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

Sickle Cell Anemia Testing and Screening Market was valued at USD 494.8 million in 2025 and is expected to reach USD 1,579 million by 2035, growing at a CAGR of 12.30% from 2026–2035.

The worldwide market for Sickle Cell Anemia Testing and Screening is growing because of the increase in the prevalence rate of sickle cell disease, increase in government-driven programs for newborn and population screening, and advancements in diagnostic technology including molecular tests, point-of-care diagnostic tests, and AI-enabled blood smear analysis. Such technological advancements are contributing to improving the accuracy of early detection, lowering test costs, and increasing availability in resource-limited and high-burden settings. The sickle cell disease, which is the most common monogenic disease in the world, impacts about 300,000 infants per year, and the number is estimated to reach nearly 400,000 by 2050, especially in sub-Saharan Africa, India, Middle East, and global diasporas. Greater government investment, research by NIH, and FDA-approved gene therapies have added to the increased demand.

The 12.30% CAGR between 2026 and 2035 of the Sickle Cell Anemia Testing and Screening Market is attributed to increasing burden of disease, increasing newborn screening policies, and advanced diagnostic techniques which allow fast and inexpensive detection in areas with high disease burden. North America accounts for 43.60% of market share, whereas Asia Pacific leads in growth rate at 13.43% CAGR.

Market Size and Forecast

• Market Size in 2025: USD 494.8 Million

• Market Size by 2035: USD 1,579 Million

• CAGR: 12.30% from 2026 to 2035

• Base Year: 2025

• Forecast Period: 2026–2035

• Historical Data: 2022–2024

Sickle Cell Anemia Testing and Screening Market Trends

• Rapid point-of-care lateral flow tests enable 10–15 minute sickle cell detection without lab infrastructure, expanding diagnosis in rural and low-resource high-burden regions globally.

• High-performance liquid chromatography systems support large-scale newborn and population screening by identifying multiple haemoglobin variants efficiently in centralized laboratory environments with high throughput.

• DNA-based molecular diagnostics using PCR and sequencing enable precise genotypic detection, supporting prenatal diagnosis, carrier identification, and precision medicine decisions in sickle cell disease.

• AI-based blood smear analysis increases the accuracy of identifying sickle-shaped red blood cells via smartphone microscopy, allowing for affordable screening without the need for specialized laboratory facilities.

• The increased newborn screening requirements in various nations such as the USA, United Kingdom, and France have led to government-sponsored demand for sickle cell testing programs.

• The increasing number of carrier screening programs within reproductive health care detects sickle cell carriers, thereby providing genetic counseling and reducing incidences of the disease.

U.S. Sickle Cell Anemia Testing and Screening Market was valued at approximately USD 163.9 million in 2025 and is expected to reach approximately USD 513 million by 2035, growing at a CAGR of 12.09% during 2026–2035.

The United States represents the world's largest sickle cell anemia testing and screening market, accounting for the majority of North America's global share in 2025. It is driven by the legislative mandate for newborn sickle cell screening in all states. The landmark 2023 FDA approvals of the gene therapies for sickle cell disease have fundamentally elevated the clinical and commercial importance of accurate, comprehensive sickle cell diagnostic testing, as pre-treatment patient selection, treatment monitoring, and long-term outcome assessment create new diagnostic testing demand across the full sickle cell patient journey that extends well beyond initial diagnosis.

Bio-Rad Laboratories' enhanced VARIANT System for newborn genetic screening and Thermo Fisher Scientific's 2024 launch of an array-based extended blood typing solution are redefining standards in diagnostic accuracy and throughput in the U.S. sickle cell testing market. These product innovations by two of the world's leading diagnostic instrument companies confirm that the sickle cell testing market is attracting premium diagnostic technology investment commensurate with the clinical significance of accurate sickle cell diagnosis in an era where curative gene therapy is available for appropriately selected patients, sustaining the U.S. market's growth through the 2026 to 2035 forecast period.

Sickle Cell Anemia Testing and Screening Market Segment Insights

• According to Test Type, Hemoglobin Electrophoresis dominated; Point-of-Care Tests are the fastest-growing test type.

• In terms of Age Group, Newborn Screening dominated as the largest age group segment; Adult Screening is growing significantly.

• By Sector Type, Government Labs dominated with approximately 40.11% to 41% of market; Private Labs are the fastest-growing sector.

Sickle Cell Anemia Testing and Screening Market Segment Analysis

By Test Type: Hemoglobin Electrophoresis dominates, Point-of-Care Tests grow fastest

The test category that emerged dominant in 2025 was the Hemoglobin electrophoresis. This test is regarded as the gold standard for diagnosing sickle cell disease since it involves separation of hemoglobin by means of migration differences in an electrical field. This allows for the detection of different types such as HbS, HbA, HbC, among others. Due to its established lab infrastructure, clinical validation, and good reimbursement structure, it will remain dominant for many years to come.

POCTs are the fastest growing category up to 2035, due to the need for diagnosing patients using tests that are easily available in underdeveloped areas such as sub-Saharan Africa and rural India. The lateral flow immunoassay platform such as HemoTypeSC and Sickle SCAN provides results within 10–15 minutes, using blood taken from a finger stick sample without the use of any lab equipment.

By Age Group: Newborn Screening dominates, Adult Screening grows alongside

In the year 2025, newborn screening became the dominant age group since it plays an essential role in the early detection of sickle cell disease even before the appearance of any clinical symptoms. Early diagnosis facilitates preventive measures including penicillin and vaccinations as well as counseling of parents. This is why the United States model of heel prick screening is considered the international standard for newborn screening, thereby contributing to a continued growth in institutional testing demand.

Adult screening is a growing segment driven by carrier detection, pre-marital testing, and ongoing disease monitoring in diagnosed patients. Rise in the number of patients opting for gene therapies like Casgevy and Lyfgenia has created additional need for pre-treatment evaluation, involving testing for the extent of the disease and assessing the functionality of organs. Such high-value testing episodes have resulted in robust growth in sickle cell testing services for adults.

By Sector Type: Government Labs dominate, Private Labs grow fastest

The government laboratories continued to dominate the sector in 2025 with market shares of 40-41%, owing to their involvement in implementing national programs for newborn and population-wide screening of sickle cell disease. The government laboratories are able to cover broad populations in terms of screening for little or no cost, particularly in low-income and rural areas, which have high levels of sickle cell disease cases. The broad health care infrastructure of the government laboratories makes them ideal for conducting national sickle cell screening programs.

The most rapidly growing segment up to 2035 is private laboratories owing to the increasing need for genetic testing, carrier testing, and more sophisticated hemoglobin variant analysis. Private laboratories like Quest Diagnostics and Labcorp are venturing into the areas of molecular diagnostics and gene therapy testing. The increasing acceptance of personalized medicine and reproductive tests is promoting high-value diagnostic services, making private laboratories crucial in managing sickle cell disease.

Regional Analysis

North America Sickle Cell Anemia Testing and Screening Market Insights

North America dominated the global Sickle Cell Anemia Testing and Screening Market in 2025 with 43.60% of revenues, led by the United States which accounted for approximately 83% of North American revenues. U.S. leadership is driven by the all-50-states newborn screening mandate and the most advanced gene therapy clinical infrastructure creating premium diagnostic testing demand for patient evaluation and post-treatment monitoring. Canada contributes through provincial newborn screening programmes and growing awareness of sickle cell disease prevalence within immigrant communities from high-burden regions.

Asia Pacific Sickle Cell Anemia Testing and Screening Market Insights

Asia Pacific is the fastest-growing regional market at approximately 13.43% CAGR through 2035, driven by rising awareness of sickle cell disease in India. This is driven by the government’s screening programme investment including India's National Sickle Cell Anaemia Elimination Mission targeting a 2047 disease elimination goal that is creating large-scale newborn and community screening infrastructure investment. Southeast Asian nations including Indonesia, Thailand, and Malaysia each have significant haemoglobinopathy burdens where growing healthcare system development is enabling the screening programme expansion that will drive testing market growth.

Europe Sickle Cell Anemia Testing and Screening Market Insights

Europe is a growing sickle cell testing market anchored by the UK, France, and the Netherlands where large African, Caribbean, and Mediterranean immigrant community populations create significant sickle cell disease prevalence. The UK NHS Sickle Cell and Thalassaemia Screening Programme providing universal antenatal and newborn screening for at-risk populations is the most comprehensive European sickle cell screening infrastructure, while France's national screening programme focusing on Ile de France and overseas territories with highest prevalence is progressively expanding national coverage.

Middle East & Africa and Latin America Sickle Cell Anemia Testing and Screening Market Insights

MEA and Latin America carry the world's highest absolute sickle cell disease burden, with sub-Saharan Africa accounting for approximately 75% of global sickle cell births according to WHO data. MEA is progressively building the screening infrastructure to match this burden, with Nigeria, Ghana, the Democratic Republic of Congo, and Angola receiving international health organisation investment in community-level sickle cell screening using POC tests that do not require centralised laboratory infrastructure. Brazil leads Latin American market revenues through its mixed-heritage population with West African genetic ancestry creating the Western Hemisphere's largest sickle cell disease burden after the United States.

Market Growth Drivers:

Expanding newborn screening mandates and gene therapy diagnostic needs are driving strong dual demand for comprehensive sickle cell testing infrastructure globally: The primary growth drivers for the Sickle Cell Anemia Testing and Screening Market are the global expansion of government-mandated newborn screening programs, and laboratory infrastructure across both high-income and high-burden regions. It is also underscored by the growing significance of diagnostic profiling during the era of gene therapy, which necessitates far more sophisticated tests for selecting patients, conducting a thorough evaluation before treatment, and monitoring patients after the procedure than does conventional hydroxyurea-based treatment.

In addition, leading diagnostic companies are accelerating innovation in sickle cell-specific technologies. Bio-Rad Laboratories’ enhanced VARIANT System for newborn screening and Thermo Fisher Scientific’s 2024 extended blood typing and array-based solutions highlight growing investment in specialized diagnostic platforms. Combined with FDA-approved gene therapies such as Casgevy and Lyfgenia, which require precise diagnostic confirmation and eligibility evaluation, these factors are collectively sustaining strong market expansion and supporting the projected 12.30% CAGR through 2035.

Market Restraints

Low awareness, cultural stigma, weak lab infrastructure, and high molecular testing costs restrain market growth: One of the important limitations that can be seen in the Sickle Cell Anemia Testing and Screening Market is the existence of a wide disparity between high burden areas and the availability of diagnosis facilities in low income countries. Areas with high prevalence of the disease in sub-Saharan Africa and rural parts of Asia have poor access to laboratory facilities needed for testing programs. The cultural stigma and poor awareness about the disease prevent patients from undergoing testing procedures. Moreover, the expensive nature of modern diagnostic machines like HPLC and molecular testing machines poses an obstacle to their adoption.

Market Opportunities

Point-of-care testing expansion, gene therapy-driven diagnostics, and AI blood smear screening are enabling accessible sickle cell detection in underserved regions globally: Point-of-care sickle cell testing is the most transformative opportunity, enabling rapid 10–15 minute diagnosis in community settings without laboratory infrastructure and expanding screening access in low-resource regions. Gene therapy era diagnostic expansion is also driving high-value testing demand, as increasing gene therapy adoption requires detailed patient evaluation, eligibility assessment, and long-term monitoring. Together, these trends are bridging critical diagnostic gaps while creating new decentralized and premium testing segments, significantly expanding the global Sickle Cell Anemia Testing and Screening Market.

Recent Developments:

• 2026: Bio-Rad Laboratories expanded adoption of VARIANT HPLC systems in national newborn screening programs with upgraded hemoglobin variant detection efficiency. This enhanced automation features for high-throughput sickle cell screening in centralized labs.

• 2026: Thermo Fisher Scientific expanded extended blood typing and molecular diagnostic panels supporting pre-gene therapy patient evaluation. Through this, the company strengthened hematology workflow integration for rare disease screening..

• 2026: Abbott Laboratories continued scaling of point-of-care hematology diagnostics integration across community health systems. The company focus on portable diagnostic platforms supporting low-resource sickle cell detection programs.

Sickle Cell Anemia Testing and Screening Market Key Players

• Bio-Rad Laboratories Inc.

• Thermo Fisher Scientific Inc.

• Abbott Laboratories

• PerkinElmer Inc.

• Danaher Corporation

• Siemens Healthineers AG

• Roche Diagnostics

• Cepheid Inc.

• Natera Inc.

• Trinity Biotech plc

• BioMedomics Inc.

• Hemex Health Inc.

• Quest Diagnostics Incorporated

• Laboratory Corporation of America Holdings

• STRECK Inc.

• Silver Lake Research Corporation

• Agilent Technologies Inc.

• bioMerieux SA

• Beckman Coulter Inc.

• Sysmex Corporation

Sickle Cell Anemia Testing & Screening Market Report Scope: