表紙:米国のDTCラボラトリー検査市場
市場調査レポート
商品コード
1078438

米国のDTCラボラトリー検査市場

The U.S. Market for Direct-to-Consumer (DTC) Laboratory Testing

出版日: | 発行: Kalorama Information | ページ情報: 英文 100 Pages | 納期: 即日から翌営業日

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米国のDTCラボラトリー検査市場
出版日: 2022年05月26日
発行: Kalorama Information
ページ情報: 英文 100 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

当レポートでは、米国のDTCラボラトリー検査市場について調査し、市場の概要とともに、業界動向、セグメント別市場の促進要因と抑制要因、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 エグゼクティブサマリー

第2章 イントロダクション

  • 米国のラボラトリーサービス産業
  • DTC検査市場の成長
  • 米国の研究所産業構造
  • CLIAラボ登録、タイプ別ラボラトリー
  • DTC検査
  • 遺伝子検査におけるDTC
  • DTCアウトレットにおける新しい機会
  • 透析クリニック
  • 病院
  • ラボラトリー産業における規制
  • 免除証明書
  • 実験室で開発された検査
  • 州ごとの評価
  • 検査とサービス

第3章 日常的DTC臨床検査

  • 定期検査
  • 血球数
  • コレステロールレベルの検査
  • 糖尿病検査
  • HIV検査
  • 妊娠検査
  • 薬物乱用検査
  • 尿検査
  • COVID-19
  • 唾液検査
  • DTC定期臨床検査市場の促進要因と抑制要因
  • 市場規模と成長
  • 競合情勢

第4章 DTC遺伝子検査市場

  • 遺伝調査
  • DTC遺伝子検査市場の成長
  • DTC遺伝子検査の種類
  • DTC遺伝子検査の進化
  • DTC遺伝子検査ビジネスモデル
  • 市場の抑制要因
  • DTC遺伝子検査市場の促進要因と抑制要因
  • 市場規模と成長
  • 競合情勢

第5章 業界の促進要因と抑制要因

  • 概要
  • 直接販売市場を牽引する問題と動向
  • 消費者主導のヘルスケア
  • 手頃な価格とアクセシビリティ
  • プライバシー
  • 高齢人口
  • 慢性疾患の増加
  • 予防ヘルスケアの強化
  • 規制環境
  • 規制経路
  • 精度
  • インフォームドコンセント
  • DTCラボラトリー検査の決済構造
  • 患者直接支払い
  • 柔軟な支出勘定と医療貯蓄口座
  • 流通チャネル別売上高
  • モバイルデバイス
  • 大規模な診断企業とDTC
  • 遠隔医療およびDTC検査

第6章 企業プロファイル

  • 23andMe, Inc
  • Any Lab Test Now, Inc.
  • Color Genomics, Inc
  • Direct Laboratory Services, LLC
  • EasyDNA
  • Everlywell
  • Laboratory Corporation of America
  • MyMedLab, Inc.
  • Medichecks.com Ltd.
  • Myriad Genetics, Inc.
  • Ombre Gut Health (formerly Thryve)
  • Quest Diagnostics, Inc.
  • Request A Test, Ltd.
目次
Product Code: 22-712

Direct to consumer laboratory testing is also known as patient-ordered laboratory testing. A variety of tests are now available for direct to consumer testing. The growing market for direct-to-consumer laboratory testing may promote awareness of health issues and genetic diseases, which will allow patients to take a more proactive role in their healthcare. With advances in technology, the completion of the sequencing of the human genome and the pressures of the pandemic, direct to consumer lab testing is becoming increasingly popular. Still, clinical laboratories are an essential part of the health industry. It is estimated that the vast majority of physician's diagnoses are a result of laboratory tests. In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

Several trends are continuing to shape the direct-to-consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring, consumer acceptance and expanded technologies. This report, “The U.S. Market for Direct-to-Consumer (DTC) Laboratory Testing”, examines these and other essential market trends.

Additionally, issues and trends explored in this report include:

  • Demographics and Aging Population
  • Growing Incidence of Disease
  • Regulatory Environment
  • Consumer Driven Health Care
  • Emphasis on Preventative Healthcare
  • Developments in Personalized Medicine
  • Mobile Devices
  • Informed Consent
  • Payment Structure
  • Sales by Distribution Channel
  • Large Diagnostic Companies and DTC
  • Telehealth and DTC Testing

Leading companies profiled in the report include:

  • 23andMe
  • Any Lab Test Now
  • Color Genomics
  • Direct Laboratory Services
  • EasyDNA
  • Everlywell
  • Laboratory Corporation of America
  • MyMedLab
  • com
  • Ombre Gut Health (formerly Thryve)
  • Quest Diagnostics
  • Request A Test

Scope

The scope of the report is direct to consumer (DTC) laboratory testing. This does not include point of care testing or over the counter testing (i.e., pregnancy testing) because the laboratory is not needed to run the test or interpret the results. This report was assembled using both secondary and primary data. Data from Kalorama Information's previous DTC Laboratory Testing report, in addition to company annual reports, trade publications, government and medical literature were used as a foundation for estimates and forecasts. Interviews with executives at 8 DTC laboratory testing companies were conducted and are a key source of estimates for the market. Kalorama Information focuses on estimates of manufacturer revenues for business planning. The geographical scope is the United States.

The base year for data was 2021. The forecast years are 2022-2026 with compound annual growth rates (CAGRs) provided for 2021-2026 periods for each segment covered. The forecasted market analysis for 2021-2026 was largely based on demographic trends, new developments, and innovative technology.

It is important to note that the market areas covered by this report are evolving very quickly, and that some of the company and technology information may be outdated even as the report goes to press. Kalorama is fully aware of these developments. Even though some of the details may have changed by the time this report is published, the major themes, players and issues remain unchanged.

Table of Contents

Chapter 1: Executive Summary

  • Overview
  • Size and Growth of the Market
    • Table 1-1: U.S. DTC Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
    • Figure 1-1: U.S. DTC Laboratory Testing Market, 2021-2026
  • Scope and Methodology
  • Key Issues and Trends Affecting the Market
  • Leading Market Participants
  • Conclusions

Chapter 2: Introduction

  • The U.S. Laboratory Service Industry
  • Growth of the DTC Testing Market
  • U.S. Laboratory Industry Structure
    • Figure 2-1: Growth in Clinical Laboratories, 1997-2021
  • CLIA Laboratory Registration, Laboratories by Type
    • Figure 2-2: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type of Facility, 2022
    • Table 2-1: CLIA Registered Laboratories by Type of Facility (Exempt/Non-exempt Combined) May 2022
  • Direct-to-Consumer Testing
    • Table 2-2: Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and LabCorp On Demand) 2022* (in US $)
  • DTC in Genetic Testing
  • New Opportunities in Direct-to-Consumer Testing Outlets
  • Dialysis Clinics
  • Hospitals
    • Table 2-3: U.S. Hospital Types
  • Regulation in the Laboratory Industry
  • Certificate of Waiver
    • Table 2-4: Selected CLIA Waived Laboratory Tests
  • Laboratory Developed Tests
  • State-by-State Evaluations
    • Table 2-5: State Regulation in DTC Laboratory Testing
  • Testing and Services
    • Table 2-6: DTC Tests with FDA Marketing Authorization

Chapter 3: Direct-to-Consumer Routine Clinical Laboratory Testing

  • Routine Testing
  • Blood Cell Count
    • Table 3-1: Laboratory Reference Parameters for CBC
  • Cholesterol Level Testing
    • Table 3-2: High Cholesterol Risk Categories
  • Diabetes Testing
  • HIV Testing
  • Pregnancy Testing
    • Table 3-3: HCG Levels in Pregnant Women by Days Past Ovulation
  • Substance Abuse Testing
    • Table 3-4: Substance Detection Periods by Test Method
  • Urinalysis
    • Table 3-5: Normal Reference Levels in a Medical Urinalysis
  • COVID-19
  • Saliva Testing
  • DTC Routine Clinical Laboratory Market Drivers and Barriers
    • Table 3-6 : DTC Routine Clinical Laboratory Testing : Market Drivers and Barriers
  • Market Size and Growth
    • Table 3-7: US DTC Routine Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
    • Figure 3-1: U.S. Direct-to-Consumer Routine Clinical Testing Market Analysis: 2021-2026
    • Figure 3-2: U.S. Direct-to-Consumer Routine Clinical Testing Compared to COVID-19 Testing, 2021
  • Competitive Landscape
    • Figure 3-3: Global Direct to Consumer Routine Clinical Testing Market, Market Share of Leading Suppliers by % 2021

Chapter 4: Direct-to Consumer Genetic Laboratory Testing Market

  • Genetic Research
  • Growth of DTC Genetic Testing Market
  • Types of DTC Genetic Testing
  • Evolution of DTC Genetic Testing
  • DTC Genetic Testing Business Model
  • Market Constraints
  • DTC Genetic Laboratory Testing Market Drivers and Barriers
    • Table 4-1: DTC Genetic Laboratory Testing, Market Drivers and Barriers
  • Market Size and Growth
    • Table 4-2: U.S. DTC Genetic Laboratory Testing Market 2021-2026 (in millions % at manufacturer level)
    • Figure 4-1: U.S. Direct-to-Consumer Genetic Laboratory Testing Market Analysis 2021-2026
  • Competitive Landscape
    • Figure 4-2: U.S. Direct to Consumer Genetic Testing Market, Market Share of Leading Suppliers by % 2021

Chapter 5: Industry Drivers and Barriers

  • Overview
    • Table 5-1: DTC Laboratory Testing Market Drivers and Barriers
  • Issues and Trends Driving the Direct-to-Consumer Market
  • Consumer Driven Healthcare
  • Affordability and Accessibility
  • Privacy
  • Aging Population
    • Figure 5-1: US Population Trends, 65 Years and Older Percent of Total Population 2000-2050
  • Increase in Chronic Disease
    • Figure 5-2: Prevalence of Disease, 2000, 2015 and Projected 2030
  • Emphasis on Preventative Healthcare
  • Regulatory Environment
  • Regulatory Pathway
  • Accuracy
  • Informed Consent
  • Payment Structure for Direct-to-Consumer Laboratory Testing
  • Patient Direct Pay
    • Table 5-2: Select Tests and Prices by Laboratory Service Providers 2022 (in US $)
  • Flexible Spending Accounts and Health Savings Accounts
  • Sales by Distribution Channel
    • Figure 5-3: Global DTC Laboratory Testing by Channel Type 2021 by Percent
  • Mobile Devices
  • Large Diagnostic Companies and DTC
  • Telehealth and DTC Testing

Chapter 6: Company Profiles

  • 23andMe, Inc
    • Table 6-1: 23andMe Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table 6-1: 23andMe Revenue (2019-2021) ($ millions)
  • Any Lab Test Now, Inc.
    • Table 6-2: Any Lab Test Now Corporate Summary
    • Company Overview
    • Products
  • Color Genomics, Inc
    • Table 6-3: Color Genomics Corporate Summary
    • Company Overview
    • Products
  • Direct Laboratory Services, LLC
    • Table 6-4: Direct Laboratory Services Corporate Summary
    • Company Overview
    • Products
  • EasyDNA
    • Table 6-5: EasyDNA Corporate Summary
    • Company Overview
    • Products
  • Everlywell
    • Table 6-6: Everlywell Corporate Summary
    • Company Overview
    • Products
  • Laboratory Corporation of America
    • Table 6-7: Laboratory Corporation of America Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table 6-8: LabCorp Revenue (2019-2021) ($ millions)
  • MyMedLab, Inc.
    • Table 6-9: MyMedLab Corporate Summary
    • Company Overview
    • Products
  • Medichecks.com Ltd.
    • Table 6-10: Medichecks Corporate Summary
    • Company Overview
    • Products
  • Myriad Genetics, Inc.
    • Table 6-11: Myriad Genetics Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table 6-12: Myriad Diagnostics Revenue (2019-2021) ($ millions)
  • Ombre Gut Health (formerly Thryve)
    • Table 6-13: Ombre Corporate Summary
    • Company Overview
    • Products
  • Quest Diagnostics, Inc.
    • Table 6-14: Quest Diagnostics Corporate Summary
    • Company Overview
    • Products
    • Company Financials
      • Table 6-15: Quest Revenue (2019-2021) ($ millions)
  • Request A Test, Ltd.
    • Table 6-16: Request A Test Corporate Summary
    • Company Overview
    • Products