Please Wait.....
Report
Healthcare Regulatory Affairs Outsourcing Market- Growth, Trends, Covid-19 Impact, and Forecasts (2023 - 2028)
Market Report I 2023-01-23 I 135 Pages I Mordor Intelligence
The Healthcare Regulatory Affairs Outsourcing Market is expected to register a CAGR of 8.5% during the forecast period of 2022-2027.
During pandemic a large number of clinical trials were postponed as well as canceled, this has impacted the regulatory outsourcing market, as clinical trials are the major driver for the industry. For instance, according to the study titled "COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective" published in the Frontier in Medicine in December 2021, there is a decrease in clinical trials between each month in 2019 and the corresponding month in 2020, the average percentage change in newly started clinical trials for diseases other than COVID-19 was -7.5% &, with a maximum of -57.3% observed between April 2019 and April 2020. Similarly, in 2019 and 2020, the average percentage change in reported results for each month was -5.1% in 2020. This is expected to reduce the overall regulatory affairs services demand in the industry.
The market growth can be attributed to the growing R&D expenditure, increasing number of clinical trials, the cost-effectiveness of the outsourcing, and lack of internal skilled professionals. For instance, according to ClinicalTrials.gov March 2022, as of March 2021, 410,703 studies were listed in 220 countries out of which 318,134 interventional studies and 90,926 observational studies. Moreover, as per the same source, the number of clinical trial studies is expected to increase from 325,775 in 2020 to 399,532 by the year 2023. Thus, an increasing number of clinical trial studies is expected to increase the regulatory affairs outsourcing over the forecast period.
Furthermore, increasing research and development investment by pharmaceutical and biotechnology firms is anticipated to drive market growth. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the members of PhRinvested MA about USD 83 billion in R&D activities in 2019. Also, more than 260 vaccines are under development for various diseases, including COVID-19, as per PhRMA, 2020.
Additionally, various strategic activities by key market players such as product launches, mergers and acquisitions are anticipated to drive market growth. For instance, in July 2021, Covance acquired GlobalCare, a global leader in patient-centric decentralized clinical trials (DCTs), in order to expand Covance's DCT offerings into international markets and meet the growing demand for patient-centric trial designs.
Thus, all the aforementioned factors are expected to boost the market over the forecast period. However, the risk associated with data security and lack of standardization are the major restraining factor for the studied market.
Healthcare Regulatory Affairs Outsourcing Market Trends
Product Registration & Clinical Trial Applications Segment is Expected to Hold Large Market Share Over the Forecast Period
Product Registration refers to the application for regulatory approval granted by the applicable governmental authority in a given country or territory to allow a product to be marketed, distributed, sold, or imported in that country or territory. And a clinical trial application contains detailed information about the investigational medicinal product and planned trial, allowing regulatory authorities to assess the study's feasibility.
The increase in outsourcing of clinical trial applications and product registrations in both developed and developing countries is driving the expansion of the clinical trial applications and product registrations segment over the forecast period. Due to the complexity of the product registration process, lack of industry professions, and lack of internal capability, most pharmaceutical and medical device companies outsource their product registration activities to third-party service providers. This is anticipated to propel the segment growth over the forecast period.
Thus, all aforementioned factors are expected to boost the segment growth over the forecast period.
North America is Expected to Hold Major Market Share Over the Forecast Period
Pricing pressure due to the changing reimbursement scenario and generic competition is causing major pharmaceutical firms to outsource regulatory affairs activities which are supplementing the growth of healthcare regulatory outsourcing services in North America. Additionally, growing research and development activity rising in the number of clinical trials anticipated the market growth in the region.
Furthermore, as per November 2021 updated data by Clinicaltrials.gov, 32% of the trials were registered in the United States where the major number of trials are related to various types of drugs which is likely to drive the regulatory affairs outsourcing thereby anticipated the market growth.
Moreover, the presence of key players in the region and strategic collaborations by these companies are driving the market's growth. For instance, in April 2021, Parexel and Veeva Systems announced a strategic partnership to speed up clinical trials by leveraging technology and process innovation. Both businesses will benefit from each other's regulatory consulting services.
Thus, all aforementioned factor expected to boost the market growth in the North America region over the forecast period.
Healthcare Regulatory Affairs Outsourcing Market Competitor Analysis
The market studied is a fragmented market owing to the presence of various market players. The market players are focusing on R&D to develop new and efficient products in the market. Some of the market players are Accell Clinical Research, LLC., Charles River Laboratories International, Inc, Criterium Inc., Covance, Inc., ICON Plc., IQVIA, PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC.
Additional Benefits:
The market estimate (ME) sheet in Excel format
3 months of analyst support
1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Number of Clinical Trials
4.2.2 Life Science Companies Focusing on Their Core Competencies
4.3 Market Restraints
4.3.1 Risk Associated with the Data Security
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 by Services
5.1.1 Regulatory Consulting
5.1.2 Legal Representation
5.1.3 Regulatory Writing & Publishing
5.1.4 Product Registration & Clinical Trial Applications
5.1.5 Other Services
5.2 by End User
5.2.1 Pharmaceutical and Biotechnology Companies
5.2.2 Medical Device Companies
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle-East
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle-East
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Accell Clinical Research, LLC.
6.1.2 Charles River Laboratories International, Inc.
6.1.3 Criterium Inc.
6.1.4 Covance, Inc.
6.1.5 ICON PLc.
6.1.6 IQVIA
6.1.7 Medpace, Inc.
6.1.8 PAREXEL International Corporation
6.1.9 Pharmaceutical Product Development, (PPD) LLC.
6.1.10 Promedica International
6.1.11 WuXi App Tec
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
- Not Sure / Need Reassuring
- Confirm Content
-
Content is provided by our partners and every effort is made to make Market Report details as clear as possible. If you are not sure the exact content you require is included in this study you can Contact us to double check. To do this you can:
Use the ‘? ASK A QUESTION’ below the license / prices and to the right of this box. This will come directly to our team who will work on dealing with your request as soon as possible.
Write to directly on support@scotts-international.com with details. Please include as much information as possible including the name of report or link so our staff will be able to work on you request.
Telephone us directly on 0048 603 394 346 and an experienced member of team will be on hand to answer.
-
- Sample Pages
-
With the vast majority of our partners we can obtain Sample Pages to support your decision. This is something we can arrange without revealing your personal details.
It is important to note that we will not be able to provide you the exact data or statistics such as Market Size and Forecasts. Sample pages usually confirm the layout or the Categories included in Charts and Graphs, excluding specific data.
To ask for Sample Pages by contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
-
- Check for Alternatives
-
Whilst we try to make our online platform as easy to use as possible there is always the possibility that a better alternative has not been found in your search.
To avoid this possibility Contact us through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346 and a Senior Team Member can review your requirements and send a list of possibilities with opinions and recommendations.
-
- Confirm Content
- Prices / Formats / Delivery
- Prices
-
All prices are set by our partners and should be exactly the same as those listed on their own websites. We work on a Revenue share basis ensuring that you never pay more than what is offered elsewhere.
Should you find the price cheaper on another platform we recommend you to Contact us as we should be able to match this price. You can Contact us though through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
-
- Discounts
-
As we work in close partnership with our Partners from time to time we can secure discounts and assist with negotiations, this is part of our personalised service to you.
Discounts can sometimes be arranged for speedily placed orders; multiple report purchases or Higher License purchases.
To check if a Discount is possible please Contact our experienced team through ‘? ASK A QUESTION’, support@scotts-international.com, or by telephoning 0048 603 394 346.
-
- Available Currencies
-
Most Market Reports on our platform are listed in USD or EURO based on the wishes of our Partners. To avoid currency fluctuations and potential price differentiations we do not offer the possibility to change the currency online.
Should you wish to pay in a different currency to that advertised online we do accept payments in USD, EURO, GBP and PLN. The price will be calculated based on the relevant exchange rate taken from our National Bank.
To pay in a different above currency to that advertised online please Contact our team and a quotation will be sent within a couple of hours with payment details.
-
- Licenses
-
License options vary from Partner to Partner as is usually based on the number of Users that will benefitting from the report. It is very important that License ordered is not breached as this could have potential negative consequences for you individually or your employer.
If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.
-
- Global Site License
-
The Global Site License is the most comprehensive license available. By selecting this license, the Market Report can be shared with other ‘Allowed Users’ and any other member of staff from the same organisation regardless of geographic location.
It is important to note that this may exclude Parent Companies or Subsidiaries.
If you have questions or need confirmation about the specific license we recommend you to Contact us and a detailed explanation will be provided.
-
- Formats
-
The most common format is PDF, however in certain circumstances data may be present in Excel format or Online, especially in the case of Database or Directories. In addition, for certain higher license options a CD may also be provided.
If you have questions or need clarification about the specific formats we recommend you to Contact us and a detailed explanation will be provided.
-
- Delivery
-
Delivery is fulfilled by our partners directly. Once an order has been placed we inform the partner by sharing the delivery email details given in the order process.
Delivery is usually made within 24 hours of an order being placed, however it may take longer should your order be placed prior to the weekend or if otherwise specified on the Market Report details page. Additionally, if details have been not fully completed in the Order process a delay in delivery is possible.
If a delay in delivery is expected you will be informed about it immediately.
-
- Shipping Charges
-
As most Market Reports are delivered in PDF format we almost never have to add additional Shipping Charges. If, however you are ordering a Higher License service or a specific delivery format (e.g. CD version) charges may apply.
If you are concerned about additional Shipping Charges we recommend you to Contact us to double check.
-
- Prices
- Ordering
- By Credit Card
-
We work in Partnership with PayU to ensure payments are made securely in a fast and effortless way. PayU is the e-payments division of Naspers.
Naspers operates in over 133 International Markets and ranks 3rd Globally in terms of the number of e-commerce customers served.
For more information on PayU please visit: https://www.payu.pl/en/about-us
-
- By Money Transfer
-
If you require an invoice prior to payment, this is possible. To ensure a speedy delivery of the Market Report we require all relevant company details and you agree to maximum payment terms of 30 days from receipt of order.
With our regular clients deliver of the Market Report can be made prior to receiving payment, however in some circumstances we may ask for payment to be received before arranging for the Market Report to be delivered.
-
- By Credit Card
- Security
- Website security
-
We have specifically partnered with leading International companies to protect your privacy by using different technologies and processes to ensure security.
Everything submitted to Scotts International is encrypted via SSL (Secure Socket Layer) and all personal information provided to Scotts International is stored on computer systems with limited access in controlled environments.
-
- Credit Card Security
-
We partner with PayU (https://www.payu.pl/en/about-us) to ensure all credit card payments are made securely in a fast and effortless way.
PayU offers 250+ various payment channels and eWallet services across 4 continents allowing buyers to pay electronically, whether on a computer or a mobile device.
-
- Website security