Global BCG Tuberculosis (TB) Vaccine Market Size By Type (Immune, Therapy), By Application (Pediatrics, Adults), By End-User (Hospitals, Clinics) By Geographic Scope And Forecast

BCG Tuberculosis (TB) Vaccine Market Size and Forecast

BCG Tuberculosis (TB) Vaccine Market size was valued at USD 53.49 Million in 2024 and is projected to reach USD 72.64 Million by 2031, growing at a CAGR of 3.90% from 2024 to 2031.

• The BCG (Bacillus Calmette-Guérin) vaccine is primarily used to treat tuberculosis. It is a weakened strain of Mycobacterium bovis, a microbe similar to M. tuberculosis that causes tuberculosis.
• The vaccine is provided shortly after delivery, particularly to infants at high risk of tuberculosis. The BCG vaccine stimulates an immunological response, protecting babies and young children from deadly types of tuberculosis. It is also used to treat bladder cancer.

Global BCG Tuberculosis (TB) Vaccine Market Dynamics

The key market dynamics that are shaping the BCG Tuberculosis (TB) vaccine market include

Key Market Drivers

• High Global Tuberculosis Burden The persistently high worldwide tuberculosis load is a major driver of the BCG vaccination business. According to the World Health Organization’s Global Tuberculosis Report 2023, an estimated 10.6 million individuals became ill with tuberculosis in 2022, including 1.3 million children. According to the analysis, tuberculosis remains one of the world’s worst infectious diseases, accounting for 1.3 million fatalities in 2022. This significant disease burden highlights the ongoing need for effective tuberculosis prevention efforts, particularly BCG vaccination.
• Increasing Government Initiatives and Funding Growing government support and financing for tuberculosis control initiatives is propelling the BCG vaccine market. According to the Stop TB Partnership, global TB financing reached $5.8 billion in 2022, the highest level reported to date. However, this falls short of the $13 billion yearly expenditure required by 2022, as indicated by the Global Plan to End Tuberculosis 2018-2022. The increased emphasis on tuberculosis elimination is anticipated to enhance expenditure on vaccination efforts.
• Rising Awareness and Expanding Immunization Programs in Developing CountriesExpanding immunization programs, particularly in developing countries with high tuberculosis burdens, are driving up demand for BCG vaccines. According to UNICEF, global BCG vaccine coverage has increased from 85% in 2000 to 88% in 2019. In South-East Asia, where tuberculosis is endemic, BCG coverage reached 95% in 2019. This trend of expanding coverage in high-burden areas is projected to continue, resulting in market growth.

Key Challenges

• Side Effects Associated with the Use of BCG Vaccine The BCG vaccine has side effects such as swollen lymph nodes, high fever, and skin infections at the injection site. Despite their rarity, these side effects hinder vaccination acceptance and market growth. Careful monitoring and control of any adverse effects is essential.
• Concerns Regarding the Efficacy of BCG Vaccines There are questions regarding the BCG vaccine’s effectiveness to protect against new tuberculosis strains that have appeared. If the vaccination is ineffective against these new strains, it diminishes demand and slows market growth. Ongoing research and improvement are required to ensure that the BCG vaccine stays effective.
• Shortage of Supply A lack of BCG vaccines limits market expansion. Supply chain problems, manufacturing challenges, or underproduction cause shortages and restrict the availability of the vaccine, particularly in high-burden nations. Meeting global demand and reducing tuberculosis require an adequate and stable supply.

Key Trends

• Increasing Global Demand Due to High TB Prevalence The global prevalence of tuberculosis remains a major public health concern, particularly in underdeveloped nations. The World Health Organization (WHO) predicts millions of new tuberculosis infections each year, fueling demand for the BCG vaccine. As governments acknowledge the importance of combating tuberculosis, they are launching vaccination campaigns and investing in healthcare facilities, which are projected to considerably enhance market growth in the future years.
• Focus on Childhood Immunization Programs Childhood immunization programs are becoming increasingly important, particularly in areas with high tuberculosis prevalence. Governments and health organizations are prioritizing neonatal vaccination to prevent serious types of tuberculosis, such as TB meningitis. This focus is reinforced by international programs and campaigns focused on raising awareness about tuberculosis prevention, which drives higher demand for the BCG vaccine.
• Emergence of Novel Vaccine Candidates New and improved tuberculosis vaccines, such as recombinant BCG vaccines and subunit vaccinations, are now under development. These candidates seek to overcome the limitations of the current BCG vaccine and improve its efficacy against various tuberculosis strains. The prospective launch of these novel vaccines is projected to disrupt the market environment and drive future growth as they go through clinical trials and regulatory approval.

Global BCG Tuberculosis (TB) Vaccine Market Regional Analysis

Here is a more detailed regional analysis of the BCG Tuberculosis (TB) vaccine market

Asia Pacific

• According to Market Research, the Asia Pacific region is estimated to dominate over the forecast period. The Asia Pacific area has a disproportionately high tuberculosis load, fueling up demand for BCG vaccines. According to the World Health Organization’s Global Tuberculosis Report 2023, six of the eight countries responsible for two-thirds of global tuberculosis cases in 2022 were in Asia PacificIndia (27%), Indonesia (9.2%), China (7.4%), the Philippines (7%), Pakistan (5.7%), and Bangladesh (3.6%). This high disease load demands ongoing and extended immunization efforts in the region.
• BCG immunization is primarily targeted at the Asia Pacific region’s huge and rising pediatric population. According to the United Nations Population Division, Asia is home to about half of the world’s children, with a projected 1.2 billion under the age of 18 in 2020. According to UNICEF, India, which has the region’s highest pediatric population, there were roughly 27 million births in 2022. The region’s BCG vaccine demand is driven by its large and expanding pediatric population.
• Furthermore, many Asia Pacific countries are currently working to improve their healthcare infrastructure and increase immunization coverage. For example, according to WHO and UNICEF estimates of national vaccination coverage, BCG vaccine coverage in Southeast Asia increased from 87% in 2000 to 95% by 2022. Since 2000, BCG coverage in the Western Pacific region, which includes China and other East Asian countries, has generally been higher than 95%. This trend of upgrading healthcare systems and extending vaccination programs is a major driver of the BCG vaccine market in the region.

North America

• North America is estimated to exhibit significant growth during the forecast period. North America, particularly the United States, sees a lot of immigration from countries with high tuberculosis rates, which drives up the demand for BCG immunization. According to the Centers for Disease Control and Prevention (CDC), 8,300 tuberculosis (TB) infections were reported in the United States in 2022. The CDC also states that foreign-born individuals account for the bulk of tuberculosis cases in the United States, with an incidence rate 14 times higher than that of U.S.-born people in 2022. This demographic pattern highlights the importance of BCG immunization in the region.
• Furthermore, the BCG vaccine is being utilized as an immunotherapy for bladder cancer, which is generating demand in North America. According to the American Cancer Society, approximately 82,290 new cases of bladder cancer (62,460 in men and 19,830 in women) are expected to be detected in the United States by 2023. The association also believes that bladder cancer is the fourth most frequent malignancy in men. The increasing prevalence of bladder cancer in North America has increased the need for the BCG vaccine as a therapy option.

Europe

• Europe region is estimated to exhibit substantial growth during the forecast period. Europe has seen a considerable influx of immigrants from countries with high tuberculosis prevalence, pushing up demand for BCG vaccine. According to the European Centre for Disease Prevention and Control (ECDC), foreign-born people accounted for 29.4% of TB infections in the EU/EEA in 2019. Foreign-born cases ranged from 0% to 95.7% in reporting nations. This demographic transition has led to a greater emphasis on tuberculosis prevention techniques, such as BCG vaccination for high-risk groups.
• Furthermore, TB vaccine research and development in Europe is on the rise, with enhanced BCG formulations among the highlights. Between 2003 and 2020, the European & Developing Countries Clinical Trials Partnership (EDCTP) contributed more than €157 million in 52 grants for clinical research on tuberculosis vaccines. This investment comprises around 15% of EDCTP’s total portfolio. The increased R&D focus is likely to stimulate innovation in the BCG vaccine industry and potentially broaden its applications.

BCG Tuberculosis (TB) Vaccine MarketSegmentation Analysis

The BCG Tuberculosis (TB) Vaccine Market is segmented based on Type, Application, End-User, and Geography.

BCG Tuberculosis (TB) Vaccine Market, By Type

• Immune BCG
• Therapy BCG

Based on Type, the market is segmented into Immune BCG and Therapy BCG. The immune BCG segment is estimated to dominate the BCG Tuberculosis (TB) vaccine market due to immune BCG’s success in preventing tuberculosis, which has led to widespread acceptance and incorporation into national immunization programs around the world. The lack of alternative vaccinations for immune BCG has further strengthened its standing, as healthcare providers continue to rely on it for tuberculosis prevention.

BCG Tuberculosis (TB) Vaccine Market, By Application

• Pediatrics
• Adults

Based on Application, the market is segmented into Pediatrics and Adults. The pediatrics segment is estimated to dominate the BCG Tuberculosis (TB) vaccine market. BCG vaccination is primarily administered to infants and young children because it gives up to 80% protection against severe types of pediatric tuberculosis, such as TB meningitis. Children have a higher risk of contracting tuberculosis than adults. Continuous government measures for tuberculosis immunization in children are helping to drive the segment’s growth.

BCG Tuberculosis (TB) Vaccine Market, By End-User

• Hospitals
• Clinics

Based on End-User, the BCG Tuberculosis (TB) vaccine market is divided into Hospitals and Clinics. According to analyst, the hospital segment is estimated to dominate the market over the forecast period due to hospitals’ extensive healthcare services, which include immunization programs for babies and at-risk groups. Hospitals are frequently equipped with the required infrastructure and skilled personnel to properly deliver the BCG vaccine, making them an ideal location for TB preventive initiatives. Furthermore, hospitals play an important role in handling tuberculosis patients, which helps to secure their market position.

BCG Tuberculosis (TB) Vaccine Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the BCG Tuberculosis (TB) vaccine market is classified into North America, Europe, Asia Pacific, and the Rest of the World. The Asia Pacific region is expected to dominate the market during the forecasted period. This domination is mostly due to the high incidence of tuberculosis in countries such as India and China, which account for a sizable proportion of worldwide TB cases. Government attempts to increase vaccine coverage, as well as raising knowledge about tuberculosis prevention, contribute to the region’s strong market position. As a result, Asia Pacific is projected to continue to drive the BCG vaccination market.

Key Players

The “BCG Tuberculosis (TB) Vaccine Market” study report will provide valuable insight with an emphasis on the global market. The major players in the market are Merck, Sanofi Pasteur, Japan BCG Lab, China National Biotec, Serum Institute of India, Intervax, and GSBPL.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

BCG Tuberculosis (TB) Vaccine Market Recent Developments

• In July 2021, The New Jersey-based Hackensack Meridian Center for Discovery and Innovation (CDI) announced that it had received USD 6.4 million in funding from the National Institutes of Health to investigate a novel idea for a tuberculosis vaccine. The CDI team has suggested that BCG would be enhanced by designing it to promote B-cell proliferation and survival.
• In March 2022, The Serum Institute of India Pvt. Ltd. requested the Drugs Controller General of India, seeking the emergency usage of authorization for its recombinant BCG vaccination to combat tuberculosis. Throughout the projected period, the BCG vaccine market will benefit from the approval of this vaccine.
• In January 2023, The WHO intended to establish a new “TB Vaccine Accelerator Council”. The committee will speed up the formation of a high-level coalition comprising international organizations, donors, end users, and governments to identify and address obstacles to the development of tuberculosis vaccines like BCG. It will also help authorize and implement innovative TB vaccines

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• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors.
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