Navigating the Path to Equitable Access to Trastuzumab in Middle-Income Countries: A qualitative analysis in South Africa and India

Note: This paper was written as the final deliverable for a Duke University Bass Connections project, "Equitable Access to Monoclonal Antibodies for Low- and Middle-Income Countries." Paper authors Ishaan Brar, Sheilla Faith Bosire, Daniela Nakinoja, Gracie Li, Ian Helgerson, Safa Alabbas, and Nate Xiao were student team members for that project, while Beth Boyer was a team leader.

Introduction

Monoclonal antibodies (mAbs) have transformed the landscape of treatment for many non-communicable and infectious diseases, offering highly targeted, biologically engineered therapies. Despite their promise, global access to mAbs remains deeply inequitable, particularly in low-and-middle-income countries (LMICs), where uptake and affordability continue to lag behind high-income countries due to numerous systemic and market-level barriers (IAVI & Wellcome Trust, 2020; Malhotra et al., 2024). Nearly 77% of the monoclonal antibody market is concentrated in the USA, Canada and Europe leaving 85% of the world’s population without access (IAVI & Wellcome Trust, 2020).

These drugs are costly to develop and manufacture, and mAbs are often prioritized for manufacturing, sale, and distribution in high-income markets where companies can recover their investment and secure profits (Morin et al., 2023; Kelley et al., 2021). While global discussions around equitable access to mAbs have focused primarily on low-and-middle-income countries and pandemic use cases, there is limited attention on identifying the specific barriers faced by middle-income countries, which often possess stronger healthcare infrastructure but still struggle to provide access to critical biotherapeutics like mAbs (Tong et al., 2022; Shah et al., 2021).

In our study, we wanted to investigate these underexplored challenges impacting access to mAbs in middle-income countries. Trastuzumab, the first-line drug of choice for breast cancer represents a particularly important and relevant case study for exploring these challenges. It is one of the longest and most well-established mAbs on the global market, has numerous biosimilar versions available, and has been off-patent in many countries for over 5 years. Yet, despite these factors that typically facilitate greater affordability and access for other types of drugs, trastuzumab continues to be difficult to access in most LMICs. (Ding et al., 2022; Malhotra et al., 2024). This perpetuates disparities in breast cancer care and outcomes in these populations.

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