Impact Analysis of Covid-19

The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

Fertility and Pregnancy Rapid Test Kits Market – Insights

Pregnancy and fertility rapid tests are the point of care tests used in male and female to qualitatively detect the presence of reproductive hormones such as FSH, LH and hCG either in urine or blood sample.

To perform rapid pregnancy or fertility tests, small amount of blood or urine sample is required, depending upon the type of device being used. These devices work on color changing immunoassay techniques.

The global fertility and pregnancy rapid test kits market is estimated to account for US$ 1,217.5 Mn in terms of value in 2019 and is expected to reach US$ 1,653.5 Mn by the end of 2027.

Global Fertility and Pregnancy Rapid Test Kits Market: Drivers

High incidence of infertility is a major factor boosting growth of the global fertility and pregnancy rapid test kits market over the forecast period. For instance, according to the National Survey of Family Growth data published in September 2018, 15.5% of all women who intend to become pregnant are infertile and 6.7% of married women aged 15 to 44 years are infertile, in the U.S.

Moreover, increasing incidence of gynecological disorders is also expected to aid in growth of the market. For instance, according to the Centers of Disease Control and Prevention’s U.S. Cancer Statistics September 2019, around 94,000 women were diagnosed with gynecologic cancer each year, in the U.S., between 2012 and 2016.

North America region held dominant position in the global fertility and pregnancy rapid test kits market in 2018, accounting for 50.7% share in terms of value, followed by Asia Pacific.

Fertility and Pregnancy Rapid Test Kits  | Coherent Market Insights

Global Fertility and Pregnancy Rapid Test Kits Market: Restraints

Lack of buyers in emerging economies is expected to hinder growth of the global fertility and pregnancy rapid test kits market. In spite of high infertility rates in countries such as South Africa, Nigeria, Bangladesh, and Morocco, lack of awareness towards fertility and pregnancy rapid test products as well as inability to buy products due to economic insufficiency can hamper growth of the global market to a certain extent.

Moreover, the market for fertility and pregnancy test products is highly competitive, with number of established and local players striving to maintain their market shares. Over 300 brands are available in market for fertility or pregnancy testing, which can lead to a problem of plenty, wherein consumers cannot choose one brand and instead opt for alternative laboratory tests. This can significantly reduce consumer base and thus, lead to decline or stagnation in market.

Global Fertility and Pregnancy Rapid Test Kits Market: Opportunities

Devices for pregnancy and fertility rapid tests are not covered in most pregnancy coverage policies or health insurance. Cost of pregnancy and fertility rapid test devices are comparatively high in the U.S. and Europe. Therefore, effective reimbursement policies and reduction in costs is expected to offer lucrative growth opportunities for players in the market.

Direct-to-consumer (DTC) medical tests can be an affordable option help low income countries. Therefore, players in the market can focus on introducing DTC medical tests.

Fertility and Pregnancy Rapid Test Kits  | Coherent Market Insights

Pregnancy rapid tests segment in the global fertility and pregnancy rapid test market was valued at US$ 678.1 in 2018 and is expected to reach US$ 951.4 Mn by 2027 at a CAGR of 4.3% during the forecast period.

Market Trends/Key Takeaways

Manufacturers are offering pregnancy test kits with dual capability as well as combined packs of fertility and pregnancy tests, which can be used to qualitatively detect the presence of hCG hormone in both urine and serum/blood. For instance, various products such as QuickVue hCG Combo, Test & Confirm, and ICON 25 hCG are available that offer dual capability.

Major players in the market such as Alere and Swiss Precision Diagnostics GmbH are employing co-promotions and co-marketing strategies to expand their commercial presence in the global market. For instance, SPD GmbH co-market their products with Alere Inc. in India and with Boots Pharmaceuticals in the U.K.

Regulations

U.S.

  • Pregnancy test devices are classified by FDA as hCG tests system under 21 CFR, section 1155(a)
  • Pregnancy and fertility rapid test devices fall under subpart B- Clinical Chemistry Tests Systems in Class II and class III medical devices
  • Pregnancy and fertility test devices are thus subject to FDA review for premarket approval (PMA) under section 510 (k) of Federal Food drug and Cosmetics Act and the submitter may market the device immediately after 510(k) clearance is obtained
  • The submitter of 510 (k) for the sale of medical devices in U.S. market can be a domestic manufacturer, specification developer, re-packer or re-labeler and foreign manufacturer/exporter
  • As per medical devices amendment of 1976, manufacturer of class II and class III devices need to submit PMA for all changes in device that affect safety and effectiveness under new section 515 (d)(6) of FDA Modernization act
  • Fertility rapid test devices are classified under 21 CFR, section 862.1300 as Follicle Stimulating hormone test systems and section 862.1485 as Luteinizing hormone test system
  • As per amendment of May 2000, these devices are exempted from premarket notification in subpart E of part 807, chapter I of FD& C Act

Fertility and Pregnancy Rapid Test Kits  | Coherent Market Insights

Global Fertility and Pregnancy Rapid Test Kits Market: Competitive Landscape

Major players operating in the global fertility and pregnancy rapid test kits market include, SPD Swiss Precision Diagnostic GmbH, DCC Plc., Procter & Gamble, Abbott Laboratories, Alere Inc., Quidel Corporation, bioMérieux SA, Church & Dwight Co., Inc., Prestige Brands Holdings, Inc., and Geratherm Medical AG.

Global Fertility and Pregnancy Rapid Test Kits Market: Key Developments

Players in the global fertility and pregnancy rapid test kits market are focused on raising funds to expand their product portfolio. For instance, in August 2019, Dadi, a health company that offers male fertility testing and sperm storage, announced the close of a US$ 5 million investment.

Players in the market are also focused on lunching new products to expand their product portfolio. For instance, in January 2019, Medical Electronic Systems announced availability of its YO Home Sperm test for PC platforms

Pregnancy testing devices are medical devices that help in identifying the possibility of pregnancy. Pregnancy testing devices analyze the samples of women’s blood or urine for the presence of human chorionic gonadotrophin (HCG). The device detects tiny amount of HCG, a female pregnancy hormone that increases during early stages of pregnancy in female body. The urine pregnancy test kit provides qualitative results i.e. positive or negative. It contains the test strip, which is directly exposed to the potential women’s urine. The blood test kit is the most sensitive pregnancy test. The test allows the clinician to detect exact levels of HCG in women’s blood, which is based on HCG molecules bound on the test strip.

Restraints of the Global Fertility and Pregnancy Rapid Test Kits Market

Factors such as availability of too many options in the market leading to confusion in buyers mind regarding quality aspects and device-related issues can hinder growth of global fertility and pregnancy testing device market.

Key features of the study:

  • This report provides in-depth analysis of the global fertility and pregnancy rapid test kits market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2019–2027), considering 2018, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by leading players
  • It profiles leading players in the global fertility and pregnancy rapid test kits market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include SPD Swiss Precision Diagnostic GmbH, DCC Plc., Procter & Gamble, Abbott Laboratories, Quidel Corporation, bioMérieux SA, Church & Dwight Co., Inc., Prestige Brands Holdings, Inc., and Geratherm Medical AG.
  • Insights from this report would allow marketers and the management authorities of companies to make informed decision regarding future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global fertility and pregnancy rapid test kits market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the market.

Detailed Segmentation

  • Global Fertility and Pregnancy Rapid Test Kits Market, By Product Type:
    • Pregnancy Rapid Tests
      • Line-Indicator Devices
        • Strips/Dip Sticks
        • Mid-Stream
        • Cassettes
      • Digital
    • Fertility Rapid Tests
      • Line-Indicator
      • Digital
  • Global Fertility and Pregnancy Rapid Test Kits Market, By Test Type:
    • LH Urine
    • FSH Urine
    • hCG Blood
    • hCG Urine
  • Global Fertility and Pregnancy Rapid Test Kits Market, By Distribution Channel:
    • Hospital Channel
    • Retail Channel
    • Online Channel
  • Global Fertility and Pregnancy Rapid Test Kits Market, By Geography:
    • North America
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
        • By Distribution Channel
          • Hospital Channel
          • Retail Channel
          • Online Channel
        • By Country:
          • U.S.
          • Canada
    • Europe
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
      • By Distribution Channel
        • Hospital Channel
        • Retail Channel
        • Online Channel
      • By Country:
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
      • By Distribution Channel
        • Hospital Channel
        • Retail Channel
        • Online Channel
      • By Country:
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
      • By Distribution Channel
        • Hospital Channel
        • Retail Channel
        • Online Channel
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East:
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
      • By Distribution Channel
        • Hospital Channel
        • Retail Channel
        • Online Channel
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Product Type
        • Pregnancy Rapid Tests
          • Line-Indicator Devices
            • Strips/Dip Sticks
            • Mid-Stream
            • Cassettes
          • Digital
        • Fertility Rapid Tests
          • Line-Indicator
          • Digital
        • Test Type
          • LH Urine
          • FSH Urine
          • hCG Blood
          • hCG Urine
      • By Distribution Channel
        • Hospital Channel
        • Retail Channel
        • Online Channel
      • By Country/Region:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Swiss Precision Diagnostic GmbH *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • DCC Plc.
    • Procter & Gamble
    • Abbott Laboratories
    • Quidel Corporation
    • bioMérieux SA
    • Church & Dwight Co., Inc.
    • Prestige Brands Holdings, Inc.
    • Geratherm Medical AG

 “*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product Type
      • Market Snippet, By Test Type
      • Market Snippet, By Distribution Channel
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Key Developments
    • Technological Advancement
    • Regulatory Scenario
  4. Global Fertility and Pregnancy Rapid Test Kits Market, By Product Type, 2019 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
      • Segment Trends
    • Pregnancy Rapid Tests
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
      • Segment Trends
      • Line-Indicator Devices
        • Strips/Dip Sticks
        • Mid-Stream
        • Cassettes
      • Digital
    • Fertility Rapid Tests
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
      • Segment Trends
        • Line Indicator
        • Digital
  5. Global Fertility and Pregnancy Rapid Test Kits Market, By Test Type, 2019 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
      • Segment Trends
    • LH Urine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • FSH Urine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • hCG Blood
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • hCG Urine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  6. Global Fertility and Pregnancy Rapid Test Kits Market, By Distribution Channel, 2019 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
      • Segment Trends
    • Hospital Channel
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Retail Channel
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Online Channel
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  7. Global Fertility and Pregnancy Rapid Test Kits Market, By Regions, 2019 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017–2027
      • Segment Trends
    • North America
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
        • North Africa
        • Central Africa
        • South Africa
  8. Competitive Landscape
    • Company Profiles
      • Swiss Precision Diagnostic GmbH
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • DCC Plc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Procter & Gamble
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Abbott Laboratories
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Quidel Corporation
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • bioMérieux SA
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Church & Dwight Co., Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Prestige Brands Holdings, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Geratherm Medical AG
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 31 market data tables and 22 figures on “Fertility and Pregnancy Rapid Test Kits Market – Global forecast to 2027.

Existing Clientele

Joining thousands of companies around the world committed to making the Excellent Business Solutions.

View All Our Clients

Our Trusted Patner