One hundred years after the ground-breaking discovery of insulin, persistent gaps in access to this highly
effective drug remain critical. The number of people with diabetes worldwide is expected to reach 643 million by 2030, and 783 million by 2045 – rising most rapidly LMICs, where there is stark inequity in access to insulin.
A new report, published today by the Foundation, examines what Eli Lilly, Novo Nordisk and Sanofi are doing to expand access to their insulin products in LMICs, including both human and analogue insulins.
Along with these three main insulin producers, the analysis looks at Biocon, which is one of the largest producers of biosimilar insulins globally. Companies’ efforts are currently fragmented, and are often focused on a few countries, patient populations and products – falling short in addressing the extent of the global insulin inequity problem.
However, the report identifies ways in which these companies are now seeking sustainable approaches to scaling up access in the long term.
It is vital that people with diabetes have access to a reliable and affordable supply of insulin in order to stay alive and healthy. Yet, in many countries, people still do not have access to human insulin – a form of insulin that was discovered almost half a century ago.
In addition to human insulin, people living with diabetes in LMICs should have access to the analogue insulin products that have become well-established and preferred by patients and healthcare professionals in higher income countries over recent decades.
Analogue insulins can allow for improved control of blood sugar levels after meals and overnight – making patients’ lives easier, reducing the risk of hypoglycaemia (low blood glucose levels), and potentially increasing adherence to
2 treatment.
However, these products can cost over two to six times more than human insulins, with prices varying significantly between countries.
“While diabetes care has advanced since the discovery of insulin 100 years ago, this highly effective drug,
and the range of products that help manage chronic diabetes, is only available to a fortunate few. Millions of people living in low- and middle-income countries still don’t have access to life-saving insulin, much less the choice of treatment available in high-income countries. This report highlights the urgent actions companies, governments and their partners can take to provide patients in resource-limited settings with the choice of treatment they deserve – no matter where they live.” – Jayasree K. Iyer, CEO, Access to Medicine Foundation
The World Health Organization (WHO) has already recognised the importance of analogue insulins, and
not just human insulins, by adding several analogues and their biosimilars to the WHO Model List of
Essential Medicines in 2021; a firm indication that they should be available to patients in every country.
Given this recognition, one of the most alarming findings of the report is how limited access to insulins –
human or analogue – currently is.
Based on analysis of the data available*, only 29 of the 108 countries in scope have all the insulins classified as “essential medicines” by WHO registered, and only one of those is a low-income country. Worse, in 24 countries, no insulins were found to be registered at all. Registering a medicine is a necessary step that enables its sale in a country.
This means that people living in these countries have no access to insulin – and the stark reality is that without access to insulin, many more diabetic children and adults will suffer and die from this life-long, chronic disease.
Scaling up and diversifying the global insulin market
The report finds that the main insulin manufacturers are pursuing a patchwork of strategies to expand
access to their products in LMICs, including paediatric programmmes, price ceilings, and equitable pricing
policies.
Eli Lilly, Novo Nordisk and Sanofi have diverse strategies in place to expand access to their products.
Notably, Novo Nordisk and Sanofi have recently taken steps to apply integrated business approaches
encompassing some of their insulin products.
However, there are persistent gaps in access to all insulins; most affordability strategies remain primarily focused on human insulins and few are found for analogue products. It is within these companies’ abilities to expand access if they build on the strategies they have already employed, with the report identifying ways in which they are now seeking sustainable approaches to scaling up access.
Such approaches will need to be holistic and consider insulin within the broader context of diabetes care, including patients’ access to all the products needed, including monitoring devices (glucometers and test strips) and delivery devices (syringes and injection pens).
Expanding the number and type of insulins on the market in LMICs will also have a positive impact on both
availability and affordability.
Although Eli Lilly, Novo Nordisk and Sanofi are dominant in the global insulin market – combined these companies control over 90% of the global market by value – several biosimilar companies are already producing a significant quantity of insulin products in LMICs. 3
A biosimilar drug is a drug that is highly similar to a biological drug (such as insulin) that is already on the market. Quality-assured biosimilar insulins hold a great deal of as-yet unrealised potential, especially with several patents on long-acting insulins recently expiring – meaning biosimilar versions can now be launched as competitors.
On this front, Biocon is currently one of the largest global manufacturers of biosimilar insulin and has a wide footprint in LMICs. The company has ambitious goals to improve access to its insulins in these countries by lowering prices and boosting affordability, although it is in the early stages of taking steps towards achieving these goals.
“Less than 30% of low- and middle-income countries currently have access to all insulins deemed essential, with the cost of insulin being a huge barrier to access. Insulin products, particularly analogue insulins, need to become affordable to every payer. Tapping into the promising potential of biosimilar insulins, for example, could expand affordability and access. While access to insulin is a complex, multifaceted issue, more efforts are needed on a greater scale, covering a wider range of products.” – Claudia Martínez, Research Programme Manager, Access to Medicine Foundation
Harnessing momentum across the global insulin ecosystem
Insulin manufacturers remain a critical link in the global chain of stakeholders needed to deliver access to
diabetes care.
Companies can take action by ensuring treatment options that are available in highincome countries are also available in LMICs, increased registration in LMICs of both human and analogue insulins, and at a minimum, ensuring that all essential insulins are registered in the poorest countries.
To ensure affordable insulins are available to people in LMICs, companies can also pursue long-term
financial sustainability.
To achieve this, further collaborations are needed with governments and partners to integrate more access programmes into local health systems, alongside company affordability strategies and initiatives, particularly for analogue insulins.
While the report concludes that current access efforts fall short, there are signs that companies are now seeking sustainable ways to scale up access. However, systematic and sustainable approaches are required across the global insulin ecosystem in order to address the gaps in access to diabetes care worldwide.
More in the report
• Four company profiles: How Eli Lilly, Novo Nordisk, Sanofi and Biocon are addressing access to
insulin
• Industry analysis: Lack of registration to essential insulins in LMICs and a patchwork of strategies
to improve affordability
• Spotlight: Access to insulin for children and young people
• Next steps: How to meet the challenge of expanding access to insulin
