Hemoglobinopathies Market

Hemoglobinopathies Market Outlook 2031

The global hemoglobinopathies market size was USD 8.72 billion in 2022 and is anticipated to reach USD 21.95 billion by 2031, expanding at a CAGR of 10.8 % during the forecast period, 2023–2031. The growth of the market is attributed to the increasing prevalence of diseases, including sickle cell disease (SCD) and thalassemia. Furthermore, the presence of a robust product pipeline for hemoglobinopathies treatment is driving the market growth.

Hemoglobinopathy is a group of hereditary illnesses caused by aberrant hemoglobin production or structural abnormalities. Sickle cell anemia, hemoglobin S-C disease, and thalassemia are among the numerous ailments of illness. The group of disorders earlier found in Mediterranean region and huge parts of Asia and Africa, have been widespread across the world due to increased migration.

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According to a survey issued by the American Society of Hematology, more than 95 percent of infants born with thalassemia are from low- and middle-income nations, with less than 5% living in North America and Europe. In low-income nations, lack of awareness and high unmet requirements linked to diagnosis and treatment are two main factors contributing to the prevalence of disorders.

Around 4.4 out of every 10,000 live births worldwide are affected with thalassemia. According to the World Health Organization (WHO), about 330,000 newborns are born each year with hemoglobin abnormalities. As per the Centers for Disease Control and Prevention (CDC), the incidence of sickle cell disease trait was determined to be 15.5 instances per 1,000 births in the US.

Moreover, sickle cell trait affects 1.5 percent of newborns born in the country. SCD affects one out of every 365 Afro-American births in the US, but it affects one out of every 16,300 Hispanic-American birth. Geographical location, race, ethnicity, and migration all influence the occurrence of hemoglobinopathies. The Mediterranean region, Sub-Saharan Africa, and Asia have greater rates of hemoglobin-related disorders.

The number of new cases of hemoglobinopathies in North America and Europe has risen dramatically as a result of migration from high-prevalence areas. Major biopharmaceutical companies are collaborating with organizations and companies to create innovative therapies for hemoglobinopathies. For instance, Sangamo Treatments, Inc. and Bioverativ, have joined forces to explore hemoglobinopathies therapeutics.

Hemoglobinopathies Market Trends, Drivers, Restraints, and Opportunities

• Increasing prevalence of hemoglobinopathies in developing and low-income countries is anticipated to boost the market growth during the forecast period.
• Lack of awareness, unmet requirements in the treatment of SCD and thalassemia, and absence of a permanent cure to these diseases are major factors contributing to the high frequency of hemoglobinopathies, spurring the growth of the market.
• Growing investment in the development of innovative medicines is expected to boost market growth.
• Several government programs such as thalassemia screening in neonates and the provision of treatments are projected to have a beneficial impact on market growth.
• Rising investment in the development of novel therapies is expected to drive the market growth during the forecast period.
• Increasing approvals from the regulatory bodies for novel therapies are expected to boost the market growth. For instance, Reblozyl, Adakveo, Zynteglo, and Oxbryta were approved by the food & drug administration (FDA) in 2019 for the treatment of hemoglobin problems.

Scope of Hemoglobinopathies Market Report

The report on the global hemoglobinopathies market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Hemoglobinopathies Market Segment Insights

Sickle cell segment is projected to account for a large market share

Based on types, the market is divided into thalassemia, sickle cell disease, and other hemoglobin (Hb) variants. The thalassemia segment is further sub-segmented into alpha-thalassemia and beta-thalassemia. The sickle cell disease segment is expected to account for a key market share during the forecast period owing to the expanding initiatives by biopharmaceutical companies and non-profit organizations at improve access to SCD treatment. Furthermore, SCD affects approximately 300,000 newborns each year.

An estimated 10% to 40% of people in Africa are transmitters of the sickle cell gene. Over the forecast period, the rising global disease burden is expected to drive the market segment growth. Globally, approximately 5% of the total population is an alpha-thalassemia carrier and approximately 1.5 percent of the population has beta-thalassemia traits. India has the most thalassemia carriers in the world.

Moreover, biopharmaceutical organizations are aggressively collaborating with each other to develop novel therapies for treating the disorder. For instance, CRISPR Therapeutics AG and Vertex Pharmaceuticals Incorporated formed a partnership in December 2017 to develop and commercialize novel gene-editing treatments for thalassemia using CRISPR/Cas9 technology.

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Thalassemia diagnosis segment is expected to expand at a significant pace

On the basis of diagnosis, the hemoglobinopathies market is segregated into thalassemia, sickle cell disease, and other hemoglobin (Hb) variants diagnosis. The thalassemia segment is further divided into blood test, genetic test, prenatal genetic test, pre-implantation genetic diagnosis, electrophoresis, and others. The sickle cell segment is segregated into blood test, genetic test, prenatal genetic test, electrophoresis, and others. The other hemoglobin (Hb) variants segment is sub-segmented into blood test, genetic test, prenatal genetic test, electrophoresis, and others.

The thalassemia segment is expected to expand at a significant pace during the forecast period owing the rising development of technologically advanced, quick, and user-friendly diagnostic tests. The sickle cell disease segment dominated the market and held more than 50% of the market share in 2020, in terms of revenue, owing to high diagnostic rates in North America and Europe.

For the diagnosis of SCD in patients, blood testing is the most commonly utilized method. Furthermore, the advent of newborn baby screening programs for SCD in countries such as the US, France, and Italy are accelerating the segment growth.

Many members of the European Union (EU) Parliament and health stakeholders for rare diseases issued a call to action for newborn screening in the year 2020. Companies such as Oasis Diagnostics and LabCorp, which perform molecular diagnostic tests for screening and detection of alpha- and beta-thalassemia using multiplex ligation-dependent probe amplification (MLPA) and Polymerase Chain Reaction (PCR) are projected to fuel category expansion in the projected timeline.

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Bone marrow transplant (BMT) sub-segment is anticipated to expand at a substantial CAGR

In terms of therapies, the market is divided into thalassemia, sickle cell disease, and other hemoglobin (Hb) variants. The thalassemia segment is further divided into blood transfusion, iron chelation therapy, bone marrow transplant, and others. The sickle cell disease segment is classified as blood transfusion, hydroxyurea, bone marrow transplant, and others. The other hemoglobin (Hb) variants is segregated into blood transfusion, hydroxyurea, iron chelation therapy, bone marrow transplant, and others.

The bone marrow transplant (BMT) sub-segment is anticipated to expand at a substantial CAGR during the forecast period. BMT is usually done if blood transfusions and other therapies fail. It has shown high efficiency in the early stages of disease progression. It aids in the provision of healthy bone marrow to patients who are unable to produce an adequate number of normal cells.

BMT is increasingly being used to treat severe cases of SCD and thalassemia by infusing healthy stem cells into the patient's body to replace diseased or damaged bone marrow. In 2020, the SCD segment accounted for more than 55% of the market share. Extensive research has been conducted to develop novel treatments for 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 with a single administration and reduces the requirements for patients to receive blood transfusions. A robust product pipeline of gene therapy products, such as CTX001 (CRISPR Therapeutics), BIVV003 (Sangamo Therapeutics, Inc. & Bioverativ Inc), and HGB-206 (bluebird bio, Inc), is expected to drive the segment growth.

The first line of treatment for hemoglobin disorders is blood transfusion. Thalassemia patients require more blood transfusions than other group of disorders. The transfusion is performed every three to four weeks to maintain normal blood component levels.

However, frequent blood transfusions increase the risk of contracting infectious diseases and having high blood iron levels. In many countries, the blood supply was disrupted in 2020 due to the complete lockdown caused by COVID-19 outbreak. The overall share of blood transfusion and iron chelation segments are expected to decline in 2020 as a result of the pandemic.

Asia Pacific is anticipated to dominate the market

On the basis of regions, the hemoglobinopathies market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. Asia Pacific is anticipated to expand at an impressive CAGR during the forecast period. The regional market growth is attributed to the presence of a large number of patients suffering from SCD and thalassemia.

Favorable government initiatives aimed at improving the standard of care provided to patients suffering from hemoglobinopathies are contributing to the market growth in the region.

North America held the largest revenue share of around 38% in 2020 due to the increased awareness about hemoglobinopathies among people and improved healthcare facilities. Various organizations are raising awareness through various programs. For instance, the Sickle Cell Disease Coalition raises awareness, funds research programs, and provides treatment in the US.

Its members include organizations involved in research, public health, and provider services, as well as faith-based organizations, industry representatives, foundations, patient groups, and federal agencies. Various initiatives are launched by research organizations and government bodies to promote research and the development of novel therapies for Hemoglobinopathies, contributing to the regional market growth.

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Segments

The global hemoglobinopathies market has been segmented on the basis of

Types

• Thalassemia
  • Alpha-thalassemia, and
  • Beta-thalassemia
• Sickle Cell Disease
• Other Hemoglobin (Hb) Variants

Diagnosis

• 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

Therapies

• 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

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• Sangamo Therapeutics
• Bluebird bio, Inc.
• Global Blood Therapeutics, Inc.
• Pfizer, Inc.
• Emmaus Life Sciences, Inc.
• Prolong Pharmaceuticals, LLC
• Celgene Corporation
• Bioverativ Inc.
• Gamida Cell
• Novartis AG.

Competitive Landscape

Key players competing in the hemoglobinopathies market are Sangamo Therapeutics, bluebird bio, Inc., Global Blood Therapeutics, Inc., Pfizer, Inc., Emmaus Life Sciences, Inc., Prolong Pharmaceuticals, LLC, Celgene Corporation, Bioverativ Inc., Gamida Cell, and Novartis AG.

Market players are engaging in various initiatives such as mergers and acquisitions, partnerships, collaborations, and extensive R&D to expand their market share. For instance, Sangamo Therapeutics, Inc., announced the acquisition of TxCell SA. The CAR-Treg platform, a proprietary technology developed by the company, has the potential to develop novel cell therapies for the treatment of autoimmune and inflammatory diseases.