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The global sickle cell disease treatment market size was USD 1.35 billion in 2019. The global impact of COVID-19 has been unprecedented and staggering, with sickle cell disease treatment witnessing a positive demand shock across all regions amid the pandemic. Based on our analysis, the global market will exhibit a growth of 6.3% in 2020. The market is projected to grow from USD 1.44 billion in 2020 to USD 7.71 billion in 2027 at a CAGR of 18.5% in the 2020-2027 period.
Sickle cell disease is considered a primary concern in the healthcare industry, owing to its significant prevalence in the Middle East and Africa. The condition is characterized to be hereditary, originated in the African region. As per the estimate of the United Nations, 12-15 million SCD patients are living in Africa. According to the American Society of Hematology, by 2050, the prevalence of sickle cell disease is anticipated to increase by 30%.
Lack of therapies and unmet needs of patients has triggered the government to take active steps. The government focuses on fast-track approval and research grants to encourage pharmaceuticals companies in developing novel therapies for the disease. For instance, the National Heart, Lung, and Blood Institute launched the Cure Sickle Cell Initiative to accelerate the development of genetic medicines to treat sickle cell disease. This, coupled with new product launches and increased research, is expected to propel the sickle cell disease treatment market growth.
COVID-19 Impact: Lack of Donors to Pose Hindrance for the Market Growth
The implications of the COVID-19 pandemic in the healthcare industry are profound. With the rapid increase in patients' number, healthcare facilities and providers' burden is also increasing. Hence, many hospitals and government organizations decided to postpone or cancel surgeries and appointments to allocate the resources to manage COVID-19 patients.
The SCD treatment market witnessed a mixed impact of the pandemic. Postponement of surgeries resulted in a decrease in the number of BMT and blood transfusion procedures. The pandemic has squeezed the demand and donor base of blood supplies. Lockdown and travel restrictions resulted in a decline in the number of donors and the cancellation of numerous blood drives across the globe. For instance, U.S. blood centers witnessed a 30% decline in blood drives scheduled for the rest of the year, leading to about 250,000 missed donations. Furthermore, according to American Red Cross Blood Services, more than 50,000 blood drives have been canceled or moved due to the pandemic.
However, pharmaceutical companies reported positive growth in 2020. This can be attributed to their ability to avoid supply chain disruptions and new regulatory approvals. Global Blood Therapeutics has seen an increase in new prescriptions of Oxbryta throughout 2020, even with the considerable rise in COVID-19 cases in the U.S. Sales of Oxbryta reached USD 36.9 million in 3Q, an increase of 161.7% from the 1Q 2020. Hence, despite the decrease in demand for transfusion and BMT, pharmaceutical therapies' high growth rendered a positive development to the overall market in 2020.
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Increasing Research on Gene Therapy to Augment the Market
Gene therapy has emerged as the ultimate cure to various serious diseases. In the case of hereditary diseases, gene therapy is a revolution that targets the disease's root cause. Research to correct the genetic mutation in SCD increases with companies shifting the R&D focus towards genetic therapy. A team of scientists at Harvard Medical School has developed an approach to introducing a virus into the RNA that will inhibit BCL11A, boosting the production of fetal hemoglobin.
Similarly, CRISPER Therapeutics and Vertex Pharmaceuticals are conducting clinical trials on CRISPR-Cas9 gene-edited therapy CTX001. Positive clinical studies on CTX001 suggest that the pipeline candidate can become a blockbuster drug when launched. This is expected to provide significant growth opportunities in the SCD treatment market.
Increasing Prevalence of SCD to Drive the Market
The rising prevalence of sickle cell disease, especially in Africa, is one of the major factors expected to augment the market's growth. According to the United Nations, around 20-25 million people are living with SCD globally. Furthermore, Sub-Saharan Africa has the highest prevalence, where nearly 240,000 children are born with sickle cell disease every year.
As per estimates of the Centers for Disease Control and Prevention, the disease occurs in around 1 of every 365 African-American births in the U.S. Due to this; the government is taking active steps to improve access to care and diagnosis for sickle cell disease patients. This is anticipated to drive the SCD treatment market growth.
New Product Launches to Favor Market Expansion
In 2017, FDA approved Emmaus Life Sciences product Endari for sickle cell disease patients aged five years and older. Until then, there was a severe lack of focus or innovation on developing a treatment, as Endari was the first sickle cell disease treatment approved in decades since hydroxyurea.
The world is seeing a massive wave of innovation with three products approved for the sickle cell disease treatment since 2017 – Endari (Emmaus Life Sciences), Oxbryta (Global Blood Therapeutics), and Adakveo (Novartis AG). Regulatory authorities such as the FDA and EMA play their part by providing speedy approval to these products. For instance, Oxbryta has approved fully three months ahead of a statutory deadline for agency action.
Apart from this, products such as Zynteglo, CTX001, Mitapivat, and FT-4202 are expected to receive approval during the 2021-2027 period. The launch of these drugs is being favored by fast track and priority review designations. For instance, CTX001 has been granted EMA’s priority medicines (PRIME) designation in Europe. This is anticipated to fuel the product demand.
High Cost of Treatment to Hamper the Growth
Sickle cell disease imposes a significant financial burden on the patients, health insurance companies, government healthcare programs due to the high cost of treatment. The bone marrow transplant, a recommended therapy in severe cases, costs around USD 100,000 – 500,000 per patient. Hydroxyurea, which is the first line of sickle cell disease treatment, costs around USD 1,000-1,500 annually. Moreover, the cost of blood transfusion is over USD 1,000 annually.
Such high cost of therapies associated with sickle cell disease has a massive impact on the number of patients opting for or having access to these treatments, especially in poor and developing countries. The addressable population for approved drugs and pipeline products is limited to patients in high-income countries having an established reimbursement system. This is expected to hinder the growth of the market.
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Potential Pipeline Candidates to Render Strong Growth to the Pharmacotherapy Segment
Based on the sickle cell disease treatment modality, the market is segmented into bone marrow transplant, blood transfusion, and pharmacotherapy. The pharmacotherapy segment is further bifurcated into hydroxyurea and branded drugs. The branded drugs segment is further segmented into Endari, Adakveo, Oxbryta, Zynteglo, CTX001, Mitapivat, and FT-4202.
The blood transfusion segment is estimated to hold a prominent position in the market. Stroke is one of the common complications of SCD. According to the American Society of Hematology, approximately 11% of SCD patients have clinically apparent strokes before age 20. Blood transfusion treatment is an effective way to prevent episodes of stroke among SCD patients. Thus, high usage of blood transfusions is the crucial factor behind the dominant share of the segment.
The pharmacotherapy segment is projected to witness remarkable growth during 2016-2027. The high growth of the segment can be attributed to the government's strong support for pharmaceutical companies. As limited treatment options are currently available in the market, the government supports research activities through funding and designations such as orphan drugs, fast track, priority review, and others. This will accelerate the introduction of new drugs into the market and provide significant momentum to the segment’s growth.
Bone Marrow Transplant (BMT) is the only option that can completely cure SCD. Thus, the inclination towards BMT is increasing in countries in North America and Europe. However, the high cost of the procedure and difficulty in finding a matching donor limits the segment's expansion.
Rising Number of ER Visits to Fuel the Hospitals Segment’s Growth
Based on end-user, the market is categorized into hospitals, specialty clinics, and others. The hospital segment is expected to dominate the market throughout the forecast period. VOC is the main reason for hospital admissions, leading to approximately 200,000 ER visits in the U.S. every year. This is expected to favor the expansion of the hospital segment in the coming years.
The increasing number of clinics is propelling the growth of the specialty clinics segment. Furthermore, as SCD is associated with various manifestations, there are frequent out-patient visits. This is another factor contributing to the expansion of the segment. The growing number of patients using drugs is thus promoting care in home care settings. This is likely to augment the growth of the others segment.
The market size in the U.S. stood at USD 0.71 billion in 2019. Improving access to sickle cell disease treatment, potential pipeline candidates, and strong government support contribute to the expanding market in the U.S. According to the Center for International Blood and Marrow Transplant Research, in 2017, 157 hematopoietic cell transplants were performed in 2017 in the U.S for SCD. The number of BMT increased by 35.3% during 2013-2017. This, in turn, is favoring the expansion of the market in the U.S.
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Favoring reimbursement policies and the increasing number of births with SCD are prominent reasons responsible for the second position of Europe in the global market. According to the Sickle Cell Society, SCD is one of England's most common serious genetic conditions, affecting approximately 1 in 2436 live births in 2017. This is expected to drive the market in Europe.
The highest prevalence of SCD is reported in Africa, the Middle East, Latin America, and the Mediterranean regions. This is one of the primary reasons for the healthy growth of the market for the rest of the world. In June 2020, Novartis AG expanded the Africa Sickle Cell Disease program to East Africa with two new MoU Ministries of Health of Uganda and Tanzania. The program aims to provide care to patients in sub-Saharan Africa, with plans to reach around 10 countries by 2022. This, coupled with the rising number of births with SCD in Brazil and Asia Pacific, is likely to augment the market in ROW.
Approval for Adakveo to Render Leading Position to Novartis AG
In terms of the sickle cell disease treatment market revenue, Novartis AG accounted for the dominant position. The company entered the market with the approval of Adakveo in 2019. The drug can reduce the sickle cell pain crises by 45% in the clinical trials and hence is. Thus, increasing VOC episodes among patients is likely to strengthen the company’s position.
Global Blood Therapeutics held the second leading position in the market. Increasing prescriptions for Oxbryta and intense focus to receive EMA and FDA extended label approval. A total of 4,000 prescriptions were written for the drug in the U.S. by September 2020. This is likely to favor the company’s position. Apart from this, the market is expected to become more competitive with various key market players such as bluebird bio Inc., CRISPER Therapeutics, Vertex Pharmaceuticals entering the market in the coming years.
An Infographic Representation of Sickle Cell Disease Treatment Market
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The sickle cell disease treatment market report provides a detailed analysis of the market and focuses on key aspects such as leading companies, sickle cell treatment types, and applications of the drugs. Besides, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors contributing to the market's growth in recent years.
Value (USD Billion)
Treatment Modality; End User, and Geography
By Treatment Modality
By End User
The value of the global market was USD 1.35 billion in 2019.
Fortune Business Insights says that the market is projected to reach USD 7.71 billion by 2027.
The U.S. market stood at USD 0.71 billion in 2019.
The market is projected to rise at a CAGR of 18.5% during 2016-2027.
Blood transfusion is the leading segment in this market.
The increasing prevalence of SCD and new product launches are the key factors driving the global market.
Novartis AG and Global Blood Therapeutics Inc. are the top players in the global market.
The U.S. is expected to hold the highest market share.
Strong government support and improving adherence to treatment are factors expected to drive the market adoption.
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