Bcg vaccine - Biologic Drug Details

Summary for bcg vaccine

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for bcg vaccine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bcg vaccine

Recent Clinical Trials for bcg vaccine

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Sponsor	Phase
Naval Medical Research Center	Phase 1
Johns Hopkins University	Phase 1
KEMRI-Wellcome Trust Collaborative Research Program	Phase 1

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Recent Litigation for bcg vaccine

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District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

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Pharmacology for bcg vaccine

Physiological Effect	Actively Acquired Immunity Increased Immunologically Active Molecule Activity Increased Macrophage Proliferation
Established Pharmacologic Class	Live Attenuated Bacillus Calmette-Guerin Immunotherapy Live Attenuated Bacillus Calmette-Guerin Vaccine
Chemical Structure	BCG Vaccine Vaccines, Attenuated

Note on Biologic Patents

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DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for bcg vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for bcg vaccine Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for bcg vaccine Derived from Patent Text Search

No patents found based on company disclosures

Bcg vaccine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of the BCG Vaccine

Introduction to BCG Vaccine

The BCG (Bacillus Calmette-Guérin) vaccine is a crucial tool in the global fight against tuberculosis (TB), a disease that remains a significant public health concern. Here, we delve into the market dynamics and financial trajectory of the BCG vaccine, highlighting key drivers, challenges, and future projections.

Market Size and Growth Projections

The global BCG vaccine market is poised for substantial growth over the next few years. As of 2023, the market was valued at approximately USD 104.6 million and is expected to expand to USD 187.9 million by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.47% during the forecast period (2024-2034)[1].

Another forecast indicates that the market was valued at USD 145.56 million in 2022 and is projected to reach USD 204.13 million by 2028, with a CAGR of 5.90% during this period[2].

Key Drivers of Market Growth

Several factors are driving the growth of the BCG vaccine market:

Increasing Prevalence of Tuberculosis

The rising incidence of TB, particularly in developing and under-developed nations, is a primary driver. According to the World Health Organization (WHO), TB remains the 13th leading cause of death worldwide, with 1.5 million deaths in 2020 and an estimated 10 million new cases annually[4].

Government Initiatives and Public Health Programs

Government support and international initiatives aimed at controlling TB are significantly boosting the market. These programs include expanded immunization efforts and nationwide campaigns to prevent the spread of infectious diseases[1][2].

Technological Advancements

Advancements in vaccine technology and research are enhancing the efficacy and broader protection of BCG vaccines. This includes the development of vaccines that can combat emergent and drug-resistant TB strains[2].

Growing Awareness of Off-Label Uses

The potential off-label uses of BCG vaccines, such as in the treatment of bladder cancer, are opening new market frontiers and contributing to the market's growth[2].

Segmentation and Market Insights

Age Group Segmentation

The pediatrics segment is the leading revenue component due to the intense focus on early childhood immunizations. This is critical in preventing the spread of TB among the pediatric population[1].

Regional Analysis

The Asia-Pacific region is expected to witness the highest growth due to the high prevalence of TB, increasing susceptibility to TB due to poverty and homelessness, and the presence of a large number of BCG vaccine manufacturers in the region. Countries like India and China are key contributors to this growth[4].

Distribution Channels

Hospitals and clinics are the primary distribution channels, ensuring widespread availability of BCG vaccines and supporting progressive healthcare paradigms focused on disease prevention[2].

Challenges Facing the Market

Supply Chain Disruptions

Supply chain disruptions, particularly those exacerbated by the COVID-19 pandemic, have impacted the availability of BCG vaccines. The pandemic led to a decrease in demand due to reduced visits to healthcare facilities and a shortage of support staff for pediatric vaccinations[4].

Limited Efficacy Against New TB Strains

The limited effectiveness of current BCG vaccines against certain TB strains and drug-resistant TB poses a significant challenge. This has prompted a focus on developing vaccines with broader protection and greater efficacy[2].

Financial Trajectory

Current Market Value

As of 2024, the global BCG vaccine market is estimated to be around USD 159.05 million[4].

Future Projections

By 2028, the market is forecasted to reach USD 204.13 million, with a CAGR of 5.90% during the period from 2023 to 2028. Another projection indicates the market could reach USD 187.9 million by 2034, growing at a CAGR of 5.47% from 2024 to 2034[1][2].

Regional Contributions

The Asia-Pacific region accounts for the largest market share and is expected to continue growing at the highest CAGR over the forecast period. North America also retains a significant position due to its advanced healthcare system and innovative research and development initiatives[2][4].

Industry Players and Collaborations

Major players in the global BCG vaccine market include Serum Institute of India Pvt. Ltd., AJ Biologics Sdn Bhd, Microgen, Merck & Co., Inc., and Japan BCG Laboratory. These companies are involved in various collaborations and initiatives to enhance vaccine efficacy and availability[4].

Innovations and Future Directions

The market is witnessing a shift towards more innovative and adaptable vaccine technologies. There is a growing focus on personalized medicine approaches and the development of vaccines that can offer broader protection against TB. This includes addressing the challenge of drug-resistant TB strains and improving the vaccine's effectiveness in diverse demographics[3].

Public Health Impact

The BCG vaccine plays a pivotal role in global public health efforts to combat TB. With the WHO highlighting the critical need for BCG vaccination, especially among the pediatric population, the market's growth is closely aligned with public health objectives. The vaccine's availability and accessibility are crucial in reducing the impact of TB, particularly in resource-limited areas[1][4].

Key Takeaways

• The global BCG vaccine market is expected to grow significantly, driven by the increasing prevalence of TB, government initiatives, and technological advancements.
• The Asia-Pacific region is anticipated to be the fastest-growing market segment.
• Supply chain disruptions and limited vaccine efficacy against new TB strains are key challenges.
• Major industry players are focusing on innovation and collaborations to enhance vaccine availability and efficacy.
• The market's growth is integral to global public health efforts aimed at reducing the impact of TB.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global BCG vaccine market? A: As of 2024, the global BCG vaccine market is estimated to be around USD 159.05 million[4].

Q: What is the projected growth rate of the BCG vaccine market? A: The market is forecasted to grow at a CAGR of 5.90% from 2023 to 2028 and 5.47% from 2024 to 2034[1][2].

Q: Which region is expected to witness the highest growth in the BCG vaccine market? A: The Asia-Pacific region is expected to witness the highest growth due to the high prevalence of TB and the presence of a large number of BCG vaccine manufacturers[4].

Q: What are the main challenges facing the BCG vaccine market? A: Supply chain disruptions and the limited efficacy of current vaccines against new TB strains are significant challenges[2][4].

Q: Who are the major players in the global BCG vaccine market? A: Major players include Serum Institute of India Pvt. Ltd., AJ Biologics Sdn Bhd, Microgen, Merck & Co., Inc., and Japan BCG Laboratory[4].

Cited Sources:

1. GlobeNewswire: "Global BCG Vaccine Market to Showcase 5.47% CAGR Through 2034 Driven by Advancements and Global Tuberculosis Burden Trends and Insights by Age Group, Application, Distribution Channel."
2. GlobeNewswire: "Global BCG Vaccines Market Forecast Report: Compound Annual Growth Rate (CAGR) of 5.90% is Forecast Through the End of 2028."
3. The Business Research Company: "Global Therapeutic BCG Vaccines Market Forecast 2024 - 2033."
4. Mordor Intelligence: "BCG Vaccine Market - Size, Share & Growth Trends."