Sickle Cell Disease Market Analysis Report 2034: Pipeline Breakthroughs, Market Size Outlook, Key Players, and Clinical Milestones by DelveInsight

Key Sickle Cell Disease companies include Cellectis, Sana Biotechnology, Global Blood Therapeutics, Inc., CSL Behring, Pfizer, Aruvant Sciences, Graphite Bio, Novartis, Agios Pharmaceuticals, Forma Therapeutics, Vertex Pharmaceuticals, Global Blood Therapeutics, Inc., Alfasigma, Novo Nordisk, bluebird bio, ExCellThera, Gamida Cell, KM Biologics/Takeda, Editas Medicine, and others.
The Sickle Cell Disease (SCD) market across the six major markets (6MM) was valued at approximately USD 650 million in 2023. In 2023, the United States represented the largest portion of the Sickle Cell Disease market, valued at approximately USD 603 million (~92% of the total market), followed by France and the UK. Sickle Cell Disease is a hereditary disorder caused by a mutation in the HBB gene, resulting in abnormal hemoglobin (HbS) that distorts red blood cells into a sickle shape. These malformed cells impair blood flow, leading to anemia, painful vaso-occlusive crises, organ damage, and reduced life expectancy.

Current management strategies include NSAIDs, blood transfusions, iron chelation therapies, supplements, antibiotics, and FDA-approved treatments such as DROXIA (hydroxyurea), ENDARI (L-glutamine), ADAKVEO (crizanlizumab), and OXBRYTA (voxelotor). The recent approvals of gene-based therapies, including CASGEVY and LYFGENIA, are expected to fuel market expansion. Pipeline candidates such as EDIT-301, Mitapivat, Inclacumab, and Osivelotor show promise for future growth. Despite these advancements, challenges such as delayed diagnosis, high treatment costs, limited adherence, and awareness gaps persist. Research in gene therapy and gene editing offers transformative potential for long-term disease management and possible cures.

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DelveInsight's report, "Sickle Cell Disease Market Insights, Epidemiology, and Market Forecast - 2034" , provides a detailed analysis of the Sickle Cell Disease landscape. The study covers historical data, epidemiological trends, and future projections across the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. It examines current therapies, investigational drugs, market share by therapy class, and forecasts from 2020 to 2034 across the seven major markets. Additionally, the report evaluates treatment algorithms, market drivers, barriers, unmet needs, and emerging opportunities shaping the global Sickle Cell Disease market.

Sickle Cell Disease Overview

Sickle Cell Disease (SCD) is a chronic inherited blood disorder caused by -globin gene mutations, producing abnormal hemoglobin (HbS) that causes red blood cells to adopt a rigid, crescent shape. This distortion results in vaso-occlusive crises, hemolytic anemia, organ damage, and reduced lifespan.

Sickle Cell Disease predominantly affects individuals of African, Mediterranean, Middle Eastern, and Indian descent. Symptoms typically appear in early childhood and include fatigue, delayed growth, swelling in extremities, recurrent infections, and painful crises. Severe complications include stroke, acute chest syndrome, and multi-organ failure.

Sickle Cell Disease Management includes preventive measures like regular vaccinations, antibiotic prophylaxis, and hydroxyurea therapy, alongside interventions for acute and chronic complications such as blood transfusions, pain management, and bone marrow transplantation. Emerging gene therapies and CRISPR-based technologies show potential to significantly improve outcomes and possibly offer a cure.

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Epidemiology of Sickle Cell Disease

In 2023, the United States recorded the highest number of prevalent Sickle Cell Disease cases among the 6MM, with sickle cell anemia (HbSS or HbS/-thalassemia) as the dominant subtype. Within the EU4 and UK, France had the largest patient population, followed by the UK, while Spain reported the lowest prevalence.

Sickle Cell Disease Epidemiology Segmentation:

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

Rising awareness, newborn screening, and emerging diagnostics are expected to further increase the diagnosed prevalence pool across these regions.

Sickle Cell Disease Drugs Uptake and Pipeline

Mitapivat (Agios Pharmaceuticals): Mitapivat, an oral pyruvate kinase activator, enhances ATP production and reduces 2,3-DPG levels. FDA-approved as PYRUKYND for pyruvate kinase deficiency in 2022, it is now being evaluated for SCD. Phase II results from the RISE UP trial (2023) demonstrated significant hemoglobin improvements at both 50 mg and 100 mg BID doses.

Inclacumab (Pfizer): Inclacumab is a fully human monoclonal antibody targeting P-selectin, a mediator of cell adhesion and vaso-occlusive crises. With the potential for quarterly dosing, it may provide best-in-class efficacy in reducing crises. Phase II studies are complete, and Phase III development is underway.

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Sickle Cell Disease Pipeline Highlights: Other promising pipeline therapies include Etavopivat, EDIT-301 (Reni-cel), Osivelotor (GBT-601), Mitapivat, and Casgevy (Exa-cel), which are projected to drive market growth from 2024-2034. Casgevy is expected to secure the largest market share in the 6MM by 2034.

Sickle Cell Disease Market Outlook

The SCD market, valued at ~USD 650 million in 2023 across the 6MM, is projected to grow substantially through 2034, fueled by the approval and launch of innovative therapies. While gene therapies offer transformative potential, challenges including market access, reimbursement hurdles, and limited patient eligibility may affect overall adoption.

Current management strategies remain symptomatic, using NSAIDs, opioids, blood transfusions, and supportive care, alongside FDA-approved therapies like DROXIA, ENDARI, ADAKVEO, and OXBRYTA. Gene-editing approvals in 2023, including CASGEVY (exa-cel) and LYFGENIA (lovo-cel), mark significant progress toward curative approaches.

Despite advancements, barriers such as limited access to care, treatment adherence, and economic burden persist. Nonetheless, ongoing R&D, healthcare investment, and newborn screening programs suggest a positive growth trajectory and potential for long-term disease control.

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Recent Clinical Developments in Sickle Cell Disease

* August 2025: Oryzon Genomics received EMA approval to initiate a Phase Ib trial of iadademstat in SCD-the first clinical trial in a non-malignant hematological setting.
* August 2025: Beam Therapeutics received FDA RMAT designation for BEAM-101, a genetically modified cell therapy targeting severe vaso-occlusive crises.
* July 2025: Fulcrum Therapeutics reported positive Phase 1b results from the PIONEER trial of pociredir.
* May 2025: Beam Therapeutics announced new BEACON Phase 1/2 findings at EHA 2025, evaluating BEAM-101 in SCD patients.
* November 2024: BioLineRx presented Phase 1 trial results of motixafortide for CD34+ hematopoietic stem cell mobilization in SCD gene therapies.
* May-July 2024: Pfizer, Afimmune, and Novo Nordisk announced results from multiple clinical studies assessing therapies like GBT021601, Epeleuton, and Etavopivat in SCD.

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Key Insights from the DelveInsight Report

* Sickle Cell Disease patient population and prevalence trends
* Sickle Cell Disease Market size, forecast, and therapy-wise segmentation
* Sickle Cell Disease Competitive landscape and key cross-competition
* Sickle Cell Disease Market drivers and barriers
* Emerging Sickle Cell Disease therapies and pipeline analysis
* Current Sickle Cell Disease treatment practices and algorithms
* Impact of novel therapies on market share and adoption
* Seven major market (7MM) projections through 2034

About DelveInsight

DelveInsight is a leading life sciences market research and business consulting firm, offering syndicated reports and customized solutions to companies in the healthcare sector. Leveraging deep analytical expertise, primary research, and expert insights, DelveInsight delivers actionable intelligence to stakeholders worldwide.

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