Global Regulatory Affairs Outsourcing Market – Industry Trends and Forecast to 2030

Global Regulatory Affairs Outsourcing Market, By Services Outlook (Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration, Clinical Trial Applications and Other Services), Size (Small, Medium and Large), Category (Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical devices, Therapeutic and Diagnostic), Indication (Oncology, Neurology, Cardiology, Immunology and Others), Stage (Preclinical, Clinical and PMA (Post Market Authorization), End-User (Medical Device Companies, Pharmaceutical Companies and Biotechnology Companies) – Industry Trends and Forecast to 2030.

Regulatory Affairs Outsourcing Market Analysis and Size

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities is the main driving factor for the regulatory affairs outsourcing market. The rising number of clinical trials is also a driving factor for the regulatory affairs outsourcing market. The improvement in the process focusing on pre-marketing and post-marketing activities, and reduced regulatory service cost is an opportunity for the regulatory affairs outsourcing market.

Risk associated with data security and system access is a big challenge for the regulatory affairs outsourcing market. However, loss of control and technological advances leading to pricing fluctuations is the main restraint in the growth of regulatory affairs outsourcing market during the forecast period.          

Data Bridge Market Research analyses that the regulatory affairs outsourcing market which was USD 9,389.20 million in 2022, would rocket up to USD 15,312.19 million by 2030, and is expected to undergo a CAGR of 10.66% during the forecast period. “Oncology” dominates the indication segment of the regulatory affairs outsourcing market owing to an increase in the prevalence of cancer. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Regulatory Affairs Outsourcing Market Scope and Segmentation

Market Definition

Regulatory affairs outsourcing is the services utilized by the pharmaceutical, biotech, and medical devices manufacturing companies for gaining fast regulatory approvals from various organizations. Regulatory mainly involves extensive testing of a particular product to ensure public health protection, marketing authorization, import and distribution and meeting product safety and performance, the market player ensures that the product meets all regulatory requirements.

Regulatory Affairs Outsourcing Market Dynamics

Drivers

• Increasing Regulatory Complexity

Regulatory requirements in industries such as pharmaceuticals, biotechnology, and medical devices are becoming more intricate and diverse. This complexity drives companies to seek specialized regulatory expertise from outsourcing partners to ensure compliance and navigate evolving regulations efficient.

• Rapid Technological Advances

Industries such as pharmaceuticals and medical devices continuously introduce innovative products and technologies. To keep up with the pace of innovation, companies rely on outsourcing partners with specialized knowledge to navigate regulatory hurdles efficiently and bring new products to market faster.

• Focus on Core Competencies 

Companies are increasingly recognizing the importance of focusing on their core competencies, such as research and development, manufacturing, and marketing. By outsourcing regulatory affairs, they can delegate regulatory tasks to experts and allocate more resources to their primary business activities.

• Flexibility and Scalability

The outsourcing model provides flexibility and scalability to adapt to changing regulatory needs. Companies can scale their regulatory operations up or down based on project requirements, allowing for efficient resource allocation.  

Opportunities

• Expanding Pharmaceutical and Healthcare Industries

The pharmaceutical and healthcare sectors are experiencing rapid growth globally, driven by an aging population, increasing healthcare expenditures, and the development of innovative therapies and medical devices. This growth creates a substantial opportunity for regulatory affairs outsourcing as companies seek efficient ways to navigate complex regulatory landscapes and bring products to market faster.

• Adoption of Advanced Technologies

The adoption of advanced technologies, such as artificial intelligence (AI) and data analytics, can enhance regulatory affairs processes. Outsourcing providers can leverage these technologies to streamline regulatory data management, submissions, and compliance, offering innovative solutions to clients.

Restraints/Challenges

• Confidentiality and Data Security Concerns

Regulatory affairs often involve sensitive and confidential data, including proprietary product information and clinical trial data. Companies may be hesitant to outsource these activities due to concerns about data security, confidentiality breaches, and intellectual property protection.

• Quality Control Challenges

Maintaining consistent quality standards and oversight can be challenging when outsourcing regulatory affairs. Companies may worry about the level of control they have over regulatory processes and whether outsourced providers can maintain the same quality and compliance standards.

• Changing Regulatory Landscapes

Regulatory environments are constantly evolving, with new regulations and guidelines being introduced in various regions and industries. Keeping up with these changes and ensuring compliance across multiple jurisdictions can be a significant challenge for outsourcing providers and their clients.

• Data Privacy and Security

Handling sensitive regulatory data, including clinical trial information and patient data, requires strict adherence to data privacy regulations like GDPR in Europe. Ensuring the security and privacy of data across borders and during the outsourcing process is a complex challenge.

This regulatory affairs outsourcing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the regulatory affairs outsourcing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In February 2021, ICON plc acquired PRA Health Sciences, Inc. in a cash and stock transaction valued at approximately USD 12 billion. This acquisition has strengthened the medical affairs service offering of the company
• In August 2021, ProPharma Group acquired India-based iSafety Systems. This acquisition is expected to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information

Global Regulatory Affairs Outsourcing Market Scope

The regulatory affairs outsourcing market is segmented on the basis of service outlook, size, category, indication, stage and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Service Outlook

• Regulatory Consulting
• Legal Representation
• Regulatory Writing and Publishing
• Product Registration
• Clinical Trial Applications
• Other Services

Size

• Small
• Medium
• Large

Category

• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Medical Devices
• Therapeutic
• Diagnostic

Indication

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Stage

• Preclinical
• Clinical
• PMA (Post Market Authorization)

End-User

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Market Regional Analysis/Insights

The regulatory affairs outsourcing market is analysed and market size insights and trends are provided by service outlook, size, category, indication, stage and end-user as referenced above.

The countries covered in the regulatory affairs outsourcing market report are U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, U.A.E., Egypt, Israel, Rest of Middle East and Africa.

North America is likely to lead the regulatory affairs outsourcing market. The regional market has been driven by the low costs of labour increased availability of a skilled workforce and increasing number of clinical trials and a rising number of companies trying to enter markets. However, growing market with new players is the main factor propelling the growth of the regional market. The market in Asia-Pacific is expected to exhibit a substantial growth rate during the forecast period 2023 to 2030 due to growing number of regulatory affairs out-sourcing companies and availability of skilled workforce.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and up-stream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Competitive Landscape and Regulatory Affairs Outsourcing Market Share Analysis

The regulatory affairs outsourcing 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 company’s focus related to regulatory affairs outsourcing market.

Some of the major players operating in the regulatory affairs outsourcing market are:

• Accell Clinical Research, LLC (U.S.)
• Genpact (U.S.)
• CRITERIUM, INC. (U.S.)
• PRA Health Sciences (U.S.)
• Promedica International(U.S.)
• WuXiAppTec (China)
• Medpace (U.S.)
• PPD Inc. (U.S.)
• Charles River Laboratories (U.S.)
• ICON plc (U.S.)
• Covance (U.S.)
• Parexel International Corporation. (U.S.)
• Freyr, Navitas Clinical Research, Inc. (U.S.)
• Medelis, Inc. (U.S.)
• Sciformix (U.S.)
• Tech Tammina(U.S.)
• Acorn Regulatory Consultancy Services Ltd. (Ireland)
• BIOMAPAS (Lithuania)
• REGULATORY PROFESSIONALS (Australia)
• CompareNetworks, Inc. (U.S.),