分散型検査およびサービスの動向と医院オフィス/ラボを対象とした成長指標

COVID-19による改革の加速と、数分で結果が出る先進技術によるポータブルウェブコネクテッド暗号化デバイスが診断医療業界に変化をもたらしています。分散型検査は、臨床医に患者の命を救う決定を下す権限を与えるもので、サプライチェーンのタイムラグを短縮し、対面式の臨床検査コストを削減し、入院期間と待ち行列を短縮し、地方や郊外でのタイムリーな医療介入のためのアクセスを改善することができます。

当レポートでは、分散型検査およびサービスの動向を調査し、市場の概要・背景、分散型検査およびサービスの主な動向、成長促進要因・抑制要因、法規制環境、ビジネスモデル、成長機会の分析などをまとめています。

目次

戦略的必須要件

• 成長課題
• The Strategic Imperative 8 (TM)
• 戦略的必須要件トップ3の影響
• GrowthPipelineEngine (TM) を推進する成長機会

成長機会の分析

• 分析範囲
• 分類
• 分散型検査およびサービスの主な動向
• 成長促進要因
• 成長抑制要因
• 主な規制動向： 米国
• 主な規制動向-：欧州・英国
• 主な規制政策の影響

ビジネスモデル・競合環境

• 場所を問わないコネクテッドヘルス
• 競合情勢

成長機会の領域

• 成長機会：新しい検査サイトでのDaaS (Diagnostics as a Service)
• 成長機会：Home-as-a-Smart Clinic
• 成長機会：農村部のヘルスケアにおける薬剤師主導の診断サービス
• 成長機会：予防可能な失明における網膜診断

付録

Personalized Diagnostics Are at the Cusp of Transformational Growth

Accelerated reforms due to COVID-19 and technologically advanced sample-in-answer-out portable, web-connected, encrypted devices that provide results in a few minutes changed the diagnostic healthcare industry. Decentralized testing empowers clinicians to make lifesaving decisions for the patient. It shortens supply chain lag time, saves costs of in-person clinical examination, reduces the length of hospital stay and wait lines, and helps improve access to rural and semi-urban settings for timely healthcare intervention.

The next-generation point-of-care diagnostics is at an inflection point and is transforming patient care in emergency, acute, chronic, and specialized care with platforms capable of monitoring/measuring a wide range of disease markers with laboratory precision. The diagnostic innovation of assays for rapid detection, miniaturization of portable devices, and automation of workflows serves the broad spectrum of setting and shift toward hyper-scaling of access and comprehensive test designs.

The study showcases several diagnostic technologies, such as a microfluidic-based hand-held portable device (lab-on-a-chip device) designed to provide atraumatic, end-to-end point-of-care automated and integrated diagnostic solution, with its sample-on-chip preparation and nucleic acid analysis assay.

• The recent paper-based devices with Nucleic Acid Testing (NAT) have shown great promise for infectious diseases and detection etiology of infection (bacterial, viral, or fungal) with its cost-effective, bio-compatible, disposable on-site monitoring/testing.

• Lateral flow devices with sensor technology enable rapid analysis of blood samples for many critical care assays. These include blood gases/electrolytes, cardiac markers, cholesterol/lipids, coagulation monitoring, glucose monitoring, hematology, infectious diseases, pregnancy and fertility, tumor/cancer markers, urinalysis, other chemistries (magnesium, lactate, micro-albumin, creatinine), and more.

• Decentralized clinical diagnostics continue to innovate a wide range of systems and assays with rapid test analyzers, instruments, reagents, strips, and cartridges. The electronic services complement it with automation, cloud computing, and deep learning for rapid and accurate results.

Digital technology is accelerating the adoption of decentralization in clinical practice as the workflows integrate with POC at-home systems delivering lab results on smartphones. Integrated, comprehensive diagnostic services are key differentiators for stakeholders, which vary in their offering to enterprises (labs, physician offices, or hospital emergency units) or patients. These services will enhance patient-centered access to care and help physicians close the diagnostic loop of the healthcare continuum.

The regulatory environment analysis of the study provides insight into policies in the US, Europe, and the UK that are currently shaping the implementation of decentralized clinical diagnostics and influencing market adoption.

The study, with an in-depth analysis of the industry environment and its participants, such as clinical laboratories, diagnostic/technology companies, retail, pharmacies, and start-ups, proposes a market model for connected healthcare and the prospective growth opportunities for stakeholders.

Frost & Sullivan predicts the decentralized diagnostic testing market and services to grow exponentially in the next 5 years. This forecast considers structural shifts and economic uncertainties, rising costs, decreasing volumes of COVID-19 tests, government regulations encouraging decentralized care adoption, the discovery of critical assays augmented with AI automation, digital integration, participation of nontraditional players in technology and retail, and more.

Key Issues Addressed:

• Which critical strategic imperatives influence the US, Europe, and the UK's diagnostic testing and service market?

• What are the regulatory trends in the US, Europe, and the UK and their impact on the decentralized testing and service market?

• What are the key segments, trends, market drivers, and restraints?

• What is the new business model and its applications?

• What is the decentralized testing and service market and the competitive landscape?

• What are the key growth opportunities?

Table of Contents

Strategic Imperatives

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on Decentralized Testing and Service Market
• Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

• Scope of Analysis
• Segmentation
• Key Trends in Decentralized Testing and Services
• Key Trends in Decentralized Testing and Services (continued)
• Growth Drivers
• Growth Restraints
• Key Regulatory Trends-US
• Key Regulatory Trends-Europe-UK
• Key Regulatory Policy Impact

Business Model and Competitive Environment

• Connected Health Everywhere
• Competitive Landscape*

Growth Opportunity Universe

• Growth Opportunity 1: Diagnostics as a Service in Newer Testing Sites
• Growth Opportunity 1: Diagnostics as a Service in Newer Testing Sites (continued)
• Growth Opportunity 2: Home-as-a-Smart Clinic
• Growth Opportunity 2: Home-as-a-Smart Clinic (continued)
• Growth Opportunity 3: Pharmacist-led Diagnostic Services in Rural Health Care
• Growth Opportunity 3: Pharmacist-led Diagnostic Services in Rural Health Care (continued)
• Growth Opportunity 4: Retinal Diagnostics in Preventable Blindness
• Growth Opportunity 4: Retinal Diagnostics in Preventable Blindness (continued)

Appendix

• Abbreviations
• Abbreviations (continued)
• Abbreviations (continued)
• List of Exhibits
• Legal Disclaimer