The Nordic regulatory affairs market size was valued at USD 153.18 Million in 2022 and is projected to reach USD 176.03 Million by 2031, expanding at a CAGR of 7.2% during the forecast period, 2023-2031. The growth of the market is attributed to the changing regulatory landscape and competitive & economic pressures.
Regulatory affairs is an industry that supervises how medical products, foods, and drugs are manufactured, developed, tested, distributed, and marketed to verify that they meet regulatory standards for human use. This profession is developed from the government of that region to protect public health by controlling the efficacy and safety of products. The regulatory affairs professionals keep the track of changing legislation in all the regions in which a corporation desires to launch its products, advice on scientific and legal requirements and restraints, and presenting registering documents to regulatory agencies and help in carrying out any following negotiations necessary to maintain marketing approval for the products concerned.
The COVID-19 pandemic outbreak had considerable impact on the market. During the pandemic, the lockdown imposed by government bodies across the region resulted in suspended enrolment in most ongoing clinical studies and delays in starting new clinical trials by leading market players in the pharmaceutical industry, which hampered the demand of these services. However, the demand for COVID-19 testing, treatment, and vaccine development has risen, which increased the demand for regulatory affair services.
Nordic Regulatory Affairs Market Trends, Drivers, Restraints, and Opportunities
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Increasing demand for faster approval process is a key factor driving the market growth.
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Rising development and use of biosimilar drugs in Nordic countries, which requires technical expertise for acquiescence with regulatory requirements is projected to drive the market expansion during the forecast period.
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Changing regulatory mandates released by government agency of each country acts as a major challenge that can restrict the market growth in the coming years.
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Escalating cost for outsourcing of these services can hamper the market growth during the projected timeline.
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Growing development of targeted gene therapies and personalized medicine in healthcare industry is projected to create significant growth opportunities for the market.
Scope of Nordic Regulatory Affairs Market Report
The report on the Nordic regulatory affairs market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Regulatory Affairs Market - Nordic Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Service Providers (Outsourcing and In-house), Categories (Medical Devices, Drugs, and Biologics), Indications (Cardiology, Oncology, Immunology, Neurology, and Others), Services (Product Registration & Clinical Trial Applications, Legal Representation, Regulatory Writing & Publishing, Regulatory Consulting, and Other Services), Company Sizes (Large, Medium, and Small), End-users (Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies), and Product Stages (PMA, Preclinical, and Clinical Studies)
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Geographical Scope
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Denmark, Finland, Iceland, Norway, and Sweden
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
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Key Players Covered in the Report
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ICON plc; Global Pharma Consultancy AB; PRA Health Sciences; Parexel International Corp., Inc.; GenPact Ltd.; Freyr; Regsmart Lifesciences AB; Accell Clinical Research LLC; and Charles River Laboratories International, Inc.
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Nordic Regulatory Affairs Market Segment Insights
Outsourcing segment to grow at rapid pace
Based on service providers, the market is bifurcated into outsourcing and in-house. The outsourcing segment is expected to grow at a rapid pace during the forecast period attributed to the several companies and start-ups, which lacks infrastructure and budget for in-house regulatory affairs department and prefers outsourcing. On the other hand, the in-house segment is anticipated to expand at a substantial CAGR in the coming years due to the control of organization over process, better workflow, and improved security.
Devices segment to account for substantial growth rate
In terms of categories, the Nordic regulatory affairs market is fragmented into devices, drugs, and biologics. The devices segment is expected to account for substantial growth rate during the projected timeline owing to surge in demand for wearables and technological advancements in additive manufacturing, material science, personalized healthcare, and design languages. However, the biologics segment is projected to expand at a rapid pace during the forecast period attributed to the rise in the development of biosimilar, escalating number of product approvals, and increasing demand for targeted therapies.
Increasing cancer patients drives the oncology segment
On the basis of indications, the market is segmented into cardiology, oncology, immunology, neurology, and others. The oncology segment is projected to expand at high growth rate in the projected timeline due to increasing number of patients with cancer and presence of several innovative pipeline products. On the other hand, the immunology segment is anticipated to register a high CAGR during the forecast period attributed to boost in use of immunological molecules in gene therapy, coupled with their potential in facilitating the treatment of various inflammatory, cardiovascular, and neurological diseases.
Regulatory writing & publishing segment to grow at high CAGR
Based on services, the Nordic regulatory affairs market is segregated into product registration & clinical trial applications, legal representation, regulatory writing & publishing, regulatory consulting, and other services. The regulatory writing & publishing segment is estimated to grow at high CAGR during the forecast period owing to surge in outsourcing of these services by pharmaceutical companies to focus on their core business. However, the legal representation segment is anticipated to register significant growth during the projected period attributed to the expansion plans of major pharmaceutical, biotechnology, and medical devices companies.
Medium segment to expand at robust growth rate
On the basis of company sizes, the market is divided into large, medium, and small. The medium segment is anticipated to expand at robust growth rate during the forecast period attributed to the presence of several medium sized established providers, especially privately held ones. Furthermore, these companies have strong presence in selected markets, which is driving the segment growth further. On the other hand, the large segment is projected to expand a considerable CAGR during the forecast period owing to the growing adoption of regulatory affairs services by the companies to fulfil their regulatory needs arising due to their wide product portfolio and large geographic network.
Pharmaceutical companies segment to register a significant growth
In terms of end-users, the Nordic regulatory affairs market is fragmented into biotechnology companies, medical device companies, and pharmaceutical companies. The pharmaceutical companies segment is projected to register a significant growth during the projected period owing to the surge in number of approved products of the leading pharmaceutical companies. However, the medical device companies segment is expected to expand at a substantial growth rate in the coming years due to the rising adoption of regulatory affair services by these companies as it helps in premarket strategy, drafting regulatory submissions, and ensuring post market compliance.
Clinical trials drives the clinical studies segment
Based on product stages, the market is segmented into PMA, preclinical, and clinical studies. The clinical studies segment is anticipated to register at robust growth rate during the forecast period attributed to the emergence of new diseases and prevalence of chronic diseases, which increases the number of clinical trials for drugs. On the other hand, the preclinical segment is anticipated to hold a key share of the market in the coming years owing to the growing number of molecules in the preclinical stage, especially in the pandemic time, as companies are trying for the development and approval of drugs and vaccines to treat COVID-19.
Sweden to constitute a key market share
In terms of regions, the Nordic regulatory affairs market is classified as the Denmark, Finland, Iceland, Norway, and Sweden. The Sweden is expected to constitute a key share of the market during the projected period attributed to the rising number of drug development projects, superior quality of results from clinical trials, and presence of key pharmaceutical companies in the country. However, the market of Denmark is anticipated to expand at a rapid pace during the forecast period owing to investment in R&D activities for the production of personalized medicine, biosimilar drugs, and advanced therapy medical products.
Segments
The Nordic regulatory affairs market has been segmented on the basis of
Service Providers
Categories
- Medical Devices
- Drugs
- Biologics
Indications
- Cardiology
- Oncology
- Immunology
- Neurology
- Others
Services
- Product Registration & Clinical Trial Applications
- Legal Representation
- Regulatory Writing & Publishing
- Regulatory Consulting
- Other Services
Company Sizes
End-users
- Biotechnology Companies
- Medical Device Companies
- Pharmaceutical Companies
Product Stages
- PMA
- Preclinical
- Clinical Studies
Regions
- Denmark
- Finland
- Iceland
- Norway
- Sweden
Key Players
Competitive Landscape
Key players competing in the Nordic regulatory affairs market are ICON plc; Global Pharma Consultancy AB; PRA Health Sciences; Parexel International Corp., Inc.; GenPact Ltd.; Freyr; Regsmart Lifesciences AB; Accell Clinical Research LLC; and Charles River Laboratories International, Inc. Companies are focusing on providing services, such as such as regulatory consulting and writing & publishing for various medical devices and pharmaceutical companies to maintain their competitive position in the market. Companies have been widely engaged in strategic partnership, merger & acquisition, new product launch, and collaborations to boost their market share and acquiring new buyers.
For instance, in January 2020, MedPass International, Europe based reimbursement and regulatory consultancy and medical device CRO, was acquired by ICON Investments Limited global provider of drug and device development and commercialization services to medical device, pharmaceutical, and biotechnology industries. This acquisition was aimed to enhance ICON’s Diagnostic Research and Medical Device Services, through the addition of new clinical and regulatory and capabilities in Europe.
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