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United States BCG Vaccine Market Analysis | Key Manufacturers, Demand Rises with WHO TB Elimination Goals & Healthcare Investments | China National Biotech Group, Serum Institute of India Pvt. Ltd, InterVax Ltd, GREENSIGNAL BIO PHARMA LIMITED (GSBPL), and
BCG Vaccine Market
According to the Global TB Report, the majority of TB cases occurred in South-East Asia (43%), Africa (25%), and the Western Pacific (18%). The 30 high-burden countries accounted for 86% of global cases, with India, China, Indonesia, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa making up two-thirds of the total. This high prevalence in emerging economies is expected to drive demand for BCG vaccines during the forecast period.
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Latest M&A
BCG-related M&A activity is moderate but expected to increase with biotech companies pursuing recombinant BCG vaccines and novel TB vaccine candidates amid a global push for tuberculosis eradication.
Big pharma and vaccine manufacturers are strengthening pipelines through licensing and acquisitions, focusing on enhanced efficacy, recombinant technologies, and better production methods.
List of Top Key Player:
Sanofi Pasteur, Merck & Co, Japan BCG Laboratory, China National Biotech Group, Serum Institute of India Pvt. Ltd, InterVax Ltd, GREENSIGNAL BIO PHARMA LIMITED (GSBPL), and STATENS SERUM INSTITUTE.
Latest News
The global BCG vaccine market was valued around $159 million in 2023 and projected to reach $243 million by 2032 with a CAGR of about 6.27%, driven by rising TB incidence and immunization efforts.
Recombinant BCG vaccines are gaining traction for improved safety and efficacy profiles; ongoing research expands their use in bladder cancer immunotherapy and immune modulation.
WHO recommends BCG vaccination at birth in endemic regions; India launched extensive campaigns including BCG revaccination strategies.
The U.S. faced a BCG vaccine shortage which ended in early 2025 with introduction of recombinant BCG by ImmunityBio in partnership with Serum Institute of India.
Forecast Projection:
The Global BCG Vaccine Market is poised for significant growth between 2025 and 2032. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.
Market Intelligence Research Process:
The BCG Vaccine Market research report by DataM Intelligence combines primary and secondary data to deliver deep, actionable insights. It examines the full spectrum of factors shaping the industry, from government regulations and market conditions to competitive dynamics, historical trends, technological breakthroughs, upcoming innovations, and potential challenges. This comprehensive analysis not only highlights growth prospects but also identifies barriers, equipping businesses to navigate market volatility and capitalize on emerging opportunities.
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Key Segmentation:
By Product: (Immune BCG, Therapy BCG)
By Demographics: (Pediatrics (0-18 Years), Adults (19-35 Years)
By Application: (Hospitals, Clinics),
Global Growth Regional Analysis:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Latest FDA Approvals
FDA approved Merck's TICE® BCG vaccine for bladder cancer and tuberculosis prevention; recombinant BCG (rBCG) received expanded access authorization to address shortages.
FDA approved gemcitabine intravesical system for BCG-unresponsive non-muscle invasive bladder cancer in September 2025.
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Reimbursement
Reimbursement frameworks vary globally; many countries provide full or partial reimbursement for BCG vaccines under public health immunization programs.
Belgium extended full Kaftrio reimbursement (CFTR modulator, related to CF and indirectly linked to immunocompromised states) to young children, indicative of pediatric drug reimbursement trends.
Neuro-implant reimbursement schemes include BCG-related therapies under some health systems, indicating growing acknowledgment of therapeutic value.
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