Nordic Regulatory Affairs Market To Reach $890.7 Million By 2030

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.

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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.

Nordic Regulatory Affairs Market Segmentation

Grand View Research has segmented the nordic regulatory affairs market based on services, categories, indication, stage, type, company size, end-use, and country:

Nordic Regulatory Affairs Type Outlook (Revenue, USD Million, 2018 - 2030)

• In-house

• Outsourcing

Nordic Regulatory Affairs Services Outlook (Revenue, USD Million, 2018 - 2030)

• Regulatory Consulting

• Legal Representation

• Regulatory Writing & Publishing

  • Writing

  • Publishing

• Product Registration & Clinical Trial Applications

• Other Services

Nordic Regulatory Affairs Categories Outlook (Revenue, USD Million, 2018 - 2030)

• Drugs

  • Innovators

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

  • Generics

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

• Biologics

  • Biotech

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

  • ATMP

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

  • Biosimilars

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

• Medical Devices

  • Diagnostics

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

  • Therapeutics

    • Preclinical

    • Clinical

    • Pre-market Approval (PMA)

Nordic Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Neurology

• Cardiology

• Immunology

• Others

Nordic Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018 - 2030)

• Preclinical

• Clinical studies

• PMA

Nordic Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018 - 2030)

• Small

• Medium

• Large

Nordic Regulatory Affairs End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Medical Device Companies

• Pharmaceutical Companies

• Biotechnology Companies

Nordic Regulatory Affairs Country Outlook (Revenue, USD Million, 2018 - 2030)

• Denmark

• Sweden

• Norway

• Finland

• Iceland

List of Key Players in the Nordic Regulatory Affairs Market

• Pharma Assist Sweden AB

• Genpact

• Criterium, Inc.

• ICON plc

• Parexel International Corporation, Inc.

• Global Pharma Consultancy AB

• Freyr

• Charles River Laboratories

• Accell Clinical Research LLC

• Regsmart Lifesciences AB

• PHARMALEX GMBH

• Pharmexon