Kenya - Country Commercial Guide
Healthcare - Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2022-08-19

Overview

Kenya’s medical device market will expand by a five-year compound annual growth rate (CAGR) of 8.9% in local currency terms and 8.2% in U.S. dollar terms, which should see it rise to $197.9 million by 2026, according to Fitch Solutions. The market is further expected to register mainly high single-digit growth through 2026. The medical device market will benefit from continued economic recovery from the COVID-19 pandemic and a rebound in the tourism sector.

Kenya is a promising market for medical devices and has been ranked as one of the fastest growing markets in the sub-Saharan Africa region according to Fitch and World Bank reports. The medical device sector is heavily reliant on imports with limited domestic production due to limited manufacturing infrastructure and technical capacity as well as lack of access to raw materials. The U.S. market share for medical devices sales in Kenya was estimated at 5.7% at the end of 2021.  The U.S. was ranked eighth after South Africa, with China and Germany taking the first and second places, respectively.

Nearly 70% of Kenya’s healthcare services are provided by the public sector, through the Ministry of Health (MOH), and other government-funded bodies. Healthcare services are supplemented by hospitals and clinics run by private companies, NGOs, and faith-based organizations. Emergency ambulance services and disaster relief management is provided by the Kenyan Red Cross. National healthcare funding is heavily supported by multilateral donor partners, including the United States through the U.S. Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC). Donors also provide in-country technical assistance to the MOH.

The country’s Universal Healthcare Coverage (UHC) program prioritizes broadening access to services, strengthening primary healthcare, increasing medical staff and medical supplies, digitizing health operations, and scaling up the National Health Insurance Fund (NHIF). Heavy investments in private hospitals coupled with availability of skilled doctors has put the country as a leading medical tourism location in East Africa.

In response to the global economic pressures from the COVID-19 pandemic, the Kenyan government introduced new economic measures in 2020. The corporate income tax rate was reduced from 30% to 25%, and the VAT rate was reduced from 16% to 14%. In addition, the government earmarked $400 million in funds for additional health, including enhanced surveillance, laboratory services, isolation units, equipment, supplies, and communication.

Kenya, like most developing countries, is facing a double burden of communicable and non-communicable diseases. The country is one of the countries in sub-Saharan Africa with the highest prevalence of non-communicable diseases (NCDs). Respiratory diseases continued to be the leading cause of outpatient disease incidence reported in public health facilities. According to the Kenya Medical Research Institute (KEMRI), NCDs such as cancers, diabetes, and others account for 27% of total deaths and over 50% of total hospital admissions.  

Table 1: U.S. – Kenya Trade Statistics (Medical Devices)

 

2019

2020

 

2021

 

2022

(Est)

Total Local Production*

 -

-

-

-

Total Exports

3.56

3.80

2.94

2.97

Total Imports

125.19

129.47

131.54

133.86

Imports from the US

5.63.60

7.50

7.89

7.64

Total Market Size

125.19

130

131.54

133.86

Exchange Rates

101.5

105

105

111

 

All figures in millions of USD with exception of the exchange rate in Kenya shillings (Kshs) 

*Data unavailable
Applicable HS Codes: 300510,300590,300610,300640,300650,901180,901190,901380,901390,901310,901320,901811, 901812, 901813, 901814, 901819, 901820, 901831, 901832, 901839, 901841,901849, 901850, 901890, 901920, 902000, 902110, 902129, 902140, 902150, 902212, 902213,902214,902219, 902221,902230,
Total Market Size = (Total Local Production + Total Imports) – (Total Exports).

Data Sources:
Total Market Size: Fitch Solutions
Total Local Production: n/a
Total Exports: Fitch Solutions
Total Imports: Fitch Solutions
Imports from U.S: Global Trade Atlas
Exchange Rate:  Central Bank of Kenya

Medical Device Procurement

Public procurement for both medical equipment and pharmaceuticals is done by the Kenya Medical Supplies Agency (KEMSA), a state corporation and a specialized medical logistics provider for the MOH. Centralized purchasing and procurement are often used in both public and private hospitals to obtain economies of scale. K All public tenders are advertised on the KEMSA website and must follow the Public Procurement Act. It is important to highlight that KEMSA is undergoing reforms after concerns by the U.S. Government, among others were brought to light. The agency is still under investigation for concerns regarding fraud, waste, and mismanagement. A report by the Auditor General highlights some of the fraudulent procurements (http://www.parliament.go.ke/auditor-general-presents-damning-special-audit-report-kemsa-senate-committee).

Regulation: The MOH is the lead healthcare policy setting government institution in Kenya. The Pharmacy and Poisons Board (PPB), an agency under the Department of Medical Services at the MOH, is the regulatory body for registration of medical devices.

Kenya has incorporated all medical devices, food supplements, medical cosmetics, herbal products, and other allied borderline healthcare products (these are products that do not fall into the medical devices category, are neither medicinal product nor food supplements) into the pre-export verification of conformity (PVoC) program. The Kenya Bureau of Standards (KEBS) and PPB announced the import requirements to protect the public against products that do not comply with local quality standards and technical regulations. These regulations for imported medical devices increase compliance for importers and improve standards in the Kenyan medical device market. A certificate of conformity (CoC) for customs clearance at the border is required by importers of these products before applying for import license permits from the PPB.

VAT Exemptions

The government also announced the exemption of various medical equipment and apparatus from VAT, under the 2022/2023 budget, which continues to drive and encourage investment in the health sector in Kenya. This includes exemptions for plant and machinery used in manufacturing of pharmaceutical products. The supply of medical oxygen to registered hospitals, urine bags, adult diapers, artificial breasts, and colostomy or ileostomy bags for medical use are also to be exempt from VAT. Learn more about information on vat exemption.

According to Fitch Solutions, these exemptions were meant to support strong medical device market growth, and the sector was expected to register double-digit increases every year between 2019 -2024. There is also a proposal under consideration at the EAC to create a single regulatory body for medical devices across the region under the East African Community (EAC) Medicines Regulatory Harmonization programme.

Leading Sub-Sectors

Diagnostic Imaging Equipment:  Leading Kenyan private sector hospital groups invest in the latest most innovative equipment. Best prospects for diagnostic equipment include electrocardiographs (ECG); ultrasound units; scintigraph apparatus; MRI equipment; angiographies; endoscopies; and biochemistry, hematology, and immunology systems. Hospital groups also invest in radiation equipment including, radiotherapy machines, CT scanners, X-ray machines, and imaging parts and accessories such as contrast media, medical x-ray films, x-ray tubes, and other parts and accessories.

Dental Equipment:  Exporters’ best prospects for dental equipment include dental drills; chairs; and X-ray equipment, instruments, and supplies such as dental cement, teeth,

and other fittings, and artificial teeth.

Orthopedics and Prosthetics:  Exporters’ best prospects include fixation devices, artificial joints, and other artificial body parts.

Patient Aids:  Exporters’ best prospects include hearing aids, pacemakers, and therapeutic appliances such as therapeutic respiration apparatus and mechano-therapy apparatus.

Lab testing equipment:  Demand for various rapid diagnostic testing kits will reduce with the reduction of COVID-19 cases in the country. Demand for lab equipment and reagents will remain static. The need for self-testing kits will grow steadily as the government approves licensing for RDTs for malaria, HIV, and COVID-19.

Consumables:  Local production of basic consumables remains low, providing opportunities for U.S. companies. Exporters’ best prospects include bandages and dressings, suturing materials, catheters, syringes, surgical gloves, and blood grouping reagents. Nearly 90% of all consumables are imported from China and India.

Other Medical Equipment: Exporters’ best prospects include hospital furniture, anesthetic machines, anesthetic trolleys, hydraulic operating tables, delivery beds, infant incubators, mortuary trolleys, hydraulic operating tables, mercurial sphygmomanometers, and oxygen flow meters.

Table 2: Summary of medical devices imports 2016-2026

Source: Fitch Solutions

Table 1: Summary of medical devices imports 2016-2026
Table 1: Summary of medical devices imports 2016-2026

Opportunities

Cancer Care: In July 2020, the government announced the opening of ten county chemotherapy centers as part of deliberate efforts to improve access to cancer services in line with the UHC developmental agenda. In addition to the ten centers, the Ministry has also operationalized the Kenyatta University Teaching Referral and Research Hospital and is in the process of establishing five additional radiotherapy centers at the Moi Teaching and Referral Hospital, Nakuru County Referral Hospital, Mombasa County Referral Hospital, Garissa County, and Kisii County.  The investments in cancer centers of excellence by both government and private hospitals provide excellent opportunities for U.S. companies.

eHealth and mHealth: Kenya has a well-defined e-Health Policy (2016-2030) outlining key areas of focus and implementation. It has provided a sound policy foundation to manage the rollout of various health information technologies in the country. The country has been ranked the second highest country on the African continent (behind South Africa), on eHealth innovation. These include telemedicine, health information systems, information for citizens, mobile health (mHealth), and eLearning. Kenya has a high mobile phone penetration, which creates a market for eHealth products such as connected devices and patient tracking.  the MOH mHealth standards provide a regulatory framework that enables coordination and implementation of robust mHealth solutions. The standardization encompasses communication protocols, device interfaces, applications, and operating systems.  These areas present excellent opportunities for U.S. companies in health IT, mobile patient monitoring platforms, and telemedicine.

Pharmaceuticals: The pharmaceutical industry in Kenya is growing at a rapid pace and offers excellent opportunities for U.S. companies to establish their products and services, whether through direct manufacturing or indirectly through local distribution channels. Kenya is currently the largest producer of pharmaceutical products in the COMESA region, supplying about 50% of the region’s market. The attractiveness of Kenya’s pharmaceutical market to innovative drug makers is however hampered by low-income levels, a poor rural population, and an underdeveloped healthcare sector, characterized by lack of infrastructure and structured sales channels. In 2022, GOK signed an MOU with covid vaccine manufacturer Moderna for the establishment of the first mRNA manufacturing facility in Africa.

There is also a demand for supply chain solutions to effectively distribute pharmaceuticals and medical supplies. The enactment of the Special Economic Zones Act (2015-SEZA) presents an opportunity to invest in manufacturing plants for medical supplies to the region.  

Resources

Kenya National Bureau of Statistics (https://www.knbts.go.ke/)

Ministry of Health  

World Health Organization  

Kenya Medical Devices Report (Fitch Solutions)

 For more information on the Healthcare sector, please contact:


Janet Mwangi
Commercial Specialist
U.S. Commercial Service, U.S. Embassy Nairobi
U.S. Department of Commerce | International Trade Administration
Tel: +254 (20) 363-6725. Janet.Mwangi@trade.gov