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体外診断（IVD）市場の2030年までの予測：製品、検体、技術、用途、エンドユーザー、地域別の世界分析

In Vitro Diagnostics (IVD) Market Forecasts to 2030 - Global Analysis By Product (Instruments, Reagents & Kits and Software), Specimen (Blood, Urine, Stool, Saliva, Tissue Biopsies and Other Specimens), Technology, Application, End User and By Geography

出版日
ページ情報
英文 200+ Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=145.63円
体外診断（IVD）市場の2030年までの予測：製品、検体、技術、用途、エンドユーザー、地域別の世界分析
出版日: 2024年06月06日
発行: Stratistics Market Research Consulting
ページ情報: 英文 200+ Pages
納期: 2～3営業日
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  • 概要
  • 図表
  • 目次
概要

Stratistics MRCによると、体外診断（IVD）の世界市場は2024年に1,041億米ドルを占め、2030年には1,485億米ドルに達すると予測され、予測期間中のCAGRは6.1%です。

体外診断（IVD）とは、血液、尿、組織など人体から採取したサンプルを用いて行う医療検査で、病気、状態、感染症を検出します。これらの検査は、体外で、管理された実験室環境で行われ、診断、治療モニタリング、疾病予防のための重要な情報を提供し、現代のヘルスケアと個別化医療において重要な役割を果たしています。

米国国立生物工学情報センター（NCBI）の報告書によると、体外診断（IVD）検査は臨床現場において貴重なものであり、患者の88％が初期診断に、77％が治療モニタリングに、72％が経過観察に利用しています。このことは、患者管理とヘルスケアにおけるIVDの不可欠な役割を浮き彫りにしています。

慢性疾患の増加

糖尿病、心血管疾患、がんなどの慢性疾患の増加傾向は、体外診断（IVD）市場の重要な促進要因です。これらの疾患は定期的なモニタリングと早期診断が必要であり、体外診断（IVD）検査はこれを促進します。世界人口の高齢化と生活習慣に関連した健康問題の増加に伴い、正確で効率的な診断ツールに対する需要は増加の一途をたどっており、市場拡大の原動力となっています。

診断プラットフォームの高コスト

高度な診断プラットフォームのコストが高いことが、体外診断用医薬品市場の大きな抑制要因となっています。これらのプラットフォームは、初期セットアップ、メンテナンス、熟練した人材など、多額の投資を必要とすることが多いです。小規模なヘルスケア施設や新興国市場では、こうした技術を導入するための費用を捻出することが難しく、導入が制限され、市場の成長が鈍化する可能性があります。さらに、コスト要因が頻繁なアップグレードや新技術の統合の妨げになることもあります。

新興市場での成長

新興市場はIVD市場にとって大きな成長機会です。アジア太平洋、ラテンアメリカ、アフリカの一部などの地域では、急速な経済発展、医療インフラの改善、医療支出の増加が見られます。これらの要因は、病気の早期発見や予防医療に対する意識の高まりと相まって、体外診断（IVD）製品やサービスの拡大にとって肥沃な土壌となっています。これらの地域に投資する企業は、十分なサービスを受けていない多くの患者を開拓することができます。

厳しい規制の枠組み

体外診断用医薬品の承認と商業化を管理する厳しい規制の枠組みは、市場の成長にとって大きな脅威です。FDAやEMAなどの規制機関は、診断検査の安全性と有効性を確保するために厳格な基準を課しています。こうした規制は患者の安全を守る一方で、製造業者にとっては承認プロセスの長期化とコスト増につながります。コンプライアンス違反は、製品回収、法的問題、市場の信用失墜につながる可能性があります。

COVID-19の影響：

COVID-19のパンデミックは、PCR、NGS、血清学ベースの迅速検査などの診断検査の需要が急増し、IVD市場を大きく押し上げました。パンデミックはポイントオブケア検査や遠隔診断の採用を加速させ、迅速で正確な診断ソリューションの重要性を浮き彫りにしました。このような需要の急増は、IVD技術とインフラへの投資の増加につながり、将来の成長の先例となった。

予測期間中、試薬・キットセグメントが最大となる見込み

試薬・キット分野は、診断検査に不可欠な役割を果たすことから、IVD市場を独占すると予測されています。試薬は、患者サンプル中の特定分析物を検出・測定するための様々な体外診断用医薬品検査で使用される重要なコンポーネントです。ルーチンの診断手順においてこれらの消耗品が継続的に必要とされることと、試薬製剤の進歩や新しい検査キットのイントロダクションが相まって、同分野の成長を牽引しています。

イムノアッセイ分野は予測期間中最も高いCAGRが見込まれる

イムノアッセイ分野は、感染症、がんバイオマーカー、ホルモンレベルの検出など、幅広い用途があるため、CAGRが最も高くなると予測されます。免疫測定法は感度と特異性が高く、臨床診断に不可欠です。自動免疫測定システムやマルチプレックスアッセイの市場開拓などの技術的進歩は、その効率性と採用率をさらに高め、市場の急成長に寄与しています。

最大のシェアを占める地域

北米は高度なヘルスケア・インフラ、高い医療費、大手体外診断用医薬品企業の存在により、体外診断用医薬品市場を独占する立場にあります。同地域は疾病の早期発見、個別化医療、先端診断技術の導入に注力しており、市場成長を牽引しています。さらに、政府の支援政策と慢性疾患の高い蔓延が北米の主要市場シェアに寄与しています。

CAGRが最も高い地域：

アジア太平洋地域は、ヘルスケア投資の増加、ヘルスケアインフラの改善、予防医療に対する意識の高まりにより、IVD市場の急成長が見込まれています。慢性疾患や感染症の有病率の上昇、経済発展や中流階級の人口拡大が、高度な診断ソリューションの需要を促進しています。ヘルスケアへのアクセスを向上させ、手ごろな価格で医療を受けられるようにする政府の取り組みが、この地域の高いCAGRをさらに後押ししています。

無料カスタマイズサービス：

本レポートをご購読のお客様には、以下の無料カスタマイズオプションのいずれかをご利用いただけます：

  • 企業プロファイル
    • 追加市場プレーヤーの包括的プロファイリング（3社まで）
    • 主要企業のSWOT分析（3社まで）
  • 地域セグメンテーション
    • 顧客の関心に応じた主要国の市場推計・予測・CAGR（注：フィージビリティチェックによる）
  • 競合ベンチマーキング
    • 製品ポートフォリオ、地理的プレゼンス、戦略的提携に基づく主要企業のベンチマーキング

目次

第1章 エグゼクティブサマリー

第2章 序文

  • 概要
  • ステークホルダー
  • 調査範囲
  • 調査手法
    • データマイニング
    • データ分析
    • データ検証
    • 調査アプローチ
  • 調査情報源
    • 1次調査情報源
    • 2次調査情報源
    • 前提条件

第3章 市場動向分析

  • 促進要因
  • 抑制要因
  • 機会
  • 脅威
  • 製品分析
  • 技術分析
  • 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

  • 供給企業の交渉力
  • 買い手の交渉力
  • 代替品の脅威
  • 新規参入業者の脅威
  • 競争企業間の敵対関係

第5章 世界の体外診断（IVD）市場：製品別

  • 機器
    • アナライザー
    • ポイントオブケア（POC）デバイス
    • 顕微鏡
    • その他の楽器
  • 試薬とキット
    • 分子診断キット
    • 臨床化学検査
    • 血液学検査
    • 微生物学アッセイ
    • その他の試薬とキット
  • ソフトウェア
    • データ分析ソフトウェア
    • 検査情報管理システム（LIMS）
    • リモート診断ソフトウェア

第6章 世界の体外診断（IVD）市場：検体別

  • 血
  • 尿
  • スツール
  • 唾液
  • 組織生検
  • その他の標本

第7章 世界の体外診断（IVD）市場：技術別

  • 免疫学的検査
    • 酵素免疫測定法（ELISA）
    • 化学発光免疫測定法（CLIA）
    • 放射免疫測定法（RIA）
  • 分子診断
    • ポリメラーゼ連鎖反応（PCR）
    • 等温核酸増幅技術（INAAT）
    • マイクロアレイ
    • 次世代シーケンシング（NGS）
  • 臨床化学
  • 血液学
  • 微生物学
  • 凝固と止血
  • その他のテクノロジー

第8章 世界の体外診断（IVD）市場：用途別

  • 感染症
    • HIV/エイズ検査
    • 肝炎検査
    • 細菌およびウイルス感染
  • 腫瘍学
    • がんのスクリーニングと診断
    • 治療反応のモニタリング
  • 内分泌学
    • 糖尿病検査
    • 甲状腺機能検査
  • 心臓病学
    • 心臓マーカー検査
    • コレステロール検査
  • 血液検査
    • 新生児スクリーニング
    • 出生前検査
  • 遺伝子検査
    • キャリアスクリーニング
    • 薬理ゲノム学
  • 自己免疫疾患
    • 関節リウマチ検査
    • セリアック病検査
  • アレルギー診断
    • 食物アレルギー検査
    • 薬物アレルギー検査
  • 薬物モニタリングと検査
    • 治療薬モニタリング
    • アンチ・ドーピング検査
  • 凝固検査
    • 血液型分類
    • 骨およびミネラル障害
  • その他の用途

第9章 世界の体外診断（IVD）市場：エンドユーザー別

  • 病院・クリニック
  • 診断ラボ
  • ポイントオブケア検査施設
  • 在宅ケア環境
  • 研究機関

第10章 世界の体外診断（IVD）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
    • その他欧州
  • アジア太平洋地域
    • 日本
    • 中国
    • インド
    • オーストラリア
    • ニュージーランド
    • 韓国
    • その他アジア太平洋地域
  • 南米
    • アルゼンチン
    • ブラジル
    • チリ
    • その他南米
  • 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
    • その他中東とアフリカ

第11章 主な発展

  • 契約、パートナーシップ、コラボレーション、合弁事業
  • 買収と合併
  • 新製品発売
  • 事業拡大
  • その他の主要戦略

第12章 企業プロファイリング

  • Roche Diagnostics
  • Siemens Healthineers
  • Abbott Laboratories
  • Danaher Corporation（Beckman Coulter）
  • Thermo Fisher Scientific
  • Becton, Dickinson and Company（BD）
  • bioMerieux SA
  • Sysmex Corporation
  • Johnson & Johnson（Ortho Clinical Diagnostics）
  • Bio-Rad Laboratories
  • Qiagen N.V.
  • Hologic, Inc.
  • Grifols
  • Illumina, Inc.
  • Agilent Technologies
図表

List of Tables

  • Table 1 Global In Vitro Diagnostics (IVD) Market Outlook, By Region (2022-2030) ($MN)
  • Table 2 Global In Vitro Diagnostics (IVD) Market Outlook, By Product (2022-2030) ($MN)
  • Table 3 Global In Vitro Diagnostics (IVD) Market Outlook, By Instruments (2022-2030) ($MN)
  • Table 4 Global In Vitro Diagnostics (IVD) Market Outlook, By Analyzers (2022-2030) ($MN)
  • Table 5 Global In Vitro Diagnostics (IVD) Market Outlook, By Point-of-care (POC) devices (2022-2030) ($MN)
  • Table 6 Global In Vitro Diagnostics (IVD) Market Outlook, By Microscopes (2022-2030) ($MN)
  • Table 7 Global In Vitro Diagnostics (IVD) Market Outlook, By Other Instruments (2022-2030) ($MN)
  • Table 8 Global In Vitro Diagnostics (IVD) Market Outlook, By Reagents & Kits (2022-2030) ($MN)
  • Table 9 Global In Vitro Diagnostics (IVD) Market Outlook, By Molecular Diagnostics Kits (2022-2030) ($MN)
  • Table 10 Global In Vitro Diagnostics (IVD) Market Outlook, By Clinical Chemistry Assays (2022-2030) ($MN)
  • Table 11 Global In Vitro Diagnostics (IVD) Market Outlook, By Hematology Assays (2022-2030) ($MN)
  • Table 12 Global In Vitro Diagnostics (IVD) Market Outlook, By Microbiology Assays (2022-2030) ($MN)
  • Table 13 Global In Vitro Diagnostics (IVD) Market Outlook, By Other Reagents & Kits (2022-2030) ($MN)
  • Table 14 Global In Vitro Diagnostics (IVD) Market Outlook, By Software (2022-2030) ($MN)
  • Table 15 Global In Vitro Diagnostics (IVD) Market Outlook, By Data Analysis Software (2022-2030) ($MN)
  • Table 16 Global In Vitro Diagnostics (IVD) Market Outlook, By Laboratory Information Management Systems (LIMS) (2022-2030) ($MN)
  • Table 17 Global In Vitro Diagnostics (IVD) Market Outlook, By Remote Diagnostics Software (2022-2030) ($MN)
  • Table 18 Global In Vitro Diagnostics (IVD) Market Outlook, By Specimen (2022-2030) ($MN)
  • Table 19 Global In Vitro Diagnostics (IVD) Market Outlook, By Blood (2022-2030) ($MN)
  • Table 20 Global In Vitro Diagnostics (IVD) Market Outlook, By Urine (2022-2030) ($MN)
  • Table 21 Global In Vitro Diagnostics (IVD) Market Outlook, By Stool (2022-2030) ($MN)
  • Table 22 Global In Vitro Diagnostics (IVD) Market Outlook, By Saliva (2022-2030) ($MN)
  • Table 23 Global In Vitro Diagnostics (IVD) Market Outlook, By Tissue Biopsies (2022-2030) ($MN)
  • Table 24 Global In Vitro Diagnostics (IVD) Market Outlook, By Other Specimens (2022-2030) ($MN)
  • Table 25 Global In Vitro Diagnostics (IVD) Market Outlook, By Technology (2022-2030) ($MN)
  • Table 26 Global In Vitro Diagnostics (IVD) Market Outlook, By Immunoassays (2022-2030) ($MN)
  • Table 27 Global In Vitro Diagnostics (IVD) Market Outlook, By Enzyme-Linked Immunosorbent Assay (ELISA) (2022-2030) ($MN)
  • Table 28 Global In Vitro Diagnostics (IVD) Market Outlook, By Chemiluminescence Immunoassays (CLIA) (2022-2030) ($MN)
  • Table 29 Global In Vitro Diagnostics (IVD) Market Outlook, By Radioimmunoassay (RIA) (2022-2030) ($MN)
  • Table 30 Global In Vitro Diagnostics (IVD) Market Outlook, By Molecular Diagnostics (2022-2030) ($MN)
  • Table 31 Global In Vitro Diagnostics (IVD) Market Outlook, By Polymerase Chain Reaction (PCR) (2022-2030) ($MN)
  • Table 32 Global In Vitro Diagnostics (IVD) Market Outlook, By Isothermal Nucleic Acid Amplification Technology (INAAT) (2022-2030) ($MN)
  • Table 33 Global In Vitro Diagnostics (IVD) Market Outlook, By Microarrays (2022-2030) ($MN)
  • Table 34 Global In Vitro Diagnostics (IVD) Market Outlook, By Next-Generation Sequencing (NGS) (2022-2030) ($MN)
  • Table 35 Global In Vitro Diagnostics (IVD) Market Outlook, By Clinical Chemistry (2022-2030) ($MN)
  • Table 36 Global In Vitro Diagnostics (IVD) Market Outlook, By Hematology (2022-2030) ($MN)
  • Table 37 Global In Vitro Diagnostics (IVD) Market Outlook, By Microbiology (2022-2030) ($MN)
  • Table 38 Global In Vitro Diagnostics (IVD) Market Outlook, By Coagulation & Hemostasis (2022-2030) ($MN)
  • Table 39 Global In Vitro Diagnostics (IVD) Market Outlook, By Other Technologies (2022-2030) ($MN)
  • Table 40 Global In Vitro Diagnostics (IVD) Market Outlook, By Application (2022-2030) ($MN)
  • Table 41 Global In Vitro Diagnostics (IVD) Market Outlook, By Infectious Diseases (2022-2030) ($MN)
  • Table 42 Global In Vitro Diagnostics (IVD) Market Outlook, By HIV/AIDS Testing (2022-2030) ($MN)
  • Table 43 Global In Vitro Diagnostics (IVD) Market Outlook, By Hepatitis Testing (2022-2030) ($MN)
  • Table 44 Global In Vitro Diagnostics (IVD) Market Outlook, By Bacterial & Viral Infections (2022-2030) ($MN)
  • Table 45 Global In Vitro Diagnostics (IVD) Market Outlook, By Oncology (2022-2030) ($MN)
  • Table 46 Global In Vitro Diagnostics (IVD) Market Outlook, By Cancer Screening & Diagnosis (2022-2030) ($MN)
  • Table 47 Global In Vitro Diagnostics (IVD) Market Outlook, By Monitoring Treatment Response (2022-2030) ($MN)
  • Table 48 Global In Vitro Diagnostics (IVD) Market Outlook, By Endocrinology (2022-2030) ($MN)
  • Table 49 Global In Vitro Diagnostics (IVD) Market Outlook, By Diabetes Testing (2022-2030) ($MN)
  • Table 50 Global In Vitro Diagnostics (IVD) Market Outlook, By Thyroid Function Testing (2022-2030) ($MN)
  • Table 51 Global In Vitro Diagnostics (IVD) Market Outlook, By Cardiology (2022-2030) ($MN)
  • Table 52 Global In Vitro Diagnostics (IVD) Market Outlook, By Cardiac Markers Testing (2022-2030) ($MN)
  • Table 53 Global In Vitro Diagnostics (IVD) Market Outlook, By Cholesterol Testing (2022-2030) ($MN)
  • Table 54 Global In Vitro Diagnostics (IVD) Market Outlook, By Blood Screening (2022-2030) ($MN)
  • Table 55 Global In Vitro Diagnostics (IVD) Market Outlook, By Newborn Screening (2022-2030) ($MN)
  • Table 56 Global In Vitro Diagnostics (IVD) Market Outlook, By Prenatal Testing (2022-2030) ($MN)
  • Table 57 Global In Vitro Diagnostics (IVD) Market Outlook, By Genetic Testing (2022-2030) ($MN)
  • Table 58 Global In Vitro Diagnostics (IVD) Market Outlook, By Carrier Screening (2022-2030) ($MN)
  • Table 59 Global In Vitro Diagnostics (IVD) Market Outlook, By Pharmacogenomics (2022-2030) ($MN)
  • Table 60 Global In Vitro Diagnostics (IVD) Market Outlook, By Autoimmune Diseases (2022-2030) ($MN)
  • Table 61 Global In Vitro Diagnostics (IVD) Market Outlook, By Rheumatoid Arthritis Testing (2022-2030) ($MN)
  • Table 62 Global In Vitro Diagnostics (IVD) Market Outlook, By Celiac Disease Testing (2022-2030) ($MN)
  • Table 63 Global In Vitro Diagnostics (IVD) Market Outlook, By Allergy Diagnostics (2022-2030) ($MN)
  • Table 64 Global In Vitro Diagnostics (IVD) Market Outlook, By Food Allergy Testing (2022-2030) ($MN)
  • Table 65 Global In Vitro Diagnostics (IVD) Market Outlook, By Drug Allergy Testing (2022-2030) ($MN)
  • Table 66 Global In Vitro Diagnostics (IVD) Market Outlook, By Drug Monitoring & Testing (2022-2030) ($MN)
  • Table 67 Global In Vitro Diagnostics (IVD) Market Outlook, By Therapeutic Drug monitoring (2022-2030) ($MN)
  • Table 68 Global In Vitro Diagnostics (IVD) Market Outlook, By Anti-doping Testing (2022-2030) ($MN)
  • Table 69 Global In Vitro Diagnostics (IVD) Market Outlook, By Coagulation Testing (2022-2030) ($MN)
  • Table 70 Global In Vitro Diagnostics (IVD) Market Outlook, By Blood Group Typing (2022-2030) ($MN)
  • Table 71 Global In Vitro Diagnostics (IVD) Market Outlook, By Bone & Mineral Disorders (2022-2030) ($MN)
  • Table 72 Global In Vitro Diagnostics (IVD) Market Outlook, By Other Applications (2022-2030) ($MN)
  • Table 73 Global In Vitro Diagnostics (IVD) Market Outlook, By End User (2022-2030) ($MN)
  • Table 74 Global In Vitro Diagnostics (IVD) Market Outlook, By Hospitals & Clinics (2022-2030) ($MN)
  • Table 75 Global In Vitro Diagnostics (IVD) Market Outlook, By Diagnostic Laboratories (2022-2030) ($MN)
  • Table 76 Global In Vitro Diagnostics (IVD) Market Outlook, By Point-of-Care Testing Sites (2022-2030) ($MN)
  • Table 77 Global In Vitro Diagnostics (IVD) Market Outlook, By Homecare Settings (2022-2030) ($MN)
  • Table 78 Global In Vitro Diagnostics (IVD) Market Outlook, By Research Institutions (2022-2030) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

目次
Product Code: SMRC26431

According to Stratistics MRC, the Global In Vitro Diagnostics (IVD) Market is accounted for $104.1 billion in 2024 and is expected to reach $148.5 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In Vitro Diagnostics (IVD) refers to medical tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are conducted outside the body, in a controlled laboratory environment, to provide crucial information for diagnosis, treatment monitoring, and disease prevention, playing a vital role in modern healthcare and personalized medicine.

According to a report by the National Center for Biotechnology Information (NCBI), IVD testing is valuable in clinical practice, with 88% of patients using it for initial diagnosis, 77% for treatment monitoring, and 72% for follow-up. This highlights the indispensable role of IVDs in patient management and healthcare outcomes.

Market Dynamics:

Driver:

Increasing prevalence of chronic diseases

The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is a significant driver for the In Vitro Diagnostics (IVD) market. These conditions require regular monitoring and early diagnosis, which IVD tests facilitate. As the global population ages and lifestyle-related health issues increase, the demand for accurate and efficient diagnostic tools continues to grow, thereby driving market expansion.

Restraint:

High cost of diagnostic platforms

The high cost of advanced diagnostic platforms poses a significant restraint to the IVD market. These platforms often require substantial investment in terms of initial setup, maintenance, and skilled personnel. Smaller healthcare facilities and developing regions may find it challenging to afford these technologies, limiting their adoption and slowing market growth. Additionally, the cost factor can deter frequent upgrades and integration of new technologies.

Opportunity:

Growth in emerging markets

Emerging markets present substantial growth opportunities for the IVD market. Regions such as Asia-Pacific, Latin America, and parts of Africa are experiencing rapid economic development, improved healthcare infrastructure, and increased healthcare spending. These factors, combined with a growing awareness of early disease detection and preventive healthcare, create a fertile ground for the expansion of IVD products and services. Companies investing in these regions can tap into a large, underserved patient population.

Threat:

Stringent regulatory framework

The stringent regulatory framework governing the approval and commercialization of IVD products is a significant threat to market growth. Regulatory bodies like the FDA and EMA impose rigorous standards to ensure the safety and efficacy of diagnostic tests. While these regulations protect patient safety, they also lead to lengthy approval processes and increased costs for manufacturers. Non-compliance can result in product recalls, legal issues, and loss of market credibility.

Covid-19 Impact:

The COVID-19 pandemic significantly boosted the IVD market, with a sharp rise in demand for diagnostic tests such as PCR, NGS, and serology-based rapid tests. The pandemic accelerated the adoption of point-of-care testing and remote diagnostics, highlighting the importance of rapid and accurate diagnostic solutions. This surge in demand led to increased investments in IVD technologies and infrastructure, setting a precedent for future growth.

The reagents & kits segment is expected to be the largest during the forecast period

The reagents and kits segment is anticipated to dominate the IVD market due to their essential role in diagnostic testing. Reagents are critical components used in various IVD tests to detect and measure specific analytes in patient samples. The continuous need for these consumables in routine diagnostic procedures, coupled with advancements in reagent formulations and the introduction of new test kits, drives the segment's growth.

The immunoassays segment is expected to have the highest CAGR during the forecast period

The immunoassays segment is projected to experience the highest CAGR due to its widespread application in detecting infectious diseases, cancer biomarkers, and hormone levels. Immunoassays offer high sensitivity and specificity, making them indispensable in clinical diagnostics. Technological advancements, such as the development of automated immunoassay systems and multiplex assays, further enhance their efficiency and adoption, contributing to rapid market growth.

Region with largest share:

North America is positioned to dominate the IVD market due to its advanced healthcare infrastructure, high healthcare expenditure, and the presence of major IVD companies. The region's focus on early disease detection, personalized medicine, and the adoption of advanced diagnostic technologies drives market growth. Additionally, supportive government policies and a high prevalence of chronic diseases contribute to North America's leading market share.

Region with highest CAGR:

The Asia Pacific region anticipates rapid growth in the IVD market, driven by increasing healthcare investments, improving healthcare infrastructure, and a growing awareness of preventive healthcare. The rising prevalence of chronic and infectious diseases, coupled with economic development and expanding middle-class populations, fuels the demand for advanced diagnostic solutions. Government initiatives to enhance healthcare access and affordability further support the region's high CAGR.

Key players in the market

Some of the key players in In Vitro Diagnostics (IVD) market include Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation (Beckman Coulter), Thermo Fisher Scientific, Becton, Dickinson and Company (BD), bioMerieux SA, Sysmex Corporation, Johnson & Johnson (Ortho Clinical Diagnostics), Bio-Rad Laboratories, Qiagen N.V., Hologic, Inc., Grifols, Illumina, Inc., and Agilent Technologies.

Key Developments:

In December 2023, Thermo Fisher Scientific Inc., the world leader in serving science, announced the launch of the Thermo Scientific(TM) KingFisher(TM) Apex(TM) Dx, an automated nucleic acid purification instrument, and Applied Biosystems(TM) MagMAX(TM) Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.

In November 2023, Roche announced the launch of the LightCycler(R) PRO System based on the proven gold standard technology of the LightCycler(R) Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in vitro diagnostics. The LightCycler PRO System further complements Roche's molecular PCR testing portfolio, which includes solutions for a variety of healthcare professionals - from those performing research, to those testing patients for cancer, infectious diseases, and other public health challenges.

In June 2023, Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Products Covered:

  • Instruments
  • Reagents & Kits
  • Software

Specimens Covered:

  • Blood
  • Urine
  • Stool
  • Saliva
  • Tissue Biopsies
  • Other Specimens

Technologies Covered:

  • Immunoassays
  • Molecular Diagnostics
  • Clinical Chemistry
  • Hematology
  • Microbiology
  • Coagulation & Hemostasis
  • Other Technologies

Applications Covered:

  • Infectious Diseases
  • Oncology
  • Endocrinology
  • Cardiology
  • Blood Screening
  • Genetic Testing
  • Autoimmune Diseases
  • Allergy Diagnostics
  • Drug Monitoring & Testing
  • Coagulation Testing
  • Other Applications

End Users Covered:

  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Point-of-Care Testing Sites
  • Homecare Settings
  • Research Institutions

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 2022, 2023, 2024, 2026, and 2030
  • 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 Technology Analysis
  • 3.8 Application Analysis
  • 3.9 End User Analysis
  • 3.10 Emerging Markets
  • 3.11 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 In Vitro Diagnostics (IVD) Market, By Product

  • 5.1 Introduction
  • 5.2 Instruments
    • 5.2.1 Analyzers
    • 5.2.2 Point-of-care (POC) devices
    • 5.2.3 Microscopes
    • 5.2.4 Other Instruments
  • 5.3 Reagents & Kits
    • 5.3.1 Molecular Diagnostics Kits
    • 5.3.2 Clinical Chemistry Assays
    • 5.3.3 Hematology Assays
    • 5.3.4 Microbiology Assays
    • 5.3.5 Other Reagents & Kits
  • 5.4 Software
    • 5.4.1 Data Analysis Software
    • 5.4.2 Laboratory Information Management Systems (LIMS)
    • 5.4.3 Remote Diagnostics Software

6 Global In Vitro Diagnostics (IVD) Market, By Specimen

  • 6.1 Introduction
  • 6.2 Blood
  • 6.3 Urine
  • 6.4 Stool
  • 6.5 Saliva
  • 6.6 Tissue Biopsies
  • 6.7 Other Specimens

7 Global In Vitro Diagnostics (IVD) Market, By Technology

  • 7.1 Introduction
  • 7.2 Immunoassays
    • 7.2.1 Enzyme-Linked Immunosorbent Assay (ELISA)
    • 7.2.2 Chemiluminescence Immunoassays (CLIA)
    • 7.2.3 Radioimmunoassay (RIA)
  • 7.3 Molecular Diagnostics
    • 7.3.1 Polymerase Chain Reaction (PCR)
    • 7.3.2 Isothermal Nucleic Acid Amplification Technology (INAAT)
    • 7.3.3 Microarrays
    • 7.3.4 Next-Generation Sequencing (NGS)
  • 7.4 Clinical Chemistry
  • 7.5 Hematology
  • 7.6 Microbiology
  • 7.7 Coagulation & Hemostasis
  • 7.8 Other Technologies

8 Global In Vitro Diagnostics (IVD) Market, By Application

  • 8.1 Introduction
  • 8.2 Infectious Diseases
    • 8.2.1 HIV/AIDS Testing
    • 8.2.2 Hepatitis Testing
    • 8.2.3 Bacterial & Viral Infections
  • 8.3 Oncology
    • 8.3.1 Cancer Screening & Diagnosis
    • 8.3.2 Monitoring Treatment Response
  • 8.4 Endocrinology
    • 8.4.1 Diabetes Testing
    • 8.4.2 Thyroid Function Testing
  • 8.5 Cardiology
    • 8.5.1 Cardiac Markers Testing
    • 8.5.2 Cholesterol Testing
  • 8.6 Blood Screening
    • 8.6.1 Newborn Screening
    • 8.6.2 Prenatal Testing
  • 8.7 Genetic Testing
    • 8.7.1 Carrier Screening
    • 8.7.2 Pharmacogenomics
  • 8.8 Autoimmune Diseases
    • 8.8.1 Rheumatoid Arthritis Testing
    • 8.8.2 Celiac Disease Testing
  • 8.9 Allergy Diagnostics
    • 8.9.1 Food Allergy Testing
    • 8.9.2 Drug Allergy Testing
  • 8.10 Drug Monitoring & Testing
    • 8.10.1 Therapeutic Drug monitoring
    • 8.10.2 Anti-doping Testing
  • 8.11 Coagulation Testing
    • 8.11.1 Blood Group Typing
    • 8.11.2 Bone & Mineral Disorders
  • 8.12 Other Applications

9 Global In Vitro Diagnostics (IVD) Market, By End User

  • 9.1 Introduction
  • 9.2 Hospitals & Clinics
  • 9.3 Diagnostic Laboratories
  • 9.4 Point-of-Care Testing Sites
  • 9.5 Homecare Settings
  • 9.6 Research Institutions

10 Global In Vitro Diagnostics (IVD) Market, By Geography

  • 10.1 Introduction
  • 10.2 North America
    • 10.2.1 US
    • 10.2.2 Canada
    • 10.2.3 Mexico
  • 10.3 Europe
    • 10.3.1 Germany
    • 10.3.2 UK
    • 10.3.3 Italy
    • 10.3.4 France
    • 10.3.5 Spain
    • 10.3.6 Rest of Europe
  • 10.4 Asia Pacific
    • 10.4.1 Japan
    • 10.4.2 China
    • 10.4.3 India
    • 10.4.4 Australia
    • 10.4.5 New Zealand
    • 10.4.6 South Korea
    • 10.4.7 Rest of Asia Pacific
  • 10.5 South America
    • 10.5.1 Argentina
    • 10.5.2 Brazil
    • 10.5.3 Chile
    • 10.5.4 Rest of South America
  • 10.6 Middle East & Africa
    • 10.6.1 Saudi Arabia
    • 10.6.2 UAE
    • 10.6.3 Qatar
    • 10.6.4 South Africa
    • 10.6.5 Rest of Middle East & Africa

11 Key Developments

  • 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 11.2 Acquisitions & Mergers
  • 11.3 New Product Launch
  • 11.4 Expansions
  • 11.5 Other Key Strategies

12 Company Profiling

  • 12.1 Roche Diagnostics
  • 12.2 Siemens Healthineers
  • 12.3 Abbott Laboratories
  • 12.4 Danaher Corporation (Beckman Coulter)
  • 12.5 Thermo Fisher Scientific
  • 12.6 Becton, Dickinson and Company (BD)
  • 12.7 bioMerieux SA
  • 12.8 Sysmex Corporation
  • 12.9 Johnson & Johnson (Ortho Clinical Diagnostics)
  • 12.10 Bio-Rad Laboratories
  • 12.11 Qiagen N.V.
  • 12.12 Hologic, Inc.
  • 12.13 Grifols
  • 12.14 Illumina, Inc.
  • 12.15 Agilent Technologies