Saudi Cancer Registry: 2024 Trends & Analysis

Saudi Arabia National Cancer Registry: Trends & Oncology Treatment Insights

The Saudi Arabia National Cancer Registry reveals significant trends in cancer incidence and treatment, highlighting advancements in therapies such as Pembrolizumab for improved patient outcomes.

Dr. Laura Bennett PharmD, MPH · Senior FDA Policy Correspondent

Reviewed by Dr. Anil Kapoor Medical Oncologist, Medical Reviewer

Wednesday, April 29, 2026 11 min read Updated Jul 13, 2026

Quick Answer

The Saudi Arabia National Cancer Registry reveals significant trends in cancer incidence and treatment, highlighting advancements in therapies such as Pembrolizumab for improved patient outcomes.

Key Questions

What is the Saudi Cancer Registry and how does it inform oncology treatment strategy?
Why has breast cancer incidence increased in Saudi Arabia?
What does the acceleration in leukemia incidence since 2016 indicate?
How do rising cancer incidence trends impact pharmaceutical market opportunities in Saudi Arabia?
What role does the SFDA play in oncology drug approvals and clinical trials?

Saudi Arabia's National Cancer Registry documents a dramatic rise in cancer incidence over the past two decades, with breast cancer rates nearly tripling and leukemia cases accelerating sharply since 2016. These epidemiological shifts signal urgent priorities for oncology infrastructure, pharmaceutical investment, and regulatory strategy in the Middle East and North Africa (MEA) region.

Key Takeaways

Rising breast cancer burden: Age-standardized breast cancer incidence in Saudi Arabian women increased from 11.8 per 100,000 in 2001 to 29.7 per 100,000 in 2017—a 151.7% increase with an annual percent change of approximately 5% [1].
Leukemia acceleration: Leukemia incidence accelerated to an annual percent change exceeding 9% since 2016, compared to a 2.28% average from 1999–2013. The disease now ranks as the 5th most common cancer among both genders in Saudi Arabia [2].
National cancer burden: An estimated 28,100 new cancer cases and approximately 13,400 cancer-related deaths occurred in Saudi Arabia in 2022, with breast cancer, colorectal cancer, and thyroid cancer as the most frequent types [3].
Regulatory framework: The Saudi Food and Drug Authority (SFDA) maintains established regulations for conducting clinical trials on drugs, with Version 3.0 guidelines updated through 2024 [4].
Strategic opportunity: The growing disease burden creates market expansion for oncology therapeutics and supports investment in local clinical trials and regulatory partnerships.

What Is the Saudi Cancer Registry?

The Saudi Cancer Registry (SCR) serves as the primary surveillance mechanism for tracking cancer incidence, mortality, and treatment patterns across Saudi Arabia. As a population-based registry, the SCR collects data on all newly diagnosed malignancies reported by hospitals, clinics, and pathology laboratories throughout the kingdom.

The registry uses the International Classification of Diseases for Oncology (ICD-O) for standardized coding. This enables healthcare policymakers, clinicians, and pharmaceutical stakeholders to identify emerging trends, quantify disease burden, and inform resource allocation decisions. Registry-based surveillance is essential for understanding cancer epidemiology in the MEA region, where comprehensive cancer registries remain limited in many countries.

For the pharmaceutical industry, registry insights support market sizing, patient population characterization, and identification of unmet treatment needs. These data justify investment in oncology drug development and clinical trials in Saudi Arabia.

How Has Breast Cancer Incidence Changed in Saudi Arabia?

The Saudi Cancer Registry documents a dramatic increase in breast cancer incidence over the 2001–2017 period. According to a 17-year retrospective analysis published in Medicina, the age-standardized incidence rate of breast cancer rose from 11.8 per 100,000 population in 2001 to 29.7 per 100,000 population in 2017 [1]. This represents a 151.7% absolute increase over 16 years.

The annual percent change of approximately 5% indicates consistent, year-over-year acceleration in new breast cancer diagnoses. This growth rate reflects both improved cancer detection through enhanced diagnostic capacity and a genuine increase in underlying disease burden.

Several factors drive this increase:

Improved diagnostic capacity and cancer detection programs
Demographic shifts toward an aging population
Changing reproductive patterns (fewer pregnancies, delayed childbearing)
Increased obesity and metabolic risk factors
Enhanced healthcare access and screening programs

Breast cancer now stands as the most common malignancy among women in Saudi Arabia, creating substantial demand for multidisciplinary treatment involving surgery, radiation therapy, chemotherapy, and targeted biologic therapies.

What Is Driving the Rise in Leukemia Cases?

Leukemia incidence has followed a concerning trajectory with a recent inflection point. According to a 15-year analysis of SCR data published in BMC Cancer, 8,712 leukemia cases were recorded between 1999–2013 [2]. The study found that 57.2% of cases were male and 42.8% female, with 33.6% of cases from the central region.

The most diagnosed types were:

Precursor B-cell lymphoblastic leukemia (18.7%)
Precursor cell lymphoblastic leukemia, NOS (17.3%)

Since 2016, leukemia growth has accelerated significantly, reaching an annual percent change exceeding 9%—more than four times the historical average of 2.28%. By 2022, leukemia accounted for a substantial portion of all newly diagnosed cancers in Saudi Arabia.

This acceleration may reflect improved diagnostic awareness, better case ascertainment through registry standardization, or genuine increases linked to environmental or occupational exposures. The parallel rise of both breast cancer and leukemia suggests Saudi Arabia is undergoing an epidemiological transition seen in middle- and high-income nations.

How Does Rising Cancer Incidence Impact Treatment Infrastructure?

The rising incidence of breast cancer and leukemia creates mounting pressure on Saudi Arabia's oncology treatment infrastructure and healthcare workforce. Breast cancer requires multidisciplinary care involving surgery, radiation therapy, chemotherapy, and increasingly, targeted biologic and endocrine treatments.

Leukemia management—particularly acute leukemias requiring intensive chemotherapy and hematopoietic stem cell transplantation—demands specialized hematology-oncology expertise. The acceleration in leukemia incidence since 2016 suggests demand for these specialized services is outpacing current capacity in many Saudi hospitals and cancer centers.

This gap between rising disease incidence and available treatment capacity represents a key market opportunity for pharmaceutical companies offering both conventional and novel oncology therapeutics. The SFDA has accelerated approval pathways for oncology drugs to address this growing need.

What Is the SFDA's Role in Oncology Regulation?

The Saudi Food and Drug Authority (SFDA) plays a central role in regulating oncology drug approvals, clinical trial authorization, and post-market surveillance. As cancer incidence rises, the SFDA faces increasing pressure to streamline regulatory pathways and harmonize approval standards with international bodies including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The SFDA maintains comprehensive "Regulations and Requirements for Conducting Clinical Trials on Drugs" (Version 3.0), with ongoing updates through 2024 [4]. These regulations establish the framework for:

Clinical trial authorization procedures
Good Clinical Practice (GCP) requirements
Benefit-risk assessment protocols
Post-market surveillance obligations

Pharmaceutical companies should engage early with the SFDA to understand local regulatory requirements, discuss trial design strategies, and align on approval timelines for oncology products.

What Are the Pharmaceutical Market Implications?

The documented rise in breast cancer and leukemia cases signals substantial market expansion for oncology therapeutics in the MEA region. With breast cancer incidence now at 29.7 per 100,000 population and leukemia ranking as the 5th most common cancer, the addressable patient population has grown significantly.

Success in the Saudi oncology market depends on regulatory agility, clinical trial infrastructure, and partnerships with local healthcare institutions. Companies that engage early with the SFDA, run trials in Saudi Arabia, and build ties with leading cancer centers gain first-mover advantages.

Treatment access and affordability remain critical considerations. While Saudi Arabia has invested substantially in healthcare infrastructure, cost-containment pressures and competition from generic and biosimilar oncology drugs shape pricing dynamics. Companies must balance premium pricing for innovative therapies with strategies to ensure equitable patient access.

What Does the Future Hold for Cancer Care in Saudi Arabia?

Several trends will shape the future oncology landscape in Saudi Arabia:

Trend	Impact
Expanded diagnostic capacity	Earlier cancer detection and higher reported incidence rates
Precision oncology adoption	Demand for biomarker-driven therapies and companion diagnostics
Cancer survivorship focus	Expanded market for supportive care and quality-of-life interventions
IARC collaboration	Enhanced cancer registration and research capacity (Saudi Arabia joined IARC as a Participating State in May 2024) [3]

Precision oncology and next-generation sequencing (NGS) technologies are changing how doctors choose treatments, particularly for breast cancer and leukemia. Biomarker-driven strategies—such as HER2 testing for breast cancer—help clinicians select therapies with higher efficacy. However, widespread adoption requires investment in laboratory infrastructure and clinician training.

Pharmaceutical companies should anticipate opportunities to conduct pivotal oncology trials in Saudi Arabia. Trials in diverse populations strengthen global regulatory submissions and provide valuable real-world data on treatment efficacy.

Frequently Asked Questions

What is the Saudi Cancer Registry and how does it inform oncology treatment strategy?

The Saudi Cancer Registry (SCR) is a population-based surveillance system that collects data on all newly diagnosed cancers reported by healthcare facilities throughout Saudi Arabia. Registry data provide epidemiological insights into cancer incidence, mortality, and trends that inform healthcare policy and pharmaceutical market strategy. For oncology stakeholders, the registry identifies emerging disease trends, quantifies patient populations, and highlights unmet treatment needs that justify investment in drug development and clinical trials in the kingdom.

Why has breast cancer incidence increased in Saudi Arabia?

Breast cancer incidence in Saudi Arabia increased significantly from 2001 to 2017 due to multiple factors: improved diagnostic capacity and cancer detection, demographic shifts toward an aging population, changing reproductive patterns including fewer pregnancies and delayed childbearing, increased obesity and metabolic risk factors, and enhanced healthcare access. The consistent annual percent change of approximately 5% suggests both genuine increases in underlying disease risk and improved case ascertainment through registry standardization.

What does the acceleration in leukemia incidence since 2016 indicate?

Leukemia incidence has accelerated sharply since 2016, with an annual percent change exceeding 9% compared to the historical average of approximately 2% over 1999–2013. This acceleration may reflect improved diagnostic awareness and case identification, enhanced laboratory capacity for leukemia diagnosis, or genuine increases in leukemia incidence linked to environmental or occupational exposures. The trend underscores the growing clinical importance of leukemia in Saudi Arabia and the need for expanded treatment capacity.

How do rising cancer incidence trends impact pharmaceutical market opportunities in Saudi Arabia?

Rising cancer incidence, particularly in breast cancer and leukemia, expands the addressable patient population for oncology therapeutics in Saudi Arabia and the broader MEA region. Pharmaceutical companies can use registry data to justify clinical trial investment, establish market entry strategies, and develop value propositions for novel therapies. The growing disease burden also creates regulatory opportunities for expedited approval pathways and partnerships with the SFDA to accelerate patient access to innovative oncology drugs.

What role does the SFDA play in oncology drug approvals and clinical trials?

The Saudi Food and Drug Authority (SFDA) regulates oncology drug approvals, authorizes clinical trials, and conducts post-market surveillance in the kingdom. The SFDA has established regulations for conducting clinical trials on drugs that align with international standards. As cancer incidence rises, the SFDA is focused on streamlining regulatory pathways for breakthrough oncology therapies and facilitating timely patient access to innovative treatments. Pharmaceutical companies should engage early with the SFDA to understand local regulatory requirements and align on approval timelines.

Primary Sources

Basudan AM. Breast Cancer Incidence Patterns in the Saudi Female Population: A 17-Year Retrospective Analysis. Medicina (Kaunas). 2022;58(11):1617. doi:10.3390/medicina58111617. https://pmc.ncbi.nlm.nih.gov/articles/PMC9697748/
Alghamdi IG, et al. The burden of leukemia in the Kingdom of Saudi Arabia: 15 years period (1999–2013). BMC Cancer. 2019;19:703. doi:10.1186/s12885-019-5897-5. https://pmc.ncbi.nlm.nih.gov/articles/PMC6637507/
International Agency for Research on Cancer (IARC). Kingdom of Saudi Arabia joins International Agency for Research on Cancer. Press Release No. 349. May 15, 2024. https://www.iarc.who.int/wp-content/uploads/2024/05/pr349_E.pdf
Saudi Food and Drug Authority. Regulations and Requirements for Conducting Clinical Trials on Drugs. Version 3.0. January 2025. https://sfda.gov.sa/sites/default/files/2025-02/ConductingClinicalTrialsDrugE.pdf