Therapeutic BCG Vaccines Market Report 2025

The therapeutic bcg vaccines market size has grown strongly in recent years. It will grow from $56.47 billion in 2024 to $59.66 billion in 2025 at a compound annual growth rate (CAGR) of 5.7%. The growth in the historic period can be attributed to government initiatives for tb control, immune system modulation, global immunization programs, treatment of bladder cancer, investments in vaccine manufacturing, emergence of drug-resistant tb strains.

The therapeutic bcg vaccines market size is expected to see strong growth in the next few years. It will grow to $77.17 billion in 2029 at a compound annual growth rate (CAGR) of 6.6%. The growth in the forecast period can be attributed to expansion to other indications, increased research on immunotherapy, global efforts against emerging infectious diseases, regulatory support for vaccine development, focus on tuberculosis elimination. Major trends in the forecast period include advancements in vaccine technology, supply chain optimization, market consolidation and partnerships, patient education and awareness, alternative delivery methods, personalized medicine approaches.

The growing number of tuberculosis (TB) cases worldwide is expected to drive the expansion of the therapeutic BCG vaccine market in the coming years. Tuberculosis is a potentially serious infectious disease that mainly affects the lungs. It spreads through the air when people cough or sneeze, releasing small droplets of bacteria. BCG vaccines are designed to boost the immune system's ability to fight infection but do not cause TB, as the bacteria used in the vaccine are weakened. The vaccine consistently provides protection against the most severe forms of TB, such as adolescent TB meningitis. By protecting against tuberculosis, the BCG vaccine helps combat infection, leading to increased use of therapeutic BCG vaccines. For example, in February 2024, a report from the UK Health Security Agency, a government body in the UK, revealed that TB cases in England rose by 10.7% in 2023, with 4,850 cases reported compared to 4,380 in 2022. As a result, the rising incidence of tuberculosis globally is fueling the growth of the therapeutic BCG vaccine market.

The increasing prevalence of drug-resistant tuberculosis (DR-TB) cases is poised to drive the expansion of the therapeutic BCG vaccine market in the coming years. Drug-resistant TB occurs when Mycobacterium tuberculosis, the causative bacteria, develops resistance to standard medications used for treatment. While therapeutic Bacillus Calmette-Guérin (BCG) vaccines are primarily recognized for preventing specific forms of TB, their potential application in addressing drug-resistant tuberculosis has gained attention. For example, as of November 2023, the Centers for Disease Control and Prevention reported that 8.4% of TB cases in the United States in 2022 exhibited resistance to at least isoniazid, including 1.4% with multidrug resistance. Within the U.S.-born population, 5.7% had isoniazid-resistant TB, with 0.7% classified as multidrug-resistant TB. The increasing incidence of drug-resistant TB cases is thus a key factor driving the therapeutic BCG vaccine market.

Strategic partnerships have become a prominent trend gaining traction in the therapeutic BCG vaccine market. Leading companies in this market are focusing on collaborating with other key players to maintain their market position. For example, in May 2024, ImmunityBio, a US-based biotechnology company, partnered with Serum Institute of India, an India-based biotechnology and biopharmaceutical company, to secure a supply of the Bacillus Calmette-Guerin (BCG) vaccine for all cancer types. The partnership aims to produce the standard BCG (sBCG) approved for use outside the US, along with a next-generation recombinant BCG (iBCG), which is currently undergoing testing. The iBCG is intended to be used alongside ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-PMLN) for approved and future indications, pending regulatory approvals.

Major players in the therapeutic BCG vaccine market are directing their efforts towards vaccine innovation for diverse therapeutic applications, such as BCG immunotherapy, to broaden their customer base and address expanding patient needs. BCG immunotherapy involves utilizing the BCG vaccine for immunotherapeutic purposes, particularly in treating certain types of cancer, such as bladder cancer. In a noteworthy development in July 2023, The Serum Institute of India, a biotechnology and biopharmaceuticals company, received government approval to export its BCG vaccine to Canada for immunotherapeutic use in bladder cancer treatment. This live freeze-dried preparation, derived from an attenuated strain of Mycobacterium bovis (Bacillus Calmette-Guérin), is administered intravenously in 40 mg and 80 mg presentations. The targeted administration directly into the bladder aims to impact cancer cells effectively while minimizing effects on other parts of the body, exemplifying the industry's focus on therapeutic innovation and strategic collaborations.

In February 2022, Sanofi S.A., a France-based multinational pharmaceutical and healthcare corporation, acquired Amunix for an undisclosed sum. This strategic acquisition grants Sanofi access to Amunix's innovative Pro-XTEN, XPAT, and XPAC technologies, facilitating the delivery of conditionally activated biologics representing the next phase in biopharmaceutical innovation. These technological advancements are expected to bolster Sanofi's efforts in advancing and diversifying its portfolio of advanced therapies, particularly in the field of oncology. With approximately 20 compounds currently in the developmental pipeline, this acquisition aligns seamlessly with Sanofi's existing research and development initiatives. Amunix, headquartered in the United States, specializes in immuno-oncology and is dedicated to the discovery, design, and development of novel biologics, proteins, and peptide therapeutics.

Major companies operating in the therapeutic bcg vaccines 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, Statens Serum Institute, AJ Vaccines, Bul Bio-National Center of Infectious and Parasitic Diseases Ltd, Biomed Lublin S.A., Microgen, Taj Pharma Ltd., PT Bio Farma, Torlak Institute of Virology, Bacille Bilie Calmette-Guerin Laboratory, China Biotechnology Co Ltd., Bharat Biotech International Ltd., Biological E. Limited, Shanghai Institute of Biological Products Co. Ltd., Cipla Limited, Instituto Butantan.

Asia-Pacific was the largest region in the therapeutic BCG vaccines market in 2024. The regions covered in the therapeutic bcg vaccines market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the therapeutic bcg vaccines market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The therapeutic BCG vaccine is designed to provide protection against tuberculosis (TB). Not included in the standard NHS vaccination schedule, this vaccine, also known as Bacillus Calmette-Guérin vaccine, is administered as a single dose throughout a person's lifetime.

There main types of therapeutic BCG vaccines such as therapy BCG and immune BCG. Therapy BCG is an intravesical immunotherapy specifically targeting early-stage bladder cancer by bolstering the immune system to target and eliminate cancer cells. This vaccine can be administered to both pediatric and adult populations and finds applications in hospitals, clinics, and various other healthcare settings.

The therapeutic BCG vaccines market research report is one of a series of new reports that provides therapeutic BCG vaccines market statistics, including therapeutic BCG vaccines industry global market size, regional shares, competitors with a therapeutic BCG vaccines market share, detailed therapeutic BCG vaccines market segments, market trends and opportunities, and any further data you may need to thrive in the therapeutic BCG vaccines industry. This therapeutic BCG vaccines market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The therapeutic BCG vaccines market consists of sales of vectors, peptides, proteins, DNA, and dendritic cells. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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