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Regulatory Affairs Outsourcing Market Huge Revenue & Latest Rising Opportunity 2020

SEP 07 2020: 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, biosimilars, and personalized medicine are propelling market growth.

A significant increase in the fixed costs of in-house resources for healthcare 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 the services such as clinical trial applications and product registration in these regions.

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Product specific clinical advice and strategy along with healthcare regulatory compliance at the early stages of product development can be critical for the product approval. Failure to address the 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 regulatory requirements.

Addressing local governing challenges and constant changes in the regulations of the major markets such as 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 governing pathway for the industry. This, in turn, is anticipated to drive the market for healthcare regulatory affairs outsourcing over the forecast period.

Further key findings from the report suggest:

• The regulatory writing and publishing segment dominated the regulatory affairs outsourcing 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 success of a product

• The legal representation segment is anticipated to register the fastest growth of 12.8% over the forecast period

• Asia Pacific held the maximum share of the global market for regulatory affairs outsourcing, accounting for 43.0% of the market 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

• Some of the players operating in the market are Accell Clinical Research, LLC.; GenPact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXi AppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance, Parexel International Corporation; Inc.; and Freyr.

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Table of Contents

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope

1.1.1. Service

1.1.2. End-use

1.1.3. Regional scope

1.1.4. 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 product and application 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. Market Dynamics

3.3.1. Market Driver Analysis Changing regulatory landscape Entry of companies in the global market


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