Global Preeclampsia Diagnostics Market - 2020-2027
Preeclampsia is a major cause of illness and deaths among mothers and their babies globally. It is characterized by elevated blood pressure and excessive protein in the urine of pregnant women which can cause the baby delivered preterm and smaller than usual. This severe pregnancy disorder occurs in up to 5% of all pregnancies. It is one of the leading hypertensive disorders of pregnancy across the developed and emerging countries. If it is not diagnosed at an early stage, then it may lead to preterm birth and other complications, such as failure of organs, seizure or eclampsia, and death. For instance, according to the Preeclampsia Foundation, it has been estimated that pregnancy-induced hypertension is responsible for causing 76,000 maternal and 500,000 infant deaths each year globally.
The global preeclampsia diagnostics market size was worth US$ XX billion in 2018 and is estimated to reach US$ XX billion by 2027, growing at a CAGR of XX % during the forecast period (2020-2027).
The global preeclampsia Diagnostics market growth is majorly driven by rising incidences of preeclampsia globally. The rapidly growing demand for its diagnosis and treatment is expected to drive the growth of preeclampsia diagnostics market. According to the Preeclampsia Foundation, more than 10 million women globally develop preeclampsia every year, and around 2.5 million preterm birth are caused by preeclampsia annually. The disorder is affecting both neonates and mothers in the developed and developing nations. According to the World Health Organization (WHO), the prevalence of preeclampsia is seven times higher in the emerging countries as compared to the developed countries. Also, as per a report by BioMed Central (BMC), the incidence of preeclampsia ranges from 1.8% to 16.7% in the developing economies. It affects around 10% of pregnant women in the African continent. The rise in maternal & perinatal mortality and morbidity rate is projected to increase the demand for early diagnosis of preeclampsia among pregnant women.
In addition, increasing research and development to innovative new tests to detect biomarkers indicating preeclampsia is expected to boost the market growth over the forecast period. For instance, in November 2019, a team of researchers at the RCSI Department of Obstetrics and Gynaecology at the Rotunda Hospital, Dublin launched three research studies which examined the experiences and impact of diabetes in women, ahead of World Diabetes Day 2019. The three studies have been awarded a total funding of €1.1 million in this region by the Health Research Board (HRB) and the European Commission. The IRELAnD Trial will examine the role that aspirin improves the health of pregnant women with diabetes. This is the first study to examine the impact of low-dose aspirin for the prevention of preeclampsia (high blood pressure during pregnancy) in women with diabetes.
Also in July 2020, researchers from University of Helsinki have showed that HLA-G gene regulates male-to-female ratio at birth. The study strengthens earlier findings of the vulnerability of male fetuses to preeclampsia.
Further, the rising awareness about the effective screening tools for the condition among the healthcare providers and increasing knowledge about the signs & symptoms associated with preeclampsia among pregnant mothers and are likely to boost the preeclampsia diagnostics market growth rapidly over the forecast period.
The preeclampsia diagnostics market is segmented by product type into instruments and consumables. Among these, the consumables segment is expected to grow at the fastest CAGR over the forecast period, owing to the increasing development of new reagents & kits by various players for the rapid detection of biomarkers indicating preeclampsia. For instance, PerkinElmer Inc. developed DELFIA Xpress PlGF 1-2-3 assay in July 2017, which is used during the first trimester. This test can detect the levels of placental growth factor, which is a biomarker that is associated with preeclampsia in serum samples.
On the basis of the test type, the preeclampsia diagnostics market is classified into blood tests and urine analysis. The blood tests accounted for the largest market share of preeclampsia diagnostics market in 2019, owing to the several advantages of blood tests in detecting the biomarkers efficiently which are responsible for preeclampsia. Several organizations are highly adopting the blood tests as a better test for detection of preeclampsia. With advancements in technology, new test are being introduced in the market, which are further boosting the blood test market growth. For instance, the NHS England approved two blood test products named Elecsys sFlt-1 and PlGF immunoassays of F. Hoffmann-La Roche under the ‘Innovation and Technology Payment’ program in June 2019. The NHS aims to implement the usage of innovative products within the hospitals in Europe and enhance the accessibility of diagnostic tools for preeclampsia among healthcare professionals to detect pregnancy-induced hypertension.
On the other hand, the urine analysis is growing significantly over the forecast period as it is a highly preferred method of the early diagnosis of preeclampsia as urine tests are simple to use. A non-invasive point-of-care paper test is used for the measurement of misfolded proteins in the urine of pregnant mothers. Some of the researchers at Ohio State and Nationwide Children’s Hospital have developed the Congo Red Dot (CRD) diagnostic test which is a simple urine test allowing rapid and accurate diagnosis of preeclampsia. Hence, such innovations in urine tests are likely to drive the growth of this segment in preeclampsia diagnosis market over the forecast period.
Based on end-user, the market is dominated by the diagnostic centers, owing to the presence of novel diagnostic instruments in these centers that are capable of detecting preeclampsia at an early stage. The hospitals segment accounts for the second-largest share of the preeclampsia diagnosis market due to the increasing number of hospitals in developing countries with advanced healthcare infrastructures. If preeclampsia is not diagnosed at early stages, this can increase the risk of preterm complications, which leads to rise in the rate of hospitalization delivery. Thus, growing rates of hospitalization are expected to boost the growth of hospitals. In 2017, according to a research conducted by Agency for Healthcare Research and Quality (AHRQ), an estimated 176,925 cases of deliveries performed at hospitalization settings had preeclampsia, and nearly one-third of the deliveries with preeclampsia had severe preeclampsia in the United States.
North America region is dominating the global preeclampsia diagnostics market accounting for the largest market share in 2019, owing to the increasing healthcare expenditure, adoption of highly advanced products, growing awareness towards preeclampsia among the patients and healthcare providers regarding the severity of the condition. The increasing prevalence of preeclampsia is leading to an increase in medical treatment cost among women with preeclampsia and their newborns. For instance, according to the American Journal of Obstetrics and Gynecology (AJOG), the total cost of maternal healthcare with preeclampsia was around one-third of the total U.S. healthcare costs of women with preeclampsia.
The Asia-Pacific region is estimated to hold second- largest market share in preeclampsia diagnostics market during the forecast period. The growth is attributed due to the rising utilization of fertility treatment options and a high pregnancy rate. Preeclampsia accounts for around 70% of all cases of hypertension in pregnancy and its sequelae eclampsia account for 24% of all maternal deaths in India.
In addition, the major players engaged in preeclampsia diagnostics are developing new diagnostic tests by entering into partnerships with several research organizations. Diabetomics launched Lumella, the first rapid, point-of-care test for preeclampsia assessment in India in February 2019. The test provides an accurate estimation of protein biomarker, Glycosylated Fibronectin (GlyFN) present in pregnant women with preeclampsia.
The Preeclampsia Diagnostics market is dominated by major players including Diabetomics, Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, PerkinElmer Inc., Siemens Healthineers AG , DRG Instruments GMBH, Metabolomic Diagnostics Ltd., Bayer AG, Sera Prognostics, among others. These players are likely to continue their dominance in the preeclampsia diagnostics area and generate significant revenue in the forthcoming years. It is because of their persistent investments in the research and development activities for the launch of cost-effective and highly advanced diagnostic kits to rapidly detect preeclampsia.
The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Preeclampsia Diagnostics market globally. For instance,
• On February 2016: Becton Dickinson (BD), a medical technology company, headquartered in New Jersey, declared that it is entering into a distribution and licensing agreement for clinical tests from DiabetOmics, Inc., a medical diagnostics company based in the U.S. It has created innovative pregnancy-specific metabolic tests that will support early detection of gestational diabetes and preeclampsia. According to DiabetOmics, the agreement would help in providing access to state-of-the-art tests for women across the globe.
• March 2015: Siemens Healthineers AG launched two new advanced urine testing solutions for the U.S. central laboratories, namely, the CLINITEK Novus Automated Urine Chemistry Analyzer and the CLINITEK AUWi PRO Automated Urine Workstation
• February 2015: Metabolomic Diagnostics Ltd. received an overall funding of ‚Äö√á¬®1.5 million from SOSventures, Enterprise Ireland and the AIB Seed Capital Fund. Through this funding, the company aims to expand its research study in metabolic biomarkers for the preeclampsia diagnosis.
• In June 2015, SRL Diagnostics has introduced a medical test to diagnose hypertensive disorders in pregnancy recently at its state of the art lab in Gurgaon, India. PLGF (Placental Growth Factor) is used for accurate diagnosis and prognosis of pre-eclampsia, a major cause of maternal, foetal, neonatal morbidity and mortality. The new test will help gynaecologists to diagnose pre-eclampsia early and in planning delivery and decision making for timely hospital transfer.
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