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Forecast Period
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2026-2030
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Market Size (2024)
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USD 60.26 Million
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CAGR (2025-2030)
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4.35%
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Fastest Growing Segment
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Gene Augmentation
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Largest Market
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Northern & Central
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Market Size (2030)
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USD 76.91 Million
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Market Overview
The Saudi Arabia gene therapy market was valued at USD 60.26 million in 2024 and is projected to reach USD 76.91 million by 2030, growing at a CAGR of 4.35% during the forecast period.
Saudi Arabia faces a high prevalence of genetic disorders due to common consanguineous marriages, leading to increased cases of thalassemia, sickle cell anemia, and cystic fibrosis compared to global averages. This growing burden has boosted interest in advanced treatments like gene therapy.
Awareness of gene therapy’s potential is rising among healthcare providers and patients as technological breakthroughs such as CRISPR-Cas9 gene editing and improved delivery systems enhance feasibility and effectiveness. These innovations are accelerating commercialization and expanding clinical applications, offering hope for curing previously untreatable conditions.
As healthcare infrastructure advances, gene therapies are expected to become more accessible and affordable, driving market growth. However, high treatment costs remain a major barrier, particularly for rare diseases, limiting access for patients without comprehensive insurance coverage.
Key Market Drivers
Growth of Healthcare Industry
The growth of Saudi Arabia's healthcare industry is a crucial driver of its expanding gene therapy market. Guided by the Ministry of Health (MoH), the country ensures equitable and accessible healthcare services through an extensive network of primary, secondary, and tertiary care facilities across all regions. This network includes specialized centers like King Faisal Specialist Hospital & Research Centre (KFSH&RC), which launched the first facility for gene and cell therapy manufacturing in the Kingdom with a target of producing 100 gene-therapy treatments annually.
Citizens receive free healthcare in government facilities, supported by national health strategies such as Vision 2030. This commitment to advanced treatments is demonstrated by the Saudi Food and Drug Authority (SFDA), which has approved 10 clinical trials for gene and cell therapies since 2020.
The MoH collaborates with regional councils to assess healthcare needs, managing health budgets and infrastructure across the Kingdom's 13 provinces. This involves analyzing the distribution of Primary Healthcare Centers (PHCs) across 20 distinct health regions to ensure healthcare resources align with demographics, geographic demands, and community-specific disease burdens.
Focus on Advanced Treatments
With the modernization of the healthcare sector, the focus is shifting toward cutting-edge treatments like gene therapy, which has transformative potential for genetic disorders and certain cancers. Rising demand for advanced healthcare solutions, combined with increasing government investment, creates fertile ground for the development and commercialization of gene therapies. Under Vision 2030, Saudi Arabia is investing $65 billion into its healthcare infrastructure, which includes the development of gene therapy facilities.
Population growth, higher incidences of chronic diseases, and awareness of advanced treatments accelerate this shift. Genetic disorders particularly strengthen the need for innovative therapies that address significant unmet medical requirements in the Kingdom. Saudi Arabia has one of the world's highest rates of genetic disorders due to consanguineous marriages, with such conditions affecting an estimated 1 in 20 births. Hematologic disorders are the most prevalent, including sickle cell anemia and beta-thalassemia.
In response, the Kingdom has made significant strides. In November 2024, the government signed a memorandum of understanding with Vertex Pharmaceuticals, an agreement expected to generate over $266 million in the country over the next five years to boost local production of gene therapies like Casgevy for sickle cell disease and beta-thalassemia. There are approximately 23,000 patients in Saudi Arabia who could be eligible for Casgevy. Additionally, King Faisal Specialist Hospital and Research Centre (KFSH&RC) has successfully administered advanced gene therapy to eight patients with hemophilia, while the Saudi Food and Drug Authority (SFDA) has approved the first gene therapy for Hemophilia B.
Breakthroughs in Genomics
Recent developments in genomic science, such as whole-genome sequencing and CRISPR-Cas9 editing, are propelling forward research on genetic diseases. The Saudi Genome Program, for instance, has processed over 63,000 samples and identified 7,500 pathogenic variants, while researchers at King Abdullah University of Science and Technology have successfully used CRISPR-Cas9 to create virus-resistant plants.
Saudi researchers are developing computational models attuned to the region’s genetic profile, especially targeting autosomal recessive (AR) diseases. A hybrid Convolutional Neural Network-Gated Recurrent Unit (CNN-GRU) model designed for diagnosing inherited conditions common in Saudi Arabia has demonstrated superior performance to traditional methods, with an accuracy of 98.8%.
As part of Vision 2030, the government continues to invest heavily in healthcare infrastructure, medical innovation, and research collaborations. The upcoming Global Health Exhibition 2025 is expected to unveil new biotechnology and pharmaceutical partnerships, building on the more than SR50 billion in investments generated at the previous year's event. The country is also promoting medical tourism with a target of 150 million arrivals by 2030—and has signed strategic partnerships with countries like Morocco to strengthen its role as a healthcare innovation hub.
Role of Regulation and Investment
Regulatory bodies such as the Saudi Food and Drug Authority (SFDA) are actively streamlining approval processes for advanced therapies, boosting market entry and clinical adoption. Since 2020, the SFDA has approved 10 clinical trials for gene and cell therapies, including the first-ever trial for a locally developed CAR-T cell gene therapy for acute lymphoblastic leukemia.
Organizations like SaudiVax, in partnership with Merck, are spearheading local production facilities to manufacture biologics and the first Halal-certified vaccines in the region. King Faisal Specialist Hospital & Research Centre (KFSH&RC) is also launching a 5,000-square-meter manufacturing facility for gene and cell therapies, expected to produce 2,400 treatment doses annually. Local manufacturing of CAR-T cells has already reduced treatment costs from SR 1.3 million to approximately SR 250,000 per patient and cut production time from 28 days to as few as 12.
These initiatives target unmet medical needs, building localized capability. By attracting skilled talent, enforcing strong regulatory processes, and investing in cutting-edge infrastructure and translational research centers like the one at Imam Abdulrahman Bin Faisal University, Saudi Arabia is positioning itself as a regional leader in healthcare, translational science, and gene therapy applications.
Technological Advancements
Technological innovations are transforming gene therapy from experimental treatments into viable therapeutic options. Breakthroughs in gene editing—particularly CRISPR-Cas9 have enabled highly precise modifications to DNA sequences, allowing the correction of genetic mutations once considered untreatable. In January 2024, the Saudi Food and Drug Authority (SFDA) approved Casgevy, the first CRISPR-based therapy, for treating sickle cell disease and transfusion-dependent beta-thalassemia.
Continuous refinement of these tools enhances accuracy, safety, and efficiency. A recent systematic review by researchers at the University of Tabuk, which analyzed six clinical trials involving 115 patients, concluded that the CRISPR/Cas9 system represents a safe and potentially curative treatment for inherited hematological disorders. Advancements in viral vector technology, such as engineered adeno-associated viruses (AAVs) and lentiviruses, further strengthen gene delivery effectiveness and safety profiles.
These advances are expanding gene therapy’s scope from rare hereditary diseases toward more common chronic and complex conditions. This is driving adoption and long-term market growth in Saudi Arabia, which saw a 40% increase in clinical studies in 2024 alone.
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Key Market Challenges
High Treatment Costs
The
development of gene therapies involves extensive research, rigorous clinical
trials, and high costs associated with the development of new drugs. The
process of developing gene therapies, which often includes modifying or
replacing faulty genes to treat diseases, requires advanced technologies and
highly specialized expertise. These R&D activities demand considerable
investment in time and resources, which are passed on to patients once the
therapy is commercialized. The expensive nature of R&D for gene therapies
poses a challenge to both manufacturers and healthcare systems, particularly in
markets like Saudi Arabia where the overall healthcare budget can face
constraints.
Gene
therapy manufacturing is complex and costly, involving highly specialized
facilities, sophisticated equipment, and skilled personnel. The production of
gene therapies typically requires the use of viral vectors to deliver genetic
material, and this process is intricate and requires strict quality controls to
ensure safety and efficacy. The need for personalized therapies, which are tailored
to individual patients, further escalates the cost of production. The high
manufacturing costs not only impact the price of the treatment but also create
barriers to scaling up production to meet increasing demand, limiting the
number of patients who can access these therapies in Saudi Arabia.
Gene
therapies are subject to stringent regulatory requirements to ensure patient
safety and therapeutic effectiveness. In Saudi Arabia, as in other countries,
the approval and regulation of gene therapies are governed by rigorous
standards set by the Saudi Food and Drug Authority (SFDA) and other relevant
health authorities. Meeting these regulations involves additional costs related
to compliance, testing, and approval processes, further driving up the overall
price of gene therapies. These regulatory hurdles can delay the introduction of
new treatments into the market, limiting their availability to patients and
placing an additional financial burden on healthcare systems.
Key Market Trends
Increased Focus on Personalized Medicine
Personalized medicine is increasingly being recognized as a key strategy in improving patient outcomes, particularly in the treatment of complex and rare genetic disorders. GCC countries have acknowledged the significance of personalized medicine, with the King Faisal Specialist Hospital and Research Centre (KFSH&RC) in Saudi Arabia pioneering genomics research alongside the massive Saudi Genome Program. It is anticipated that other institutions will follow suit.
In Saudi Arabia, the high prevalence of genetic disorders, which affect an estimated 8% of births, has contributed to the rising demand for targeted therapies that are customized to an individual’s genetic profile. Gene therapies, which aim to correct genetic mutations or introduce new genes to treat diseases, are a perfect fit for this approach.
By focusing on the genetic makeup of patients, personalized gene therapies can offer more precise and effective treatment options, improving the chances of successful outcomes. This is exemplified by new partnerships, such as the October 2025 joint venture between PGxAI and Najashi Holding to deploy an AI-powered pharmacogenomics platform in the Kingdom. The shift towards personalized care in Saudi Arabia is aligning with global healthcare trends, where patients and healthcare providers are increasingly seeking treatments that go beyond traditional approaches.
The country’s growing understanding of the benefits of personalized medicine is reflected in a nationwide study where 52.3% of clinicians reported that genetic tests helped them understand their patients' disorder risks. Combined with its substantial investments in healthcare infrastructure, this positions it as a strong contender in the global gene therapy market. The rise of personalized medicine in Saudi Arabia's gene therapy market is driven by significant advancements in genomic research and biotechnology.
With the increasing availability of genomic sequencing technologies, such as next-generation sequencing (NGS), healthcare providers are now able to identify genetic mutations more quickly and accurately. This is demonstrated by the Saudi Genome Program, which has processed over 63,000 samples and identified 7,500 pathogenic variants, allowing for a deeper understanding of diseases at the molecular level and making it easier to develop personalized treatment plans.
Segmental Insights
Type Insights
Based
on Type, Gene Augmentation have emerged as the fastest growing segment in the Saudi
Arabia Gene Therapy Market in 2024. One
of the primary drivers of the gene augmentation segment’s growth is the rise in
the number of genetic disorders in Saudi Arabia. The country has a
higher-than-average prevalence of inherited genetic conditions, such as sickle
cell disease, thalassemia, and other hemoglobinopathies, many of which are
treatable or manageable through gene augmentation techniques. These conditions,
which often require long-term management or even lifelong treatments, create a
compelling need for more permanent, curative solutions like gene augmentation.
The potential to offer life-changing or life-saving treatments for patients
with these genetic diseases has accelerated the adoption of gene augmentation
therapies.
Moreover,
Saudi Arabia’s commitment to advancing its healthcare system under Vision 2030
has led to significant investments in medical research, biotechnology, and the
development of cutting-edge therapies. This includes support for gene therapy
initiatives, where gene augmentation is at the forefront of innovation. As the
healthcare infrastructure in the kingdom continues to improve, more specialized
treatment centers and facilities are being established to offer these advanced
therapies, making gene augmentation more accessible to patients.
Application Insights
Based
on Application, Oncological Diseases have emerged as the fastest growing
segment in the Saudi Arabia Gene Therapy Market during the forecast period. One
of the primary reasons for the growth of oncological diseases within the gene
therapy market is the limitations of traditional cancer treatments, such as
chemotherapy, radiation, and surgery. While these methods remain essential,
they often come with significant side effects and limited effectiveness,
especially in advanced stages of cancer. Gene therapy provides a potential
alternative by targeting the genetic mutations that drive cancer, offering a
more precise and potentially less toxic treatment approach. By modifying the
genetic makeup of cancer cells or boosting the body's immune system to better
fight cancer, gene therapy aims to address the root causes of cancer at a
molecular level.
Advancements
in gene editing technologies, particularly CRISPR-Cas9, have significantly
improved the ability to target cancer cells and correct genetic mutations that
cause or promote tumor growth. These innovations have made it possible to
develop gene therapies that can be tailored to individual patients, increasing
the effectiveness of treatments and minimizing side effects. The ability to
personalize cancer treatments based on a patient's genetic profile has created
new opportunities for gene therapy in oncology, contributing to its growth in
Saudi Arabia.
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Regional Insights
Based
on Region, Northern & Central have emerged as the dominating region in the Saudi
Arabia Gene Therapy Market in 2024. The Northern and Central regions are home
to some of Saudi Arabia's largest and most advanced healthcare institutions,
particularly in cities like Riyadh, the capital. Riyadh is a central hub for
medical research, clinical trials, and the implementation of advanced
therapies. The concentration of specialized hospitals, medical universities,
and research centers in this region has fostered a conducive environment for
the development and adoption of gene therapies.
The
Northern and Central regions have a higher concentration of healthcare
professionals, researchers, and specialists in gene therapy and molecular medicine.
This skilled workforce is essential for advancing the adoption of gene therapy
technologies, as it facilitates the development, clinical testing, and
administration of gene therapies. The region’s robust educational and training
systems also contribute to an increasing talent pool in the field of gene
therapy.
Recent Development
- In January 2025, one month after US regulators approved the first therapeutic use of CRISPR/Cas9 a gene therapy for sickle cell disease (SCD) and beta thalassemia the Kingdom of Saudi Arabia followed suit. Notably, Casgevy became the first drug to advance through the country's Breakthrough Medicines Program, underscoring the Saudi government's dedication to introducing cutting-edge therapeutics to a region with a higher prevalence of genetic disorders compared to Western countries.
- In
October 2024, King Faisal Specialist Hospital & Research Centre (KFSHRC)
achieved a significant milestone in cancer treatment with the initiation of
local CAR-T cell manufacturing, marking a groundbreaking medical advancement
for the Kingdom of Saudi Arabia. This strategic move has resulted in an 80%
reduction in therapy costs, from USD 0.35 million per patient to a more
affordable price. Building on this success, KFSHRC aims to scale its production
capacity to 100 gene therapies annually, broadening access to this cutting-edge
treatment for more patients. As a Platinum Sponsor at the Global Health
Exhibition, which opened today in Riyadh, KFSHRC highlights its expertise in
CAR-T cell production. The exhibition booth provides an in-depth overview of
the rationale behind local manufacturing, detailing the production process,
treatment mechanisms, and success stories, including remarkable outcomes in
cases of highly resistant leukemia and lymphoma.
- In
January 2024, Vertex Pharmaceuticals Incorporated announced that the Saudi Food
and Drug Authority (SFDA) had granted Marketing Authorization for CASGEVY™
(exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for
the treatment of sickle cell disease (SCD) and transfusion-dependent beta
thalassemia (TDT). CASGEVY is now approved for use in individuals aged 12 and
older with SCD or TDT. Saudi Arabia has one of the highest prevalence rates of
SCD and TDT globally, with thousands of patients affected by these genetic
blood disorders.
- In
December 2024, the Ministry of Industry and Mineral Resources, in collaboration
with the Ministries of Investment and Health in Saudi Arabia, signed a
Memorandum of Understanding (MoU) with American pharmaceutical company Vertex.
The agreement aims to strengthen the biotechnology sector by localizing gene
therapy manufacturing in the Kingdom, facilitating knowledge transfer, and
fostering local innovation and research. The MoU seeks to position Saudi Arabia
as a global leader in biotechnology through three key initiatives: advancing
research, development, and medical expertise within the Kingdom; enhancing
local biomanufacturing capabilities in cell and gene therapy; and developing
local talent to accelerate the growth of Saudi health professionals.
Key Market Players
- Vertex
Pharmaceuticals (Europe) Limited
- CRISPR
Therapeutics AG
- Merck
Limited
- Medical
Business Center Co.
- Salehiya
Medical
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By Type
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By Application
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By Region
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- Gene Augmentation
- Gene Silencing
- Others
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- Oncological Diseases
- Genetic Diseases
- Cardiovascular Diseases
- Neuromuscular Diseases
- Hematological Diseases
- Infectious Diseases
- Others
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- Eastern
- Western
- Northern & Central
- Southern
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Report Scope
In this report, the Saudi Arabia Gene Therapy
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Saudi Arabia Gene Therapy Market, By Type:
o Gene Augmentation
o Gene Silencing
o Others
- Saudi Arabia Gene Therapy Market, By Application:
o Oncological Diseases
o Genetic Diseases
o Cardiovascular Diseases
o Neuromuscular Diseases
o Hematological Diseases
o Infectious Diseases
o Others
- Saudi Arabia Gene Therapy Market, By Region:
o Eastern
o Western
o Northern & Central
o Southern
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Saudi
Arabia Gene Therapy Market.
Available Customizations:
Saudi Arabia Gene Therapy Market report with the
given market data, Tech Sci Research offers customizations according to a
company's specific needs. The following customization options are available for
the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
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Therapy Market is an upcoming report to be released soon. If you wish an early
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