KSA Market Highlights:

The human vaccine industry in Saudi Arabia is predominantly controlled by multinational vaccine manufacturers, with only one local production facility. In 2021, Sanofi, GlaxoSmithKline (GSK), and Pfizer held a combined market share of over 90% in the country, with Sanofi and GSK alone accounting for 70% of the market. This aligns with the global vaccine market, where the top five vaccine producers hold 77% of the market share.

In the Saudi Arabian vaccine market in 2021, the combined market value of the top five most requested vaccines accounted for 83% of the total, and these vaccines are the pneumococcal conjugate vaccine (PCV), meningococcal conjugate vaccine (MCV), rotavirus vaccine (RV), varicella zoster vaccine (VZV), and the diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b, and hepatitis b (DTaP/IPV/Hib/HepB) vaccine.

ُ The vaccines listed above are included in the national immunization schedule of the Ministry of Health (MOH). These vaccines are sourced from global pharmaceutical companies such as GlaxoSmithKline (GSK), Sanofi, and Pfizer as they are imported into Saudi Arabia.

In 2021, a significant majority of the requested doses for RV and VZV vaccines, accounting for 76% and 97% respectively in terms of value, were supplied by GSK. Similarly, Sanofi provided 99% of the requested doses for MCV vaccine and 95% for DTaP/IPV/Hib/HepB vaccine. Additionally, Pfizer supplied over 99% of the requested doses for PCV vaccine. These statistics demonstrate that Saudi Arabia heavily depends on international pharmaceutical companies to meet its vaccination demands for the national immunization program.

As the occurrence of new and previously known infectious diseases increases worldwide, there is a growing anticipation for higher demand for human vaccines. This can be attributed to factors such as increased travel and higher population density in many areas, which contribute to the spread of these diseases. Additionally, there is an expected rise in the demand for region-specific vaccines, including halal variations. Gelatin, which is derived from the boiling of animal skin and bones, including cows, is commonly used in certain vaccines as a stabilizing agent. However, in halal vaccines, gelatin sourced from bovine animals is used as a substitute for non-halal ingredients.

Due to the expanding population in the Kingdom of Saudi Arabia, there is an expected increase in the demand for vaccines in the local market. The population in Saudi Arabia has grown by approximately 1.2% between mid-2020 and mid-2021, according to the General Authority for Statistics (GAS). This demographic shift may result in a greater requirement for pediatric vaccinations to cater to the needs of the growing population. It is estimated that the vaccine market in Saudi Arabia will witness a compound annual growth rate (CAGR) of 3% over the next five years.

Multinational companies that produce human vaccines often adopt a tiered pricing approach, where the pricing of vaccines is determined based on the income level and financial capacity of different countries. This means that the same vaccine may be sold at a higher price to wealthier countries and at a lower price to developing countries. In the Kingdom of Saudi Arabia, the selling prices of human vaccines are regulated by the Saudi Food and Drug Authority (SFDA).

Vaccines are priced on a per-dose basis and the price may vary depending on factors such as the type of vaccine, the income group of the purchasing country, the procurement method, and the terms of the contract. In the Kingdom of Saudi Arabia, the National Unified Procurement Company (NUPCO) is responsible for sourcing and purchasing medications and medical devices. Regarding the top five most sought-after vaccines in the country, the cost per dose is provided in the table below. It is important to note that most vaccines require multiple doses to achieve immunity in an individual

Source: SFDA Drug List

The Saudi Food & Drug Authority (SFDA) is in charge of overseeing and supervising the human vaccine industry in Saudi Arabia. SFDA has implemented numerous laws and regulations to regulate this sector. Local factories are required to meet the “Good Manufacturing Practice” standards in order to be permitted to operate in Saudi Arabia. Additionally, human vaccines must obtain Market Authorization Approval from SFDA before they can be sold and distributed in the Saudi market.

Saudi Arabia is actively working towards establishing local production of human vaccines. On July 6th, 2023, the Arab Company for Pharmaceutical Products (Arabio), Sanofi, and Lifera (a biopharmaceutical company owned by the Public Investment Fund (PIF)) entered into a Memorandum of Understanding (MOU) with the aim of developing local vaccine manufacturing capacity. According to the MOU, Lifera will serve as a contract manufacturer for Sanofi and Arabio, while Tamer Group (a significant shareholder of Arabio) will handle local and regional vaccine distribution needs.

In May 2023, SaudiVax, a biopharmaceutical company based in Saudi Arabia, entered into a partnership with the Human Resources Development Fund (HRDF) to develop a biomanufacturing training program. The objective of this program is to equip individuals with the necessary knowledge and skills to pursue careers in the biopharmaceutical industry. The training program commenced in June 2023 and has recently been accredited by the Saudi Commission for Health Specialties (SCFHS).