Therapeutic BCG Vaccine Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Type (Immune BCG, Therapy BCG), by Demographics (Adults, Pediatrics), by End User (Clinics, Hospitals), by region, and Competition

Market Overview

Global Therapeutic BCG Vaccine Market has valued at USD 45.60 million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 3.30% through 2028.  Bacillus Calmette-Gurin (BCG) vaccine is referred to by the acronym BCG vaccine. It is the only vaccination on the market that can aid in TB prevention. A single dosage is administered to a newborn in nations where TB is common shortly after delivery. In nations where it is rare, TB is only administered to high-risk newborns. The BCG vaccination is used to treat tuberculosis. Although it mostly affects the lungs, the serious illness known as tuberculosis can also spread to other regions of the body. After birth, healthy infants who should receive a vaccination dose are given one because of their high risk and recommended age for immunization. The Bacille Calmette-Guerin vaccination is one of the most popular ones currently available. The national childhood immunization program includes it. Ongoing research into the potential therapeutic uses of BCG vaccines for various diseases beyond bladder cancer, such as tuberculosis, autoimmune diseases, and certain cancers, has expanded the market's potential.

Clinical trials exploring the efficacy of BCG vaccines for different therapeutic applications have generated promising results. Positive clinical outcomes have driven interest and investment in BCG vaccine development. BCG vaccines continue to be an essential tool in the global effort to control tuberculosis (TB). Initiatives and programs aimed at TB prevention and treatment drive the production and distribution of BCG vaccines. Advances in biotechnology have improved the manufacturing and quality control processes for BCG vaccines, making them more reliable and accessible. Healthcare professionals' awareness of the therapeutic potential of BCG vaccines and patient education about treatment options have driven the adoption of BCG immunotherapy.

Key Market Drivers

Biotechnology Advancements

 Biotechnology advancements refer to the progress and innovations in the field of biotechnology, which is the application of biological principles and techniques to develop products and technologies that improve and enhance various aspects of human life, including healthcare, agriculture, industry, and environmental sustainability. Biotechnology encompasses a wide range of scientific disciplines and technologies, and advancements in this field have far-reaching implications. Advances in genetic engineering have enabled the manipulation and modification of the genetic material of organisms. Techniques such as CRISPR-Cas9 have revolutionized gene editing, allowing for precise and targeted genetic modifications in a variety of organisms, including humans, animals, and plants. Biotechnology has led to the development of biopharmaceuticals, which are therapeutic drugs produced using biotechnological processes. This includes monoclonal antibodies, vaccines, gene therapies, and other advanced treatments for various diseases. The sequencing of the human genome and advancements in genomics have paved the way for personalized medicine. Healthcare can now be tailored to an individual's genetic makeup, allowing for more effective and customized treatments. Progress in stem cell research holds promise for regenerative medicine, tissue engineering, and the treatment of degenerative diseases. Stem cells can differentiate into various cell types, offering potential solutions for tissue and organ repair. Synthetic biology involves the design and construction of biological parts, devices, and systems for useful purposes. It has applications in creating biofuels, designing biosensors, and engineering microorganisms for various industrial processes.

Advancements in biotechnology have led to genetically modified (GM) crops with traits such as resistance to pests and diseases, tolerance to herbicides, and improved nutritional content. These innovations aim to enhance crop yields and food security. Biotechnology is used for environmental purposes, such as bioremediation, where microorganisms are employed to clean up pollutants and contaminants in soil and water. Biotechnology plays a crucial role in vaccine development, including the creation of mRNA vaccines like those developed for COVID-19. Immunotherapies, which harness the immune system to combat diseases like cancer, are also a significant biotechnological advancement. Bioprocessing techniques, such as fermentation, are used to produce a wide range of products, including pharmaceuticals, biofuels, and industrial enzymes. Advances in bioprocessing have improved production efficiency and product quality. The field of bioinformatics combines biology with computer science to analyze and interpret biological data, such as genomic sequences. This is essential for genomics research, drug discovery, and personalized medicine. The convergence of nanotechnology and biotechnology has led to the development of nanobiotechnology, which involves the manipulation of biological molecules at the nanoscale. It has applications in drug delivery, diagnostics, and imaging. Biotechnology is being used to address environmental challenges, including the development of biodegradable plastics, wastewater treatment technologies, and the production of sustainable biofuels. This factor will help in the development of the Global Therapeutic BCG Vaccine Market.

Rising Tuberculosis Control Efforts

BCG vaccines were originally developed for the prevention of tuberculosis. In countries with a high burden of TB, BCG vaccination is often part of routine childhood immunization programs. As TB control efforts continue, the need for preventive BCG vaccines persists, driving demand. Regions with a high incidence of TB, such as parts of Asia, Africa, and some Eastern European countries, have a substantial demand for therapeutic BCG vaccines. This demand arises from the need to treat TB infections and prevent disease from spreading within communities. Organizations like the World Health Organization (WHO) have set ambitious goals for TB eradication and control. These goals include increasing TB case detection and treatment rates. Therapeutic BCG vaccines can be used as an adjunct therapy for TB patients, and their administration aligns with these goals. The emergence of drug-resistant TB strains, such as multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), has created a need for alternative treatments. Therapeutic BCG vaccines are being explored as potential adjunct therapies to improve the outcomes of drug-resistant TB treatment.

BCG vaccines have immunomodulatory properties, meaning they can enhance the body's immune response. This property makes them valuable in the context of TB control, as they can boost the immune system's ability to combat TB infections. Ongoing research and clinical trials are investigating the potential therapeutic applications of BCG vaccines beyond TB prevention. These studies explore the vaccine's efficacy in treating other diseases, such as certain cancers and autoimmune conditions, which can increase demand if positive outcomes are demonstrated. BCG vaccines are relatively affordable compared to some other TB treatments, making them a viable option for resource-constrained regions where TB is prevalent. This affordability supports their use in TB control efforts. Many TB control programs and initiatives are integrated into broader community health programs. BCG vaccination and therapeutic use are often part of these comprehensive efforts to combat TB and improve public health. International organizations, governments, and NGOs collaborate on TB control initiatives and share resources to ensure access to TB treatments, including BCG vaccines, in regions where they are needed most. This factor will pace up the demand of the Global Therapeutic BCG Vaccine Market.

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Growing Research into New Indications

Research efforts have expanded the potential applications of BCG vaccines beyond TB prevention. They are being investigated as treatments for various diseases, including certain cancers, autoimmune disorders, and infectious diseases. This diversification broadens the market for therapeutic BCG vaccines. When research studies demonstrate positive clinical outcomes and efficacy in treating specific conditions, it generates interest from healthcare professionals and patients. Positive results can lead to increased adoption of BCG immunotherapy for those indications. In cases where conventional treatments may have limitations or side effects, therapeutic BCG vaccines may offer an alternative or complementary therapeutic option. Patients and healthcare providers seek alternative treatments, which can drive demand. Clinical trials are essential for assessing the safety and efficacy of therapeutic BCG vaccines in new indications. The participation of patients in these trials can create demand as individuals seek access to experimental therapies that show promise. When regulatory agencies approve the use of BCG vaccines for specific therapeutic indications based on robust clinical data, it legitimizes their use and can lead to increased demand for these vaccines in clinical practice. As patients become more informed about the potential benefits of therapeutic BCG vaccines for their specific conditions, they may request these treatments from their healthcare providers. Patient demand can drive increased prescription and use of BCG vaccines.

When medical associations and organizations update treatment guidelines to include therapeutic BCG vaccines for certain diseases, it encourages healthcare professionals to consider these vaccines as part of the standard of care, contributing to increased demand. Research collaborations between institutions and healthcare organizations worldwide promote the sharing of knowledge and best practices in using BCG vaccines for new indications, fostering global demand. Funding and resources allocated to research on new indications for therapeutic BCG vaccines contribute to the development of evidence-based therapies and can encourage their adoption. Innovations in the production, formulation, and delivery methods of BCG vaccines for therapeutic use can lead to the development of patented or proprietary products, which may drive demand. Disease-specific awareness campaigns and advocacy groups can raise awareness about therapeutic BCG vaccines as potential treatments, increasing demand from affected patient populations. Educating healthcare providers about the latest research findings and clinical applications of therapeutic BCG vaccines can lead to more informed treatment decisions and increased utilization. This factor will accelerate the demand of the Global Therapeutic BCG Vaccine Market.

Key Market Challenges

Vaccine Shortages

BCG vaccine production is a complex process that involves growing live bacteria cultures under controlled conditions. Any disruptions in the production process, such as contamination or quality control issues, can lead to shortages. The production of BCG vaccines is limited to a relatively small number of manufacturers worldwide. A lack of diversity in the supply chain can make the market vulnerable to shortages if any single manufacturer faces production challenges. Ensuring the quality and safety of BCG vaccines is paramount. Stringent quality control measures may lead to delays in production or batches being discarded if they do not meet quality standards. Meeting regulatory requirements for vaccine production is essential. Changes in regulatory guidelines or delays in approvals can impact the production and distribution of BCG vaccines. Demand for therapeutic BCG vaccines can fluctuate based on disease prevalence, clinical trial needs, and emerging therapeutic applications. Manufacturers may face challenges in accurately predicting and meeting demand. Vaccine shortages can be exacerbated by regional disparities in demand and distribution. Some regions with a high demand for therapeutic BCG vaccines may face shortages due to uneven distribution. In the event of a sudden increase in demand, such as during a disease outbreak or clinical trial enrollment, existing vaccine stockpiles may be quickly depleted, leading to shortages.

Growing Competition

There are a relatively small number of manufacturers worldwide that produce BCG vaccines for therapeutic purposes. This limited number of players can lead to intense competition as they vie for market share. Some manufacturers may have established market dominance due to their reputation, history, or the quality of their products. Competing against dominant players can be challenging for newer entrants or smaller companies. Price competition can be fierce in the BCG vaccine market, particularly in regions where healthcare budgets are constrained. Manufacturers may engage in pricing strategies that can make it difficult for competitors to enter the market or maintain profitability. Developing and testing therapeutic BCG vaccines for new indications can be costly and time-consuming. Companies need substantial resources to fund research and navigate regulatory processes, which can deter potential competitors. Regulatory approval for therapeutic BCG vaccines in new indications is often a complex and lengthy process. Meeting the stringent requirements of regulatory agencies can be a barrier to entry for some companies. Ensuring the safety and quality of BCG vaccines is of utmost importance. Competing manufacturers must invest in robust quality control and assurance processes to meet regulatory standards and gain the trust of healthcare professionals and patients. Competing manufacturers must conduct extensive clinical trials and generate strong scientific evidence to support the efficacy and safety of their BCG vaccines for therapeutic use. Building this evidence base can be time-consuming and costly.

Key Market Trends

Tuberculosis (TB) Treatment and Prevention

Traditional Use: BCG vaccines have a long history of use for the prevention of TB, particularly in regions with a high TB burden. They are administered to individuals, typically in childhood, to reduce the risk of TB infection and severe forms of the disease. Treatment of Bladder Cancer: BCG immunotherapy is a well-established treatment for non-muscle-invasive bladder cancer (NMIBC). It is administered directly into the bladder and can stimulate the immune system to attack cancer cells. This application of BCG is considered a form of adjunct therapy for cancer treatment. Ongoing research is exploring the therapeutic potential of BCG vaccines for various diseases and conditions beyond TB and bladder cancer. This includes research into autoimmune diseases, infectious diseases, and cancer types other than bladder cancer. Drug-Resistant Strains: The emergence of drug-resistant TB strains, such as multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), poses a global health threat. Therapeutic BCG vaccines are being investigated as potential adjunct therapies to improve the outcomes of drug-resistant TB treatment.

Segmental Insights

Type Insights

In 2022, the Global Therapeutic BCG Vaccine Market largest share was held by Immune BCG segment and is predicted to continue expanding over the coming years. BCG immunotherapy has been widely used for the treatment of bladder cancer, particularly non-muscle-invasive bladder cancer (NMIBC). It has a long history of effectiveness in preventing tumour recurrence and progression in this specific indication. This established use may have contributed significantly to the dominance of the Immune BCG segment. The therapeutic efficacy of BCG vaccines in stimulating the immune system's response against cancer cells has been supported by clinical trials and research. These studies have demonstrated BCG's ability to activate the immune system and induce an anti-tumour response. In certain cases of bladder cancer, BCG therapy has been the standard of care, and there may be limited alternative treatments that offer comparable effectiveness. This lack of viable alternatives can drive the demand for Immune BCG. BCG therapy for bladder cancer has received regulatory approval in many countries, further solidifying its position in the market.

End User Insights

In 2022, the Global Therapeutic BCG Vaccine Market largest share was held by Hospitals segment in the forecast period and is predicted to continue expanding over the coming years.  BCG vaccines, when used for therapeutic purposes, are typically administered in a clinical or hospital setting. This is because the administration of BCG vaccines requires medical expertise to ensure proper dosage and minimize the risk of adverse reactions. The use of BCG vaccines for therapeutic applications, such as bladder cancer treatment, involves a complex treatment regimen. It often requires multiple doses and careful monitoring of the patient's condition. Hospitals are well-equipped to handle such complex treatment protocols. Hospitals have specialized medical personnel, including urologists and oncologists, who are trained to administer and manage BCG immunotherapy for conditions like bladder cancer. These specialists play a critical role in determining the treatment approach and ensuring patient safety. Patients receiving BCG immunotherapy often require close monitoring to assess treatment response and manage potential side effects. Hospitals are equipped to provide this level of patient care and monitoring.

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Regional Insights

The North America region dominates the Global Therapeutic BCG Vaccine Market in 2022. North America, particularly the United States and Canada, has a relatively high incidence of bladder cancer. Bladder cancer is one of the primary therapeutic indications for BCG vaccines. The higher prevalence of bladder cancer patients in this region increases the demand for BCG immunotherapy. North America boasts advanced healthcare infrastructure with well-equipped hospitals, specialized cancer treatment centers, and a network of healthcare professionals who are experienced in administering BCG immunotherapy. This infrastructure supports the effective delivery of BCG vaccines for therapeutic purposes. North America is a hub for medical research and clinical trials. There has been ongoing research into the use of BCG vaccines for various therapeutic applications beyond bladder cancer. The region's robust research ecosystem has contributed to advancements in the field and the development of new therapeutic approaches using BCG vaccines. North America is home to several pharmaceutical companies and biotechnology firms that specialize in the production and distribution of BCG vaccines for therapeutic purposes. These companies play a crucial role in supplying the vaccines to healthcare facilities and patients.

Recent Developments

• In March 2022, The Serum Institute has requested emergency use authorisation from the Drugs Controller General of India for their recombinant BCG (rBCG) vaccination for TB prevention. The BCG vaccine is presently available as part of India's TB immunisation programme from birth or as early as feasible up to one year of age. Pneumococcal, IPV, and Rotavirus vaccines, among others, are already provided to the government under the Universal Immunisation Programme by SII. An official noted that recombinant BCG vaccinations are created using cutting-edge technology that enables the insertion of foreign genes or the overexpression of local genes into the BCG vaccine.
• In January 2021, The Board of Directors of Merck, also known as MSD, outside of the United States and Canada, approved plans to build a new manufacturing facility to significantly increase production capacity for TICE BCG (BCG Live for Intravesical Use), a drug used to treat specific types of bladder cancer. Since Merck abruptly stopped producing BCG in several nations across the world in 2012, the demand for the vaccine has grown more quickly than our present production capacity can keep up with. We will increase the company's present manufacturing capacity once this new facility is fully operating, which should be enough to meet the anticipated demand for TICE BCG for the foreseeable future. Merck's long-standing dedication to making this medication for people in need is reaffirmed by this investment.

Key Market Players

• Merck & Co.
• Sanofi Pasteur Inc.
• Japan BCG Laboratory
• China National Biotec Group
• Serum Institute of India Pvt. Ltd,
• InterVax Ltd
• GreenSignal Bio Pharma Limited
• Statens Serum Institute
• PowderJect Pharmaceuticals
• Biomed Lublin

Report Scope:

In this report, the Global Therapeutic BCG Vaccine Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

•    Therapeutic BCG Vaccine Market, By Type:

o   Immune BCG

o   Therapy BCG

•    Therapeutic BCG Vaccine Market, By End User:

o   Clinics

o   Hospitals

• Global Therapeutic BCG Vaccine Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Therapeutic BCG Vaccine Market.

Available Customizations:

Global Therapeutic BCG Vaccine Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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