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A high burden of chronic diseases, improving regulatory guidelines and the launch of new products will provide the necessary impetus for the growth of the pharmaceutical market in Saudi Arabia. The Saudi pharmaceutical market is one of the largest markets in the Middle East and the largest among the Gulf Co-operation Council (GCC) members. It was valued at approximately $4 billion in 2013 and is projected to reach $5.9 billion in 2020 at a Compound Annual Growth Rate (CAGR) of 5.8% (Shaikh, 2011).
The incidence of heart diseases has been increasing annually. The major risk factors for cardiovascular disease are a lack of physical activity, unhealthy diet, and tobacco use. Approximately 42% of deaths from non-communicable disease were due to cardiovascular diseases in 2010. In 2010, 50,213 men and 42,790 women with cardiovascular disease visited primary healthcare centers (MOH, 2013).
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Increasing access to medicines, increasing affordability and increasing general awareness of common diseases are the other factors that will drive the pharmaceutical market.
Patented drugs have a dominant position in the pharmaceutical market. In 2012, the share of patented drugs was 77.6% of the pharmaceutical market. In 2013, the generic market was worth $320.1 million. The OTC drug market had a low market share of 15.2% of the pharmaceutical market. The OTC drugs market expanded at a CAGR of 11.3% during the 2008–2013 (Shaikh, 2011).
The major multi-national pharmaceutical companies in Saudi Arabia are GlaxoSmithKline (GSK), Pfizer and Novartis. Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO) and Tabuk are the major local players. Imports accounted for 82.4%, or $3.1 billion, of the pharmaceutical market in 2012. The price of pharmaceuticals was less expensive compared with other GCC member countries. These low prices enhance the affordability of pharmaceuticals, boosting the pharmaceutical market.
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The size of the medical device market was approximately $1.7 billion in 2013. The market is projected to reach approximately $2.3 billion by 2020 at a projected CAGR of 4.7%. In vitro diagnostics (20.1%), diagnostic imaging (17.1%) and ophthalmic devices (11.5%) were the major segments in the medical device market in 2013. The key challenges faced by the medical device industry are low expenditure on Research and Development (R&D) by the domestic sector. The government is working to ease cumbersome regulatory processes in order to accelerate the approval of pharmaceuticals and medical devices, which will positively influence the healthcare market.
The Saudi Food and Drug Authority (SFDA) is responsible for ensuring the safety of food and drugs as well as biological and chemical substances. The main task of SFDA is to regulate, manage and control food, drug, medical devices as well as setting up of compulsory standard specifications, whether they are imported or locally manufactured.
SFDA has established an online application and registration system for market authorization procedure, and the applicant can also now provide the information for the application in either English or Arabic or both. This benefits local and foreign pharmaceutical companies, as language will cease to be a barrier for them. The SFDA has also unified the various marketing-authorization application processes. It also extended the time limit for submitting documents by the applicant, when SFDA asks the applicant for specific data.
Saudi Arabia became a member of the World Trade Organization (WTO) in December, 2005. Prior to its accession, Saudi Arabia reformed its trade.
Table of Contents
1 Table of Contents
2 Introduction
3 Overview of the Pharmaceutical and Medical Device Market
4 Market Access
5 Country Analysis
6 Opportunities and Challenges
7 Appendix
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