Saudi Arabia Biosimilars Market Overview, 2030

In Saudi Arabia, as the biosimilars are about to capture the pharma market, hence it is essential to determine the current awareness in terms of knowledge and awareness about biosimilars among physicians in Saudi Arabia. To date, there is a lack of published data about physicians’ knowledge and awareness about the required information about biosimilars. Biosimilars are biological products designed to closely resemble and exhibit no clinically significant differences from an already FDA-approved reference product. These products are crafted to mirror the original in terms of mechanism of action, route of administration, dosage form, and strength. Although they are not identical due to the intricate nature and production methods involved in biologics, biosimilars maintain comparable levels of safety, purity, and potency. Acting as more affordable alternatives to high-cost reference biologics, these biologic drugs foster competition, ultimately enhancing accessibility to treatment for patients. The entry of biosimilars into the market undergoes rigorous testing and stringent regulatory scrutiny, ensuring therapeutic equivalence and prioritizing patient safety. In recent years, biosimilars have gained significant traction across various therapeutic areas, including oncology, diabetes, and autoimmune diseases. The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.

According to the research report, “Saudi Arabia Biosimilars Market Overview, 2030” published by Bonafide Research, the Saudi Arabia Biosimilars market is anticipated to add to more than USD 450 Million by 2025–30. The biosimilar market in KSA is expanding and is expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by healthcare providers. Biosimilar regulation is evolving, and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost savings for the healthcare system. The rising focus on providing patients with access to effective and more affordable treatment options is primarily driving the market growth. The Saudi Arabia biosimilar market is characterized by a growing demand for these products, driven by the need to address rising healthcare costs and improve patient access to advanced therapies. Besides this, as the country continues to prioritize healthcare innovation and affordability, biosimilars contribute to creating a competitive pharmaceutical landscape. The cost-effectiveness of biosimilars fosters competition, ultimately benefiting patients and healthcare providers. Moreover, the regulatory framework in Saudi Arabia ensures that biosimilars meet stringent standards, assuring both healthcare professionals and patients of their safety and efficacy. The increasing acceptance and adoption of biosimilars in Saudi Arabia align with the emerging trend towards harnessing the potential of these biologic drugs. With ongoing advancements and investments in the healthcare sector, the biosimilar market in Saudi Arabia is poised for sustained growth in the coming years.

Erythropoietin (EPO) is experiencing high compound annual growth rate (CAGR) in the biosimilars industry in Saudi Arabia due to a convergence of rising healthcare demands, increasing prevalence of chronic diseases such as chronic kidney disease (CKD) and cancer, and strong governmental efforts to expand access to affordable biologics. Erythropoietin is widely used to treat anemia associated with CKD, which is prevalent among Saudi Arabia’s aging population and patients with diabetes—one of the most common non-communicable diseases in the country. The increasing number of dialysis centers and nephrology units across Saudi Arabia has also contributed to the rising demand for EPO-based therapies. Furthermore, cancer patients undergoing chemotherapy frequently develop anemia, necessitating erythropoietin treatment, and with cancer incidence on the rise in the Kingdom, this has further fueled the demand for EPO biosimilars. Additionally, the high cost of originator biologic EPO has led the Saudi government to actively support the adoption of biosimilars as a cost-containment measure in the public health system. Under Saudi Vision 2030, which emphasizes the localization of pharmaceutical manufacturing and strengthening of the healthcare system, biosimilars—especially those like EPO that address high-burden diseases—have received significant policy and regulatory support. The Saudi Food and Drug Authority (SFDA) has streamlined approval pathways for biosimilars, encouraging local and regional companies to invest in EPO biosimilar development and production. This has not only improved availability but also lowered prices, increasing accessibility in both public and private healthcare sectors.

Chronic and autoimmune disorders are witnessing high CAGR growth in the biosimilars industry in Saudi Arabia due to the rapid rise in non-communicable diseases and the government's focus on expanding affordable healthcare solutions. Conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, lupus, Crohn’s disease, and ulcerative colitis are becoming increasingly prevalent in the Kingdom, driven by factors like sedentary lifestyles, dietary habits, genetic predisposition, and increasing life expectancy. These disorders often require long-term, biologic-based treatments, which are typically expensive and place a significant financial burden on both patients and the healthcare system. Biosimilars, offering comparable therapeutic efficacy at a much lower cost, have emerged as a strategic solution to improve access to biologics for managing chronic and autoimmune diseases across both public and private healthcare settings. Saudi Arabia’s Vision 2030 health sector transformation aims to modernize and streamline healthcare services while making them more cost-effective, particularly for chronic care. As part of this, the Saudi Food and Drug Authority (SFDA) has facilitated more efficient regulatory pathways for biosimilars, encouraging both domestic and international players to introduce biosimilar alternatives for widely used biologics like infliximab, adalimumab, etanercept, and rituximab. These drugs are central to autoimmune disease management and their biosimilar versions are being increasingly included in hospital formularies and government procurement systems. This is further supported by national health insurance reforms that increasingly reimburse biosimilars, leading to greater physician and patient acceptance.

Contract Research and Manufacturing Services (CRAMS) are experiencing high CAGR growth in the biosimilars industry in Saudi Arabia due to several converging factors that reflect the Kingdom’s broader ambitions to develop its pharmaceutical sector and improve healthcare self-sufficiency. As the biosimilars market expands rapidly to meet the growing demand for affordable biologic therapies, local and regional pharmaceutical companies are increasingly turning to contract research organizations (CROs) and contract manufacturing organizations (CMOs) to accelerate drug development timelines, optimize production costs, and comply with stringent regulatory requirements. Saudi Arabia’s Vision 2030 explicitly aims to diversify the economy and build a robust biopharmaceutical industry, encouraging investments in advanced manufacturing capabilities, clinical research infrastructure, and technology transfer partnerships. This policy environment has stimulated growth in CRAMS, as domestic companies seek expertise from global partners for biosimilar development, including bioequivalence studies, clinical trials, and large-scale manufacturing.

Moreover, the Saudi Food and Drug Authority (SFDA) has streamlined biosimilar approval processes and established clear guidelines for clinical trials and manufacturing standards, making contract research and manufacturing a practical and attractive option for biosimilar developers. Outsourcing research and manufacturing activities allows companies to focus on core competencies like marketing and distribution, while benefiting from the specialized knowledge, regulatory experience, and economies of scale offered by contract service providers. This model significantly reduces upfront capital expenditure and operational risks associated with biosimilar production. Additionally, the increasing number of local biopharmaceutical parks and industrial zones equipped with state-of-the-art facilities has enhanced the capacity and capabilities of contract manufacturers in the Kingdom. The growth of CRAMS is further propelled by the strategic goal to reduce dependency on imported biologics by fostering local production of biosimilars. Partnerships between Saudi firms and international biotech companies have resulted in knowledge exchange and technology transfer, enabling local manufacturers to meet international quality standards. Show more