表紙
市場調查報告書
商品編碼
1078438

美國 DTC 實驗室檢驗市場

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

出版日期: | 出版商: Kalorama Information | 英文 | 商品交期: 最快1-2個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

本報告調查了美國 DTC 實驗室檢測市場,並概述了市場、行業趨勢、細分市場驅動因素和限制,以及進入市場的公司概況。

目錄

第 1 章執行摘要

第二章介紹

  • 美國實驗室服務業
  • DTC檢測市場的增長
  • 美國研究院產業結構
  • CLIA 實驗室註冊,實驗室類型
  • DTC檢查
  • 基因檢測中的DTC
  • DTC 網點的新機遇
  • 透析診所
  • 醫院
  • 實驗室行業法規
  • 豁免證明
  • 實驗室開發的檢測
  • 逐州評估
  • 檢驗與服務

第 3 章常規 DTC 實驗室測試

  • 定期檢查
  • 血細胞計數
  • 膽固醇水平測試
  • 糖尿病測試
  • 艾滋病毒檢測
  • 驗孕
  • 藥物濫用測試
  • 尿液分析
  • 新冠肺炎 (COVID-19)
  • 唾液測試
  • 促進和限制 DTC 常規臨床實驗室市場的因素
  • 市場規模和增長
  • 競爭形勢

第 4 章 DTC 基因檢測市場

  • 基因研究
  • DTC基因檢測市場的增長
  • DTC 基因檢測的種類
  • DTC 基因檢測的演變
  • DTC基因檢測商業模式
  • 市場限制
  • DTC 基因檢測市場的推動者和抑制者
  • 市場規模和增長
  • 競爭形勢

第 5 章行業促進者和抑制者

  • 概覽
  • 推動直銷市場發展的問題和趨勢
  • 以消費者為主導的醫療保健
  • 經濟實惠且易於使用
  • 隱私
  • 老年人口
  • 慢性病增加
  • 加強預防保健
  • 受監管的環境
  • 調節路線
  • 準確度
  • 知情同意
  • DTC實驗室檢驗結算結構
  • 患者直接付款
  • 靈活的支出賬戶和醫療儲蓄賬戶
  • 按分銷渠道銷售
  • 移動設備
  • 大型診斷公司和 DTC
  • 遠程醫療和 DTC 測試

第 6 章公司簡介

  • 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.
目錄
Product Code: 22-712c

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