North America IVD Regulatory Affairs Outsourcing Market to 2032
Overview
The North America IVD Regulatory Affairs Outsourcing Market is expected to reach a 1.12 USD Million by 2032 and is projected to grow at a CAGR of 19.37% from 2025 to 2032.
Revenue, 2024 (USD Million)
0.41
Forecast, 2032 (USD Million)
1.12
CAGR, 2024 - 2032
19.37%
Report Coverage
North America
North America IVD Regulatory Affairs Outsourcing Market 2018-2032 USD Million
North America IVD Regulatory Affairs Outsourcing Market, Key Findings (2025-2032)
Market Growth and Projections:
- Market Size (2024): 0.41 USD Million
- Projected Market Size (2032): 1.12 USD Million
- CAGR (2025-2032): 19.37%
Key Findings of North America IVD Regulatory Affairs Outsourcing Market
- The North America IVD Regulatory Affairs Outsourcing Market was valued at 0.41 USD Million in 2024.
- The North America IVD Regulatory Affairs Outsourcing Market is likely to grow at a CAGR of 19.37% during the forecast period of 2024 to 2032.
- In 2024, the Largest segment Large Enterprises in Organization Size Segment accounted for the largest share of the market with a revenue of 0.25 USD Million
- The fastest growing segment Clinical Chemistry And Immunoassays in Indication Segment grew Fastest with a CAGR of 20.77% during the forecast period from 2024 to 2032.
North America IVD Regulatory Affairs Outsourcing Market Scope
North America IVD Regulatory Affairs Outsourcing Market Segmentation & Scope
End User
- Others
- Biotechnology Companies
- Pharmaceutical Companies
- Medical Device Companies
Class
- Class II
- Class III
- Class I
Stage
- PMA (Post Market Authorization)
- Preclinical
- Clinical
Indication
- Others
- Genetic Testing
- HIV/AIDS
- Neurology
- Oncology
- Point Of Care
- Cardiology
- Blood Transfusion
- Diabetes
- Precision Medicine
- Drug Testing/Pharmacogenomics
- Haematology
- Infectious Diseases
- Clinical Chemistry And Immunoassays
Deployment Mode
- On-Premises
- Cloud
Organization Size
- Small & Medium Enterprises (SMEs)
- Large Enterprises
Service
- Others
- Data Management Services
- Chemistry Manufacturing And Controls (CMC) Services
- Regulatory Registration & Clinical Trial Applications
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Submissions
North America IVD Regulatory Affairs Outsourcing Market Data Coverage Insights
| Study Period | 2024-2032 |
| Base Year | 2021 |
| Unit | Revenue in USD Million |
| Market Value in 2024 | 0.41 USD Million |
| Market Value in 2032 | 1.12 USD Million |
| CAGR (2025-2032) | 19.37% |
| Historic Data | 2016-2023 |
| Market Segments Covered | End User,Class,Stage,Indication,Deployment Mode,Organization Size,Service |
Regional Insights:
-
Leading Market (2024-2032): North America, leading in terms of revenue 0.41 USD Million in 2024
- Key Country: U.S., leading in terms of revenue with value of 0.31 USD Million in 2024.
Segments and Scope
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By End User
- Medical Device Companies is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.22 USD Million in the year 2024.
- Medical Device Companies is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 20.11 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Class
- Class I is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.21 USD Million in the year 2024.
- Class I is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 20.11 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Stage
- Clinical is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.20 USD Million in the year 2024.
- Clinical is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 20.36 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Indication
- Clinical Chemistry And Immunoassays is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.12 USD Million in the year 2024.
- Clinical Chemistry And Immunoassays is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 20.77 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Deployment Mode
- Cloud is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.25 USD Million in the year 2024.
- Cloud is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 20.25 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Organization Size
- Large Enterprises is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.25 USD Million in the year 2024.
- Small & Medium Enterprises (SMEs) is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 18.58 % in forecast period 2025-2032.
-
North America IVD Regulatory Affairs Outsourcing Market to 2032, By Service
- Regulatory Writing & Submissions is the largest segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a revenue of 0.18 USD Million in the year 2024.
- Legal Representation is the Fastest growing segment in North America IVD Regulatory Affairs Outsourcing Market to 2032 with a Growth rate of 19.78 % in forecast period 2025-2032.
North America IVD Regulatory Affairs Outsourcing Market Company Share Analysis
| Company Name |
|
||
| Medpace | |||
| Parexel International Corporation | |||
| ICON plc | |||
| LORENZ Life Sciences Group | |||
| MakroCare | |||
North America IVD Regulatory Affairs Outsourcing Market Geographical Sales Distribution, 2018-2032 USD Million
North America IVD Regulatory Affairs Outsourcing Market Company Profiling
Industry Related Reports
Frequently Asked Questions
The North America IVD Regulatory Affairs Outsourcing Market is segmented based on Segmentation End User,Class,Stage,Indication,Deployment Mode,Organization Size,Service.
North America IVD Regulatory Affairs Outsourcing Market was valued at USD 0.41(Revenue in USD Million) in 2021.
North America IVD Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 19.37% during the forecast period of 2024 to 2032.
The Large Enterprises segment is expected to dominate the North America IVD Regulatory Affairs Outsourcing Market, holding a largest market share of 0.25 USD Million in 2024
North America IVD Regulatory Affairs Outsourcing Market Scope
North America IVD Regulatory Affairs Outsourcing Market Segmentation & Scope
End User
- Others
- Biotechnology Companies
- Pharmaceutical Companies
- Medical Device Companies
Class
- Class II
- Class III
- Class I
Stage
- PMA (Post Market Authorization)
- Preclinical
- Clinical
Indication
- Others
- Genetic Testing
- HIV/AIDS
- Neurology
- Oncology
- Point Of Care
- Cardiology
- Blood Transfusion
- Diabetes
- Precision Medicine
- Drug Testing/Pharmacogenomics
- Haematology
- Infectious Diseases
- Clinical Chemistry And Immunoassays
Deployment Mode
- On-Premises
- Cloud
Organization Size
- Small & Medium Enterprises (SMEs)
- Large Enterprises
Service
- Others
- Data Management Services
- Chemistry Manufacturing And Controls (CMC) Services
- Regulatory Registration & Clinical Trial Applications
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Submissions
Frequently Asked Questions
The North America IVD Regulatory Affairs Outsourcing Market is segmented based on Segmentation End User,Class,Stage,Indication,Deployment Mode,Organization Size,Service.
North America IVD Regulatory Affairs Outsourcing Market was valued at USD 0.41(Revenue in USD Million) in 2021.
North America IVD Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 19.37% during the forecast period of 2024 to 2032.
The estimated market value of the North America IVD Regulatory Affairs Outsourcing Market for final year is USD 1.12 (USD Million).
North America IVD Regulatory Affairs Outsourcing Market Company Profiling
Frequently Asked Questions
The North America IVD Regulatory Affairs Outsourcing Market is segmented based on Segmentation End User,Class,Stage,Indication,Deployment Mode,Organization Size,Service.
North America IVD Regulatory Affairs Outsourcing Market was valued at USD 0.41(Revenue in USD Million) in 2021.
North America IVD Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of 19.37% during the forecast period of 2024 to 2032.
The estimated market value of the North America IVD Regulatory Affairs Outsourcing Market for final year is USD 1.12 (USD Million).
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