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美国 DTC 实验室检验市场
市场调查报告书
商品编码
1078438

美国 DTC 实验室检验市场

The U.S. Market for Direct-to-Consumer (DTC) Laboratory Testing
出版日期: | 出版商: Kalorama Information | 英文 100 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

本报告调查了美国 DTC 实验室检测市场，并概述了市场、行业趋势、细分市场驱动因素和限制，以及进入市场的公司概况。

目录

第 1 章执行摘要

第二章介绍

  • 美国实验室服务业
  • DTC检测市场的增长
  • 美国研究院产业结构
  • CLIA 实验室註册，实验室类型
  • DTC检查
  • 基因检测中的DTC
  • DTC 网点的新机遇
  • 透析诊所
  • 医院
  • 实验室行业法规
  • 豁免证明
  • 实验室开发的检测
  • 逐州评估
  • 检验与服务

第 3 章常规 DTC 实验室测试

  • 定期检查
  • 血细胞计数
  • 胆固醇水平测试
  • 糖尿病测试
  • 艾滋病毒检测
  • 验孕
  • 药物滥用测试
  • 尿液分析
  • 新冠肺炎 (COVID-19)
  • 唾液测试
  • 促进和限制 DTC 常规临床实验室市场的因素
  • 市场规模和增长
  • 竞争形势

第 4 章 DTC 基因检测市场

  • 基因研究
  • DTC基因检测市场的增长
  • DTC 基因检测的种类
  • DTC 基因检测的演变
  • DTC基因检测商业模式
  • 市场限制
  • DTC 基因检测市场的推动者和抑制者
  • 市场规模和增长
  • 竞争形势

第 5 章行业促进者和抑制者

  • 概览
  • 推动直销市场发展的问题和趋势
  • 以消费者为主导的医疗保健
  • 经济实惠且易于使用
  • 隐私
  • 老年人口
  • 慢性病增加
  • 加强预防保健
  • 受监管的环境
  • 调节路线
  • 准确度
  • 知情同意
  • DTC实验室检验结算结构
  • 患者直接付款
  • 灵活的支出账户和医疗储蓄账户
  • 按分销渠道销售
  • 移动设备
  • 大型诊断公司和 DTC
  • 远程医疗和 DTC 测试

第 6 章公司简介

  • 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.
简介目录
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