A study by BIO Ventures for Global Health (BVGH) demonstrates that new vaccines to prevent tuberculosis (TB) present a significant opportunity for industry investment with potential global markets of US $450 million to nearly $1 billion. The first study of its kind, Tuberculosis Vaccines: A Case for Investment also shows that TB vaccines are cost-effective interventions for donors, potentially saving millions of lives.
As part of BVGH’s efforts to build new market-based solutions to catalyze global health product development, the report assesses the global demand for tuberculosis vaccines, the target product profiles needed to meet that demand, the potential return on industry investment, and the pathways needed to bring safe and effective vaccines to the developing world.
The global need for a TB vaccine
Each year, TB kills more than two million people and approximately eight million people are newly infected, according to the World Health Organization. While the disease occurs throughout the world, developing nations are hit hardest by the pandemic. Beyond the tremendous loss of human life, tuberculosis limits economic growth in the poorest countries by striking working people in their most productive years of life.
Prevention is vital to the fight against TB. There is a profound need for new vaccines both in developing countries, where TB is endemic, and in industrialized countries, which face an emerging threat of multi-drug resistant TB (MDR-TB). The current TB vaccine known as BCG – used extensively throughout the world – has limited efficacy. Existing therapies are decades old, require months of costly treatment, and can fail to eliminate the infection.
Vaccine research and development, however, is progressing. Today, there are about a dozen TB vaccine candidates under development, with several candidates undergoing human clinical trials. Increased industry involvement is necessary to build on the scientific progress of these candidates and ensure that new vaccines are ultimately successful. 
Key Findings:
A strong case for investment in TB vaccines |
The market for TB vaccines is sufficient to attract experienced, innovative vaccine developers.
- The estimated peak annual market for TB vaccines could reach $1 billion, depending on the vaccine: $450 million for a more efficacious replacement for today’s BCG vaccine, $750 million for a “booster” vaccine, and approximately $1 billion for a combined vaccination strategy utilizing both vaccines.
- The positive return is primarily driven by developed world and emerging economies.
The public health impact of a TB vaccine justifies substantial public sector investment.
- In Asia and Sub-Saharan Africa, two regions with the greatest disease burden, TB vaccines could reduce deaths by as much as 62 percent, saving millions of lives.
- Investments in these regions are highly cost-effective for public sector donors.
|
Business case for investment
The study explored factors driving demand in key market segments and estimated expected returns for three vaccine profiles: a replacement for the existing vaccine (“BCG replacement”), a booster given to individuals already vaccinated with existing BCG vaccines (“booster vaccine”), and a combination of the two vaccines—the BCG-replacement vaccine administered at birth and a booster vaccine given at ten-year intervals (“prime-boost strategy”). Under a range of market scenarios, BVGH found that TB vaccines could yield significant value for innovators for each of these vaccine profiles.
- BCG replacement vaccine (prime): The estimated annual global market for a BCG-replacement vaccine administered at birth is approximately $450 million at market peak, representing nearly 50 million doses per year. High-income markets would generate half the global revenue.
- Booster vaccine: The estimated peak annual market for a booster vaccine administered in infancy and at ten-year intervals is more than $750 million based on 60 million doses, with high-income markets driving most of the revenue.
- Prime-boost strategy: A combination of the two new vaccines in a prime-boost strategy may be required to achieve optimum protection. The estimated peak annual market for a prime-boost combination approaches $1 billion from more than 100 million doses. Most of the demand comes from high-income markets and private markets in low- and middle-income countries.
Recommendations to spur innovation
The global market for TB vaccines presents a viable investment opportunity for industry. The market is sufficiently attractive to compete with other opportunities a company might pursue, and given the early stage of the TB vaccine pipeline, the time is right for developers to launch TB vaccine development programs.
Despite the strong market potential, however, certain hurdles to development remain high. Initiatives to shorten development timelines, reduce development costs and mitigate clinical trial risk can all be achieved through targeted donor interventions.
- Ensure access to TB vaccines in developing countries: Even the least expensive TB vaccines may still be out of reach for developing countries. Additional public support, through mechanisms such as Advance Market Commitments, which are under active consideration by the G8 countries and other nations, will ensure that developing countries can access TB vaccines when they are available.
- Shorten development timelines: Today there are no surrogate markers to predict the efficacy of a TB vaccine, so clinical trials will be long (up to 4 years) and require large patient populations. Public and private sector investment in research for new, highly predictive biomarkers to measure immune activity could reduce the length of clinical trials and the risk to developers.
- Develop new clinical test sites: There is currently a shortage of clinical trial sites for TB vaccines. As multiple innovative products progress through clinical development, a bottleneck in clinical trial capacity could emerge. Additional clinical trial sites are needed to support the existing pipeline.
| Call to Action |
Industry
- Evaluate the opportunity for TB vaccine development.
- Seek efficient development processes that will keep the manufacturing costs down and help make TB vaccines more affordable to resource-poor countries.
- Develop rapid diagnostics and novel biomarkers for TB.
Public Sector
- Support the development of novel biomarkers to predict vaccine efficacy and rapid diagnostics that can be used in the field to detect the presence of disease.
- Support the development of clinical trial sites.
- Explore new ways to ensure smooth regulatory pathways.
|
About the report
Tuberculosis Vaccines: A Case for Investment was developed by BVGH with research and analysis from the Boston Consulting Group. BVGH is grateful for the advice and support of advisers including the Aeras TB Vaccine Foundation and leading companies with initiatives in TB vaccine development. Please consult the full report for more details on the study’s findings, methodology, assumptions, and conclusions.
