The Nordic regulatory affairs market size is expected to reach USD 272.7 million by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 7.5% from 2021 to 2028. 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.
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Nordic Regulatory Affairs Market Report Highlights
- By service, the regulatory writing and publishing segment led the market in 2020 owing to an increase in the outsourcing of selected regulatory functions by major life sciences companies
- Based on category, the medical devices segment held the largest share in 2020. The segment is driven by stiff competition owing to the increased demand for wearable devices
- Sweden dominated the market with a share of 59.6% in 2020 due to a rise in the number of drug development projects
- 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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Nordic Regulatory Affairs Market Segmentation
Grand View Research has segmented the Nordic regulatory affairs market based on service, service provider, company size, category, product stage, indication, end-use, and country:
Nordic Regulatory Affairs Service Outlook (Revenue, USD Million, 2016 – 2028)
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
Nordic Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2016 – 2028)
- In-house
- Outsourcing
Nordic Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2016 – 2028)
- Small
- Medium
- Large
Nordic Regulatory Affairs Category Outlook (Revenue, USD Million, 2016 – 2028)
- Drugs
- Biologics
- Medical Devices
Nordic Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2016 – 2028)
- Preclinical
- Clinical Studies
- PMA
Nordic Regulatory Affairs Indication Outlook (Revenue, USD Million, 2016 – 2028)
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
Nordic Regulatory Affairs End-use Outlook (Revenue, USD Million, 2016 – 2028)
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
Nordic Regulatory Affairs Country Outlook (Revenue, USD Million, 2016 – 2028)
- Sweden
- Norway
- Denmark
- Finland
- Iceland
List of Key Players of Nordic Regulatory Affairs Market
- Pharma Assist Sweden AB
- GenPact Ltd.
- PRA Health Sciences
- Charles River Laboratories International, Inc.
- ICON plc
- Parexel International Corporation, Inc.
- Freyr
- Global Pharma Consultancy AB
- Accell Clinical Research LLC
- Regsmart Lifesciences AB
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Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting), By Type (Diagnostics, Therapeutics), By Service Provider, By Region, And Segment Forecasts, 2021 – 2028
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