Nordic Regulatory Affairs Market Size, Share & Trends Analysis Report 2021 - 2028

 Nordic Regulatory Affairs Industry Overview

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 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:

Based on the Service Insights, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services.

  • The regulatory writing and publishing segment held the largest revenue share of 36.8% in 2020. Pharmaceutical and biotech companies are increasingly opting for outsourcing selected regulatory functions, such as regulatory writing and publishing, to focus on core business needs.

 

  • The legal representation segment is projected to register the fastest growth rate of 8.3% over the forecast period owing to the expansion plans of major biotech/pharma companies and medical devices companies in the Nordic region.

 

Based on the Service Provider Insights, the market is segmented into In-house, and Outsourcing.

  • The outsourcing segment accounted for the largest revenue share of 59.9% in 2020 and is anticipated to expand at the fastest CAGR during the forecast period. Several medical devices, pharmaceutical, and biotechnology startups generally lack the budget and infrastructure for a sustainable in-house regulatory affairs team and mainly rely on outsourcing, thus creating lucrative opportunities for service providers.

 

Based on the Company Size Insights, the market is segmented into Small, Medium, and Large.

  • The medium-sized companies segment led the market and accounted for a revenue share of 46.8% in 2020. The presence of several mid-sized established providers, especially privately held ones, is anticipated to contribute to this segment growth. 

 

  • The large-sized companies segment is anticipated to register the fastest CAGR over the forecast period. They generally tend to prefer service providers of similar size to meet various regulatory needs arising due to their large geographic network and wide product lines and tend to seek long-term partnerships with service providers.

 

Based on the Category Insights, the market is segmented into Drugs, Biologics, and Medical Devices.

  • The medical devices segment accounted for the largest revenue share of 39.2% in 2020. This can be attributed to the increased competition due to the high demand for wearables and technological advancements in material science, design languages, personalized healthcare, and additive manufacturing. 

 

  • The drugs segment is further segmented into innovator and generic while the biologics segment is sub-segmented into biosimilars, ATMPs, and biotech products. Innovator drugs dominated the market in 2020. The biologics segment is anticipated to register the fastest growth rate of 8.6% over the forecast period. 

 

Based on the Product Stage Insights, the market is segmented into Preclinical, Clinical Studies, and PMA.

  • The clinical studies segment led the market and accounted for a 46.2% share in 2020. The increasing prevalence of chronic diseases and the emergence of new diseases are anticipated to increase the number of clinical trials.

 

  • The preclinical segment is anticipated to expand at the fastest CAGR during the forecast period. This can be attributed to the increasing number of molecules in the preclinical stage, especially in recent times, as companies are lined up for the development and approval of vaccines and drugs to treat COVID-19.

 

Based on the Indication Insights, the market is segmented into Oncology, Neurology, Cardiology, Immunology, and Others.

  • The oncology segment dominated the market in 2020 and accounted for a revenue share of 33.1%. The segment will expand further on account of the increasing prevalence of chronic diseases, such as cancer, along with the presence of several innovative pipeline products.
  • The immunology segment is anticipated to register the fastest CAGR of 9.0% over the forecast period. The growing use of immunological molecules in cancer therapy, coupled with their potential in facilitating the treatment of various cardiovascular, neurological, and inflammatory diseases, is anticipated to boost segment growth.

 

Based on the End-use Insights, the market is segmented into Medical Device Companies, Pharmaceutical Companies, and Biotechnology Companies.

  • The pharmaceutical companies segment dominated the market with a revenue share of 38.9% in 2020 and is projected to register the fastest CAGR from 2021 to 2028. This growth is attributed to the increase in the number of approved products of the leading pharmaceutical companies. 

 

  • Biopharmaceutical companies are actively involved in the development of innovative molecules that fulfill the unmet needs of patients. With an increasing number of companies in the late-stage development of their biologics, the biologics market is anticipated to witness substantial growth in the future.

 

Key Companies Profile & Market Share Insights

Companies provide various services such as regulatory consulting and writing and publishing for various pharmaceutical and medical devices companies. In January 2020, ICON Investments Limited acquired MedPass International, which has a significant presence in the European region as a regulatory and reimbursement consultant. The core competencies of MedPass are in market access and medical device development (class III). 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
  • Charles River Laboratories International, Inc.
  • Parexel International Corporation, Inc.
  • Accell Clinical Research LLC

 

Order a free sample PDF of the Nordic Regulatory Affairs Market Intelligence Study, published by Grand View Research.

 

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

 

Contact:

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Phone: 1-415-349-0058

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Email: sales@grandviewresearch.com

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