Hemoglobinopathies Market Size, Share & Trends Analysis Report By Type (Thalassemia, Sickle Cell Disease, Other Hemoglobin (Hb) Variants), By Diagnosis, By Therapy, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global hemoglobinopathies market size was valued at USD 7.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 10.8% from 2021 to 2028. The rising prevalence of conditions such as sickle cell disease (SCD) and thalassemia, coupled with the presence of a strong product pipeline for the treatment of hemoglobinopathies, is expected to fuel the market growth. It is estimated that thalassemia affects around 4.4 per 10,000 live births globally. Moreover, around 40 million thalassemia carriers are present in India. Furthermore, according to the WHO, over 330,000 babies are born with hemoglobin disorders each year. Major factors leading to the high prevalence of hemoglobinopathies include lack of awareness, unmet needs related to the treatment of sickle cell disease and thalassemia, and lack of a permanent cure.

Increasing prevalence of hemoglobinopathies in developing and low-income countries is anticipated to boost the market growth over the forecast period. According to a report published by the American Society of Hematology, more than 95% of children born with thalassemia in the world are from low- and middle-income countries, and less than 5% of children born with thalassemia live in North America and the European region. Lack of awareness and high unmet needs related to the diagnosis and treatment are some of the major factors increasing the prevalence in low-income countries. According to the CDC, the incidence of sickle cell disease trait in the U.S. was found to be 15.5 cases per 1,000 births. In addition, 1.5% of babies born in the U.S. have sickle cell trait.

The incidence of hemoglobinopathies depends upon geography, race, ethnicity, and migration. Moreover, the incidence of hemoglobin related diseases is higher in the Mediterranean area and sub-Saharan Africa and Asia region. The migration from high prevalence regions has substantially increased the number of new cases of hemoglobinopathies in North America and the European region. For instance, according to the CDC, there are around 100,000 Americans with sickle cell disease living in the country. In the U.S., sickle cell disease occurs in one out of every 365 African-American births, whereas in Hispanic-American, the incidence of SCD is 1 out of every 16,300 births. Around 1 in 13 African-American newborns has sickle cell trait.

Rising investment in the development of novel therapies is expected to provide impetus to market growth in the coming years. Major biopharmaceutical players are collaborating to develop novel therapeutics for hemoglobinopathies using the latest technology platforms. For instance, Sangamo Therapeutics, Inc. and Bioverativ have collaborated to develop therapeutics for hemoglobinopathies. Moreover, increasing approvals from the regulatory bodies for novel therapies are expected to boost the market growth. For instance, in 2019, the FDA approved Reblozyl, Adakveo, Zynteglo, and Oxbryta for the treatment of hemoglobin disorders. Moreover, various programs undertaken by governments such as thalassemia screening in neonates and providing medicines are expected to impact the market growth positively. Increasing awareness about hemoglobin disorders may lead to an increase in the demand for prevention, diagnosis, and treatment methods.

Type Insights

The sickle cell disease segment held the largest share of 56.6% in 2020 and is expected to grow at the fastest rate during the forecast period. This is attributed to growing initiatives by biopharmaceutical companies and nonprofit organizations focused on improving access to SCD treatment. Furthermore, sickle cell disease affects around 300,000 newborns annually. An estimated 10% to 40% of the individuals in many African countries are carriers of sickle cell gene, which has resulted in a prevalence of around 2% in these countries. The increasing global disease burden is expected to fuel market growth over the forecast period.

The thalassemia segment is further sub-segmented into alpha-thalassemia and beta-thalassemia. Globally, 5% of the total population are carriers of alpha-thalassemia and around 1.5% of the population have beta-thalassemia traits. India has the maximum number of thalassemia carriers in the world. Moreover, biopharmaceutical companies are actively collaborating with each other to develop novel therapies for treating the disorder. For instance, in December 2017, CRISPR Therapeutics AG and Vertex Pharmaceuticals Incorporated entered into a partnership to develop and commercialize novel gene-editing treatments for thalassemia using CRISPR/Cas9 technology.

Diagnosis Insights

The sickle cell disease diagnosis segment dominated the market and accounted for more than 50.0% share in 2020 owing to high diagnostic rates in North America and Europe. Blood tests are most widely used for the diagnosis of SCD in patients. Moreover, the introduction of newborn baby screening programs for sickle cell disease in countries, such as the U.S., France, and Italy, will drive the segment at the fastest rate. In 2020, a call of action for the newborn screening was signed by many members of the European Parliament and health stakeholders for rare diseases.

The thalassemia diagnosis segment is estimated to grow at a significant rate over the forecast period. The introduction of technologically advanced, rapid, and user-friendly diagnostic tests is driving the segment. In addition, the presence of companies such as Oasis Diagnostics and LabCorp, which provide molecular diagnostic tests based on Multiplex Ligation-dependent Probe Amplification (MLPA) and Polymerase Chain Reaction (PCR) for screening and detection of alpha- and beta-thalassemia, is expected to fuel the segment growth.

Therapy Insights

The sickle cell disease segment held the largest revenue share of 59.4% in 2020. Extensive research has been carried out to develop novel therapies for treating the disorder, which is contributing to the segment growth. Gene therapy has emerged as a promising treatment option for managing the disorder as it targets the underlying genetic cause of the condition through one-time administration and reduces the need for patients to undertake blood transfusions. Robust product pipeline of gene therapy products, including CTX001 (CRISPR Therapeutics), BIVV003 (Sangamo Therapeutics, Inc. & Bioverativ Inc), and HGB-206 (bluebird bio, Inc), is expected to support segment growth.

Blood transfusion is considered to be the first line of treatment for hemoglobin disorders. The frequency of blood transfusion is higher in thalassemia cases as compared to other hemoglobinopathies. The transfusion is done every 3 to 4 weeks to help maintain the normal level of blood components. However, blood transfusion at frequent intervals increases the risk of acquiring infectious diseases and high blood iron levels. In 2020, the blood supply was interrupted because of a complete lockdown due to COVID-19 in many countries. The overall share of blood transfusion therapy and iron chelation therapy was estimated to decline due to the pandemic in the year 2020.

Bone marrow transplant (BMT) therapy is expected to expand at a significant growth rate over the forecast period. BMT is often used when blood transfusion and other therapies fail. BMT is reported to be effective when performed in the early stages of disease progression. It helps to provide healthy bone marrow to patients who are unable to produce a sufficient number of normal cells. BMT infuses healthy stem cells in the patient’s body to replace the diseased or damaged bone marrow and is increasingly being used to treat severe cases of sickle cell disease and thalassemia.

Regional Insights

North America held the largest revenue share of 38.2% in 2020 owing to increasing awareness of hemoglobinopathies among people and improving healthcare facilities. Various organizations spread awareness by conducting different programs. For instance, the Sickle Cell Disease Coalition creates awareness, funds research programs, and provides access to treatment in the U.S. Its membership includes research, public health, and provider organizations, faith-based organizations, industry representatives, foundations, patient groups, and federal agencies. Various initiatives undertaken by research organizations and government bodies to promote research to develop novel therapies for treating hemoglobinopathies are likely to contribute to the market growth in the region.

Moreover, increasing immigration to North America and Europe from high prevalence areas and improving diagnosis and treatment for common and rare genetic diseases, such as thalassemia and sickle cell disease, are some of the factors expected to fuel the market growth in these regions. The prevalence of hemoglobinopathies among migrated people in North America and Europe is high as compared to native people.

Asia Pacific is estimated to exhibit a lucrative growth rate over the forecast period. The presence of a large number of patients suffering from sickle cell disease and thalassemia is expected to propel market growth in the coming years. Favorable government initiatives, which are aimed at improving the standard of care provided to patients affected with hemoglobinopathies, are contributing to the market growth in the region. Due to improved healthcare facilities, the burden of SCD and thalassemia is growing in the region.

Key Companies & Market Share Insights

Market players are taking up various initiatives, such as mergers & acquisitions, partnerships, collaborations, and extensive R&D, in order to gain a greater share in the market. For instance, Sangamo Therapeutics, Inc. announced the acquisition of TxCell SA. The company’s proprietary technology CAR-Treg platform has the potential to develop novel cell therapies for the treatment of autoimmune and inflammatory diseases. Some prominent players in the global hemoglobinopathies market include:

• Sangamo Therapeutics, Inc.

• Global Blood Therapeutics, Inc.

• bluebird bio, Inc.

• Emmaus Life Sciences Inc.

• Pfizer, Inc.

• Novartis AG

• Prolong Pharmaceuticals, LLC

• Bioverativ Inc.

• Gamida Cell

Hemoglobinopathies Market Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-markets from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global hemoglobinopathies market report on the basis of type, diagnosis, therapy, and region:

• Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Thalassemia

  • Sickle Cell Disease

  • Other Hemoglobin (Hb) Variants

• Diagnosis Outlook (Revenue, USD Million, 2017 - 2028)

  • Thalassemia

    • Blood Test

    • Genetic Test

    • Prenatal Genetic Test

    • Pre-implantation Genetic Diagnosis

    • Electrophoresis

    • Others

  • Sickle Cell Disease

    • Blood Test

    • Genetic Test

    • Prenatal Genetic Test

    • Electrophoresis

    • Others

  • Other Hemoglobin (Hb) Variants

    • Blood Test

    • Genetic Test

    • Prenatal Genetic Test

    • Electrophoresis

    • Others

• Therapy Outlook (Revenue, USD Million, 2017 - 2028)

  • Thalassemia

    • Blood Transfusion

    • Iron Chelation Therapy

    • Bone Marrow Transplant

    • Others

  • Sickle Cell Disease

    • Blood Transfusion

    • Hydroxyurea

    • Bone Marrow Transplant

    • Others

  • Other Hemoglobin (Hb) Variants

    • Blood Transfusion

    • Hydroxyurea

    • Iron Chelation Therapy

    • Bone Marrow Transplant

    • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • India

    • China

    • Japan

    • Singapore

    • Australia

    • South Korea

  • Latin America

    • Argentina

    • Brazil

    • Mexico

  • Middle East & Africa

    • Saudi Arabia

    • United Arab Emirates

    • South Africa