IVD Assay Development Market Size, Share, Forecast, & Trends Analysis by Offering (Assay Development, Packaging Development) Technology (Immunoassay, Molecular Diagnostics, Biochemistry) Application (Oncology, Diabetes)

List of Tables

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

Product Code: MRHC - 1041354

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