• Lily Chhatwal & Eliza Ennis – US

Discovering IV iron's untapped market in LMICs, drip by drip

Intravenous (IV) iron can support improved maternal health and chronic disease outcomes globally. Public and private interventions are critical to increasing access.


The World Health Organization estimates up to 27% of the global population suffers from iron-deficient anaemia and that 71% of the associated mortality burden falls in Africa and Asia. Iron-deficient anaemia is often associated with lower availability of iron-rich foods, though it is also tied to chronic illnesses, which impede the body's ability to absorb iron in the digestive tract, and pregnancy, which increases the body's iron requirements.


Without adequate iron, the body struggles to make enough hemoglobin, a protein in red blood cells that is critical to the transportation of oxygen throughout the body. This can lead to fatigue, irregular heartbeats, or even death.


While oral iron tablets are the most common initial treatment for iron-deficient anaemia, intravenous (IV) iron has become the standard of care for chronic disease patients in cases of oral tablet intolerance and for patients requiring a quick replenishment of iron stores. Globally, the number of patients using IV iron has grown significantly as treatments have become safer, less expensive, and more accessible. However, the availability and access of IV iron in low and middle-income countries (LMICs) lags, impacting patients across sub-Saharan Africa and South Asia.


The global IV iron product market is currently dominated by high-income countries, including Italy, the United States, Germany, Japan, and middle-income country Brazil. In 2020, this market was valued at US$2.2 billion [1] —with projected growth of 8.5% annually between 2021 and 2028.


With some initial investment to increase awareness, access, and affordability in five LMICs in sub-Saharan Africa and South Asia, the market size for IV iron could become larger. Targeted interventions in Nigeria, Kenya, India, Bangladesh, and Pakistan could increase the market by US$450 million in 2021. By 2031, the market size of these five countries alone could be US$825 million (assuming 6% annual growth).


The market size in LMICs stems from the significant unmet need for IV iron in sub-Saharan Africa and South Asia based on high prevalence of iron-deficient anaemia. If need were met, we estimate benefits for a total of 13.2 million people in India and an additional 2.1 million in Nigeria, Kenya, Bangladesh, and Pakistan in 2021. By 2031, this could rise to 25.8 million people across the five countries and include pregnant and postpartum women and people with chronic disease. It is important to note that while some people with iron-deficient anaemia can rely on oral iron tablets, many go without any supplementation.


Throughout late 2021 and early 2022, the global management consulting firm, Dalberg Advisors, conducted landscape assessments across two regions (sub-Saharan Africa and South Asia) and five

countries (Nigeria, Kenya, India, Bangladesh, and Pakistan) and built a comprehensive analytical model to calculate population need, demand, and uptake for IV iron given targeted interventions such as awareness building among providers.


This work included expert interviews with local doctors and health system coordinators, collation of national and regional medical data, and a survey of pregnant and postpartum patients and their partners. Our research demonstrates that supporting people with iron deficiency requires building an IV iron product market in LMICs with adequate access to and affordability of products, as well as an increase in awareness of iron-deficient anaemia and IV iron among providers and patients.


Crucially, there are significant opportunities for a range of stakeholders and interested parties. Foundations, non-profits, and government agencies interested in reducing the incidence of iron-deficient anaemia have an opportunity to drive the awareness, acceptance, and affordability of IV iron for patients and providers in LMICs. Already, some have expressed interest in improving access to screening and diagnosis and supporting guideline updates to facilitate increased use and insurance coverage. Tackling these access barriers will enable private manufacturers and distributors of IV iron to more easily expand their market size, either through new product introductions or by expanding the access to currently available IV iron products.


Benefits and barriers to widespread use


For people with depleted iron stores or a reduced ability to absorb iron, oral iron tablets are typically considered the first line of defence. Extremely inexpensive, oral iron works for many people with mild cases of iron-deficient anaemia.


However, compliance can be an issue, mostly due to adverse gastrointestinal side effects or low visibility of tangible results, as it may take months to absorb enough iron from the tablets to reduce iron-deficient anaemia. The most recent demographic and health survey data from each of the five countries showed that while 59-78% of pregnant women took some form of oral iron supplement, only about half of the women (8-46% of all pregnant women) took the supplement for the full recommended 90 days.


IV iron, while currently more expensive than oral tablets, is typically tolerated well with few side effects and can increase iron levels more quickly than oral tablets, which is particularly useful in cases of severe anaemia. Because many chronic disease patients have difficulty absorbing sufficient iron from tablets, IV iron is the standard of care for those patients, particularly in high-income countries. For IV iron users, compliance is typically not a concern, given the need for fewer doses and the lack of gastrointestinal side effects.

In addition to cost, a key reason for limited IV iron use in LMICs is provider hesitance. While the earliest formulations of IV iron were associated with some cases of anaphylaxis (a severe allergic reaction) there is a high safety profile for the IV iron formulations today [2]. This historical safety concern has discouraged physicians in many LMICs from using IV iron, as there are not always enough ICU beds to quickly treat anaphylaxis. While safety has improved, physician hesitance continues to restrict IV iron use for patients in LMICs, even in cases where IV iron might be considered the standard of care in higher-income countries. Provider hesitance may prevent doctors from mentioning IV iron as an option for eligible patients. Currently, more than 60% of oral iron users in the five countries were unaware of IV iron as an alternative (more than 80% in Kenya and Bangladesh) and more than 60% of those would consider IV iron with eligibility and more information.


Identifying target patients


While a range of patient groups are vulnerable to iron-deficient anaemia, IV iron is most relevant and needed for pregnant and postpartum women and chronic disease patients.


Iron-deficient anaemia affects around 45% of pregnant and postpartum women in Nigeria and 19-46% in the other four countries. Beyond fatigue, headaches, chest pain, dizziness, and other symptoms experienced by people with iron-deficient anaemia, low iron is particularly dangerous in pregnant women, as it can increase the risk of complications during birth, such as premature birth or low birth weight for the child, and also of postpartum depression.





The current global standard of care for most cases of mild iron-deficient anaemia in pregnant women is oral iron, particularly in the first two trimesters. However, in cases of intolerance and ineffectiveness, as well as throughout the third trimester, IV iron is used to rapidly replete iron stores before birth. Additionally, during birth and for postpartum patients, IV iron is used to treat moderate to severe iron-deficient anaemia. Access to treatment during birth is often simplified because the patient is already in hospital. We found these standards of care consistent across countries in sub-Saharan Africa and South Asia, though availability of IV Iron constrained use in some cases.


Among patients with chronic diseases including cancer, chronic health failure, and chronic kidney disease, those with inflammatory bowel disease are especially at risk for iron-deficient anaemia, with 25-38% of patients affected in Nigeria, Kenya, India, Bangladesh, and Pakistan. Iron-deficient anaemia in chronic disease patients is often due to a reduced ability to absorb iron in food. Therefore, many chronic disease patients also face issues with oral iron supplements, as they may be unable to absorb enough iron or face significant gastrointestinal side effects. IV iron can be a useful alternative in these situations and it is used as the standard of care for severe iron-deficient anemia in chronic disease patients.


Projected market size of IV iron


In our study, we looked at five countries: Nigeria, Kenya, India, Pakistan, and Bangladesh, which are disproportionately affected by iron-deficient anaemia for at least some patient populations. While the global prevalence of iron-deficient anaemia is approximately 14%, it differs by country and patient population. For example, the 2019 rate of iron-deficient anaemia for pregnant women was 46% in Nigeria, 40% in India, 36% Kenya, 33% Bangladesh, and 19% in Pakistan. Chronic disease patients also see higher rates of iron-deficient anaemia. For example, 25-38% of patients with inflammatory bowel disease across surveyed countries and up to 47% of chronic heart failure patients in India suffer from iron-deficient anaemia.


Interestingly, while population-wide iron-deficient anaemia prevalence in India, Pakistan, and Nigeria is quite similar, the patient populations differ significantly. In 2021, there were four times as many maternal health patients as chronic disease patients in Nigeria and 1.5 times as many maternal health patients as chronic disease patients in Pakistan. In comparison, India has almost three times more chronic disease patients than maternal health patients.


As the rate of chronic diseases rises globally, projections of patient populations in 2031 anticipate a greater increase in chronic disease patients than maternal health patients across all countries. In India, the maternal health population is expected to grow from 3.6 million to 4.3 million in the next 10 years compared to the chronic disease population suitable for iron supplementation, which is expected to nearly double from 9.6 million to 17.2 million by 2031. In Nigeria, the number of maternal health patients is expected to double from 375,000 to 775,000 by 2031, while the number of chronic disease patients suitable for iron supplementation is projected to more than triple from 90,000 to 330,000.


The differences in patient populations by country highlight the differences in the potential market size for IV iron. India, with its large population and growing population with chronic diseases, has the largest market size with 13.2 million potential IV iron patients today and a projected 21 million by 2031 (leading to an estimated US$599 million gross revenue). Pakistan and Nigeria host the next largest market sizes with an expected 2.2 million and 1 million patients, respectively, by 2031 (US$45 million and US$80 million respectively). Bangladesh and Kenya are projected to have about 500,000 IV iron patients by 2031 (US$34 million and US$65 million respectively).


All up, we expect the IV iron market size to grow by 6% annually, with a projected gross revenue of US$824 million by 2031.

Proposing solutions to growth barriers


Ensuring patients in need receive IV iron through a robust marketplace will require investment in patient awareness, provider acceptance, and affordability. Specifically, we recommend the following considerations to drive demand for IV iron among eligible patients with iron-deficient anemia.


Increase awareness of IV iron as a treatment option, as well as the need for iron-deficient anemia screenings, hospital births, and postnatal care, among maternal health patients


Some people with mild chronic illnesses may be unaware that they are affected and of associated iron-deficient anaemia. It is estimated that only about 25% of people with inflammatory bowel disease and 10% of people with chronic kidney disease in high-income countries (and likely fewer in LMICs) are aware of their condition, seek regular medical visits for their condition, and therefore are aware of any associated iron-deficient anaemia.


For pregnant and postpartum women, encouraging screenings for iron-deficient anaemia, hospital births, and pre- and postnatal care can ensure women are aware of their health metrics, including iron levels. Even when pregnant women and diagnosed chronic disease patients are aware of their iron-deficiency, most need further education that IV iron is an option for treatment. Therefore, sharing information with patients and providers about the uses and safety of IV iron can be a promoting factor.


Support clinical education among providers to share latest knowledge on IV iron in accordance with standards of care and known safety parameters


In multiple focus countries, medical practitioners were hesitant to prescribe IV iron to patients, despite being aware of its existence. Often this was due to concerns about the historical safety of high-molecular-weight iron dextran, a lack of local studies demonstrating their safety and efficacy in their respective countries, or lack of national guidelines. However, the most common older generation IV iron products are widely considered to be safe, as are the newer formulations.


Therefore, educational campaigns focused on the uses and safety profile of IV iron might ease concerns among providers. Based on patient surveys, information shared by providers is often highly trusted by patients for decision making, which makes the provider’s knowledge even more important.


Other concrete steps can include advocating for national guidelines for prescribing IV iron (which are currently lacking in Nigeria, Kenya, and Bangladesh), adding more IV iron formulations to national essential medicine lists, and conducting local clinical trials to establish the safety profile and efficacy of new IV iron formulations.


Ensure price parity of IV iron formulations and seek to lower IV iron prices, either directly or through national insurance coverage


In our focus countries, price is a major barrier to access, as most people pay for IV iron out of pocket. In our survey of patients, 100% of people in Nigeria and India, 79% of people in Pakistan, and 56% of people in Kenya paid for IV iron out of pocket.[1] The alternative, pill supplements, are significantly less expensive and often covered by public health insurance schemes. Costs differ by product and country, so there is an opportunity to find price parity across LMICs or find ways to reduce costs in countries that bear higher prices.


In addition to raising greater awareness of IV iron products, manufacturers and distributors can increase demand by lowering prices and therefore growing overall market size. In Kenya and Nigeria, all IV iron products are imported and priced higher than other surveyed countries, leaving an opportunity for new global entrants with lower prices or current distributors to capture increased market size by lowering prices. For example, prices for iron sucrose in Kenya can be as high as US$250 per 1000mg, more than 5 times the next highest LMIC.


This is harder for international brands seeking market share in South Asia, where locally manufactured products dominate more than 90% of the IV iron market and prices are 2 to 14 times lower for the same formulations than in Kenya and Nigeria. However, even in South Asia, the active pharmaceutical ingredients that go into IV Iron production are imported, creating an opportunity for global API developers to reduce prices in an effort to boost demand.


Beyond lowering prices, a key step for IV iron affordability is supporting the rollout of national health insurance schemes and coverage for IV iron.

This has the potential to reduce physician hesitance and the number of people affected by iron-deficient anaemia.


While there is a greater cost for IV iron compared to oral tablets, insurance coverage paired with clear national guidelines on IV iron usage can ensure that people who are most in need have affordable access.


Harnessing future potential


Ultimately, reducing iron-deficient anaemia for millions of maternal health and chronic illness patients will require some initial investment, but the market size in LMICs is significant. Greater awareness, acceptance, and affordability in these five LMICs could have increased the global market by 20% in 2021.


As incidence of chronic disease, as well as population size, continue to rise, the untapped market size of IV iron patients in India, Nigeria, Kenya, Bangladesh, and Pakistan will continue to grow. We call for patient advocates and IV iron manufacturers and distributors to come together to build a sustainable and effective approach that meets the needs of people affected by iron-deficient anaemia in LMICs.




[1] https://www.grandviewresearch.com/industry-analysis/intravenous-iron-drugs-market [2] The safety profile of prevalent and new-generation IV Iron products shows that they have, at most, a 0.0003% prevalence of life-threatening adverse reactions. Only the formerly used high-molecular-weight iron dextran was shown to have a high rate of adverse reactions. [3] Dalberg surveyed 205-244 individuals with experience as pregnant/postpartum patients or partners of patients in each of India, Pakistan, Bangladesh, and Kenya. InSiGHt surveyed 145 individuals in Nigeria, including 38 chronic disease patients.

 

The opinions expressed are those of the author and do not necessarily reflect the position of Re:solve Global Health.


Lily Chhatwal is an Associate Partner at Dalberg Advisors and co-leads Dalberg’s Americas Health Practice. She advises a range of clients on market entry strategies and product expansion opportunities globally. Her experience includes advising private corporations, governments, and philanthropies on sustainable and scalable healthcare solutions.


Eliza Ennis is a former senior consultant at Dalberg Advisors and current PhD candidate in health policy at Stanford University. She has advised governments and philanthropic organisations on equitable

health access and health system strategy. She works on innovative financing mechanisms, health crisis response, and patient access to contraceptive, safe abortion, and maternal health products.


With thanks to the Bill and Melinda Gates Foundation for funding this research, as well as InSiGHt Health Consulting for research collaboration in Nigeria, and an extended Dalberg team: Carlijn Nouwen, Sylvia Mwangi, Jyothi Oberoi, Jasper Gosselt, Stephanie Mambo, Jasper Okoth, Jamila Raji, Sriraghav Srinivasan, Anup Itale, Jorge Garcia, Elizabeth Sitai, Simon Mbai and Aisha Said .