The global Preterm Birth and PROM Testing Market was valued at around USD 1.7 Billion in 2021. With a projected CAGR of 3.2% for the next ten years, the market is likely to reach a valuation of nearly USD 2.5 Billion by the end of 2032.
| Attributes | Details |
|---|---|
| Preterm Birth and PROM Testing Market Size (2021A) | USD 1.7 Billion |
| Estimated Market Value (2022E) | USD 1.8 Billion |
| Forecasted Market Value (2032) | USD 2.5 Billion |
| Global Market Growth Rate (2022 to 2032) | 3.2% CAGR |
| North America Growth Rate (2021) | 3.1% |
| United States Growth Rate(2022 to 2032) | 3.4% CAGR |
| Key Companies Profiled | Qiagen N.V.; Cooper Surgical Inc.; Hologic; Abbott; Biosynex; Medixbiochemica; Sera Prognostics; IQ Products; Creative Diagnostics; Nan jing Liming Biological Preparations Co., Ltd.,; Clinical Innovations LLC;Bioserv Diagnostic GmbH |
Future Market Insights’ analysis reveals that most of the market revenue is grossed from Ultrasound Testing, which has a forecasted CAGR of 3.1% from 2022 to 2032. The USA is the leading country for demand, with the forecasted market size in 2032 being USD 777.8 Million.
World Health Organization statistics show that across the globe, around 15 Million preterm births occur annually, and more than one out of every 10 babies are born preterm. Studies have shown that around 12% of births in the USA are preterm. The increased use of fertility treatments to conceive and the higher global maternity age have led to an increase in the number of multiple births.
France’s latest Perinatal Survey puts the country’s Preterm births at 7.5%, with the frequency being preterm being 6.0% for a single birth and 47.5% for a multiple pregnancy delivery. According to data from the CDC, in 2019 17% of infant deaths were due to preterm birth and low birth weight. Infants born before 24 months have only a 50% chance of survival and over 40% of the babies who make it suffer long-term health complications. However, more than 3/4th of preterm babies can be saved with timely and early identification through testing and subsequent medical care.
A study conducted found that 3% of pregnancies have an occurrence of PROM or Premature Rupture of Membranes. At term, PROM is a complication in nearly 8% of pregnancies. PROM is a large cause of preterm births, accounting for almost a third of preterm deliveries. One of the most serious consequences of the term PROM is the chances of intrauterine infection, with the risk increasing with the duration. According to a study, mothers with a PROM duration of over 72 hours showed a much higher risk of placental infection. Their babies, if born preterm due to PROM complications were also at a higher risk for pneumonia and intracranial hemorrhage.
Since as of yet there is no guaranteed way to prevent PROM from occurring, an accurate assessment of thorough testing is essential to the management and care of these pregnancies in order to ensure the well-being of both the mother and the child. PROM also has a high risk of recurrence, between 16% to 32%, so the frequent observation and testing of mothers who display any possible symptoms are encouraged in order to prevent any complications. This, as well as the fact that providers and researchers are working on studying PROM and Preterm births and are working on rapidly developing new technology and tests, which is leading to the growth in demand.
Point-of-Care or POC testing, through which a diagnosis can occur at the time and place of patient care has been a growing field for research. This form of testing can increase access to treatment, especially in remote or resource-scarce areas since it does not require one to send samples away to far-off labs and wait for several days for the results.
Low-cost POC diagnostics when supported by effective treatment strategies, will increase testing, can reduce PROM-related complications, and ensure its management even in low-resource countries and regions. Research is attempting to reduce per-test cost and enhance the accuracy of results, which will benefit the market significantly if there is enough development.
Studies find that Urea and Creatinine based PROM testing, measures with a spectrometer and an enzymatic-based essay, respectively show promise for sensitive and specific detection. As per studies a significant amount of pregnant women around the globe do not have access to ultrasounds or other diagnostic tools. Rapid POC tests are a viable solution for untapped markets in less resource-rich areas and regions such as the Middle East and Africa(MEA) and Asia Pacific, where Preterm birth rates are high.
The prevalent method for testing preterm birth due to preterm labor is fetal fibronectin tests, in which the presence of fetal fibronectin in vaginal discharge is tested for, in some cases accompanied by a transvaginal ultrasound test. The results of this test, which are either positive or negative, indicate whether labor will occur in the following two weeks. With a negative fFN test indicating less than 1% risk of delivery in the upcoming 2 weeks, the test is widely used because of this high negative predictive value, since if the results are negative, the healthcare provider and the expecting mother, especially women who may have been symptomatic but are not in true labor and can avoid the use of strong medication and further invasive testing unless absolutely necessary.
While the most prevalent fFN tests currently in use are a solid-phase enzyme-linked immunosorbent assay or ELISA, a rapid bedside version of the test, which can take around 30 minutes to show results, unlike the ELISA which requires 4 to 48 hours after being sent to a laboratory, is expected to boost demand for this type of testing.
The preterm birth and PROM testing market in North America was held at USD 591 Million in 2021. By 2032, the market is expected to reach a valuation of USD 853 Million, growing at a CAGR of 3.4% from 2022 to 2032.
According to data from the CDC, the provisional number of births in the USA grew by 1% from the previous year, in contrast to the 2% average decline since 2014. Further, even though the 15 to 24 age group saw a decline in birth rates, birth rates rose for later pregnancies in the 25 to 49 age group. Further, the preterm birth rate rose to the highest reported levels since 2007, with a 4% increase in 2021 compared to that in 2020.
The USA has a significant proportion of births that have preterm and PROM complications, with 12% being preterm and 3% dealing with PROM-related complications. This is owing to several demographic factors of the American population. However, technological advancements, availability of resources, and an increase in approvals for testing methods mean that the USA is the highest contributor to revenue, having witnessed a 3.1% CAGR from 2017 to 2022 and having a forecasted CAGR of 3.4%, with a USA USD 219.7 Absolute Dollar growth.
The preterm birth and PROM testing market in the United Kingdom was held at USD 76 Million in 2021. The market is expected to reach a valuation of USD 103 Million by 2032, growing at a CAGR of 2.6% from 2022 to 2032.
In Japan, the preterm birth and PROM testing market is projected to gross an absolute dollar opportunity of USD 28.7 Million during the forecast period. By 2032, the market is expected to reach USD 98 Million.
The preterm birth and PROM testing market in South Korea was held at USD 37 Million in 2021. The market is likely to be valued at USD 54 Million by 2032, growing at a CAGR of 3.5%.
Once patients are diagnosed with PROM or preterm birth, period assessments are conducted. Studies have found that in the absence of other maternal or fetal factors, routine and frequent ultrasound examinations are an efficient way to manage PROM. The market through this test type witnessed a CAGR of 2.9% between 2017 and 2021 and is forecasted to gain a CAGR of 3.1%. The frequency of the conduction of these tests, their non-invasive nature, and their use combined with other diagnostic tests means that they lead the market for testing.
Preterm Birth and PROM testing providers are focused on increasing the efficiency, accuracy, and affordability of their tests. The key companies operating in the market include Qiagen N.V., Cooper Surgical Inc., Hologic, Abbott, Biosynex, Medixbiochemica, Sera Prognostics, IQ Products, Creative Diagnostics, Nanjing Liming Biological Preparations Co., Ltd., Clinical Innovations, LLC, and Bioserv Diagnostic GmbH.
Some of the recent development in Preterm Birth and PROM testing are as follows:
Similarly, recent developments related to companies manufacturing Preterm Birth and PROM testing have been tracked by the team at Future Market Insights, which is available in the full report.
Table 1: Global Market Value (US$ Million) Forecast by Region, 2017 to 2032
Table 2: Global Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Table 3: North America Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 4: North America Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Table 5: Latin America Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 6: Latin America Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Table 7: Europe Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 8: Europe Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Table 9: Asia Pacific Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 10: Asia Pacific Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Table 11: Middle East and Africa Market Value (US$ Million) Forecast by Country, 2017 to 2032
Table 12: Middle East and Africa Market Value (US$ Million) Forecast by Test Type, 2017 to 2032
Figure 1: Global Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 2: Global Market Value (US$ Million) by Region, 2022 to 2032
Figure 3: Global Market Value (US$ Million) Analysis by Region, 2017 to 2032
Figure 4: Global Market Value Share (%) and BPS Analysis by Region, 2022 to 2032
Figure 5: Global Market Y-o-Y Growth (%) Projections by Region, 2022 to 2032
Figure 6: Global Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 7: Global Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 8: Global Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 9: Global Market Attractiveness by Test Type, 2022 to 2032
Figure 10: Global Market Attractiveness by Region, 2022 to 2032
Figure 11: North America Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 12: North America Market Value (US$ Million) by Country, 2022 to 2032
Figure 13: North America Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 14: North America Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 15: North America Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 16: North America Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 17: North America Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 18: North America Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 19: North America Market Attractiveness by Test Type, 2022 to 2032
Figure 20: North America Market Attractiveness by Country, 2022 to 2032
Figure 21: Latin America Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 22: Latin America Market Value (US$ Million) by Country, 2022 to 2032
Figure 23: Latin America Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 24: Latin America Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 25: Latin America Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 26: Latin America Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 27: Latin America Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 28: Latin America Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 29: Latin America Market Attractiveness by Test Type, 2022 to 2032
Figure 30: Latin America Market Attractiveness by Country, 2022 to 2032
Figure 31: Europe Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 32: Europe Market Value (US$ Million) by Country, 2022 to 2032
Figure 33: Europe Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 34: Europe Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 35: Europe Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 36: Europe Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 37: Europe Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 38: Europe Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 39: Europe Market Attractiveness by Test Type, 2022 to 2032
Figure 40: Europe Market Attractiveness by Country, 2022 to 2032
Figure 41: Asia Pacific Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 42: Asia Pacific Market Value (US$ Million) by Country, 2022 to 2032
Figure 43: Asia Pacific Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 44: Asia Pacific Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 45: Asia Pacific Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 46: Asia Pacific Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 47: Asia Pacific Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 48: Asia Pacific Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 49: Asia Pacific Market Attractiveness by Test Type, 2022 to 2032
Figure 50: Asia Pacific Market Attractiveness by Country, 2022 to 2032
Figure 51: Middle East and Africa Market Value (US$ Million) by Test Type, 2022 to 2032
Figure 52: Middle East and Africa Market Value (US$ Million) by Country, 2022 to 2032
Figure 53: Middle East and Africa Market Value (US$ Million) Analysis by Country, 2017 to 2032
Figure 54: Middle East and Africa Market Value Share (%) and BPS Analysis by Country, 2022 to 2032
Figure 55: Middle East and Africa Market Y-o-Y Growth (%) Projections by Country, 2022 to 2032
Figure 56: Middle East and Africa Market Value (US$ Million) Analysis by Test Type, 2017 to 2032
Figure 57: Middle East and Africa Market Value Share (%) and BPS Analysis by Test Type, 2022 to 2032
Figure 58: Middle East and Africa Market Y-o-Y Growth (%) Projections by Test Type, 2022 to 2032
Figure 59: Middle East and Africa Market Attractiveness by Test Type, 2022 to 2032
Figure 60: Middle East and Africa Market Attractiveness by Country, 2022 to 2032
The global Preterm Birth and PROM testing market was valued at USD 1.7 Billion in 2021.
The Preterm Birth and PROM testing industry is set to witness a growth rate of 3.2% over the forecast period and be valued at USD 1.8 Billion by 2032.
The Preterm Birth and PROM testing market expanded by 3% from 2017 through 2021.
Qiagen N.V., Abbott, Hologic, Biosynex, and Cooper Surgical Inc. are some of the key players.
The USA, United Kingdom, China, Japan, and South Korea are expected to be the major drivers of sales.
USA accounts for over 30% of the global preterm birth and PROM testing market.
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Preterm Births and PROM Testing Market
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