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Q2 2024
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Egypt
Pharmac
Pharmaceuticals
euticals R
Report
eport
Includes 10-year forecasts to 2033
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Egypt Pharmaceuticals Report | Q2 2024

Contents
Key View............................................................................................................................................................................................ 4

SWOT .................................................................................................................................................................................................. 6

Industry Forecast........................................................................................................................................................................... 7
Pharmaceutical Market Forecast ........................................................................................................................................................................................... 7
Prescription Drug Market Forecast......................................................................................................................................................................................10
Patented Drug Market Forecast............................................................................................................................................................................................12
Generic Drug Market Forecast...............................................................................................................................................................................................14
OTC Medicine Market Forecast .............................................................................................................................................................................................16
Pharmaceutical Trade Forecast ............................................................................................................................................................................................18

Industry Risk/Reward Index ....................................................................................................................................................21


Innovative Pharmaceuticals Risk/Reward Index ...........................................................................................................................................................21

Regulatory Review.......................................................................................................................................................................23

Market Overview..........................................................................................................................................................................28
Egypt Healthcare Overview....................................................................................................................................................................................................31

Competitive Landscape.............................................................................................................................................................32

Company Profile...........................................................................................................................................................................35
Amoun Pharmaceutical Company ......................................................................................................................................................................................35
Egyptian International Pharmaceutical Industries .......................................................................................................................................................37
Medical Union Pharmaceuticals...........................................................................................................................................................................................40
South Egyptian Drug Industries............................................................................................................................................................................................42
VACSERA.........................................................................................................................................................................................................................................44

Egypt Demographic Outlook....................................................................................................................................................46

Pharmaceuticals Glossary ........................................................................................................................................................50

Pharmaceuticals Methodology ...............................................................................................................................................52

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This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Egypt Pharmaceuticals Report | Q2 2024

Key View
Key View: Government support for an improved healthcare provision through various activities including the formation of
international industry partnerships, Egypt's pharmaceutical market is maintaining its position as one of the most dynamic in the
Middle East and North Africa region. Against a backdrop of growth in universal healthcare coverage, we forecast prescription
medicines will gain market share over our forecast period, with the patented segment also making gains within the prescription and
total markets through to 2033. The outlook for generics is mixed, with some loss of market share within the prescription segment,
but a gain in total sales, at the expense of the dwindling OTC drugs market.

Headline Expenditure Projections

• Pharmaceuticals: EGP134.5bn (USD4.4bn) in 2023 to EGP148.8bn (USD3.5bn) in 2024; +10.6% in local currency terms and
-19.3% in US dollar terms. Forecast unrevised from the previous quarter.

Pharmac
Pharmaceuticals
euticals FFor
orecasts
ecasts (Egypt 2022-2028)
Indicator 2022 2023e 2024f 2025f 2026f 2027f 2028f
Pharmac
Pharmaceutical
eutical sales, USDbn 6.475 4.379 3.534 4.061 4.352 4.661 4.984
Pharmac
Pharmaceutical
eutical sales, EEGPbn
GPbn 124.067 134.516 148.774 163.057 178.221 194.672 212.357
Pharmac
Pharmaceutical
eutical sales, EEGP
GP per capita 1,117.8 1,193.4 1,299.5 1,402.3 1,509.6 1,624.5 1,746.2
Pharmac
Pharmaceutical
eutical sales, USD per capita 58.3 38.9 30.9 34.9 36.9 38.9 41.0
Pharmac
Pharmaceutical
eutical sales, % of GDP 1.58 1.33 1.15 1.07 1.05 1.03 1.01
Pharmac
Pharmaceutical
eutical sales, % of health eexpenditur
xpendituree 23.2 20.3 19.7 19.7 19.1 18.5 18.0
e/f = BMI estimate/forecast. Source: National sources, BMI

Latest Updates

• In December 2023, UK-based drugmaker GSK and Egypt-based fintech company Valu entered into a partnership to provide
flexible financing solutions for various GSK vaccines available at pharmacies across Egypt. The collaboration is designed to
enhance accessibility to GSK’s vaccines across a wider demographic, thereby ensuring that more individuals in Egypt can benefit
from essential immunisations.
• Also in December, Sanofi and Minapharm announced an exclusive Manufacturing and Supply Agreement for the localisation of
the full range of its flagship market leader product, Clexane. The agreement boosts Egypt's national localisation strategy of
biopharmaceutical manufacturing.
• In October 2023, the Egyptian Customs Authority and the Libyan Ministry of Finance reached an agreement to ban the trade
into Libya of pharmaceutical products not manufactured in Egypt. The agreement follows the announcement in August 2023 by
the government of Egypt to upgrade the Sallum land port at the border with Libya to boost trade traffic between the two
countries. This move is seen as a significant step to strengthen economic ties and promote local pharmaceutical industry in
Egypt.
• In October 2023, Egypt and Novartis discussed improved cooperation in the areas of oncological, heart and immunity
diseases at a meeting between the Chairman of Egypt Healthcare Authority (EHA) Ahmed El-Sobky and a delegation from the
Swiss firm.
• In September 2023, several Mainland China-based pharmaceutical companies participated in Pharmaconex 2023, an
international pharmaceutical exhibition held in Cairo, to explore business opportunities in Egypt, alongside the rest of Africa and
the Middle East. The three-day event formed part of Egypt's aim to support and develop the pharmaceutical industry, in line with
Egypt’s vision to localise modern pharmaceutical manufacturing.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Risk/Reward Index

While we forecast growth, Egypt will remain a challenging pharmaceutical market for innovative drugmakers. With low per capita
medicine expenditure and persistent market access barriers, the country scores 39.9 out of 100 in this quarter's Innovative
Pharmaceuticals Risk/Reward Index. Although this represents an improvement from the previous period, political instability poses
downside risks for market entry opportunities, while restrictive market conditions continue to hinder access for innovative
drugmakers.

Key Economic View

We forecast a modest increase in Egypt’s real GDP growth from 3.8% in FY2022/23 (June 2022-July 2023) to 4.2% in FY2023/24,
although this marks a downward revision for both years. The Egyptian Ministry of Planning and Economic Development reduced its
growth estimate for FY2022/23 from 4.2% in August 2023, likely because data showed a steeper economic slowdown in Q4
FY2022/23 due to weaker investment activity and goods exports growth. This brought the ministry’s estimate in line with the
growth forecast that we had in May 2023. A pick-up in foreign investment will offset the slowdown in domestic demand and
exports, and a small increase in imports. Risks are skewed towards slower growth if the Israel-Hamas war leads to a more
pronounced slowdown in tourism and investment and/or renewed bouts of inflationary pressures.

Key Political View

We see limited risk from the Israel-Hamas war to Egypt’s political stability under our baseline scenario. Since October 7 2023, the
Egyptian leadership’s response has balanced the country’s ties with Israel and its population support for the Palestinian cause. The
authorities have repeatedly condemned Israel’s attacks on civilians, authorised pro-Palestine manifestation in Cairo (albeit with tight
security monitoring), and have pushed for aid to enter Gaza through the Rafah Crossing. The government has somewhat aligned
with popular sentiment while maintaining working relations with Israel, which will help redirect social unrest away from the
government. We maintain our view that current President Abdel Fattah el-Sisi will secure a clear majority in the first round of the
December 2023 presidential elections, which bodes well for the continuity of policies, particularly for ongoing negotiations with the
IMF and it reduces the chance of a policy shift towards Israel. Egypt’s geographic proximity to the Israel-Hamas war will increase
geopolitical risks, weighing on the tourism sector and increasing investor risk perception.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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SWOT
Strengths Weaknesses

• Well-established manufacturing industry comprising both • Strict pricing controls and reference pricing system reduces
state-owned and private local companies. innovative drugmakers' potential earnings.
• Low labour costs and a large pool of highly trained doctors, • A challenging regulatory regime for foreign firms, as patent
pharmacists, engineers and skilled technicians. laws remain notably below international standards and data
• A growing number of free trade agreements and protection and enforcement are major concerns.
increased political will to develop the healthcare sector. • Prevalence of counterfeit drugs is significant.
• Highly favourable demographic factors. • Growing emphasis on private sector investment is
leaving key publicly-funded health centres (eg, those
for the treatment of
cancer and other serious illnesses) critically short of
resources.

Opportunities Threats

• Initiatives advancing public health in Egypt, with a focus on • Elevated political and security risks discouraging investment.
the gradual roll out of a comprehensive healthcare insurance • Authorities' continued resistance to reform the pricing
system. system and allow inflation-based price increases.
• Proposals for a new Egyptian Drug Authority (EDA) and the • While Egypt’s currency devaluation will unlikely lead to
registration of biosimilars heralding regulatory system significant drug shortages and price hikes, rising inflationary
improvements. pressures will impact drugmaker revenues in 2023.
• The 'New Investment Law' improves the operating • Ongoing regulatory issues have been overlooked as a result
environment for foreign investors. of the push to accelerate the pace of local pharmaceutical
• Multinational drug makers' interest in PPPs with the productive capacity.
government could accelerate the development of certain • A high number of drug vendors replacing trained
areas of the health sector. pharmacists is exacerbating safety issues stemming from
• Recent decision by Bayer to establish a drug production hub counterfeit medicine batches.
in Egypt vindicates policies prioritising drug infrastructural
development.
• Government push to ramp up local drug production for
exportation to Africa will strengthen Egypt's position in the
regional market and further incentivise multinational
investment.
• The government's efforts to digitise medical records and the
national surveillance for the evaluation of antibiotics will help
to improve the quality and efficiency of healthcare services
in the country.
• Strategic digitisation initiatives across the healthcare sector
are creating a more compliant and efficient environment to
sustain long-term growth of the local pharmaceutical
industry.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Industry Forecast
Pharmaceutical Market Forecast
Key View: Our upbeat outlook for Egypt's pharmaceutical industry is informed by the ongoing benefits of significant
transformation in recent years. Government initiatives and continued development of agreements and partnerships between the
domestic industry and global firms will also be supportive over our extended forecast period through to 2033. Egypt's healthcare
sector is also benefitting from a digitisation strategy, resulting in local pharmaceutical companies following suit and this is attractive
to foreign firms, investors and exporters due to the the ease of use of a digital infrastructure for supply chains and logistics.

Latest Updates

• In January 2024, Egyptian Prime Minister Mostafa Madbouly met with officials from Greece's Athens Medical Group to discuss
cooperation opportunities in the healthcare sector. Discussions included the company's investment plans in Egypt and potential
collaboration with the Egyptian Ministry of Health and Population to pump investments into the health sector and boost
healthcare services.
• Also in January, the General Authority for Investment and Free Zones (GAFI) has signed a contract with Maxim Investment Group
(MIG) and Misr Investment Development (MID) to set up the first medical and healthcare resort in Egypt with investments of
EGP1.5bn. The resort will be established on a 40-feddan area in El Saf Investment Zone, and is set to provide over 4,500 job
opportunities after operation.

Pharmaceutical Market Forecast


(2019-2033)

e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

Structural Trends

Egypt's pharmaceutical sales are forecast to grow from EGP134.5bn (USD4.4bn) in 2023 to EGP148.8bn (USD3.5bn) in 2024. By
2028, the market will be worth EGP212.4bn (USD5.0bn), growing at a compound annual growth rate (CAGR) of 9.6% in local
currency terms and -19.4% in US dollar terms. By 2033, the market's value will have increased to EGP317.4bn (USD6.8bn), growing
at a CAGR of 9.0% (4.4% in US dollar terms).

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Key growth drivers of Egypt's pharmaceutical spending will be volume-based, as the population expands and as the authorities roll
out universal health coverage (UHC). However, we note that downward pressures on prices and the relatively faster expansion of
medical services, drug spending as a proportion of total healthcare spending is expected to decrease from 20.3% in 2023 to 18.0%
in 2033. On a per capita basis, the market will continue to provide modest returns, despite spending increasing from USD38.9 in
2023 to USD41.0 in 2028 and USD51.7 in 2033.

After hiking by 300 basis points in the year-to-August 2023, we expect that the Central Bank of Egypt will keep its benchmark policy
rates unchanged until the end of the year and then hike by about a further 300 basis points in 2024. The CBE will resume hiking in
Q124, around the same time as its decision to devalue the currency. Meanwhile, we anticipate that the Egyptian pound will remain
stable around EGP31.00/USD until early 2024 before depreciating to between EGP40.00/USD and EGP45.00/USD by end-Q124.
This will allow Egypt to meet a key IMF requirement, unlocking additional funding.

As a result, efforts to bolster the local pharmaceutical sector in order to reduce reliance on drug imports has risen to the top of the
government’s agenda in Egypt. In April 2022, the Ministry of Public Business Sector together with the Holding Company for
Pharmaceuticals and Medical Supplies (HOLDIPHARMA) launched a study of the local manufacturing of pharmaceutical raw
materials in cooperation with Indian drug producer, SysChem. The study assessed the preparedness of the Egypt's infrastructure for
the production of active substances for antibiotics, the application of GMP standards and the expansion of the production of active
substances through local company, El Nasr Pharmaceutical Chemicals Company. These included for metformin, paracetamol,
colchicine and acetylsalicylic acid.

Egypt is moving to deepen its trading partnerships for pharmaceuticals and healthcare with strategic partners within the Middle East
and North Africa (MENA) region. For example, in June 2022 the CEO of the General Authority for Investment and Free Zones
Mohamed Abdel Wahab announced the launch of a new production facility with good manufacturing practice (GMP) manufacturing
capability established by Jamjoom, a Saudi Arabian pharmaceutical company. The announcement comes in the same month that
Egyptian firm Pharco Pharmaceuticals would establish a ‘pharma city’ in Saudi Arabia, to the value of USD150mn.

The emergence of respiratory illness, heart disease and cardiovascular diseases, in particular, is driving the growth of higher-value
prescription medicines in Egypt. A population boom, increasing life expectancy and rising levels of lifestyle-related diseases such as
obesity and diabetes are putting pressure on Egypt’s relatively underdeveloped healthcare system. Rapid reforms are underway,
which highlight the challenges that face Egypt’s healthcare sector over the next decade. Egypt’s population is forecast to grow from
its current 102mn to 120mn by 2030 and 160mn by 2050. There are currently 5.7mn people aged over 65 years (5.4% of the
population), and this figure is expected to rise to 7.7mn (6.4% of the population) by 2030, which will drive demand for geriatrics
services with long-term care, rehabilitations and home care. Birth rates are also set to increase, which will simultaneously drive
demand for neonatal and maternal health services such as obstetrics, gynaecology and paediatrics.

As of October 2023, Egypt remains well positioned for future growth with its steadily improving regulatory profile and a strong
emphasis on boosting local manufacturing through innovation, research and integrated production technologies. A renewed focus
on increasing the scope of private funding will be a key driver, particularly with respect to the digitalisation of the pharmaceutical
sector and broader digital health.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Pharmac
Pharmaceutical
eutical Sales, Historical Data And FFor
orecasts
ecasts (Egypt 2020-2028)
Indicator 2020 2021 2022 2023e 2024f 2025f 2026f 2027f 2028f
Pharmac
Pharmaceutical
eutical sales, EEGPbn
GPbn 67.138 114.316 124.067 134.516 148.774 163.057 178.221 194.672 212.357
Pharmac
Pharmaceutical
eutical sales, EEGPbn,
GPbn, % yy-o-y
-o-y -16.94 70.27 8.53 8.42 10.60 9.60 9.30 9.23 9.08
Pharmac
Pharmaceutical
eutical sales, EEGP
GP per capita 624.7 1,046.3 1,117.8 1,193.4 1,299.5 1,402.3 1,509.6 1,624.5 1,746.2
Pharmac
Pharmaceutical
eutical sales, USDbn 4.260 7.307 6.475 4.379 3.534 4.061 4.352 4.661 4.984
Pharmac
Pharmaceutical
eutical sales, USDbn, % yy-o-y
-o-y -11.60 71.52 -11.38 -32.37 -19.30 14.93 7.16 7.09 6.95
Pharmac
Pharmaceutical
eutical sales, USD per capita 39.6 66.9 58.3 38.9 30.9 34.9 36.9 38.9 41.0
Pharmac
Pharmaceutical
eutical sales, % of GDP 1.09 1.72 1.58 1.33 1.15 1.07 1.05 1.03 1.01
Pharmac
Pharmaceutical
eutical sales, % of health eexpenditur
xpendituree 15.0 26.0 23.2 20.3 19.7 19.7 19.1 18.5 18.0
e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Prescription Drug Market Forecast


Key View: We forecast a positive pace of growth for the Egyptian prescription market over the medium-to-long term, as demand
for medicines expands due to rising numbers of chronic and long-term conditions among the growing population. The goal of
achieving universal healthcare will also support an expansion in market share of the segment by 2033, we expect the more cost-
effective generics segment will benefit the most from that development, although innovative drug sales will also grow at a good
pace.

Prescription Drug Market Forecast


(2019-2033)

e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

Structural Trends

We forecast prescription drug spending in Egypt increasing from EGP115.3bn (USD3.8bn) in 2023 to EGP127.9bn (USD3.0bn) in
2024 and further to EGP185.2bn (USD4.3bn) in 2028. This will deliver a five-year compound annual growth rate (CAGR) of 9.9% in
local currency terms (3.3% in US dollar terms). By this time, the prescription drug segment will account for 87.2% of all spending on
pharmaceuticals in the country, rising from 85.7% at the end of 2023.

By the end of our 10-year current forecast period in 2033, we forecast that prescription medicine sales will account for 88.4% of
pharmaceutical sales at EGP280.6bn (USD5.9bn), which corresponds to a 10-year local currency CAGR of 9.3% (4.7% in US dollar
terms). On a per capita basis, prescription spending will have risen from USD33.3 in 2023 to USD45.7 in 2033.

Prescription drug sales in Egypt will benefit from a robust set of growth drivers over the coming years. Despite the government's
focus on reducing healthcare costs, a rapidly growing population and rising chronic disease burden will ensure that prescription
drugs remain the dominant market segment, especially given the gradual roll out of the country's health insurance
system. However, we note that, in line with the need for cost containment in public spending, generic drugmakers are expected to
be the greatest beneficiaries from Egypt's pharmaceutical trends over the long term, given their more competitive prices.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Pr
Prescription
escription Drug Mark
Market
et Indicator
Indicators,
s, Historical Data And FFor
orecasts
ecasts (Egypt 2020-2028)
Indicator 2020 2021 2022 2023e 2024f 2025f 2026f 2027f 2028f
Pr
Prescription
escription drug sales, EEGPbn
GPbn 55.974 97.051 105.773 115.263 127.929 140.701 154.323 169.154 185.159
Pr
Prescription
escription drug sales, EEGPbn,
GPbn, % yy-o-y
-o-y -16.83 73.39 8.99 8.97 10.99 9.98 9.68 9.61 9.46
Pr
Prescription
escription drug sales, USDbn 3.552 6.204 5.520 3.752 3.039 3.505 3.769 4.050 4.346
Pr
Prescription
escription drug sales, USDbn, % yy-o-y
-o-y -11.50 74.66 -11.01 -32.03 -19.02 15.33 7.53 7.46 7.32
Pr
Prescription
escription drug sales, % of total sales 83.4 84.9 85.3 85.7 86.0 86.3 86.6 86.9 87.2
e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Patented Drug Market Forecast


Key View: We forecast the patented medicine segment in Egypt will grow at a positive pace over our extended forecast period, over
which time it will also gain market share. While demand for innovative treatments will drive gains, the government's preference for
more cost-effective generic drugs as it strives towards universal healthcare coverage, will place some limits on the pace of
expansion. Overall, we note that opportunities available to innovative drugmakers will also be a little limited until Egypt's healthcare
system is fully developed, and adequate funding for the expansion of reimbursement for more expensive treatments becomes more
readily available.

Patented Drug Market Forecast


(2019-2033)

e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

Structural Trends

We forecast that the value of Egypt's patented drug market will edge lower from EGP23.1bn (USD751mn) in 2023 to EGP22.9bn
(USD554mn) in 2024, before the return of growth lifts the market value to EGP27.5bn (USD645mn) in 2028. This means that the
market will post a five-year compound annual growth rate (CAGR) of 3.6% in local currency, but decline by 3.0% in US dollar terms.
By 2033, we forecast Egypt's patented drug market to have grown in value to EPG62.1bn (USD1.3bn). This corresponds to a
10-year CAGR of 10.4% and 5.8% in local currency and US dollar terms respectively.

Supported by its absolute growth, we believe that patented drug spending will begin to gain in its share as a proportion of total
pharmaceutical spending, rising from 17.1% in 2023 to 19.6% in 2033. We base this view on the expectation that demand for
innovative treatments will grow in line with the growing and ageing population and amid the expansion of healthcare and
pharmaceutical access. However, domestic drugmakers are focused mainly on generic and OTC medicines and therefore contribute
a limited amount to the patented product list, with this situation also impacting on prescribing patterns.

The rising popularity of generic drugs will place downward pressure on Egypt's patented medicines sales over the coming years.
Egyptian drugmakers are unlikely to make forays into the patented sector unless restricted to the OTC segment, largely because
pricing policies and the regulatory environment carry unresolved issues and, therefore, increased risk. Overall, the outlook for
patented drugs is not as positive as for its generics counterpart; however, the need to treat Covid-19 patients with novel medicines

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Egypt Pharmaceuticals Report | Q2 2024

even now that the pandemic is over will continue to provide a steady commercial prospect for importers in the short-to-medium
term.

Patented Drug Mark


Market
et Indicator
Indicators,
s, Historical Data And FFor
orecasts
ecasts (Egypt 2020-2028)
Indicator 2020 2021 2022 2023e 2024f 2025f 2026f 2027f 2028f
Patented drug sales, EEGPbn
GPbn 17.928 27.477 27.243 23.053 22.885 23.155 23.661 25.051 27.468
Patented drug sales, EEGPbn,
GPbn, % yy-o-y
-o-y -30.15 53.26 -0.85 -15.38 -0.73 1.18 2.18 5.88 9.65
Patented drug sales, USDbn 1.138 1.756 1.422 0.751 0.544 0.577 0.578 0.600 0.645
Patented drug sales, USDbn, % yy-o-y
-o-y -25.66 54.39 -19.04 -47.22 -27.57 6.10 0.18 3.80 7.50
Patented drug sales, % of total sales 26.7 24.0 22.0 17.1 15.4 14.2 13.3 12.9 12.9
e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Generic Drug Market Forecast


Key View: The generics drugs segment in Egypt accounts for the largest proportion, and we forecast a further increase in sales over
our extended forecast period. The segment will account for a growing proportion of both the total and prescription market although
after making gains over the medium term; by 2033, it will have lost a little prescription market share. We see population growth
among the key drivers of this forecast, along with the continued rollout of universal health insurance and expansion of the local
generics manufacturing industry. The cost-effectiveness of generic medicines will also prove beneficial during a period of stretched
public sector finances.Meanwhile, Egypt's existing, ineffective intellectual property protections and aggressive localisation policies
continue to favour local generic drugmakers over their innovative counterparts, which further contributes to the growth of the
generic drug market.

Generic Drug Market Forecast


(2019-2033)

e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

Structural Trends

Egypt's generic drug market will increase in value from EGP92.2bn (USD3.0bn) in 2023 to EGP105.0bn (USD2.5mn) in 2024, and
further to EGP157.7bn (USD3.7bn) in 2028. This translates into a five-year local currency compound annual growth rate (CAGR) of
11.3% (4.3% in US dollar terms). In 2028, the generic drug market will account for 74.3% of the total drug spending and 85.2% of all
prescription spending, compared with 68.6% and 80.0% respectively in 2023, with the subsequent five years to continue witnessing
similarly strong segment growth.

Actual volumes could rise even more dynamically as generic drugmakers increase production to meet rising demand and cost-
containment measures encouraged by the Egyptian government, especially as major products come off patent. In 2033, we
forecast spending on generic medicines reaching EGP218.5bn (USD4.6bn) and representing 68.8% of drug sales and 77.9% of
prescriptions in value terms. This corresponds to a local currency 10-year CAGR of 9.0% (4.5% in US dollar terms).

With a growing population and rising healthcare costs, there is a high demand for affordable generic drugs in Egypt. This has led to
an increase in the production and consumption of generic drugs in the country. Local production of generics still overwhelmingly
accounts for most local demand which is further supported by ineffective intellectual property protections and aggressive

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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localisation policies. However, in value terms, patented drugs have a larger market share. Domestic firms import the majority of their
raw materials, which means they are particularly susceptible to the fluctuations of the Egyptian currency, having to carry
devaluation costs themselves in the absence of price increases. The consequence of needing to treat Covid-19 patients is that
there has been a greater focus on the imports of both generic and patented medicines, which continues in the current quarter.

Generic Drug Mark


Market
et Indicator
Indicators,
s, Historical Data And FFor
orecasts
ecasts (Egypt 2020-2028)
Indicator 2020 2021 2022 2023e 2024f 2025f 2026f 2027f 2028f
Generic drug sales, EEGPbn
GPbn 38.046 69.575 78.530 92.210 105.044 117.546 130.662 144.103 157.692
Generic drug sales, EEGPbn,
GPbn, % yy-o-y
-o-y -8.63 82.87 12.87 17.42 13.92 11.90 11.16 10.29 9.43
Generic drug sales, USDbn 2.414 4.447 4.099 3.002 2.495 2.928 3.191 3.450 3.701
Generic drug sales, USDbn, % yy-o-y
-o-y -2.76 84.21 -7.84 -26.76 -16.88 17.34 8.98 8.12 7.28
Generic drug sales, % of total sales 56.7 60.9 63.3 68.5 70.6 72.1 73.3 74.0 74.3
e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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OTC Medicine Market Forecast


Key View: We continue to expect a positive pace of growth of sales of Egypt's OTC drug segment; however, this will not be enough
to halt the erosion of its market share which will continue as the universal healthcare rollout continues to encourage use of
prescription medicines across the country. Opportunities for OTC manufacturers do remain, as the market is still at an early stage of
development.

OTC Medicine Market Forecast


(2019-2033)

e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

Structural Trends

OTC medicine spending in Egypt will increase from EGP19.3bn (USD627mn) in 2023 to EGP20.8bn (USD495mn) in 2024, and
further to EGP27.2bn (USD638mn) in 2028. This translates in to a five-year compound annual growth rate (CAGR) of 7.2% in local
currency terms (0.4% in US dollar terms). The fact that hospitals remain the primary point of access for healthcare services and that
the distribution of consumer health products is only permitted through pharmacies mean that the OTC sector is underdeveloped. In
2023, OTCs represented 14.3% of the total market by value, as the need to treat Covid-19 patients also increased the demand for
prescription medicines.

OTC spending is forecast to reach EGP36.8bn (USD783mn) in 2033, by which point it will account for a reduced 11.6% of total
pharmaceutical expenditure. The 10-year CAGRs will nevertheless rise, to 6.7% in local currency and 2.2% in US dollar terms
respectively as per capita expenditure will remain stable at around USD5 over the forecast period through 2032.

Low-income households and those without health insurance tend to favour OTC medicines. However, the market's development
has been hampered by factors such as the lack of healthcare awareness among patients and the low prices of OTC medicines,
which are rigidly controlled by the Ministry of Health. Adding to this, the OTC market, despite its relatively large size, suffers from an
absence of advertising and consumer-orientated marketing.

The interest in OTCs is changing, with customers moving away from essential medicines like analgesics and into more evolved
therapeutic categories like dermatologicals, digestives and vitamins. Due to this development, the OTC market will be well placed to

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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take advantage of Egypt's growing middle class and increasingly affluent population over the medium-to-long term in particular,
despite the dominance of prescription medicines.

OTC Medicine Mark


Market
et Indicator
Indicators,
s, Historical Data And FFor
orecasts
ecasts (Egypt 2020-2028)
Indicator 2020 2021 2022 2023e 2024f 2025f 2026f 2027f 2028f
OTC medicine sales, EEGPbn
GPbn 11.164 17.264 18.294 19.252 20.845 22.356 23.898 25.519 27.198
OTC medicine sales, EEGPbn,
GPbn, % yy-o-y
-o-y -17.44 54.64 5.97 5.24 8.27 7.25 6.90 6.78 6.58
OTC medicine sales, USDbn 0.708 1.104 0.955 0.627 0.495 0.557 0.584 0.611 0.638
OTC medicine sales, USDbn, % yy-o-y
-o-y -12.14 55.77 -13.48 -34.36 -21.00 12.46 4.80 4.69 4.49
Ov
Over
er-the-c
-the-counter
ounter (O
(OTTC) medicine sales, % of total sales 16.6 15.1 14.7 14.3 14.0 13.7 13.4 13.1 12.8
e/f = BMI estimate/forecast. Source: DESA/UNSD United Nations Comtrade Database, local news sources, domestic companies, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Pharmaceutical Trade Forecast


Key View: Egypt is continuing with its efforts to boost the domestic pharmaceutical landscape and reduce its reliance on imports.
Initiatives aiming to expand local drug manufacturing capacities are supported by the government, although raw materials will
continue to be imported. An increase in trade partnerships also remains firmly on the agenda, which is further supported by a
growing capacity for local production. Manufacturing and supply deal activity is continuing between domestic and foreign firms,
providing a boost for the country's export profile.

Pharmaceutical Trade Forecast


2019-2028

e/f = BMI estimate/forecast. Source: United Nations Comtrade Database DESA/UNSD, BMI

Structural Trends

While the Egyptian government aims to boost self-sufficiency in pharmaceutical manufacturing, the limited technological capability
and capacity of local producers means that the market relies on imported drugs, especially in the field of sophisticated medicines.
The need to inoculate and treat coronavirus patients will require imports of vaccines and other medicines. Around one-third of
Egyptian pharmaceutical imports come from EU member states, which are likely to continue meeting much of the local patented
drug market.

In 2023, Egypt's pharmaceutical imports stood at EGP68.6bn (USD2.2bn). We forecast that the value will reach EGP73.8bn
(USD1.8bn) in 2024 and EGP96.4bn (USD2.3bn) in 2028, posting a five-year local currency compound annual growth rate (CAGR) of
7.1% and 0.3% in US dollar terms. The devaluation of the local currency, in the aftermath of the pound flotation in late 2016 as well
as March 2022 continues to have an impact on the market size in US dollar terms.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Pharmaceutical exports are forecast to increase to EGP7.7bn (USD182.9mn) in 2024, but from a very modest base of EGP5.4bn
(USD175.1mn) in 2023. In 2028, exports will be worth a still-modest EGP11.2bn (USD262.4mn). This translates into a five-year local
currency CAGR of 15.8% (8.4% in US dollars). Most exports will continue to target other Middle East and North Africa (MENA)
markets, with a focus on Saudi Arabia, the UAE, Iraq, Yemen, Sudan and Jordan. Due to the product mix and the relative higher cost
of imported medicines, the country's trade deficit will continue to increase. Many actions, such as ineffective intellectual property
(IP) protections, localisation policies and flawed government pricing policies, continue to undermine the investment climate in
Egypt, creating a difficult operating environment for foreign investors and trade partners.

Exports may grow faster than forecast, depending on the success of the programme promoted by the Egyptian Export Council of
Medical Industries (ECMI), which aims to have doubled the exports of medical products by 2023, including pharmaceuticals over the
2020 levels of USD540mn.

We note that the aim to increase exports is in line with Egypt’s aim of developing its domestic pharmaceutical industry as a means of
economic growth and reducing its import reliance. Egypt is well positioned to act as a regional hub for pharmaceutical trade for
neighbouring healthcare systems undergoing significant government investment. However, doubling within the next three years is
a steep goal, in our view, especially when taking recent pharmaceutical trade growth challenges posed by the post-Covid pandemic
landscape in mind.

A number of drug manufacturing plants are under construction, many of which will be built in industrial zones across the country.
Exporting generic drugs is the main avenue to long-term gains for Egyptian firms, particularly in keeping prices low and therefore
competitive. In 2018, ECMI established EGYCOPP, which will serve as a launching base for Egyptian pharmaceutical products into
Africa by forming contract manufacturing agreements and thus saving on transportation costs and non-transparent registration
laws.

Egypt is seeking to strengthen trade routes as the country pushes ahead with international pharmaceutical cooperation. Egypt is
also looking to other countries and multinational pharmaceutical firms in a bid to improve international cooperation and localise the
production of specialist expertise, such as the development of vaccines. For example, in September 2021, the Egyptian Drug
Authority and South Korea initiated discussions to explore strategic pharmaceutical cooperation opportunities. This is expected to
include increased investment from South Korean drugmakers as well as expanding pharmaceutical trade agreements with Egypt.

Pharmac
Pharmaceutical
eutical TTrrade Data And FFor
orecasts
ecasts (Egypt 2022-2028)
Indicator 2022 2023e 2024f 2025f 2026f 2027f 2028f
Pharmac
Pharmaceutical
eutical eexpor
xports,
ts, USDmn 259.56 175.11 182.86 204.78 221.81 239.32 262.35
Pharmac
Pharmaceutical
eutical eexpor
xports,
ts, USDmn, % yy-o-y
-o-y -2.54 -32.53 4.42 11.99 8.31 7.89 9.63
Pharmac
Pharmaceutical
eutical impor
imports,
ts, USDmn 3,369.79 2,231.83 1,754.13 1,979.18 2,075.31 2,170.55 2,262.70
Pharmac
Pharmaceutical
eutical impor
imports,
ts, USDmn, % yy-o-y
-o-y -4.00 -33.77 -21.40 12.83 4.86 4.59 4.25
Pharmac
Pharmaceutical
eutical tr
trade
ade balanc
balance,
e, USDmn -3,110.23 -2,056.72 -1,571.27 -1,774.40 -1,853.51 -1,931.23 -2,000.34
e/f = BMI estimate/forecast. Source: United Nations Comtrade Database DESA/UNSD, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Pharmac
Pharmaceutical
eutical TTrrade Data And FFor
orecasts
ecasts LLocal
ocal Curr
Currency
ency (Egypt 2022-2028)
Indicator 2022 2023e 2024f 2025f 2026f 2027f 2028f
Pharmac
Pharmaceutical
eutical eexpor
xports,
ts, EEGPmn
GPmn 4,973.26 5,378.94 7,698.33 8,221.42 9,083.04 9,996.13 11,177.49
Pharmac
Pharmaceutical
eutical eexpor
xports,
ts, EEGPmn,
GPmn, % yy-o-y
-o-y 19.36 8.16 43.12 6.79 10.48 10.05 11.82
Pharmac
Pharmaceutical
eutical impor
imports,
ts, EEGPmn
GPmn 64,566.60 68,555.06 73,848.73 79,459.31 84,984.91 90,662.68 96,401.82
Pharmac
Pharmaceutical
eutical impor
imports,
ts, EEGPmn,
GPmn, % yy-o-y
-o-y 17.57 6.18 7.72 7.60 6.95 6.68 6.33
Pharmac
Pharmaceutical
eutical tr
trade
ade balanc
balance,
e, EEGPmn
GPmn -59,593.34 -63,176.11 -66,150.40 -71,237.89 -75,901.87 -80,666.55 -85,224.33
e/f = BMI estimate/forecast. Source: United Nations Comtrade Database DESA/UNSD, BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Industry Risk/Reward Index


Innovative Pharmaceuticals Risk/Reward Index
Key View: While we forecast growth, Egypt will remain a challenging pharmaceutical market for innovative drugmakers. With low
per capita medicine expenditure and persistent market access barriers, the country scores 39.9 out of 100 in this quarter's
Innovative Pharmaceuticals Risk/Reward Index. Although this represents an improvement from the previous period, political
instability poses downside risks for market entry opportunities, while restrictive market conditions continue to hinder access for
innovative drugmakers.

Egypt: Innovative Pharmaceuticals RRI - Global And Regional Rank

• Regional Rank (out of 14): 9th


• Global Rank (out of 109): 73rd

Egypt: Innovative Pharmaceuticals Risk/Reward Index


(Q224)

Note: Scores out of 100, higher scores = lower risk. Source: BMI's Innovative Pharmaceuticals Risk/Reward Index

Industry Rewards: Egypt scores a higher 44.2 this quarter, an increase from the previous period but remaining below the regional
average of 46.8. The attractiveness of Egypt's pharmaceutical market to innovative drugmakers is weakened by the modest drug
expenditure per capita, which is among the lowest in the region. The country cannot draw on oil wealth in the same way as its Arab
peers in order to boost income levels and low affordability levels have prompted the Egyptian government to ensure that
pharmaceuticals are affordable on a national scale. This will reduce the rewards for pharmaceutical drugmakers producing high-
value innovative products; however, the country's demographic and epidemiological profile are a draw.

Country Rewards: Reflective of its unfavourable demographic profile, Egypt's score of 49.5 a notable increase from the Q124
period and moving above the regional average of 45.2. Egypt has a relatively young population and a very high birth rate, which is
regarded as a disadvantage as ageing populations tend to show a higher demand for pharmaceuticals and healthcare services.
However, population growth is high, which is advantageous as this should gradually translate into a growing pharmaceuticals
market. A downside risk for innovative drugmakers stems from Egypt's unfavourable urban/rural split. Egypt is sparsely populated in

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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some areas, with the Western Desert covering large portions of the country where access to healthcare services is limited. This
reduces the demand for innovative pharmaceuticals. In other areas, the country is densely populated. For example, Cairo accounts
for around 11% of the population. This raises the country's score in this category.

Industry Risks: Egypt scores 28.5, unchanged from the previous period and which is well below the regional score of 47.1.
Intellectual property (IP) laws are markedly below international standards, with data protection and enforcement being major
concerns to innovative drugmakers. Reinforcing our views, Egypt has been included on Pharmaceutical Research and
Manufacturers of America's (PhARMA) Watch List Special 301 Submission for 2022, with restrictive pricing and approval delays cited
as key issues for concern. Medicine prices are among the lowest in the region, which is an unattractive feature for innovative
drugmakers. This has encouraged the use of discounted pharmaceutical pricing as a market access strategy for innovative
drugmakers looking to exploit opportunities in Egypt. A non-transparent, outdated regulatory system has also been noted as
leading to unnecessarily long review periods, depriving patients of access to innovative pharmaceuticals.

Country Risks: Egypt's unstable economic, political and operational climate reflected in its score of 30.9, a little higher than the
previous period and remaining below the regional average of 43.3. The country has strongly felt the impact of the Russia-War
Ukraine on its economy in 2022 through a rise in inflation and a slower rebound in tourism. We expect a slight acceleration in
Egypt’s real GDP growth from 3.8% in FY2022/23 (June 2022-July 2023) to 4.2% in FY2023/24, driven mostly by foreign investment
through the divestment programme. This will more than offset slowing domestic demand and exports, and limited ability to further
compress imports. Growth will remain weak by recent trends, and we expect that inflation and subsidy cuts will significantly weigh
on consumption. The country's operating environment presents a myriad of risks underscored by a rigid labour market structure,
the significant threat of domestic terrorist attacks, an uncertain political outlook and currency weakness. While the long-term
economic outlook will get brighter as structural reforms gather momentum, Egypt's transition to a fully fledged democracy is
unlikely over our forecast period to 2033, as the military retains substantial control over the political system.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Regulatory Review
In August 2018, Egyptian Parliament prioritised a draft law published by the Ministry of Health on a new Egyptian Drug Authority
(EDA). Speaking at the CPhI Middle Exhibition Centre in Abu Dhabi in September 2018, South Egyptian Drug Industries' (SEDICO)
Chairman and Managing Director Dr Awad Gabr, announced that 'the reformed EDA will be inaugurated in the coming weeks;
making up part of a strategic decision by the Ministry of Health to further expedite the growth of Egypt’s pharmaceutical market.
The jurisdiction of the new body will increase the number of product registrations and further enhance pharmaceutical exports'.
Member of Parliament Abdel Aziz Hamouda highlighted the importance of reforming the EDA to achieve medicine sustainability.

In August 2019, Egypt's President Abdel Fatah al-Sisi approved the establishment of an authority to monitor unified drug
procurement, medical supply and medical technology management along with the EDA. The authority's aims are to develop the
health system and the medical industry, to provide medication on a regular basis, and to counter the phenomenon of counterfeit
medicines and pharmaceutical monopolies. Although we remain cautious about the swift establishment of the new authority and
the extent of its capabilities, we believe that it will help streamline the approval process and will be beneficial to drugmakers
operating in the country.

As of February 2021, the Ministry of Health fully transferred regulatory powers over Egypt’s pharmaceutical market to a new
regulatory body, the EDA, in accordance with a 2019 legislation (Law 151/2019). The EDA will manage new product registrations,
maintain production standards, enhance pharmaceutical exports and set customs rates in imported products in order to achieve
medicine sustainability.

Central Administration of Pharmaceutical Affairs is a regulatory body in Egypt and includes the Registration Department, Licensing
and Pharmacists' services Department, Inspection and Control Department, and Importation and Exportation Department.
Together, these departments handle licencing, registration and the import and export of drugs. The National Organisation for Drug
Control and Research is responsible for quality control and bioavailability testing of pharmaceutical products while the National
Organisation for Research and Control of Biologicals is responsible for quality control and analysis of biologics.

The Egyptian Pharmacovigilance Centre monitors drugs after their release for adverse drug reactions. The reporting of adverse drug
effects has been made compulsory for pharmaceutical firms, as part of a wider increase in regulatory activity in the field of
pharmacovigilance in Africa, which seems to have moved up the continent's agenda in light of soaring rates of drug counterfeiting.

Alongside the EDA, the Egyptian Authority for Unified Drug Procurement (EAUDP) is exclusively responsible for buying all medicinal
products for governmental entities. Private entities are also able to purchase their medicinal products via the EAUDP. The goal of the
EAUDP is to buy in bulk, enjoy higher negotiating power and obtain the maximum discounts possible. In practice, the EAUDP deals
directly with drug manufacturers instead of importers and wholesale distributers in a move to counter the of counterfeit medicines
and pharmaceutical monopolies. Although we remain cautious about the swift establishment of the new authority and the extent of
its capabilities, we believe that it will help streamline the approval process and will be beneficial to drugmakers operating in the
country.

EDA's guidelines for the registration of biosimilars take into account European Medicines Agency (EMA), International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and World Health Organization (WHO) guidelines,
along with the draft biosimilars guidance from the US FDA and India's guidelines on 'similar biologics'. The guidelines aim to facilitate
the registration of biosimilar products in Egypt through an abbreviated pathway.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Regional Harmonisation

The Arab Union of the Manufacturers of Pharmaceuticals & Medical Appliances - which includes major industry players across 15
Arab countries, including the UAE, Egypt, Saudi Arabia, Tunisia, Morocco, Algeria and Jordan - is trying to develop a regional drug
registration process in the region. Meetings have taken place, but we are not aware of any ongoing regional drug registration
processes.

In 2014, 55 African countries, including Egypt, adopted the Luanda commitment, which paved the way for the development of an
African Medicines Agency (AMA). In July 2021, Egypt became the 21st African country to sign and ratify the treaty for the
establishment of the AMA. In August 2023, three more countries, namely Kenya, Cape Verde and the Democratic Republic of
Congo, ratified the AMA treaty. This means that, to date, 26 countries have officially ratified the agreement, with a total of 37 being
supportive of it. The AMA aims to provide regulatory harmonisation across the African continent, promote clinical trials, and simplify
the registration and commercialisation of safe and affordable medicines. Although this is not expected to come to fruition in the
short-term, it will increasingly attract innovative drugmakers and act as a catalyst for greater sector investment and long-term
growth driver for Egypt’s pharmaceutical market.

The AMA’s vision is to give all Africans access to affordable medical products and fight substandard medicines, ensuring that all
medicines meet standards of efficacy, safety and quality; however, it is yet to be fully approved and implemented. The WHO, African
Union (AU) and New Partnership for African Development set up a task team to establish the scope of the AMA. This task team is
responsible for:

• Evaluating medical products for the treatment of priority diseases, determined by the AU.
• Inspecting, coordinating and sharing information about products authorised for marketing across Africa.
• Coordinating joint reviews of applications for clinical trials.
• Coordinating quality control in laboratories and manufacturing facilities.
• Harmonising pharmaceutical and healthcare regulatory legislation across Africa.

Intellectual Property Issues

Egypt is a member of the WTO, and legal provisions exist for granting patents to manufacturers that cover pharmaceuticals.
Intellectual property rights are managed and enforced by the Egyptian Patent Office. However, poor intellectual property protection
remains an issue in Egypt. There are no legal provisions existing for the data exclusivity for pharmaceuticals, patent term extension
or linkage between patent status and marketing authorisation.

Overall, the Egyptian pharmaceutical industry faces a number a number of regulatory challenges around product registration,
including delayed governmental approvals and marketing authorisation for registered products.

The pharmaceutical industry in Egypt generally faces regulatory, developmental and manufacturing challenges, starting from
product registration, including delayed governmental approvals and marketing authorisation for registered products, the high cost
associated with product registration, and the lack of communication between academia and government institutions with respect
to the formation of drug regulatory affairs. The poor intellectual property protection of licensed products due to the delayed
coordination and implementation of the common technical document (CTD) is an issue that extends to product development,
which is something that extends to product development.

At the start of 2005, Egypt's comprehensive intellectual property rights law brought the country's legislation in line with the
requirements of Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS-compliant legislation should have had a
significant impact on the local pharmaceuticals industry, as the grace period allowed under TRIPS obligations for non-compliance of
patent rules ended in January 2005.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Egypt remained on the Watch List of the Pharmaceutical Research and Manufacturers of America's (PhARMA) Special 301
Submission in 2022 due to its lack of intellectual property, patent and trademark protection. The country's lack of regulatory data
protection and ineffective patent enforcement allows manufacturers to obtain marketing licences for generic products prior to the
expiration of the original patent.

On a positive note, the submission noted that Egypt had successfully reduced the patent backlog from 10 years to five years. It had
also improved enforcement. In February 2020, Egypt’s government issued Decree 251/2020 forming the Ministerial Committee,
which has the authority to issue compulsory licenses or expropriate any patented product. The decree as well as Egypt’s patent law
(Law 82/2002) enable the committee board to take patents and its discretion for almost any reason. Votes of only three of the total
five members of the committee are necessary to issue a compulsory licence. Although these actions favour local generic drug
produces, this poses a significant risk to innovative drugmakers by further weakening intellectual property protections, which risks
the excessive use of compulsory licences and possibly denies patent holders the right to adequately defend their property interests.

In September 2021, the United States Trade Representative (USTR) issued its 2021 Special 301 Report. Although the report noted
Egypt’s enhanced engagement on IP issues with stakeholders, Egypt remained on the Watch List in 2021, with intellectual property
(IP) violations and weak patent enforcement cited as key issues.

Pricing Regime

Egyptian pharmaceutical companies are subject to an unfavourable pricing system controlled by the government's Ministry of
Health, which aims to make medicines affordable to the public. Egypt's current method of pharmaceutical pricing does not allow for
price increases to compensate for inflation and the pricing policy has failed to adjust for the rising costs of importing raw materials.
These strict pricing controls result in some of the lowest prices for innovative drugs in the region. Although some progress has been
made towards developing a more transparent and fair pricing system, current policies will continue to impact Egypt’s access to
innovative drugs.

In 2012, the Ministry of Health issued Decree 499, which discriminates against foreign innovative products by offering differential
treatment for those products in the supply chain. Specifically, Decree 499 imposed higher distributor and pharmacy margins on
imported products compared with locally produced products (which were deducted from the ex-factory price); thereby
discriminating against multinational manufacturers. These actions contradict the country’s WTO commitments.

The authorisation process also encourages localisation in accordance with Decree 425 (2015). The law stipulates that the
authorisation of a medical product can only be issued if there is availability in the relevant box of pharmaceuticals with similar
specifications, the maximum number of which is 12 products, including the originator product. In general, only one imported
product is allowed per box; thereby restricting the use and availability of foreign-made products. The government’s 2016 decision to
liberate the foreign exchange rate triggered a substantial devaluation of the Egyptian pound, which negatively impacted
multinational drugmaker revenues.

The decision by the Egyptian Ministry of Health to raise the price of a number of medicines in 2017 provided some relief to
domestic drugmakers in the country, given the lasting effects of the devaluation of the Egyptian pound. Despite the Ministry of
Health's pledge to implement the second phase of price adjustments in August 2017, it has yet to be implemented. We expect that
the government will remain hesitant to significantly raise the price of a large number of medicines as their commitment to
affordability will remain the top priority given the unfavourable currency fluctuations.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Reimbursement Regime

The Egyptian Technical Committees perform a comparative assessment between new, expensive products and the general
standard of care guidelines. These assessments inform decisions for formulary listing. Cost-effectiveness analyses are used in
reimbursement processes when requested by a manufacturer or deemed necessary by the Egyptian Reimbursement Committee.
Clinical and economic value are also considered. Reimbursement decisions are based on comparative clinical benefit assessments
conducted by medical committees. The reimbursement decision is accompanied by a cost comparison with current practice or
treatment; where innovative drugs have a higher price, the manufacturer is required to engage in one-to-one negotiations with the
payer, possibly leading to a price review.

The Ministry of Health compiles 'essential' and 'non-essential' drug lists, with the former including 26 categories and medicines such
as insulin, antibiotics and cardiovascular treatments. The authorities are under pressure to establish a universal reimbursement
system, as the vast majority of healthcare spending in the country is currently accounted for by out-of-pocket spending. However,
the fiscal situation is making moves in this directly unlikely in the short-to-medium term.

Egypt is yet to announce a positive reimbursement list outlining medicines that will be covered within the country’s new universal
healthcare system; however, innovative medicines are unlikely to be a priority, as the country tackles the initial challenges
associated with universal healthcare such as staffing and financing.

We note that medicines to treat hepatitis C (HCV) are expected to be an exception to this pro-generics reimbursement stance. Egypt
has made the testing and treatment of HCV a key goal of its healthcare project owing to the high prevalence of the disease in the
country.

Following this, a report issued by the Ministry of Health in October 2022 confirmed that the World Economic Forum (WEF) had
endorsed Egypt's treatment model for HCV, which was accelerated through a presidential initiative to eliminate the disease and
other non-communicable diseases. The report noted that Egypt is on its way to obtaining global certification as a result of the WHO
declaring it free of HCV.

Egypt – Pharmac
Pharmaceutical
eutical Pricing And R
Reimbur
eimbursement
sement Landscape
Feature Description
Char
Characteristics
acteristics Egypt's pharmaceutical market is among the largest in the MENA region and is transitioning from a generics focus to
of more sophisticated, high-value products as part of efforts to secure additional multinational investment. Prescription
pharmac
pharmaceutical
eutical medicines dominate the market, with patented medicines accounting for as much as 57% of prescriptions in value terms.
mark
market
et OTC medicines are of marginal importance, given the market's stage of development and per capita incomes.
Main sour
sourcce(s) Approximately a third of total health expenditure is earmarked for pharmaceuticals in Egypt. Though the government
of public plays a significant role in pharmaceutical spending, it has consistently pursued a policy of minimising public financing of
pharmac
pharmaceutical
eutical medicines and pushed for private out-of-pocket expenditure for both OTC and prescription medicines, which is the
spending dominant share of the market.
Health Egypt’s commitment to achieve Universal Health Coverage (UHC) by 2030 has moved HTA up the agenda to accelerate
technology healthcare reform towards these goals. Here, situational analyses has been conducted to inform future HTA efforts in
assessment Egypt, indicating a commitment to institutionalising HTA1.The local HTA unit needs to be implemented as a policy, aiming
(HT
(HTA)
A) to encourage systematic, evidence-based decisions for healthcare priority setting.
Decree 373/2009 and subsequent amendments established two pricing systems for new medicines registered in the
International
market, one for branded pharmaceuticals and one for generic drugs. The decree uses 36 reference countries, which
ref
efer
erenc
encee
include Canada, European markets and countries in the Persian Gulf, with prices reviewed every five years or upon
pricing (IRP)
request by the drug manufacturers.
Pric
Pricee cuts With some of the lowest drug prices in the region, Egypt has a holistic strategy for price cuts that involves implementing a

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Feature Description
strict pricing policy, setting compulsory retail prices through the Central Administration of Pharmaceutical Affairs (CAPA),
and exploring innovative pricing models to ensure affordable access to medicines for the population. However, as this is
an unattractive environment for innovative drug makers the EPA receives requests from pharmaceutical companies to
raise prices and since April 2022, the prices of 400-500 medicines have been increased between 15-20%.
The Tender Drug List (TDL) includes all essential drugs required by the Ministry of Health institutions including drugs for
Reimbur
eimbursement
sement reimbursement. It is generally the lowest priced medication in each active ingredient group that is added to the list for
mechanisms reimbursement. Once approved, the product is added to the TDL for two years, with listed products needing around eight
months for reimbursement, as specified by the Procurement Technical Committee.
Egyptian health authorities have long been in favour of maximising generics as a cost reduction strategy largely due to
Generic persistent strain on public sector finances. Generic substitution is widespread in Egypt and pharmacists recommend
substitution generic medicines to help patients with cost savings, with studies showing that up to 84% of prescriptions are generically
substituted.
Go
Govvernment
Health sector reform under Egypt’s UHC 2030 goal has expedited the established of Unified Procurement Authority
tender
tenders/
s/
(UPA), as laid out under Law 151/ 2019. This mandates the UPA to ensure the financial sustainability of the health system
national
and applying value-based procurement processes.
pr
procur
ocurement
ement
In Egypt, the EDA enacts policies of drug localisation to reduce the possibility of shortages in the local market, in addition
Localisation
to encouraging pharmaceutical investment in Egypt. The EDA has reformed its policies to promote localisation efforts by
pricing policies
providing flexible regulations for licensing drugs and fast-track clearance for new products.
Research published in 2020 showed that 56% of local healthcare stakeholders were not currently using risk sharing
Risk sharing
agreements. Some 60% consider that risk sharing agreements and managed entry agreements will be used primarily for
agr
agreements
eements
the reimbursement of new pharmaceuticals and the revision of previous reimbursement decision over the next five years.
The Ministry of Health compiles 'essential' and 'non-essential' drug lists, with the former including 26 categories and
Drug pric
pricee list
medicines such as insulin, antibiotics and cardiovascular treatments.
Aggressive localisation polices and intellectual property protections play a large role in generics dominance of the drug
Regional pricing landscape. The authorisation process also encourages localisation in accordance with Decree 425 (2015). The law
policies stipulates that the authorisation of a medical product can only be issued if there is availability in the relevant box of
pharmaceuticals with similar specifications.

Source: BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Market Overview
Multinational pharmaceutical and healthcare companies will find Egypt an attractive yet challenging investment destination.
Increasing efforts to develop the pharmaceutical and healthcare sector offers some promise at a time when currency issues and an
uncertain economic future threaten drugmakers' revenue-earning capabilities. Over the long term, private investments will drive
health expenditure in Egypt and lead to an improvement in the delivery of specialised healthcare services in hospitals.

Egypt's pharmaceutical market is among the largest in Middle East and North Africa (MENA) region, having been valued at
EGP134.5bn (USD4.4bn) in 2023, representing 20.3% of the country's healthcare spending. Despite its large population of over
100mn, per capita pharmaceutical expenditure was just USD38.9, which is one of the lowest regionally. At around 85.7% of the total
value, prescription medicines dominate the market, with patented medicines accounting for 20.0% of prescriptions in value terms
(however, this percentage has been falling in relation to previous years). OTC medicines are of marginal importance, given the
market's stage of development and per capita incomes, representing roughly 14.3% of the total drug sales in 2023, or just USD5.6
per capita.

Egypt's domestic pharmaceutical manufacturing industry is strong, with the main players being Egyptian International
Pharmaceutical Industries (EIPICO), South Egyptian Drug Industries (SEDICO), Medical Union Pharmaceuticals (MUP), VACSERA and
Amoun Pharmaceuticals (APC) - acquired by Canada-based Valeant in 2015. Multinational drugmakers hold the greatest market
share in value terms, with notable players including GSK, Novartis, Sanofi, Pfizer and Merck & Co.

Research And Development

Egypt does not invest heavily in pharmaceutical product development and this is one of the local industry's weaknesses. We uphold
our view that this is unlikely to change in the medium term. Domestic firms undertake limited R&D activity due to the prohibitive
cost of developing new chemical entities. The domestic industry thus remains based on the formulation of legal and illegal generic
drugs and the production of under-license products.

In line with several other countries in the region, Egypt is increasing its efforts to boost the domestic pharmaceutical landscape and
reduce import reliance. Egyptian pharmaceutical companies are investing in research and development to develop new drugs and
technologies. This has helped to increase their competitiveness in the global market. Alongside developing the country’s
manufacturing capabilities, Egypt is also looking to other countries and multinational pharmaceutical firms in a bid to improve
international cooperation and localise the production of specialist expertise, such as the development of vaccines. For example, in
September 2021, the Egyptian Drug Authority (EDA) and South Korea initiated discussions to explore strategic pharmaceutical
cooperation opportunities. This is expected to include increased investment from South Korean drugmakers as well as expanding
pharmaceutical trade agreements with Egypt. In November 2021, Egypt inaugurated MENA’s largest Covid-19 vaccine production
factory. The factory formed part of plans to increase the cooperation with multinational drugmakers specialising in vaccines in a bid
to boost the local vaccine industry.

Clinical Trials

Clinical trials activity will be boosted by the demographic profile of Egypt and large numbers of treatment-naïve patients, as well as
low research and labour costs. A number of firms (eg, Roche) have also conducted trials in the therapeutic area of infectious
diseases - hepatitis C (HCV) in particular. There are no legal provisions requiring authorisation for conducting clinical trials by the
Medicines Regulatory Authority in Egypt.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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There are no legal provisions for good manufacturing practice compliance of investigational products. National good clinical
practices are not published by the government, and inspection of facilities where clinical trials are performed is not permitted. As of
2022, there were 278 new clinical trials registered in Egypt, of which the majority were New Phase IV (29.8%), New Phase III (50.4%)
and New Phase II (14.0%).

New Clinical Trial Registrations


(2019-2022)

Note: New Trials begun in the given year. Sourced by date of initial registration. Includes clinical trials of drugs, medical devices, surgical procedures and behavioural
interventions. Source: ClinicalTrials.gov, BMI

Epidemiology

A population boom, increasing life expectancy and rising levels of lifestyle-related diseases such as obesity and diabetes are putting
pressure on Egypt’s relatively underdeveloped healthcare system. Rapid reforms are underway, which highlight the challenges that
will face Egypt’s healthcare sector over our forecast period. Egypt’s population is forecast to grow from its current 102mn to 120mn
by 2030 and 160mn by 2050. There are currently 5.5mn people aged over 65 years (5.3% of the population), and this figure is
expected to rise to 7.7mn (6.4% of the population) by 2030, which will drive demand for geriatrics services with long-term care,
rehabilitations and home care. Birth rates are also set to increase, which will simultaneously drive demand for neonatal and maternal
health services such as obstetrics, gynaecology and paediatrics.

Alongside demographic factors, rises in chronic diseases are also set to fuel healthcare demand. Globally, Egypt has one of the
highest prevalence of lifestyle diseases with approximately 16% of the population aged 20 years and over with diabetes, 31% with
obesity and 26% with hypertension. Non-communicable diseases, including cardiovascular disease, diabetes, cancer and chronic
respiratory disease are currently the leading national causes of death in Egypt, accounting for 84% of all deaths and 67% of
premature deaths. The health issues impacting young people are increasingly mirroring those in more developed countries, such as
the prevalence of psychiatric disorders. In the long term, the burden of communicable diseases (such as HCV) is forecast to
marginally increase; however, the overall burden of non-communicable diseases will increase at a much faster rate; boosted by
better detection.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Diabetes

Diabetes and obesity are MENA's biggest epidemiological challenges. The rapid societal transition to a more urbanised lifestyle with
little exercise and westernised diets has caused a huge increase in obesity, which in turn has seen significant increases in diabetes
mellitus rates. Diabetes prevalence in Egypt is high compared to global levels, but low compared with some MENA countries,
particularly the Gulf Cooperation Council (GCC).

According to the latest data from the International Diabetes Federation (IDF), there were over 10.9mn cases of diabetes in Egypt in
2021, with diabetes-related deaths reaching 122,684.

The IDF estimates that 20.9% of the adult population in Egypt is currently diagnosed with diabetes and that USD250.5 was the
mean annual diabetes-related spending per person in 2021. The IDF estimates that in 2021, there were 6.8mn cases of diabetes in
adults that were undiagnosed. By 2045, the IFD estimates that 20mn people in Egypt will have diabetes, accounting for 23.4% of the
total adult population. This is a concern, as there are numerous medical complications from diabetes, leading to considerable
indirect healthcare costs.

Cancer

According to Globocan, the number of new cases of cancer in Egypt will increase from 134,632 in 2020 to 235,152 by 2040, which
is an increase of 75%. The majority of these new cases will come from females over the age of 65. Liver cancer is the most common
cancer in males, followed by bladder, lung and prostate cancer. Breast cancer is the most frequent cancer in females, followed by
liver, non-Hodgkin lymphoma and ovarian cancer. Many cases are often undiagnosed or misdiagnosed, which is partly due to the
widespread lack of awareness regarding the disease. Significant barriers to funding cancer treatment still Exist in Egypt which is
having a significant impact on the treatment progression in the country. In December 2022, for example, it was announced that
Egypt's main children's cancer hospital was on the verge of closure after a sharp drop in donations of almost 90%, with public
donations being the main revenue source of the hospital since it opened in Cairo in 2007.

Hepatitis C

Egypt continues to report among the highest incidence of HCV in the world, estimated at 10-15mn sufferers in 2017. Secondary
problems associated with HCV include cirrhosis of the liver, which represents a major morbidity burden in the country. The Egyptian
government is upholding its pledge towards reducing the HCV burden in the country. The Ministry of Health recently announced its
plans to strengthen the national campaign against the virus, largely through greater cooperation with pharmaceutical
manufacturers of antivirals. In October 2023, Egypt became the first country to achieve 'gold tier' status, which indicates that it is on
the way towards eliminating HCV as per the World Health Organization's (WHO) criteria. This means that Egypt has fulfilled WHO's
programmatic coverage targets that will set the country up to achieve the reduced incidence and mortality targets of full
elimination before 2030.

HIV/AIDS

The number of HIV positive people in Egypt is estimated at some 22,000. While the figure suggests a relatively low prevalence of
HIV/AIDS, Egypt has one of the fastest growing HIV epidemics among Middle Eastern countries. Official estimates suggest a
25-30% annual increase in the number of cases since 2010. HIV treatment is provided free of charge at some
government hospitals; however, estimates suggest that only around a third of patients have access to the treatment, or are
actively taking it.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Egypt Healthcare Overview


Key View: Egypt has a highly pluralistic healthcare system and a range of providers of health services, with the private sector
providing the highest quality services. The country's number of healthcare professionals is below the global average and growth in
the number of doctors is expected to be low, with increases only projected for some medical staff. Egypt has a high burden of non-
communicable diseases and the country's elderly population is expected to grow significantly over the next few decades.

Egypt has a highly pluralistic healthcare system with many different players and providers of health services. The highest-quality
services will continue to be provided in the private sector, with lower standards across the public sector. The implementation of
universal healthcare coverage and continued efforts to improve the healthcare system, along with strong market fundamentals, will
offer a variety of commercial opportunities for healthcare providers.

Egypt’s healthcare system has shortages of key medical personnel when compared to global medians, with increases only projected
for some medical staff. Notably, the number of doctors is expected to decrease, contributing to a decline in inpatient visits, surgical
procedures and outpatient visits. However, the rise of digital health solutions is also a factor and these technologies are viewed as
important tools in supporting the healthcare system in the long term.

Egypt’s median age is slowly increasing, but is below the global median. This will limit the country's attractiveness to providers of
medical products and services. However, Egypt has an expanding population and its elderly population is expected to grow
significantly over the next several decades, which will drive demand for healthcare services. Chronic diseases are the leading cause
of death, with ischemic heart disease, by far the leading single cause over recent years.

Key Healthcar
Healthcaree SSyystem Indicator
Indicatorss
2023
Health spending, USDbn 22
Health spending, % of GDP 6.7
Health spending, LLCU,
CU, 5 yyear
ear ffor
orecast
ecast CA
CAGR
GR 12.2
Hospitals, total 1,748
Hospitals, beds 128,126
Phy
Physicians,
sicians, total 86,724
Nur
Nurses,
ses, total 291,611
Sur
Surgical
gical pr
proc
ocedur
edures
es 931,231

Source: BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Competitive Landscape
Research-Based Industry

While multinational companies supply about two thirds of the market through direct local manufacturing or through licensing
agreements, few have domestic production facilities, instead preferring to import drugs or license production to local
manufacturers. Due to the great diversity of products, local and foreign companies tend to specialise, making the Egyptian
pharmaceuticals market highly fragmented.

Leading multinationals such as Pfizer, GlaxoSmithKline (GSK) and AstraZeneca have relatively extensive local operations. The current
market leaders with production facilities include Bristol-Myers Squibb, GSK, Novartis and Pfizer. Other leading multinationals present
in the market include France-based Servier and US-based Johnson & Johnson, Eli Lilly and Merck & Co. According to Egyptian news
sources, in 2019, Johnson & Johnson invested EGP125mn (USD7.8mn) in pharmaceutical operations in the country, while GSK
disclosed that its total investment in Egypt has totalled USD800mn.

The Egyptian government has previously offered research grants for innovative projects that result in the development of
pharmaceutical products using domestic expertise, production of pharmaceutical raw materials, manufacture of interferon, insulin
and early identification of viral ailments such as hepatitis. The licensed manufacturing of products from foreign drugmakers is
common and has helped local firms to develop good manufacturing practice standards which has, in turn, led to improvement in
the competitiveness of exports. However, more activity is needed to achieve internationally acceptable standards across the
industry.

Multinational Mark
Market
et Activity
Company Operations
No
Novvar
artis
tis Novartis operates in Egypt through its subsidiary Novartis Pharma. Based in Cairo, Novartis employs approximately
1,750 associates at its manufacturing site, including in its scientific office for OTC and prescription pharmaceutical
products. In June 2022, Novartis announced plans to explore public-private partnerships with Egypt to develop the
health and pharmaceutical sectors and in October 2023, the company discussed improved cooperation with Egypt
in the fields of oncological, heart and immunity diseases.
Pfiz
Pfizer
er Pfizer operates in Egypt through its 100% owned subsidiary Pfizer Egypt. The company currently has around 70
drugs on the Egyptian market. It operates a local manufacturing facility through its biopharmaceuticals subsidiary
UpJohn which deals in cardiovascular medicines, pain management and oncology, among a number of other major
therapeutic areas. However, in late 2020, Pfizer completed a transaction to combine its UpJohn business with Myaln
to form Viatris. Pfizer now focuses on innovative products while Viatris will take over Pfizer's generic drugs,
biosimilars and OTC products.
Roche Swiss drugmaker Roche has a scientific office in Cairo, but does not manufacture locally. The company has a
manufacturing license agreement with EIPICO. Roche has an agreement with the Ministry of Health allowing
differential pricing, allowing the local branded medicine to be available at a significantly reduced price to the
government in order to enable greater public access.

Sanofi Sanofi, operating through its local affiliate Sanofi Egypt, is among the largest pharmaceutical firms in Egypt. Sanofi
Egypt has a plant and four offices, employing more than 800 people. The company's manufacturing capacity is
50mn boxes and 20mn packs per annum. Sanofi markets the following medicines in Egypt: Plavix (clopidogrel
bisulphate), Aprovel (irbesartan), Tritace (ramipril), Actonel (risedronate), Depakine (sodium valproate), Amaryl
(glimepiride), Lantus (insulin glargine), Eloxatin (oxaliplatin) and Taxotere (docetaxel), among a number of other
products. Sanofi has also provided the vaccines used in mass polio immunisation programmes in the country.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Company Operations
Mer
Merck
ck & Co. US major Merck operates in Egypt through its fully owned subsidiary Merck Sharp & Dohme Egypt. Until 1984, the
company imported its products through a public sector distribution company Egydrug, or manufactured them
locally through a government-owned manufacturer (Al-Kahira Co.) and private sector company EIPICO. Ramco
Pharm, SoficoPharm and Egydrug are the main distributors of Merck Sharp & Dohme products in Egypt.

Johnson & JJohnson


ohnson Johnson & Johnson does not have a direct presence in Egypt, instead importing its product into the country. In 2019,
the company invested EGP125mn (USD7.8mn) in local pharmaceutical operations.

GSK GSK operates in Egypt through its 91%-owned subsidiary GSK Egypt, which employs around 1,500 staff. While the
subsidiary mainly manufactures ethical drugs, it also markets and distributes other pharmaceuticals products and
toiletries.

Astr
AstraZ
aZeneca
eneca AstraZeneca's production in Egypt was previously contracted out to a local manufacturer. AstraZeneca has since
built a pharmaceuticals production facility near Cairo, which produces a broad range of the company's products
including cardiovascular and cancer treatments. The decision by AstraZeneca to focus on three product lines in
Egypt - cardiovascular, cancer and psychiatric drugs - follows local epidemiological trends. AstraZeneca has become
one of the few multinationals with a direct manufacturing presence in Egypt. Some of the output is destined for
exports to Middle Eastern, European and African markets.

AbbVie AbbVie opened a scientific office in Cairo in 2015. It imports its products into Egypt.

Source: Pharmaceutical companies, BMI

Generic Drugmakers

According to December 2019 data from the Egyptian Council of Pharmaceuticals Exports (ECPE), the country has around 158
pharmaceutical manufacturing plants, as well as 125 and 120 plants producing medical materials and cosmetics, respectively. The
industry is increasingly targeting exports to other African countries, with the aim of reaching a 10% market share on the continent.

Domestic producers are mainly small- to medium-sized firms that manufacture generic drugs, with many being copies of patent-
protected drugs owing to the country's weak patent law and the nature of local demand. Most active pharmaceutical ingredients
are imported, leading to cost pressure in times of negative foreign currency fluctuations. Price is a major barrier to accessing
healthcare in Egypt. Therefore, rationalising prescriptions to reflect purchasing power bodes well for generic drugmakers.

Egypt has the potential to become a major manufacturing hub in the longer term, especially as the operating climate and low public
and private purchasing power favours the use of generic medicines, both locally and regionally. However, in order to achieve this
status, the government may have to improve regulations, notably those covering the intellectual property regime.

Leading local producers include Egyptian International Pharmaceutical Industries (EIPICO), Amoun Pharma (APC), Pharco, Medical
Union Pharmaceuticals (MUP), and South Egyptian Drug Industries (SEDICO). Smaller players include Jedco International
Pharmaceuticals, established in 2000 and producing solids and liquid forms; Atco Pharma, which also deals in veterinary drugs; and
Bio CarePharma, which has a distribution and import and export arm. Few local drugmakers in Egypt are wholly state-owned, with
the remainder either partially or fully privatised. Public production is represented by state-owned Holding Company for
Pharmaceuticals (HOLDIPHARMA).

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sources. Fitch Ratings analysts do not share data or information with BMI.

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In July 2020, as part of its aim to increase local production, shore up raw materials imports and reduce medical shortages, the
Egyptian military (via the National Authority for Military Production) was given a licence to create a pharmaceutical manufacturing
company to be called Egyptian National Company for Pharmaceutical Products. However, concerns have been raised over the level
of the army’s control of the country's economy.

In April 2021, Egypt opened the largest pharmaceutical manufacturing centre in the Middle East and North Africa (MENA) region,
with the goal to produce 150mn packs of medication per year covering 150 different drugs. The project, known as Gypto Pharma
City, also aims to increase cooperation between the public and private sectors, attract multinational drugmakers for collaboration
and control drug prices. It has been set up to produce safe and effective medicines at reasonable prices, and will manufacture
Covid-19 remedies and drugs for chronic diseases. Production of some vitamins will also be given priority.

Pharmaceutical Distribution

The leading wholesalers in Egypt are United Company of Pharmacies, Egyptian Pharmaceutical Trading Company (Egydrug) and
Pharma Overseas. Other smaller players include Bio CarePharma, which also deals in veterinary drugs.

Public drug manufacturers are required to distribute a considerable percentage of their products through public wholesalers,
namely Egydrug, which claims to be the largest trading and distribution company for pharmaceutical products in the Middle East.
Private sector companies are required to distribute their products through the two public players, both of which are 100%-owned
by HOLDIPHARMA, but to a lesser extent.

In August 2020, the Egyptian Drug Authority (EDA) signed a cooperation protocol with both Pfizer’s Upjohn and healthcare
technology company IQVIA Egypt and Saudi Arabia to automate the drug distribution process in the local market. The protocol is
consistent with the private sector’s role in the development process across the country.

Pharmaceutical Retail Sector

According to the Egyptian Pharmacists Syndicate 2020 records, the country has around 75,165 pharmacies, or one per 1,261
population (eight pharmacies per 10,000 population). This figure is reportedly the highest in the world - higher even than in Saudi
Arabia, for example, which has 8,500.

Pharmacies deal with both foreign companies and state-owned local players, as well as with wholesalers. The majority of
pharmacies are publicly-owned, although a handful of chains have emerged in more recent years. For example, El-Ezaby -
established in 1975 and part of the Multipharma Group - aims to become a leading pharmacy chain in the Middle East region. Other
chains include Misr Pharmacies, Seif Pharmacies, part of the Seif Group, which targets higher-income groups, and
SEhha Pharmacies, which also offers services such as biometric screening and tobacco cessation programmes.

Pharmacies must be licensed to a specific pharmacist and theoretically not owned as such by a corporate entity. One pharmacist
cannot hold more than two pharmacy licences. Egypt has a good regional reputation for pharmacy schools, from which many other
MENA pharmacists also graduate.

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Company Profile
Amoun Pharmaceutical Company

Strengths Weaknesses

• One of the leading pharmaceutical producers in Egypt, • Low per capita incomes constrain discretionary spending on
fielding a broad range of branded generics. pharmaceuticals, especially given the modest
• Contract manufacturing for foreign players. reimbursement coverage.
• Owned by a foreign major. • Local currency weakness making imports of raw ingredients
more expensive.
• Stringent drug registration policy, with restrictions on the
number of drugs available on the market per indication.

Opportunities Threats

• Regional modernisation. • Rising competition from imports and multinationals


• Rising demand for healthcare and pharmaceuticals in line operating within the country.
with demographic and epidemiological trends. • An increase in cheap generic drug imports.
• Egypt serves as a gateway to less penetrable Middle Eastern, • Egyptian government is keen to keep drug prices low.
Asian and African markets.
• Rising prices of some pharmaceuticals.

Company Overview

Amoun Pharmaceutical Company (APC), established in 1998, was acquired by Canada-based Valeant Pharmaceutical for
USD800mn in 2015. The company operates a state-of-the-art production facility in El-Obour City as well as five commercial
branches through Egypt. Amoun exports to a number of countries throughout Africa, Europe and the Middle East, with sister
companies operating in the US, Romania, Russia and Kenya.

APC is the first private drug company founded in the country to import and distribute drugs. It is also the largest domestic
drugmaker in Egypt and the top domestic company in terms of revenue, and third overall. The company currently has five branches
in Egypt manufacturing human and veterinary pharmaceuticals (in a range of forms, including solid, liquid and semi-solid forms) and
nutritional supplements.

APC's product portfolio includes anaesthetics, analgesics, gastrointestinal drugs, medicines for the endocrine system, topical
preparations, cardiovascular drugs, vitamins and minerals. Its product portfolio numbers around 175 human (across over 15
therapeutic classes) and 21 animal medicine. It has around 2,200 employees. APC's portfolio is well aligned with the key therapeutic
needs in Egypt.

In March 2021, it was announced that ADQ, one of the largest holding companies in the Middle East, had signed an agreement for
the acquisition of APC from Bausch Health Companies for USD740mn. With the acquisition, ADQ aims to diversify and
complement regional holdings of high-demand pharmaceuticals while accelerating information and technology transfer to
boost local manufacturing capabilities.

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Strategy

APC's contract manufacturing deals will allow it to continue performing well in the local market, although it will also increasingly
target exports, as domestic prices continue to be an issue. The company has continued to invest in its manufacturing facilities.

APC aims to increase its exports so as to become 'the leading Egyptian pharmaceuticals exporter.' Currently, it has partners that
distribute its products in 28 countries across the Middle East, Africa, Asia and Eastern Europe. APC has over 230 registered products
in many of the countries in these regions and is focusing on increasing its products’ reach to cover all countries of the Gulf
Cooperation Council (GCC) as well as main importers in the African region. The company's mission is based on 'quality and trust'. It
operates websites that offer patient advice for a number of therapeutic areas, including neuropathic pain and hypertension.

Developments

2021

• In March 2021, it was announced that ADQ, one of the largest holding companies in the Middle East, signed an agreement for
the acquisition of APC from Bausch Health Companies for a reported USD740mn. With the acquisition, ADQ aims to diversify and
complement regional holdings of high-demand pharmaceuticals while accelerating information and technology transfer to
boost local manufacturing capabilities.

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Egyptian International Pharmaceutical Industries

Strengths Weaknesses

• Strong focus on generic drugs, which comprise the majority • Lack of strong financial capabilities.
of its portfolio (the remainder being accounted for by in- • Local currency depreciation to increase costs and reduce
licenced products). profitability.
• Contract manufacturing projects for foreign partners. • Stringent drug registration policy, with restrictions on the
• Sales and distribution network covering most of the Middle number of drugs available on the market per indication.
East and Africa (MENA) region as well as parts of Europe and
Asia.

Opportunities Threats

• Trade agreements giving a boost to Egyptian exports. • Low per capita incomes constrain discretionary spending on
• Government policy more inclined towards local producers. pharmaceuticals, especially given the modest
• Increased focus on generic drugs, driven by cost reimbursement coverage.
containment. • Persistence of the unsettled political situation reducing
• Egypt serving as a gateway to other emerging and less investment potential.
penetrable Middle Eastern, Asian and African markets. • An increase in cheap imports could threaten the company's
• Investment in biotechnology research to take advantage of market share.
increasing demand for such products, nationally and • Failure of government to fully revise its overly opaque and
internationally. discriminatory pricing policy.

Company Overview

Egyptian International Pharmaceutical Industries (EIPICO) started production in 1985 and is now one of the largest domestic drug
manufacturers in Egypt. It exports medicines around the world, accounting for almost 30% of Egypt's total pharmaceuticals exports,
according to the company's own figures. Currently, the company is present in 65 countries with a strategic plan to expand this
number to 100 countries by 2025.

EIPICO owns a majority share in Egyptian International Ampoules Company, which produces some 800mn units annually.
EIPICO also holds shares in Universal for Pharmaceutical Production based in Saudi Arabia, having invested EGP27.7mn.

In December 2019, the company purchased 4,780mn shares in Medical Union Pharmaceuticals (MUP), an acquisition representing
a 9.8% stake in the firm. The investment was made in coordination with Arab Co For Drug Industries & Medical Appliances, its main
shareholder. The acquisition became possible as a result of EgyLease exiting the pharmaceutical sector.

EIPICO has its own R&D laboratories, including one for chemical control and the Biotechnology Centre, and has around 5,000
employees.

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Strategy

EIPICO manufactures more than 400 prescription and OTC pharmaceuticals, covering 25 therapeutic classes. This includes all
known pharmaceutical forms, either traditional or non-traditional dosage forms, such as soft gelatin capsules, spansules, lyophilised
products, gels, sprayers and effervescent tablets. The company also manufactures high-value drugs such as anaesthetics and
analgesics.

EIPICO caters for the local and African market by producing anti-parasitic drugs against infections and schistosomiasis. This includes
antibiotics, antifungals, anti-dysenterics, antihistamines, antimalarials, blood substitutes, antihypertensives and cardiovascular
medicines as well as central nervous system-acting drugs, dermatological treatments, endocrine and ophthalmological therapies,
and steroidal anti-inflammatories.

EIPICO has a number of licence agreements with a group of international pharmaceutical companies to produce their specialities.
These include US-based Allergan; UK-based Riker; Germany-based Dolorgiet Arzneimittel, Hek Pharma and Dr Willmar Schwabe;
Switzerland-based Ginsana Products Lugano and Roche; Denmark-based Biogena; Italy-based Angelini And Menarini; and South
Korea-based Shin Poong.

In line with the government's aim to reduce its medicine import reliance, EIPICO selects which pharmaceuticals it is able to produce
based on replacing imported versions. To this end, it liaises closely with multinational drugmakers regarding licence agreements.
Through such agreements, the company also stands to gain from knowledge and technological transfer, which will ultimately make
it more competitive within Egypt, the Middle East and Africa.

Developments

2023

• In June 2023, In EIPICO announced that Pharmadule Morimatsu AB, a Swedish company specialising in the design and
construction of modular pharmaceutical manufacturing facilities, had completed a new 5,000sq m monoclonal antibody and
small molecule protein hybrid production plant in Egypt.
• In January 2023, the board of directors of EIPICO approved increasing the company’s issued capital by 15% to EGP1.14bn from
EGP991.7mn. The EGP 148.75mn capital hike will be distributed among 14.87mn shares as per the fair value with no issuance
expenses, according to a bourse disclosure.

2022

• In September 2022, EIPICO announced a new partnership with the Scientific Research City in Borg El Arab Alexandria for
the strengthening of cooperation in the production of bio-alternative medicines.
• In February 2022, EIPICO announced that it had begun producing Covapravir (molnupiravir), a drug used for the treatment of
Covid-19.
• In January 2022, EIPICO announced that it had obtained the Egyptian Drug Authority’s (EDA) approval to produce the anti-Covid
drug Covapravir.

2021

• In April 2021, EIPICO signed an agreement with Kambal International to establish a pharmaceutical plant in Sudan with
investments of USD30mn. Construction of the plan is expected to take two years.

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• In February 2021, EIPICO signed an agreement with India-based Reliance Life Science to produce seven biologic drugs. The
products include injections such as erythropoietin, follitropin, darbepoetin, rituximab, bevacizumab, adalimumab and
trastuzumab. EIPICO already obtained the necessary preliminary approvals to register these drugs under the EDA.

2020

• In September 2020, the company's representatives met with Belarus's ambassador to Egypt to discuss how the previously
signed collaboration agreement between the two countries is to be activated. The collaboration, which includes vaccine
technology transfer from Belarus and the building of Egyptian biologics and biosimilars production plant (EIPICO-3), was briefly
paused due to the coronavirus pandemic.
• In August 2020, the company's CEO announced that EIPICO would bring to the market a product known internationally as
Avigan (epifluovir - favipiravir 200 mg), which would be used to treat Covid patients. The medicine was due to be launched via the
Ministry of Health and the Unified Procurement Authority (UPA).

Financial Data

2023

• For the full year ended December 31 2022, EIPICO's reported sales were EGP3.96bn, compared with EGP3.41bn in 2021. Net
income was EGP643mn compared with EGP487.8mn the previous year.

2022

• For the first nine months of 2022, EIPICO reported a consolidated net profit increase of 28.8% to EGP417.79mn, compared with
EGP324.17mn for the same period in 2021, including minority shareholders' rights.

2021

• In FY21, EIPICO reported total revenues of 3.4bn, a 20.4% y-o-y increase versus FY20. Net profits for the year amounted to
EGP484mn.
• In 9MFY21, EIPICO reported total revenues of EGP2.4bn, a 17% y-o-y increase versus 9MFY20.
• In H121, EIPICO reported a 3.7% y-o-y increase in consolidated net profit, reaching EGP270.8mn. Total revenues in H121
reached EGP1.5bn.

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Medical Union Pharmaceuticals

Strengths Weaknesses

• One of the top 10 pharmaceutical companies in the country. • Sizeable counterfeit activity in the country impacts on brand.
• Sizeable product portfolio across a number of therapeutic • Rising competition from imports and multinationals
areas. operating within the country.
• Contract manufacturing for major multinational drugmakers • Presence of strong generic players in its export markets.
reflecting strong quality control.

Opportunities Threats

• Regional modernisation. • Government keen to keep drug prices low.


• Rising demand for healthcare and pharmaceuticals. • An increase in cheap generic drug imports.
• Ability to build on existing partnerships. • Low per capita incomes constraining discretionary spending
on pharmaceuticals, especially given the modest
reimbursement coverage.

Company Overview

First established in 1984 through the cooperation of the Professional Syndicates Union, Medical Union Pharmaceuticals (MUP) was
listed on the Egyptian stock exchange in April 1997 and has since become one of the largest domestic drugmakers in the country.
Its portfolio includes some 190 products, which are also exported to around 30 countries.

MUP has three key business areas, namely branded generics; biologicals (insulin and heparin); and contract manufacturing for
medicines, cosmetics and special food products within Egypt and abroad. The company's product lines consist of its own specialties,
as well as licenced products, covering more than 30 therapeutic areas. The company's annual production volumes are in the region
of 233mn units (making it the fifth largest in the country) across a variety of forms.

Strategy

MUP was originally mainly focused on the local market, generating the majority of its sales in Egypt; however, only partly via public
sector tenders. It has reported its greater international positions to be in Africa, Eastern Europe and the Middle East and North Africa
(MENA) region. Its product portfolio, which includes cephalosporin and penicillin, is well-suited for placement in those emerging
markets.

The company at present covers around 30 countries and employs around 2,500 staff globally. Domestically, it has strengthened its
position and reach through contract manufacturing for major multinationals, which reflects strong quality control. MUP reportedly
has around 70 products in various stages of development.

In June 2019, Egyptian International Pharmaceutical Industries Company (EIPICO), one of the most prominent Egyptian drugmakers,
bought 4.8mn shares in MUP, which is equivalent to a 9.8% stake. The investment is likely to lead to some collaborative efforts
between the two companies.

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MUP has been vocal about its ambitions to increase its revenue base in China through a series of strategic infrastructure
investments. As part of the company's plans to secure a foothold in China, it has established three new clinics and service centres in
Shenzhen in H220. As at March 31 2021, the company employed 13 full-time and exclusive registered practitioners and operated

15 clinics and service centres in China. MUP opened a further six new clinics and service centres in Shenzhen and Guangzhou over
the remainder of 2021.

Developments

2022

• In November 2022, the spokesman for the Ministry of Health Hossam Abdel Ghaffar, during a tour of the MUP factory,
announced that the company would start a new manufacturing line for the production of insulin. The new line is part of
government efforts to expand the local production of insulin for exportation across Africa.

2021

• MUP detailed major expansion plans for 2021, which included targeted sales of EGP2.9bn over 2021. The sales target proposed
by the company implies a growth of 16% y-o-y to EGP184.8mn. MUP also planned to inaugurate three extra production lines by
the end of the first quarter of 2021, using total investments of EGP1bn raised through a capital increase. The three new facilities
include a production line for single and regular eye drops, in addition to a line for producing ampoules.

Financial Data

2021

• In 2021, the company’s total revenues reached EGP2.3bn, down 1.9% y-o-y.

2020

• In 2020, the company’s total revenues reached EGP2.4bn, down 9.9% y-o-y. Local sales represented 78% of the total and were
down 1.6% y-o-y to EGP1.8bn. The company’s consolidated net profit reached EGP203.4mn in 2020, up 13.9% y-o-y, despite the
decrease in sales volume in 2020 compared to 2019.

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sources. Fitch Ratings analysts do not share data or information with BMI.

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South Egyptian Drug Industries

Strengths Weaknesses

• One of the more prominent local companies. • Stringent drug registration policy, with restrictions on the
• Focuses on generic medicines, but also has three patented number of drugs available on the market per indication.
products in its portfolio. • Low per capita incomes constrain discretionary spending on
• One of the leading producers of insulin. pharmaceuticals, especially given the modest
• Contract manufacturing for foreign players. reimbursement coverage.

Opportunities Threats

• Trade agreements giving a boost to Egyptian exports. • Failure of the government to revise its overly opaque and
• Access to foreign capital. discriminatory pricing policy.
• Rising competition from imports and multinationals
operating within the country.
• An increase in cheap generic drug imports.
• Currency volatility to affect margins.

Company Overview

South Egyptian Drug Industries (SEDICO) is one of the leading local players. It started production in 1990 and its facilities are good
manufacturing practices (GMP) certified. The company focuses on generic medicines and fields patented medicines. SEDICO is
engaged in the production of some biotechnology products, in partnership with foreign players.

SEDICO's product portfolio includes some 180 products across 14 groups, such as analgesics, antihistamines and nasal
decongestants, antidepressants and cardiovascular drugs. The company is well placed to continue taking advantage of the
country's disease profile and its growing population. SEDICO manufactures its own products and those under licence from various
multinationals, including AstraZeneca UK, as well as other foreign players, such as Trenka (based in Austria). It employs around 1,800
staff.

SEDICO is one of the most technologically advanced pharmaceuticals producers in the Middle East and North Africa (MENA) region.
For example, its sterile areas are environmentally controlled and able to utilise filtered air. Its water purification system supplies the
company's production lines with demineralised and distilled water. SEDICO also manufactures a range of forms, including solids
(such as tablets and powders) and semi-solids (such as creams and gels) and liquid fills.

Strategy

SEDICO's official strategy is based on two objectives, namely to create a strong R&D-driven manufacturing base and to collaborate
with existing players in a variety of therapeutic areas. The benefits of the inclusion of biotechnology products in its portfolio are likely
to be realised in the medium-to-longer term, as the healthcare modernisation initiatives continue and as public and private funding
for pharmaceuticals becomes more readily available. The company manufactures biotechnology products including insulin,
streptokinase, angikinase, follicle-stimulating hormone, somatropin and erythropoietin.

SEDICO aims to increase its export activity. Its products are already available in some 30 countries across Eastern Europe (including
Russia, Romania and Moldova), Africa (including Sudan, Ethiopia, Tanzania and Kenya), the Gulf region (including Kuwait and

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Oman) and in Arab countries (including Yemen, Iraq, Morocco and Jordan). SEDICO is also expanding into Italy through the
establishment of a manufacturing plant, the first such Egyptian undertaking in Italy.

The company is engaged in patient and professional education initiatives. For example, its website offers diabetes information as
well as prescription information specifically targeting either patients or professionals.

Developments

2022

• On November 30 2022, Egypt’s Health Minister Khaled Abdel Ghaffar stressed the necessity of expanding insulin production and
export to African countries, particularly after Egypt managed to achieve self-sufficiency in insulin supply to meet the local
market’s demand. This came during his meeting with Olfat Ghorab, the board chairman of the Arab Company for Drug Industries
and Medical Appliances (ACDIMA), during his inspection tour of factories of SEDICO and the Medical Union Pharmaceuticals
(MUP).

2019

• In December 2019, a SEDICO-sponsored conference discussed refractory allergic and asthma conditions as part of the
conference held at the Allergy & Immunology Unit of faculty of Medicine of the Ain Shams University in Cairo.
• In October 2019, SEDICO's representatives held seminars in a number of kidney units across Egypt to highlight the benefits of
the use of the company's products flazacor and deflazacort in the treatment of kidney disease and haematology.

Financial Data

2019

• SEDICO achieved around EGP1.3bn in FY2019 sales, generating EGP107mn from exports.

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VACSERA

Strengths Weaknesses

• In-house R&D capacities. • Lacks strong financial capabilities.


• The only vaccine producer in Egypt. • Stringent drug registration policy, with restrictions on the
• One of the main blood banks in the country. number of drugs available on the market per indication.
• Low per capita incomes and modest reimbursement
coverage.

Opportunities Threats

• Trade agreements giving a boost to Egyptian exports. • An increase in cheap generic drug imports.
• Rising demand for healthcare and pharmaceuticals. • Difficulties in overcoming corruption allegations.
• Egypt serving as a gateway to other emerging and less
penetrable Middle Eastern, Asian and African markets.

Company Overview

VACSERA was formed in 1897 by the Department of Health as a cholera vaccine producing company. It became a holding company
in 2002 and remains in the hands of the Egyptian government. VACSERA - the holding company for Biological Products & Vaccines -
is a vaccine producer, comprising five subsidiaries. VACSERA's plants manufacture blood and biotech treatments and vaccines. As
the only producer of vaccines and sera in Egypt, the firm also has solid R&D infrastructure and an important blood bank.

Strategy

In addition to building on its existing R&D capacities, VACSERA is looking to expand sales abroad, providing the capital to complete
its unfinished projects. The most important of these is a plan to produce retractable syringes. In the long term, VACSERA is looking
to become the top vaccine supplier in the Middle East and North Africa (MENA) region. According to the list of registered vaccines,
the company supplies vaccines in Egypt including Bacillus Calmette–Guérin, and vaccines for measles, cholera, typhoid, rabies,
meningitis hepatitis B, diphtheria and poliomyelitis. The company also deals in veterinary medicines.

Internationally, the company is present in a number of regional markets, including Eritrea, Sudan, Yemen and Lebanon. It also
exports to farther afield to markets such as Cyprus.

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Developments

2023

• In March 2023, the Ministry of Health announced that the first production line of hepatitis B and Pentavalent (five-in-one)
vaccines with the capacity to produce 100mn vaccines annually had been launched as part of a collaboration between VACSERA
and the Serum Institute of India.
• In January 2023, VACSERA announced that it was negotiating with China’s Sinovac Biotech over the establishment of an
integrated plant for the production of vaccines. The announcement came six months after the company settled debts of
EGP712.5mn with the National Investment Bank.

2022

• In July 2022, VACSERA announced plans to increase the localisation of the pharma industry, in line with the directives of the
political leadership. According to the Chairman of the Board of Directors Dr. Heba Wali two factories are currently being
established for human and veterinary vaccines to help boost Egypt's presence on the global the pharmaceutical market.
• In June 2022, the Ministry of Health spokesperson Hossam Abdel Ghaffar announced that Egypt secured about 140mn doses of
different Covid-19 vaccine varieties since the start of the pandemic, including Sinovac, Sinopharm, AstraZeneca, Pfizer, Johnson
& Johnson, Moderna and Sputnik V. VACSERA also produced millions of doses of the Chinese Sinovac vaccine over the past year.
• In April 2022, the Ministry of Health announced that construction would begin on a logistics refrigeration complex for
preserving biological products and vaccines in 6th of October City.
• In February 2022, Acting Minister for Health Khaled Abdel Ghaffar announced that Egypt had produced over 30mn doses of the
Sinovac-VACSERA Covid-19 vaccine.
• In January 2022, Kazakh Ambassador to Egypt Khairat Lama Sharif and Egyptian Minister of Higher Education and Scientific
Research along with acting Minister of Health and Population Khaled Abdel Ghaffar discussed cooperation in manufacturing
Covid-19 vaccines through VACSERA and the Medical Research Centre in Kazakhstan. They also discussed cooperation in the
medical field at large. The ambassador expressed his hopes that cooperation between the two countries would continue and
that Egypt would continue sharing its expertise in manufacturing vaccines with Kazakhstan.

2021

• In late December 2021, Egypt held talks with Sinovac and VACSERA on boosting local production and development of vaccines
and the transfer of manufacturing technology. The two companies discussed the manufacture of vaccines for Covid-19,
influenza and polio at VACSERA’s factories, with a view to making Egypt a centre for the production of such products in Africa.
• In April 2021, Sinovac announced that it would provide technical support and assistance to VACSERA in building and equipping
manufacturing facilities for Covid-19 vaccine production to meet international standards.

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Egypt Demographic Outlook


Demographic analysis is a key pillar of our macroeconomic and industry forecasting model. The total population and demographic
profile of a market are key variables in consumer demand and are essential to understanding issues ranging from future population
trends to productivity growth and government spending requirements.

The accompanying charts detail the population pyramid for 2022, the change in the structure of the population between 2022 and
2045 and the total population between 1990 and 2045. The tables show indicators from all of these charts, in addition to key
metrics such as population ratios, the urban/rural split and life expectancy.

Population
Egypt - Population, mn (1990-2050)

f = BMI forecast. Source: World Bank, UN, BMI

Population Pyramid
Egypt - 2022 Male vs Female Population, '000 (LHC) & 2022 vs 2050 Population, '000 (RHC)

Source: World Bank, UN, BMI

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Population Headline Indicator


Indicatorss (Egypt 1990-2025)
Indicator 1990 2000 2005 2010 2015 2020 2025f
Population, total, '000 57,214.6 71,371.4 79,075.3 87,252.4 97,723.8 107,465.1 116,275.5
Population, % yy-o-y
-o-y 2.09 2.00 2.05 2.23 1.75 1.56
Population, total, male, '000 28,850.6 36,137.3 40,071.8 44,175.7 49,472.6 54,357.4 58,764.9
Population, total, ffemale,
emale, '000 28,364.1 35,234.1 39,003.5 43,076.7 48,251.2 53,107.7 57,510.6
f = BMI forecast. Source: World Bank, UN, BMI

Key P
Population
opulation Ratios (Egypt 1990-2025)
Indicator 1990 2000 2005 2010 2015 2020 2025f
Activ
Activee population, total, '000 31,251.7 41,746.6 48,413.7 54,599.3 60,743.3 66,715.5 73,093.5
Activ
Activee population, % of total population 54.6 58.5 61.2 62.6 62.2 62.1 62.9
Dependent population, total, '000 25,963.0 29,624.8 30,661.6 32,653.1 36,980.5 40,749.6 43,181.9
Dependent rratio,
atio, % of total w
working
orking age 83.1 71.0 63.3 59.8 60.9 61.1 59.1
Youth population, total, '000 23,541.0 26,430.3 27,241.6 29,039.1 32,715.9 35,689.4 37,180.8
Youth population, % of total w
working
orking age 75.3 63.3 56.3 53.2 53.9 53.5 50.9
Pensionable population, '000 2,421.9 3,194.5 3,420.1 3,614.0 4,264.6 5,060.2 6,001.1
Pensionable population, % of total w
working
orking age 7.7 7.7 7.1 6.6 7.0 7.6 8.2
f = BMI forecast. Source: World Bank, UN, BMI

Urban/R
Urban/Rur
ural
al P
Population
opulation And Lif
Lifee Expectancy (Egypt 1990-2025)
Indicator 1990 2000 2005 2010 2015 2020 2025f
Urban population, '000 24,875.8 30,544.8 34,023.7 37,535.1 41,811.1 45,976.8 50,514.7
Urban population, % of total 43.5 42.8 43.0 43.0 42.8 42.8 43.4
Rur
ural
al population, '000 32,338.9 40,826.6 45,051.6 49,717.3 55,912.7 61,488.3 65,760.8
Rur
ural
al population, % of total 56.5 57.2 57.0 57.0 57.2 57.2 56.6
Lif
Lifee eexpectancy
xpectancy at bir
birth,
th, male, yyear
earss 62.2 65.9 66.4 67.1 68.0 68.7 69.9
Lif
Lifee eexpectancy
xpectancy at bir
birth,
th, ffemale,
emale, yyear
earss 66.0 70.1 71.2 72.3 73.1 73.4 74.9
Lif
Lifee eexpectancy
xpectancy at bir
birth,
th, av
aver
erage,
age, yyear
earss 64.1 68.0 68.8 69.7 70.5 71.0 72.4
f = BMI forecast. Source: World Bank, UN, BMI

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sources. Fitch Ratings analysts do not share data or information with BMI.

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Population B
Byy Age Gr
Group,
oup, % (Egypt 1990-2025)
Indicator 1990 2000 2005 2010 2015 2020 2025f
Population, 0-4 yr
yrs,
s, total, '000 8,855.1 8,995.9 9,578.7 10,580.8 12,635.0 12,548.7 12,075.0
Population, 5-9 yr
yrs,
s, total, '000 7,902.3 8,735.9 8,944.0 9,532.7 10,555.7 12,598.0 12,520.1
Population, 10-14 yr
yrs,
s, total, '000 6,783.7 8,698.5 8,718.8 8,925.5 9,525.2 10,542.6 12,585.7
Population, 15-19 yr
yrs,
s, total, '000 5,719.0 7,841.3 8,680.2 8,682.8 8,922.0 9,498.9 10,519.9
Population, 20-24 yr
yrs,
s, total, '000 5,083.0 6,706.5 7,832.3 8,620.1 8,703.0 8,873.5 9,458.3
Population, 25-29 yr
yrs,
s, total, '000 4,478.6 5,622.1 6,694.8 7,760.1 8,644.0 8,642.6 8,823.9
Population, 30-34 yr
yrs,
s, total, '000 3,806.8 4,972.6 5,601.9 6,622.1 7,766.4 8,581.6 8,589.9
Population, 35-39 yr
yrs,
s, total, '000 3,141.0 4,360.5 4,938.4 5,530.7 6,603.0 7,699.7 8,518.7
Population, 40-44 yr
yrs,
s, total, '000 2,651.3 3,681.1 4,306.5 4,859.8 5,486.8 6,523.9 7,618.5
Population, 45-49 yr
yrs,
s, total, '000 1,829.7 3,005.3 3,608.5 4,211.1 4,787.5 5,392.3 6,418.0
Population, 50-54 yr
yrs,
s, total, '000 1,646.3 2,481.6 2,891.5 3,465.8 4,073.5 4,636.8 5,223.8
Population, 55-59 yr
yrs,
s, total, '000 1,590.1 1,656.6 2,338.9 2,715.5 3,276.1 3,861.5 4,393.6
Population, 60-64 yr
yrs,
s, total, '000 1,306.1 1,419.0 1,520.6 2,131.2 2,481.0 3,004.7 3,529.0
Population, 65-69 yr
yrs,
s, total, '000 996.1 1,270.1 1,240.1 1,325.3 1,849.8 2,154.7 2,587.6
Population, 70-74 yr
yrs,
s, total, '000 695.1 922.4 1,035.8 1,005.2 1,079.1 1,493.1 1,714.8
Population, 75-79 yr
yrs,
s, total, '000 422.0 574.3 654.4 734.4 712.7 771.1 1,038.8
Population, 80-84 yr
yrs,
s, total, '000 210.8 288.8 331.8 373.7 424.9 412.7 441.7
Population, 85-89 yr
yrs,
s, total, '000 77.1 108.1 123.4 138.2 156.4 181.2 166.7
Population, 90-94 yr
yrs,
s, total, '000 18.4 26.8 30.0 32.6 36.6 41.8 45.2
Population, 95-99 yr
yrs,
s, total, '000 2.4 3.8 4.3 4.3 4.8 5.3 5.9
Population, 100+ yr
yrs,
s, total, '000 0.1 0.2 0.3 0.3 0.3 0.3 0.4
f = BMI forecast. Source: World Bank, UN,BMI

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sources. Fitch Ratings analysts do not share data or information with BMI.

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Population B
Byy Age Gr
Group,
oup, % (Egypt 1990-2025)
Indicator 1990 2000 2005 2010 2015 2020 2025f
Population, 0-4 yr
yrs,
s, % total 15.48 12.60 12.11 12.13 12.93 11.68 10.38
Population, 5-9 yr
yrs,
s, % total 13.81 12.24 11.31 10.93 10.80 11.72 10.77
Population, 10-14 yr
yrs,
s, % total 11.86 12.19 11.03 10.23 9.75 9.81 10.82
Population, 15-19 yr
yrs,
s, % total 10.00 10.99 10.98 9.95 9.13 8.84 9.05
Population, 20-24 yr
yrs,
s, % total 8.88 9.40 9.90 9.88 8.91 8.26 8.13
Population, 25-29 yr
yrs,
s, % total 7.83 7.88 8.47 8.89 8.85 8.04 7.59
Population, 30-34 yr
yrs,
s, % total 6.65 6.97 7.08 7.59 7.95 7.99 7.39
Population, 35-39 yr
yrs,
s, % total 5.49 6.11 6.25 6.34 6.76 7.16 7.33
Population, 40-44 yr
yrs,
s, % total 4.63 5.16 5.45 5.57 5.61 6.07 6.55
Population, 45-49 yr
yrs,
s, % total 3.20 4.21 4.56 4.83 4.90 5.02 5.52
Population, 50-54 yr
yrs,
s, % total 2.88 3.48 3.66 3.97 4.17 4.31 4.49
Population, 55-59 yr
yrs,
s, % total 2.78 2.32 2.96 3.11 3.35 3.59 3.78
Population, 60-64 yr
yrs,
s, % total 2.28 1.99 1.92 2.44 2.54 2.80 3.04
Population, 65-69 yr
yrs,
s, % total 1.74 1.78 1.57 1.52 1.89 2.01 2.23
Population, 70-74 yr
yrs,
s, % total 1.21 1.29 1.31 1.15 1.10 1.39 1.47
Population, 75-79 yr
yrs,
s, % total 0.74 0.80 0.83 0.84 0.73 0.72 0.89
Population, 80-84 yr
yrs,
s, % total 0.37 0.40 0.42 0.43 0.43 0.38 0.38
Population, 85-89 yr
yrs,
s, % total 0.13 0.15 0.16 0.16 0.16 0.17 0.14
Population, 90-94 yr
yrs,
s, % total 0.03 0.04 0.04 0.04 0.04 0.04 0.04
Population, 95-99 yr
yrs,
s, % total 0.00 0.01 0.01 0.00 0.00 0.00 0.01
Population, 100+ yr
yrs,
s, % total 0.00 0.00 0.00 0.00 0.00 0.00 0.00
f = BMI forecast. Source: World Bank, UN, BMI

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Pharmaceuticals Glossary
Terms Used In Datasets, Daily Analysis And Reports

Pharmaceuticals, medicines, drugs: Synonym terms used interchangeably.

Pharmaceutical market/sales: The sum of revenues generated by generic, patented and over-the-counter (OTC) drugs through
hospitals, retail pharmacies and other channels. Unless otherwise stated, market value is reported at final consumer price including
mark-ups, taxes, etc.

Prescription drugs: Patented and generic medicines regulated by legislation that requires a physician's prescription before they
can be sold to a patient.

Patented drug: An innovative medicine granted intellectual property protection by a patent office. The patent may encompass a
wide range of claims, such as active ingredient, formulation, mode of action, etc, giving the patent holder the sole right to sell the
drug while the patent is in effect.

Generic drug: A bioequivalent medicine that contains the same active ingredient as an originator drug. The originator drug is an
innovative medicine that no longer has intellectual property protection due to patent expiry. The definition for generic drugs
includes off-patent originator medicines.

Over-the-counter (OTC) drug: A medicine that does not require a prescription to be sold to patients. Also known as non-
prescription medicines.

Biosmilar: A drug that is similar to a biological reference product, and which is manufactured by a company other than the
originator. Regulatory approval of biosimilars is technically possible following patent expiry of the reference product. There are
several terms used to describe these drugs in various markets, including 'similar biologics' (India), 'similar biological products'
(Singapore) and 'subsequent entry biologics' (Canada). However, biosimilars is the official name given in the EU pharmaceutical
directives, and that was adopted in the 2010 US legislation.

Health Expenditure: The sum of funds mobilised by public sector and private systems for the operation of a healthcare system. It
includes the purchase of healthcare services and goods by public entities such as ministries and social security institutions; or by
private entities such as non-profit institutions, commercial insurance and households acting as complementary funders to the
previously cited institutions or unilaterally disbursing health commodities. The revenue base of these entities varies by market.

Government Health Expenditure: The sum of outlays for health maintenance, restoration or enhancement paid by public sector
entities such as a ministry of health, other ministries, parastatal organisations and social security agencies, including transfer
payments to households to offset medical care costs and extra budgetary funds to finance healthcare provision.

Private Health Expenditure: The sum of outlays for health by private entities such as commercial or mutual health insurance,
households, non-profit institutions serving households, resident corporations and quasi-corporations not controlled by the
authorities.

Hospitals: All institutions that are built, staffed and equipped for the diagnosis of disease; for the treatment, both medical and
surgical, of the sick and the injured; and for their housing during this process. They operate for 24 hours. Two types of patients can
be treated in the hospital: outpatients and inpatients.

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Public Hospitals: All hospitals owned by the authorities or ministry of health in the market (including public specialist, general and
day hospitals).

Private Hospitals: All non-public sector owned hospitals (includes philanthropic, private and union specialist, general and day
hospitals).

Hospital Beds: All beds specially designed for hospitalised patients or others in need of some form of healthcare, which are
regularly maintained and staffed and immediately available for the care of admitted patients.

Public Hospital Beds: All hospital beds in public hospitals.

Private Hospital Beds: All hospital beds in private hospitals.

Bed Occupancy Rate: Daily percentage of beds occupied by patients, averaged over a specified year.

Medical devices: Equipment and products used for diagnosis or therapy in patients. Whereas pharmaceuticals achieve their
principal action by pharmacological, metabolic or immunological means, medical devices act by physical or mechanical means.
Medical devices include a wide range of products, including syringes, thermometers, blood glucose tests, prosthetic limbs,
ultrasound scans and X-ray machines.

Clinical trials: For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or
groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be
referred to as interventional trials. Interventions include, drugs, cells and other biological products, surgical procedures, radiologic
procedures, devices, behavioural treatments, process-of-care changes and preventive care. This definition includes Early Phase I to
Phase IV trials.

Proprietary Tool Terminology

Disability-adjusted life years (DALYs): The sum of the years of life lost (YLL) due to premature mortality in a population and the
years lost due to disability (YLD) for incident cases of the health condition. The DALY is a health gap measure that extends the
concept of potential years of life lost due to premature death (PYLL) to include equivalent years of 'healthy' life lost in states of less
than full health (broadly termed 'disability'). One DALY represents the loss of one year of equivalent full health.

Communicable disease: An infectious disease transmissible (as from person to person) by direct contact with an affected
individual or the individual's discharges or by indirect means (as by a vector).

Non-communicable disease: Also known as chronic diseases, non-communicable diseases are not passed from person to
person. They are of long duration and generally of slow progression.

Innovative Pharmaceuticals Risk/Reward Index (RRI): Quantifies and ranks a market's attractiveness in terms of its
pharmaceuticals industry; it balances the Risks and Rewards of launching innovative medicines in different markets. It should be
emphasised that the RRI broadly assesses the rewards and the risks that a company will face when looking to launch an innovative
drug in a market. For example, we do not differentiate between drugs that are part of different therapeutic groups or whether the
drug being launched is the first to be launched in the market or will be one of the many different drugs of the same therapeutic
class that has been launched in the market.

Rewards: This component of the RRI is composed of an evaluation of an industry's size and growth potential (Industry Rewards),
and also macro industry and/or characteristics that directly impact the size of business opportunities in a specific sector (Country
Rewards).

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Risks: This component of the RRI is composed of an evaluation of micro, industry-specific characteristics, crucial for an industry to
develop to its potential (Industry Risks) and a quantifiable assessment of the market's political, economic and operational profile
(Country Risks).

Acronyms

CAGR: Compound annual growth rate

WHO: World Health Organization

LHS: Left-hand side

RHS: Right-hand side

EUR: Euro

USD: US dollar

Pharmaceuticals Methodology
Connected Thinking

BMI employs a unique methodology known as 'Connected Thinking'. This means that our analysis captures the inter-relatedness of
the global economy, and takes into account all of the relevant political, macroeconomic, financial market and industry factors that
underpin a forecast and view. We then integrate them so as to explain how they interact and affect each other. Our Connected
Thinking approach provides our customers with unique and valuable insight on all relevant macroeconomic, political and industry
risk factors that will impact their operations and revenue-generating potential in the industry/industries within which they operate.

We use a transparent forecasting model as a base for our industry forecasts, but rely heavily on our analysts' expert judgement to
ensure our forecasts capture all of the insights we derive using our unique Connected Thinking approach. We believe analyst
expertise and judgement are the best ways to provide the most accurate, up-to-date and comprehensive insight to our customers.

Pharmaceuticals Methodology

For the Pharmaceuticals industry, we have historical data and 10-year forecasts for 10 pharmaceutical market-level and core
industry variables. Pharmaceutical sales are broken down into over-the-counter (OTC) and prescription (generic and patented)
drugs. We also have historical data and five-year forecasts for pharmaceutical trade balance for each market covered.

Our forecasts are a combination of regression modelling and analyst expert judgement. Our Pharmaceuticals analysts interact with
other analytical teams in BMI, primarily the Country Risk team, to ensure they have a comprehensive understanding of external
factors that may impact the Pharmaceuticals industry outlook either on a market, regional or global level.

In addition, our Pharmaceuticals forecasts draw on considerations of burden of disease levels, healthcare access, spending power,
market and regulatory regime characteristics (pricing, approvals and intellectual property) and company activity.

There is a rolling cycle of data monitoring, with databases being updated on a quarterly basis. Analysts will use their expert

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sources. Fitch Ratings analysts do not share data or information with BMI.

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judgement outside of these cycles to implement forecasts changes when necessary.

Pharmaceuticals Methodology

* Historical data only. ** Five-year forecasts.

Pharmaceutical Sales Forecast Model

Historic pharmaceutical sales data is collected from a range of sources, including:

• national statistics offices


• regulatory agencies
• pharmaceutical trade associations
• company press releases and annual reports
• local news sources

Our pharmaceutical sales forecasts are based on a regression model, using a market's historical time series and key
macroeconomic explanatory variables, primarily total final consumption, from our Country Risk service.

To remove the effect of inflation, real pharmaceutical sales figures are calculated by removing the annual average consumer price
index (CPI).

In addition, we also apply analyst expert judgement to refine and finalise the pharmaceuticals sales forecast based on exogenous
and endogenous variables or events that are not captured by our regression model.

Pharmaceutical sales are expressed in local currency, US dollars and euros.

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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Healthcare Expenditure Forecast Model

We use multiple sources of qualitative and quantitative information to get a comprehensive and balanced view of the healthcare
market. We prioritise local sources such as the ministry of health, the ministry of finance and the statistics agency. To support
comparisons across markets, we use international institutions such as the World Health Organization (WHO), the World Bank and
Eurostat. Other sources of information include private healthcare providers, medical academic researchers and local news sources.
We use historical sources and forecast political, macroeconomic and demographic information, where indicated, from BMI. We have
attempted to provide full coverage of key healthcare indicators for all markets, but some datasets are not made available by the
primary sources.

The models used for healthcare projections are produced by a dedicated quantitative modelling team. Our models use
demographic, macroeconomic and public health projections from our specialist Country Risk and Industry Research teams, using
our ‘Connected Thinking’ methodology to account for quantitative drivers across multiple industries both domestically and
internationally. Proprietary econometric models and inputs are adjusted based on rigorous statistical testing and accuracy tracking
to ensure models are as statistically sound as possible. Following the generation of quantitative projections by the forecast models,
analysts occasionally make adjustments to the results. Using their expert knowledge of the healthcare industry, the analysts amend
growth rates, taking into account factors that have demonstrated influence on particular data indicators in the past. These factors
include, among others, new regulations and changes to the competitive environment. To reinforce the quality of the forecasts, the
datasets are scrutinised regularly, through processes such as analyst peer review, regional/global evaluations and identification of
datapoint outliers. At minimum, every data forecast is updated annually; larger markets and those with fluctuating macroeconomic
variables are updated more frequently.

Pharmaceuticals Trade – Exports/Imports Forecast Model

Historic pharmaceutical trade data is collected from UN COMTRADE and the ITC Trade Map.

Our trade balance is calculated as exports minus imports to determine if a market is a net exporter or importer of pharmaceuticals.
Pharmaceuticals trade data is broken down into blood, vaccines and cultures; pharmaceuticals in bulk form; and pharmaceuticals in
finished dose form.

Our five-year forecasts are based on a regression model, using a market's historical time series. In addition, we also apply analyst
expert judgement to refine and finalise the pharmaceuticals sales forecast based on exogenous and endogenous variables or
events that not captured by our regression model.

Pharmaceutical trade is expressed in local currency, US dollars and euros.

Pharmaceuticals Risk/Reward Index

Our Innovative Pharmaceuticals Risk/Reward Index (RRI) quantifies and ranks a market's attractiveness in terms of its
pharmaceuticals industry; it balances the Risks and Rewards of launching innovative medicines in different markets. It should be
emphasised that the RRI broadly assesses the rewards and the risks that a company will face when looking to launch an innovative
drug in a market. For example, we do not differentiate between drugs that are a part of different therapeutic groups or whether the
drug being launched is the first to be launched in the market or will be one of the many different drugs of the same therapeutic
class that has been launched in the market.

We combine industry-specific characteristics with broader economic, political and operational market characteristics. We weight

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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these inputs in terms of their importance to investor decision-making in a given industry. The result is a nuanced and accurate
reflection of the realities facing investors in terms of first the balance between opportunities and risk and second between industry-
specific and broader market traits. This enables users of the index to assess a market's attractiveness in a regional and global
context.

The RRI also encompasses a combination of our proprietary forecasts and analyst assessment of the regulatory climate, as well as
globally acceptable benchmark indicators (eg, Transparency International's Corruption Perceptions Index). As regulations evolve and
forecasts change, so does the RRI score, providing a highly dynamic and forward-looking result.

The Innovative Pharmaceuticals RRI universe comprises 109 markets.

Benefits Of Using Our Innovative Pharmaceuticals RRI

• Global Rankings: One global table, ranking 109 markets for the launch of innovative pharmaceuticals from least (closest to
zero) to most attractive (closest to 100).
• Accessibility: Easily accessible, top-down view of global, regional or sub-regional Risk/Reward profiles.
• Comparability: Identical methodology across 109 markets allows users to build lists of markets they wish to compare, beyond
the confines of a global or regional grouping.
• Scoring: Scores out of 100 with a wide distribution, provide nuanced investment comparisons. The higher the score, the more
favourable the market profile.
• Quantifiable: Quantifies the Risks and Rewards of doing business in the innovative pharmaceuticals industry in different
markets around the world and helps identify specific flashpoints in the overall business environment.
• Comprehensive: Comprehensive set of indicators, assessing industry-specific risks and rewards alongside political, economic
and operational risks.
• Entry Point: A starting point to assess the outlook for the innovative pharmaceuticals industry, from which users can dive into
more granular forecasts and analysis to gain a deeper understanding of the market.
• Balanced: Multi-indicator structure prevents outliers and extremes from distorting final scores and rankings.
• Methodology: The index is a combination of proprietary BMI forecasts, analyst insights and globally acceptable benchmark
indicators.

Weightings Of Categories And Indicators


Pharmaceuticals Risk/Reward Index

Source: BMI

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sources. Fitch Ratings analysts do not share data or information with BMI.

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The RRI matrix can be split into two distinct components:

Rewards: This component of the RRI is composed of an evaluation of an industry's size and growth potential (Industry Rewards),
and macro industry and/or market characteristics that directly impact the size of business opportunities in a specific industry
(Country Rewards).

Risks: This component of the RRI is composed of an evaluation of micro, industry-specific characteristics, crucial for an industry to
develop to its potential (Industry Risks) and a quantifiable assessment of the political, economic and operational profile (Country
Risks).

Assessing Our Weightings

We deliberately afford Rewards a greater weighting (65% of a market's final RRI score) and within this, the Industry Rewards pillar
accounts for a majority 75%. This is to reflect the fact that when it comes to long-term investment potential, industry size and
growth potential carry the most weight in indicating opportunities, with other structural factors weighing in but to a slightly lesser
extent. In addition, our focus and expertise in emerging and frontier markets has dictated this bias towards industry size and growth
to ensure we are able to identify opportunities in markets where regulatory frameworks are not as developed and industry size is
not as big as in developed markets, but where we know there is a strong desire to invest.

Pharmac
Pharmaceuticals
euticals RRI Indicator
Indicatorss - Rationale And Sour
Sourcces
Source Rationale
Rewards
Industr
Industryy R
Rewar
ewards
ds
Market Expenditure, USDbn BMI Forecast Denotes breadth of pharmaceutical market. Large markets score higher than
smaller ones. Scores are based on annual average expenditure over a five-year
forecast period.
Spending Per Capita, USD BMI Forecast Denotes depth of pharmaceutical market. High-value markets score better than
low-value ones. Scores are based on annual average expenditure over a five-year
forecast period.
Industry Value Growth, % BMI Forecast Denotes industry dynamism. Scores are based on annual average growth over a
five-year forecast period.
Countr
Countryy R
Rewar
ewards
ds
Urban/Rural Split BMI Forecast Urbanisation is used as a proxy for the development of medical facilities.
Predominantly, rural markets score lower.
Pensionable Population, % BMI Forecast Shows the proportion of the population over 65. Markets with ageing
populations tend to have higher per capita expenditure.
Population Growth, % BMI Forecast Fast-growing markets suggest better long-term demand and thus growth for all
industries. Scores are based on annual average growth over a 5-year forecast
period.
Risks
Industr
Industryy Risks
Patent Respect BMI Subjective Markets with fair and enforced intellectual property regulations score higher
Indicator than those with endemic counterfeiting.
Pricing Regime BMI Subjective Markets with a free pricing environment score higher than markets where
Indicator governments and private sector payers put downward pressure on

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Egypt Pharmaceuticals Report | Q2 2024

Source Rationale

pharmaceutical prices as a mechanism to control expenditure.


Protectionism BMI Subjective High scores are awarded to markets which have realised the economic and social
Indicator benefit of pharmaceuticals, in turn modernising the provision of healthcare
through reforms and essential drug lists and encouraging local manufacturing
and research and development by foreign firms.
Countr
Countryy Risks
Long-Term Economic Risk BMI Country Risk Takes into account the structural characteristics of economic growth, the labour
Index Index market, price stability, exchange rate stability and the sustainability of the
balance of payments, as well as fiscal and external debt outlooks for the coming
decade.
Short-Term Economic Risk BMI Country Risk Seeks to define current vulnerabilities and assess real GDP growth, inflation,
Index Index unemployment, exchange rate fluctuation, balance of payments dynamics, as
well as fiscal and external debt credentials over the coming two years.
Long-Term Political Risk Index BMI Country Risk Assesses structural political characteristics based on our assumption that liberal,
Index democratic markets with no sectarian tensions and broad-based income equality
exhibit the strongest characteristics in favour of political stability, over a multi-
year time frame.
Short-Term Political Risk BMI Country Risk Assesses pertinent political risks to investment climate stability over a shorter
Index Index time frame, up to 24 months forward.
Operational Risk Index BMI Operational Risk Focuses on existing conditions relating to four main risk areas: Labour Market,
Index Trade & Investment, Logistics and Crime & Security.

Source: BMI

This commentary is published by BMI – A Fitch Solutions Company, and is not a comment on Fitch Ratings' Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent
sources. Fitch Ratings analysts do not share data or information with BMI.

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