1. Global Market Potential for Halal Vaccines
October 29, 2014
Dr. Tabassum Khan

2. Halal Vaccines- An Introduction
As the Muslim population continues to grow (estimated at 1.6 billion people in 2014), demand for halal alternatives is increasing, driving investments in this area. Therefore, it has become strategically essential to know about the potential for halal vaccines covering financial, medical and social aspects.
The Million Dollar Question: Will Halal Vaccines have a negative impact on the current immunization goals? Will the arrival of halal vaccines in immunization coverage lead to disease prevention in larger segments of the populations through increased acceptability?

3. Global Potential for Halal Vaccines
It is extremely important to comprehend that studying the potential for halal vaccines does not undermine the importance of current vaccines nor does it entail that the unavailability of halal vaccines should jeopardize the current immunization goals
On the contrary it creates a larger canvas where the current immunization coverage could be improved by removing the mental blockade in certain segments of the population
It should also be well understood that development of halal vaccines should not in any way compromise on the quality and should not be inferior in any aspect to the existing vaccines.
The development of halal vaccines should be based on two principles; first and foremost they should exhibit at least non-inferiority to the existing vaccines and secondly they should be acceptable from a social Muslim perspective.

4. Halal Pharmaceuticals: A Definition
Halal pharmaceuticals are drug products that do not contain any parts or products of animals that are regarded as non-halal by Sharia law (dogs, pigs, and their descendants) or any parts or products of animals that are not slaughtered according to Sharia law
During their preparation, processing, handling, packaging, storage, and distribution, halal pharmaceutical products need to be physically separated from other pharmaceutical products that do not meet the requirements for halal products, or any other items that have been regarded as non-halal by Sharia law
As with other pharmaceutical products, halal pharmaceuticals are also safe for consumption, non-poisonous, non-intoxicating, and non-hazardous to health according to prescribed dosage

5. Perceived definitions of Halal vaccines in key markets
Through interviews with a cross-section of the population in the Islamic world, where they were asked how they perceive halal vaccines, the following points emerged:
In the current scenario, in some Muslim populated countries pork-free and alcohol free vaccines are regarded as halal, though not certified as halal
In most Islamic countries, authorities did not have a clear cut definition of halal vaccines based on Shariah law
Malaysia, and to a lesser extent India, had a more clear cut approach towards halal certification of vaccines
It was a common perception that Islamic religious leaders would play a key role in defining Halal vaccine standards
All the countries across APAC, North Africa, and GCC region follow similar definition for halal vaccines in compliance with the Shariah law
Islamic leaders in the region play a key role in defining acceptance of a given vaccine as halal

6. Perceived definition contd.
However according to experts in the field, any vaccine can be certified as halal ONLY if it complies with following guidelines:
The vaccine does not contain any parts or products of animals that are non- halal by Shariah law or any parts or products of animals that are not slaughtered according to Shariah law
Entire production line and manufacturing facility, including devices, machines, and processing aides deployed at a manufacturing facility must be used for production of halal vaccines or halal pharmaceutical products only
Sufficient measures should be taken to prevent contamination of vaccine at all stages of production
Processing, handling, packaging, storage, and transportation should be physically separated from any other non-halal product or najs

7. Guidelines for Halal Pharmaceuticals MS 2424

8. Global Pharmaceutical Market Sales and Dynamics by Segment (2013)

9. Global Vaccine Market Performance
World Vaccine Market as a fraction of the Global Pharmaceutical Market: 2.8 percent

10. Global Market Potential for Halal Vaccines

11. Global Potential for Halal Vaccines- Introduction
Malaysia is a global hub of halal industry and can become the world's first halal vaccine hub
The potential for Halal vaccines
It was estimated that Muslim consumers globally spent USD 70 billion on pharmaceuticals in 2012, which was 6.6% of global pharmaceuticals expenditure
Vaccines can be controversial:
Many Muslims refuse to vaccinate their children due to various reasons, including the belief of the presence of porcine elements in the manufacturing process in some vaccines The meningitis vaccine is required for hajj pilgrims but the halal status of the variants that are available in the market have been contested
Etc.
The Organization of the Islamic Conference (OIC) is emphasizing a push to make vaccines that conform to religious dietary restrictions in an effort to increase their use and improve public health
According to several specialists, Malaysia has potential to position itself as the leader in the production of halal vaccines and medicines
Source: “State of the global Islamic economy”, Thomson Reuters,

12. Most attractive countries
The first Muslim population is in India even if they represent a minority, while in Indonesia and Pakistan, the 2nd and 3rd countries, they count for more than 80%
Muslim population - Top 20 countries
Total Muslim population 2014: Billion
Top 20 countries = 82% of Muslims
Muslim population (million)
Muslim percentage of total population
14.4%
86.1%
96.4%
90.4%
94.7%
47.9%
99.6%
98.6%
98.2%
99.9%
98.9%
71.4%
99.8%
33.8%
96.5%
97.1%
99.0
1.8%
92.8%
61.4%
Percentage of World Muslim population
13.4%
12.7%
10.9%
9.2%
4.9%
4.7%
4.6%
2.1%
2.0%
1.9%
1.8%
1.6%
1.5%
1.4%
1.3%
1.1%
Source: "Muslim Population by Country". The Future of the Global Muslim Population. Pew Research Center. Retrieved 22 December "Region: Middle East-North Africa". The Future of the Global Muslim Population. Pew Research Center. Retrieved 22 December Pew Research Center 2014

13. Most attractive countries
The Organization of the Islamic Conference counts 57 countries, mainly localized in the Middle-East, Africa and South Asia and does not count India
Organization of the Islamic Conference (OIC) countries
Islamic Republic of Afghanistan
Republic of Gabon
Republic of Maldives
Republic of The Sudan*
Republic of Albania
Republic of The Gambia
Republic of Mali
Republic of Suriname
People’s Democratic Republic of Algeria
Republic of Guinea
Islamic Republic of Mauritania
Syrian Arab Republic
Republic of Azerbaijan
Republic of Guinea-Bissau
Kingdom of Morocco
Republic of Tajikistan
Kingdom of Bahrain
Republic of Guyana
Republic of Mozambique
Republic of Togo
People’s Republic of Bangladesh
Republic of Indonesia
Republic of Niger
Republic of Tunisia
Republic of Benin
Islamic Republic of Iran
Federal Republic of Nigeria
Republic of Turkey
Brunei-Darussalam
Republic of Iraq
Sultanate of Oman
Republic of Turkmenistan
Burkina-Faso
Hashemite Kingdom of Jordan
Islamic Republic of Pakistan
Republic of Uganda
Republic of Cameroon
Republic of Kazakhstan
State of Palestine
State of The United Arab Emirates
Republic of Chad
State of Kuwait
State of Qatar
Republic of Uzbekistan
Union of The Comoros
Kyrgyz Republic
Kingdom of Saudi Arabia
Republic of Yemen
Republic of Côte d’Ivoire
Republic of Lebanon
Republic of Senegal
Republic of Djibouti
Great Socialist People’s Libyan Arab Jamahiriya
Republic of Sierra Leone
Arab Republic of Egypt
Malaysia
Republic of Somalia *
Source:
* South Sudan not included

14. Most attractive countries
In 2012, the first country in terms of pharmaceutical Muslim consumers was Turkey, followed by Saudi Arabia and Indonesia
Muslim pharmaceutical expenditures
Top 20 countries (2012)
Top 5 countries (2012) 1 4 2 5 3
Source: “State of the global Islamic economy”, Thomson Reuters, 2013

15. Most attractive countries
Turkey is the only country belonging to both top 5 medicines importers and top 5 exporters to the Organization of the Islamic Conference (OIC) countries
Top medicines importers and exporters to the OIC countries
Top 5 countries (2012)
Top importing countries
USD B 1 2 1 2 3 4 5
5/2 3 4 5
Top exporting countries
USD B 1 2 3 4 5
Source: State of the Global Islamic Economy Report 2013

16. Most attractive countries
UNICEF procures vaccines and immunization supplies on behalf of around 100 countries annually
Overview of UNICEF procurement
Immunization Supplies
Vaccines: BCG , DTP, TT/Td/DT, Measles containing, OPV, HepB, YF, DTP-HepB, DTP-HepB/Hib, DTP/Hib, Hib, MR, Meningitis, MMR, PCV, RV, HPV, IPV, etc.
Safe Injection equipment
Cold Chain Equipment
Countries UNICEF procures on behalf of
2012
Vaccines Supplies
USD 1,053m
1.89 B doses
1,946 shipments
Full schedule
Partial schedule
Source: UNICEF Procurement Advancements, October 2013

17. Most attractive countries
34 OIC countries are eligible for GAVI or UNICEF or both supports; the majority of these counties are located on the African continent
Overview of both UNICEF / GAVI and OIC countries
South America: 1 country
Africa: 24 countries
Middle-east: 7 countries
Asia: 2 countries
Number of countries eligible for GAVI and/or UNICEF support
OIC + UNICEF full or partial schedule procurement
OIC + eligible for GAVI support
OIC + UNICEF + GAVI support
Sources: UNICEF, GAVI, OIC

18. Most attractive countries
Indonesia is a secular state with a high percentage of Muslims; it’s the 2nd biggest market in terms of target population but suffers from low immunization coverage
Top 10 most attractive countries for halal vaccines (2/10)
Place of Islam
Indonesia
Islamic republic
State religion
Secular state
Population data
Immunization data
Total population (2015):
Muslim population (2015):
(86.1%)
Births / year (2012):
Surviving infants (2012):
Infants mortality rate (per 1000 live birth, 2012): 26
Under-five mortality rate (per 1000 live birth, 2012): 31
Gross national income/capita (USD, 2012):
4 810
Percentage of routine EPI¹ vaccines financed by government (2012):
No data
Immunization coverage (2012)
Corresponding population / year (2015)
Immunization schedules (2012)
BCG: 1 month
DT: 6 years
DTwPHep: 2, 3, 4 months
Hep. B: 0-7 days
Polio: 2, 3, 4 months
Oral polio: 1, 2, 3, 4 months
Measles: 9 month, 6 years
Tetanus, diphteria: 7-8 years
Vitamin A: 6-59 months
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Sources: United Nations, Department of Economic and Social Affairs, Population Division – WHO immunization summary, 2014 edition – PEW Research on religion and public life – Smart Pharma Consulting analyses
¹Bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), oral polio, measles, hepatitis B (HepB), yellow fever in countries endemic for the disease, and Haemophilus influenzae meningitis (Hib) conjugate vaccine in countries with high burden of disease

19. Most attractive countries
The Islamic republic of Pakistan is an important market in terms of target population but has low immunization coverage and is relatively poor
Top 10 most attractive countries for halal vaccines (3/10)
Place of Islam
Pakistan
Islamic republic
State religion
Secular state
Population data
Immunization data
Total population (2015):
Muslim population (2015):
(96.4%)
Births / year (2012):
Surviving infants (2012):
Infants mortality rate (per 1000 live birth, 2012): 69
Under-five mortality rate (per 1000 live birth, 2012): 86
Gross national income/capita (USD, 2012):
3 030
Percentage of routine EPI¹ vaccines financed by government (2012):
No data
Immunization coverage (2012)
Corresponding population / year (2015)
Immunization schedules (2012)
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BCG: birth
DT: 6 years
DTwPHibHep: 6, 10, 14 weeks
Measles: 9, 15 months
Oral polio: birth, 6, 10, 14 weeks
Pneumo. conjugate: 6, 10, 14 weeks
Tetanus: 1st contact or pregnancy, +1 month, +6 months, +1 year, +1 year
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Sources: United Nations, Department of Economic and Social Affairs, Population Division – WHO immunization summary, 2014 edition – PEW Research on religion and public life – Smart Pharma Consulting analyses
¹ Expanded Program on Immunization: Bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), oral polio, measles, hepatitis B (HepB), yellow fever in countries endemic for the disease, and Haemophilus influenzae meningitis (Hib) conjugate vaccine in countries with high burden of disease

20. Most attractive countries
Malaysia’s high vaccination coverage and extensive immunization schedule make this relatively rich country an attractive market for halal vaccines
20th most attractive country for halal vaccines - Malaysia
Place of Islam
Malaysia
Islamic republic
State religion
Secular state
Population data
Immunization data
Total population (2015):
Muslim population (2015):
(61.4%)
Births / year (2012):
Surviving infants (2012):
Infants mortality rate (per 1000 live birth, 2012): 7
Under-five mortality rate (per 1000 live birth, 2012): 9
Gross national income/capita (USD, 2012):
16 530
Percentage of routine EPI¹ vaccines financed by government (2012):
No data
Immunization coverage (2012)
Corresponding population / year (2015)
Immunization schedules (2012)
BCG: birth
DT: 7 years
DTwPHibPolio: 2, 3, 5, 18 months
Hep. B: birth, 1, 6 month, health workers
HPV: 13 years
Jap. E: 9, 10, 18 months, 5, 8, 11 years
Measles: 6 months
MMR: 1 year
MR: 7 years
Oral polio: 7 years
Tdap: 15 years
Tetanus: 15 years, pregnancy
Typhoid: food handlers
Yellow fever: travelers to endemic countries
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Sources: United Nations, Department of Economic and Social Affairs, Population Division – WHO immunization summary, 2014 edition – PEW Research on religion and public life – Smart Pharma Consulting analyses
¹ Expanded Program on Immunization: Bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), oral polio, measles, hepatitis B (HepB), yellow fever in countries endemic for the disease, and Haemophilus influenzae meningitis (Hib) conjugate vaccine in countries with high burden of disease

21. Key success factors on the halal vaccines market
Pharmaceutical companies involved in halal medicines and/or vaccines should help the public understand that halal products are not necessarily just food and drinks
Drivers and limiters in the Halal pharmaceutical market
DRIVERS
LIMITERS
Increasing population of Muslims
Rising income among Muslim consumers
Increasing demand for Halal pharmaceuticals and vaccines, thus, huge opportunities for global suppliers as well as niche producers in the pharmaceutical value chain (e.g. companies that produce halal adjuvants)
OIC exporters/producers: many large pharmaceutical companies (eg. Julphar, Eczacıbaşı’s, Hikma, Kalbe Farma, etc.) from OIC countries have the infrastructure and resources to boost the market
Both authorities and NGOs are working to deliver universal access to immunization
Regulations/certifications:
Difference in certification standards and regulations (e.g. in Indonesia, making mandatory halal regulations for pharmaceuticals is getting industry pushback)
Certification process and standard may differ from country to country and one certification body to another
Long product development cycles
Controversy on vaccine usage that might be palliated through education, transparency and regulation/compliance
Lack of education and awareness: majority of the consumers (especially in Muslim majority markets) are ambivalent or unaware of non-allowed ingredients in medicine or cosmetics
Emerging competition on the halal vaccines market : Novartis MenA- CWY135 is the first quadrivalent conjugate vaccine and Global Vacc al- shifa’s HiB vaccine have received a halal certification
Source: “State of the global Islamic economy”, Thomson Reuters, Factors driving halal pharma market, Ecron Acunova – Smart Pharma Consulting analyses

22. Market sales potential by 2030
Expanded Program on Immunization, pneumococcal and rotavirus vaccines account for USD 14.9 B and 62% of the vaccines market among the top 4 companies
Methodology – Analyzed vaccines
Meningococcal vaccines
Influenza vaccines
Human papillomavirus vaccines
Herpes zoster vaccines
Adult booster vaccines
Travel or endemics vaccines
Others
Value of the global market by vaccine category in 2013
Value of the global market by vaccine category in 2030
Non-WHO EPI or pneumococcal or rotavirus
USD M
(38%)
Non-EPI & non-pneumococcal & non-rotavirus vaccines global market:
USD 10.5 B
Non-EPI & non-pneumococcal & non-rotavirus vaccines global market:
USD 30.8 B
Measles containing vaccines
Hepatitis B vaccines
DTP vaccines
Hib vaccines
BCG vaccines
Pneumococcal vaccines
Rotavirus vaccines
WHO EPI + pneumococcal + rotavirus
USD M
(62%)
EPI
EPI + pneumococcal + rotavirus vaccines global market:
USD 17.5 B
EPI + pneumococcal + rotavirus vaccines global market:
USD 50.2 B
Total = USD 28 B
Total = USD 81 B
Analyzed vaccines
Estimated split after the 2013 sales of top 4 manufacturers
Sources: Annual reports 2013 – Evaluate Pharma World Preview 2018 (2013) – Smart Pharma Consulting analyses
EPI: Expanded Program on Immunization: Bacillus Calmette-Guérin (BCG), diphtheria-tetanus-pertussis (DTP), oral polio, measles, hepatitis B (HepB), yellow fever in countries endemic for the disease, and Haemophilus influenzae meningitis (Hib) conjugate vaccine in countries with high burden of disease

23. Market sales potential by 2030
The estimate of the number of doses per year takes into account the % of newborn Muslims p.a., the immunization coverage and the received number of doses
Methodology – Number of doses
1000
820 40
Number of Muslim infants
Illustrative
Immunization coverage
for each vaccine in each country (according to WHO data)
Recommended number of doses
for each vaccine in each country (according to UNICEF & WHO data)
Potential number
of doses per year of halal vaccines in the top 20 Muslim countries
Sources: PEW research – United Nations – UNICEF/WHO immunization summary report 2014 – WHO immunization coverage – Smart Pharma Consulting analyses

24. Market sales potential by 2030
Three price categories were chosen to cover the analyzed countries and penetrations rates have been set according to the place of Islam and the % of Muslim in the country
Methodology – Prices & penetration rates
Prices
Penetration rates
Pharmaceutical expenditures per capita
Place of Islam in the country
Low
Medium
High
Secular country
State religion
Islamic republic
Low
Very low penetration
N/A
N/A
UNICEF / GAVI procurement prices
PAHO procurement prices + 11%¹
European prices based on the French case
Medium
% of Muslim in the country
Afghanistan Bangladesh
Ethiopia
India
Nigeria
Pakistan  
 Uzbekistan
Yemen
Algeria
China
Egypt
Indonesia 
Iraq
Iran
Malaysia
Morocco
Sudan
Syria
Saudi Arabia Turkey
Low
penetration
Medium penetration
N/A
High
Medium penetration
High
penetration
Very high penetration
Sources: World Bank – GAVI – PAHO – GERS – Smart Pharma Consulting analyses
¹ According to PAHO revolving fund director "A country that purchases through the Revolving Fund can save at least 11% in comparison to direct purchases from the producers”

25. Market sales potential by 2030
In 2020, 2 years after the estimated arrival of the first halal vaccines, the considered market is expected to be worth USD 96 million in the top 20 Muslim countries
Halal vaccines market in the top 20 Muslim countries
Halal vaccines market in selected countries: USD ≈ 96 M
Market in USD, million
BCG
DTP & combinations
Hepatitis B & combinations
Haemophilus influenzae & combinations
Measles containing vaccines
Polio
Pneumococcal
Rotavirus
Vaccines considered
Sources: Smart Pharma Consulting analyses

26. Market sales potential by 2030
In 2030, the considered halal vaccines market is estimated to be worth USD 1.1 billion in the top 20 countries in terms of Muslim population
Halal vaccines market in the top 20 Muslim countries
Halal vaccines market in selected countries: USD ≈ 1,144 M
Market in USD, million
BCG
DTP & combinations
Hepatitis B & combinations
Haemophilus influenzae & combinations
Measles containing vaccines
Polio
Pneumococcal
Rotavirus
Vaccines considered
Sources: Smart Pharma Consulting analyses

27. Market sales potential by 2030
The two countries (Turkey & Saudi Arabia) showing the highest pharmaceutical expenditures count for almost half of the selected halal vaccines market in 2030
Halal vaccines market in the top 20 Muslim countries – 2020 / 2030
USD m
Market in USD m
High pharmaceutical expenditures
Middle pharmaceutical expenditures
Low pharmaceutical expenditures
USD 96 M
Sources: Smart Pharma Consulting analyses

28. Market sales potential by 2030
The extrapolated halal vaccines market could reach USD 188 m in 2020 and USD 2.2 B in 2030
Extrapolated halal vaccines market – 2020 / 2030
Market in USD m
Considering that the top 20 countries analyzed account for 82% of the Muslims, the halal market among the total Muslim population is estimated to be worth:
Considering that the analyzed vaccines account for 62% of the total vaccines market, the total halal vaccines market is worth:
2020
2030
USD 116 m
USD m
2020
2030
USD 188 m
USD m
Sources: Smart Pharma Consulting analyses

29. Key Learning & Recommendations
Conclusion
There is a huge opportunity as the halal vaccines market could reach 2.2 B in 2030 but they would face several hurdles
Key Learning & Recommendations
There is an opportunity to develop halal vaccines as the Muslim population is increasing and so is the demand for halal pharmaceuticals, including vaccines
Both authorities and NGOs are working to deliver universal access to immunization and the halal vaccine could touch population that are under vaccinated or not vaccinated
In 2030, the Halal market could reach approximately USD 2.2 billion, representing a niche on the global preventive vaccines market (approximately 3%) estimated at USD 84 billion
Source: Smart Pharma Consulting

30. Key Learning & Recommendations
Conclusion
There is a huge opportunity as the halal vaccines market could reach 2.2 B in 2030 but they would face several hurdles
Key Learning & Recommendations
Nevertheless, there would be several hurdles:
In terms of regulations and certifications complexity
Due to the long cycle development (10-15 years)
Due to production and distribution constraints
And high associated costs (investment required to launch a new vaccine is approximately USD 700 million)