Sickle Cell Disease Market Reaches USD 650 Million in 2023, Gene Therapies and Novel Pipelines Set to Transform Growth Through 2034, estimates DelveInsight

Sickle Cell Disease market players active in the domain include Cellectis, Sana Biotechnology, Global Blood Therapeutics, CSL Behring, Pfizer, Aruvant Sciences, Graphite Bio, Novartis, Agios Pharmaceuticals, Forma Therapeutics, Vertex Pharmaceuticals, Alfasigma, Novo Nordisk, bluebird bio, ExCellThera, Gamida Cell, KM Biologics/Takeda, Editas Medicine, among several others.
The Sickle Cell Disease (SCD) market across the six major markets (6MM) was estimated to be worth nearly USD 650 million in 2023. The United States accounted for the dominant share, generating approximately USD 603 million, representing around 92% of the total market value, with France and the United Kingdom following behind. Sickle Cell Disease is an inherited genetic condition caused by mutations in the HBB gene, leading to the production of abnormal hemoglobin S (HbS). This abnormality causes red blood cells to become rigid and sickle-shaped, disrupting normal blood flow and resulting in chronic anemia, recurrent vaso-occlusive pain episodes, progressive organ damage, and shortened survival.

Standard treatment approaches for SCD include NSAIDs, blood transfusions, iron chelation therapy, nutritional supplements, antibiotics, and approved drugs such as DROXIA (hydroxyurea), ENDARI (L-glutamine), ADAKVEO (crizanlizumab), and OXBRYTA (voxelotor). Recent regulatory approvals of gene-based treatments such as CASGEVY and LYFGENIA are anticipated to significantly accelerate market growth. Emerging pipeline therapies including EDIT-301, Mitapivat, Inclacumab, and Osivelotor further strengthen future prospects. However, persistent challenges such as late diagnosis, high therapy costs, suboptimal adherence, and limited awareness continue to hinder optimal disease management. Ongoing advances in gene therapy and gene-editing technologies hold promise for durable disease modification and potential cures.

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DelveInsight's publication, "Sickle Cell Disease Market Insights, Epidemiology, and Market Forecast - 2034," offers an in-depth evaluation of the global SCD landscape. The report analyzes historical performance, epidemiological patterns, and future outlooks across the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. It reviews existing treatment options, pipeline therapies, therapy-class-wise market shares, and forecasts spanning 2020-2034 across the seven major markets. The study also assesses treatment pathways, growth drivers, obstacles, unmet clinical needs, and evolving opportunities influencing the worldwide Sickle Cell Disease market.

Sickle Cell Disease Overview

Sickle Cell Disease (SCD) is a lifelong inherited hematologic disorder resulting from mutations in the -globin gene, which lead to abnormal hemoglobin formation (HbS). This defect causes red blood cells to assume a rigid, crescent-like structure, triggering vaso-occlusion, chronic hemolytic anemia, organ dysfunction, and reduced life expectancy.

SCD predominantly affects populations of African, Mediterranean, Middle Eastern, and Indian ancestry. Clinical symptoms typically emerge in early childhood and may include chronic fatigue, delayed physical development, swelling of hands and feet, frequent infections, and recurrent pain crises. Severe disease manifestations include stroke, acute chest syndrome, and failure of multiple organs.

Management of Sickle Cell Disease focuses on prevention and symptom control through routine immunizations, prophylactic antibiotics, hydroxyurea therapy, blood transfusions, pain control measures, and bone marrow transplantation in select cases. Novel gene-based therapies and CRISPR-driven approaches are emerging as potentially transformative solutions, offering the possibility of long-term disease control or cure.

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Epidemiology of Sickle Cell Disease

In 2023, the United States reported the highest number of prevalent SCD cases among the 6MM, with sickle cell anemia (HbSS or HbS/-thalassemia) representing the most common disease subtype. Within the EU4 and the UK, France accounted for the largest patient population, followed by the UK, whereas Spain recorded the lowest prevalence.

Sickle Cell Disease Epidemiology Segmentation Includes:

* Total prevalent cases of Sickle Cell Disease trait
* Total prevalent Sickle Cell Disease cases
* Diagnosed Sickle Cell Disease cases
* Age-specific prevalence of Sickle Cell Disease
* Type-specific prevalence of Sickle Cell Disease

Increasing disease awareness, widespread newborn screening programs, and improved diagnostic techniques are expected to drive growth in the diagnosed patient population across these regions.

Sickle Cell Disease Drug Uptake and Pipeline

Mitapivat (Agios Pharmaceuticals): Mitapivat is an orally administered pyruvate kinase activator that boosts cellular ATP levels while lowering 2,3-DPG concentrations. Approved by the FDA in 2022 under the brand name PYRUKYND for pyruvate kinase deficiency, the therapy is now under clinical investigation for SCD. Phase II data from the RISE UP trial in 2023 demonstrated meaningful increases in hemoglobin levels at both 50 mg and 100 mg twice-daily dosing regimens.

Inclacumab (Pfizer): Inclacumab is a fully human monoclonal antibody designed to inhibit P-selectin, a key contributor to cell adhesion and vaso-occlusive events. With a potential quarterly dosing schedule, Inclacumab may offer best-in-class efficacy for reducing pain crises. Phase II studies have been completed, and the drug has progressed into Phase III clinical development.

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Sickle Cell Disease Pipeline Highlights

Additional high-potential pipeline candidates include Etavopivat, EDIT-301 (Reni-cel), Osivelotor (GBT-601), Mitapivat, and Casgevy (Exa-cel). These therapies are projected to be key contributors to market expansion between 2024 and 2034. Casgevy is anticipated to capture the largest share of the Sickle cell disease market across the 6MM by 2034.

Sickle Cell Disease Market Outlook

The Sickle Cell Disease market, valued at approximately USD 650 million in 2023 across the 6MM, is expected to experience strong growth through 2034, driven by the introduction of novel and innovative therapies. Although gene therapies represent a paradigm shift, factors such as access limitations, reimbursement challenges, and restricted patient eligibility may impact uptake.

Current treatment remains largely supportive and symptomatic, relying on NSAIDs, opioids, blood transfusions, and standard care, along with FDA-approved agents including DROXIA, ENDARI, ADAKVEO, and OXBRYTA. The 2023 approvals of gene-editing therapies CASGEVY (exa-cel) and LYFGENIA (lovo-cel) mark a significant step toward potentially curative treatment options.

Despite clinical progress, hurdles such as limited healthcare access, adherence challenges, and financial burden continue to affect patients. Nevertheless, sustained R&D investment, healthcare infrastructure improvements, and expanded newborn screening initiatives are expected to support long-term market growth and improved disease outcomes.

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Recent Clinical Advancements in Sickle Cell Disease

* August 2025: Oryzon Genomics received EMA authorization to initiate a Phase Ib study of iadademstat in SCD, marking its first trial in a non-malignant hematologic condition.
* August 2025: Beam Therapeutics secured FDA RMAT designation for BEAM-101, a genetically engineered cell therapy targeting severe vaso-occlusive crises.
* July 2025: Fulcrum Therapeutics announced positive Phase 1b data from the PIONEER trial evaluating pociredir.
* May 2025: Beam Therapeutics presented updated BEACON Phase 1/2 results at EHA 2025 assessing BEAM-101 in SCD patients.
* November 2024: BioLineRx shared Phase 1 trial findings of motixafortide for CD34+ stem cell mobilization in SCD gene-therapy applications.
* May-sJuly 2024: Pfizer, Afimmune, and Novo Nordisk released clinical data from multiple studies investigating therapies such as GBT021601, Epeleuton, and Etavopivat.

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Key Highlights from the DelveInsight Report

* Trends in Sickle Cell Disease prevalence and patient population
* Market size forecasts and therapy-based segmentation
* Competitive landscape and cross-market competition analysis
* Market growth drivers and limiting factors
* Analysis of emerging therapies and clinical pipelines
* Current treatment paradigms and care algorithms
* Impact of innovative therapies on market penetration
* Seven major market (7MM) outlook through 2034

About DelveInsight

DelveInsight is a prominent life sciences market research and business consulting organization that delivers syndicated intelligence and bespoke solutions to healthcare stakeholders. Through robust analytics, primary research, and expert-driven insights, DelveInsight provides actionable data to support strategic decision-making worldwide.

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