Regulatory Affairs Outsourcing Market To Experience Robust Growth In Order To Deal With Trends Till 2027 | Grand View Research, Inc.

Regulatory Affairs Outsourcing Market To Experience Robust Growth In Order To Deal With Trends Till 2027 | Grand View Research, Inc.

Grand View Research, Inc. – Market Research And Consulting.
Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting), By End Use (Medical Device Companies, Pharmaceutical Companies), By Region, And Segment Forecasts, 2020 – 2027

The global regulatory affairs outsourcing market size is expected to reach USD 15.6 billion by 2027, expanding at a CAGR of 11.9%, according to a new report by Grand View Research, Inc. The entry of life sciences companies in global markets and the evolution of new areas such as orphan drugs, biosimilar, and personalized medicine are propelling the market growth.

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities are driving life science firms to outsource these functions. Also, the rising number of clinical trials is expected to boost the demand for regulatory affairs services such as clinical trial applications and product registration in these regions.

Product-specific clinical advice & strategy along with administrative compliance at the early stages of product development can be critical to product approval. Failure to address administrative compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the administrative requirements.

Addressing local regulatory challenges and constant changes in the regulations of the major markets such as the U.S., Europe, and Asia is creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay current with developments around the world. Amendments to current regulations are likely to complicate the regulatory pathway for the industry. Thus, the demand for regulatory affairs outsourcing is increasing. In addition, the presence of major players in the regions contributed to market growth.

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The U.S. regulatory affairs outsourcing market size, by service, 2016 - 2027 (USD Million)

Regulatory Affairs Outsourcing Market Report Highlights

  • The regulatory writing and publishing services dominated the market in 2019 with a share of around 35.6% as they are offered from early stages of development to post-marketing authorization phase and is vital for the success of a product
  • The large companies segment accounted for the highest revenue share in 2019 and is anticipated to maintain its dominance over the forecast period due to increasing demand for outsourcing services provided by the large companies to various pharma industries
  • The drugs segment was the largest in 2019 in terms of both revenue and market share due to increasing prevalence of various chronic diseases and increasing expenditure on drug R&D activities
  • The oncology segment holds the largest revenue share as of 2019 due to the increasing prevalence of cancer cases globally
  • The clinical segment accounted for the largest revenue share of 45.0% in 2019 due to increasing demand for clinical trials in developing countries
  • Based on end-use, the pharmaceutical companies segment was the largest in 2019 due to growth in evolving areas such as orphan drugs and adaptive trial designs
  • Asia Pacific dominated the market and accounted for 43.0% of the revenue share in 2019. This can be attributed to the relatively lower cost for outsourcing, skilled workforce with technical expertise, and expansion of life sciences companies in countries such as India and China
  • In the U.S., the market is expected to witness the fastest growth over the forecast period owing to the growing adoption of large molecule therapeutics as an alternative for small molecules.

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Global regulatory affairs outsourcing market share, by end use, 2019 (%)

Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global regulatory affairs outsourcing market based on services, company size, category, indication, stage, end-user, and region:

Regulatory Affairs Outsourcing Services Outlook (Revenue, USD Million, 2016 – 2027)

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

Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2016 – 2027)

  • Small
  • Medium
  • Large

Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2016 – 2027)

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

Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2016 – 2027)

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2016 – 2027)

  • Preclinical
  • Clinical
  • PMA (Post Market Authorization)

Key Topic Covered

Chapter 1. Methodology and Scope
                  1.1. Market Segmentation & Scope
                      1.1.1. Services
                      1.1.2. Company Size
                      1.1.3. Category
                      1.1.4. Indication
                      1.1.5. Stage
                      1.1.6. End User
                      1.1.7. Regional scope
                      1.1.8. Estimates and forecast timeline
                  1.2. Research Methodology
                  1.3. Information Procurement
                      1.3.1. Purchased database
                      1.3.2. GVR’s internal database
                      1.3.3. Secondary sources
                      1.3.4. Primary research
                  1.4. Information or Data Analysis
                      1.4.1. Data analysis models
                  1.5. Market Formulation & Validation
                  1.6. Model Details
                      1.6.1. Commodity flow analysis (Model 1)
                 Approach 1: Commodity flow approach
                      1.6.2. Volume price analysis (Model 2)
                 Approach 2: Volume price analysis
                  1.7. List of Secondary Sources
                  1.8. List of Primary Sources
                  1.9. Objectives
                      1.9.1. Objective 1: Understanding the market dynamics
                      1.9.2. Objective 2: Understanding the market estimates and forecasts
                      1.9.3. Objective 3: Understanding the attributes such as strategy framework, competitor categorization
                      1.9.4. Objective 4: Understanding the key service scopes to conclude on the market size
Chapter 2. Executive Summary
                  2.1. Market Outlook
                  2.2. Segment Outlook
                  2.3. Competitive Insights
Chapter 3. Regulatory Affairs Outsourcing Market Variables, Trends & Scope
                  3.1. Market Lineage outlook
                      3.1.1. Parent market outlook
                      3.1.2. Related/ancillary market outlook
                  3.2. Penetration & Growth Prospect Mapping
                  3.3. Product Pipeline Analysis, by Service
                  3.4. Market Dynamics
                      3.4.1. Market Driver Analysis
                 Changing regulatory landscape
                 Entry of companies in the global market
                 Growth in emerging areas such as personalized medicine, biosimilar, and orphan drugs
                 Demand for faster approval process for breakthrough drugs and devices
                 Economic and competitive pressures
                 Life science companies focusing on their core competencies
                      3.4.2. Market Restraint Analysis
                 Data insecurity
                 Monitoring issues and lack of standardization
                      3.4.3. Industry Challenges
                 Managing the relationships
                      3.4.4. Emerging Trends in Technology
                  3.5. Regulatory Affairs Outsourcing Market: Market Analysis Tools
                      3.5.1. Industry Analysis – Porter’s
                 Supplier Power
                 Buyer Power
                 Substitution Threat
                 Threat from new entrant
                 Competitive rivalry


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About Grand View Research

Grand View Research provides syndicated as well as customized research reports and consulting services on 46 industries across 25 major countries worldwide. This U.S.-based market research and consulting company is registered in California and headquartered in San Francisco. Comprising over 425 analysts and consultants, the company adds 1200+ market research reports to its extensive database each year. Supported by an interactive market intelligence platform, the team at Grand View Research guides Fortune 500 companies and prominent academic institutes in comprehending the global and regional business environment and carefully identifying future opportunities.

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