The global Preterm Birth and PROM Testing Market was valued at around US$ 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 US$ 2.5 Billion by the end of 2032.
| Attributes | Details |
|---|---|
| Preterm Birth and PROM Testing Market Size (2021A) | US$ 1.7 Billion |
| Estimated Market Value (2022E) | US$ 1.8 Billion |
| Forecasted Market Value (2032) | US$ 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 |
|
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 US$ 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.
Principal Consultant
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 US$ 591 Million in 2021. By 2032, the market is expected to reach a valuation of US$ 853 Mn, 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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USA Preterm Birth and PROM testing Market Analysis
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 US $219.7 Absolute Dollar growth.
United Kingdom Preterm Birth and PROM testing Market Analysis
The preterm birth and PROM testing market in the United Kingdom was held at US$ 76 Million in 2021. The market is expected to reach a valuation of US$ 103 Million by 2032, growing at a CAGR of 2.6% from 2022 to 2032.
Japan Preterm Birth and PROM testing Market Analysis
In Japan, the preterm birth and PROM testing market is projected to gross an absolute dollar opportunity of US$ 28.7 Million during the forecast period. By 2032, the market is expected to reach US$ 98 Million.
South Korea Preterm Birth and PROM testing Market Analysis
The preterm birth and PROM testing market in South Korea was held at US$ 37 Million in 2021. The market is likely to be valued at US$ 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 US$ 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 US$ 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.
1. Executive Summary | Preterm Births and PROM Testing Market 1.1. Global Market Outlook 1.2. Demand-side Trends 1.3. Supply-side Trends 1.4. Technology Roadmap Analysis 1.5. Analysis and Recommendations 2. Market Overview 2.1. Market Coverage / Taxonomy 2.2. Market Definition / Scope / Limitations 3. Market Background 3.1. Market Dynamics 3.1.1. Drivers 3.1.2. Restraints 3.1.3. Opportunity 3.1.4. Trends 3.2. Scenario Forecast 3.2.1. Demand in Optimistic Scenario 3.2.2. Demand in Likely Scenario 3.2.3. Demand in Conservative Scenario 3.3. Opportunity Map Analysis 3.4. Product Life Cycle Analysis 3.5. Investment Feasibility Matrix 3.6. PESTLE and Porter’s Analysis 3.7. Regulatory Landscape 3.7.1. By Key Regions 3.7.2. By Key Countries 3.8. Regional Parent Market Outlook 4. Global Market Analysis 2017 to 2021 and Forecast, 2022 to 2032 4.1. Historical Market Size Value (US$ Million) Analysis, 2017 to 2021 4.2. Current and Future Market Size Value (US$ Million) Projections, 2022 to 2032 4.2.1. Y-o-Y Growth Trend Analysis 4.2.2. Absolute $ Opportunity Analysis 5. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Test Type 5.1. Introduction / Key Findings 5.2. Historical Market Size Value (US$ Million) Analysis By Test Type, 2017 to 2021 5.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Test Type, 2022 to 2032 5.3.1. Biochemical Markers 5.3.2. Pelvic exam 5.3.3. Ultrasound 5.3.4. Uterine Monitoring 5.3.5. Nitazine Test 5.3.6. Ferning Test 5.3.7. Pooling 5.3.8. PAMG-1 Immunoassay 5.3.9. IGFBP Test 5.3.10. Fetal Fibronectin (fFN) 5.3.11. Other Test Types 5.4. Y-o-Y Growth Trend Analysis By Test Type, 2017 to 2021 5.5. Absolute $ Opportunity Analysis By Test Type, 2022 to 2032 6. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Region 6.1. Introduction 6.2. Historical Market Size Value (US$ Million) Analysis By Region, 2017 to 2021 6.3. Current Market Size Value (US$ Million) Analysis and Forecast By Region, 2022 to 2032 6.3.1. North America 6.3.2. Latin America 6.3.3. Europe 6.3.4. Asia Pacific 6.3.5. Middle East and Africa 6.4. Market Attractiveness Analysis By Region 7. North America Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 7.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2017 to 2021 7.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2022 to 2032 7.2.1. By Country 7.2.1.1. USA 7.2.1.2. Canada 7.2.2. By Test Type 7.3. Market Attractiveness Analysis 7.3.1. By Country 7.3.2. By Test Type 7.4. Key Takeaways 8. Latin America Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 8.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2017 to 2021 8.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2022 to 2032 8.2.1. By Country 8.2.1.1. Brazil 8.2.1.2. Mexico 8.2.1.3. Rest of Latin America 8.2.2. By Test Type 8.3. Market Attractiveness Analysis 8.3.1. By Country 8.3.2. By Test Type 8.4. Key Takeaways 9. Europe Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 9.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2017 to 2021 9.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2022 to 2032 9.2.1. By Country 9.2.1.1. Germany 9.2.1.2. United Kingdom 9.2.1.3. France 9.2.1.4. Spain 9.2.1.5. Italy 9.2.1.6. Russia 9.2.1.7. Rest of Europe 9.2.2. By Test Type 9.3. Market Attractiveness Analysis 9.3.1. By Country 9.3.2. By Test Type 9.4. Key Takeaways 10. Asia Pacific Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 10.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2017 to 2021 10.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2022 to 2032 10.2.1. By Country 10.2.1.1. China 10.2.1.2. Japan 10.2.1.3. India 10.2.1.4. South Korea 10.2.1.5. Australia 10.2.1.6. Rest of Asia Pacific 10.2.2. By Test Type 10.3. Market Attractiveness Analysis 10.3.1. By Country 10.3.2. By Test Type 10.4. Key Takeaways 11. Middle East and Africa Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 11.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2017 to 2021 11.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2022 to 2032 11.2.1. By Country 11.2.1.1. South Africa 11.2.1.2. Saudi Arabia 11.2.1.3. United Arab Emirates(UAE) 11.2.1.4. Israel 11.2.1.5. Rest of Middle East and Africa(MEA) 11.2.2. By Test Type 11.3. Market Attractiveness Analysis 11.3.1. By Country 11.3.2. By Test Type 11.4. Key Takeaways 12. Key Countries Market Analysis 12.1. USA 12.1.1. Pricing Analysis 12.1.2. Market Share Analysis, 2021 12.1.2.1. By Test Type 12.2. Canada 12.2.1. Pricing Analysis 12.2.2. Market Share Analysis, 2021 12.2.2.1. By Test Type 12.3. Brazil 12.3.1. Pricing Analysis 12.3.2. Market Share Analysis, 2021 12.3.2.1. By Test Type 12.4. Mexico 12.4.1. Pricing Analysis 12.4.2. Market Share Analysis, 2021 12.4.2.1. By Test Type 12.5. Germany 12.5.1. Pricing Analysis 12.5.2. Market Share Analysis, 2021 12.5.2.1. By Test Type 12.6. United Kingdom 12.6.1. Pricing Analysis 12.6.2. Market Share Analysis, 2021 12.6.2.1. By Test Type 12.7. France 12.7.1. Pricing Analysis 12.7.2. Market Share Analysis, 2021 12.7.2.1. By Test Type 12.8. Spain 12.8.1. Pricing Analysis 12.8.2. Market Share Analysis, 2021 12.8.2.1. By Test Type 12.9. Italy 12.9.1. Pricing Analysis 12.9.2. Market Share Analysis, 2021 12.9.2.1. By Test Type 12.10. Russia 12.10.1. Pricing Analysis 12.10.2. Market Share Analysis, 2021 12.10.2.1. By Test Type 12.11. China 12.11.1. Pricing Analysis 12.11.2. Market Share Analysis, 2021 12.11.2.1. By Test Type 12.12. Japan 12.12.1. Pricing Analysis 12.12.2. Market Share Analysis, 2021 12.12.2.1. By Test Type 12.13. India 12.13.1. Pricing Analysis 12.13.2. Market Share Analysis, 2021 12.13.2.1. By Test Type 12.14. South Korea 12.14.1. Pricing Analysis 12.14.2. Market Share Analysis, 2021 12.14.2.1. By Test Type 12.15. Australia 12.15.1. Pricing Analysis 12.15.2. Market Share Analysis, 2021 12.15.2.1. By Test Type 12.16. South Africa 12.16.1. Pricing Analysis 12.16.2. Market Share Analysis, 2021 12.16.2.1. By Test Type 12.17. Saudi Arabia 12.17.1. Pricing Analysis 12.17.2. Market Share Analysis, 2021 12.17.2.1. By Test Type 12.18. United Arab Emirates(UAE) 12.18.1. Pricing Analysis 12.18.2. Market Share Analysis, 2021 12.18.2.1. By Test Type 12.19. Israel 12.19.1. Pricing Analysis 12.19.2. Market Share Analysis, 2021 12.19.2.1. By Test Type 13. Market Structure Analysis 13.1. Competition Dashboard 13.2. Competition Benchmarking 13.3. Market Share Analysis of Top Players 13.3.1. By Regional 13.3.2. By Test Type 14. Competition Analysis 14.1. Competition Deep Dive 14.1.1. Qiagen N.V. 14.1.1.1. Overview 14.1.1.2. Product Portfolio 14.1.1.3. Profitability by Market Segments 14.1.1.4. Sales Footprint 14.1.1.5. Strategy Overview 14.1.1.5.1. Marketing Strategy 14.1.2. Cooper Surgical Inc. 14.1.2.1. Overview 14.1.2.2. Product Portfolio 14.1.2.3. Profitability by Market Segments 14.1.2.4. Sales Footprint 14.1.2.5. Strategy Overview 14.1.2.5.1. Marketing Strategy 14.1.3. Hologic 14.1.3.1. Overview 14.1.3.2. Product Portfolio 14.1.3.3. Profitability by Market Segments 14.1.3.4. Sales Footprint 14.1.3.5. Strategy Overview 14.1.3.5.1. Marketing Strategy 14.1.4. Abbott 14.1.4.1. Overview 14.1.4.2. Product Portfolio 14.1.4.3. Profitability by Market Segments 14.1.4.4. Sales Footprint 14.1.4.5. Strategy Overview 14.1.4.5.1. Marketing Strategy 14.1.5. Biosynex 14.1.5.1. Overview 14.1.5.2. Product Portfolio 14.1.5.3. Profitability by Market Segments 14.1.5.4. Sales Footprint 14.1.5.5. Strategy Overview 14.1.5.5.1. Marketing Strategy 14.1.6. Medixbiochemica 14.1.6.1. Overview 14.1.6.2. Product Portfolio 14.1.6.3. Profitability by Market Segments 14.1.6.4. Sales Footprint 14.1.6.5. Strategy Overview 14.1.6.5.1. Marketing Strategy 14.1.7. Sera Prognostics 14.1.7.1. Overview 14.1.7.2. Product Portfolio 14.1.7.3. Profitability by Market Segments 14.1.7.4. Sales Footprint 14.1.7.5. Strategy Overview 14.1.7.5.1. Marketing Strategy 14.1.8. IQ Products 14.1.8.1. Overview 14.1.8.2. Product Portfolio 14.1.8.3. Profitability by Market Segments 14.1.8.4. Sales Footprint 14.1.8.5. Strategy Overview 14.1.8.5.1. Marketing Strategy 14.1.9. Creative Diagnostics 14.1.9.1. Overview 14.1.9.2. Product Portfolio 14.1.9.3. Profitability by Market Segments 14.1.9.4. Sales Footprint 14.1.9.5. Strategy Overview 14.1.9.5.1. Marketing Strategy 14.1.10. Nan jing Liming Biological Preparations Co., Ltd., 14.1.10.1. Overview 14.1.10.2. Product Portfolio 14.1.10.3. Profitability by Market Segments 14.1.10.4. Sales Footprint 14.1.10.5. Strategy Overview 14.1.10.5.1. Marketing Strategy 14.1.11. Clinical Innovations LLC 14.1.11.1. Overview 14.1.11.2. Product Portfolio 14.1.11.3. Profitability by Market Segments 14.1.11.4. Sales Footprint 14.1.11.5. Strategy Overview 14.1.11.5.1. Marketing Strategy 14.1.12. Bioserv Diagnostic GmbH 14.1.12.1. Overview 14.1.12.2. Product Portfolio 14.1.12.3. Profitability by Market Segments 14.1.12.4. Sales Footprint 14.1.12.5. Strategy Overview 14.1.12.5.1. Marketing Strategy 15. Assumptions & Acronyms Used 16. Research Methodology
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Preterm Births and PROM Testing Market
