The State of R&D in Nigeria: Playing Catch Up?

Immunotherapy oncology drugs, curative cell therapies for pediatric leukemia and the initially controversial mRNA COVID-19 vaccines - all a testament to significant pharmaceutical research and development (pharma R&D) innovation around the globe.  

These innovative therapies offer extended life, improved quality of life and productivity to patients with the most severe diseases. The pharma R&D engine has driven several of these innovative therapies from initial drug discovery to the marketplace, a process that takes at least 10 years on average and billions of dollars to finance. 

Much of the pharma R&D has been targeted at Western and high-income countries; the clinical trials testing new treatments are largely conducted in Western (mostly Caucasian) populations, at least at initial launch. ClinicalTrials.gov (the largest clinical trials database) currently lists over 377,000 ongoing clinical trials in all 50 US states and 219 countries around the globe. Almost 38% of these trials have sites in the USA, and 5% in the UK.

As a result of this Western R&D focus, there is a lack of effective treatments for several illnesses that exclusively impact the African continent and are outside the scope of the research efforts of high-income countries. Additionally, the controversial history of Western clinical research on the African continent has created a relatively high level of skepticism about participating in trials among the general public. As such, building self-reliant, domestic R&D capabilities is crucial to develop treatments that address Africa’s specific unmet medical needs.

But where does Nigeria fit into the picture? 

As of May 12 2021, 223 trials had sites in Nigeria, representing a mere 0.1% of all ongoing clinical trials worldwide. However, quantity does not always equal quality. Taking a deeper look into the trials reveals some insightful data on Nigeria’s R&D focus.

With about 1 in 3 ongoing clinical trials, there seems to be a heavy R&D focus on infectious diseases in Nigeria. Specifically, HIV/AIDS and malaria seem to be prioritized within the total number of trials - roughly 1 in 7 of the trials are studying HIV/AIDS, while 1 in 10 are studying malaria.

The next most common focus seems to be cardiovascular (CV) diseases, with 1 in 7 ongoing studies focusing on CV. This is likely due to the worsened cardiovascular health outcomes associated with the increased access to processed foods, tobacco and alcohol and the increasingly sedentary lifestyle that comes with urbanization and globalization. 

Given the harrowing maternal mortality stats in Nigeria, it’s unsurprising to see that 1 in 8 ongoing studies focus on  maternal health.

With at least 150,000 newborns born with sickle cell disease annually in Nigeria, a focus on this disease in the country’s R&D efforts is expected.

Lastly, when compared to the highly innovative developments in cancer care globally, the minimal R&D focus on oncology (only 1 in 13 ongoing trials focus on cancer) is somewhat disappointing. 50% of the ongoing clinical trials focus on breast cancer, which is unsurprising given that breast cancer has the highest mortality rate among cancers in the Nigerian population.

But what do these stats really mean about the focus of R&D in Nigeria? Are the data aligned with the leading causes of morbidity and mortality in the country? 

Nigeria’s most recent WHO NCD profile shows that non-communicable diseases (NCDs), also known as chronic diseases, account for an estimated 29% of all deaths. Cardiovascular diseases account for 11% of these NCD deaths - the rest are cancer (4%), chronic respiratory diseases (2%), diabetes (1%) and other NCDs (12%). As significant as these stats are, that still leaves a whopping 63% of all deaths, which are mostly caused by communicable, maternal, perinatal and nutritional conditions.

At first glance, it appears that the R&D focus is somewhat aligned with Nigeria’s current healthcare needs. R&D in communicable diseases is just as valuable as in NCDs. In fact, the speed with which vaccines were developed to address the COVID-19 pandemic highlights the importance of R&D efforts in infectious and communicable diseases. However, in its 2008-2013 Action Plan for NCDs, the WHO estimated a 27% increase in NCDs in Africa over the next 10 years - a faster growth rate than the projected 17% rise in global NCDs over the same period. As a result, by 2030, deaths from NCDs are projected to exceed deaths from communicable, maternal, perinatal and nutritional diseases on the continent.

So what does this say about the pace of Nigeria’s R&D? While our healthcare system continues to be strained under the pressure of communicable diseases, urbanization and globalization has led to an increase in chronic diseases, causing a significant double burden of disease in the country. R&D in foreign markets continues to lead the way in pharmaceutical innovation, providing effective new treatments across a range of serious illnesses. While these novel therapies can be imported for use in Nigeria, it is only fair to question the reliability of the data that Nigerian doctors use to drive prescribing decisions when there is hardly enough efficacy and safety data for Nigerian patients specifically. 

For instance, Pfizer/BioNTech and Oxford/AstraZeneca, 2 of the major COVID-19 vaccines currently in use worldwide, did not include Nigerian sites in their clinical trials and the latter has already been administered to millions of Nigerians as part of the national COVID-19 vaccine rollout. The only trial sites for both vaccines on the continent were in South Africa, with roughly 10% of the trial participants being Black African/African American across all sites globally.

So what is being done to improve the inclusivity of Nigerian and African patient data in the pharma R&D space?

54Gene, a health tech genomics and AI start-up dedicated to tackling the disparity in precision medicine, opened a lab in Lagos in February 2021. 54Gene is building one of the world’s richest and most diverse genomics datasets to pioneer the inclusion of the African genome in research and generate insights that uncover the true drivers of disease. The inclusion of Nigerian and African genomic data in the growing body of precision medicine research is a pivotal step to producing therapies with more reliable data for patients on the continent.

There have also been fascinating developments pushing for the inclusivity of African data in COVID-19 research. Shortly after the first COVID-19 case was reported in Nigeria in February 2020, a team of scientists led by Dr. Christian Happi, the director of the African Center of Excellence for Genomics of Infectious Diseases (ACEGID) at Redeemer’s University in Nigeria, shared the very first genome sequence of the SARS-CoV-2 virus from Africa within 48 hours of receiving the sample. Dr. Happi and the ACEGID team have been at the forefront of advanced genomics and deep sequencing technology to develop diagnostics for several infectious disease, including Ebola, HIV and Lassa fever, and have paved the way for a potentially cutting-edge COVID-19 vaccine that targets strains of the novel coronavirus circulating on the African continent.

While these examples are promising, there are still significant barriers that undermine the R&D efforts in the country. For instance, in May 2020, as a policy response to the COVID-19 pandemic, the Central Bank of Nigeria (CBN) launched the Healthcare Research and Development Intervention Scheme (HSRDIS) to provide innovative financing for R&D in new and improved drugs, vaccines and diagnostics in Nigeria. The HSRDIS aims to provide grants to biotech and pharma companies, institutions, researchers and research institutes to drive R&D activities to develop a Nigerian vaccine and drugs for COVID-19 as well as other communicable and non-communicable diseases. However, the CBN set a maximum limit of N500 million (~$1.3 million) for development and manufacturing grants, which pales in comparison to the billions of dollars the US government poured into the COVID-19 vaccine development via the Operation Warp Speed initiative. In addition to an underfunded R&D landscape, Nigeria also lacks the adequate infrastructure and facilities to conduct research and clinical trials, further hampering the R&D efforts in the country.

Key Takeaways from TC Health: Ideally, the future of Nigeria’s R&D efforts should focus on developing effective drugs that treat the specific illnesses faced by Nigerian patients with research driven by reliable, country-specific patient data. While pharma R&D is becoming an increasingly risky endeavor, to achieve this ideal future significant investments are required to catch up with growing health trends. Public investments in academic and medical institutions could increase the ability of these centers to bolster their research efforts and engage in global collaborations with pharma companies, biotechs and other research bodies. Additionally, increased government expenditure on healthcare and research infrastructure could stimulate R&D activities and local manufacturing capabilities in the private sector.