{"id":45760,"date":"2022-07-01T19:01:46","date_gmt":"2022-07-01T17:01:46","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/regulatory-affairs-outsourcing-market-report-2022-increasing-use-of-digital-platforms-solutions-in-regulatory-affairs-driving-growth-researchandmarkets-com\/"},"modified":"2022-07-01T19:01:46","modified_gmt":"2022-07-01T17:01:46","slug":"regulatory-affairs-outsourcing-market-report-2022-increasing-use-of-digital-platforms-solutions-in-regulatory-affairs-driving-growth-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/regulatory-affairs-outsourcing-market-report-2022-increasing-use-of-digital-platforms-solutions-in-regulatory-affairs-driving-growth-researchandmarkets-com\/","title":{"rendered":"Regulatory Affairs Outsourcing Market Report 2022: Increasing Use of Digital Platforms\/Solutions in Regulatory Affairs Driving Growth &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5614341\/regulatory-affairs-outsourcing-market-global?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=9lpwmq&amp;utm_campaign=1721049+-+Regulatory+Affairs+Outsourcing+Market+Report+2022%3A+Increasing+Use+of+Digital+Platforms%2FSolutions+in+Regulatory+Affairs+Driving+Growth&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Regulatory Affairs Outsourcing Market &#8211; Global Outlook and Forecast 2022-2027&#8221;<\/a> report has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220701005406\/en\/1503441\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220701005406\/en\/1503441\/21\/logo.jpg\"><\/a><\/p>\n<p>\n<strong>The following factors will drive the global regulatory affairs outsourcing market growth during the forecast period:<\/strong>\n<\/p>\n<ul>\n<li>\nIncreasing Use of Digital Platforms\/Solutions in Regulatory Affairs\n<\/li>\n<li>\nChanging Regulatory Landscape\n<\/li>\n<li>\nRising Demand For Fast Drug &amp; Medical Device Approvals\n<\/li>\n<li>\nImpact of Strict Government Regulations\n<\/li>\n<\/ul>\n<p>\n<strong>REGULATORY AFFAIRS OUTSOURCING MARKET SCENARIO<\/strong>\n<\/p>\n<p>\nRegulatory 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.\n<\/p>\n<ul>\n<li>\nThe 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&#8217; pipeline molecules are currently sourced outside.\n<\/li>\n<li>\nIn recent years, both pharma and medical device industries have witnessed many M&amp;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.\n<\/li>\n<li>\nThe 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.\n<\/li>\n<\/ul>\n<p>\n<strong>Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines<\/strong>\n<\/p>\n<ul>\n<li>\nOver 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.\n<\/li>\n<li>\nPfizer 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.\n<\/li>\n<\/ul>\n<p>\n<strong>The emergence of Virtual Trials and Virtual Communication<\/strong>\n<\/p>\n<ul>\n<li>\nMany 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&#8217;s Health Science Authority.\n<\/li>\n<li>\nA 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).\n<\/li>\n<li>\nBefore 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&#8217; homes.\n<\/li>\n<li>\nSponsors 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.\n<\/li>\n<\/ul>\n<p>\n<strong>Changing Regulatory Landscape<\/strong>\n<\/p>\n<ul>\n<li>\nIn 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.\n<\/li>\n<li>\nA 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.\n<\/li>\n<li>\nChanges 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.\n<\/li>\n<li>\nContract 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.\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>1 Research Methodology<\/strong>\n<\/p>\n<p>\n<strong>2 Research Objectives<\/strong>\n<\/p>\n<p>\n<strong>3 Research Process<\/strong>\n<\/p>\n<p>\n<strong>4 Scope &amp; Coverage<\/strong>\n<\/p>\n<p>\n<strong>5 Report Assumptions &amp; Caveats<\/strong>\n<\/p>\n<p>\n5.1 Key Caveats\n<\/p>\n<p>\n5.2 Currency Conversion\n<\/p>\n<p>\n5.3 Market Derivation\n<\/p>\n<p>\n<strong>6 Market at a Glance<\/strong>\n<\/p>\n<p>\n<strong>7 Introduction<\/strong>\n<\/p>\n<p>\n7.1 Overview\n<\/p>\n<p>\n<strong>8 Market Opportunities &amp; Trends<\/strong>\n<\/p>\n<p>\n8.1 Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines\n<\/p>\n<p>\n8.2 Impact of Covid-19\n<\/p>\n<p>\n8.3 Advancements in Regulatory Affairs Services\n<\/p>\n<p>\n8.4 Emergence of Virtual Trials &amp; Virtual Communication\n<\/p>\n<p>\n<strong>9 Market Growth Enablers<\/strong>\n<\/p>\n<p>\n<strong>10 Market Restraints<\/strong>\n<\/p>\n<p>\n10.1 Concerns Over Data Breaches &amp; Privacy Issues Among End-Users\n<\/p>\n<p>\n10.2 Dearth of Skilled Professionals in Regulatory Affairs Outsourcing\n<\/p>\n<p>\n10.3 Lack of Standardization &amp; Monitoring Issues in Regulatory Affairs\n<\/p>\n<p>\n<strong>11 Market Landscape<\/strong>\n<\/p>\n<p>\n11.1 Market Overview\n<\/p>\n<p>\n11.2 Market Size &amp; Forecast\n<\/p>\n<p>\n11.3 Five Forces Analysis\n<\/p>\n<p>\n<strong>12 Product<\/strong>\n<\/p>\n<p>\n<strong>13 Company Size<\/strong>\n<\/p>\n<p>\n<strong>14 End-User<\/strong>\n<\/p>\n<p>\n<strong>15 Service Type<\/strong>\n<\/p>\n<p>\n<strong>16 Geography<\/strong>\n<\/p>\n<p>\n<strong>17 North America<\/strong>\n<\/p>\n<p>\n<strong>18 Europe<\/strong>\n<\/p>\n<p>\n<strong>19 Apac<\/strong>\n<\/p>\n<p>\n<strong>20. Latin America<\/strong>\n<\/p>\n<p>\n<strong>21. Middle East &amp; Africa<\/strong>\n<\/p>\n<p>\n<strong>22. Competitive Landscape<\/strong>\n<\/p>\n<p>\n<strong>23. Key Company Profiles<\/strong>\n<\/p>\n<p>\n23.1 Genpact\n<\/p>\n<p>\n23.2 Labcorp Drug Development\n<\/p>\n<p>\n23.3 Freyr\n<\/p>\n<p>\n23.4 Icon\n<\/p>\n<p>\n23.5 Iqvia\n<\/p>\n<p>\n23.6 Medpace\n<\/p>\n<p>\n23.7 Parexel International\n<\/p>\n<p>\n23.8 PPD\n<\/p>\n<p>\nFor more information about this report visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5614341\/regulatory-affairs-outsourcing-market-global?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=9lpwmq&amp;utm_campaign=1721049+-+Regulatory+Affairs+Outsourcing+Market+Report+2022%3A+Increasing+Use+of+Digital+Platforms%2FSolutions+in+Regulatory+Affairs+Driving+Growth&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/bfxczt<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;&#111;&#x3a;&#112;&#x72;&#101;s&#x73;&#64;&#x72;&#101;&#x73;&#101;&#x61;&#114;&#x63;&#104;a&#x6e;d&#x6d;&#97;&#x72;&#107;&#x65;&#116;s&#x2e;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;r&#x65;s&#x73;&#64;&#x72;&#101;&#x73;&#101;a&#x72;c&#x68;&#97;&#x6e;&#100;&#x6d;&#97;&#x72;&#107;e&#x74;s&#x2e;&#99;&#x6f;&#109;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Regulatory Affairs Outsourcing Market &#8211; Global Outlook and Forecast 2022-2027&#8221; report has been added to ResearchAndMarkets.com&#8217;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 &amp; Medical Device Approvals &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/regulatory-affairs-outsourcing-market-report-2022-increasing-use-of-digital-platforms-solutions-in-regulatory-affairs-driving-growth-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45760","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Affairs Outsourcing Market Report 2022: Increasing Use of Digital Platforms\/Solutions in Regulatory Affairs Driving Growth - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/regulatory-affairs-outsourcing-market-report-2022-increasing-use-of-digital-platforms-solutions-in-regulatory-affairs-driving-growth-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Affairs Outsourcing Market Report 2022: Increasing Use of Digital Platforms\/Solutions in Regulatory Affairs Driving Growth - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Regulatory Affairs Outsourcing Market &#8211; Global Outlook and Forecast 2022-2027&#8221; report has been added to ResearchAndMarkets.com&#8217;s offering. 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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 &amp; Medical Device Approvals ... 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