit organizations, particularly in developing countries. As awareness grows and funding increases, the human tuberculosis vaccine industry is expected to expand, providing critical tools to combat this infectious disease. However, the human tuberculosis vaccine industry faces challenges such as the global shortage of BCG vaccines and potential adverse effects from vaccination, which may restrain the growth.

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Insights By Type: Immunological Advantage Propels the Live Attenuated Vaccine Segment Growth

In terms of type, live attenuated vaccine segment is estimated to contribute the highest market share of 65.7% in 2024 in the human tuberculosis vaccine industry, due to its unique ability to induce long-lasting protective immunity through immunological memory. These vaccines mimic natural infections, triggering robust humoral and cell-mediated immune responses. By actively replicating in the body, live attenuated vaccines present all pathogen antigens simultaneously, enhancing immune system exposure.

Insights By Age Group: Pediatric Population Prioritized to Reduce Community Transmission

In terms of age group, pediatrics segment is estimated to contribute the highest market share of 60.4% in 2024 in human tuberculosis vaccine industry, due to public health initiatives targeting young children, who are at the highest risk of developing active tuberculosis. Their still-developing immune systems make them significant reservoirs for transmission. Vaccinating this age group not only protects individuals but also reduces community spread, making it a cost-effective strategy for mass vaccination programs.

Insights, By Distribution Channel: Private Sector Fills Gaps in Public Health Coverage

In terms of distribution channel, the private segment is expected to contribute the highest market share of 49.2% in 2024, due to gaps in public health coverage. Despite national recommendations for BCG vaccination, the effectiveness of public programs varies significantly based on infrastructure, funding, and social determinants. Underserved geographic and demographic populations present lucrative opportunities for private providers to meet vaccination needs.

Regional Insights

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Dominating Region: Asia Pacific

Asia Pacific is expected to dominate the human tuberculosis vaccine sector with the highest market share of 36.8% in 2024, owing to significant burden of tuberculosis, with countries like India and China accounting for a large percentage of global cases.

Fastest-Growing Region: Africa

The Africa region exhibits the fastest growth with an estimated 22.7% market share in 2024. This is due to increased government funding and initiatives aimed at enhancing vaccination coverage, which is driving the demand for TB vaccines.

Human Tuberculosis Vaccine Market Outlook for Key Countries

U.S.’ increasing R&D investments and collaborations

The U.S. human tuberculosis vaccine industry is driven by increasing investments in research and development, alongside collaborations between government entities and industry leaders. These partnerships aim to accelerate the development of new vaccines, addressing the urgent need for effective TB prevention strategies amid rising incidence rates and drug-resistant strains.

China’s strong government funding

China human tuberculosis vaccine sector is supported by strong government funding and its status as one of the top TB-burdened nations. Significant investments in public health initiatives aim to enhance vaccination coverage, addressing the high prevalence of tuberculosis. This proactive approach facilitates access to vaccines, driving demand and improving community health outcomes.

India’s collaboration with global stakeholders to accelerate the introduction of new vaccines

India continues to face a significant disease burden, particularly from tuberculosis. The government is collaborating with global stakeholders to accelerate the introduction of new vaccines, aiming to enhance public health outcomes and reduce mortality rates associated with this infectious disease.

Japan’s research and development activities

Japan human tuberculosis vaccine industry is significantly shaped by domestic players dedicated to advancing innovative vaccine technologies. Companies like Japan BCG Laboratory are at the forefront, striving to enhance public health and effectively combat tuberculosis and other infectious diseases.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Key Market Players

• Established players focus heavily on R&D investments to drive innovation. Companies like Serum Institute, GlaxoSmithKline, and Merck have earmarked large budgets for R&D activities exploring new vaccine formulations and production technologies. They also pursue strategic partnerships with academic institutions to leverage external expertise and fast-track clinical trials of novel candidates.
• Mid-level players have adopted cost-effective strategies to remain competitive. Companies including GreenSignal and Biofabri focus on affordable solutions targeting price-sensitive markets. They keep production costs low by optimizing supply chains and leveraging generic technologies. Many also explore collaborations to strengthen infrastructure for meeting regulatory standards and expanding to new regions.
• Small-scale vendors have specialized in niche segments. Startups like MBio Diagnostics and Redx Pharma develop vaccines for drug-resistant strains through focused R&D. Others utilize technological advancements like AI-guided vaccine design at Anthropic to customize solutions. Local partnerships are also growing - companies like Bharat Biotech collaborate with regional bodies to address community-level needs.

Emerging Startups in the Human Tuberculosis Vaccine Industry

• On the technology front, Anthropic applies machine learning to accelerate traditional R&D processes and design highly effective TB vaccine candidates.
• Mvine Technologies is piloting 'host-pathogen interaction maps' leveraging multi-omics data to pinpoint novel vaccine targets. Their approach has potential to overcome challenges from evolving mycobacterial strains and drug resistance.
• Several startups are also championing sustainable approaches. PledgeBio develops vaccines via cell-free protein synthesis requiring minimal resources. Anthropic, LexaGene and others commit to OpenVaccine partnerships for equitable global access aligned with United Nation Sustainable Development Goals (SDGs).
• Many startups carve niches in developing student/traveler vaccines, thermostable formulations for last-mile access, or personalized solutions based on risk profiles.

Human Tuberculosis Vaccine Industry News

• On May 8, 2024, Bharat Biotech, a biotechnology company, announced that the Central Drug Standard Control Organisation (CDSCO) approved its proposal to conduct Phase II clinical trials for the Mycobacterium Tuberculosis (Live Attenuated) Vaccine, known as MTBVAC. The Phase II clinical trials aim to assess the safety and immunogenicity of MTBVAC in healthy adolescent and adult populations.
• On March 24, 2024, Bharat Biotech announced the start of clinical trials for its tuberculosis vaccine, MTBVAC, on adults in India. MTBVAC is a live attenuated vaccine derived from a human strain of Mycobacterium tuberculosis. Unlike the traditional BCG vaccine, MTBVAC includes all antigens found in strains that infect humans, potentially providing broader protection against tuberculosis
• In May 2023, Biofabri, a subsidiary of Zendal, and IAVI, an international nonprofit focused on vaccine and antibody development, announced a partnership for the comprehensive development of the tuberculosis vaccine candidate MTBVAC. Under this agreement, IAVI will assist with development, global regulatory strategies, resource mobilization, and access planning for the MTBVAC program targeting adolescents and adults.
• In January 2023, the World Health Organization (WHO) announced the creation of a Tuberculosis Vaccine Accelerator Council. This initiative aims to accelerate the development and deployment of effective tuberculosis vaccines by addressing barriers and fostering collaboration among stakeholders in the global health community.

Key Takeaways from Analyst

The human tuberculosis vaccine market is expected to see steady growth over the forecast period driven by the rising prevalence of tuberculosis globally.

Asia Pacific is projected to continue dominating the market attributed to high TB burden countries including India and China present in the region. However, Africa is anticipated to emerge as the fastest growing regional market supported by increasing government focus on TB immunization programs across countries.

While vaccines have shown effectiveness in eliminating several deadly diseases, development of a strong vaccine for tuberculosis remains a challenge posed by the complexity of Mycobacterium tuberculosis. This constitutes a key restraint to rapid market expansion.

Market Report Scope

Market Dynamics

Market Driver - Increasing awareness campaigns of tuberculosis disease

Increasing number of tuberculosis disease awareness campaigns conducted by government authorities is expected to drive the global human tuberculosis vaccine market. For instance, in March 2022, the Moroccan Ministry of Health and Social Protection launched its sixth national campaign to facilitate the early diagnosis of tuberculosis (TB) and improve treatment for the infection. The campaign took place from March 25 to June 30 in 2022 under the slogan “Towards a national mobilization to save lives and eliminate tuberculosis in Morocco.”

Market Challenge - Termination of clinical trials of human tuberculosis vaccine

One major challenge in the human tuberculosis vaccine market is the discontinuation of clinical trials for potential new vaccines. Several candidates, such as GSK’s M72/AS01E and Serum Institute of India's VPM1002, faced setbacks due to insufficient efficacy in trials, which is hindering research progress and discouraging investments in vaccine development.

Market Opportunity - Advancements in vaccine technologies for market

Advancements in vaccine technologies present significant opportunities for the human tuberculosis vaccine market. Innovative platforms such as nucleic acid (DNA/RNA) and virus-like particle (VLP) vaccines show promise in preclinical research, enabling rapid candidate generation with optimized immunogenicity. Additionally, novel adjuvants from companies like GSK plc, enhance efficacy, while improved clinical trial methodologies expedite development timelines.

Market Segmentation

• By Type Insights (Revenue, USD Mn, 2019 - 2031)
• • Live attenuated vaccine
  • Inactivated
  • Others
• By Age Group Insights (Revenue, USD Mn, 2019 - 2031)
• • Pediatrics
  • Adults
• By Distribution Channel Insights (Revenue, USD Mn, 2019 - 2031)
• • Private
  • Public
• By Regional Insights (Revenue, USD Mn, 2019 - 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• • 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.
  • BioNTech SE