Middle East and North Africa (MENA) Region

List of Countries: Afghanistan, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon,
Libya, Morocco, Oman, Pakistan, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates,
Yemen.

(GCC countries: Saudi Arab, Kuwait, Oman, Qatar, Bahrain, UAE)

Countries we have operations in: Bahrain, Iraq, Jordon, Kuwait, Oman, Qatar, UAE.

Overview of unexplored countries:

1. Algeria:
Capital:
Algiers

Algeria, Africa’s largest country by area, stands as a promising

investment destination for the global life sciences industry,
with a sizeable local market and a growing number of
multinationals choosing to base their regional operations out
of Algiers.

Population:
41.8 Million

Currency:
Algerian dinar

Exchange Value in USD:       

1000 Algerian Dinar equivalent to 8.77 USD
Official Language:
Arabic official language; 2nd preferred language is French.

Destination Sea Port or Airport:   

Algeria has 18 ports, major Port is Algiers. The Port of Algiers handles 33% of the
Algerian foreign trade.

International Borders/Surrounding Countries:

Algeria is a country in northwestern Africa.
North - Mediterranean Sea
West - Morocco & small border stretch to Western Sahara
East - Libya and Tunisia
South West - Mauritania and Mali  
South East - Niger
Algeria shares maritime borders with Italy and Spain.

Pharma Market Value:

Around USD 6 Bn. Algeria opened its pharmaceutical market in 2005. The Algerian
pharmaceutical market is the third market in Africa. Some reports claim that it is the
2nd biggest market after South Africa.
Algeria remains highly dependent on the global medicines market, as it imports
average 70% of the consumed medicines and that too mainly from France.
Market Share:

Market Share Market Share Market Share

25% 16% 28%

Top 10 MNCs
Innovator Public
Other
44%
Generic Private
International
Companies

Local 28%
75% 84% Companies

Healthcare Budget:
Market Growth:
Average growth of 10% per year

FDA:
MOH and National Laboratory for the Control of Pharmaceutical Products (LNCPP)
grants MA.
National Laboratory of Pharmaceutical Products control, which generally require 30
ampoule units for drugs of 5 ml/mg or above, and 50 ampoule units for drugs of 1 to
1.5 ml.

Registration Time:
Generally, a period of 3 months or more is required to evaluate the dossiers and
conduct lab tests on the samples. However, if any particular product is found to be
very competitive, Ministry of Health's registration can also be provided in a very short
period.

Validity of Registration:
A provisional registration valid for one year.
A longer duration registration, valid for five years, is granted only after they receive a
positive report on technical/laboratory evaluation of the samples. The provisional
registration also entitles the specific product for marketing/distribution in Algeria.

Registration Fees:
USD 6410 for New Drug & USD 3850 for Generic Drug  

Type of Dossier: 
CTD dossier. All documentation submitted to Algeria regulators must be translated
into either French or Arabic language.

Name of Tender Body:

The Central Pharmacy Purchasing Body is the main tender body for hospitals
represent around 30-40% of the total market.    
Significant Points:

 Latest figures demonstrate that 48 drug importers have now established local
production facilities and operate 75 manufacturing units.

 Incentives for local and generic production.

 Hydrocarbons-rich Algeria is a particularly attractive to international drugs

companies.

 55% of the Algerian population was currently covered by social security.

 Domestic production has tripled over the past five years (since 2015).

 The government has the ambition to reach 70% local production by 2017, from
the current rate of 38%.

 Despite the ban on importation of pharmaceuticals (specifically pharmaceuticals

that can be produced domestically) there is a growth in Pharma Industry.

 The customs duty on imported pharmaceutical product is 15% and 5% on API.

Indian Pharma Companies:

Cipla set up manufacturing unit in Algeira where Cipla will have 40% stake in the
company, with the balance held by a local consortium led by Biopharm. (2015)

Hetero Drugs Pvt Ltd has signed a partnership agreement with the Algerian company
Industries Médico-Chirurgicales (IMC) in December 2010 to set up a Joint-Venture of
oncology medicines. 

Characteristics of the market:

 Stable market in volatile region
 Sheer market size
 Decreasing fertility rate
 More than 50% government health spending
Disease Burden:
CD/NCD split and trend:
Causes of Death and Disability compared with other locations:

Disease trend & Risk Factors:

Top Therapy
areas:

Macro Health Indicators:

2. Egypt:
Capital:
Cairo

Algeria, Africa’s largest country by area, stands as a

promising investment destination for the global life
sciences industry, with a sizeable local market and a
growing number of multinationals choosing to base their
regional operations out of Algiers.

Population:
99.4 Million

Currency:
Egyptian Pound

Exchange Value in USD:       

1000 Egyptian Pound equivalent to 63.69 USD

Official Language:
Arabic official language, 2nd preferred language is English.

Destination Sea Port or Airport:   

Egypt has 15 ports, major Port is Alexandria. Alexandria Port, controlled by
the Alexandria Port Authority, is the country's largest and it handles approximately
55% of Egypt's international trade.

International Borders/Surrounding Countries:

Egypt is a country in northeastern Africa and southwestern Asia.
North - Mediterranean Sea
West - Libya
East – Palestine, Israel and Red Sea
South - Sudan
Egypt shares maritime borders with 9 countries.

Pharma Market Value:

Egypt pharma market is valued $3.8Bn with a growth rate of 26% over last MAT.
Alimentary and Antiinfectives are the top selling TAs together accounting for 36%
sales of the total market.
Novartis is the leading corporation with $301Mn sales in 2018 while Nestle(b. $27M)
is the fastest growing corporation, growing at 131% PPG over last MAT.
 Market
Share:

Top 20 Pharma Companies:

Healthcare Budget:

Healthcare spending
200
150
100
50
0
2014 2015 2016 2017

Healthcare spending
Market Growth:
Average growth of 26% last year.

FDA:
The Egyptian Drug Authority (EDA) is the pharmaceutical regulatory body of the
Egyptian MoH. The EDA has three suborganisations - the Central Administration of
Pharmaceutical Affairs (CAPA), the National Organization for Drug Control and
Research (NODCAR) and the National Organization for Research and Control of
Biologics (NORCB).

Registration Time:

Validity of Registration:
For medicinal products according to Ministry Decree 425/2015 the renewal process
should be done every 10 years. (48) For Biologicals, a renewal of the marketing
authorization is required every 5 years.

Registration Fees:
The approximate fees for marketing application form is EGP 10,000. The registration
fee is EGP 1000 for each “Application Form”; the fee is non-refundable.

Type of Dossier: 
In Egypt, the submission dossier cannot be submitted as eCTD sequence. The
applicant has to submit the dossier as simple PDF documents.

Name of Tender Body:

Indian Pharma Companies:

On February 21, 2017, Sun Pharma opened its manufacturing unit in Cairo.

Characteristics of the market:

 Steadily growing population
 Increasing penetration (57%) of insurance
 Increasing aging population
 Growing healthcare awareness
 Growing demand for prescription medicine
 Encouragement by government to private sector to take lead role in providing
healthcare services.
 Decreasing fertility rate

Disease Burden:
Selected Adult Risk Factor Trends:

Top therapy areas:

Causes of Death and Disability compared with other locations:

Disease trend and Risk factors: