BCG Vaccine Market Size, Share, Growth & Industry Analysis, By Type (BCG Vaccine for Bladder Cancer, BCG Vaccine for Tuberculosis), By Strain, By Route of Administration, By End-User, By Age Group, and Regional Analysis, 2024-2031

BCG Vaccine Market Size

The global BCG Vaccine Market size was valued at USD 86.4 million in 2023 and is projected to grow from USD 90.3 million in 2024 to USD 127.9 million by 2031, exhibiting a CAGR of 5.11% during the forecast period. The market is witnessing substantial expansion due to the expansion of global immunization strategies and the introduction of new vaccine technologies.

As health agencies prioritize TB prevention, especially in high-risk areas, the market is experiencing growing investments in research and development. Additionally, the growing interest in the BCG vaccine's potential therapeutic uses beyond TB is contributing to market expansion.

In the scope of work, the report includes products offered by companies such as AJ Vaccines A/S, Serum Institute of India Pvt. Ltd., GSBPL, Taj Pharmaceuticals Limited, Japan BCG Laboratory, Merck & Co., Inc., Microgen, Biomed Lublin S.A., BCG Vaccine Laboratory, Statens Serum Institut, and others.

The growth of the BCG vaccine market is driven by several key factors, including the rising prevalence of tuberculosis, technological advancements in vaccine research and development, and increased government initiatives to support vaccination programs.

• For instance, the WHO reported that in 2022, approximately 10.6 million people globally contracted tuberculosis (TB), comprising 5.8 million men, 3.5 million women, and 1.3 million children.

Tuberculosis remains a major global health challenge, particularly in regions affected by poverty, homelessness, and high HIV infection rates, all of which are primary factors in the transmission of the disease. As the sole vaccine available for preventing infection by Mycobacterium tuberculosis, the BCG vaccine plays a crucial role in global TB prevention strategies. The growth of the market is further propelled by ongoing efforts to enhance vaccine efficacy and expand immunization coverage worldwide.

The Bacillus Calmette-Guérin (BCG) vaccine is a live attenuated vaccine specifically developed to prevent tuberculosis (TB), with a particular emphasis on protecting against severe forms such as TB meningitis in children. Introduced in the early 20th century, the BCG vaccine is derived from Mycobacterium bovis, a bacterium closely related to Mycobacterium tuberculosis, which causes TB.

As the only licensed vaccine for TB, it is predominantly used in regions with a high prevalence of the disease. While it effectively prevents severe TB in children, its efficacy against pulmonary TB in adults varies, prompting ongoing research aimed at identifying more effective vaccine alternatives.

Analyst’s Review

Rising government initiatives focused on expanding immunization programs and enhancing healthcare infrastructure are supporting the growth of the BCG vaccine market. These efforts are aimed at increasing vaccine accessibility and coverage, particularly in regions with high tuberculosis prevalence, thereby fueling market expansion.

• In January 2023, the WHO established a new “TB Vaccine Accelerator Council.” This committee assist in authorizing and utilizing effective novel TB vaccines. It facilitates high-level collaboration among global agencies, funders, end users, and governments to address challenges in tuberculosis vaccine development, including those related to the BCG vaccine.

Key market players are continuously leveraging strategic collaborations and global initiatives to accelerate product development and expand their market reach, thereby fostering growth and enhancing their competitive positioning.

BCG Vaccine Market Growth Factors

The rising global incidence of tuberculosis (TB) is contributing to the growth of the BCG vaccine market, as governments and health organizations are actively increasing their vaccination efforts to control the disease's spread.

• According to an article published in bioRxiv in 2023, Bacillus-Calmette-Guerin (BCG) was administered to approximately 130 million children each year to provide protection against Mycobacterium tuberculosis (Mtb), the causative agent of tuberculosis (TB).

These entities are implementing expanded immunization programs, particularly in regions with high TB prevalence, where the BCG vaccine plays a critical role in prevention. Additionally, there is a concerted effort to target vulnerable populations, including children and immunocompromised individuals, to reduce TB transmission. This proactive approach is continuously fueling the demand for the BCG vaccine, thereby propelling market growth.

The BCG vaccine market faces significant challenges, including variable efficacy against pulmonary tuberculosis in adults and limited advancements in vaccine formulation. This issue is compounded by logistical and distribution difficulties in low-resource settings, where TB prevalence is highest. To address these challenges, key players are investing heavily in research and development to create next-generation vaccines with improved protection.

• For instance, in March, 2024, the Bill & Melinda Gates Medical Research Institute launched a phase 3 trial to evaluate the M72/AS01E vaccine's effectiveness in preventing the progression from latent to active TB. The trial, which began in South Africa, follows a 2019 phase 2b trial where the vaccine demonstrated roughly 50% protection against TB progression.

Key players are further exploring advanced delivery systems and adjuvants to enhance efficacy. Additionally, strategic partnerships with global health organizations and governments are being formed to overcome distribution barriers and ensure vaccines reach high-risk populations efficiently. These efforts aim to strengthen market presence and maximize impact.

BCG Vaccine Market Trends

The market is experiencing a growing trend toward the development of more effective and less reactive formulations. Leading pharmaceutical companies and research institutions are increasingly focusing on enhancing the vaccine's efficacy to provide stronger protection against tuberculosis while reducing side effects.

• For instance, in May 2023, the Spanish biopharmaceutical firm Biofabri and IAVI, an organization dedicated to developing vaccines and antibodies for infectious and neglected diseases, announced a partnership for the comprehensive development of the tuberculosis (TB) vaccine candidate MTBVAC.

This trend is further fueled by the surging need to optimize patient outcomes, particularly among diverse populations with varying immune responses. Innovations in vaccine delivery systems and the incorporation of advanced adjuvants are being actively developed to enhance overall effectiveness.

These advancements are positioning next-generation BCG vaccines as pivotal components of global tuberculosis control strategies, offering safer and more reliable immunization solutions, which is likely to support market growth in the coming years.

The BCG vaccine market is experiencing increased demand due to its potential applications beyond tuberculosis treatment, particularly in addressing non-tuberculosis conditions such as bladder cancer and diabetes. This exploration is attracting significant attention from the medical and pharmaceutical sectors, leading to a surge in research and development activities.

Clinical studies are demonstrating promising results, which is bolstering market confidence in BCG's broader therapeutic applications. As pharmaceutical companies invest in these innovative uses, the BCG vaccine is being positioned as a fundamental element in the prevention of tuberculosis. Additionally, it is being explored as a potential breakthrough treatment for oncology and metabolic disorders, thereby expanding its market scope and fostering market expansion.

Segmentation Analysis

The global market is segmented based on type, strain, route of administration, end-user, and geography.

By Type

Based on type, the market is categorized into BCG vaccine for bladder cancer and BCG vaccine for tuberculosis. The BCG vaccine for bladder cancer segment led the BCG vaccine market in 2023, reaching a valuation of USD 64.1 million.

The use of BCG as an immunotherapy for bladder cancer has gained immense traction, as clinical evidence demonstrates its ability to reduce both recurrence and progression of the disease. This segment is expanding as an increasing number of healthcare providers and institutions recognize BCG's benefits in bladder cancer management, leading to its increased adoption and the development of treatment protocols.

Additionally, ongoing research aimed at optimizing BCG therapy for bladder cancer is supporting segmental growth, highlighting its critical role in oncology and enhancing its market presence.

By Strain

Based on strain, the market is categorized into Danish 1331 strain, Pasteur 1173p2 strain, Tokyo 172 strain, Russian BCG-I strain, and other strains. The Danish 1331 strain segment captured the largest market share of 36.18% in 2023.

This strain, known for its consistency and reliability, is the most commonly used BCG vaccine globally, which underscores its strong market presence. The segment benefits from robust production and quality control processes that ensure the optimal performance of high vaccine.

As global TB control programs intensify and new markets expand, the Danish 1331 strain segment continues to witness growth. Additionally, its established safety profile and effectiveness are strengthening its role in global immunization strategies.

By Route of Administration

Based on route of administration, the market is categorized into percutaneous and intravesical. The percutaneous segment dominated the market in 2023 and is anticipated to maintain its dominance, reaching a valuation of USD 79.3 million by 2031. This method, which involves administering the vaccine via a needle prick on the skin, offers simplicity and effectiveness, contributing to its increasing adoption in TB prevention programs.

The percutaneous approach is valued for its ease of administration and minimal invasiveness, which enhance patient compliance and expand vaccination coverage. As global health initiatives aimed at more comprehensive TB control, the percutaneous segment is experiencing growth due to enhanced distribution and training efforts.

By End-User

Based on end-user, the market is categorized into hospitals, clinics, ambulatory surgical centers, research & academic institutes, and others. The hospitals segment is expected to capture the largest BCG vaccine market share of 47.64% by 2031. Hospitals are the primary settings for administering BCG vaccines, particularly to infants and high-risk patients.

The segment is witnessing notable growth as hospitals enhance their TB management protocols and invest in advanced vaccine delivery systems. Increased hospital-based vaccination programs and the rising focus on infection control further contribute to this growth.

Additionally, hospitals are increasingly adopting updated BCG formulations and treatment guidelines, thereby boosting demand. The segment's growth reflects hospitals' ongoing commitment to comprehensive TB care and prevention strategies.

BCG Vaccine Market Regional Analysis

Based on region, the global market is classified into North America, Europe, Asia-Pacific, MEA, and Latin America.

Asia-Pacific BCG vaccine market share stood around 42.45% in 2023 in the global market, with a valuation of USD 36.7 million. This significant market presence is facilitated by the high prevalence of tuberculosis (TB) in developing countries such as India, Indonesia, and China, which creates a strong demand for BCG vaccination.

The impact of poverty and homelessness further increases TB susceptibility, thereby boosting the need for vaccination. Moreover, the presence of numerous BCG vaccine manufacturers in the region supports domestic market expansion.

The rising focus on enhancing BCG vaccination rates among children in countries such as India and China is crucial for addressing these challenges and fueling regional market growth.

North America is anticipated to witness significant growth at a CAGR of 4.54% over the forecast period. The North America market is influenced by the region's relatively low tuberculosis prevalence. However, it remains critical due to its targeted applications for high-risk groups and medical conditions such as bladder cancer.

Both the U.S. and Canada continue to implement BCG vaccination programs, supported by robust government and healthcare initiatives aimed at TB control. The regional market benefits from established BCG manufacturers and ongoing advancements in vaccine research and development. Despite the decrease in TB rates, targeted vaccination efforts and continual healthcare innovations boost demand and contribute to market stability in the region.

Competitive Landscape

The global BCG vaccine market report will provide valuable insight with an emphasis on the fragmented nature of the industry. Prominent players are focusing on several key business strategies such as partnerships, mergers and acquisitions, product innovations, and joint ventures to expand their product portfolio and increase their market shares across different regions.

Companies are implementing impactful strategic initiatives, such as expanding services, investing in research and development (R&D), establishing new service delivery centers, and optimizing their service delivery processes, which are likely to create new opportunities for market growth.

List of Key Companies in BCG Vaccine Market

• AJ Vaccines A/S
• Serum Institute of India Pvt. Ltd.
• GSBPL
• Taj Pharmaceuticals Limited
• Japan BCG Laboratory
• Merck & Co., Inc.
• Microgen
• Biomed Lublin S.A.
• BCG Vaccine Laboratory
• Statens Serum Institut

Key Industry Development

• May 2024 (Partnership): ImmunityBio, Inc. entered into a global agreement with the Serum Institute of India, the largest vaccine manufacturer worldwide by production volume, to supply Bacillus Calmette-Guerin (BCG). The deal covers the production of standard BCG (sBCG), which is approved for use outside the U.S., and a next-generation recombinant BCG (iBCG), which is currently undergoing testing. The iBCG is intended to be used in conjunction with ImmunityBio’s ANKTIVA for both current and future indications, subject to regulatory approval.

The global BCG vaccine market is segmented as:

By Type

• BCG Vaccine for Bladder Cancer
• BCG Vaccine for Tuberculosis (TB)

By Strain

• Danish 1331 Strain
• Pasteur 1173P2 Strain
• Tokyo 172 Strain
• Russian BCG-I Strain
• Other Strains

By Route of Administration

• Percutaneous
• Intravesical

By End-User

• Hospitals
• Clinics
• Ambulatory Surgical Centers (ASCs)
• Research & Academic Institutes
• Others

By Age Group

• Pediatric
• Adult

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • France
  • U.K.
  • Spain
  • Germany
  • Italy
  • Russia
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia-Pacific
• Middle East & Africa
  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America