Market Scenario 

The Global BCG Tuberculosis Vaccine Market was valued at US$ 63.58 million in 2022 and is expected to attain a market valuation of US$ 91.10 million by 2031, at a CAGR of 4.5% During the Forecast Period 2023-2031.

One of the key drivers of this growth is the high global prevalence of tuberculosis (TB). TB remains a significant public health challenge worldwide, particularly in developing countries. The World Health Organization (WHO) estimates that there were approximately 10 million new cases of TB in 2020. The need to combat this highly infectious disease has led to a growing demand for BCG vaccines, which are effective in preventing severe forms of TB in children.

Governments across the globe have recognized the urgency of addressing TB and are making substantial investments to eradicate the disease. They are implementing comprehensive TB control programs that include vaccination campaigns as a crucial component. These initiatives involve collaborations with international organizations, such as the WHO, to ensure the availability and accessibility of BCG vaccines to the population.

Furthermore, governments are investing in healthcare infrastructure to strengthen the delivery of vaccines. They are focusing on expanding healthcare facilities, especially in underserved regions, to ensure efficient vaccine distribution and administration. This includes establishing vaccination centers, training healthcare professionals, and developing robust cold chain systems to maintain the quality and efficacy of vaccines.

The combined efforts of governments, healthcare organizations, and international bodies are propelling the growth of the BCG tuberculosis vaccine market. Increasing awareness about the importance of TB prevention and the availability of government-funded vaccination programs are driving the demand for BCG vaccines.

However, challenges persist, such as limited vaccine supply, particularly in resource-constrained areas. It is crucial for governments and manufacturers to collaborate and address these supply constraints to meet the rising demand and achieve the goal of global TB eradication.

To Get more Insights,  Request A Free Sample 

Market Dynamics 

Driver: High Prevalence of Tuberculosis Worldwide

The global burden of tuberculosis is a driving force behind the increasing demand for BCG tuberculosis vaccine market in the predicted period. The specific vaccination requirements for different stages of tuberculosis will play a crucial role in shaping the future demand. As the epidemic of this disease continues to expand, it will impact the supply and demand dynamics of the BCG vaccine, leading to further market growth.

Tuberculosis predominantly affects individuals in their prime working years, although all age groups are at risk. A staggering 95% of the incidence and deaths occur in underdeveloped nations. The presence of HIV infection increases the likelihood of active TB by 18 times, and individuals with weakened immune systems due to other illnesses are also more susceptible. Malnourished individuals are three times more vulnerable to the disease. Shockingly, in 2020, malnutrition was responsible for causing 1.9 million new TB cases worldwide, according to the World Health Organization (WHO).

Furthermore, the WHO South-East Asian BCG tuberculosis vaccine market witnessed the highest number of new TB cases, accounting for around 43% in 2020. The WHO Western Pacific Region followed with 18% of new cases, and the WHO African Region accounted for 25%. The 30 countries with the highest burden of TB were responsible for 86% of the new cases in 2020. Notably, India, China, Indonesia, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa contributed to two-thirds of the new TB cases. The escalating incidence of tuberculosis globally has significantly propelled the growth of the BCG Tuberculosis (TB) Vaccine market.

Challenge: Limited accessibility and affordability of vaccines

The challenge of limited accessibility and affordability poses a significant hurdle in the global tuberculosis vaccine market. Many developing countries with high tuberculosis burdens face difficulties in procuring and distributing vaccines to their populations in the global BCG tuberculosis vaccine market. The cost of vaccines, especially for newer and more advanced formulations, can be prohibitive for resource-constrained healthcare systems. Limited healthcare infrastructure and distribution networks further exacerbate the challenge of reaching remote and underserved areas.

To overcome this challenge, collaborations between pharmaceutical companies, governments, and international organizations are crucial. Initiatives such as technology transfer, capacity building, and subsidized pricing schemes can enhance accessibility and affordability. Additionally, investments in strengthening healthcare systems, supply chains, and cold storage facilities in high-burden regions can improve vaccine distribution and coverage.

Opportunity: Advancements in Vaccine Research and Development

The global BCG tuberculosis vaccine market presents an opportunity for advancements in research and development (R&D) to develop more effective and innovative vaccines. While the Bacillus Calmette-Guérin (BCG) vaccine remains the primary vaccine for tuberculosis prevention, its efficacy against pulmonary tuberculosis in adults is limited. There is a need for new vaccines that can provide enhanced protection and address the various stages and manifestations of tuberculosis.

The emergence of novel vaccine candidates, such as recombinant BCG vaccines and subunit vaccines, has shown promise in preclinical and clinical trials. These candidates aim to improve upon the limitations of the current BCG vaccine and offer greater efficacy and durability of protection. Collaborative efforts between academia, pharmaceutical companies, and research institutions can drive R&D activities, leading to the development of next-generation tuberculosis vaccines.

Investments in research infrastructure, clinical trials, and regulatory pathways can accelerate the development and approval of new vaccines in the global BCG tuberculosis vaccine market. Successful development and commercialization of advanced tuberculosis vaccines have the potential to transform the market, improve global tuberculosis control, and reduce the burden of the disease.

Segmental Analysis 

By Type

Based on product type, the BCG tuberculosis vaccine market is segmented into immune BCG and therapy BCG. Among these, the immune BCG segment held a majority of the market share of 82.6% in 2020. The factors contributing toward the growth of this segment include the role of BCG in effectively helping TB prevention and as of now, there is no substitute vaccine for immune BCG. Moreover, it has become mandatory in most countries as part of the national immunization program. The immune BCG vaccine segment is further estimated to project the fastest compound annual growth rate (CAGR) of 4.6% during the forecast period.

The immune BCG vaccine, due to its effectiveness in preventing tuberculosis, has gained widespread acceptance in the market. Governments and healthcare organizations have recognized the significant role of BCG in combating TB, leading to the incorporation of immune BCG into national immunization programs. This has resulted in a substantial market share for the immune BCG segment.

Furthermore, the absence of alternative vaccines for immune BCG has further strengthened its position in the market. With no substitute available, healthcare providers continue to rely on immune BCG for TB prevention. The steady growth of the immune BCG segment is expected to continue, driven by its crucial role in public health and the absence of viable alternatives.

By Application

Based on application, the BCG tuberculosis vaccine market is bifurcated into hospitals and clinics. The hospitals segment constituted a major market share of 79.9% in 2022 and is expected to project a CAGR of 4.7% during the forecast period. The growth of this segment is attributed to the increasing administration of the vaccine to infants in hospitals and the rising procurement and availability of vaccines in hospital settings.

Hospitals have emerged as primary points of vaccination for infants, owing to the well-established infrastructure and medical expertise available within these facilities. The convenience and reliability of vaccine administration in hospitals have contributed to the significant market share held by the hospitals segment.

Moreover, hospitals have become central hubs for the procurement and distribution of BCG vaccines. The increasing availability of vaccines in hospital settings has facilitated their easy access to healthcare professionals and patients, further driving the market growth. Hospitals, being key stakeholders in the healthcare system, play a vital role in the widespread adoption and administration in the global BCG tuberculosis vaccine market.

The hospitals segment is projected to maintain its dominance in the market during the forecast period. The continued emphasis on infant immunization programs and the growing healthcare infrastructure globally are expected to fuel the demand for BCG vaccines in hospital settings, driving the growth of this segment.

 To Understand More About this Research:  Request A Free Sample 

Regional Analysis

The global BCG tuberculosis vaccine market is seeing significant expansion in several areas, including China, Japan, India, ASEAN, Taiwan, Hong Kong, Australia, and South Korea. The market in Asia Pacific was estimated at US$41.02 million in 2022, and it's anticipated to reach US$ 59.94 million by 2031. This reflects the highest expected compound annual growth rate (CAGR) of 4.9% within the forecast period.

India holds about 25% of the worldwide TB cases. In 2019, the estimated incidence of TB was about 2.64 million. The same year, an estimated 9,500 HIV positive people and approximately 436,000 HIV negative individuals succumbed to the disease. In response, the government launched the Nikshay Poshan Yojana in 2018, a direct benefit transfer scheme providing nutritional support for TB patients. This was among several similar programs initiated that year. Furthermore, in 2018, the UN General Assembly (UNGA) held its inaugural high-level meeting on Tuberculosis, which resulted in the adoption of a Political Declaration to eradicate the TB epidemic by 2030 in the BCG tuberculosis vaccine market.

Meanwhile, China, carrying the world's second-largest TB burden after India, contributes to a quarter of the global cases. The widespread presence of TB in China constitutes a substantial public health issue. Every year, around 900,000 new TB cases are reported, with the Xinjiang Uygur autonomous region recording the highest prevalence - 184.5 cases per 100,000 people. However, the incidence of TB in China was projected to reduce to under 58 cases per 100,000 people in 2020.

Top Players in the Global BCG Tuberculosis Vaccine Market 

• Japan BCG Laboratory
• China Biotechnology Co., Ltd
• Merck KGaA
• Serum Institute of India Pvt. Ltd.
• GSBPL
• AJ Vaccines
• Statens Serum Institute
• Other Prominent players

Recent Developments:

• January 27, 2020: GSK licensed its M72/AS01 TB vaccine candidate to the Gates Medical Research Institute (MRI). This strategic move was aimed at facilitating further development and potential use of the vaccine in lower-income nations with a high TB burden.
• March 9, 2021: UNICEF delivered 450,000 doses of the BCG vaccine to Ukraine upon the request of the Ministry of Health (MOH) of Ukraine. This large-scale delivery aimed to protect children in the country from TB.
• July 14, 2021: Biofabri and the International AIDS Vaccine Initiative (IAVI) announced their partnership to conduct efficacy trials of a TB vaccine candidate named MTBVAC. This collaboration signified a promising development in the fight against TB.
• August 9, 2022: A study led by a researcher from the School of Public Health, published in The Lancet Global Health, found that BCG vaccination at birth provides significant protection against Tuberculosis (TB) in children under the age of 5 years. However, the study did not find the same level of protection among adolescents or adults.
• August 15, 2022: Researchers at Massachusetts General Hospital (MGH) published a paper in Cell Reports Medicine, showcasing the potential protective effects of multiple doses of the BCG vaccine against Covid-19 and other infectious diseases. This finding indicated the possible multifunctional benefits of the BCG vaccine.

Market Segmentation Overview:

(Note*: We also provide granular level reports, made to sub-segment level or only for niche segments. Contact us, if you require more details.)

By Type

• Immune BCG
• Therapy BCG

By Application

• Hospital
• Clinics

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia & New Zealand
  • ASEAN
  • Rest of Asia Pacific
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • South Africa
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America