Nordic Regulatory Affairs Industry Overview
The Nordic regulatory affairs market size was valued at USD 153.2 million in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.5% from 2021 to 2028. Changing regulatory landscape, increasing demand for the faster approval process, and economic and competitive pressures are some of the key factors expected to drive the market. The entry of life sciences companies in the Nordic markets, especially in countries such as Denmark and Sweden, for R&D collaborations and the evolution of new areas, such as orphan drugs, biosimilars, advanced therapy medicinal products (ATMPs), and personalized medicine, are further anticipated to contribute to the market growth. This is because new areas would require advanced technical expertise for compliance with regulatory requirements.
For instance, the development and use of biosimilars continue to grow in the Nordic region. Countries, especially Sweden and Norway, are known to hold leadership positions in crafting policies that facilitate the production of biosimilars. Thus, for faster approval of their biosimilar drugs, companies have to rely on clearance from regulatory bodies, thus creating demand for services in the Nordic countries.
Gather more insights about the market drivers, restraints and growth of the Nordic Regulatory Affairs Market
At present, the healthcare industry is focused not only on the development of blockbuster therapies for the treatment of various diseases but also on targeted gene therapies, especially drugs and precision medicine, which help to treat specific diseases and disorders. Some of these products are also being combined with medical devices to enhance the quality of drug delivery and patient monitoring or adherence, thus increasing the complexity of defining the regulatory strategy and pathway to market.
In view of this, in 2018, Genomic Medicine Sweden (GMS) was launched for the development of precision medicine in Sweden. It aimed at implementing precision medicine into the clinical trial settings in the country. In June 2020, Vinnova, an innovation agency, invested USD 4.4 million to promote R&D and collaborations in the field of precision medicine. Precision medicine is a potential area of growth in Sweden. Stockholm, the country’s capital, is home to over 50% of companies focused on the area of precision medicine. Many of these companies are actively pursuing international collaboration and partnerships. Thus, compliance with regulatory affairs during clinical trials and product approvals is expected to boost demand for regulatory affairs in the Nordic countries.
The sudden spread of the COVID-19 pandemic affected the ongoing clinical trials at the global level. The impact was also visible in the Nordic countries, such as Norway, Sweden, and Denmark. In Norway, a temporary halt of patient recruitment for new clinical trials was seen. Adherence to new mandates released by each country’s government agency has further created challenges to continue ongoing clinical trials.
Furthermore, with new guidelines being imposed, several companies are taking assistance of CROs, thus increasing demand for regulatory affairs in the Nordic countries. In addition, R&D for the development of vaccines and drugs is ongoing in these Nordic countries. For instance, since the outbreak of COVID-19, 260 clinical studies relating to COVID-19 have been approved by the Swedish Ethical Review Authority. Thus, the need for regulatory affairs is expected to increase in the Nordic countries.
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Regulatory Affairs Market - The global regulatory affairs market size was valued at USD 12.8 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 8.7% over the forecast period.
Clinical Trials Market - The global clinical trials market size was valued at USD 47.0 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030.
Nordic Regulatory Affairs Industry 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
Market Share Insights:
June 2020: Japan-based Fujifilm announced an investment of USD 1.0 billion to build a biologics plant in Denmark.
January 2020: ICON Investments Limited acquired MedPass International, which has a significant presence in the European region as a regulatory and reimbursement consultant.
Key Companies profiled:
Some prominent players in the Nordic Regulatory Affairs Industry include
- 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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