The global BCG vaccine market size was USD 51.35 Million in 2021 and is expected to register a CAGR of 4.5% during the forecast period. Rapidly rising prevalence of tuberculosis across the globe, advancements in vaccine and drug research, growing focus of governments and health authorities on accelerating immunization, and rising demand for BCG vaccine to prevent childhood tuberculosis meningitis are key factors expected to drive market revenue growth over the forecast period.
BCG vaccine is highly effective against severe forms of tuberculosis in children and is commonly administered in newborns and young children to prevent the probability of tuberculosis. Childhood tuberculosis is a preventable and curable infectious disease, and increasing focus on preventing childhood tuberculosis by public health authorities, TB control programs, and health policy makers is further contributing to increasing procurement and administration of BCG vaccine and is expected to fuel revenue growth of the market going ahead.
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Tuberculosis is one of the major causes of death globally, especially among communities facing socioeconomic challenges. In over 90 percent of the infected patients, Mycobacterium tuberculosis, the agent responsible for tuberculosis is contained by the host immune response as a latent TB infection. Bacillus Calmette-Guérin (BCG) is the only available vaccine that can combat the disease and offers protection for at least 10 years with a residual vaccine effectiveness of up to 20-25 years. Bacillus Calmette-Guérin is made from attenuated Mycobacterium bovis – found in cows and does not cause disease in humans –is used to prevent tuberculosis and other mycobacterial infections. It is a widely administered vaccine and is a major part of the routine newborn immunization schedule. The vaccine is safe and not associated with severe complications, and is also administered to protect against non-tuberculosis mycobacterial infections such as leprosy and in treatment of superficial carcinoma of the bladder. The vaccine can be administered intradermally or intracutaneously. In the recent years, extensive research and development activities have been carried out to explore respiratory administration of BCG vaccine, considering natural infection and sensitization to Mycobacterium tuberculosis in humans occurs chiefly in the respiratory tract. Increasing investment to accelerate research activities and advancements in understanding mycobacterial immunology are further expected to contribute to market growth going ahead. BCG vaccination trials have shown that BCG vaccine prevents approximately 50% of pulmonary tuberculosis cases in adults and children, as well as over 50-80% of severe tuberculosis cases such as disseminated and meningeal. According to statistical analysis, over 100 million doses of BCG vaccine have been administered per year, and is a cheap and cost-effective vaccine. The efficacy of BCG vaccine can vary according to age and geographical location and is possibly influenced by increasing exposure to environmental mycobacteria or helminthic infections. According to the guidelines published by WHO, a single dose of BCG is administered to neonates or as soon as possible after birth in regions with an extremely high prevalence of tuberculosis.
Majority of high-burden countries have employed BCG vaccination as a part of the national childhood immunization programs. Recent strategies to improve TB vaccination include substitution of primary immunization with recombinant BCG strains that drastically improve antigen presentation or over-express immunodominant antigens. In addition, BCG vaccine has beneficial off-target effects on immune system that offer protection against a wide range of other infections and is widely used to treat bladder cancer, which has further boosted its demand, in turn, driving market growth. However, shortage of BCG vaccine across the globe, increasing controversies surrounding BCG vaccine, and manufacturing problems are some key factors expected to restrain market growth to a certain extent over the forecast period.
Driver: Increasing research activities to explore linkage between BCG vaccination and COVID-19 mortality is a key growth driving factor
BCG vaccine confers broad spectrum protection against other infectious diseases and, over the last year, has been proposed to reduce severity of COVID-19 infection. Accessibility to the Bacillus Calmette-Guérin vaccine can help mitigate the impact of the pandemic in several countries, and it offers significant advantages and flexibility in the way clinical vaccines are administered. Clinical laboratories across the globe have been exploring possibility that BCG vaccine can be used alone or synergistically to reduce the severity of COVID-19 infections owing to its enhanced protective response against viral respiratory diseases. Certain research studies suggest immunization with recombinant BCG vaccine protects against respiratory syncytial virus-associated lung damage, reduces infiltration of inflammatory immune cells into the lungs, and reduces the viral load in lung tissues. This evidence has further highlighted the possibility that mucosal administration of BCG that stimulates trained memory can lead to a more effective innate immune response in lungs of COVID-19 patients. Recent research has also indicated that BCG vaccination may minimize sickness associated with COVID-19 infection. Robust safety and immunogenicity profile of BCG vaccine has further boosted its potential as an attractive vector for vaccine development against several viral and bacterial diseases. Antigens expressed by recombinant BCG strains can elicit long-term humoral and cellular immunity to foreign antigens, and development of novel BCG-based approaches is expected to further fuel revenue growth of the market going ahead.
Restraint: Global shortages of BCG vaccine and increase in child mortality are key restraining factors
Increasing problems with vaccine production and limited supplier options in various developing and underdeveloped countries have drastically affected the global availability and procurement of BCG vaccine. Inaccessibility and shortage of BCG vaccine are also increasing concerns regarding a substantial increase in childhood mortality across the globe. Disruptions to vaccine supply chain can have severe effects on the health system delivery of BCG. In addition, problems with manufacturing processes, modification of quality control processes, and scarcity and inaccessibility of raw materials can also hamper vaccine supply chain. Considering the robust transmissibility of infectious diseases, vaccine shortages can impact both individual and population health through herd effect, which further represents a worldwide threat. BCG vaccine shortages can also greatly increase pediatric TB mortality and even remotely small shortfalls can lead to a considerable number of additional pediatric TB deaths. In addition, dependence on a single vaccine producer, increasing costs of alternative medicines, and growing controversies regarding vaccine shortages are some other key factors expected to restrain market growth to a certain extent over the forecast period.
Based on type, the global BCG vaccine market has been segmented into immune BCG and therapy BCG. Immune BCG vaccine segment is expected to account for largest revenue share over the forecast period, attributable to increasing use of BCG vaccine to prevent tuberculosis in adults and children. BCG vaccine provides robust protection against the disseminated form of tuberculosis in children. It is administered soon after birth to all infants in countries with high burden of tuberculosis. Large-scale randomized clinical trials in different clinical settings across the globe have further suggested that BCG vaccination against pulmonary tuberculosis has a protective efficacy that ranges from 0-80%. BCG vaccine has also been reported to decrease susceptibility to respiratory tract infections as it boosts innate immune mechanisms. It has also been linked with a 50% reduction in childhood mortality due to increased protection against unrelated infectious agents, respiratory tract infections, and neonatal sepsis. BCG vaccination of healthy humans results in high production of pro-inflammatory cytokines such as tumor necrosis factor (TNF), IL-1β, and IL-6. According to certain research studies, BCG leads to epigenetically trained populations of monocytes and natural killer cells, which on exposure to pathogen-associated molecular patterns, enhanced response, in turn, promoting host defense. As a result, BCG vaccine leads to protection against multiple pathogens. These key factors have further resulted in rapid revenue growth of the immune BCG segment.
Based on application, the global BCG vaccine market has been segmented into pediatric and adults. Pediatric segment is expected to register robust revenue CAGR over the forecast period, attributable to increasing prevalence of childhood tuberculosis, growing focus on implementing TB control programs, and mandatory BCG vaccination of neonates and infants. Tuberculosis in children presents a different set of challenges and has remained a heavy burden on the international public health landscape. However, research activities and advancements in pediatric TB research have provided wider insights and opportunities for TB control. This has further boosted demand for better diagnostic tools to improve individual case management, provide a more strong case definition for drug and vaccine trials, and for studies of TB epidemiology and protective immunity in childhood. BCG vaccine prevents severe disseminated diseases in young children, including tuberculosis meningitis and military TB. In addition, BCG vaccine is often considered for children who have negative TB test or are increasingly exposed to untreated or ineffectively treated tuberculosis, and this is further boosting demand for BCG vaccination in children and neonates.
Based on end use, the global BCG vaccine market has been segmented into hospitals, clinics, and others. Hospital segment is expected to register significant revenue growth over the forecast period, attributable to administration of BCG vaccines to new born babies in hospitals, rising procurement and availability of vaccine in hospital settings, favorable reimbursement policies, and presence of robust healthcare infrastructure and facilities. Implementation of TB control strategies, availability of proper storage and handling facilities, presence of skilled healthcare professionals, and priority access of hospitals to BCG vaccine are some other key factors expected to contribute to revenue growth of the segment over the forecast period.
Based on regional analysis, North America is expected to register significant revenue growth over the forecast period, attributable to increasing focus on immunization in the United States, efforts taken by government and healthcare authorities to procure and administer vaccine, availability of cost-effective vaccine dosages and reimbursement policies, increasing initiatives to promote vaccination in the region, presence of key manufacturers, and establishment of advanced healthcare facilities. In addition, increasing investment to accelerate pediatric TB research, growing number of clinical trials to test efficacy of BCG vaccines in cohorts of different ethnicity, and rising number of high-risk populations are some other factors expected to drive market growth in the region.
Asia Pacific is expected to account for largest revenue share in the global market during the forecast period owing to increasing demand for BCG vaccine due to rapidly rising incidence of tuberculosis and other respiratory infections in APAC countries such as China, India, and Japan, growing caseload of HIV, AIDS, and drug-resistant TB, rising focus on rapid immunization of at-risk individuals and implementation of childhood immunization schedules, and development of pin-point strategies to combat infections in high-risk groups, hard-to-reach populations, and elderly persons. Tuberculosis is the leading cause of death in Asia Pacific accounting for more than 40% of newly diagnosed cases globally. Over the recent years, high-quality TB services have been made available in Asia Pacific and majority cases have been effectively treated, with the treatment success rate reaching over 80% for new cases in most APAC countries. In most parts of the region, incidence rates have also drastically dropped over the last decade. In addition, governments across the region are now focusing on forming collaborations, associations, and groups to further boost commitment to control tuberculosis – both on international and domestic levels. These key factors are expected to further boost revenue growth of the market in the region.
The global BCG vaccine market is fragmented with presence of several players operating on a global and regional scale. Key players are engaged in product development and strategic alliances to cater to growing global demand and gain a robust footing in the market. Major companies in the market include Merck & Co., Inc., Sanofi Pasteur, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India Pvt. Ltd., InterVax Ltd., GreenSignal Bio Pharma Limited (GSBPL), and Statens Serum Institut.
Some Strategic Developments in the Market Include:
- In July 2021, Hackensack Meridian Center for Discovery and Innovation (CDI), which is based in New Jersey, announced it has received USD 6.4 million grant from the National Institutes of Health for the research of new tuberculosis vaccine concept. The team from CDI has proposed to improve BCG by engineering it to stimulate B-cell development and survival.
A new research study suggested that if given at birth, BCG vaccine can protect newborns against a wide range of common infections such as upper respiratory tract infections, diarrhea, and chest infections and can potentially reduce childhood mortality significantly. Conducted in a hospital in Uganda, the clinical trial was a single-blind – in which the assessors were unaware, randomized, controlled trial. The trial had 560 healthy participants who were assigned 1:1, randomly, to receive BCG vaccine dose, either at birth or at six weeks of age. The participants were followed for a 10-week period after birth. According to researchers, this trial is the first ever research to rigorously investigate the full spectrum of illnesses that BCG could provide protection against in infants. The results have also highlighted the potential of vaccine to protect children and adults against COVID-19 vaccine and other infectious diseases.
In July 2021, the King Edward Memorial (KEM) Hospital in Mumbai submitted its report to the ICMR on its clinical trial for the anti-tuberculosis vaccination – the BCG vaccine – on elderly patients. The trial enrolled 112 volunteers between the age group of 60 and 75 years and the vaccine was used on people above 60 years to assess the efficacy of BCG vaccine to elicit and immune response against COVID-19 patients in elderly people.
A team of researchers from the Massachusetts General Hospitals (MGH) have found in clinical trials that BCG vaccine can safely and effectively lower blood sugar levels in patients with type 1 diabetes. The clinical trial results were presented at the 2021 Annual Scientific Sessions of the American Diabetes Association. Over 140 patients with diabetes have received at least 2 doses of BCG vaccine – including the 25 volunteers enrolled in the recently commenced clinical trials of adults suffering from pediatric onset of type 1 diabetes. The trial has found that BCG boosts the TNF, which in turn, eliminates the self-attacking T cells and contributes to development of regulatory T cells. MGH is aiming to launch a multi-center pediatric trial later in 2021 and is subjected to FDA approval.
Segments Covered in the Report:
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the sub-segments from 2022 to 2030. For the purpose of this report, Reports and Data has segmented the BCG vaccine market based on type, application, end use, and region:
BCG Vaccine Market Report Scope
Segments covered By Type Outlook, Application Outlook, End Use Outlook, Regional Outlook
By Type Outlook
By Application Outlook
By End Use Outlook
Middle East & Africa
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