Ethiopia Manufacturing Sector
Ethiopia Manufacturing Sector
AN EMERGING
MANUFACTURING
HUB IN AFRICA
Tilahun E. Kassahun
Senior Policy Advisor, Ethiopian Investment Commission
Pharmaceutical manufacturing is a nascent industry in Ethiopia but has the potential
to promote import substitution, grow exports, and improve health through access to
medicines
Pharmaceutical manufacturing market
• Awareness, diagnosis and treatment of diseases are increasing for both communicable
Increased and non-communicable diseases in Ethiopia
determination to – Ethiopia is affected by the burden of communicable diseases; the country is
address disease among the highest burden countries for Malaria, HIV/AIDS and TB
burden – In addition, prevalence of non-communicable diseases, such as diabetes, cancer,
and hypertension has also increased.
• With a population size of > 100M, Ethiopia has the second-largest population in Africa
Progressive growth of • Ethiopia is expected to become a middle income country by 2025 with an average
the Ethiopian economic growth of 10% per year resulting in an increase in the disposable income
population and of the population; the increase in disposable income will influence spending on
economy healthcare pharma products
Strategic objectives
1.Improve access to medicines through quality local production
2.Strengthen the national medicine regulatory system
3.Create incentives designed to move along the value chain
4.Develop HR through relevant education and training
5.Encourage cluster development & API production
6.Create a R&D platform
7.Attract FDI in the pharmaceutical sector
8.Exploit the LDC status to locally produce patented products
Selected targets
Indicators 2015 2020 2025
target target
Pharmaceutical manufacturers with 2 5 20
international GMP compliance (n)
WHO prequalified products produced 0 4 15
locally (n)
New manufacturing companies and 0 5 11
local capital invested (n)
Joint ventures with international GMP 3 8 15
compliant companies (n)
API manufacturers (n) 0 1 3
Export of locally produced meds by 2 30 80
GMP-complaint producers (USDmn)
The study also incorporated other reports from the MOI, e.g. proposed incentive package, implementation plan for national
strategy, policy advisory report on intellectual property and local pharma manufacturing in FDR Ethiopia
Source: National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015-2025) 4
Clustering, infrastructure and exports: Pharmaceutical industrial parks have
unique infrastructure requirements from ones focused on other sectors
• Power consumption is dependent on the pharmaceutical product line, although it is not different from other
industries
- Power reliability is as important as availability in the pharmaceutical sector, as interruptions highly affect
the production process and quality of the end products
• Water supply is vital for pharmaceutical production. Depending on the product, different grades of water purity
are required (potable, bulk purified water, bulk highly purified water, water for injections, etc.)
- Input water treatment is typically done individually by investors, but GoE can provide the standards for
potable water. It can also be provided at different purity levels (Potable water < cleaning water < water for
syrups & suspension < water for injections)
• Waste Management: Pollution prevention, reduction, and/or treatment is required for air emissions, liquid
Pharmaceutical effluents and solid wastes. The toxic concentration depends on the type of product. Pre-treatment at the
Industrial facility / cluster before joining the CETP is most often required. Zero-liquid discharge is also a possible
Park (but quite expensive) technology. HVAC for air emissions should be chosen and justified by companies
• Warehouse: Storage area should be of sufficient capacity to allow orderly storage of the various categories of
materials and products (raw materials, intermediaries, packaging, finished, quarantined, released & rejected
products). Segregation and labelling is required to prevent errors/mix-ups
- Warehouses should be designed to ensure good storage conditions (clean & dry, maintained within
acceptable temperature/humidity limits). Highly active products stored in a secure area
• Others: transportation facilities and one stop shop services should be included
- Ideal if the one-stop-shop include customs, FMHACA, environmental protection and other government
offices for ease of operation
6
7
Kilinto industrial park - dedicated to pharmaceuticals
EIC will:
• Lead targeted recruitment of anchor investors
• Conduct due diligence on potential investors
• Cooperate with relevant GoE agencies (MoI, FBPIDI, MoH, FMHACA, PFSA, MoFA)
32 4 38 35 2 364 3 74
Ethiopia 74.71902.3526
38 3
Source: The National Strategic Plan of Action for Pharmaceutical manufacturing development in Ethiopia (2015-2020) 11
Government is the largest customer; 75% of all medicines consumed in
Ethiopia is procured through the public sector
Public Private
3.4
3.1
2. 9
– ~75% of all medicines
2. 8
2.9
2.3
2.5
2.5
1. 6 1. 7 1. 8 2. 0 2. 1 2. 3 2. 4 2. 5 2. 6 consumed in Ethiopia is
procured through the public
1.3
1.6
1
2.0
. 2 1. 4 1. 5
00..76 10..06 0.8 0.9 1.0 1. 1.2 1.3 1.4 1.5 1.6 1.8 1.9 2.0 2.1 2.
sector*
2010 201 2012 2013 2014 2015E 2016F 2017F 2018F 2019F 2020F 2021F 202 F 2023F 2024F 2025F
Note: *Based on National Strategy and Plan of Action for Pharmaceutical Manufacturing Development
12
Source: BMI, AGI analysis, Interviews
The majority of drugs are procured through the public sector
~30% ~70%
Government purchases Program purchase
(Revolving drug fund)** (donor funded)
Note: *Public sector includes RDF and Program Purchases (in-kind donations are not included). **private sector share was estimated at 25% of the total domestic market size
Source: PFSA, Interviews, NS-POA, AGI analysis 13
Market access and other incentives
91. Regulation
102. Talent development & facilitation
Operational efficiency
Incentives that facilitate setting 113. Availability of infrastructure
up and running a business in the 124. Access to R&D
sector
135. Access to foreign exchange
146. One-stop-shop services
14
According to manufacturers, 6 out of the 14 incentives are critical
Critical Important
Category Sub-category Importance to Feedback from manufacturers
manufacturers Moderate Low
Procurement: Closed bids
1 • Manufacturers indicated that closed bid RDF procurements by
2
Price advantages in tenders PFSA and protection of the domestic market through import
Market
Access tariffs are the most important market access incentives
(Revenue 3 Export incentives and • Existing domestic manufacturers indicate that the 25% price
enhancing) facilitation
premium offered by PFSA in international tenders is less
4 Reduced import
competition
important, as they are seldom competitive even with the price
advantage
5 Custom duty exemptions • As a majority of inputs to pharmaceutical production are
Tax and 6 Corporate income tax imported, e.g. APIs, excipients, and primary packaging, custom
Finance exemption duty exemptions are one of the most important incentives to
(Profit
enhancing) 7 VAT taxes maintain
8 Access to finance
• Local closed-bid tenders are currently offered for products being produced in
sufficient quantity by two or more domestic manufacturers;
• Hence, the exercise of closed-bid tenders to encourage local manufacturers is
available
Closed tender • A number of improvements have been recently be introduced
for local • A significant trade-off with public health must be considered
manufacturers
Increase transparency of the tender system
• Review procurement/tender management system: Manufacturers associations/private sector should be
engaged
• Procurement results should be made public so that local manufacturers and/or other suppliers can submit
objections
• Enhance PFSA laboratory and technical evaluation capacity to ensure quality of procurement
• Long-term purchase contracts are attractive for MNCs looking to invest in Ethiopia
• The experience of Anti-retroviral (ARV) production in South Africa and Uganda
Long term • South Africa: Central Procurement Authority has a long-term contact with a local
market
manufacturer, Aspen, to supply ARVs
guarantee
(volume or • Uganda attracted Cipla to manufacture ARVs locally by signing MOU, providing 20%
price) price preference for local production and guaranteed volumes
Note: Closed/restricted bid: a bid restricted to participants selected based on a specified criteria by the procuring body. In Ethiopia, closed-bid tenders are allowed only to local manufacturers.
Source: Interviews, EIC & AGI analysis
16
Market access 2:
While the Ethiopian market ~$684 M – 1billion, the African pharmaceutical market is
valued at >$25B and is growing at a rate of ~13% per annum
CAGR%
17%
13%
10%
CAGR** 6%
9%
6%
As developed markets stagnate, Africa represents a promising source of growth for multinational pharmaceutical
companies
Note: * 2013 numbers are approximate; 2020 numbers are estimates; ** CAGR is for the top seven countries in Africa (Algeria, Egypt, Ghana, Kenya,
Morocco, Nigeria, and South Africa)
Source: McKinsey (2015) Africa: A continent of Opportunity for Pharma 17
Pharmaceutical market in Africa, however, is led by seven countries, which
constituted ~70% of the total market in 2015
Ethiopia represented
only ~2% of the African
pharma market in 2015
Note: The order of the countries is based on their Pharmaceutical sales in 2020F
Source: BMI, AGI analysis 18
South Africa, Egypt, and Kenya are the largest exporters of pharmaceuticals
in Africa; top 5 countries represent 90% of the continent’s exports
Note: *While UN COMTRADE states that Ethiopian pharmaceutical exports was only $998K in 2015, the Ethiopian government in its GTP-II states that
the actual figure was $2.7M. For consistency, the data in this graph is from UN COMTRADE.
Source: Calculations based on UN COMTRADE statistics, AGI analysis 19
Across the continent, pharmaceuticals produced locally are typically
consumed domestically or traded regionally
6000
South Africa
Ethiopia Algeria
Egypt
2000 Tunisia
Kenya Tanzania
Uganda Zimbabwe Botswana
Benin Togo
0
0 0.1 0.2 0.3 0.4 0.5 0.6
Concentration of exporting countries**
Note: *Size of bubble is proportional to the export value. **The concentration is based on the Herfindahl index. Indices between 0.10 and 0.18 is considered
to be moderately concentrated and indices above 0.18 to be concentrated. This indicator is a measure of the dispersion of trade value across an
exporter’s partners.
Source: Calculations based on UN COMTRADE statistics 20
Manufacturers indicate that the key criteria when selecting export destinations are
market size, registration requirements, trade agreements, distance and competition
Target regions with high export Prioritize countries with high export
potential and pursue RECs-based potential in Africa and pursue bilateral
regulatory harmonization, which is likely to harmonization / mutual recognition of
be achieved in the medium to long-term regulatory frameworks
This may be a necessary pre-condition − FMHACA is pursing this approach with
for the GoE to realize its vision to become countries like Jordan
the leading regional hub for − Recommend initiating the same with
pharmaceutical production and export prioritized export destinations
23
Source: Accelerating regulatory approval through WHO (2016), Impact of regulatory requirements on medicine registration in Africa (2012)
Harmonization is occurring through RECs; EAC is the furthest along, while
IGAD and COMESA are lagging behind
24
Source: Accelerating regulatory approval through WHO (2016), Impact of regulatory requirements on medicine registration in Africa (2012)
COMESA represents a large export market with an addressable market size
of $6.2B; other neighbouring regions, IGAD and EAC, are considerable in
market size as well
6.2B
4.3B
2.8B
2.2B
1.4B
Low
ECOWAS 15 countries – $2.8B NO 6% 2
▪ Not member
GoE should champion regulatory harmonization within IGAD, as it represents a favourable regional market
with relatively low competition; COMESA also represents a significant opportunity provided regularity
harmonization is pursued in the medium to long-term
Note: * Import of pharmaceutical products was used as a proxy for addressable market size **local supply as % of market
26
Source: Calculations based on UN COMTRADE statistics and BMI, Interviews, AGI analysis
In the following prioritized countries, the GoE should seek to harmonize its regulatory
procedures, facilitate information exchange, and foster vendor/distributor relationships
Zambia Malawi
Zimbabwe Access to forex 4.8
Lack of competitiveness of
locally produced products 4.8
in export markets
Prioritized export markets
Most challenging issues
29