薬事未承認検査（LDT）の世界市場の予測（～2028年）：検査タイプ・製品・用途・エンドユーザー・地域別の分析

世界の薬事未承認検査（LDT）の市場規模は、2022年の48億8,000万米ドルから2028年までに84億5,000万米ドルに達し、予測期間中にCAGRで9.6％の成長が予測されています。

当レポートでは、世界の薬事未承認検査（LDT）市場について調査分析し、市場動向、セグメント分析、地域分析、企業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 序文

第3章 市場動向の分析

• 促進要因
• 抑制要因
• 機会
• 脅威
• 製品分析
• 用途分析
• エンドユーザー分析
• 新興市場
• COVID-19の影響

第4章 ポーターのファイブフォース分析

第5章 世界の薬事未承認検査（LDT）市場：検査タイプ別

• クリティカルケア
• 微生物学
• 臨床生化学
• 免疫学
• 血液学
  • ヘモグロビン検査
  • 凝固・止血
  • 血球数検査
• 分子診断学

第6章 世界の薬事未承認検査（LDT）市場：製品別

• 研究開発
• 商用サービス
• 質量分析
• マイクロアレイ
• ポリメラーゼ連鎖反応（PCR）
• 次世代シーケンシング（NGS）

第7章 世界の薬事未承認検査（LDT）市場：用途別

• 遺伝学
• 自己免疫疾患
• 腫瘍
• 感染症
• 神経学

第8章 世界の薬事未承認検査（LDT）市場：エンドユーザー別

• 専門診断センター
• 学術機関
• 病院検査室
• 臨床研究機関

第9章 世界の薬事未承認検査（LDT）市場：地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • イタリア
  • フランス
  • スペイン
  • その他の欧州
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • ニュージーランド
  • 韓国
  • その他のアジア太平洋
• 南米
  • アルゼンチン
  • ブラジル
  • チリ
  • その他の南米
• 中東・アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • カタール
  • 南アフリカ
  • その他の中東・アフリカ

第10章 主な発展

• 合意・パートナーシップ・提携・共同事業
• 買収と合併
• 新製品の発売
• 拡張
• その他の主要戦略

第11章 企業プロファイル

• Qiagen
• Epic Sciences, Inc.
• F. Hoffmann-La Roche Ltd
• Bruker Corporation
• Illumina, Inc.
• Bio-Rad Laboratories, Inc.
• Eurofins Scientific
• Thermo Fisher Scientific Inc.
• Quest Diagnostics
• Siemens Healthcare Private Limited
• Sonic Healthcare Ltd.
• Abbott Laboratories
• Adaptive Biotechnologies
• OPKO Health Inc.
• Rosetta Genomics Ltd.
• Guardant Health
• Genoptix, Inc.
• Quidel Corporation

List of Tables

• Table 1 Global Laboratory-Developed Testing Market Outlook, By Region (2020-2028) ($MN)
• Table 2 Global Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 3 Global Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 4 Global Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 5 Global Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 6 Global Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 7 Global Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 8 Global Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 9 Global Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 10 Global Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 11 Global Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 12 Global Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 13 Global Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 14 Global Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 15 Global Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 16 Global Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 17 Global Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 18 Global Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 19 Global Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 20 Global Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 21 Global Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 22 Global Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 23 Global Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 24 Global Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 25 Global Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 26 Global Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 27 Global Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 28 Global Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 29 Global Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)
• Table 30 North America Laboratory-Developed Testing Market Outlook, By Country (2020-2028) ($MN)
• Table 31 North America Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 32 North America Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 33 North America Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 34 North America Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 35 North America Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 36 North America Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 37 North America Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 38 North America Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 39 North America Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 40 North America Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 41 North America Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 42 North America Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 43 North America Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 44 North America Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 45 North America Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 46 North America Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 47 North America Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 48 North America Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 49 North America Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 50 North America Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 51 North America Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 52 North America Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 53 North America Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 54 North America Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 55 North America Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 56 North America Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 57 North America Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 58 North America Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)
• Table 59 Europe Laboratory-Developed Testing Market Outlook, By Country (2020-2028) ($MN)
• Table 60 Europe Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 61 Europe Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 62 Europe Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 63 Europe Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 64 Europe Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 65 Europe Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 66 Europe Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 67 Europe Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 68 Europe Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 69 Europe Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 70 Europe Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 71 Europe Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 72 Europe Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 73 Europe Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 74 Europe Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 75 Europe Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 76 Europe Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 77 Europe Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 78 Europe Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 79 Europe Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 80 Europe Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 81 Europe Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 82 Europe Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 83 Europe Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 84 Europe Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 85 Europe Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 86 Europe Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 87 Europe Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)
• Table 88 Asia Pacific Laboratory-Developed Testing Market Outlook, By Country (2020-2028) ($MN)
• Table 89 Asia Pacific Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 90 Asia Pacific Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 91 Asia Pacific Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 92 Asia Pacific Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 93 Asia Pacific Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 94 Asia Pacific Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 95 Asia Pacific Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 96 Asia Pacific Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 97 Asia Pacific Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 98 Asia Pacific Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 99 Asia Pacific Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 100 Asia Pacific Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 101 Asia Pacific Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 102 Asia Pacific Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 103 Asia Pacific Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 104 Asia Pacific Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 105 Asia Pacific Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 106 Asia Pacific Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 107 Asia Pacific Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 108 Asia Pacific Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 109 Asia Pacific Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 110 Asia Pacific Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 111 Asia Pacific Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 112 Asia Pacific Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 113 Asia Pacific Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 114 Asia Pacific Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 115 Asia Pacific Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 116 Asia Pacific Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)
• Table 117 South America Laboratory-Developed Testing Market Outlook, By Country (2020-2028) ($MN)
• Table 118 South America Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 119 South America Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 120 South America Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 121 South America Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 122 South America Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 123 South America Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 124 South America Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 125 South America Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 126 South America Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 127 South America Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 128 South America Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 129 South America Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 130 South America Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 131 South America Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 132 South America Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 133 South America Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 134 South America Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 135 South America Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 136 South America Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 137 South America Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 138 South America Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 139 South America Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 140 South America Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 141 South America Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 142 South America Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 143 South America Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 144 South America Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 145 South America Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)
• Table 146 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Country (2020-2028) ($MN)
• Table 147 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Test Type (2020-2028) ($MN)
• Table 148 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Critical Care (2020-2028) ($MN)
• Table 149 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Microbiology (2020-2028) ($MN)
• Table 150 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Clinical Biochemistry (2020-2028) ($MN)
• Table 151 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Immunology (2020-2028) ($MN)
• Table 152 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Haematology (2020-2028) ($MN)
• Table 153 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Hemoglobin Testing (2020-2028) ($MN)
• Table 154 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Coagulation and Hemostasis (2020-2028) ($MN)
• Table 155 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Blood Count Testing (2020-2028) ($MN)
• Table 156 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
• Table 157 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Product (2020-2028) ($MN)
• Table 158 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Research and Development (R&D) (2020-2028) ($MN)
• Table 159 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Commercial Service (2020-2028) ($MN)
• Table 160 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Mass Spectrometry (2020-2028) ($MN)
• Table 161 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Microarrays (2020-2028) ($MN)
• Table 162 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Polymerase Chain Reaction (PCR) (2020-2028) ($MN)
• Table 163 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Next-Generation Sequencing (NGS) (2020-2028) ($MN)
• Table 164 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Application (2020-2028) ($MN)
• Table 165 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Genetics (2020-2028) ($MN)
• Table 166 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Autoimmune Disorders (2020-2028) ($MN)
• Table 167 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Oncology (2020-2028) ($MN)
• Table 168 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Infectious Diseases (2020-2028) ($MN)
• Table 169 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Neurology (2020-2028) ($MN)
• Table 170 Middle East & Africa Laboratory-Developed Testing Market Outlook, By End User (2020-2028) ($MN)
• Table 171 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Specialty Diagnostics Centers (2020-2028) ($MN)
• Table 172 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Academic Institutes (2020-2028) ($MN)
• Table 173 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Hospital Laboratories (2020-2028) ($MN)
• Table 174 Middle East & Africa Laboratory-Developed Testing Market Outlook, By Clinical Research Organizations (2020-2028) ($MN)

According to Stratistics MRC, the Global Laboratory-Developed Testing Market is accounted for $4.88 billion in 2022 and is expected to reach $8.45 billion by 2028 growing at a CAGR of 9.6% during the forecast period. Laboratory developed test is a type of in vitro diagnostic test that is planned and utilized within a single laboratory. These tests can be used to gauge or discriminate a wide variety of analytes materials such as proteins, chemical compounds like cholesterol or glucose, or DNA, from a specimen received from human anatomy. The development of automated in vitro diagnostics (IVD) techniques for labs and dispensaries to deliver exact and error-free analysis is expected to fuel the increment. Laboratory developed tests are beneficial for the detection and monitoring of oncology, genetics, infections, and autoimmune diseases. These tests are the best option for the population curious about their genetic makeup concerning the presence of any disease-related markers. This testing offers numerous advantages such as improved quality of life, monitoring pre-existing conditions, and maintaining one's lifestyle accordingly, which makes them preferable over hospitalization for daily checkups or the treatment of disease occurrence.

According to the American Heart Association, in 2017, 868,662 people died due to various forms of cardiovascular diseases in the U.S. Moreover, in 2018, coronary heart disease (42.1%) was one of the leading causes of death along with high blood pressure (11%), stroke (17%), arteries diseases (2.9%), and heart failure (9.6%). Therefore, for detection and treatment of these cardiovascular diseases, in-vitro diagnostics methods are highly preferred by the doctors. In addition, As per American Cancer Society, in 2020, about 1.8 million new cancer cases were diagnosed, and approximately 606,520 cancer deaths occurred in the United States. Moreover, people with chronic conditions are the most frequent users of healthcare facilities in the United States.

Market Dynamics:

Driver:

Increasing product offerings related to genetic health risks

Manufacturers of laboratory-developed tests across the world will have ample of lucrative prospects in the future. They have begun to recognize the value of R&D spending to provide a diversified product line. For instance, 23andMe and Virgin Group's VG Acquisition Corp. merged to become a publicly-traded company that will transform personalized healthcare and therapeutic advancement using human genetics. Many companies are taking extensive measures to make their product offerings more versatile through innovations, such as providing data related to genetic health risks, ancestry, and traits.

Restraint:

Stringent regulations

The in vitro diagnostic medical devices regulation (IVDR) will produce results in May 2022. This rule has a large impact on both the clinical laboratories and manufacturers of in vitro diagnostic medical devices. For clinical laboratories, the IVDR poses limitations on the exploit of laboratory developed tests (LDTs). To give a uniform interpretation of the IVDR for contemporaries in clinical practice, the IVDR task force was created by the scientific societies of laboratory specialties. A guidance document with explanations and interpretations of pertinent passages of the IVDR was drafted to assist laboratories prepare for the impact of this new legislation. With new regulations, a massive amount of work will be required to transition from the IVDD to the IVDR. IVDR is more intricate and detailed and will need more resources to uphold and implement for IVD manufacturers.

Opportunity:

Continuous research on personalized medicines provides growth opportunities to laboratory developed test market players

LDTs play a crucial function in the expansion of personalized medicines that are probable to show as hopeful means of handling diseases during distant eluded effectual treatments or cures. According to the Personalized Medicine Coalition, personalized medicines accounted for only 5% of the new FDA-approved molecular entities in 2005; though, in 2016, this numeral rose to more than 25%. Moreover, 42% of all compounds and 73% of oncology compounds in the pipeline have the potential to serve as personalized medicines. Biopharmaceutical companies have nearly doubled their R&D investments in personalized drugs in the last five years, and they are additionally anticipated to augment their investments by 33% in the next five years. Biopharmaceutical researchers also forecast a 69% increase in the expansion of personalized medicines in the next five years. Laboratory tests are used to diagnose disease and foresee and monitor drug response as well as to get informatics data required for complex predictive algorithms. Personalized medicines are becoming the trademark of cancer treatment; it is a continually evolving approach that is based on the customization of treatments as per the individual genetic makeup. In 2019, the FDA approved 12 personalized medications to investigate and address the root causes of disease, thus combining precision medicine in clinical care.

Threat:

Operational barriers faced in conducting diagnostic tests

Clinical laboratories across significant markets are still developing; technicians face operational challenges in guaranteeing effectual storage, sample procurement, and transportation, particularly while adopting new technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also wants to be reconfigured to meet the necessities of conducting precise diagnostic tests used for pathogen detection as a means of avoiding cross-contamination and ensuring efficient time management. This results in substantial cost escalation to uphold and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type. In addition, owing to the rapid mutation of microbes and the growing outbreak of epidemics, clinical laboratories require to adopt innovative technologies capable of rapid sample diagnosis. Though, the shortage of skilled laboratory technicians to operate advanced diagnostic products has hindered their overall adoption, particularly in emerging markets. Numerous providers find it difficult to transition to IT-based approaches from manual or traditional approaches or may not prefer to make the shift at all.

COVID-19 Impact

As part of the response to COVID-19, virtually all OECD countries affected by the virus have introduced strict restrictions to social and economic life, including social distancing and even full lockdowns. Gaining intelligence on the evolution of the epidemic, including on when a threshold for herd immunity has been reached. In the case of COVID-19, it has been estimated that 50% to 60% of the population needs to be immune to the virus to halt its spread. During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers. Hundreds of molecular tests and immunoassays were rapidly developed, albeit many still await clinical validation and formal approval.

The molecular diagnostics segment is expected to be the largest during the forecast period

The molecular diagnostics segment is estimated to have a lucrative growth, due to the increasing attention toward the development of genetic therapeutics and growing research in human genomics. Technological advantages in molecular tests make them valuable diagnostic tools for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS). It is designed to enable clinical laboratories to develop sequencing-based laboratory developed tests in a quick, simple, and efficient manner.

The clinical research organizations segment is expected to have the highest CAGR during the forecast period

The clinical research organizations segment is anticipated to witness the fastest CAGR growth during the forecast period, as these organizations can develop LDTs based on any diagnostic test technology used in the clinical lab. For some technologies, such as chemistry tests or immunoassays, automated platforms with large test menus are commercially available. As a result, in some labs, there may be less development and use of LDTs based on these technologies than LDTs based on newer technologies such as next-generation sequencing. Clinical research organizations may also perform tests on types of specimens that are not included in the approved labeling for a test or may have other reasons why they decide to develop an LDT.

Region with highest share:

North America is projected to hold the largest market share during the forecast period, due to the developed laboratory infrastructure, availability of skilled personnel in the region, technological advancements, and trends like personalized medicine, and growing elderly population. The elderly population in countries like the United States are covered with social reimbursement schemes like MediCaid, which provides all healthcare benefits to people over 65. The growth of the elderly population, the cost-effective nature of lab-based testing, and available social support will drive tremendous growth for players in the market.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period due to the presence of well-developed healthcare infrastructure, government support, increasing research and development activities along with the growing medical tourism in the region, growing usage of laboratory developed test in combating COVID-19, increasing incidents of cancer and genetic disorders, and large number of product launches. In Asia Pacific, India is the largest market for laboratory developed test.

Key players in the market

Some of the key players profiled in the Laboratory-Developed Testing Market include Qiagen, Epic Sciences, Inc., F. Hoffmann-La Roche Ltd, Bruker Corporation, Illumina, Inc., Bio-Rad Laboratories, Inc., Eurofins Scientific, Thermo Fisher Scientific Inc., Quest Diagnostics, Siemens Healthcare Private Limited, Sonic Healthcare Ltd., Abbott Laboratories, Adaptive Biotechnologies, OPKO Health Inc., Rosetta Genomics Ltd., Guardant Health, Genoptix, Inc., and Quidel Corporation.

Key Developments:

In May 2022, Epic Sciences, Inc. announced the launch of DefineMBC™, a novel comprehensive blood-based test for distinguishing metastatic breast cancer. This test will provide both cell-based and cell-free analysis from a single blood draw to provide comprehensive profiling in the absence of a tissue biopsy result.

In March, 2022, Illumina, Inc. announced the release of TruSightTM Oncology (TSO), a single test that examines numerous tumor genes and biomarkers to determine a patient's cancer molecular profile.

In December 2021, Roche launched the AVENIO Edge System, which simplifies and automates sample preparation for next-generation sequencing, reducing human error and advancing precision medicine.

In September 2021, QIAGEN N.V. received a contract from the United States government to grow its production capacity for consumables for its NeuMoDx 96 and 288 integrated PCR testing systems.

In January 2021, Eurofins launched the NovaType test for detecting and monitoring new variants of SARS-CoV-2. This RT-PCR assay is clinically validated for identifying B.1.1.7 and B.1.351 variants with a short time. NovaType is already available as an LDT in Germany, and it will be made available in over 50 Eurofins laboratories worldwide for testing patients for COVID-19.

Test Types Covered:

• Critical Care
• Microbiology
• Clinical Biochemistry
• Immunology
• Haematology
• Molecular Diagnostics

Products Covered:

• Research and Development (R&D)
• Commercial Service
• Mass Spectrometry
• Microarrays
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)

Applications Covered:

• Genetics
• Autoimmune Disorders
• Oncology
• Infectious Diseases
• Neurology

End Users Covered:

• Specialty Diagnostics Centers
• Academic Institutes
• Hospital Laboratories
• Clinical Research Organizations

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 Application Analysis
• 3.8 End User Analysis
• 3.9 Emerging Markets
• 3.10 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Laboratory-Developed Testing Market, By Test Type

• 5.1 Introduction
• 5.2 Critical Care
• 5.3 Microbiology
• 5.4 Clinical Biochemistry
• 5.5 Immunology
• 5.6 Haematology
  • 5.6.1 Hemoglobin Testing
  • 5.6.2 Coagulation and Hemostasis
  • 5.6.3 Blood Count Testing
• 5.7 Molecular Diagnostics

6 Global Laboratory-Developed Testing Market, By Product

• 6.1 Introduction
• 6.2 Research and Development (R&D)
• 6.3 Commercial Service
• 6.4 Mass Spectrometry
• 6.5 Microarrays
• 6.6 Polymerase Chain Reaction (PCR)
• 6.7 Next-Generation Sequencing (NGS)

7 Global Laboratory-Developed Testing Market, By Application

• 7.1 Introduction
• 7.2 Genetics
• 7.3 Autoimmune Disorders
• 7.4 Oncology
• 7.5 Infectious Diseases
• 7.6 Neurology

8 Global Laboratory-Developed Testing Market, By End User

• 8.1 Introduction
• 8.2 Specialty Diagnostics Centers
• 8.3 Academic Institutes
• 8.4 Hospital Laboratories
• 8.5 Clinical Research Organizations

9 Global Laboratory-Developed Testing Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Qiagen
• 11.2 Epic Sciences, Inc.
• 11.3 F. Hoffmann-La Roche Ltd
• 11.4 Bruker Corporation
• 11.5 Illumina, Inc.
• 11.6 Bio-Rad Laboratories, Inc.
• 11.7 Eurofins Scientific
• 11.8 Thermo Fisher Scientific Inc.
• 11.9 Quest Diagnostics
• 11.10 Siemens Healthcare Private Limited
• 11.11 Sonic Healthcare Ltd.
• 11.12 Abbott Laboratories
• 11.13 Adaptive Biotechnologies
• 11.14 OPKO Health Inc.
• 11.15 Rosetta Genomics Ltd.
• 11.16 Guardant Health
• 11.17 Genoptix, Inc.
• 11.18 Quidel Corporation