The global sickle cell anemia testing and screening market size was valued at USD 223.04 million in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 5.44% from 2020 to 2027. Hemoglobinopathies comprise a group of disorders that are inherited, of which is the sickle cell disease (SCD) that occurs due to the abnormal hemoglobin damaging and deforming RBCs. The sickle cell disease affects millions of people across the globe and is more prevalent in sub-Saharan Africa, the Western Hemisphere region, India, Saudi Arabia, and the Mediterranean region. Since there is no easily accessible and widely available therapy for patients suffering from sickle cell anemia, early detection of the affected population becomes imperative.
SCD has been largely a neglected global health concern, specifically across developing regions witnessing elevations in the disease incidence, which is attributed to the lack of awareness among patients/public as well as the healthcare policymakers operating locally in these areas.
Initiatives taken up by the government to support the diagnosis are expected to boost market growth substantially. For instance, in March 2020, the National Institutes of Health (NIH) launched a Technology Accelerator Challenge with a prize of USD 1 Million to boost the development of efficient point-of-care diagnostic methods. The challenge is focused on diseases that have high health impact, such as malaria, sickle cell disease, and anemia.
Newborn screening programs have been implemented at a pilot-scale across various sickle cells anemia affected countries, such as Ghana, Democratic Republic of the Congo (DRC), Kenya, and Benin. Successful control of this disease in these above-mentioned countries has compelled developing economies to mandate newborn programs, further propelling the market growth.
Development of non-invasive, hand-held and digital technologies to facilitate the detection of the SCD is set to assist in overcoming the barriers associated with targeted sickle cell diagnosis and treatment management. Presently developed POC devices are based on methodologies, such as densitometry, lateral flow immunoassay, and microfluidic electrophoresis.
Companies are focusing on developing point-of-care tests that are portable, affordable, and highly sensitive and specific to HbA, HbC, and HbS. Prioritization of newborn/neonatal testing is expected to assist in sustainable scaleâ€up and delivery of the key diagnostic and therapeutic interventions for sickle cell disease.
Hemoglobin electrophoresis dominated the market in 2019 with a share of 38.9%. The point-of-care technology segment is expected to grow at a lucrative pace in the coming years. Lateral flow assays held a considerable share owing to the rise in usage of commercialized tests that fall within this segment. Smartphone-based and paper-based assays are anticipated to witness substantial developments, thereby boosting the growth of the point-of-care technology segment.
Quantification, as well as the determination of varying percentages and combination of hemoglobin variants, such as HbS, HbF, HbA, and HbC, in patient’s RBCs, are imperative to perform a definitive diagnosis and distinction between hemoglobinopathies. These hemoglobinopathies are inclusive of homozygous sickle cell anemia (HbSS), heterozygous sickle cell anemia (HbSA), beta-thalassemias, and HbSC disease. Sickling and solubility tests are the most basic approaches employed for testing of SCD.
These tests are simpler to perform, however, they cannot make a clear distinction between HbSA, beta-thalassemias, HbSS, and HbSC traits in the patients. This has led to the advent of additional tests that can confirm all sickle hemoglobin variants among positive and carrier patients. These tests include hemoglobin electrophoresis, high-performance liquid chromatography (HPLC), isoelectric focusing (IEF), and molecular tests.
Newborn screening dominated the global market in terms of revenue with a share of 53.4% in 2019. The adult screening segment is expected to expand at the fastest CAGR throughout the forecast period. SCD treatment and management differ at distinct levels based on the patient’s stage. This is attributed to the observed differences in the SCD associated pain, comorbidities, psychosocial impact, and healthcare expenditure with respect to the age group of sickle cell anemia patients.
Additionally, increasing number of research activities are aimed at analyzing the impact of age-specific healthcare strategies on improving the management of sickle cell disease population. Employment of targeted screening with respect to age group of sickle cell patients has also extended life span of these patients into adulthood. Moreover, evaluation of challenges specific to age group of sickle cell anemia patients helps in designing patient-specific therapeutic and diagnostic interventions.
Population-based surveys conducted on symptomatic sickle cell anemia patients depict that older sickle cell disease patients are expected to have a higher incidence of comorbidities as well as organ failure, thus offering a significant momentum to the adult testing market space.
The government laboratories led the market with a share of 42.8% and is anticipated to maintain its lead throughout the forecast period. The PPP sector is expected to register the fastest CAGR of 6.35% over the forecast period. Sickle cell disease testing is a two-tiered approach that starts with testing of patients in the medical settings, followed by confirmatory testing or follow-up screening of patients to validate if the sample screened belonged to the right patient and with the right outcome.
Currently, this preliminary screening as well as confirmatory testing are also being performed at laboratories, medical centers, and hospitals that are either affiliated with the government, private organizations, commercial sectors, and NGOs. Increasing developments and active participation of the aforementioned sectors are expected to propel the demand for sickle cell anemia screening, along with the awareness regarding the latest tests for sickle cell patients and their associated efficacies.
North America led the market with a share of 27.0% in 2019. Newborn screening programs are carried out in 50 of the U.S. states and 8 Canadian provinces, which has created a favorable environment for the companies actively operating in the market.
Criteria for developing and implementing sickle cell disease neonatal screening programs have been well-established in developing regions, such as Africa and Asia. Sickle cell screening program is largely recommended in regions, where the incidence rate of the disease is 0.05% or higher. These screening programs include a systematic or targeted screening of all newborns with hemoglobin C or sickle cell trait.
Presently, very few countries have employed newborn screening programs at the national level, which is attributed to the lack of appropriate facilities to undertake newborn screening programs. Rising acknowledgment and recognition of sickle cell screening targeted towards newborns have been recently witnessed in the Asia Pacific countries, specifically India.
Additionally, these developing countries are devising strategies to address challenges associated with newborn screening programs across high-income countries, which is inclusive of streamlining follow-up screening or diagnosis. This is set to offer a significant momentum to the Asia Pacific market in the near future.
Key players in the market are contributing to market growth through collaborations and business expansions in order to gain a greater market share. In addition, companies are designing sickle cell anemia (HbS) testing and screening specific to research needs, which in turn, is expected to increase the uptake of screening products. Some of the prominent players in the global sickle cell anemia testing and screening market include:
Laboratory Corporation of America Holdings
Request A Test, Ltd.
HALCYON BIOMEDICAL INCORPORATED
Silver Lake Research Corporation
Bio-Rad Laboratories, Inc.
Market size value in 2020
USD 237.75 million
Revenue forecast in 2027
USD 340.71 million
CAGR of 5.44% from 2020 to 2027
Base year for estimation
2016 - 2018
2020 - 2027
Revenue in USD million and CAGR from 2020 to 2027
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Technology, age group, sector type, region
North America; Europe; Asia Pacific; Latin America; MEA
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; South Africa
Key companies profiled
STRECK, INC.; Daktari Diagnostics; BIOMEDOMICS INC.; Laboratory Corporation of America Holdings; Request A Test, Ltd.; HALCYON BIOMEDICAL INCORPORATED; Silver Lake Research Corporation; HEMOTYPE; HEMEX HEALTH; Bio-Rad Laboratories, Inc.; PerkinElmer Inc.; Quest Diagnostics
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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-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global sickle cell anemia testing and screening market report on the basis of technology, age group, sector type, and region:
Technology Outlook (Revenue, USD Million, 2016 - 2027)
High-performance Liquid Chromatography (HPLC)
Lateral Flow Immunoassay
Paper-Based Rapid Diagnostics
Age Group Outlook (Revenue, USD Million, 2016 - 2027)
Newborn Screening (12 months and below)
Adult Screening (25 to 60 years)
Other Age Groups (1 to 25 & above 60 years)
Sector Type Outlook (Revenue, USD Million, 2016 - 2027)
Regional Outlook (Revenue, USD Million, 2016 - 2027)
b. The global sickle cell anemia (HbS) testing & screening market size was estimated at USD 223.04 million in 2019 and is expected to reach USD 237.75 million in 2020.
b. The global sickle cell anemia (HbS) testing & screening market is expected to grow at a compound annual growth rate of 5.44% from 2020 to 2027 to reach USD 340.71 million by 2027.
b. POC based tests are anticipated to witness lucrative growth due to key developments in hand held devices and digital platforms for screening and diagnosis.
b. Some key players operating in the sickle cell anemia (HbS) testing & screening market include STRECK, INC., BIOMEDOMICS INC., Laboratory Corporation of America Holdings, Request A Test, Ltd., HALCYON BIOMEDICAL INCORPORATED, HEMOTYPE, HEMEX HEALTH, Bio-Rad Laboratories, Inc., PerkinElmer Inc., and Quest Diagnostics.
b. Key factors that are driving the market growth include pilot scale implementation of newborn screening programs across underdeveloped countries and development of pointâ€ofâ€care (POC) tests to facilitate the detection of sickle cell disease population.
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