According to latest report, the U.S. hemoglobinopathies market size was valued at USD 3.15 Billion in 2023 and is poised to grow from USD 3.55 Billion in 2024 to USD 10.32 Billion by 2033, at a CAGR of 12.6% during the forecast period (2024-2033)
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Key Takeaways:
- Sickle cell disease dominated the market and accounted for a share of 60.15% in 2023.
- Sickle cell disease accounted for the largest market revenue share in 2023 and is expected to grow at the fastest CAGR over the forecast period.
- The sickle cell disease segment dominated the market in 2023 and is anticipated to grow at fastest CAGR over the forecast period.
- Bone marrow transplant (BMT) therapy is poised for significant growth in the upcoming period.
The market is attributed to the increasing prevalence of diseases such as thalassemia and sickle cell disease (SDC) and the increasing product pipeline focused on treating such diseases. In the U.S., sickle cell disease affects around 100,000 individuals, according to the Centers for Disease and Prevention (DCD) estimates. At least 1 in 13 African American infants are born with sickle cell conditions, out of every 16,300 Hispanic American births report SDC disorders.
The U.S. hemoglobinopathies market deals with blood disease that directly influences red blood cells. It is a genetic defect that results in the abnormal structure of the globin chains of the hemoglobin molecule. Hemoglobin S-C disorder, thalassemia, hemoglobin C disease, and sickle cell anaemia. The market is experiencing growth leading to various, with a significant trend being the commercialization and advancement of innovative therapies, such as gene therapies and gene editing.
These novel approaches concentrate on the fundamental genetic molecules in hemoglobinopathies, thereby driving market growth. For example, in August 2022, Zynteglo, the first cell-based gene therapy, was approved by the Food and Drug Administration (FDA) for treating pediatric and adult patients suffering from Beta-thalassemia. This groundbreaking approval provides a significant treatment option and marks a significant milestone in gene therapy for patients with this genetic blood disorder.
In addition, the U.S. hemoglobinopathies market is witnessing a notable trend in increased research and development activities across the pharmaceutical sector. This growth in financial commitment is significantly fueled by the unyielding quest to enhance and discover advanced treatment methodologies and the persistent pursuit of innovation. For instance, in October 2022, a biopharmaceutical company specializing in distributing, developing, and researching life-altering therapies, Pfizer announced the acquisition of Global Blood Therapeutics.
These therapies provide expectations to underserved patient communities. In the U.S., the increasing initiatives taken by organizations and companies with the objective of making people aware of hemoglobinopathies are further driving the market growth.
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U.S. Hemoglobinopathies Market Trends
- The growing prevalence of hemoglobinopathies in underdeveloped and developed regions significantly fueled the market growth.
- The increasing investment in research and development and increasing collaborations are expected to drive the market growth.
- The growing interest from both public and private sectors in clinical trials, novel drug development, and gene therapies is expected to enhance market growth.
- The growing emphasis on personalized medicines to influence the demand for specialized diagnostic treatments and tests is further anticipated to drive market growth.
U.S. Hemoglobinopathies Market Segment Insights
By Type Insights
Sickle cell disease dominated the market and accounted for a share of 60.15% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period. The segment growth is driven by the growing initiatives of nonprofit organizations and biopharmaceutical companies fuels improved access to Sickle Cell Disease (SCD) Treatment. Awareness campaigns concentrated on disease diagnosis play an important role in boosting market growth. For instance, providing support for those affected by sickle cell disease and promoting early diagnosis is a priority for several organizations. Two significant organizations owing these efforts are the local chapters and the Sickle Cell Disease Association of America (SCDAA), which organize health fairs, community workshops, and educational events to improve early detection and raise awareness of sickle cell disease.
In addition, scientific trials are improving the efficacy and safety of potential therapies for hemoglobinopathies. These approaches include treatments on patients and testing new drugs to determine their optimal usage, risks, and benefits. Scientific trials help inform regulatory approval processes and clinical decision-making, by generating robust data on the effectiveness of various treatment options. Thus, all the above factors are expected to drive the segment growth in the U.S.
By Diagnosis Types
Sickle cell disease accounted for the highest market share in 2023 and is expected to grow fastest during the forecast period. There has been a notable trend in the sickle cell disease diagnosis market towards adopting and developing innovative diagnostic technologies, in recent years. These technological advancements involve genetic testing methods such as molecular diagnostics and next-generation sequencing, which have greatly improved the efficiency and accuracy of identifying sickle cell disease and its variants. Rapid diagnostic kits and point-of-care devices have become increasingly popular in various healthcare industries. These tools allow convenient and rapid screening, potentially improving patient outcomes and facilitating quicker decision-making.
In addition, there has been a significant growth in the focus on newborn screening programs for hemoglobinopathies, which are genetic diseases impacting the structure of hemoglobin. This heightened significance aims to ensure early detection of these diseases, allowing medical professionals to improve patient outcomes and initiate timely interventions. Healthcare providers can more effectively manage and identify hemoglobinopathies such as thalassemia and sickle cell disease, by incorporating advanced screening methods into newborn care. As a result, the impacted infants have a strong chance of getting appropriate treatment and owning healthier lives.
By Therapy Types
The sickle cell disease segment dominated the U.S. hemoglobinopathies market in 2023. The segment growth is driven by the approval and advancement of innovative therapies, such as targeted treatments and gene therapies designed to address disease symptoms or modify genetic abnormalities, which plays an important role in driving market growth. Stem cell transplantation from matched unrelated donors is rapidly being identified as a viable option. In addition, there is an increasing prevalence of supportive care strategies such as hydroxyurea therapy, infection prevention, and pain management. The preference towards patient-centered care models and personalized medicine approaches is gaining momentum to improve treatment outcomes for sickle cell disease.
Blood transfusions are a significant treatment method for hemoglobin diseases, such as thalassemia and other related diseases. These transfusions are important for patients with thalassemia, who need more transfusions. The primary goal of these transfusions is to maintain normal levels and alleviate the symptoms and blood components associated with the disease. In addition, blood transfusions are administered every three to four weeks.
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U.S. Hemoglobinopathies Market Company Insights
Some of the major players are operating in the hemoglobinopathies market in the U.S. such as Novartis AG, Pfizer, Inc., Emmaus Life Sciences Inc., Bluebird Bio, Inc., Global Blood Therapeutics, and others.
- Bluebird bio. Concentrates on developing gene therapies for various genetic diseases, such as hemoglobinopathies such as beta-thalassemia, and sickle cell disease. Bluebird Bio has cutting-edge innovative treatments for these disorders and provides curative therapies that aim to meet the underlying genetic diseases of hemoglobinopathies.
- Pfizer, Inc. Is a major pharmaceutical company that has notable prevalence in the market. Hemoglobinopathies are a group of genetic diseases characterized by abnormalities in the production or structure of hemoglobin, the red blood cell protein that carries oxygen throughout the body. These diseases involve thalassemia and sickle cell disease among others.
Some of the prominent players in the U.S. 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.
- Celgene Corp.
U.S. Hemoglobinopathies Market Recent Developments
- In December 2023, two milestone treatments, Casgevy and Lyfgenia, were approved by the U.S. Food and Drug Administration representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. In addition, Casgevy is the first FDA-approved treatment to use a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.
- In September 2022, Vertex Pharmaceuticals Inc. And CRISPR announced that Vertex received approval from the U.S. FDA for exagamglogene autotemcel. The treatment is helpful in transfusion-dependent sickle cell disease and beta-thalassemia.
U.S. Hemoglobinopathies Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2033. For this study, Nova one advisor, has segmented the U.S. hemoglobinopathies market report based on type, diagnosis, therapy, and region.
- By Type
- Thalassemia
- Sickle Cell Disease
- Other Hemoglobin (Hb) Variants
- By Diagnosis
- Thalassemia
- Alpha
- Blood Test
- Genetic Test
- Prenatal Genetic Test
- Pre-implantation Genetic Diagnosis
- Electrophoresis
- Others
- Beta
- 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
- (Hb) Variants
- Blood Test
- Genetic Test
- Prenatal Genetic Test
- Electrophoresis
- Others
- By Therapy
- Thalassemia
- Alpha
- Blood Transfusion
- Iron Chelation Therapy
- Bone Marrow Transplant
- Others
- Beta
- Blood Transfusion
- Iron Chelation Therapy
- Bone Marrow Transplant
- Others
- Sickle Cell Disease
- Blood Transfusion
- Hydroxyurea
- Bone Marrow Transplant
- Others
- (Hb) Variants
- Blood Transfusion
- Hydroxyurea
- Bone Marrow Transplant
- Others
- By Regional
- West
- Midwest
- Northeast
- Southwest
- Southeast
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