Market Overview
The Saudi Arabia Sterile Injectables market is US$ XX million in 2023 and is estimated to grow at a CAGR of XX% during the forecast period (2024-2031) to reach a value of US$ XX million in 2031.
Sterile injectables are administered through injection and are required to be free from any living microorganisms or contaminants. These injectables are produced and packaged in a sterile environment to prevent the introduction of bacteria, viruses, fungi, or other harmful substances that could compromise the safety and efficacy of the medication.
Saudi Arabia has witnessed a notable increase in the prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer. The aging population, lifestyle changes, and genetic factors contribute to the higher incidence of these conditions.
Chronic diseases often require long-term and effective management. Sterile injectables are vital in delivering medications directly into the bloodstream, ensuring rapid and precise treatment. This is especially crucial in the case of emergency situations or for patients who have difficulty taking oral medications.
Sterile injectables offer a more efficient drug delivery mechanism compared to oral medications. They ensure that the medication reaches the bloodstream quickly and directly, allowing for faster onset of action and better control of chronic conditions. Thus rise of chronic diseases helps to boost the market growth.
Sterile injectables play a crucial role in surgical procedures by facilitating the administration of medications directly into the patient's bloodstream during the operation. This ensures rapid onset of action and precise control of the patient's physiological parameters.
Many sterile injectables are used in anesthesia induction, maintenance, and pain management during surgical procedures. These medications are administered intravenously or intramuscularly to ensure the patient's comfort and safety throughout the surgery.
Sterile injectables often require specific temperature and storage conditions to maintain their stability and efficacy. This can pose logistical challenges in terms of transportation and storage, particularly for products that are sensitive to temperature fluctuations. The need for specialized cold chain logistics adds complexity and cost to the distribution process.
The limited shelf life of sterile injectables means that they must be used within a certain timeframe to ensure safety and effectiveness. This can lead to wastage if products expire before use, impacting cost-effectiveness. Healthcare facilities must manage their inventory carefully to minimize wastage while ensuring an adequate supply of necessary medications.
Insulin segment is expected to dominate during the forecast period owing to the factors like, rise in the prevalence of diabetes in the country, product launches by key players, advancements in the new formulations and others help the segment to grow during the forecast period.
According to the IDF DIabetes Atlas, the study reveals that diabetes affects a significant number of people in the Saudi Arabia, with a prevalence of 19.6% in the 20-79 age group and a proportion of 43.6 in undiagnosed cases. Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) are also prevalent in the population.
Covid 19 had a substantial impact on the sterile injectable where the sterile injectable products have a higher risk of shortage than other forms, and the unavailability of raw materials was an important reason for drug shortages in Saudi Arabia. Additionally, the COVID-19 pandemic caused shortages of active pharmaceutical ingredients, excipients, and drugs worldwide.
Market Drivers
Increasing prevalence of chronic diseases
Saudi Arabia has witnessed a notable increase in the prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer. The aging population, lifestyle changes, and genetic factors contribute to the higher incidence of these conditions.
Chronic diseases often require long-term and effective management. Sterile injectables are vital in delivering medications directly into the bloodstream, ensuring rapid and precise treatment. This is especially crucial in the case of emergency situations or for patients who have difficulty taking oral medications.
Sterile injectables offer a more efficient drug delivery mechanism compared to oral medications. They ensure that the medication reaches the bloodstream quickly and directly, allowing for faster onset of action and better control of chronic conditions. Thus rise of chronic diseases helps to boost the market growth.
For instance, according to National Heart Centre 2023, estimated that approximately 31% of all deaths are attributed to Cardiovascular Disease (CVD). This leading cause of mortality is emerging as a signicant public health concern for Middle East countries where 45% of all deaths have been attributed to CVD. Each year in the Kingdom of Saudi Arabia (KSA), 294 per 100,000 popeletion die from CVD, with a further 3,702 per 100,000 popeletion non-fatal CVD events, which includes the number of disability-adjusted life years (DALYs) resulting from both hypertensive and ischemic heart disease. Thus above factors helps to boost the market growth.
Market Restraints
Limited shelf life and storage requirements
Sterile injectables often require specific temperature and storage conditions to maintain their stability and efficacy. This can pose logistical challenges in terms of transportation and storage, particularly for products that are sensitive to temperature fluctuations. The need for specialized cold chain logistics adds complexity and cost to the distribution process.
The limited shelf life of sterile injectables means that they must be used within a certain timeframe to ensure safety and effectiveness. This can lead to wastage if products expire before use, impacting cost-effectiveness. Healthcare facilities must manage their inventory carefully to minimize wastage while ensuring an adequate supply of necessary medications.
The requirement for specialized storage facilities, refrigeration, or freezing equipment can increase the overall cost of handling and storing sterile injectables. Healthcare providers and distributors may incur additional expenses to comply with these storage requirements, contributing to the overall cost of healthcare delivery.
The stringent storage conditions and limited shelf life make the supply chain for sterile injectables more vulnerable to disruptions. Events such as power outages, natural disasters, or logistical issues can compromise the integrity of the products, leading to potential shortages and challenges in meeting demand. Thus above factors restrain the market growth.
Market Opportunity
With the increasing incidence of cancer, there is a growing demand for injectable oncology therapeutics. Sterile injectables are commonly used in cancer treatments, and the development of targeted therapies further expands opportunities in the oncology segment.
Many cancer treatments, including chemotherapy and targeted therapies, require precise drug delivery to the tumor site. Sterile injectables offer a direct and controlled method of drug administration, ensuring that the therapeutic agents reach their target with accuracy.
Intravenous (IV) chemotherapy, a common modality in cancer treatment, involves the administration of drugs directly into the bloodstream. Sterile injectables, particularly in the form of IV infusions, are essential for delivering chemotherapy agents efficiently and ensuring a systemic effect against cancer cells.
Sterile injectables play a role in minimizing systemic side effects by allowing for the localized delivery of cancer therapies. This targeted approach can improve treatment outcomes while reducing the impact on healthy tissues and minimizing adverse reactions.
Covid-19 Impact Analysis
The pandemic has led to disruptions in global supply chains, affecting the availability of raw materials, components, and finished products for sterile injectables. Lockdowns, restrictions on movement, and transportation challenges have contributed to delays in manufacturing and distribution. The surge in COVID-19 cases has increased the demand for critical care medications, including sterile injectables used in the treatment of severe respiratory distress and complications associated with the virus.
The development and global distribution of COVID-19 vaccines have prompted pharmaceutical companies to scale up production capacity for sterile injectables, particularly for vaccines that require injection.
Covid 19 had a substantial impact on the sterile injectable where the sterile injectable products have a higher risk of shortage than other forms, and the unavailability of raw materials was an important reason for drug shortages in Saudi Arabia. Additionally, the COVID-19 pandemic caused shortages of active pharmaceutical ingredients, excipients, and drugs worldwide.
Also, Saudi Arabia has experienced 475,500 COVID-19 cases and 7000 fatalities. The country has implemented preventive measures, including banning international flights, closing mosques, schools, and universities, and implementing a reliable vaccine program to mitigate the impact of disease.
The Saudi Arabian Food and Drug Authority approved four COVID-19 vaccines, including Pfizer-BioNTech, Oxford-AstraZeneca, Johnson & Johnson, and Moderna, nationwide. The program began in December 2021 and has immunized around 16 million people.12–14 Vaccine campaign targeted high-risk groups, including the elderly and healthcare professionals.15 Saudi Arabia initiates early immunization drive to combat COVID-19.
Market Segmentation – By Drug Type
The market value for insulin is likely to reach USD XX million in 2031, from its recorded value of USD XX million in 2023, growing with a CAGR of XX% during the forecast period 2024 to 2031.
The rise of insulin in the sterile injectable market can be attributed to various factors driven by the increasing prevalence of diabetes worldwide. Insulin, a hormone that regulates blood sugar, is a critical treatment for individuals with diabetes.
The global increase in diabetes cases, including both type 1 and type 2 diabetes, has significantly expanded the demand for insulin. As diabetes becomes more prevalent, the need for injectable insulin as a treatment option has risen.
Obesity is a significant risk factor for developing type 2 diabetes. With the global increase in obesity rates, particularly in developed and developing countries, the incidence of diabetes has also risen, driving the demand for insulin.
Improved screening and diagnostic methods have led to earlier detection of diabetes cases. Early diagnosis often results in the initiation of insulin therapy, contributing to increased utilization of insulin products.
Insulin segment is expected to dominate during the forecast period owing to the factors like, rise in the prevalence of diabetes in the country, product launches by key players, advancements in the new formulations and others help the segment to grow during the forecast period.
According to the IDF DIabetes Atlas, the study reveals that diabetes affects a significant number of people in the Saudi Arabia, with a prevalence of 19.6% in the 20-79 age group and a proportion of 43.6 in undiagnosed cases. Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) are also prevalent in the population.
Mortality attributable to diabetes is estimated at 15,399.0 deaths in 20-79 years, with a proportion of 13.8 in people under 60 years. Type 1 diabetes in children and adolescents is estimated at 28.9%. Hyperglycaemia in pregnancy (HIP) affects live births in 1,000s, with a prevalence of 3.8 in 1,000s. Live births affected by other types of diabetes first detected in pregnancy are also prevalent.
Diabetes-related health expenditure is estimated at USD 7,459.5 million and ID 17,686.2 million, with a per person expenditure of USD 1,745.3. Demographics include a total adult population of 10,581.0, 17,023.2, and 27,810.9, respectively.
Additionally, investments by companies product launches by key players also help the segment to grow during the forecast period. For instance, in June 2023, Saudi Arabia's Public Investment Fund (PIF) has launched a new commercial-scale contract development and manufacturing organization (CDMO) called Lifera.
According to the Kingdom, the CDMO will help grow the local biopharmaceutical industry, strengthen national resilience, and bolster Saudi Arabia's position as a global pharmaceutical manufacturing destination. Lifera have been focusing on manufacturing pharmaceutical products, including insulins, vaccines, plasma therapeutics, monoclonal antibodies, cell and gene therapies, and innovative small molecules.
Thus many individuals with diabetes prefer insulin injections as an effective and convenient method of managing blood glucose levels. The sterile injectable form provides a reliable and precise way to administer insulin. The above factors helps to boost the segment growth.
Company Share Analysis
The Saudi Arabia Sterile Injectables market is expected to be moderately competitive, owing to the presence of big brands. Also, the market is expanding due to the presence of several large and regional players entering the market.
The key players that are contributing to the growth of the Saudi Arabia market include the Pharmaceutical Solutions Industry (PSI), Advanced Pharmaceutical Factory, Pfizer Inc., Amgen Inc., GlaxoSmithKline plc, Merck & Co., Inc, Novartis AG, Sanofi SA, Hikma Pharmaceuticals PLC, Glenmark Pharmaceuticals Limited among others.
The key players are adopting strategies such as partnerships, mergers, acquisitions and regional expansion to stand out as strong competitors in the market. Novel services and enhanced focus on research and development are other ways the leading players can improve their market presence.
Pfizer Inc – Overview
Pfizer is a research based global biopharmaceutical company that engaged in the discovery, development & manufacturing of healthcare products that includes medicines and vaccines to improve patient’s lives. It has been operating in Saudi Arabia since early 1960s.
Company had a portfolio in different therapeutic areas include internal medicines, vaccines, oncology, inflammation & Immunology, rare diseases, hospital healthcare, cardiovascular and among others.
The Pfizer Sterile Injectable business is positioned for future growth as evidenced by our $800 million investment in 2018, and a planned additional investment of up to $1.4 billion in manufacturing capabilities over the next several years.
The total number of 4.4 Million patients in Saudi Arabia benefited from Pfizer’s innovative and diversified therapies during 2019.
