妊娠検査キット市場：製品タイプ、検査タイプ、エンドユーザー、地域別、2024年～2031年

妊娠検査キット市場の評価、2024年～2031年

女性の間で妊娠早期発見の意識と必要性が高まっており、より高い精度と使いやすさを提供する医療技術の開発も進んでいます。望まない妊娠の増加、市販の検査キットへのアクセスの増加、新興諸国におけるヘルスケア施設の改善などはすべて、2024年に14億4,000万米ドルを突破し、2031年には20億7,000万米ドルに達する市場成長の要因となっています。

さらに、セルフケアやホームベースのヘルスケアソリューションの人気の高まりは、それらが提供する利便性とプライバシーに後押しされ、妊娠検査キットの需要を押し上げています。ヘルスケア機関のマーケティングイニシアティブや教育活動も、これらのキットの入手可能性や利点に関する知識を高めるのに役立っています。同市場は2024年～2031年の間に5.17％のCAGRで成長する見込みです。

妊娠検査キット市場定義/概要

妊娠検査キットは、尿中のホルモンHCG（ヒト絨毛性ゴナドトロピン）の存在を検出する医療機器です。これらのキットは、簡便性、プライバシー、迅速な結果のため、家庭での検査に人気があります。治療には、早期の妊娠確認が含まれ、これにより迅速な出生前治療と十分な情報に基づいた意思決定が可能になります。妊娠検査キットの将来は楽観視できそうで、精度の向上、早期発見機能、より良いユーザーエクスペリエンスのためのデジタル統合、ヘルスケアへのアクセスが伸びている新しい地域への成長に開発が集中しています。さらに、キットの再利用や環境に優しい素材などの開発が市場開拓に影響を与えると予測されます。

家庭用妊娠検査薬の需要増は妊娠検査キット市場を牽引するか？

家庭用妊娠検査薬に対する需要の高まりが、妊娠検査キット業界を後押ししています。多くの消費者は、在宅検査が提供する利便性とプライバシーを重視しており、これが利用拡大に繋がっています。これらの検査によって、女性はヘルスケア施設を訪れることなく、自宅のプライバシーを守りながら妊娠を確認することができ、これはCOVID-19の余波で特に重要となっています。在宅検査への動きは、セルフケアと遠隔ヘルスケア決定への大きな傾向を反映しています。

政府の施策もまた、在宅妊娠検査の増加に寄与しています。2023年8月、米国疾病予防管理センター（CDC）は、母親の健康増進のためのより大きなイニシアチブの一環として、在宅妊娠検査の使用を奨励するキャンペーンを開始しました。このキャンペーンの目標は、妊娠早期発見の利点について女性を教育し、タイムリーな妊婦ケアを確保するために家庭用検査の使用を奨励することです。このようなイニシアチブは、利用しやすく便利な検査オプションの重要性が高まっていることを示しており、これが妊娠検査キット市場の需要と成長の原動力となっています。

2024年4月、妊娠検査事業は、生理不順の6日前まで妊娠を検出できる新しい超高感度ライン検査の発売を発表しました。この製品改良は、より迅速な検出を求める消費者ニーズを満たすために検査感度を向上させるという継続的な動向を反映しています。同社は、2024年第1四半期のライン検査の収益が前年同期比20％増を記録し、堅調な市場成長を示しています。このイントロダクションは、ライン妊娠検査薬セグメントを後押しし、市場全体の成長に貢献すると思われます。

2024年1月、世界保健機関（WHO）は、低資源環境における妊娠検査のガイドラインを更新しました。このガイドラインでは、低コストで解釈が容易であることから、基本的なライン検査の使用が特に推奨されています。WHOの勧告は、低開発国でのライン式妊娠検査の使用を促進し、メーカーに新しい市場を開く可能性があると予想されます。このような世界の保健政策の転換は、現在進行中の製品の進歩や家族計画に関する知識の増加とともに、妊娠検査キット市場、特にライン検査セグメントの成長を促進すると思われます。

高まる規制上のハードルは妊娠検査キット市場の成長を妨げるか？

規制上の制約の増大は、より厳しいコンプライアンス要件を強制し、メーカーの運営経費を増加させることにより、妊娠検査キット市場の拡大を阻害する可能性があります。規制は製品の安全性、正確性、有効性を確保することを目的としており、その結果、試験や承認プロセスがより厳しくなる可能性があります。このような規制を乗り越えることは、企業にとって時間とコストがかかることであり、製品の上市を遅らせたり、新製品を市場に投入するための全コストを増加させたりする可能性があります。

規制変更の影響は市場に影響を与える可能性が高いです。2024年5月、米国食品医薬品局（FDA）は、精度を向上させ、異なる製品間で一貫した性能を確保するため、家庭用妊娠検査薬に関する推奨事項を修正しました。承認される前に、改訂された基準は、より広範な臨床評価と検証を要求しています。この法改正は、顧客の信頼を高めるためのものだが、メーカーにはコンプライアンス活動により多くの費用を支払う必要があり、技術革新が遅れ、コストが上昇する可能性があります。

さらに、欧州医薬品庁（EMA）は2023年7月、妊娠検査薬などの体外診断用医薬品について、製品管理と安全要件の改善を目的とした新規制を発表しました。これらの規制は、より包括的な市販後調査と報告義務を求めています。これらの規制は消費者を保護することを意図している一方で、製造者の規制負担を増大させるものでもあります。これらの新基準への準拠は、欧州市場への製品参入を遅らせ、特に経営資源の限られた中小企業にとっては、成長に影響を及ぼす可能性があります。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 妊娠検査キット市場：製品タイプ別

• ライン式妊娠検査薬（最も一般的）
• デジタル機器

第5章 妊娠検査キット市場：検査タイプ別

• hCG尿検査
• hCGの血液検査

第6章 妊娠検査キット市場：エンドユーザー別

• 家庭用
• 婦人科クリニック
• 病院

第7章 地域別分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• Abbott Laboratories
• Church & Dwight Co. Inc.
• Germaine Laboratories Inc.
• Mankind Pharma
• Piramal Enterprises
• Procter & Gamble Company（Swiss Precision Diagnostics GmbH）
• QuidelOrtho Corporation

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

Pregnancy Detection Kits Market Valuation - 2024-2031

The increasing awareness and necessity of early pregnancy detection among women, along with developments in medical technology that provide greater accuracy and ease of use. The rise in unwanted pregnancies, more access to over-the-counter testing kits, and improved healthcare facilities in developing countries all contribute to market growth surpassing USD 1.44 Billion in 2024 and reachingUSD 2.07 Billion by 2031.

Furthermore, the growing popularity of self-care and home-based healthcare solutions, driven by the convenience and privacy they provide, boosts demand for pregnancy detection kits. Healthcare organizations' marketing initiatives and educational activities also help to raise knowledge about the availability and benefits of these kits future years is expected to grow at aCAGR of 5.17% from 2024 to 2031.

Pregnancy Detection Kits Market: Definition/ Overview

Pregnancy detection kits are medical instruments that detect the presence of the hormone HCG (human chorionic gonadotropin) in urine. These kits are popular for home testing because of their simplicity, privacy, and speedy results. Applications include early pregnancy confirmation, which enables prompt prenatal treatment and informed decision-making. The future of pregnancy detection kits seems optimistic, with developments concentrating on boosting accuracy, early detection capabilities, digital integration for a better user experience, and growth into new regions where healthcare access is growing. Furthermore, developments such as reuse kits and eco-friendly materials are projected to influence the market's development.

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Will Rising Demand for Home-Based Pregnancy Tests Drive the Pregnancy Detection Kits Market?

The growing demand for home-based pregnancy tests is propelling the pregnancy detection kits industry. Many consumers value the convenience and privacy that home-based testing provide, which has led to growing usage. These tests enable women to confirm pregnancy in the privacy of their own homes without having to visit a healthcare facility, which has become especially crucial in the aftermath of COVID-19. The move to home-based testing mirrors a larger trend toward self-care and remote healthcare decisions.

Government measures also contribute to the rise of home pregnancy tests. In August 2023, the Centers for Disease Control and Prevention (CDC) launched a campaign to encourage the use of home-based pregnancy tests as part of a larger initiative to enhance mother health. The campaign's goal is to educate women about the benefits of early pregnancy detection and encourage the use of home tests to ensure timely prenatal care. Such initiatives demonstrate the growing relevance of accessible and convenient testing options, which drives demand and growth in the pregnancy detection kit market.

In April 2024, pregnancy testing business, announced the release of their new ultra-sensitive line test, which can detect pregnancy up to 6 days before a missed period. This product improvement reflects the continued trend of increasing test sensitivity to fulfill consumer needs for faster detection. The company recorded a 20% year-over-year rise in line test revenues in the first quarter of 2024, showing robust market growth. This introduction is likely to boost the line pregnancy test segment and contribute to the overall market growth.

In January 2024, the World Health Organization (WHO) issued updated guidelines for pregnancy testing in low-resource settings. These guidelines notably advocate the use of basic line tests because of their low cost and ease of interpretation. The WHO's recommendation is anticipated to boost the usage of line pregnancy tests in underdeveloped nations, potentially opening up new markets for manufacturers. This worldwide health policy shift, together with ongoing product advancements and increased knowledge about family planning, is likely to drive growth in the pregnancy detection kits market, particularly in the line test segment.

Will Growing Regulatory Hurdles Hinder the Growth of the Pregnancy Detection Kits Market?

Growing regulatory constraints may stymie the expansion of the pregnancy testing kits market by enforcing tougher compliance requirements and raising operational expenses for manufacturers. Regulations are intended to ensure product safety, accuracy, and efficacy, which might result in more stringent testing and approval processes. Navigating these rules may be time-consuming and expensive for businesses, possibly delaying product launches and increasing the entire cost of introducing new products to the market.

The impact of regulatory changes is likely to affect the market. In May 2024, The United States Food and Drug Administration (FDA) modified its home pregnancy test recommendations to improve accuracy and ensure consistent performance across different products. Before being approved, the revised standards call for more extensive clinical assessment and validation. This legislative reform is designed to boost customer trust, but it also requires manufacturers to pay more in compliance activities, which may slow down innovation and raise costs.

Furthermore, in July 2023, the European Medicines Agency (EMA) issued new regulations for in vitro diagnostic devices, such as pregnancy tests, with the goal of improving product control and safety requirements. These regulations call for more comprehensive post-market surveillance and reporting obligations. While these regulations are intended to safeguard consumers, they also increase regulatory burdens on producers. Compliance with these new criteria may delay product entry into the European market and have an impact on growth, especially for smaller enterprises with limited resources.

Category-Wise Acumens

Will Rising Demand for Urine Test for HCG Propel the Pregnancy Detection Kits Market?

The increasing demand for HCG urine testing. Urine HCG tests are popular among women for early pregnancy detection because they are convenient, affordable, and simple to use. These kits are easily obtained over the counter without a prescription, allowing women to confirm their pregnancy in the comfort of their own homes. Urine tests are becoming increasingly popular and widely used due to their non-invasive nature and speedy results.

In February 2024, Abbott Laboratories, a significant leader in the medical equipment and diagnostics business released a more advanced digital pregnancy test. This test claims to detect pregnancy up to six days before a missed menstruation, with 99% accuracy. The company recorded a 15% growth in pregnancy test kit sales in the fourth quarter of 2023, showing a positive market trend. This introduction is expected to strengthen Abbott's position in the pregnancy detection kits market, reflecting the industry's continual innovation to address consumer needs for faster and more reliable findings.

In November 2023, the United States Food and Drug Administration (FDA) published new recommendations for over-the-counter pregnancy test manufacturers. These guidelines seek to improve the accuracy and reliability of home pregnancy tests, with a special emphasis on detecting HCG in urine samples. The FDA's decision is expected to spur additional research and development in this area, potentially resulting in even more sensitive and reliable tests entering the market in the coming years. This legislative push, together with rising consumer demand and technology improvements, is expected to drive the pregnancy detection kits market, notably in the urine-based HCG testing segment.

The second fastest-growing area is blood HCG testing, which, while primarily performed in clinical settings, are gaining popularity due to their superior accuracy and ability to detect pregnancy sooner than urine tests. The growing awareness of the benefits of early and precise detection is driving the need for HCG blood tests.

Will Rising Usage of Line Pregnancy Tests Drive the Growth of Pregnancy Detection Kits Market?

The increasing use of line pregnancy tests is pushing the market for pregnancy detection kits. Line pregnancy tests are popular because they are simple, inexpensive, and effective. These tests, which use a simple two-line method to display findings, provide a low-cost and user-friendly solution for detecting early pregnancy. Their widespread availability and ease of use have made them a popular alternative for women looking for fast and dependable results at home, contributing significantly to market growth.

For instance, in July 2023, global health firm Procter & Gamble announced the debut of a new range of pregnancy tests under the name always. This device claims increased sensitivity and faster results, addressing the growing customer demand for dependable and accessible pregnancy testing alternatives. The introduction of such solutions demonstrates major firms' continuous commitment to meeting expanding demand for line testing and driving market growth.

Furthermore, government health campaigns are promoting the use of line pregnancy tests. In August 2023, the US Department of Health and Human Services (HHS) initiated a public awareness campaign to educate women on the necessity of early pregnancy detection. The campaign encourages the use of home pregnancy tests, including line tests, to ensure prompt access to prenatal care. Such measures not only raise awareness, but also boost consumer adoption of pregnancy detection kits, so contributing to the overall market growth.

Digital gadgets are the fastest expanding segment. These modern tests have extra features such as digital readouts and higher accuracy, and they may frequently identify the number of weeks after conception. As consumers seek more precise and user-friendly solutions, the demand for digital gadgets grows. This segment's growth is being driven by technological improvements as well as a shift toward premium items that provide increased usefulness and convenience.

Country/Region-wise

Will Advanced Healthcare in North America Drive the Pregnancy Detection Kits Market?

Advanced healthcare in North America has a huge impact on the pregnancy detection kit market. The region has a well-established healthcare infrastructure, high consumer awareness, and a strong focus on early and accurate pregnancy detection. The availability of technologically sophisticated pregnancy testing kits, such as digital and early detection kits, addresses the increased demand for dependable and easy-to-use home-based diagnostic instruments. These kits are particularly popular in the United States and Canada due to the convenience and privacy they provide.

For instance, in June 2023, Clearblue, a market leader, introduced its Clearblue Advanced Pregnancy Test with Weeks Estimator. This revolutionary tool not only verifies pregnancy, but also calculates the number of weeks since conception, giving the consumer more detailed information. Such improvements demonstrate the region's commitment to incorporating cutting-edge technology into healthcare solutions, which improves the user experience and increases market demand.

Furthermore, the COVID-19 pandemic has pushed the demand for home-based healthcare products, such as pregnancy detection kits. Over-the-counter diagnostic technologies have become increasingly popular as people avoid frequent hospital visits. According to the American Pregnancy Association's study issued in August 2023, sales of home pregnancy tests increased significantly during the pandemic, illustrating the trend toward self-care and remote healthcare. This trend is projected to continue, aided by North America's strong healthcare infrastructure, which provides widespread access and ongoing innovation in pregnancy detection kits.

Will Rising Awareness about Early Pregnancy Detection in Asia-Pacific Propel the Pregnancy Detection Kits Market?

The rise in Asia-Pacific, which is experiencing rapid urbanization and improvements in healthcare infrastructure, resulting in increasing access to healthcare information and services. Educational campaigns and initiatives by both governmental and non-governmental organizations are playing a critical role in spreading awareness about the importance of early pregnancy detection.

A big milestone occurred in June 2023, when the Ministry of Health and Family Welfare launched a public health campaign in India to promote the benefits of early pregnancy detection. The campaign, which featured television and web commercials, stressed the health benefits of early prenatal care and how home pregnancy tests can help with early discovery. This program is expected to lead to an increase in the use of pregnancy detection kits as more women become aware of the necessity of confirming pregnancy early and seek out these goods.

Furthermore, market participants in the region are responding to rising awareness with tailored product offerings and marketing methods. For instance, in July 2023, Tianjin-based Tianjin Zhendong Pharmaceutical Co., Ltd., a leading pharmaceutical business in China, launched a new line of economical and highly accurate pregnancy testing kits customized to the needs of the local market. These kits are intended to meet the growing need in rural and semi-urban areas, where access to healthcare institutions may be limited. The company's efforts to make these kits more widely available through collaborations with retail chains and online platforms are projected to accelerate market growth in Asia-Pacific.

Competitive Landscape

The competitive landscape of the pregnancy detection kits market is characterized by intense competition among numerous local and regional manufacturers, who focus on affordability and accessibility to capture market share. Innovation in product features, such as digital readouts and early detection capabilities, also plays a significant role. Additionally, partnerships with healthcare providers and retailers to expand distribution channels and improve market penetration are common strategies. The market is also influenced by regulatory standards and the push for more accurate and user-friendly products.

Some of the prominent players operating in the pregnancy detection kits market include:

Abbott Laboratories

Church & Dwight Co., Inc.

Germaine Laboratories, Inc.

Mankind Pharma

Piramal Enterprises

QuidelOrtho Corporation

Latest Developments

In July 2024, E.P.T. (Early Pregnancy Test) has expanded its product line to include environmentally friendly pregnancy test kits, with an emphasis on decreasing environmental effect through the use of recyclable materials and the elimination of plastic waste. This approach addresses the increased consumer demand for sustainable products.

In August 2024, MomMed has released a new app-integrated pregnancy test kit that syncs findings to a smartphone for precise tracking and notifications. This solution seeks to blend traditional testing with current technology to provide a more comprehensive user experience.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Pregnancy Detection Kits Market, By Product Type

• Line Pregnancy Tests (most popular)
• Digital Devices

5. Pregnancy Detection Kits Market, By Test Type

• Urine test for hCG
• Blood test for hCG

6. Pregnancy Detection Kits Market, By End User

• Household
• Gynecology Clinics
• Hospitals

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Abbott Laboratories
• Church & Dwight Co. Inc.
• Germaine Laboratories Inc.
• Mankind Pharma
• Piramal Enterprises
• Procter & Gamble Company (Swiss Precision Diagnostics GmbH)
• QuidelOrtho Corporation

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References