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.
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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.
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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.
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.
| Estimated Market Size (2024E) | USD 152.2 million |
|---|---|
| Projected Market Value (2034F) | USD 316.5 million |
| Value-based CAGR (2024 to 2034) | 7.6% |
| Market Size (2024) | USD 1.70 billion |
|---|---|
| Market Forecasted Size (2034) | USD 4.49 billion |
| Projected Value CAGR (2024 to 2034) | 10.2% |
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Preterm Births and PROM Testing Market
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