Nordic Regulatory Affairs Market Size, Share & Trends Analysis Report By Services (Regulatory Consulting, Legal Representation), By Category, By Type, By Company Size, By Product Stage, By Indication, By End-use, By Country, And Segment Forecasts, 2025 -

Nordic Regulatory Affairs Market Growth & Trends

The Nordic Regulatory Affairs market size is estimated to reach USD 890.7 million by 2030, registering a CAGR of 7.25% from 2025 to 2030, according to a new report by Grand View Research, Inc. An increase in R&D activities in countries such as Denmark and Norway, drug pipeline, and clinical trial applications are some of the key factors expected to drive the market.

Denmark is the hub of R&D activities in Europe. The country is known for its long tradition for collaborative R&D and the fastest approval of clinical trials makes it a preferred destination to perform drug discovery and development. Denmark also has the largest commercial drug-development pipeline in Europe. Thus, the urge for a faster drug approval process is one of the key factors expected to drive the market in the country.

In Sweden, as stated by the SwedenBIO, around 148 companies have 420 drug development projects; an increase by 51 projects compared to 2016. In addition, around 6% of the total exports from Sweden are related to pharmaceuticals. Hence, this is projected to create demand for regulatory affairs services in the country.

The ongoing COVID-19 pandemic is expected to create the need for regulatory affairs in the Nordic countries. Countries such as Sweden and Denmark, which are the hub of clinical trials, are expected to witness an increase in demand for regulatory services as many of the trials are put on hold. In addition to this, due to COVID-19, a significant number of vaccines and drugs are in the development stage, which requires faster approval. This is possible only through clearance by regulatory bodies. Thus, the need for regulatory affairs is expected to increase in the Nordic countries.

Nordic Regulatory Affairs Market Report Highlights

  • By service, the regulatory writing and publishing segment led the market in 2024, owing to an increase in the outsourcing of selected regulatory functions by major life sciences companies.
  • Based on category, the biologics segment is projected to witness considerable growth during the forecast year, attributed to factors such as increasing R&D investments from pharmaceutical and biotechnology firms.
  • Denmark regulatory affairs market accounted for the largest revenue share of 34.13% in 2024, owing to its strong pharmaceutical and biotechnology sector, supported by a well-established regulatory framework.
  • Changing regulatory landscape, increasing need for companies to focus on core business activities, and economic and competitive pressures are the main factors responsible for the market growth.
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Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Market Definitions
1.2.1. Type Segment
1.2.2. Services Segment
1.2.3. Category Segment
1.2.4. Indication Segment
1.2.5. Product Stage Segment
1.2.6. Company Size Segment
1.2.7. Indication Segment
1.2.8. End-use Segment
1.3. Information analysis
1.3.1. Market formulation & data visualization
1.4. Data validation & publishing
1.5. Information Procurement
1.5.1. Primary Research
1.6. Information or Data Analysis
1.7. Market Formulation & Validation
1.8. Market Model
1.9. Total Market: CAGR Calculation
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Insights Landscape
Chapter 3. Nordic Regulatory Affairs Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook.
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.1.1. Changing Regulatory Landscape
3.2.1.2. Life Science Companies Focusing on Their Core Competencies
3.2.1.3. Economic and Competitive Pressures
3.2.1.4. Demand For the Faster Approval Process for Breakthrough Drugs and Devices
3.2.1.5. Growth in Emerging Areas Such as Personalized Medicine, Biosimilars, And Orphan Drugs
3.2.2. Market restraint analysis
3.2.2.1. Risk Associated with Data Security
3.2.2.2. Monitoring Issues and Lack of Standardization
3.3. Regulatory Affairs Market Analysis Tools
3.3.1. Porter’s Five Forces Analysis
3.3.2. PESTEL Analysis
3.3.3. COVID-19 Impact Analysis
Chapter 4. Nordic Regulatory Affairs Market: Services Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Nordic Regulatory Affairs Market Services Movement Analysis
4.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Services, 2018 to 2030 (USD Million)
4.4. Regulatory Consulting
4.4.1. Regulatory consulting market estimates and forecasts, 2018 to 2030 (USD Million)
4.5. Legal Representation
4.5.1. Legal representation market estimates and forecasts, 2018 to 2030 (USD Million)
4.6. Regulatory Writing & Publishing
4.6.1. Regulatory writing & publishing market estimates and forecasts, 2018 to 2030 (USD Million)
4.6.1.1. Writing
4.6.1.1.1. Writing market estimates and forecasts, 2018 to 2030 (USD Million)
4.6.1.2. Publishing
4.6.1.2.1. Publishing market estimates and forecasts, 2018 to 2030 (USD Million)
4.7. Product Registration & Clinical Trial Applications
4.7.1. Product registration & clinical trial applications market estimates and forecasts, 2018 to 2030 (USD Million)
4.8. Other Services
4.8.1. Other services market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 5. Nordic Regulatory Affairs Market: Category Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Nordic Regulatory Affairs Market Category Movement Analysis
5.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Category, 2018 to 2030 (USD Million)
5.4. Drugs
5.4.1. Drugs market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.2. Innovators
5.4.2.1. Innovators market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.2.2. Preclinical
5.4.2.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.2.3. Clinical
5.4.2.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.2.4. Pre-Market Approval (PMA)
5.4.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.3. Generics
5.4.3.1. Generics market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.3.2. Preclinical
5.4.3.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.3.3. Clinical
5.4.3.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.4.3.4. Pre-Market Approval (PMA)
5.4.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.5. Biologics
5.5.1. Biologics market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.2. Biotech
5.5.2.1. Biotech market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.2.2. Preclinical
5.5.2.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.2.3. Clinical
5.5.2.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.2.4. Pre-Market Approval (PMA)
5.5.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.3. ATMP
5.5.3.1. ATMP market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.3.2. Preclinical
5.5.3.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.3.3. Clinical
5.5.3.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.5.3.4. Pre-Market Approval (PMA)
5.5.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.6. Biosimilars
5.6.1. Biosimilars market estimates and forecasts, 2018 to 2030 (USD Million)
5.6.1.1. Preclinical
5.6.1.1.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.6.1.2. Clinical
5.6.1.2.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.6.1.3. Pre-Market Approval (PMA)
5.6.1.3.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.7. Medical Devices
5.7.1. Medical devices market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.2. Diagnostics
5.7.2.1. Diagnostics market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.2.2. Preclinical
5.7.2.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.2.3. Clinical
5.7.2.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.2.4. Pre-Market Approval (PMA)
5.7.2.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.3. Therapeutics
5.7.3.1. Therapeutics market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.3.2. Preclinical
5.7.3.2.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.3.3. Clinical
5.7.3.3.1. Clinical market estimates and forecasts, 2018 to 2030 (USD Million)
5.7.3.4. Pre-Market Approval (PMA)
5.7.3.4.1. Pre-Market Approval (PMA) market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 6. Nordic Regulatory affairs market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Nordic Regulatory Affairs Market Indication Movement Analysis
6.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Indication, 2018 to 2030 (USD Million)
6.4. Oncology
6.4.1. Oncology market estimates and forecasts, 2018 to 2030 (USD Million)
6.5. Neurology
6.5.1. Neurology market estimates and forecasts, 2018 to 2030 (USD Million)
6.6. Cardiology
6.6.1. Cardiology market estimates and forecasts, 2018 to 2030 (USD Million)
6.7. Immunology
6.7.1. Immunology market estimates and forecasts, 2018 to 2030 (USD Million)
6.8. Others
6.8.1.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 7. Nordic Regulatory Affairs Market: Product Stage Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Nordic Regulatory Affairs Market Product Stage Movement Analysis
7.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Product Stage, 2018 to 2030 (USD Million)
7.4. Preclinical
7.4.1. Preclinical market estimates and forecasts, 2018 to 2030 (USD Million)
7.5. Clinical studies
7.5.1. Clinical studies market estimates and forecasts, 2018 to 2030 (USD Million)
7.6. Pre-Market Approval (PMA)
7.6.1. PMA market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 8. Nordic Regulatory Affairs Market: Type Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Nordic Regulatory Affairs Market Type Movement Analysis
8.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
8.4. In-house
8.4.1. In-house market estimates and forecasts, 2018 to 2030 (USD Million)
8.5. Outsourced
8.5.1. Outsourced market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 9. Nordic Regulatory Affairs Market: Company Size Estimates & Trend Analysis
9.2. Nordic Regulatory Affairs Market Company Size Movement Analysis
9.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by Company Size, 2018 to 2030 (USD Million)
9.4. Small
9.4.1. Small market estimates and forecasts, 2018 to 2030 (USD Million)
9.5. Medium
9.5.1. Medium market estimates and forecasts, 2018 to 2030 (USD Million)
9.6. Large
9.6.1. Large market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 10. Nordic Regulatory Affairs Market: End-use Estimates & Trend Analysis
10.1. Segment Dashboard
10.2. Nordic Regulatory Affairs Market End-use Movement Analysis
10.3. Nordic Regulatory Affairs Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
10.4. Medical Device Companies
10.4.1. Medical device companies market estimates and forecasts, 2018 to 2030 (USD Million)
10.5. Pharmaceutical Companies
10.5.1. Pharmaceutical companies market estimates and forecasts, 2018 to 2030 (USD Million)
10.6. Biotechnology Companies
10.6.1. Biotechnology companies market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 11. Nordic Regulatory Affairs Market: Country Estimates & Trend Analysis
11.1. Country Market Share Analysis, 2024 & 2030
11.2. Country Market Dashboard
11.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
11.4. Denmark
11.4.1. Key country dynamics
11.4.2. Competitive scenario
11.4.3. Regulatory Scenario
11.4.4. Denmark market estimates and forecasts, 2018 to 2030 (USD Million)
11.5. Norway
11.5.1. Key country dynamics
11.5.2. Competitive scenario
11.5.3. Regulatory Scenario
11.5.4. Norway market estimates and forecasts, 2018 to 2030 (USD Million)
11.6. Sweden
11.6.1. Key country dynamics
11.6.2. Competitive scenario
11.6.3. Regulatory Scenario
11.6.4. Sweden market estimates and forecasts, 2018 to 2030 (USD Million)
11.7. Finland
11.7.1. Key country dynamics
11.7.2. Competitive scenario
11.7.3. Regulatory Scenario
11.7.4. Finland market estimates and forecasts, 2018 to 2030 (USD Million)
11.8. Iceland
11.8.1. Key country dynamics
11.8.2. Competitive scenario
11.8.3. Regulatory Scenario
11.8.4. Iceland market estimates and forecasts, 2018 to 2030 (USD Million)
Chapter 12. Competitive Landscape
12.1. Company Categorization
12.2. Company Market Share/Assessment Analysis, 2024
12.3. Company Profiles
12.3.1. Pharma Assist Sweden AB
12.3.1.1. Company overview
12.3.1.2. Financial performance
12.3.1.3. Product benchmarking
12.3.1.4. Strategic initiatives
12.3.2. Genpact
12.3.2.1. Company overview
12.3.2.2. Financial performance
12.3.2.3. Product benchmarking
12.3.2.4. Strategic initiatives
12.3.3. Criterium, Inc.
12.3.3.1. Company overview
12.3.3.2. Financial performance
12.3.3.3. Product benchmarking
12.3.3.4. Strategic initiatives
12.3.4. ICON plc
12.3.4.1. Company overview
12.3.4.2. Financial performance
12.3.4.3. Product benchmarking
12.3.4.4. Strategic initiatives
12.3.5. Parexel International Corporation, Inc.
12.3.5.1. Company overview
12.3.5.2. Financial performance
12.3.5.3. Product benchmarking
12.3.5.4. Strategic initiatives
12.3.6. Global Pharma Consultancy AB
12.3.6.1. Company overview
12.3.6.2. Financial performance
12.3.6.3. Product benchmarking
12.3.6.4. Strategic initiatives
12.3.7. Freyr
12.3.7.1. Company overview
12.3.7.2. Financial performance
12.3.7.3. Product benchmarking
12.3.7.4. Strategic initiatives
12.3.8. Charles River Laboratories
12.3.8.1. Company overview
12.3.8.2. Financial performance
12.3.8.3. Product benchmarking
12.3.8.4. Strategic initiatives
12.3.9. Accell Clinical Research LLC
12.3.9.1. Company overview
12.3.9.2. Financial performance
12.3.9.3. Product benchmarking
12.3.9.4. Strategic initiatives
12.3.10. Regsmart Lifesciences AB
12.3.10.1. Company overview
12.3.10.2. Financial performance
12.3.10.3. Product benchmarking
12.3.10.4. Strategic initiatives
12.3.11. PHARMALEX GMBH
12.3.11.1. Company overview
12.3.11.2. Financial performance
12.3.11.3. Product benchmarking
12.3.11.4. Strategic initiatives
12.3.12. Pharmexon
12.3.12.1. Company overview
12.3.12.2. Financial performance
12.3.12.3. Product benchmarking
12.3.12.4. Strategic initiatives

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