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Nordic Regulatory Affairs market driven by increase in R&D activities in Denmark and Norway

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.

Nordic Regulatory Affairs Market Share By Geographical Regions:

Sweden serves as the global hub for drug development, eventually increasing the need for regulatory affairs in the country. Sweden is known for its advanced healthcare system, willingness among the population to participate in research, and several collaborations with industry, academia, and healthcare organizations. Sweden dominated the market in 2020 with a share of 59.6%. It is anticipated to witness the fastest growth over the forecast period owing to a rise in the number of drug development projects in the country.

Nordic Regulatory Affairs Market Insights By Key Players:

Some prominent players in the Nordic regulatory affairs market include Pharma Assist Sweden AB; GenPact Ltd.; ICON plc; Freyr; Global Pharma Consultancy AB; Regsmart Lifesciences AB; PRA Health Sciences; and Charles River Laboratories International, Inc. Companies provide various services such as regulatory consulting and writing and publishing for various pharmaceutical and medical devices companies. The core competencies of MedPass are in market access and medical device development (class III).

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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

COVID-19 is an incomparable global public health emergency that has affected almost every industry. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.

Base year for estimation


Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Service, service provider, company size, category, product stage, indication, end-use, country

Regional scope


Country scope

Sweden; Norway; Denmark; Finland; Iceland

Key companies profiled

PRA Health Sciences; Charles River Laboratories International, Inc.; ICON plc; Parexel International Corporation, Inc.; Accell Clinical Research LLC

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.


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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


on March 4 at 12:57

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