Summary

Market Overview
The Global Therapeutic BCG Vaccine Market was valued at USD 60.29 Million in 2024 and is projected to reach USD 75.68 Million by 2030, growing at a CAGR of 3.86% during the forecast period. The BCG vaccine (Bacillus Calmette-Guérin) remains the only approved vaccine for tuberculosis (TB) prevention. Typically administered at birth in TB-endemic countries, and to high-risk infants in low-incidence regions, it helps prevent TB, which primarily affects the lungs but may spread to other organs. BCG is also incorporated in national immunization schedules due to its effectiveness. Beyond TB, therapeutic applications of the BCG vaccine are expanding to include diseases like bladder cancer, autoimmune disorders, and various cancers, driven by ongoing research. This broader therapeutic scope, along with its established safety and accessibility, continues to support steady growth in the market.
Key Market Drivers
Biotechnology Advancements
Biotechnology advancements involve innovations in utilizing biological systems and organisms to develop new technologies and products that improve human health and other sectors. In healthcare, progress in genetic engineering—such as the use of CRISPR-Cas9—has enabled precise gene editing, leading to breakthroughs in vaccine development, including therapeutic BCG vaccines. Additionally, the rise of biopharmaceuticals such as monoclonal antibodies and gene therapies is reshaping treatment approaches. Personalized medicine, driven by human genome sequencing and advanced genomics, is also emerging, enabling more targeted and effective treatments. Stem cell research continues to offer promise in regenerative medicine and organ repair. Synthetic biology further supports the creation of engineered organisms for practical uses in health, industry, and the environment. Together, these advancements enhance the development and application of therapeutic BCG vaccines across various disease areas.
Key Market Challenges
Vaccine Shortages
Producing BCG vaccines is a sensitive and intricate process, requiring controlled conditions to culture live bacteria. Any disruption—such as contamination or quality issues—can significantly hamper production. The global supply is dependent on a limited number of manufacturers, making the market susceptible to disruptions if one producer faces setbacks. Strict regulatory and quality control standards, although necessary, can delay production or cause batch rejections. Variability in demand due to disease trends or clinical trial requirements adds to the difficulty in maintaining consistent supply. Furthermore, imbalances in regional distribution and unexpected spikes in demand, such as during outbreaks or new therapeutic applications, can quickly deplete stockpiles and exacerbate shortages.
Key Market Trends
Tuberculosis (TB) Treatment and Prevention
The BCG vaccine has long been used to prevent tuberculosis, especially in areas with a high disease burden, by reducing the risk of infection and severe forms of TB in children. Beyond prevention, BCG is used in immunotherapy to treat non-muscle-invasive bladder cancer (NMIBC), where it activates the immune system to target cancer cells. Research is expanding into new therapeutic areas, exploring its potential in autoimmune diseases, infectious diseases, and other types of cancer. The emergence of drug-resistant TB strains, such as MDR-TB and XDR-TB, has further heightened the relevance of BCG vaccines, prompting investigations into their use as complementary treatments in drug-resistant TB management.
Key Market Players
• Merck & Co., Inc.
• Sanofi Pasteur Inc.
• Japan BCG Laboratory
• China National Biotec Group
• Serum Institute of India Pvt. Ltd,
• InterVax Ltd
• GreenSignal Bio Pharma Limited
• Statens Serum Institute
• PowderJect Pharmaceuticals
• Biomed Lublin
Report Scope:
In this report, the Global Therapeutic BCG Vaccine Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
• Therapeutic BCG Vaccine Market, By Type:
o Immune BCG
o Therapy BCG
• Therapeutic BCG Vaccine Market, By End User:
o Clinics
o Hospitals
• Therapeutic BCG Vaccine Market, By region:
o North America
§ United States
§ Canada
§ Mexico
o Asia-Pacific
§ China
§ India
§ South Korea
§ Australia
§ Japan
o Europe
§ Germany
§ France
§ United Kingdom
§ Spain
§ Italy
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Therapeutic BCG Vaccine Market.
Available Customizations:
Global Therapeutic BCG Vaccine Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
• Detailed analysis and profiling of additional market players (up to five).

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Table of Contents

1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Therapeutic BCG Vaccine Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Type (Immune BCG, Therapy BCG)
5.2.2. By End User (Clinics, Hospitals)
5.2.3. By Country
5.2.4. By Company (2024)
5.3. Market Map
6. Asia Pacific Therapeutic BCG Vaccine Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Type
6.2.2. By End User
6.2.3. By Country
6.3. Asia Pacific: Country Analysis
6.3.1. China Therapeutic BCG Vaccine Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Type
6.3.1.2.2. By End User
6.3.2. India Therapeutic BCG Vaccine Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Type
6.3.2.2.2. By End User
6.3.3. Australia Therapeutic BCG Vaccine Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Type
6.3.3.2.2. By End User
6.3.4. Japan Therapeutic BCG Vaccine Market Outlook
6.3.4.1. Market Size & Forecast
6.3.4.1.1. By Value
6.3.4.2. Market Share & Forecast
6.3.4.2.1. By Type
6.3.4.2.2. By End User
6.3.5. South Korea Therapeutic BCG Vaccine Market Outlook
6.3.5.1. Market Size & Forecast
6.3.5.1.1. By Value
6.3.5.2. Market Share & Forecast
6.3.5.2.1. By Type
6.3.5.2.2. By End User
7. Europe Therapeutic BCG Vaccine Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Type
7.2.2. By End User
7.2.3. By Country
7.3. Europe: Country Analysis
7.3.1. France Therapeutic BCG Vaccine Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Type
7.3.1.2.2. By End User
7.3.2. Germany Therapeutic BCG Vaccine Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Type
7.3.2.2.2. By End User
7.3.3. Spain Therapeutic BCG Vaccine Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Type
7.3.3.2.2. By End User
7.3.4. Italy Therapeutic BCG Vaccine Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Type
7.3.4.2.2. By End User
7.3.5. United Kingdom Therapeutic BCG Vaccine Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Type
7.3.5.2.2. By End User
8. North America Therapeutic BCG Vaccine Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Type
8.2.2. By End User
8.2.3. By Country
8.3. North America: Country Analysis
8.3.1. United States Therapeutic BCG Vaccine Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Type
8.3.1.2.2. By End User
8.3.2. Mexico Therapeutic BCG Vaccine Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Type
8.3.2.2.2. By End User
8.3.3. Canada Therapeutic BCG Vaccine Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Type
8.3.3.2.2. By End User
9. South America Therapeutic BCG Vaccine Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Type
9.2.2. By End User
9.2.3. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Therapeutic BCG Vaccine Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Type
9.3.1.2.2. By End User
9.3.2. Argentina Therapeutic BCG Vaccine Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Type
9.3.2.2.2. By End User
9.3.3. Colombia Therapeutic BCG Vaccine Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Type
9.3.3.2.2. By End User
10. Middle East and Africa Therapeutic BCG Vaccine Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Type
10.2.2. By End User
10.2.3. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Therapeutic BCG Vaccine Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Type
10.3.1.2.2. By End User
10.3.2. Saudi Arabia Therapeutic BCG Vaccine Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Type
10.3.2.2.2. By End User
10.3.3. UAE Therapeutic BCG Vaccine Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Type
10.3.3.2.2. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Developments
12.2. Product Launches
12.3. Mergers & Acquisitions
13. Global Therapeutic BCG Vaccine Market: SWOT Analysis
14. Porter’s Five Forces Analysis
14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Product
15. PESTLE Analysis
16. Competitive Landscape
16.1. Merck & Co., Inc.
16.1.1. Business Overview
16.1.2. Company Snapshot
16.1.3. Products & Services
16.1.4. Financials (In case of listed companies)
16.1.5. Recent Developments
16.1.6. Key Personnel Details
16.1.7. SWOT Analysis
16.2. Sanofi Pasteur Inc.
16.3. Japan BCG Laboratory
16.4. China National Biotec Group
16.5. Serum Institute of India Pvt. Ltd,
16.6. InterVax Ltd
16.7. GreenSignal Bio Pharma Limited
16.8. Statens Serum Institute
16.9. PowderJect Pharmaceuticals Ltd.
16.10.Biomed Lublin
17. Strategic Recommendations
18. About Us & Disclaimer