Background

Despite remarkable advancements in healthcare over the past decade, substantial global disparities persist in ensuring timely access to cutting-edge treatments. Monoclonal antibodies — lab-made proteins that can stimulate the immune system — are a prime example of groundbreaking innovation that has significantly improved the treatment of various diseases, including both infectious and noncommunicable ones. 

However, for most of the world’s population, particularly in low- and middle-income countries (LMICs), monoclonal antibodies (mAbs) remain out of reach. 

This disparity was underscored by the inequitable access of mAb therapies for Covid-19 during the height of the pandemic. A recent comprehensive review of global mAb access reveals that 80% of the mAb market is concentrated in the United States, Europe and Canada. While some LMICs are slowly gaining access to mAb treatments, their entry into the market has been notably delayed.

Previous research has identified six primary access barriers: regulatory; pricing and demand; manufacturing; supply; licensing; and health system and clinical research capacity. Countries vary in the degree to which these barriers play a role in inhibiting access to mAbs, and more research is needed on each challenge. 

Project Description

This project team will examine how pricing and demand for monoclonal antibodies (mAbs) affect the availability and uptake of mAb therapies in low- and middle-income countries. Team members will characterize the market-related challenges on both the country and industry side that hinder access to mAbs, fostering an in-depth understanding of what factors prevent companies from pursuing these markets and the challenges countries face introducing these products. 

The team will also develop a compelling case for why and how companies might engage in sustainable and responsible business practices to expand access to mAbs and build a persuasive case for country governments to prioritize expanding access to mAbs for patients.

Team members will select 3-4 countries to examine in two subteams. One subteam will conduct a landscape analysis of the country-level challenges for market entry of mAbs in the selected countries, particularly related to cost and financing. This may include exploring how these countries decide which new medicines to include in their health systems and examples of how the country has approached other innovative therapies.

The other subteam will conduct a landscape analysis of the industry perspective and perceived barriers to expanding access in the selected countries. This will include identifying past examples of pricing strategies, partnerships or business models used to introduce new products in those countries.

Both subteams will conduct literature reviews, gather publicly available data and conduct stakeholder interviews. After each subteam collects their respective data, they will come together to share their findings and synthesize them into a paper that will lay out the key challenges identified and potential recommendations and/or areas for further research. 

Anticipated Outputs

Report or academic paper on mAb access and expansion in selected countries; presentations; data collection for future research

Student Opportunities

Ideally, this team will include 3 graduate students and 6 undergraduates interested in health policy, global health, bioethics, economics, business/management and bioethics. Students with interests in global health equity, ethical business practices, access to medicines and market-based solutions to health challenges are encouraged to apply.

All team members will have the opportunity to actively engage with global health stakeholders, enhancing their ability to navigate real-world healthcare contexts and fostering networks within the field. Students will gain skills in professionalism and an understanding of the key stakeholders in global health and medicine access and their roles. 

Students will also be equipped with practical training and hands-on experience in various research activities, including stakeholder interviews, literature reviews, qualitative data analysis, data interpretation, and writing to develop actionable tools and recommendations for policymakers and key stakeholders. 

Graduate students will have opportunities to develop skills in project management and leadership by serving as project and subteam leads. They will also be able to apply advanced research and writing techniques taught through their graduate programs.

The full team will initially meet weekly, and then pivot to biweekly meetings with subteams continuing to meet weekly. Full team meetings will be used for instructional purposes and subteam meetings will be used for team-specific project work. In the second semester, full team meetings will become more frequent again as the two subteams work together to prepare final deliverables. Collaborators will be brought in as needed to contribute their expertise and may be asked to present on a topic or skill during a full team meeting.

Timing

Fall 2024 – Spring 2025

• Fall 2024: Begin comprehensive literature review; develop strategic plan for data collection and sourcing; divide into subteams
• Spring 2025: Analyze data; translate findings into project deliverables; present findings at showcase and advisory committee meeting

Crediting

Academic credit available for fall and spring semesters

Image: A digital 3D representation of the West Nile virus in complex with the Fab fragment of a neutralizing monoclonal antibody, by NIH Image Gallery, licensed under CC BY-NC 2.0