Nordic Regulatory Affairs Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

Published Date : Mar 2021 | No. of Pages : 250 Pages | Category : Healthcare

The global Nordic Regulatory Affairs market size is expected to be worth around US$ 327.7 million by 2030, according to a new report by Vision Research Reports.

The global Nordic Regulatory Affairs market size was valued at US$ 160.2 million in 2020 and is anticipated to grow at a CAGR of 7.10% during forecast period 2021 to 2030.

Growth Factors

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.

Report Highlights

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. This eventually encourages manufacturers and technology developers to focus on core competencies and outsource non-core activities. Based on the category, the market is segmented into drugs, biologics, and medical devices. The medical devices category is sub-segmented into diagnostics and therapeutics.

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. The growing number of product approvals, increasing demand for targeted therapies, and the rise in the development of biosimilars are anticipated to contribute to segment growth.

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. In Sweden, oncology holds the leading position in terms of drug development activity.

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.

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. Furthermore, several companies conduct clinical trials on existing molecules for either indication expansion or combination therapy. For instance, many companies are running clinical trials for the use of previously approved anti-viral, antibiotics, corticosteroids, and monoclonal antibodies to treat Covid-19. In November 2020, Eli Lilly's monoclonal antibody received the FDA approval for COVID-19. Such activities are anticipated to increase the need for regulatory services related to medical writing and regulatory labeling.

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.

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.

In January 2021, Recipharm, a Sweden-based contract development and manufacturing organization (CDMO), formed a manufacturing agreement with a Sweden-based medical device startup, Enzymatica AB. Enzymatica AB outsourced manufacturing of its product, ColdZyme, a mouth spray against the common cold, to Recipharm.

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. These companies have a strong presence in selected markets or in multiple markets across the Nordic region. Their services may also vary from a few to a full range of services.

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.

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. Based on end-use, the market has been segmented into pharmaceutical, biotechnology, and medical device 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 , the biologics market is anticipated to witness substantial growth in the future.

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. Based on service, the market is segmented into regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial applications, and others.

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. For instance, in June 2020, Japan-based Fujifilm announced an investment of USD 1.0 billion to build a biologics plant in Denmark. Since this is an entry of a company from outside the Nordic region, the company will require the assistance of a legal representative. Legal representatives play a key role in bridging the gap between the difference in the local regulations and the entry of major pharma/biotech and medical device companies,

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. From an international perspective, it is shown that clinical trials performed in Sweden sites deliver superior quality results.

Despite a small population of almost 10 million, 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. Major pharma companies such as Pfizer, MSD, and GSK prefer Sweden for a significant number of their researches. Sweden is also included in GSK’s list of 9 EU countries, which it prefers for accelerating its clinical trial operations. In addition, Swedish clinics participate in 25% of all Pfizer global projects. Thus, Sweden serves as the global hub for drug development, eventually increasing the need for regulatory affairs in the country.

Key Players

  • 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

Market Segmentation

  • Service Outlook 

    • Regulatory Consulting

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Applications

    • Other Services

  • Service Provider Outlook 

    • In-house

    • Outsourcing

  • Company Size Outlook 

    • Small

    • Medium

    • Large

  • Category Outlook 

    • Drugs

    • Biologics

    • Medical Devices

  • Product Stage Outlook 

    • Preclinical

    • Clinical Studies

    • PMA

  • Indication Outlook 

    • Oncology

    • Neurology

    • Cardiology

    • Immunology

    • Others

  • End-use Outlook 

    • Medical Device Companies

    • Pharmaceutical Companies

    • Biotechnology Companies

  • Country Outlook 

    • Sweden

    • Norway

    • Denmark

    • Finland

    • Iceland

The Nordic Regulatory Affairs market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Nordic Regulatory Affairs market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Nordic Regulatory Affairs market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Nordic Regulatory Affairs market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Nordic Regulatory Affairs market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Nordic Regulatory Affairs capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Nordic Regulatory Affairs by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Nordic Regulatory Affairs market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Nordic Regulatory Affairs market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Nordic Regulatory Affairs market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Nordic Regulatory Affairs industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Nordic Regulatory Affairs market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Nordic Regulatory Affairs market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Nordic Regulatory Affairs market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Nordic Regulatory Affairs market. These factors have benefited the growth of the global market for Nordic Regulatory Affairs. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Nordic Regulatory Affairs. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Nordic Regulatory Affairs are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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