Global Bacillus Calmette-Guerin (BCG) Vaccine Market – Industry Trends and Forecast to 2031

Bacillus Calmette-Guerin (BCG) Vaccine Market Analysis and Size

The Bacillus Calmette-Guérin (BCG) vaccine market is driven by its critical role in tuberculosis (TB) prevention, particularly in regions with high TB prevalence. According to the World Health Organization (WHO), tuberculosis claimed the lives of 1.5 million people in 2020, making it the 13th leading cause of death globally. In addition, an estimated 10 million individuals worldwide contracted tuberculosis in 2020. The disease is pervasive across all nations and affects people of all ages. As the prevalence of tuberculosis rises and mortality rates increase, the BCG vaccine market is anticipated to experience growth. BCG vaccination programs target infants and young children, aiming to reduce severe TB infections such as meningitis and disseminated disease. The market benefits from continuous government initiatives and funding to expand immunization coverage, especially in developing countries where TB remains a significant public health concern.         

Global bacillus calmette-guerin (BCG) vaccine market size was valued at USD 58.84 billion in 2023 and is projected to reach USD 87.60 billion by 2031, with a CAGR of 5.10% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation       

Market Definition

The Bacillus Calmette-Guérin (BCG) vaccine is a live attenuated vaccine derived from a strain of Mycobacterium bovis, a bacterium related to Mycobacterium tuberculosis, which causes tuberculosis (TB). It is primarily used to protect against tuberculosis, particularly in infants and young children. The BCG vaccine is administered through injection and stimulates the immune system to recognize and respond to TB bacteria if exposed, thereby reducing the risk of severe forms of tuberculosis, such as meningitis and disseminated disease in children.

Bacillus Calmette-Guerin (BCG) Vaccine Market Dynamics

Drivers

• High Burden of Tuberculosis (TB) Worldwide    

With millions of new TB cases reported annually and high mortality rates associated with the disease, BCG vaccination continues to be a critical strategy in TB prevention efforts. The urgent need to reduce TB incidence and associated mortality underscores the sustained demand for BCG vaccines, particularly in regions where TB remains endemic. The persistent high burden of tuberculosis (TB) worldwide, particularly prevalent in developing nations, remains a significant driver for the demand for the bacillus calmette guerin BCG vaccine market.      

• Government Immunization Programs 

Governments across various countries allocate substantial funding to enhance vaccine coverage, aiming to achieve universal immunization against tuberculosis. These initiatives not only facilitate the widespread distribution of the bacillus calmette-guerin vaccine but also raise public awareness about TB prevention and the importance of vaccination. The concerted efforts of governments and NGOs in immunization campaigns contribute significantly to market growth by increasing vaccine accessibility and adoption rates globally. Strong government support and robust immunization programs spearheaded by international organizations play a pivotal role in boosting the BCG vaccine market.

Opportunities

• New BCG Vaccine Formulations   

Researchers are actively exploring modifications to the existing vaccine to enhance its protective efficacy against tuberculosis. Innovations in vaccine technology aim to address challenges such as variability in efficacy across different TB strains and the duration of protection provided by the current BCG vaccine. These advancements not only seek to optimize TB prevention outcomes but also open doors to new market segments and applications beyond traditional immunization programs.The development of novel BCG vaccine formulations with improved efficacy and stability represents a promising opportunity for market expansion.               

• Extended Use in Oncology   

BCG therapy has long been established as a standard treatment for non-muscle-invasive bladder cancer due to its immunostimulatory properties. Ongoing research focuses on harnessing BCG's immune-modulating effects to target other types of cancer and enhance treatment outcomes. The expanding role of the bacillus calmette-guerin vaccine in oncology highlights their versatility and underscores their potential as a therapeutic agent beyond infectious disease prevention, thereby broadening market opportunities and attracting investments in new clinical applications.

Restraints/Challenges

• Vaccine Supply Constraints  

Challenges in vaccine manufacturing and supply chain logistics pose significant constraints to the BCG vaccine market, particularly in resource-limited settings. Issues such as production capacity limitations, distribution challenges, and cold chain requirements impact vaccine availability and accessibility in regions with high TB prevalence. Addressing these supply chain constraints through strategic investments in manufacturing capacity and logistics infrastructure is crucial to meeting global demand and achieving equitable vaccine distribution.          

• Changing Efficacy of BCG Vaccine

Variability in the efficacy of the BCG vaccine against different strains of Mycobacterium tuberculosis presents a notable challenge in TB prevention efforts. While BCG vaccination is generally effective in reducing severe forms of TB in children, its protective efficacy can vary based on geographic region and TB strain prevalence. For instance, in November 2023, the Centers for Disease Control and Prevention reported that 8.4% of tuberculosis cases in the U.S. in 2022 showed resistance to at least isoniazid, with 1.4% displaying multidrug resistance. This variability underscores the need for continuous research to enhance vaccine efficacy and address strain-specific immune responses.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In July 2023, The Serum Institute of India, a biotechnology and biopharmaceuticals company, obtained government authorization to export its BCG vaccine to Canada for use in immunotherapy treatments for bladder cancer  
• In February 2022, Sanofi S.A., a multinational pharmaceutical and healthcare corporation based in France, acquired Amunix for an undisclosed amount. This strategic acquisition provides Sanofi with access to Amunix's advanced technologies such as Pro-XTEN, XPAT, and XPAC. These innovations enable the delivery of conditionally activated biologics, marking a significant advancement in biopharmaceutical innovation for Sanofi

Bacillus Calmette-Guerin (BCG) Vaccine Market Scope

The market is segmented on the basis of diseases, population type, drug type, end-users, and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Diseases

• Tuberculosis
• Cancer
• Others

Population Type

• Children
• Health Care Workers
• Others

Drug Type

• Immune BCG
• Therapy BCG

End-Users

• Hospitals
• Specialty Clinics
• Home Healthcare
• Others

Distribution Channel

• Direct Tender
• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

Bacillus Calmette-Guerin (BCG) Vaccine Market Regional Analysis/Insights

The market is analyzed and market size insights and trends are provided by country, diseases, population type, drug type, end-users, and distribution channel as referenced above.

The countries covered in the market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, rest of Middle East and Africa, Brazil, Argentina, and rest of South America.

Asia-Pacific is expected to dominate the market due to the high consumption of the BCG vaccine for tuberculosis (TB) treatment. TB remains a significant public health concern in many countries across Asia-Pacific, leading to widespread vaccination programs. Countries such as India and China, with large populations and higher incidences of TB, contribute significantly to the demand for BCG vaccines.   

Middle East and Africa are expected to witness significant growth during the forecast period due to the increased prevalence of respiratory diseases and the presence of well-established medical facilities in certain countries. Respiratory diseases, including TB, pneumonia, and other lung infections, are prevalent in parts of the Middle East and Africa, necessitating substantial use of vaccines such as BCG.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Bacillus Calmette-Guerin (BCG) Vaccine Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• Merck & Co Inc. (U.S.)
• Sanofi Pasteur (France)
• Japan BCG Laboratory (Japan)
• China National Biotec Group (China)
• Serum Institute of India Pvt. Ltd. (India)
• InterVax Ltd. (Canada)
• GreenSignal Bio Pharma Limited (India)
• Statens Serum Institute (Denmark)
• AJ Vaccines (Denmark)
• Biomed Lublin S.A. (Poland)

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