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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Regulatory Affairs Outsourcing Market Report Highlights
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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 Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2016 – 2027)
Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2016 – 2027)
Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2016 – 2027)
Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2016 – 2027)
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) 1.6.1.1. Approach 1: Commodity flow approach 1.6.2. Volume price analysis (Model 2) 1.6.2.1. 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 3.4.1.1. Changing regulatory landscape 3.4.1.2. Entry of companies in the global market 3.4.1.3. Growth in emerging areas such as personalized medicine, biosimilar, and orphan drugs 3.4.1.4. Demand for faster approval process for breakthrough drugs and devices 3.4.1.5. Economic and competitive pressures 3.4.1.6. Life science companies focusing on their core competencies 3.4.2. Market Restraint Analysis 3.4.2.1. Data insecurity 3.4.2.2. Monitoring issues and lack of standardization 3.4.3. Industry Challenges 3.4.3.1. 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 3.5.1.1. Supplier Power 3.5.1.2. Buyer Power 3.5.1.3. Substitution Threat 3.5.1.4. Threat from new entrant 3.5.1.5. 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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