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: 2021-09-13

Overview

 

2018

2019

2020

 

2021

(Estimated)

Total Local Production

n/a*

n/a

0.63

1.26

Total Exports

-

-

n/a*

n/a

Total Imports

133.10

118.20

129.47

132.54

Imports from the US

8.24

11.60

7.50

11.89

Total Market Size

133.10

118.2

130

132.54

Exchange Rates

99

101.5

105

105

All figures in millions of USD with exception of 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: BMI Research
Total Local Production: N/A
Total Exports: N/A
Total Imports: BMI Research
Imports from U.S: Global Trade Atlas
Exchange Rate:  Central Bank of Kenya

*Data not available locally

Kenya is a promising market for medical devices and has been ranked as among the fastest growing markets in the sub-Saharan Africa region according to Business Monitor International (BMI). The country has one of the largest most advanced economies in East Africa, but its low GDP per capita makes health services inaccessible to many Kenyans. The country, however, is still advanced in terms of healthcare infrastructure compared to its neighbors and serves as a medical tourism destination with visitors from neighboring East African countries.

Most medical devices are imported with domestic production focused on basic consumable items and personal protective equipment (PPE) following the coronavirus pandemic. Imported devices may be new or refurbished if they comply with the local standard and regulatory requirements. Most hospitals in the country however still use old, un-serviced and out of date equipment. The Kenya medical device market was estimated at nearly $130mn at the end of 2020 according to BMI. Demand for medical devices remains high, as many healthcare facilities require modernization. In both the public and private sector, there is a demand for affordable, high quality medical devices. In the private sector especially, there is a steady demand for western standard therapeutic and diagnostic equipment. The U.S. market share for medical devices was estimated at 8.2% in 2020, with major investments by leading U.S. medical companies expected to increase at the end of 2021.

Over half of Kenya’s healthcare services are provided by the public sector, through the Ministry of Health (MOH), and other government funded bodies. These services are supplemented by those offered in hospitals and clinics that are operated by private companies, NGOs, faith-based organizations, and emergency ambulance and disaster relief services offered by the Kenyan Red Cross. Healthcare funding is heavily supported by multilateral donor partners, including the United States through the US Agency for International Development (USAID) and the Centers for Disease Control (CDC). Donors also provide in country technical assistance to the MOH.

The Management Equipment Service (MES) project is designed to address major problems related to lack of adequate medical equipment and heavy capital expenditure. According to the GOK, the MES project is a flexible, long-term contractual arrangement that involves outsourcing the provision of specialized, modern medical technology and equipment to private sector service providers. The project comprises contracts between the MOH and various contractors for the supply, installation, maintenance, replacement, and disposal of various equipment, as well as training and reporting for the entirety of the contract period. The program, which is now in its sixth year, has been implemented in 98 hospitals across the 47 counties, with a focus on theatre, central sterile services department, renal, ICU and radiology equipment.  The project, valued at a sum of $432mn, will run for an initial term of seven years with the possibility of extension for an additional three years.

The GOK intends to provide Universal Health Coverage (UHC) for all as part of its Big Four Agenda. The UHC program will prioritize 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).

The government significantly increased total spending in the healthcare sector because of the coronavirus pandemic. In the recently passed Kenya National Budget 2021/2022, the government allocated $1.21bn to the healthcare sector, of which $39m is for the procurement of COVID vaccines, and $95m s for the engagement of COVID-19 specialists and supplying 28 hospitals with equipment. The Finance Bill has proposed VAT exemptions for various medical inputs such as ventilators, physiotherapy accessories, treadmills for cardiology therapy, diagnostic or laboratory reagents, electro-diagnostic apparatus, instruments, and appliances used in dental sciences, categories of medical instruments and appliances including breathing appliances. All these exemptions are expected to result in increased affordability of medical services for the Kenyan people.

In response to the economic pressures from the Covid-19 pandemic, the Kenyan government has introduced new economic measures. The corporate income tax rate was reduced from 30% to 25%, and the VAT rate from 16% to 14%. In addition, the government earmarked $400m 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.  Respiratory diseases continued to be the leading cause of outpatient disease incidence reported in public health facilities. The country is also one of the countries in SSA with the highest prevalence of non-communicable diseases (NCDs). 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. Evidence shows that young people aged 10-24 have higher vulnerability due the following lifestyle risk factors: tobacco use; physical inactivity; unhealthy diets; and harmful use of alcohol.  The GOK’s Kenya Health Policy 2014-2030 seeks to reduce and reverse the burden of NCDs.

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. KEMSA, the largest source of healthcare public procurement in Kenya, uses open international tenders, open national tenders (limited to local Kenyan suppliers only), restricted tenders or direct procurement (from government agencies only) to source for products.

All national and local level facilities are required to first purchase from KEMSA, and only if the items are not available are they allowed to source their supplies from other private sector distributors. KEMSA procures medical supplies for county governments, referral hospitals, and for programs funded by donors. KEMSA does not receive direct funding from the GOK, as it relies on a revolving fund which is dependent on the payment from the public purchases and has program support partnerships with various donors such as: UNICEF, Global Fund, DFID, USAID, KFW, UNFP, and JHPIEGO. GOK funded programs prefer local suppliers and range from 10-20% of total procurements. All public tenders are advertised on the KEMSA website and must follow the Public Procurement Act. KEMSA has of late come under scrutiny for alleged mishandling of tenders and multiple allegations of corruption. The U.S. Commercial Service is monitoring this situation.

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.

In September 2017, Kenya incorporated all medical devices, food supplements, medical cosmetics, herbal products, and other allied borderline healthcare products into the Pre-Export Verification of Conformity (PVoC) program. The Kenya Bureau of Standards (KEBS) and PPB announced the new import requirements to protect the public against products that do not comply with local quality standards and technical regulations. These new regulations for imported medical devices will increase compliance for importers and drive-up standards in the Kenyan medical device market.

These products now require a Certificate of Conformity (CoC) for customs clearance at the border. The importers of these products are required to obtain the CoC for their goods before applying for import permits from the PPB, through the Kenya National Single Window Electronic (KenTrade) System.

The government also announced the exemption of medical equipment and apparatus from VAT, under the 2019/20 budget, which continues to drive and encourage investment in the health sector in Kenya. According to BMI, these exemptions will support strong medical device market growth and is expected to register double-digit increases every year between 2019 -2024. There is also a proposal underway at the East African Community (EAC) to create a single regulatory body for medical devices across the region.

Leading Sub-Sectors

Personal Protective Equipment (PPE) and Related Equipment: With global supply pressures for countries to manage the COVID-19 pandemic, demand for PPE will continue to rise in 2021 to compliment the country’s local production. Demand for rapid diagnostic test kits and polymerase chain reaction (PCR) kits will rise as the country struggles with the pandemic.

Diagnostic Imaging Equipment: Leading private sector hospital groups continue to invest in the latest most innovative equipment. Best prospects for diagnostic equipment include CT scanners, ultrasound units, X-ray equipment, MRI equipment, angiography, endoscopy, biochemistry, hematology and immunology systems, radiotherapy machines, electro-medical devices (X-ray machines, ultrasound scanners, and mammography units), and electrocardiographs.

Dental Equipment: In the last three years the United States was the leading supplier of dental equipment with an import share of around 20%. 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. However, U.S. exports of dental equipment have recently dropped due to heavy competition from China and India.

Consumables: Local production of basic consumables remains low providing opportunities for U.S. companies. Best prospects include bandages and dressings, suturing materials, catheters, syringes, surgical gloves, and blood grouping reagents.

Orthopedics and Prosthetics: Best prospects include fixation devices, artificial joints, and other artificial body parts.

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

Other Medical Equipment: 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 1: Summary of medical devices imports 2015-2025

Kenya Medical Devices Imports: 2021-2025
​​Kenya Medical Devices Imports

 

Source: Fitch Solutions

Opportunities

There will continue to be a higher prioritization of healthcare by both the national and county governments with the COVID-19 crisis. This will provide commercial opportunities for medical device manufacturers with government incentives.

Under the GOK’s Vision 2030, the government is pursuing the nationwide rehabilitation of major hospitals and community health centers with plans to establish at least one model health center in every constituency. The Big Four agenda will also drive investments for the next four years and aims to achieve four critical objectives, one of which is UHC across Kenya. Efforts by the government to make healthcare accessible to all the citizens across the country through innovative procurement solutions and policies such as the $38bn Managed Equipment Service leasing model will offer business opportunities for U.S. companies.

U.S. medical equipment suppliers are in an excellent position to increase their market share in Kenya give as patients and practitioners appreciate the quality and reliability of U.S. medical equipment. Leading private sector hospitals are very active in modernizing their medical equipment inventories, while public sector hospitals are expected to engage in a re-equipping strategy following improved budgetary allocations. At present, most public health institutions lack basic medical equipment even at the county level.

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

Universal Healthcare Coverage (UHC):  As part of the Big Four Agenda, the government of Kenya has outlined various strategies to support the President’s pledge and commitment to UHC and deliver equal access to high quality treatment to all Kenyans. The GOK aims at achieving this by scaling up the National Health Insurance Fund (NHIF), increasing insurance coverage and achieving 100% coverage of the poor. As a result, Kenyans would be guaranteed access to medical care and at minimal cost.

Implementation of UHC will benefit medical device manufacturers and innovations in integrated healthcare management systems. The GOK has made the following allocations towards achievement of the Universal Health Coverage (UHC): $500mn to activities and programs for the attainment of UHC by the drivers and enablers; $190mn to address and lower cases of HIV, malaria and tuberculosis in the country; $62mn for the MES; $53mn to transform the health care systems for UHC; $41mn to cater for free maternity health care; and $18mn to provide medical cover for the elderly and severely disabled in society.

eHealth: Kenya has a comprehensive eHealth strategy. The country has been ranked the second highest country from the African continent (behind South Africa), on eHealth innovation. Further, it has made noteworthy progress in developing a sound policy foundation to manage the rollout of Health information technologies (Health IT) in the country.

Kenya’s e-Health Strategy is anchored on the achievement of Vision 2030, whose overall goal in health is to have an “equitable and affordable healthcare at the highest achievable standard” to her citizens. It is informed by the strategies and results emanating from the implementation of the Kenya Health Policy Framework (1994-2010), the health sector strategic plans and the e-Government and shared services strategies implemented through the e-Government Directorate and the ICT Board respectively.

The GOK has a well-defined eHealth strategy with a specific e-Health policy tool, the Kenyan e-Health strategy (2016-2030). The document identifies five main areas of focus and implementation: Telemedicine; Health Information Systems; Information for Citizens; mHealth, and eLearning.

As compared to other African countries, Kenya has a high mobile phone penetration, which creates a market for eHealth products such as connected devices and patient tracking. The GOK recently launched mHealth standards, which will provide a regulatory framework that will enable coordination and implementation of robust mHealth solutions. The standardization will encompass communication protocols, device interfaces, applications, and operating systems. This will support standards for information exchange to serve as the building blocks for the seamless and secure exchange of health information for better and improved health service delivery and outcomes. Standardization further aims to move the mHealth sector from the silo-based pilot phases to scalable fully-fledged interoperable solutions. 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 Common Market for Eastern and Southern Africa (COMESA) region, supplying about 50% of the regions’ market. According to BMI, Kenya’s pharmaceutical industry was valued at $2.9 billion at the end of 2020. Prescription drugs account for around 75% of the market closely followed by over-the-counter (OTC) product sales. The attractiveness of Kenya’s pharmaceutical market to innovative drugmakers is hampered by low-income levels, a poor rural population, and an underdeveloped healthcare sector, characterized by lack of infrastructure and structured sales channels.

The pharmaceutical industry in Kenya consists of three segments, manufacturers, distributors, and retailers. All play a major role in supporting the country’s health sector, which is estimated to have about 5,000 health facilities country-wide. The number of companies engaged in manufacturing and distribution of pharmaceutical products in Kenya continue to expand, driven by the government’s efforts to promote local and foreign investment in the sector. There are about 700 registered wholesale and 1,300 retail dealers in Kenya, manned by registered pharmacists and pharmaceutical technologists.  These pharmacies are accorded a 25% mark-up on retail drugs. The pharmaceutical sector in Kenya is also engaged in assembling capsules, disposable syringes, paracetamol, and surgical gauze amongst others.

Registration by the Kenya Pharmacy and Poisons Board is done after a manufacturer has applied to the board (refer to regulations).  The manufacturer can only be registered after complying with several standards set by the regulatory board.

The manufacturer must comply with good manufacturing practices (GMPs) and payment of registration fees. During registration, the manufacturers separately apply for the registration of a drug or medicinal product. The products which are eligible to be registered are those which are useful in the diagnosis, treatment, and prevention of illness.  

NCDs – Cancer: 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. Besides the ten centers, the Ministry has also operationalized the Kenyatta University Teaching Referral and Research Hospital (KUTRRH) 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. Other initiatives to support cancer management by the GOK include the MES through which level 4 and 5 hospitals were equipped with various hi-tech diagnostic machines such as X-ray, CT-SCAN, ultrasound, and mammography machines to boost cancer diagnosis. The government has also provided the Human Papillomavirus vaccine for schoolgirls aged ten to prevent cervical cancer. The investments in Cancer Centers of Excellence by both government and investments by private hospitals will provide excellent opportunities for U.S. companies.

Resources

  • Health Care Resources Guide
  • Kenya National Bureau of Statistics
  • Kenya Medical Supplies Agency (KEMSA)
  • Ministry of Health
  • Ministry of Health mHealth Guidelines
  • World Health Organization
  • Kenya Medical Devices Report (BMI)
  • Kenya Medical Research Institute  
  • Kenya Budget Highlights 2021 Deloitte
  • Sub Saharan Africa Combating Cancer Initiative (CCI) report

For more information on the Health 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