Empowering Independence: Advancing Local API & Monoclonal Antibody Production in Africa
Summary
Local manufacturers in the Sub-Saharan African pharmaceutical industry face significant challenges, such as limited investment in R&D and regulatory systems which are resource constrained to conduct drug registration and quality control adequately.
As much as 90% of the drugs consumed in sub-Saharan Africa are imported, with India and China being the dominant players in the global pharmaceutical market.
Sub-Saharan African countries must invest in the resources required to develop and implement adequate drug registration and quality control regulatory systems to create a clear path for manufacturers to supply safe, affordable, and quality medicines.
Efforts must be made to strengthen local pharmaceutical manufacturing infrastructure to ensure compliance with international quality standards.
Local manufacturers should encourage and pursue collaborations with global manufacturers to provide technical support and knowledge transfer to improve their capacity and capabilities.
Government policies are required to reduce the reliance on imports by local pharmaceutical manufacturers in Sub-Saharan Africa by encouraging and protecting domestic producers of APIs and other essential materials.
Introduction
Only 20-30% of medicines consumed in sub-Saharan Africa are produced locally, meaning Africa still imports more than 80% of its pharmaceutical and medical consumables. As of 2019, 70 to 90 percent of the drugs consumed in sub-Saharan Africa’s estimated $14 billion pharmaceutical market were imported.
Medicines are the cornerstone of any healthcare system as they are crucial for preventing, treating, and managing illnesses and conditions. Undoubtedly, modern pharmacology and medicine have made significant strides in improving people’s lives across the globe, giving rise to a thriving pharmaceutical industry. However, the global medical landscape has seen the emergence of cutting-edge medical technologies like cell and gene therapies, while Sub-Saharan Africa (SSA) is still grappling with producing even the most rudimentary ingredients along the pharmaceutical supply chain, indicating a significant disparity in technological advancement and capabilities.
Active pharmaceutical ingredients (APIs) are the fundamental building block of drug manufacturing, constituting the primary ingredient for producing a medicine’s desired health effect. APIs are made from raw materials with specified strength and chemical concentration. Some common APIs include paracetamol, ibuprofen, and amoxicillin, among others.
Monoclonal antibodies (MABs) are used to diagnose and treat many diseases, particularly some types of cancer. MABs are a type of protein synthesized in the laboratory that can selectively bind to specific targets within the body, such as antigens on the surface of cancer cells. The development of monoclonal antibodies has grown significantly since the first MAB was generated in 1975, and the first MAB was fully licensed in 1986. This advancement is primarily due to rapid advances in genetic sequencing and testing. The unique specificity of MABs, which allows each MAB to bind to only one antigen, makes them a promising therapeutic option. As a result, MABs are currently the fastest-growing group of biotechnology-derived molecules in clinical trials.
Despite the advancements in local manufacturing capabilities in many countries and regions worldwide, sub-Saharan Africa must catch up. Only three countries, Kenya, Nigeria, and South Africa, have a relatively sizeable pharmaceutical industry with a limited range of value chain offerings. The size of the Kenyan, Nigerian, and South African pharmaceutical markets in 2021 were US$0.5 billion, US$1.5 billion, and US$3.9 billion, respectively.
Most of the pharmaceutical companies in Sub-Saharan Africa are drug-product manufacturers who buy APIs from other manufacturers and formulate them into finished pills, syrups, creams, capsules, and other drugs for local markets or export. In contrast, up to a hundred manufacturers in sub-Saharan Africa only package finished medications in bulk, and very few companies produce APIs, with no significant R&D activities.
MABs are highly complex biologic drugs that require advanced manufacturing processes and significant investments in research and development. Most MAB production facilities are concentrated in countries such as the United States, Europe, and China, with none in Africa.
This article will examine API and monoclonal antibody manufacturing in Africa, including challenges local manufacturers face, reliance on imports from India and China, and growth potential. It will also discuss the benefits of local manufacturing, including economic and social impacts, and its potential impact on public health.
Current API & MAB Manufacturing Capabilities in Sub-Saharan Africa
There are only three API manufacturers in Sub-Saharan Africa. One of these manufacturers offers valuable insight into the capabilities of the region.
Aspen Pharmacare is a global pharmaceutical company that was founded in 1850. The company has a strong presence in Africa and has expanded its footprint to have manufacturing facilities in South Africa, Kenya, Tanzania, and Mozambique through strategic acquisitions. In 2012, the Aspen Group acquired Kenyan-based Beta Healthcare International Ltd and Tanzania-based Shelys Africa Limited.
Through its API facility in Cape Town, South Africa, Aspen produces specialized API and high-potency manufacturing for domestic and export markets. Aspen manufactures many APIs, including those used to treat HIV/AIDS, malaria, tuberculosis, and other infectious diseases. However, API manufacturing contributes only 3% to Aspen’s regional revenue in Africa and the Middle East, while it accounts for 44% in Europe.
Monoclonal antibody products are not commonly used in resource-limited settings, and unfortunately, there are no known manufacturers of monoclonal antibodies in sub-Saharan Africa. Most African countries need to establish protocols for registering biologics and biosimilars. Only 1% of monoclonal antibodies, including biosimilars, are registered in Africa, with Nigeria registering only ten and Zimbabwe only seven. However, these MABs are imported as final products given that manufacturing of MABs is non-existent on the continent. In contrast, Western countries such as the US, Canada, and Europe account for 77% of registered MABs, with 112 MABs registered in the US and 77 in Brazil.
Access to monoclonal antibodies is necessary to ensure that millions of Africans can benefit from these drugs, with prohibitively high costs further limiting access for those in need. Governments in Africa cannot afford to procure these drugs for the public health sector, and private sector options are often too expensive for many people. Additionally, registration and launch of monoclonal antibodies in sub-Saharan Africa face various barriers, including differing registration requirements across national medicines regulatory authorities, increasing manufacturers’ time, cost, and complexity. This makes the sub-Saharan African market less appealing to manufacturers interested in submitting their products for regulatory review.
Challenges faced by Local Manufacturers in Sub-Saharan Africa
The pharmaceutical manufacturing industry in Sub-Saharan Africa remains underdeveloped mainly due to limited investment in research and development and inadequate regulatory systems for drug registration and quality control. As a result, as much as 90% of the drugs consumed in sub-Saharan Africa are imported. The major import destinations are South Africa, Egypt, Morocco, Kenya, Algeria, Ethiopia, Tunisia, Sudan, Tanzania, and Nigeria.
India and China have emerged as the dominant players in the global pharmaceutical market, exporting a significant portion of their products to African countries.
India’s pharmaceutical industry is characterized by high fragmentation, with approximately 1,500 API manufacturing plants operating nationwide. India is a significant exporter of pharma products, with nearly two-thirds of its exports going to NAFTA, Europe, and Africa. The USA, UK, South Africa, Russia, and Nigeria are among the top five destinations for Indian pharma products. South Africa and Nigeria received US$ 612.3 million and US$ 588.6 million worth of Indian pharma products, respectively, in 2021-22. While India’s API market is highly competitive, with several manufacturers, the MAB market has only ten major players. Despite exporting significant amounts of APIs to Africa, India exports most of its monoclonal antibodies to Iraq, the United States, and China, underscoring the need for increased regulatory capacity and infrastructure to register and use MABs in the region.
China is the largest supplier of APIs globally, producing more than 2000 API molecules at over 1000 manufacturing facilities, and constituting 40% of global API production. Nigeria, South Africa, Egypt, Ghana, and Kenya are among the countries that import the most from China. China also has over 60 pharmaceutical companies in the monoclonal antibody production field. As a result, Chinese pharmaceutical companies significantly impact the global pharmaceutical market, supplying APIs and finished drugs to countries around the world. Consequently, all global pharmaceutical manufacturers are exposed to significant API supply concentration risk. The concentration risk is, however, more severe for local manufacturers in Africa who import most of their supplies of APIs and excipients.
Beyond the substantial reliance on imports from China and India, local pharmaceutical manufacturers in sub-Saharan Africa face significant challenges that hinder their ability to provide affordable and quality medicines to their populations. One major issue is the competition with fake, substandard drugs that flood the African continent due to inadequate resourcing of the regulatory infrastructure. Local manufacturers often struggle to compete with these cheap, low-quality products, which further necessitates investment in effective regulation.
The World Health Organization (WHO) estimates that at least 30% of national medicines regulatory agencies globally have limited capacity to conduct the core regulatory functions such as product assessment and registration, licensing manufacturers, wholesalers and distributors, and import and export controls, among other functions. Among Africa’s 54 national medicines regulatory agencies, only 7% have moderately developed capacity, with over 90% having minimal or no capacity. Additionally, these agencies have varying requirements for medicines registration, which introduces significant complexity in the drug registration process for manufacturers. As a result, it can take up to 4-7 years between the first regulatory submission and final approval in some Sub-Saharan African countries, significantly impacting the availability of drugs on the market.
In addition to regulatory challenges, local manufacturers in Africa also need better manufacturing infrastructure. These facilities are often affected by unreliable power and road infrastructure, which causes frequent power interruptions, and high logistics costs. Many manufacturing plants in Africa are yet to meet the WHO standards, making it difficult to export their products or obtain funding from international organizations. Furthermore, the cost and time required to obtain WHO certification can be prohibitive for many manufacturers. The certification process involves significant investment and can take up to five years to complete, including installing a sophisticated HVAC system. This has led to several companies in Nigeria giving up WHO certification, resulting in bankruptcy and the need to merge with new companies to stay afloat.
Another significant challenge for local pharmaceutical manufacturers is the need for more availability of raw and packaging materials, which often need to be imported at great cost. For example, roughly 98% of the raw materials used to manufacture drugs in Nigeria are imported. And more issues arise once the raw materials brave the often-challenging journey along poorly built and managed roads to the manufacturing facilities. Much of the equipment used in these facilities needs to be updated, making it challenging to implement basic Good Manufacturing Practices (GMP) in line with compliance and quality assurance protocols. This leads to significant wastage issues, with waste levels reaching 4-6% instead of the recommended 2%. Human resource challenges, such as enforcing compliance to GMP among staff and absenteeism due to road networks, traffic, and economic challenges, further exacerbate the situation.
Local pharmaceutical manufacturers in sub-Saharan Africa face multiple challenges that limit their ability to produce and distribute quality medicines. The prevalence of fake, substandard drugs, inadequately resourced regulatory infrastructure, inadequate manufacturing infrastructure, and human resource challenges contribute to a complex operating environment. Addressing these challenges will require significant investment and the development of effective policy and regulatory frameworks that promote the growth and sustainability of local manufacturers. Additionally, there is a need for increased collaboration between governments, international organizations, and local manufacturers to build more robust and resilient pharmaceutical industries in the region.
Potential Solutions for the Expansion of Local Capabilities in Sub-Saharan Africa
There are potential solutions that can support the growth of local pharmaceutical industries in the region.
One of these is the need to bolster the regulatory capacity on the continent to be able to support the registration of new drugs and biologics in Sub-Saharan Africa (SSA). A treaty to establish an African Medicines Agency (AMA) was endorsed by the African Union (AU) in 2019 and came into force in late 2021. The aim is to improve access to safe, effective, affordable, and quality medical products across African countries by creating and enabling the regulatory environment. Developing common standards and regulations, coordinating reviews of clinical trial applications, and sharing information about products authorized for marketing will foster the growth of domestic production and facilitate trade across the continent. The AMA is positioned to work closely with the Africa Centers for Disease Control and Prevention and other platforms, such as the African Vaccine Regulatory Forum, to enhance Africa’s contribution to clinical research and innovation and improve diversity in clinical trials.
Another potential solution is government policies supporting and protecting the local manufacturing industry. For example, the production of APIs in South Africa has survived mainly due to government policies that banned imports of finished paracetamol as it is locally manufactured in the country. Establishing API manufacturing plants requires profitable production economies of scale, strategic technology transfer from leading API manufacturers, incentives on land acquisition, and energy costs, amongst other things. This requires government capabilities to support the emergence of this sub-sector.
Additionally, AU policies to promote local production can be a potential solution. On May 10, 2022, the African Union called for agencies responsible for bulk purchasing vaccines to offtake at least 30% of all vaccines produced by Africa for global consumption. In Africa, 99% of all vaccines administered are currently imported, underscoring the importance of these AU policies to support the growth of local manufacturing on the continent.
Global collaboration is also required to improve the capabilities of manufacturing in Africa. In the public sector, the European Union (EU), the European Medicines Agency (EMA), EU member states Belgium, France, and Germany, and the Bill & Melinda Gates Foundation (BMGF) have mobilized more than €100 million over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels. This support to strengthen regulatory capacity will improve health security in Africa by expanding local manufacturing of quality, safe, efficacious, and affordable medicines, vaccines, and other health tools. Cooperation with the African Union and national and regional organizations to strengthen Africa’s medicines regulators forms a critical pillar of the Team Europe Initiative on local manufacturing and access to vaccines, medicines, and health technologies in Africa (MAV+).
In the private sector, international collaborations can be a potential solution. In 2007, LaGray Chemical Company of Nsawam, Ghana and Anuh Pharma of Mumbai, India, signed a collaborative agreement to manufacture certain APIs in Ghana. In the agreement, Anuh Pharma transferred to LaGray technology to manufacture the active ingredients for two antibiotics, amoxicillin and clavulanic acid. Anuh Pharma would supply the raw materials, while LaGray would manufacture the active ingredients and export them to Anuh Pharma for final formulation and packaging. The agreement enabled LaGray to increase the availability of quality medicines in Ghana, while Anuh Pharma could leverage LaGray’s access to the African market. The collaboration between LaGray and Anuh Pharma demonstrates the potential for cross-border partnerships in Africa to support local manufacturing.
Expanding local pharmaceutical manufacturing capabilities in Sub-Saharan Africa requires concerted efforts from various stakeholders. The potential solutions discussed above are not exhaustive, but they provide insights into the types of interventions that can support the growth of the pharmaceutical industry in the region. By implementing policies that support local manufacturing, bolstering regulatory capacity, and fostering global collaborations, Sub-Saharan Africa can improve access to quality, safe, and affordable medicines, vaccines, and other health tools.
Benefits of Local Pharmaceutical Manufacturing in Sub-Saharan Africa
Local pharmaceutical manufacturing in Sub-Saharan Africa has the potential to yield significant economic and social benefits. One key advantage is the lower cost of drugs with reduced reliance on imports and foreign exchange, as well as supply chain fluctuations. The availability of more affordable drugs could translate into government procurement of a wider range of medications, which could be provided through national health insurance programs. This expansion of access to care would significantly boost the quality and universality of healthcare, ultimately improving health outcomes across the region.
Moreover, localizing pharma manufacturing could accelerate the industry’s growth and innovation while mitigating supply chain disruption risks. By fostering local development of pharmaceuticals, Sub-Saharan Africa could generate substantial economic impact, creating jobs and supporting local entrepreneurship. Affordable drugs would offer people greater access to treatment choices while reducing African health systems’ vulnerability to supply chain disruptions. In sum, local pharmaceutical manufacturing could create a virtuous cycle of economic growth, healthcare expansion, and improved health outcomes in Sub-Saharan Africa.
The impact of local pharmaceutical manufacturing in Sub-Saharan Africa extends far beyond economic and industrial growth. The region can significantly improve public health by ensuring more people have access to affordable drugs. This expansion of access to care could help to reduce the incidence of preventable diseases, such as malaria, HIV/AIDS, and tuberculosis, as well as non-communicable diseases, like diabetes and hypertension. By fostering innovation and localizing pharma manufacturing, Sub-Saharan Africa can also accelerate the development of life-saving vaccines, which can be crucial in mitigating the impact of pandemics like COVID-19. Ultimately, wider availability of affordable drugs would offer people greater access to treatment choices, ensuring that healthcare is available to all who need it.
