Sickle Cell Anemia Testing & Screening Market Size, Share & Trends Analysis Report By Technology (Hemoglobin Electrophoresis, POC, HPLC), By Age Group, By Sector Type, And Segment Forecasts, 2020 - 2027

Report Overview

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 scale‐up and delivery of the key diagnostic and therapeutic interventions for sickle cell disease.

Technology Insights

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.

Age Group Insights

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.

Sector Type Insights

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.

Regional Insights

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 Companies & Market Share Insights

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:

• 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

Sickle Cell Anemia Testing & Screening Market Report Scope

Segments Covered in the Report

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)

  • Hemoglobin Electrophoresis

    • Isoelectric focusing

    • Others

  • High-performance Liquid Chromatography (HPLC)

  • Point-of-Care Tests

    • Lateral Flow Immunoassay

    • Paper-Based Rapid Diagnostics

    • Others

  • Other Tests

• 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)

  • Government Labs

  • Private Labs

  • Corporate Labs

  • PPP (Public-Private-Partnerships)

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

  • MEA

    • South Africa