Regulatory Affairs Outsourcing Market Report 2022: Increasing Use of Digital Platforms/Solutions in Regulatory Affairs Driving Growth - ResearchAndMarkets.com

The "Regulatory Affairs Outsourcing Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

The following factors will drive the global regulatory affairs outsourcing market growth during the forecast period:

• Increasing Use of Digital Platforms/Solutions in Regulatory Affairs
• Changing Regulatory Landscape
• Rising Demand For Fast Drug & Medical Device Approvals
• Impact of Strict Government Regulations

REGULATORY AFFAIRS OUTSOURCING MARKET SCENARIO

Regulatory affairs service providers offer comprehensive services to companies, from strategic regulatory advice to regulatory maintenance and lifecycle support. It is the responsibility of RA outsourcing companies to keep abreast of current legislation, guidelines, and other regulatory intelligence.

• The healthcare industry is witnessing new compounds originating outside the companies ultimately responsible for marketing them. For instance, around one-third of approved drugs commercialized by big pharma/biotech companies were sourced from outside a decade ago. Approximately 50% to 70% of large companies' pipeline molecules are currently sourced outside.
• In recent years, both pharma and medical device industries have witnessed many M&As, with oncology, orthopedic, and cardiovascular diseases being a particular area of interest. For instance, the pharma industry saw around 2,880 deals worth more than $1 trillion between 2014 and the first half of 2019 in gene therapy, immuno-oncology, microbiome, and orphan drugs.
• The healthcare regulatory affairs outsourcing market is highly competitive and competes with traditional CROs and in-house regulatory affairs departments in pharma/biotech and medical device companies.

Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines

• Over the next five years, it is expected that the number of biosimilars and their market authorization will increase significantly as top-selling biologics such as Herceptin (Trastuzumab; Roche/Genentech), Enbrel (Etanercept; Amgen), Humalog (Insulin Lispro;), MabThera (Ritziximab; Roche, Basel), and Aranep (Darbepoetin Alpha; Amgen) go off patent.
• Pfizer has agreed with Biocon (India) to produce biosimilar insulin. Eli Lilly and AstraZeneca have announced plans to produce biosimilars, and Boehringer Ingelheim has established a specialized business to develop and sell biosimilars.

The emergence of Virtual Trials and Virtual Communication

• Many regulatory authorities around the globe issued guidance documents containing information on how trials could continue during the pandemic, which includes the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and Singapore's Health Science Authority.
• A constellation of emerging technology and services has permitted the relocation of clinical-trial activities closer to patients. Without in-person visits, investigators can maintain relationships with study participants using electronic consent, telehealthcare, remote patient monitoring, and electronic clinical outcome assessments (eCOAs).
• Before the pandemic, an Industry Standard Research survey in December 2019 found that 38% of pharma and contract research organizations (CROs) expected virtual trials to be a major part of their portfolios, and 48% expected to run a trial with most activities taking place in participants' homes.
• Sponsors and service providers attempting to execute decentralized trials must manage technological and approach uncertainties while balancing the demands of each stakeholder group and providing a good, distinctive experience.

Changing Regulatory Landscape

• In recent years, life sciences companies have faced increasing pressure, including regulatory requirements, technological advances, and pricing pressure. COVID-19 has only provided more reasons for modernizing compliance and improving values and partnerships within the organization and with external stakeholders.
• A recent global survey of pharmaceutical company CEOs reveals that regulations are being scrutinized for many aspects of business, including sales and marketing practices, government reporting of drug prices, privacy controls, and clinical practice.
• Changes in the regulation viewed it as one of the top three disruptive business trends facing pharmaceutical and life sciences companies. Large pharmaceutical companies recognize these changes as the greatest threat to their potential future growth.
• Contract research organizations (CROs) are well experienced and have updated on all changes in regulatory affairs in the pharmaceutical or the medical device industry. Thus, the pharmaceutical and medical devices companies are increasingly outsourcing the regulatory affairs activities to CROs.

Key Topics Covered:

1 Research Methodology

2 Research Objectives

3 Research Process

4 Scope & Coverage

5 Report Assumptions & Caveats

5.1 Key Caveats

5.2 Currency Conversion

5.3 Market Derivation

6 Market at a Glance

7 Introduction

7.1 Overview

8 Market Opportunities & Trends

8.1 Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines

8.2 Impact of Covid-19

8.3 Advancements in Regulatory Affairs Services

8.4 Emergence of Virtual Trials & Virtual Communication

9 Market Growth Enablers

10 Market Restraints

10.1 Concerns Over Data Breaches & Privacy Issues Among End-Users

10.2 Dearth of Skilled Professionals in Regulatory Affairs Outsourcing

10.3 Lack of Standardization & Monitoring Issues in Regulatory Affairs

11 Market Landscape

11.1 Market Overview

11.2 Market Size & Forecast

11.3 Five Forces Analysis

12 Product

13 Company Size

14 End-User

15 Service Type

16 Geography

17 North America

18 Europe

19 Apac

20. Latin America

21. Middle East & Africa

22. Competitive Landscape

23. Key Company Profiles

23.1 Genpact

23.2 Labcorp Drug Development

23.3 Freyr

23.4 Icon

23.5 Iqvia

23.6 Medpace

23.7 Parexel International

23.8 PPD

For more information about this report visit https://www.researchandmarkets.com/r/bfxczt

View source version on businesswire.com: https://www.businesswire.com/news/home/20220701005406/en/