IVDアッセイ開発の市場規模、シェア、予測、動向分析：オファリング別（アッセイ開発、パッケージ開発）、技術別（免疫測定、分子診断、生化学）、用途別（腫瘍学、糖尿病） - 2031年までの世界予測

世界のIVDアッセイ開発市場は、2024年から2031年までのCAGRが7.9%で、2031年までに83億9,000万米ドルに達すると予測されています。

本レポートは、広範な2次調査と1次調査、市場シナリオの詳細な分析を経て、主要な業界促進要因、抑制要因、課題、機会の分析から構成されています。この市場の成長は、慢性疾患の有病率上昇と高齢者人口の増加、感染症による高い負担、POC IVDアッセイの市場開拓への注目の高まり、ヘルスケア支出の増加によってもたらされます。しかし、規制状況の変化が市場の成長を抑制しています。

さらに、新興経済諸国とIVDアッセイ開発における先端技術の利用は、この市場で事業を展開するプレーヤーに成長機会をもたらすと期待されています。しかし、製品の品質維持と専有情報の保護は、市場成長に影響を与える大きな課題です。

本レポートでは、主要企業の製品と地域情勢、過去数年間（2021年～2024年）に採用された主要成長戦略の広範な評価に基づく競合情勢を提供しています。IVDアッセイ開発の世界市場で事業を展開している主な企業は、Thermo Fisher Scientific Inc（米国）、Avioq, Inc.（米国）、Creative Biolabs, Inc（米国）、Maxim Biomedical, Inc.（米国）、Bio-Techne Corporation（米国）、Merck KGaA（ドイツ）、PeploBio Ltd（英国）、ICON plc（アイルランド）、NeoDx Biotech Labs Pvt. Ltd.（インド）、Eclevar Medtech（フランス）、Savyon Diagnostics（イスラエル）、Promega Corporation（米国）、Future Diagnostics Solutions B.V.（オランダ）です。

本レポートでカバーするオファリングの中で、IVD安定性試験分野は2024年から2031年の予測期間中に8.1%を超える最高のCAGRを記録すると予測されています。この成長の原動力となっているのは、安定性試験の利点であり、時間の経過に伴う潜在的な故障や性能の変化を特定するのに役立ちます。安定性試験により、企業は光曝露や温度変化など、体外診断用医薬品の有効性に影響を与える要因に関連するリスクを検出し、管理することができます。

本レポートでカバーする技術のうち、2024年には免疫測定/免疫化学分野がIVDアッセイ開発市場で最大のシェアを占めると予想されます。同分野の市場シェアが高いのは、免疫診断学が他の技術に比べて、固有の特異性と高いスループットにより、より高く選好されていること、および高度な診断用免疫アッセイフォーマットの出現によるものです。

本レポートが対象とする用途のうち、2024年には感染症分野がIVDアッセイ開発市場で最大のシェアを占めると予想されます。このセグメントの市場シェアが大きいのは、HIVの有病率の増加とHIVの迅速診断アッセイの普及が進んでいるためです。

世界のIVDアッセイ開発市場の地域別シナリオの詳細分析では、5つの主要地域（北米、欧州、アジア太平洋、ラテンアメリカ、中東・アフリカ）の詳細な質的・量的洞察を、各地域の主要国のカバレッジとともに提供しています。2024年には、北米がIVDアッセイ開発市場で37.8%以上の最大シェアを占めると予測されています。この地域内では、米国が2024年にIVDアッセイ開発市場で最大のシェアを占めると予想されています。同国の市場シェアが高いのは、感染症の流行が拡大していること、疾病調査・予防に対する政府の投資や資金調達が順調であること、ヘルスケア支出が増加していることなどが背景にあります。

調査範囲：

IVDアッセイ開発市場：オファリング別

• IVDアッセイ開発サービス
• IVDパッケージング開発サービス
• IVDアッセイ安定性試験
• レギュラトリーサポート
• その他のオファリング

（注：その他のオファリングには、技術移転、技術サポートサービス、カスタムQAおよびQCテストが含まれます）

IVDアッセイ開発市場：技術別

• 免疫測定 / 免疫化学
• 分子診断学
• 臨床化学 / 生化学
• 血液学
• 微生物学
• 尿検査

IVDアッセイ開発市場：用途別

• 感染症
• 腫瘍学
• 糖尿病
• 循環器
• その他の用途

（注：その他の用途には、腎臓学、凝固検査、神経疾患が含まれます）

IVDアッセイ開発市場：地域別

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • フランス
  • 英国
  • イタリア
  • スペイン
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • オーストラリア
  • 韓国
  • その他アジア太平洋
• ラテンアメリカ
  • ブラジル
  • メキシコ
  • その他ラテンアメリカ
• 中東・アフリカ

目次

第1章 イントロダクション

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場洞察

• 市場概要
• 市場成長に影響を与える要因
  • 促進要因
    • 慢性疾患の有病率の上昇と高齢者人口の増加
    • 高い感染症負担
    • POC IVDアッセイ開発への注目の高まり
    • ヘルスケア支出の増加
  • 抑制要因
    • 規制状況の変化
  • 機会
    • 新興経済国
    • IVDアッセイ開発における先端技術の利用
  • 課題
    • 製品の品質維持と専有情報の保護
  • マクロ指標
• 隣接市場分析
• IVDアッセイ開発市場：規制状況
  • 北米
    • 米国
    • カナダ
  • 欧州
  • アジア太平洋
    • 日本
    • 中国
    • インド
  • ラテンアメリカ
  • 中東・アフリカ
• ポーターのファイブフォース分析

第5章 IVDアッセイ開発市場の評価：オファリング別

• 概要
• IVDアッセイ開発サービス
• IVDアッセイ安定性試験
• IVDパッケージ開発サービス
• レギュラトリーサポート
• その他のサービス

第6章 IVDアッセイ開発市場：技術別

• 概要
• 免疫測定 / 免疫化学
• 分子診断学
• 臨床化学 / 生化学
• 血液学
• 微生物学
• 尿検査

第7章 IVDアッセイ開発市場の評価：用途別

• 概要
• 感染症
• 腫瘍学
• 糖尿病
• 循環器
• その他の用途

第8章 IVDアッセイ開発市場の評価：地域別

• 概要
• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • オーストラリア
  • 韓国
  • その他アジア太平洋
• ラテンアメリカ
  • ブラジル
  • メキシコ
  • その他ラテンアメリカ
• 中東・アフリカ

第9章 競合分析

• 概要
• 競合ベンチマーキング
• 競合ダッシュボード
  • 業界リーダー
  • 市場の差別化要因
  • バンガード
  • 新興企業
• 市場ランキング：主要企業別（2023年）

第10章 企業プロファイル（事業概要、財務概要、製品ポートフォリオ、戦略的展開、SWOT分析*）

• Creative Biolabs, Inc.
• Avioq, Inc.
• Thermo Fisher Scientific Inc.
• Neodx Biotech Labs Pvt. Ltd.
• Merck KGaA
• PeploBio Ltd
• Icon Plc
• Savyon Diagnostics
• Maxim Biomedical, Inc.
• Eclevar Medtech
• Promega Corporation
• Future Diagnostics Solutions B.V.

（注：上位5社のSWOT分析を提供します）

第11章 付録

LIST OF TABLES

• Table 1 Healthcare Expenditure per Capita, by Country, 2021/2022 (USD)
• Table 2 Global Human Immunodeficiency Virus (HIV) Statistics, 2023
• Table 3 Percentage of the Population Aged 65 Years or over, by Region, 2022 VS. 2030 VS. 2050
• Table 4 Global IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 5 Global IVD Assay Development Services Market, by Country/Region, 2022-2031 (USD Million)
• Table 6 Global IVD Assay Stability Testing Market, by Country/Region, 2022-2031 (USD Million)
• Table 7 Global IVD Packaging Development Services Market, by Country/Region, 2022-2031 (USD Million)
• Table 8 Global IVD Assay Development Regulatory Support Market, by Country/Region, 2022-2031 (USD Million)
• Table 9 Global Other IVD Assay Development Offerings Market, by Country/Region, 2022-2031 (USD Million)
• Table 10 Global IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 11 Global IVD Assay Development Market for Immunoassay/ Immunochemistry, by Country/Region, 2022-2031 (USD Million)
• Table 12 Global IVD Assay Development Market for Molecular Diagnostics, by Country/Region, 2022-2031 (USD Million)
• Table 13 Global IVD Assay Development Market for Clinical Chemistry/Biochemistry, by Country/Region, 2022-2031 (USD Million)
• Table 14 Global IVD Assay Development Market for Hematology, by Country/Region, 2022-2031 (USD Million)
• Table 15 Global IVD Assay Development Market for Microbiology, by Country/Region, 2022-2031 (USD Million)
• Table 16 Global IVD Assay Development Market for Urinalysis, by Country/Region, 2022-2031 (USD Million)
• Table 17 Global IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 18 Global IVD Assay Development Market for Infectious Diseases, by Country/Region, 2022-2031 (USD Million)
• Table 19 Global IVD Assay Development Market for Oncology, by Country/Region, 2022-2031 (USD Million)
• Table 20 Number of People with Diabetes Aged 20-79 Years, BY Region, 2021 VS. 2030 VS. 2045 (In Million)
• Table 21 Global IVD Assay Development Market for Diabetes, by Country/Region, 2022-2031 (USD Million)
• Table 22 Global IVD Assay Development Market for Cardiology, by Country/Region, 2022-2031 (USD Million)
• Table 23 Global IVD Assay Development Market for Other Applications, by Country/Region, 2022-2031 (USD Million)
• Table 24 Global IVD Assay Development Market, by Country/Region, 2022-2031 (USD Million)
• Table 25 North America: IVD Assay Development Market, by Country, 2022-2031 (USD Million)
• Table 26 North America: IVD Assay Development Market, BY offering, 2022-2031 (USD Million)
• Table 27 North America: IVD Assay Development Market, BY Technology, 2022-2031 (USD Million)
• Table 28 North America: IVD Assay Development Market, BY Application, 2022-2031 (USD Million)
• Table 29 U.S.: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 30 U.S.: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 31 U.S.: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 32 Canada: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 33 Canada: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 34 Canada: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 35 Europe: IVD Assay Development Market, by Country/Region, 2022-2031 (USD Million)
• Table 36 Europe: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 37 Europe: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 38 Europe: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 39 Germany: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 40 Germany: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 41 Germany: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 42 Number of Incidents of Influenza and Other Respiratory Diseases in England, by Institution and Virus Type, Winter 2022 To 2023
• Table 43 U.K.: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 44 U.K.: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 45 U.K.: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 46 France: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 47 France: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 48 France: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 49 Italy: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 50 Italy: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 51 Italy: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 52 Spain: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 53 Spain: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 54 Spain: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 55 Roe: Estimated Number of New Cancer Cases, by Country (2022 Vs. 2030)
• Table 56 Rest of Europe: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 57 Rest of Europe: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 58 Rest of Europe: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 59 Asia-Pacific: IVD Assay Development Market, by Country/Region, 2022-2031 (USD Million)
• Table 60 Asia-Pacific: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 61 Asia-Pacific: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 62 Asia-Pacific: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 63 China: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 64 China: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 65 China: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 66 Japan: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 67 Japan: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 68 Japan: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 69 India: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 70 India: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 71 India: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 72 Australia: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 73 Australia: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 74 Australia: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 75 South Korea: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 76 South Korea: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 77 South Korea: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 78 Rest of Asia-Pacific: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 79 Rest of Asia-Pacific: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 80 Rest of Asia-Pacific: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 81 Latin America: IVD Assay Development Market, by Country/Region, 2022-2031 (USD Million)
• Table 82 Latin America: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 83 Latin America: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 84 Latin America: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 85 Brazil: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 86 Brazil: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 87 Brazil: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 88 Mexico: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 89 Mexico: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 90 Mexico: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 91 Rest of Latin America: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 92 Rest of Latin America: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 93 Rest of Latin America: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 94 Middle East & Africa: IVD Assay Development Market, by Offering, 2022-2031 (USD Million)
• Table 95 Middle East & Africa: IVD Assay Development Market, by Technology, 2022-2031 (USD Million)
• Table 96 Middle East & Africa: IVD Assay Development Market, by Application, 2022-2031 (USD Million)
• Table 97 Global IVD Assay Development Market Rankings, by Key Players, 2023

LIST OF FIGURES

• Figure 1 Research Process
• Figure 2 Secondary Sources Referenced for This Study
• Figure 3 Primary Research Techniques
• Figure 4 Key Executives Interviewed
• Figure 5 Breakdown of Primary Interviews (Supply-Side & Demand-Side)
• Figure 6 Market Sizing and Growth Forecast Approach
• Figure 7 Global IVD Assay Development Market, by offering, 2024 Vs.2031 (USD Million)
• Figure 8 Global IVD Assay Development Market, by Technology, 2024 Vs. 2031 (USD Million)
• Figure 9 Global IVD Assay Development Market, by Application, 2024 Vs. 2031 (USD MILLION)
• Figure 10 Global IVD Assay Development Market, by Geography, 2024 VS 2031 (USD Million)
• Figure 11 Impact Analysis of Market Dynamics
• Figure 12 GLOBAL Biopharmaceutical R&D Expenditure, 2016-2026 (USD Billion)
• Figure 13 Estimated Number of New Cancer Cases, by Region, 2022 VS. 2030
• Figure 14 Number of People with Diabetes Aged 20-79 Years, by Region, 2021 VS. 2030 VS. 2045 (in Million)
• Figure 15 IVD Market Share, BY Technology, 2024
• Figure 16 IVD Reagents Market, by Type, 2024 Vs. 2031 (USD Million)
• Figure 17 IVD Contract Manufacturing Services Market, by Type, 2024 Vs. 2031 (USD Million)
• Figure 18 Porter's Five Forces Analysis
• Figure 19 Global IVD Assay Development Market, by offering, 2024 VS. 2031 (USD Million)
• Figure 20 IVD Assay Development Phases
• Figure 21 Global IVD Assay Development Market, by Technology, 2024 VS. 2031 (USD Million)
• Figure 22 Global IVD Assay Development Market, by Application, 2024 VS. 2031 (USD Million)
• Figure 23 Estimated Number of New Cancer Cases, by Region, 2022-2030
• Figure 24 Global IVD Assay Development Market, by Country/Region, 2024 Vs. 2031 (USD Million)
• Figure 25 North America: IVD Assay Development Market Snapshot
• Figure 26 Europe: IVD Assay Development Market Snapshot
• Figure 27 France: Percentage of the Population Aged 65 Years and Above (2016-2020)
• Figure 28 Number of HIV Tests Performed in Catalonia (Spain), 2014-2021
• Figure 29 Asia-Pacific: IVD Assay Development Market Snapshot
• Figure 30 China: Independent Medical Laboratories Market Size (USD Million)
• Figure 31 Japan: Percentage of Aging Population (65 Years and Above), 2016-2050
• Figure 32 Latin America: IVD Assay Development Market Snapshot
• Figure 33 IVD Assay Development Market: Competitive Benchmarking (Based on Offering)
• Figure 34 IVD Assay Development Market: Competitive Benchmarking (Based on Geography)
• Figure 35 Competitive Dashboard: IVD Assay Development Market
• Figure 36 Bio-Techne Corporation: Financial Snapshot (2023)
• Figure 37 Thermo Fisher Scientific Inc.: Financial Snapshot (2023)
• Figure 38 Merck KGaA: Financial Snapshot (2023)
• Figure 39 ICON Plc: Financial Snapshot (2023)

The global IVD assay development market is projected to reach $8.39 billion by 2031 at a CAGR of 7.9% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. The growth of this market is driven by the rising prevalence of chronic diseases & the increasing geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures. However, the evolving regulatory landscape restrains the growth of this market.

Furthermore, the emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for the players operating in this market. However, maintaining product quality & protecting proprietary information are major challenges impacting market growth.

The report offers a competitive landscape based on an extensive assessment of the leading players' offerings and geographic presence and the key growth strategies adopted by them over the past few years (2021-2024). The key players operating in the global IVD assay development market are Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands).

Among the offerings covered in this report, the IVD stability testing segment is projected to register the highest CAGR of over 8.1% during the forecast period of 2024-2031. This growth is driven by the benefits of stability testing, which helps identify potential breakdowns or alterations in performance over time. Stability testing enables companies to detect and manage risks related to factors that can affect the effectiveness of IVD assays, including light exposure and temperature variations.

Among the technologies covered in this report, in 2024, the immunoassay /immunochemistry segment is expected to account for the largest share of the IVD assay development market. The segment's large market share is attributed to the higher preference for immunodiagnostics compared to other technologies due to its inherent specificity and high throughput, and the emergence of advanced diagnostic immunoassay formats.

Among the applications covered in this report, in 2024, the infectious diseases segment is expected to account for the largest share of the IVD assay development market. The large market share of this segment can be attributed to the increasing prevalence of HIV and the growing availability of rapid diagnostic assays for HIV.

An in-depth analysis of the geographical scenario of the global IVD assay development market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. In 2024, North America is expected to account for the largest share of over 37.8% of the IVD assay development market. Within this region, the U.S. is expected to account for the largest share of the IVD assay development market in 2024. The country's large market share is attributed to the increasing prevalence of infectious diseases, favorable government investments and funding for disease investigation & prevention, and rising healthcare expenditure.

Scope of the Report:

IVD Assay Development Market-by Offering

• IVD Assay Development Services
• IVD Packaging Development Services
• IVD Assay Stability Testing
• Regulatory Support
• Other Offerings

(Note: Other offerings include technology transfer, technical support services, and custom QA & QC testing)

IVD Assay Development Market-by Technology

• Immunoassay/Immunochemistry
• Molecular Diagnostics
• Clinical Chemistry/Biochemistry
• Hematology
• Microbiology
• Urinalysis

IVD Assay Development Market-by Application

• Infectious Diseases
• Oncology
• Diabetes
• Cardiology
• Other Applications

(Note: Other applications include nephrology, coagulation tests, and neurological disorders.)

IVD Assay Development Market-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Process
• 2.2. Data Collection & Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
• 2.3. Market Sizing and Forecast
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Factors Affecting Market Growth
  • 4.2.1. Drivers
    • 4.2.1.1. Rising Prevalence of Chronic Diseases & the Increasing Geriatric Population
    • 4.2.1.2. High Burden of Infectious Diseases
    • 4.2.1.3. Growing Focus on the Development of POC IVD Assays
    • 4.2.1.4. Rising Healthcare Expenditures
  • 4.2.2. Restraints
    • 4.2.2.1. Evolving Regulatory Landscape
  • 4.2.3. Opportunities
    • 4.2.3.1. Emerging Economies
    • 4.2.3.2. Use of Advanced Technologies in IVD Assay Development
  • 4.2.4. Challenges
    • 4.2.4.1. Maintaining Product Quality & Protecting Proprietary Information
  • 4.2.5. Macro Indicators
• 4.3. Adjacent Market Analysis
• 4.4. IVD Assay Development Market: Regulatory Landscape
  • 4.4.1. North America
    • 4.4.1.1. U.S.
    • 4.4.1.2. Canada
  • 4.4.2. Europe
  • 4.4.3. Asia-Pacific
    • 4.4.3.1. Japan
    • 4.4.3.2. China
    • 4.4.3.3. India
  • 4.4.4. Latin America
  • 4.4.5. Middle East & Africa
• 4.5. Porter's Five Forces Analysis
  • 4.5.1. Bargaining Power of Suppliers
  • 4.5.2. Bargaining Power of Buyers
  • 4.5.3. Threat of Substitutes
  • 4.5.4. Threat of New Entrants
  • 4.5.5. Degree of Competition

5. IVD Assay Development Market Assessment-by Offering

• 5.1. Overview
• 5.2. IVD Assay Development Services
• 5.3. IVD Assay Stability Testing
• 5.4. IVD Packaging Development Services
• 5.5. Regulatory Support
• 5.6. Other offerings

6. IVD Assay Development Market-by Technology

• 6.1. Overview
• 6.2. Immunoassay/Immunochemistry
• 6.3. Molecular Diagnostics
• 6.4. Clinical Chemistry/Biochemistry
• 6.5. Hematology
• 6.6. Microbiology
• 6.7. Urinalysis

7. IVD Assay Development Market Assessment-by Application

• 7.1. Overview
• 7.2. Infectious Diseases
• 7.3. Oncology
• 7.4. Diabetes
• 7.5. Cardiology
• 7.6. Other Applications

8. IVD Assay Development Market Assessment-by Geography

• 8.1. Overview
• 8.2. North America
  • 8.2.1. U.S.
  • 8.2.2. Canada
• 8.3. Europe
  • 8.3.1. Germany
  • 8.3.2. U.K.
  • 8.3.3. France
  • 8.3.4. Italy
  • 8.3.5. Spain
  • 8.3.6. Rest of Europe
• 8.4. Asia-Pacific
  • 8.4.1. China
  • 8.4.2. Japan
  • 8.4.3. India
  • 8.4.4. Australia
  • 8.4.5. South Korea
  • 8.4.6. Rest of Asia-Pacific
• 8.5. Latin America
  • 8.5.1. Brazil
  • 8.5.2. Mexico
  • 8.5.3. Rest of Latin America
• 8.6. Middle East & Africa

9. Competition Analysis

• 9.1. Overview
• 9.2. Competitive Benchmarking
• 9.3. Competitive Dashboard
  • 9.3.1. Industry Leaders
  • 9.3.2. Market Differentiators
  • 9.3.3. Vanguards
  • 9.3.4. Emerging Companies
• 9.4. Market Ranking, by Key Players (2023)

10. Company Profiles (Business Overview, Financial Overview, Product Portfolio, Strategic Developments, And SWOT Analysis*)

• 10.1. Creative Biolabs, Inc.
• 10.2. Avioq, Inc.
• 10.4. Thermo Fisher Scientific Inc.
• 10.5. Neodx Biotech Labs Pvt. Ltd.
• 10.6. Merck KGaA
• 10.7. PeploBio Ltd
• 10.8. Icon Plc
• 10.9. Savyon Diagnostics
• 10.10. Maxim Biomedical, Inc.
• 10.11. Eclevar Medtech
• 10.12. Promega Corporation
• 10.13. Future Diagnostics Solutions B.V.

(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)

11. Appendix

• 11.1. Available Customization
• 11.2. Related Reports