相关临床试验
90
8 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
6
6.7%
已完成
74
82.2%
尚未招募
2
2.2%
招募中
4
4.4%
Unknown
4
4.4%
暂无批准数据
- The global vaccine sales market is projected to reach US$141.40 billion by 2036, driven by next-generation platforms including mRNA and viral vector technologies. - U.S. tariff policies and cross-border supply chain vulnerabilities are reshaping competitive strategy, with manufacturers localizing production and diversifying suppliers to manage cost pressures. - Competition is increasingly defined by platform capabilities, regulatory credentials, manufacturing scale, and access to government and multilateral procurement contracts. - The report profiles 21 leading vaccine companies including GSK, Pfizer, Sanofi, Moderna, Merck, BioNTech, AstraZeneca, and Serum Institute of India, with forecasts across 26 national markets.
- India has selected its first batch of biotechnology startups—Fermbox Bio, Sea6 Energy, Revelations Biotech, 4baseCare, and Telluris Biotech—for funding under the ₹1 trillion Research, Development and Innovation (RDI) initiative. - The initial biotech projects could receive approximately ₹450 crore in government support through a co-funding model requiring companies to contribute remaining project costs. - The RDI initiative targets strategic sectors including biotechnology, AI, quantum computing, and energy security, with the Anusandhan National Research Foundation serving as first-level custodian of funds. - Experts have raised concerns about the absence of a robust legal framework ensuring transparency in funding decisions and protection of public interest in intellectual property generated through publicly funded research.
- Pandorum Technologies raised $18 million in Series B funding led by Protons Corporate to advance clinical development of its programmable exosome-based regenerative therapies. - The company's lead therapy Kuragenx has received FDA Orphan Drug Designation for treating rare ocular surface diseases including Stevens-Johnson Syndrome and Neurotrophic Keratitis. - Funding will support global manufacturing scale-up through partnerships with AGC Biologics and Nucelion Therapeutics, while expanding operations across the US, Japan, and Middle East markets.
- Biofabri and Bharat Biotech have signed a technology transfer agreement to expand global access to MTBVAC, the only live, attenuated Mycobacterium TB vaccine currently in development. - The partnership will enable BBIL to manufacture and supply MTBVAC to more than 70 countries across Africa and Southeast Asia, regions with the highest TB burden. - MTBVAC has successfully completed Phase I and II clinical trials in India, demonstrating safety and immunogenicity, with a pivotal Phase III efficacy study expected to begin recruitment in Q1 2026. - The initiative aligns with WHO's Finance and Access Working Group Solution and India's TB Mukt Bharat initiative to combat tuberculosis through innovative vaccine development.
- The global cell and gene therapy market is expected to exceed $105 billion by 2033, driven by significant expansion in clinical pipelines with Phase I trials experiencing approximately 11% growth. - Cell therapy dominates the market with 61.2% share, reaching $14.66 billion in 2023, while manufacturing costs remain a challenge with CAR-T therapies exceeding $100,000 per patient. - North America leads the market with 43.7% share at $11.97 billion in 2023, supported by advanced regulatory frameworks including the FDA's RMAT designation for accelerated therapy review. - Advanced delivery vectors and viral vector platforms are driving innovation, with companies like AGC Biologics and Charles River Laboratories launching new manufacturing solutions to improve scalability and reduce costs.
- Researchers at Trinity College Dublin have developed a needle-free nasal vaccine using antibiotic-inactivated Bordetella pertussis (AIBP) that prevents both whooping cough infection and bacterial transmission. - The vaccine outperformed current injected vaccines in preclinical mouse studies by activating T-cells and providing mucosal immunity directly at respiratory infection sites. - This breakthrough addresses a critical gap in whooping cough prevention, as current vaccines protect against severe disease but fail to prevent bacterial colonization and community spread. - The technology could serve as a platform for developing vaccines against other respiratory pathogens including tuberculosis and pneumonia-causing bacteria.
- Bharat Biotech International has launched Nucelion Therapeutics, a wholly owned CRDMO subsidiary dedicated to cell and gene therapy development and manufacturing from a 30,000 sq ft GMP facility in Genome Valley. - The new entity offers comprehensive advanced therapy manufacturing capabilities including plasmid DNA, viral vectors, and autologous/allogeneic cell therapies, with compliance to US FDA and European Medicines Agency regulatory frameworks. - Nucelion aims to position India as a contributor to breakthrough therapies rather than merely a consumer, targeting the fast-growing global CGT market that is expanding at double-digit CAGR rates. - The launch represents Bharat Biotech's strategic diversification into advanced biologics, addressing India's limited share in global CGT manufacturing capacity and reducing dependence on US and European contract manufacturers.
- Researchers at the University of Maryland completed a successful Phase 1 trial of a novel trivalent Salmonella conjugate vaccine (TSCV) designed to protect against typhoid fever and invasive non-typhoidal Salmonella infections. - The vaccine demonstrated 100% immune response rates in all 22 healthy adult participants, with strong antibody responses persisting over a year after vaccination. - TSCV targets the leading causes of illness and death among children in sub-Saharan Africa, where typhoid fever caused 8,751 deaths and invasive Salmonella caused 66,000 deaths in 2017. - The vaccine was found to be safe and well-tolerated, with only mild injection site pain reported, providing a strong foundation for future pediatric trials in endemic regions.
- ImmunoACT reported ₹62 crore in revenue and ₹12 crore profit before tax in FY25, marking rare profitability for an Indian biotech startup in its first full year of operations. - The company's NexCAR19 therapy, priced 90% lower than US and European counterparts, has been administered to over 350 patients across 70 hospitals since its April 2024 launch. - NexCAR19 demonstrated significant clinical benefits with 40% progression-free survival in B-cell non-Hodgkin lymphoma and 60% in B-cell acute lymphoblastic leukemia patients. - The therapy's cost has decreased from ₹42 lakh to ₹30 lakh per dose, with further price reductions expected as production scales and demand increases.
- Bharat Biotech and GSK announced they will reduce the price of the world's first malaria vaccine RTS,S by more than half to less than $5 per dose by 2028. - The price reduction is enabled by process improvements, expanded production capacity, cost-effective manufacturing, and minimal profit margins as part of technology transfer between companies. - Bharat Biotech has invested over $200 million in new manufacturing facilities and technology transfers to support the production scale-up and cost reduction. - With Gavi's support, 12 endemic African countries will introduce RTS,S through routine immunization programs by the end of 2025, aiming to protect 50 million more children by 2030.
