薬事未承認検査 (LDT) の世界市場：市場規模・シェア分析 (種類別・用途別・エンドユーザー別)、産業需要の予測 (～2030年)

世界の薬事未承認検査 (LDT) の市場規模は、2023年に103億7,580万米ドルに達した後、CAGR7.2%で推移し、2030年には165億3,990万米ドルに達します。この産業の発展は、がんや遺伝的疾患の増加によるところが大きいです。

さらに、この成長は、現在この業界では希少疾患のために利用できない試験管内実験室で開発された検査に対する要求が高まっていることに起因しています。

分子診断薬カテゴリーが業界をリード

2023年には、分子診断薬カテゴリーが40%のシェアで業界をリードしており、これは今後数年間も続く見通しです。その背景には、高齢化社会の進展と疾病の早期発見に対するニーズの高まりがあります。

がんカテゴリーが最大の市場シェアを占める

用途別では、がんの早期発見を目的とした先端技術の分子診断アプローチへの要求が高まっていることから、がんカテゴリーが20%のシェアを占めて業界をリードしています。がんは死因の第2位を占めています。

北米が主な収益を生み出す

北米は2023年に約40%のシェアを占めて業界をリードしており、今後数年間も堅調な伸びを示すと思われます。これは、同地域の高度な検査室インフラと熟練したスタッフの採用可能性に起因します。

当レポートでは、世界の薬事未承認検査 (LDT) の市場について分析し、市場の基本構造・最新情勢や主な促進・抑制要因、世界全体および地域別・主要国の市場規模の動向見通し (数量・金額ベース、2017～2030年)、種類別・用途別・エンドユーザー別の詳細動向、現在の市場競争の状況、主要企業のプロファイルなどを調査しております。

目次

第1章 調査範囲

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場指標

第5章 業界の展望

• 市場力学
  • 動向
  • 促進要因
  • 抑制要因/課題
  • 促進要因/抑制要因の影響分析
• 新型コロナウイルス感染症 (COVID-19) の影響
• ポーターのファイブフォース分析

第6章 世界市場

• 概要
• 市場規模：種類別 (2017～2030年)
• 市場収益：種類別 (2017～2030年)
• 市場規模：用途別 (2017～2030年)
• 市場収益：用途別 (2017～2030年)
• 市場規模：エンドユーザー別 (2017～2030年)
• 市場収益：エンドユーザー別 (2017～2030年)
• 市場規模：地域別 (2017～2030年)
• 市場収益：地域別 (2017～2030年)

第7章 北米市場

• 概要
• 市場規模：種類別 (2017～2030年)
• 市場収益：種類別 (2017～2030年)
• 市場規模：用途別 (2017～2030年)
• 市場収益：用途別 (2017～2030年)
• 市場規模：エンドユーザー別 (2017～2030年)
• 市場収益：エンドユーザー別 (2017～2030年)
• 市場規模：国別 (2017～2030年)
• 市場収益：国別 (2017～2030年)

第8章 欧州市場

第9章 アジア太平洋市場

第10章 ラテンアメリカ市場

第11章 中東・アフリカ (MEA) 市場

第12章 米国市場

• 概要
• 市場規模：種類別 (2017～2030年)
• 市場収益：種類別 (2017～2030年)
• 市場規模：用途別 (2017～2030年)
• 市場収益：用途別 (2017～2030年)
• 市場規模：エンドユーザー別 (2017～2030年)
• 市場収益：エンドユーザー別 (2017～2030年)

第13章 カナダ市場

第14章 ドイツ市場

第15章 フランス市場

第16章 英国市場

第17章 イタリア市場

第18章 スペイン市場

第19章 日本市場

第20章 中国市場

第21章 インド市場

第22章 オーストラリア市場

第23章 韓国市場

第24章 ブラジル市場

第25章 メキシコ市場

第26章 サウジアラビア市場

第27章 南アフリカ市場

第28章 アラブ首長国連邦 (UAE) 市場

第29章 競合情勢

• 市場参入企業とその提供製品/サービスの一覧
• 主要企業の競合ベンチマーク
• 主要企業の製品ベンチマーク
• 最近の戦略展開状況

第30章 企業プロファイル

• Quest Diagnostics Incorporated
• Abbott Laboratories
• Illumina Inc.
• F. Hoffmann-La Roche Ltd.
• Siemens AG
• Bio-Rad Laboratories Inc.
• NeoGenomics Laboratories Inc.
• Guardant Health Inc.
• Becton, Dickinson and Company
• QIAGEN N.V.

第31章 付録

The laboratory-developed tests market had a value of USD 10,375.8 million in 2023, which will power at a compound annual growth rate of 7.2%, to reach USD 16,539.9 million by 2030. The development of this industry is mostly powered by the increase in the occurrence of cancer and genetic ailments.

Furthermore, the growth is credited to the growing requirement for in vitro laboratory-developed tests, currently not available in the industry for rare ailments.

Growth Drivers

The rise in the funding for research and clinical diagnosis of rare diseases and disorders, for example, hematology testing, by a lot of regulatory authorities and the government, powers the industry.

Moreover, these tests are available at lower cost and can aid in developing a wide range of diagnostic tools for various health conditions.

Also, because of the progression in and microarrays, mass spectrometry, lab-developed tests have evolved since complete authority was given to the FDA to control all the instruments for in vitro diagnoses in the year 1976.

Some LDTs are now numerous times more intricate, accessible across the country, able to notice the risk of breast cancer and Alzheimer's disease; and a lot of other IVD tests, which are under premarket review.

The pandemic has also powered the requirement for these tests because of the massive increase in the count of persons screened at public places and health centers.

Molecular Diagnostics Category Leads the Industry

The molecular diagnostic category led the industry with a 40% share in 2023, and this will continue in the years to come as well. This is because of the development of the aging populace and a growth in the requirement for early disease detection.

The increase in the occurrence of infectious and chronic diseases and the surge in the requirement to control healthcare spending are also fueling the growth, by improving the requirement for early diagnosis of the disease and regular monitoring.

Furthermore, the rising acceptance of molecular diagnostics for examining biological markers in the proteome and genome and cell detection expressions makes the category dominant.

Oncology Category Accounted for Largest Share

On the basis of application, the oncology category leads the industry with a 20% share, because of the growing requirement for tech-advanced molecular diagnosis approaches for the early discovery of cancers. Cancer is the second major cause of death.

So, the growing R&D expenditure in oncology would surge the use of enhanced tests.

Moreover, the enhancements in the healthcare infra of developing nations have led to a large share of the category.

North America Generates the Major Revenue

North America leads the industry, with a share of about 40%, in 2023, and it will power at a robust rate in the years to come as well. This will be attributable to the advanced lab infra and availability of skilled staff in the region.

Furthermore, the elevating menace of ailments in the region, the existence of trustworthy healthcare businesses, and strong support for the setup of novel research and development facilities bode well for the industry.

Table of Contents

Chapter 1. Research Scope

• 1.1. Research Objectives
• 1.2. Market Definition
• 1.3. Analysis Period
• 1.4. Market Size Breakdown by Segments
  • 1.4.1. Market size breakdown, by type
  • 1.4.2. Market size breakdown, by application
  • 1.4.3. Market size breakdown, by end user
  • 1.4.4. Market size breakdown, by region
  • 1.4.5. Market size breakdown, by country
• 1.5. Market Data Reporting Unit
  • 1.5.1. Volume
  • 1.5.2. Value
• 1.6. Key Stakeholders

Chapter 2. Research Methodology

• 2.1. Secondary Research
  • 2.1.1. Paid
  • 2.1.2. Unpaid
  • 2.1.3. P&S Intelligence database
• 2.2. Primary Research
• 2.3. Market Size Estimation
• 2.4. Data Triangulation
• 2.5. Currency Conversion Rates
• 2.6. Assumptions for the Study
• 2.7. Notes and Caveats

Chapter 3. Executive Summary

Chapter 4. Market Indicators

Chapter 5. Industry Outlook

• 5.1. Market Dynamics
  • 5.1.1. Trends
  • 5.1.2. Drivers
  • 5.1.3. Restraints/challenges
  • 5.1.4. Impact analysis of drivers/restraints
• 5.2. Impact of COVID-19
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Bargaining power of buyers
  • 5.3.2. Bargaining power of suppliers
  • 5.3.3. Threat of new entrants
  • 5.3.4. Intensity of rivalry
  • 5.3.5. Threat of substitutes

Chapter 6. Global Market

• 6.1. Overview
• 6.2. Market Volume, by Type (2017-2030)
• 6.3. Market Revenue, by Type (2017-2030)
• 6.4. Market Volume, by Application (2017-2030)
• 6.5. Market Revenue, by Application (2017-2030)
• 6.6. Market Volume, by End User (2017-2030)
• 6.7. Market Revenue, by End User (2017-2030)
• 6.8. Market Volume, by Region (2017-2030)
• 6.9. Market Revenue, by Region (2017-2030)

Chapter 7. North America Market

• 7.1. Overview
• 7.2. Market Volume, by Type (2017-2030)
• 7.3. Market Revenue, by Type (2017-2030)
• 7.4. Market Volume, by Application (2017-2030)
• 7.5. Market Revenue, by Application (2017-2030)
• 7.6. Market Volume, by End User (2017-2030)
• 7.7. Market Revenue, by End User (2017-2030)
• 7.8. Market Volume, by Country (2017-2030)
• 7.9. Market Revenue, by Country (2017-2030)

Chapter 8. Europe Market

• 8.1. Overview
• 8.2. Market Volume, by Type (2017-2030)
• 8.3. Market Revenue, by Type (2017-2030)
• 8.4. Market Volume, by Application (2017-2030)
• 8.5. Market Revenue, by Application (2017-2030)
• 8.6. Market Volume, by End User (2017-2030)
• 8.7. Market Revenue, by End User (2017-2030)
• 8.8. Market Volume, by Country (2017-2030)
• 8.9. Market Revenue, by Country (2017-2030)

Chapter 9. APAC Market

• 9.1. Overview
• 9.2. Market Volume, by Type (2017-2030)
• 9.3. Market Revenue, by Type (2017-2030)
• 9.4. Market Volume, by Application (2017-2030)
• 9.5. Market Revenue, by Application (2017-2030)
• 9.6. Market Volume, by End User (2017-2030)
• 9.7. Market Revenue, by End User (2017-2030)
• 9.8. Market Volume, by Country (2017-2030)
• 9.9. Market Revenue, by Country (2017-2030)

Chapter 10. LATAM Market

• 10.1. Overview
• 10.2. Market Volume, by Type (2017-2030)
• 10.3. Market Revenue, by Type (2017-2030)
• 10.4. Market Volume, by Application (2017-2030)
• 10.5. Market Revenue, by Application (2017-2030)
• 10.6. Market Volume, by End User (2017-2030)
• 10.7. Market Revenue, by End User (2017-2030)
• 10.8. Market Volume, by Country (2017-2030)
• 10.9. Market Revenue, by Country (2017-2030)

Chapter 11. MEA Market

• 11.1. Overview
• 11.2. Market Volume, by Type (2017-2030)
• 11.3. Market Revenue, by Type (2017-2030)
• 11.4. Market Volume, by Application (2017-2030)
• 11.5. Market Revenue, by Application (2017-2030)
• 11.6. Market Volume, by End User (2017-2030)
• 11.7. Market Revenue, by End User (2017-2030)
• 11.8. Market Volume, by Country (2017-2030)
• 11.9. Market Revenue, by Country (2017-2030)

Chapter 12. U.S. Market

• 12.1. Overview
• 12.2. Market Volume, by Type (2017-2030)
• 12.3. Market Revenue, by Type (2017-2030)
• 12.4. Market Volume, by Application (2017-2030)
• 12.5. Market Revenue, by Application (2017-2030)
• 12.6. Market Volume, by End User (2017-2030)
• 12.7. Market Revenue, by End User (2017-2030)

Chapter 13. Canada Market

• 13.1. Overview
• 13.2. Market Volume, by Type (2017-2030)
• 13.3. Market Revenue, by Type (2017-2030)
• 13.4. Market Volume, by Application (2017-2030)
• 13.5. Market Revenue, by Application (2017-2030)
• 13.6. Market Volume, by End User (2017-2030)
• 13.7. Market Revenue, by End User (2017-2030)

Chapter 14. Germany Market

• 14.1. Overview
• 14.2. Market Volume, by Type (2017-2030)
• 14.3. Market Revenue, by Type (2017-2030)
• 14.4. Market Volume, by Application (2017-2030)
• 14.5. Market Revenue, by Application (2017-2030)
• 14.6. Market Volume, by End User (2017-2030)
• 14.7. Market Revenue, by End User (2017-2030)

Chapter 15. France Market

• 15.1. Overview
• 15.2. Market Volume, by Type (2017-2030)
• 15.3. Market Revenue, by Type (2017-2030)
• 15.4. Market Volume, by Application (2017-2030)
• 15.5. Market Revenue, by Application (2017-2030)
• 15.6. Market Volume, by End User (2017-2030)
• 15.7. Market Revenue, by End User (2017-2030)

Chapter 16. U.K. Market

• 16.1. Overview
• 16.2. Market Volume, by Type (2017-2030)
• 16.3. Market Revenue, by Type (2017-2030)
• 16.4. Market Volume, by Application (2017-2030)
• 16.5. Market Revenue, by Application (2017-2030)
• 16.6. Market Volume, by End User (2017-2030)
• 16.7. Market Revenue, by End User (2017-2030)

Chapter 17. Italy Market

• 17.1. Overview
• 17.2. Market Volume, by Type (2017-2030)
• 17.3. Market Revenue, by Type (2017-2030)
• 17.4. Market Volume, by Application (2017-2030)
• 17.5. Market Revenue, by Application (2017-2030)
• 17.6. Market Volume, by End User (2017-2030)
• 17.7. Market Revenue, by End User (2017-2030)

Chapter 18. Spain Market

• 18.1. Overview
• 18.2. Market Volume, by Type (2017-2030)
• 18.3. Market Revenue, by Type (2017-2030)
• 18.4. Market Volume, by Application (2017-2030)
• 18.5. Market Revenue, by Application (2017-2030)
• 18.6. Market Volume, by End User (2017-2030)
• 18.7. Market Revenue, by End User (2017-2030)

Chapter 19. Japan Market

• 19.1. Overview
• 19.2. Market Volume, by Type (2017-2030)
• 19.3. Market Revenue, by Type (2017-2030)
• 19.4. Market Volume, by Application (2017-2030)
• 19.5. Market Revenue, by Application (2017-2030)
• 19.6. Market Volume, by End User (2017-2030)
• 19.7. Market Revenue, by End User (2017-2030)

Chapter 20. China Market

• 20.1. Overview
• 20.2. Market Volume, by Type (2017-2030)
• 20.3. Market Revenue, by Type (2017-2030)
• 20.4. Market Volume, by Application (2017-2030)
• 20.5. Market Revenue, by Application (2017-2030)
• 20.6. Market Volume, by End User (2017-2030)
• 20.7. Market Revenue, by End User (2017-2030)

Chapter 21. India Market

• 21.1. Overview
• 21.2. Market Volume, by Type (2017-2030)
• 21.3. Market Revenue, by Type (2017-2030)
• 21.4. Market Volume, by Application (2017-2030)
• 21.5. Market Revenue, by Application (2017-2030)
• 21.6. Market Volume, by End User (2017-2030)
• 21.7. Market Revenue, by End User (2017-2030)

Chapter 22. Australia Market

• 22.1. Overview
• 22.2. Market Volume, by Type (2017-2030)
• 22.3. Market Revenue, by Type (2017-2030)
• 22.4. Market Volume, by Application (2017-2030)
• 22.5. Market Revenue, by Application (2017-2030)
• 22.6. Market Volume, by End User (2017-2030)
• 22.7. Market Revenue, by End User (2017-2030)

Chapter 23. South Korea Market

• 23.1. Overview
• 23.2. Market Volume, by Type (2017-2030)
• 23.3. Market Revenue, by Type (2017-2030)
• 23.4. Market Volume, by Application (2017-2030)
• 23.5. Market Revenue, by Application (2017-2030)
• 23.6. Market Volume, by End User (2017-2030)
• 23.7. Market Revenue, by End User (2017-2030)

Chapter 24. Brazil Market

• 24.1. Overview
• 24.2. Market Volume, by Type (2017-2030)
• 24.3. Market Revenue, by Type (2017-2030)
• 24.4. Market Volume, by Application (2017-2030)
• 24.5. Market Revenue, by Application (2017-2030)
• 24.6. Market Volume, by End User (2017-2030)
• 24.7. Market Revenue, by End User (2017-2030)

Chapter 25. Mexico Market

• 25.1. Overview
• 25.2. Market Volume, by Type (2017-2030)
• 25.3. Market Revenue, by Type (2017-2030)
• 25.4. Market Volume, by Application (2017-2030)
• 25.5. Market Revenue, by Application (2017-2030)
• 25.6. Market Volume, by End User (2017-2030)
• 25.7. Market Revenue, by End User (2017-2030)

Chapter 26. Saudi Arabia Market

• 26.1. Overview
• 26.2. Market Volume, by Type (2017-2030)
• 26.3. Market Revenue, by Type (2017-2030)
• 26.4. Market Volume, by Application (2017-2030)
• 26.5. Market Revenue, by Application (2017-2030)
• 26.6. Market Volume, by End User (2017-2030)
• 26.7. Market Revenue, by End User (2017-2030)

Chapter 27. South Africa Market

• 27.1. Overview
• 27.2. Market Volume, by Type (2017-2030)
• 27.3. Market Revenue, by Type (2017-2030)
• 27.4. Market Volume, by Application (2017-2030)
• 27.5. Market Revenue, by Application (2017-2030)
• 27.6. Market Volume, by End User (2017-2030)
• 27.7. Market Revenue, by End User (2017-2030)

Chapter 28. U.A.E. Market

• 28.1. Overview
• 28.2. Market Volume, by Type (2017-2030)
• 28.3. Market Revenue, by Type (2017-2030)
• 28.4. Market Volume, by Application (2017-2030)
• 28.5. Market Revenue, by Application (2017-2030)
• 28.6. Market Volume, by End User (2017-2030)
• 28.7. Market Revenue, by End User (2017-2030)

Chapter 29. Competitive Landscape

• 29.1. List of Market Players and their Offerings
• 29.2. Competitive Benchmarking of Key Players
• 29.3. Product Benchmarking of Key Players
• 29.4. Recent Strategic Developments

Chapter 30. Company Profiles

• 30.1. Quest Diagnostics Incorporated
  • 30.1.1. Business overview
  • 30.1.2. Product and service offerings
  • 30.1.3. Key financial summary
• 30.2. Abbott Laboratories
  • 30.2.1. Business overview
  • 30.2.2. Product and service offerings
  • 30.2.3. Key financial summary
• 30.3. Illumina Inc.
  • 30.3.1. Business overview
  • 30.3.2. Product and service offerings
  • 30.3.3. Key financial summary
• 30.4. F. Hoffmann-La Roche Ltd.
  • 30.4.1. Business overview
  • 30.4.2. Product and service offerings
  • 30.4.3. Key financial summary
• 30.5. Siemens AG
  • 30.5.1. Business overview
  • 30.5.2. Product and service offerings
  • 30.5.3. Key financial summary
• 30.6. Bio-Rad Laboratories Inc.
  • 30.6.1. Business overview
  • 30.6.2. Product and service offerings
  • 30.6.3. Key financial summary
• 30.7. NeoGenomics Laboratories Inc.
  • 30.7.1. Business overview
  • 30.7.2. Product and service offerings
  • 30.7.3. Key financial summary
• 30.8. Guardant Health Inc.
  • 30.8.1. Business overview
  • 30.8.2. Product and service offerings
  • 30.8.3. Key financial summary
• 30.9. Becton, Dickinson and Company
  • 30.9.1. Business overview
  • 30.9.2. Product and service offerings
  • 30.9.3. Key financial summary
• 30.10. QIAGEN N.V.
  • 30.10.1. Business overview
  • 30.10.2. Product and service offerings
  • 30.10.3. Key financial summary

Chapter 31. Appendix

• 31.1. Abbreviations
• 31.2. Sources and References
• 31.3. Related Reports