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Preterm Birth Diagnostic Test Kits Market

Preterm Birth Diagnostic Test Kits Market, by Product Type (ffN Test, PAMG-1 Test, IGFBP-1 Test), by Sample Type (Blood, Urine, and Vaginal Discharge), by End-User (Hospitals, Diagnostic Laboratories, Outpatient Clinics, and Research Centres) and by Region: Forecast for 2022-2028

Preterm Birth Diagnostic Test Kits Market, by Product Type (ffN Test, PAMG-1 Test, IGFBP-1 Test), by Sample Type (Blood, Urine, and Vaginal Discharge), by End-User (Hospitals, Diagnostic Laboratories, Outpatient Clinics, and Research Centres) and by Region: Forecast for 2022-2028

Preterm Birth Diagnostic Test Kits Market - Analysis, Outlook, Growth, Trends, Forecasts

Preterm Birth Diagnostic Test Kits Market Snapshot

[257 Pages Report] According to Future Market Insights (FMI), the global Preterm Birth Diagnostic Test Kits Market registered sales worth U.S. $ 121.3 Mn in 2021 and will expand 1.6X over the forecast period. The market is anticipated to expand at a CAGR of 7.6% during the forecast period of 2022-2028 and will register sales of U.S. $ 203.2 Mn in the year 2028.

The Preterm Birth Diagnostic Test Kits Market accounted for nearly 1% of the global rapid diagnostic test kits market in the year 2021, which was valued at U.S. $ 15.6 Bn during that year. The lack of awareness regarding preterm diagnostic kits amongst the emerging markets of Asia Pacific, Middle East & Africa presents many lucrative opportunities for the manufacturers in these regions.

High expenses associated with hospital admissions incur a great financial burden on the people relying on out-of-pocket expenses to avail preterm diagnostic services. Preterm diagnostic test kits provide easily accessible and swift test results for the determination of preterm labour & premature rupture of membranes. The increasing demand for cost effective diagnostic test is expected to fuel the demand for preterm birth diagnostic test kits market over the forecast period.

Initiatives have been taken up by various regional and international organizations in order to address the on-going preterm birth scenario. These campaigns are aimed to help raise awareness regarding preterm births, their diagnosis and symptoms. For instance, in March 2017, March of Dimes, a non-profit organization of the U.S. convened a “Prematurity Campaign Collaborative” which involved around 200 leading maternal and child health organizations across the country which also included parents and community groups. The aim of this campaign was to help foster communities in which premature new-borns are given all the care that is needed to start their life in a healthiest way possible. The rising awareness regarding preterm births would help creative adequate diagnostic techniques which would fuel the demand for preterm birth diagnostic test kits.

According to the Centre for Disease Control and Prevention (CDC), in the U.S. in the year 2020, preterm birth occurred once in every 10 infants. The overall preterm birth rate was 10.1% in that year. The high prevalence rate of preterm birth will also contribute to the growth of preterm birth diagnostic test kits market over the forecast period.

The sales of PAMG-1 test kits are expected to be around U.S. $ 132.7 Mn in 2028, which would contribute to about 65% of the total preterm birth diagnostic test kits market by the end of 2028. This is an important biomarker used to diagnose premature rupture of foetal membrane (PROM), which usually means the initiation of labour in pregnant women. Since this is an important parameter to determine premature birth, the sales of this test will positively impact the market growth over the forecast period (2022-2028).

Preterm Birth Diagnostic Test Kits Market Outlook:

Data Points

Market Insights

Market Value 2022

USD 130.7 Mn

Market Value 2028

USD 203.2 Mn

CAGR 2022-2028

7.6%

Share of top 5 countries

66.1%

Key Players

The key players of this industry are Qiagen, Medixbiochemica, Hologic Inc., Sera Prognostics, IQ Products, Creative Diagnostics, Nanjing Liming Biological Preparations Co., Ltd., Clinical Innovations, LLC, and Bioserv Diagnostic GmbH.

2012-2021 Preterm Diagnostic Test Kits Demand Outlook Compared to 2022-2028 Forecast

According to Future Market Insights (FMI), the demand for preterm birth diagnostic test kits expanded at a CAGR of 5.9% during the period of 2013-2021. Rising awareness regarding preterm births and the resulting complications, high costs associated with other diagnostic tests for preterm labour are some of the key drivers which helped the market grow over the past few years.

Recent innovations in maternal and child health, availability of rapid tests to detect preterm labour, preterm rupture of foetal membrane, increasing government initiatives to manage the growing rates of preterm births, improving healthcare infrastructure are some of the other key drivers which will help the preterm birth diagnostic test kits market grow over the forecast period.

According to the World Health Organization 2018, the top 5 countries which have the greatest number of preterm births are India, China, Nigeria, Pakistan and Indonesia. These countries represent the untapped market for cost-effective preterm birth diagnostic test kits for all the key players of the industry.

The key players of this industry are adopting strategies of acquisition, partnerships and product launches to expand their market existence and strengthen their foothold around the world. For instance:

  • In September 2018, QIAGEN announced a strategic partnership with NeuMoDx Molecular Inc., with the aim to launch and commercialize 2 new fully integrated systems in Europe for the automation of PCR testing. This partnership allowed QIAGEN to distribute their products into other major markets outside of the U.S., thus broadening their market space.
  • In July 2021, Medix Biochemica announced the acquisition of Diaclone, a monoclonal antibodies provider. This acquisition helped the company to expand their portfolio of in-vitro diagnostics raw materials and strengthen their market presence in Western Europe.

The market is consolidated with players such as Qiagen, Medixbiochemica, Hologic Inc., Sera Prognostics, IQ Products, Creative Diagnostics, Nanjing Liming Biological Preparations Co., Ltd., Clinical Innovations, LLC, and Bioserv Diagnostic GmbH.

Future Market Insights expects the global preterm birth diagnostic test kits market to expand at a CAGR of 7.6% over the forecast period owing to the efforts taken by the key players of this industry to expand themselves in the global market.

What is the impact of COVID-19 on this industry?

In a study funded by the National Institute of Health in the U.S., in January 2021, it was explained that, pregnant women who exhibited severe symptoms of COVID-19 infection, were at high risk of suffering from complications such as preterm birth, hypertensive disorders of pregnancy, postpartum haemorrhage, caesarean delivery and others.

The COVID-19 pandemic had catastrophic effect on the healthcare industry in the first half of 2020. The latter half of 2020 witnessed high rates of research and development activities conducted in all aspects of healthcare. The preterm birth diagnostic test kits market experienced an ambiguous impact of COVID-19. Since the lockdown prevented people to visit hospitals, the at-home diagnostic tests witnessed a hike in sales during the peak of the pandemic. The industry is thus expected to recover at a steady rate during the forecast period.

What are the key opportunities for manufacturers of preterm diagnostic test kits industry?

Preterm birth diagnostic test kits do not help in the delivery of a new born but help detect symptoms of preterm labour and Premature Rupture of Foetal Membrane (PROM). These tests help in evaluating pregnancy status. Further Studies and development of these products could further enhance the chance of product penetration globally.

Pregnancy test kits, indicating pregnancy, have over the years shown substantial growth. Preterm birth diagnostic kits indicate towards the chance of preterm labour or symptoms of premature rupture of membrane. Methodological marketing and advertisement could boost the growth of this market.

Manufacturers could target countries of regions such as Middle-East & Africa, Latin America, and Asia Pacific where the preterm birth rates are predominantly high. Such regions also comprise of a majority of the population with lower per capita income who could be benefited by the cost effective preterm birth diagnostic test kits.

What are the restraining factors for this market?

Preterm birth diagnostic kits could experience stiff competition from companies which manufacture and market pregnancy-related diagnostic products and services. In addition, healthcare providers tend to use diagnostic techniques such as clinical examinations, ultrasound, and certain other tests and evaluations to diagnose pre-term birth.

Standard ultrasound, trans-vaginal scans, advanced ultrasound are some of the examinations adopted by healthcare providers. These tests evaluations are preferred over the use of preterm birth diagnostic kits. Healthcare professionals in Asia-Pacific examine the patient by analysing the cervical lengths, patient height & weight, blood haemoglobin levels, and examination for vaginal tears, and use ultrasound in order to diagnose the possibility of preterm birth.

The adoption of preterm birth diagnostic test kits is poor in comparison to the prevalent preterm birth rates, especially in the emerging markets of Asia Pacific with respect to healthcare. The reason for this is not only improper nutrition and healthcare infrastructure, but the lack of awareness of technologies such as preterm birth diagnostic test kits. This could be another restraining factor for this market.

Preterm Birth Diagnostic Test Kits Market - Country-wise Insights

Will the U.S. remain a key market for preterm diagnostic test kits?

U.S. is expected to hold 94.3% market share, by value of North America in the year 2021 and is anticipated to expand at a CAGR of 8.1% over the forecast period 2022-2028. The preterm birth diagnostic kits have high adoption rates in the U.S. which explains the high market share of this country. High level of awareness regarding these test kits and their cost-effectiveness also contribute to the growth of this market in the U.S.

Why Germany is considered a more lucrative Preterm Birth Diagnostic Test Kits Market within Western Europe?

In Western Europe, Germany is expected to account for 19.0% share of the total Western Europe preterm birth diagnostic test kits market, by value by the end of 2021. Presence of market leaders in the country contributes to high availability of these products in the local market, which is one of the key factor contributing to the high share of Germany in this industry.

What are the factors supporting preterm diagnostic test kits sales in India?

India is anticipated to hold 73.8% share of the total APAC preterm birth diagnostic test kits market, by value in 2021 and will expand at a CAGR of 8.6% over the forecast period. High prevalence rate of preterm birth in the country, increasing awareness of preterm birth diagnostic test kits, developing healthcare infrastructure are some of the factors that attribute to the large market share of India in Asia Pacific region for this market.

Preterm Birth Diagnostic Test Kits Market - Category-wise Insights

What is the Preterm Birth Diagnostic Test Kits Market value?

The global preterm birth diagnostic test kits market is expected to register sales worth U.S. $ 121.3 Mn by the end of 2021 and is projected to reach U.S. $ 203.2 Mn by the end of 2028 with a cumulative CAGR of 7.6%.

Why is the demand for PAMG-1 Test highest, by product?

PAMG-1 test is expected to 62.2% market share, by value by the end of 2021, and will expand at a CAGR of 8.4% over the forecast period. Since this biomarker is used in detecting premature rupture of foetal membrane, which indicates the beginning of labour, it is the most commonly used diagnostic test by product.

Which sample holds the maximum share in the preterm diagnostic test kits?

Blood samples are most common and widely accepted in the preterm birth diagnostic test kits and is expected to hold the maximum share of 42.1%, by value of the preterm birth diagnostic test kits market by the end of 2021. This segment is expected to expand at a CAGR of 7.0% over the forecast period.

Which end-user contributes to highest market share in the Preterm Birth Diagnostic Test Kits Market?

Hospitals are expected to hold the highest share of 66.5%, by value in 2021. The segment is set to expand at a CAGR of 8.2% over the forecast period, owing to the high demand of these tests in the hospitals for quick and cost effective diagnosis of preterm birth.

Preterm Birth Diagnostic Test Kits Market - Competitive Landscape

The key players of this market are adopting strategies such as product launch, acquisition, partnership and collaborations to gain expand their market presence and open up new streams of revenue generation.

  • In June 2021, Medix Biochemica announced the launch of a new molecular diagnostic reagents division named “MedixMDx” to offer extensive range of products and services for their customers.
  • In September 2020, QIAGEN announced the acquisition of NeuMoDx Molecular Inc., which helped the company to complete their product portfolio of PCR technology based automated molecular testing solutions.
  • In May 2021, Sera Prognostics announced a strategic commercial partnership with Anthem Inc., to make their “PreTRM® “tests available to all the customers of Anthem in the U.S.

Since the awareness of preterm birth diagnostic test kits is increasing, the demand for these kits will rise in the next few years. This creates many lucrative opportunities for the key players of this industry.

Preterm Birth Diagnostic Test Kits Market - Scope of the Report

Attribute

Details

Forecast Period      

2022-2028

Historical Data Available for

2013-2021

Market Analysis

USD Million for Value.

Key Countries Covered

US, Canada, Germany, U.K., France, Italy, Spain, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Australia, New Zealand, GCC Countries, Turkey, South Africa

Key Segments Covered

Product, Sample, End-User and Region.

Key Companies Profiled

  • Qiagen
  • Medix Biochemica
  • Hologic Inc.
  • Sera Prognostics
  • IQ Products
  • Creative Diagnostics
  • Nanjing Liming Biological Preparations Co., Ltd.
  • Clinical Innovations, LLC
  • Bioserv Diagnostic GmbH

Report Coverage

Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives

Customization & Pricing

Available upon Request

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Preterm Birth Diagnostic Test Kits Market, By Category

Product

  • ffN Test
  • PAMG-1 Test
  • IGFBP-1 Test

Sample

  • Blood
  • Urine
  • Vaginal Discharge

End User         

  • Hospitals
  • Diagnostic Laboratories
  • Outpatient Clinics
  • Research Centers

Region

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • Middle-East & Africa
  • APECJ
  • China
  • Japan

Key Questions Answered in the Report

How is the Preterm Birth Diagnostic Test Kits Market growth?

The global preterm birth diagnostic test kits market is expected to expand at a CAGR of 7.6% over the forecast period.
North America accounts for the highest share of 24.7%, by value in the year 2021, in the global preterm birth diagnostic test kits market.
The preterm birth diagnostic test kits market is expected to register sales worth U.S. $ 121.3 Mn by the end of 2021 and will reach U.S. $ 203.2 Mn by 2028.
High demand for cost effective preterm birth diagnostic tests, increasing awareness of preterm birth diagnostic test kits in the emerging markets are some of the key drivers of preterm birth diagnostic test kits market.
The key players of this industry are Qiagen, Medixbiochemica, Hologic Inc., Sera Prognostics, IQ Products, Creative Diagnostics, Nanjing Liming Biological Preparations Co., Ltd., Clinical Innovations, LLC, and Bioserv Diagnostic GmbH.

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