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Sickle Cell Anemia Testing & Screening Market Report Scope & Overview:

The sickle cell anemia testing & screening market size was valued at USD 440.65 million in 2024 and is expected to reach USD 1125.33 million by 2032, growing at a CAGR of 12.30% over the forecast period of 2025-2032.

The growing incidence of sickle cell disease, the growing implementation of newborn screening programs, and increasing awareness in developed and developing regions are the prime drivers for the growth of the global sickle cell anemia testing & screening market. With the growing government initiatives, enhanced diagnostic infrastructure, and developments in genetic testing, the market is rising. As there are increasing efforts directed towards developing personalized medicine, deploying accurate and cost-effective testing solutions will drive the growth of the market.

The U.S. sickle cell anemia testing & screening market size was valued at USD 146.24 million in 2024 and is expected to reach USD 367.87 million by 2032, growing at a CAGR of 12.09% over the forecast period of 2025-2032.

The North America sickle cell anemia testing & screening market was led by the U.S., owing to the high prevalence of the disease in the African-American population, various legislatively proposed newborn screening programs led by the government, and well-established diagnostic infrastructure across various healthcare settings.

Market Dynamics:

Drivers

  • Increasing Global Prevalence and Carrier Rates of Sickle Cell Disease (SCD) are One of the Factors Driving the Market Growth

The rising incidence of sickle cell anemia, particularly in sub-Saharan Africa, India, the Middle East, and certain parts of the U.S., is a major factor influencing the market due to its Solubility, leading to increased testing and screening. These diseases affect millions of people worldwide, and many more are asymptomatic carriers, making prompt and accurate diagnosis via testing a critical step in the management, genetic counseling, and prevention of these diseases. This, in turn, results in governments and health organizations expanding screening programs, especially for infants and at-risk populations, stimulating market growth.

More than 300,000 babies are born every year in the world with sickle cell disease (SCD), and the World Health Organization (WHO) thinks this number will reach 400,000 by the year 2050, mainly in sub-Saharan Africa.

To help improve U.S. newborn screening programs, the CDC has implemented numerous initiatives, especially in Black and Hispanic populations where incidences of the disease are highest.

  • Screening Programs and Awareness Campaigns Led by the Government and NGO are Driving the Market Growth

Growing momentum across the market is likely to be fortified by funding and implementing a large-scale screening program by public health authorities and non-governmental organizations. Examples include the national neonatal screening policies (e.g., U.S. vs. U.K.) and health communication programs (e.g., WHO vs. CDC) that led to increased numbers of tests. In addition to enhancing early detection and care, these are further encouraging partnerships with diagnostics firms, therefore driving investment into more accessible and advanced testing solutions.

Newborn screening programs for early detection of genetic disorders such as SCD have been implemented in many geographic regions through the collaboration of public health agencies and international NGOs. In high-burden regions globally in which the disease cannot be avoided or averted, initiatives driven by the CDC, NIH, and international organizations, including the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF), are increasing the availability of sickle cell screening programs.

Recent developments in low-cost microfluidic chip-based testing facilitate the rapid diagnosis of sickle cell disease from drops of whole blood in low-resource settings, where skilled personnel are not available, Science Direct reported.

In 2024, BioMedomics Inc. released a next-generation point-of-care Sickle SCAN test that delivers results in less than 5 minutes and is being rolled out across Africa and Southeast Asia.      

Restraint

  • Limited Awareness and Misconceptions Among Populations in Low-Income and Rural Areas are Restraining the Market From Growing

In many of the geographies in sub-Saharan Africa, South East Asia, and parts of the Middle East, the awareness of sickle cell disease and the need to test and screen early on is still low, especially among citizens living in the rural and/or underserved regions of these areas. Genetic diseases often carry stigma due to misconceptions associated with them, either regarding their fatalistic nature or the stigma associated with positive diagnoses; these factors, when combined with a lack of educational outreach, result in underutilization of testing services. It hampers government and NGO-sponsored programs by reducing their impact and coverage.

In a study done in BMC Public Health, in a number of African countries entries of mothers who were aware of sickle cell disease was less than 20% and their understanding of the hereditary nature of the disease was less than 10%. This was a primary barrier for screening acceptance and follow-up testing in those areas.

Segmentation Analysis:

By Test Type

The hemoglobin electrophoresis segment dominated the sickle cell anemia testing & screening market share in 2024 with a 31.5%. Hemoglobin electrophoresis provides a highly accurate and specific assessment of abnormal hemoglobin variants (e.g., HbS, HbC) that are essential for SCD diagnosis; thus, driving segment growth. Due to the reliability of the method and its standardization, this assay is frequently performed in clinical laboratories and hospital settings, representing the gold standard for hemoglobinopathy screening. Furthermore, it provides an unambiguous distinction between sickle cell disease and trait, making it a required confirmatory test in neonatal screening programs and prenatal testing.

The Point-of-Care Tests segment is expected to register the highest rate of growth during the forecast period. This harbors the increasing need for fast, low-cost, and on-site diagnostic solutions, particularly in low-resource and rural locations. These tests can detect sickle cell anemia early in life, so it can be managed promptly at the community and primary care levels, with no need for high-end lab infrastructure. Portable diagnostics have higher long-term growth potential owing to enhanced market penetration driven by the increasing adoption of portable diagnostic tools among NGOs, public health campaigns, and mobile health units in Africa, Asia, and Latin America.

By Technology:

In 2024, the sickle cell anemia testing & screening market is dominated by the molecular testing segment due to better diagnostic accuracy, early detection capabilities, and growing demand for it in both developed and developing countries. Tools such as polymerase chain reaction (PCR), DNA sequencing, and isoelectric focusing enable exact detection of sickle cell mutants, even in newborns, facilitating earlier clinical management and improved treatment course of the disease. Growing awareness amongst physicians about molecular diagnostics, combined with government-led infant screening programs, further strengthened the market leader's position.

Based on technology, the molecular testing segment is expected to be the fastest growing over the forecast time period owing to the ongoing development of genetic testing, falling prices of molecular-associated techniques, and growing access to diagnostic infrastructure by low- and middle-earnings countries. Moreover, the rapid adoption rate can be attributed to factors such as increasing awareness with respect to carrier screening and prenatal diagnosis, along with various public health initiatives towards early and accurate diagnosis of hemoglobinopathies.

By Age Group

The newborn screening (12 months and below) segment accounted for the largest share in the sickle cell anemia testing & screening market growth in 2024 with a 43.15% market share, as many country government bodies have implemented mandates in newborn screening programs to screen children by testing at an early stage. Early detection at birth allows for a timely intervention and dramatically reduces morbidity and mortality due to the disease. Neonatal screening has been integrated into national health strategies and offered as a public health measure to address this unfortunate disease phenomenon in high-prevalence areas such as Sub-Saharan Africa, the Middle East, and sections of the Americas.

The other age groups (1 to 25 & above 60 years) segment is expected to experience the fastest growth during the forecast period. The increasing awareness, late diagnoses in underserved populations, and more health check-up programs targeting school-aged children, young adults, and the elderly are among the factors driving this trend. In various areas where newborn screening is not yet universal or where access to health care remains sparse, people are generally diagnosed later in life after the symptoms have appeared. Better access to healthcare, the trend of population aging, and increasing prevalence of comorbidities in older adults, which create a need for more extensive screening, are also driving the growth of this age group.

By Sector Type

The government labs segment held the largest share within the sickle cell anemia testing & screening market in 2024, with around 40.11%, owing to the implementation of various national health programs and screening of regions with high prevalence. In many countries with a high burden of sickle cell disease (especially in Africa, but also the Middle East and India), early identification has been implemented as the highest priority in public health care systems. These laboratories generally perform extensive newborn and population-based screening programs supported by public health departments, providing access to testing services to a large number of people, particularly in rural or low-income urban regions often underserved.

Due to the increasing need for sophisticated and personalized diagnostic services, the private labs segment is experience to grow at the highest CAGR during the forecast period. As awareness of genetic disorders rises, and disposable revenues rise in emerging economies, the growing population is choosing private health care facilities, as they provide shorter wait times, highly accurate diagnostics, and newer molecular testing instruments. Moreover, private labs and telemedicine provider partnerships are increasing access to screening services in semi-urban and urban centres, which is accelerating the growth of this segment.

Regional Analysis:

North America dominated the sickle cell anemia testing & screening market trend with 43.60% market share in 2024, which can be interrelated to existing healthcare infrastructure, awareness programs in the near past, and mandatory screening of newborns in many countries such as the U.S. & Canada. Supported by robust government policies for early diagnosis, the region has an advanced level of molecular diagnostic tools. The Asia Pacific is the fastest-growing region with 13.43% CAGR over the forecast period due to rising awareness towards hemoglobinopathies, increasing government-led screening initiatives, and increasing birth rates in countries such as India, Indonesia, and Thailand, where sickle cell disease is emerging as beneficial. Further driving the market, a rise in investments in diagnostic infrastructure, partnering up with global health organisations to extend healthcare access in hinterland regions. With regional governments acknowledging the socio-economic toll of late diagnosis, many developing countries are quickly adopting early screening programs.

Europe shows substantial growth in the sickle cell anemia testing & screening market analysis owing to the increasing awareness regarding genetic disorders, coupled with the increasing expansion of newborn screening programs in countries such as the UK, France, and Italy. Public health efforts, including newly federally funded rare disease research, will increase opportunities for early detection and diagnosis, especially among risk groups, for instance, among people born in sub-Saharan Africa. Furthermore, with the increasing acceptance of molecular diagnostic techniques and next-generation sequencing, the accuracy and efficiency of screening have improved, making Europe an imperative emerging region in the global market landscape.

The sickle cell anemia testing & screening market also witnesses moderate growth in Latin America and the Middle East & Africa (MEA), owing to a combination of increasing disease burden, escalating awareness, and gradual improvement in healthcare access rates in these regions. Countries in Latin America, including Brazil, have been experiencing growing government push and partnerships with global health organizations to increase neonatal screening programs and to enhance early diagnostics. The prevailing limitations of insufficient healthcare structure and budget restrictions, in certain parts of the region, still prove to be a barrier in predominantly implementing testing and advanced screening technologies.

Sickle cell disease is a significant public health problem in the MEA region, particularly in sub-Saharan Africa and the Middle East. Although numerous initiatives are being made to rock the boat of the aforementioned disease, such as newborn screening programs and health education initiatives, the availability of quality healthcare products remains limited, which results in moderate market growth. However, more international support and investments in public health initiatives are slowly improving the region’s ability to implement sickle cell anemia testing and screening.

Key Players:

The sickle cell anemia testing & screening market companies are Bio-Rad Laboratories, Thermo Fisher Scientific, Abbott Laboratories, PerkinElmer, Danaher Corporation, BioMedomics, Natera, Agios Pharmaceuticals, Trivitron Healthcare, Siemens Healthineers, Hemex Health, Roche Diagnostics, Hologic, Inc., Cepheid, Streck, Baebies, ERBA Diagnostics, Grifols, SD Biosensor, Trinity Biotech, and other players.

Recent Developments:

  • October 2024 – Bio-Rad Laboratories pointed out the importance of early genetic disorder screening in newborns, calling attention to the extensive use of its VARIANT System in many national newborn screening programs around the globe. The system allows for thorough patient analysis in one run, facilitating timely and proper follow-up and treatment of every infant.

  • May 2024 – Thermo Fisher Scientific announced the release of a new array-based solution to expand extended blood type research. This technology is anticipated to play an important role in shaping future breakthroughs toward safer blood transfusion practices.

    Sickle Cell Anemia Testing & Screening Market Report Scope:
    Report Attributes Details
    Market Size in 2024 USD 440.65 million 
    Market Size by 2032 USD 1125.33 million 
    CAGR CAGR of 12.30% From 2025 to 2032
    Base Year 2024
    Forecast Period 2025-2032
    Historical Data 2021-2023
    Report Scope & Coverage Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
    Key Segments • By Test Type (Hemoglobin Electrophoresis, High-Performance Liquid Chromatography (HPLC), Point-of-Care Tests, Other Tests)
    • By Technology (Molecular Testing, Immunoassay Testing, Others (e.g., spectrophotometry))
    • By Age Group (Newborn Screening (12 months and below), Adult Screening (25 to 60 years), Other Age Groups (1 to 25 & above 60 years))
    • By Sector Type (Government Labs, Private Labs, Corporate Labs, PPP (Public Private Partnerships)
    Regional Analysis/Coverage North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)
    Company Profiles The sickle cell anemia testing & screening market companies are Bio-Rad Laboratories, Thermo Fisher Scientific, Abbott Laboratories, PerkinElmer, Danaher Corporation, BioMedomics, Natera, Agios Pharmaceuticals, Trivitron Healthcare, Siemens Healthineers, Hemex Health, Roche Diagnostics, Hologic, Inc., Cepheid, Streck, Baebies, ERBA Diagnostics, Grifols, SD Biosensor, Trinity Biotech, and other players.