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BIOPHARMACEUTICALS
From Site Selection magazine, March 2023
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An Exclusive Look At Emerging Africa

A new report from KPMG sheds light on Sub-Saharan opportunities.

BIOPHARMACEUTICALS
Dignitaries including several country presidents broke ground in June 2022 for BioNTech’s module-based, scalable mRNA vaccine manufacturing facility in Kigali, Rwanda. The site is expected to become a node in a manufacturing network in Africa, including sites in South Africa and Senegal and fill-and-finish facilities in Ghana and South Africa.
Photos courtesy of BioNTech

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André Guedel, Director and Head of Site Selection and Location Development Services, KPMG Switzerland
André Guedel, Director and Head of Site Selection and Location Development Services, KPMG Switzerland

he Sub-Saharan African population is set to double by 2050. That means the region needs to build up its healthcare systems and the life sciences manufacturing and distribution systems to support them. But how to assess the landscape for biopharma investment?

André Guedel, director and head of Site Selection and Location Development Services for KPMG Switzerland, says much of the manufacturing of pharmaceutical products for African markets is performed in India and China. “However, like everybody, these countries want to have manufacturing,” he says, despite challenges in supply chain (especially cold chain facilities), scarcity of talent (due to brain drain) and a regulatory framework that can be byzantine at best. Life sciences companies want to find out if they can localize some aspects of manufacturing in-country (say, packaging and labeling, if not outright API production), especially in countries where they sell to governments.

“Most of these countries have decent med schools or pharma schools,” Guedel says. “If you graduated from a pharma school in one of these countries, it should be sufficient to work in a factory. That’s also a benefit of locating manufacturing there. In Nigeria, for instance, people are leaving the country and there’s a big brain drain. If more companies set up, they’d say ‘Let’s stay here.’ Finding the qualified workforce is a big issue.”

Among other promising developments, Guedel sees the potential for R&D clusters developing around universities in Africa, as well as the clinical studies and presence of such organizations as the Swiss Tropical and Public Health Institute or the newly established African Medicines Agency in Kigali, Rwanda, which Guedel calls “a huge step forward” in a country that, 30 years after a shocking genocide, today could be called a role model for development in Africa. He also says the rising importance of equity, sustainability and governance (ESG) goals to multinationals is a factor: “If a company can prove it is investing in African local production, it’s a nice add-on for the ESG ranking.”

Biopharma-NM-oneAgainst this backdrop, the KPMG team collaborated with Venture Valuation to produce “Site Selection for Life Sciences Companies in Sub-Saharan Africa,” which features detailed regulatory, incentive and business climate analysis as well as profiles of Ghana, Kenya, Mauritius, Nigeria, Rwanda, South Africa and Zambia. By special arrangement, we present here an adaptation of the report’s findings and resources. For this report and other analyses of life sciences markets worldwide, visit kpmg.com/ch/en/home/industries/life-sciences. — Adam Bruns, Managing Editor

Localized Manufacturing: Challenges, Progress and Support

Creating and sustaining a resilient healthcare ecosystem is an ambitious undertaking, even for countries in the industrialized world. For low- and middle-income countries (LMICs) like those of Sub-Saharan Africa, this is even more of a challenge. 

Establishing local presence for production is one way how manufacturers of biopharma and medical devices may seek to increase access to medicines and devices in LMICs. Even localizing just a small part of production processes (such as packaging) in LMICs can significantly contribute to the strengthening of local healthcare ecosystems. Local production contributes to local (health) systems in the following ways:  

  • Providing high-quality jobs for locally trained scientists, MDs and laboratory workers
  • Shifting the perception of healthcare from a “cost factor” to a value driver for economic development;
  • Improving resilience and limiting import dependency for (generic) medicines; 
  • Incentivizing the local government to strengthen the general business environment, adjust regulations, improve infrastructure, and invest in education to attract investments; 
  • Strengthening local supply networks and improving the availability of essential medicines, vaccines, diagnostics and medical devices.

On the regional level, the African Development Bank, together with industry associations, strongly support the increase of biopharma and medical device manufacturers in the Sub-Saharan region. At the country level, many governments aspire to build and strengthen their domestic medical product industry. They are offering financial incentives and other governmental support for locally manufactured drugs. As a result, biopharma manufacturers are increasingly considering shifting parts of their production chain closer to the Sub-Saharan African market. A local presence also helps manufacturers in better understanding the local and regional context, building long-term relationships, and paving the way for successful commercialization of their products. 

There are some key factors to consider in order to realize local production. These govern the decision where to establish local manufacturing presence or even launch medicinal products:  

Availability of talent: While many African-based technology companies find sufficient tech talents for developing E-health solutions, the qualified talent pool is still small for those seeking sciences, medical, pharmaceutical or manufacturing expertise. A number of research institutions and universities are offering quality education, but the numbers of graduates do not (yet) match demand.

Navigating the regulatory environment: With more than 40 different systems, the Sub-Saharan regulatory environment is complex. As a result, foreign manufacturers struggle when it comes to navigating market authorization and regulations with regard to current Good Manufacturing Practice (CGMP). Implementation of the new African Medicines Agency should gradually improve this situation.

Logistics, trade barriers and bureaucracy: Also here, improvements are underway. For instance, the new African Free Trade Zone to help strengthen intra-African trade.  

Lack of affordability and uncertainty of demand.

Other important parameters for biopharma and medtech manufacturers to evaluate the potential of LMIC markets include the robustness of the healthcare system, prevailing procurement partnerships with NGOs/governments, the organization of the local distribution network and pricing and reimbursement dynamics.

Even with a population of 1.4 billion, there are only 340 manufacturers of medicines, vaccines and diagnostics in Africa, compared to 5,000 in China and 10,500 in India.

Several international initiatives support the development of life sciences ecosystems and the manufacturing of medicines, vaccines and medical devices in Africa. Among them: In June 2022, the African Development Bank (AfDB, www.afdb.org/) approved the establishment of the African Pharmaceutical Technology Foundation to boost the continent’s access to technologies needed to produce vaccines, medicines and other pharmaceutical products with a commitment package of around $3 billion over the next decade.

The development of a framework to strengthen the African capacity for drug discovery and development is the goal of the partnership launched in September 2021 by the South African based H3D-Foundation (h3dfoundation.org/) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA, www.ifpma.org/).

At the G20 Global Health Summit in May 2021, the European Union pledged €1 billion to an initiative to help create an enabling environment where vaccines can be manufactured in Africa, to tackle barriers on both the demand and supply side. The “Team Europe” initiative focuses on manufacturing of vaccines, medicines and health technologies in Africa. 


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