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Pharmaceutical and Life Sciences Real World Evidence, 2020-2030: Distribution by Type of Applications, Type of Real World Data Sources, Therapeutic Area, and Geography
INTRODUCTION Drug discovery and development is a complex and time intensive process that requires a significant amount of resources and capital investments (~USD 2. 6 billion). In fact, on an average, the journey from establishment of initial proof-of-concept to product launch, takes around 10-12 years.New York, April 22, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Pharmaceutical and Life Sciences Real World Evidence, 2020-2030: Distribution by Type of Applications, Type of Real World Data Sources, Therapeutic Area, and Geography" - https://www.reportlinker.com/p06064556/?utm_source=GNW Moreover, regulatory approval is dependent on the results of randomized clinical trials (RCTs), which are estimated to account for a staggering 40% of the pharmaceutical industry’s budget in the US. It is also well known that clinical research is fraught with various other challenges, including inefficiencies in medical data management and processing, unforeseen delays, risk of failure / study termination and several patient recruitment and retention-related concerns. Further, since such trials are conducted under controlled conditions and involve a fairly homogenous patient population, there are chances that, post commercial launch, approved products fail to perform as expected. In this context, the application of insights from real world data, accrued from past trials, has been demonstrated to have the potential to save up to USD 1 billion per year. In fact, real world evidence can actually complement results from controlled RCTs, thereby, validating the therapeutic potential of a new chemical / biological entity.In December 2016, after the 21st Century Cures Act was passed, the United States Food and Drug Administration (USFDA) began considering the application of real world evidence in healthcare decision-making. Ever since, pharmaceutical companies and health economists have developed advanced tools and analytical algorithms to mine pharmaceutical big data, in order to better understand the clinical value of product candidates targeting some of the rarest medical conditions. Presently, big pharmaceutical companies are estimated to spend nearly USD 20 million on an annual basis, on generating real world evidence to support their respective clinical development programs. Over time, insights from real world data have not only influenced product approval-related decisions, but also helped convince insurance provider / payers into offering reimbursement for new drugs / therapies. The growing adoption of artificial intelligence and machine learning in big data analysis, is anticipated to better inform future drug discovery initiatives, thereby, reducing the risk of product failure. The adoption of real world evidence in healthcare decision making is projected to grow substantially as the healthcare industry shifts towards the personalized medicine.SCOPE OF THE REPORTThe “Pharmaceutical and Life Sciences Real World Evidence (2nd Edition), 2020-2030: Distribution by Type of Applications (Early Stage Research, Clinical Development, Regulatory Approval, Pricing / Reimbursement, Post-Approval Studies), Type of Real World Data Sources (Medical Claims, Clinical Trials, Clinical Setting, Patient Powered and Other Data Sources), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Neurological / Psychiatric Disorders, Oncological Disorders, Respiratory Disorders and Other Disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World)” report features an extensive study of the current market landscape and future potential of the industry players that are engaged in offering real world data / analytics / services to the pharmaceutical and life sciences industries. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the study features: A detailed assessment of the current market landscape of companies that claim to offer real world evidence related solutions based on a number of relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of services offered (real world data, analytics, consulting and services), real world data sources (medical claims, clinical trials, clinical setting, pharmacy, patient-powered and others), and target application areas (early stage research, clinical development, regulatory submission / reimbursement / market access, and post-approval studies). A detailed analysis of completed, ongoing and planned clinical trials conducted in the real world setting based on the multiple parameters, such as trial status, trial registration year, regional distribution, enrolled patient population, type of study, leading industry and non-industry players, emerging focus areas and key therapeutic areas. A detailed publication analysis of more than 950 peer-reviewed, scientific articles that have been published between 2016 and September 2020, highlighting the research focus within the industry. It also highlights the key trends observed across publications, including information on type of publication, year of publication, study objective, popular keywords, types of real world datasets utilized, key disease indications, type of publisher, leading players (in terms of number of publications), region, and key journals (in terms of number of articles published in this domain and impact factor of the journal). A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of companies that have acquired other firms, offering a means for other industry stakeholders to identify potential acquisition targets. A social media analysis depicting prevalent and emerging trends, and the popularity of real world evidence solutions, as observed on the social media platform, Twitter. In addition to providing information on yearly trends related to the volume of tweets, the analysis highlights the most frequently talked about real world data sources, target applications, therapeutic areas, active players, and influential authors. The analysis was based on tweets posted on the platform in the last few years. An in-depth analysis of recent events (summits / forums / conferences / annual meetings) that were organized for stakeholders in this domain, highlighting the evolution of discussion topics related to real world evidence. The analysis also provides details on type of event, regional distribution, emerging agendas, popular organizers, active industry and non-industry players, and a schematic mapping of upcoming events. A comparative analysis to understand the needs of different stakeholders (manufacturers, regulators, payers, providers and patients) involved in this domain. Elaborate profiles of prominent real world evidence service providers. Each company profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key members of the executive team), details related to their respective portfolio of technologies / platforms / services, recent developments, and an informed future outlook. An elaborate discussion on data governance and the existing regulatory framework related to real world evidence across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific and rest of the world (Australia, China and Japan). A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall real world evidence market. An insightful discussion on how the recent COVID-19 pandemic likely to impact the real world evidence market, along with key initiatives undertaken by industry players to combat the challenges faced to the pandemic. A list of recent use cases where real world evidence was leveraged by pharmaceutical / medical device companies, highlighting the ways in which companies have utilized such information to support regulatory decisions, advance disease understanding, and develop outcome-based reimbursement model.One of the key objectives of the report was to estimate the existing market size and future growth potential within the real world evidence market. We have developed informed estimates of the financial evolution of the market, over the period 2021-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] target application areas (early stage research, clinical development, regulatory approval, pricing / reimbursement, and post-approval studies), [B] type of real world data sources used (medical claims, clinical trials, clinical setting, patient-powered and other data sources), [C] therapeutic areas (autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, neurological / psychiatric disorders, oncological disorders, respiratory disorders and other disorders), and [D] geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our forecast model, we have provided three scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.The opinions presented in this study were also influenced by discussions held with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order): Limor BH Epstein (Founder, Data2Life) Anonymous (Vice President, A Big Pharmaceutical Company) Wirth Peter (Vice President, RTI Health Solutions) Douglas Drake (Senior Director, Clinerion) Fernando Santa (Chief Operating Officer, Adarna Health Data) Jonathan Moshinsky (Chief Strategy Officer, uMotif) Anonymous (Savana)All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.RESEARCH METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.The secondary sources of information include: Annual reports Investor presentations SEC filings Industry databases News releases from company websites Government policy documents Industry analysts’ viewsWhile the focus has been on forecasting the market till 2030, the report also provides our independent view on technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.KEY QUESTIONS ANSWERED Who are the leading players engaged in offering real world evidence services? What are the primary elements of the real world data governance model? What is the current regulatory framework for real world evidence across various geographies? What are the requirements of different stakeholders involved in this domain? What are the key drivers for the acquisition activity in the real world evidence domain? Which are the most active clinical trial sites related to this domain? How is the COVID-19 pandemic likely to impact the overall real world evidence market? What is the cost saving potential associated with the use of real world evidence solutions in the drug discovery process? How is the current and future opportunity likely to be distributed across key market segments? What are the anticipated future trends related to real world evidence solutions market?CHAPTER OUTLINESChapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the real world evidence market in the short-mid term and long term.Chapter 3 is an introductory chapter that presents a general overview of investment required for developing new medical products, along with information on the limitations associated with randomized clinical trials. Further, it features a detailed discussion on the growing importance of real world evidence and its potential to complement RCTs in healthcare decision-making. It also includes a description of how real world evidence insights is generated from raw, unstructured data, along with details on different sources of data, and the potential applications of this novel approach. Further, the chapter features a discussion on the key growth drivers and roadblocks related to real world evidence, and the novel technologies that are likely to have a notable impact on this industry’s evolution over the coming decade.Chapter 4 provides a detailed description on the primary elements of data governance and regulatory framework related to real world evidence across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific and rest of the world (Australia, China and Japan).Chapter 5 provides a detailed assessment of the industry players that claim to offer real world evidence solutions. The chapter presents analysis of these players on the basis of the year of establishment, company size (in terms of number of employees), location of headquarters, type of services offered (real world data, analytics, consulting and services), real world data sources (medical claims, clinical trials, clinical setting, pharmacy, patient-powered and others), and target application areas (early stage research, clinical development, regulatory submission / reimbursement / market access, and post-approval studies).Chapter 6 features profiles of prominent real world evidence service providers. Each company profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key members of the executive team), details related to their respective portfolio of technologies / platforms / services, recent developments and an informed future outlook.Chapter 7 presents a detailed geographical clinical trial analysis of completed, ongoing and planned studies conducted in the real world setting based on the multiple parameters, such as current trial status, trial registration year, regional distribution, enrolled patient population, type of study, leading industry and non-industry players, emerging focus areas and key therapeutic areas. It also highlights the clinical trials conducted for the novel COVID-19 disease. Further, it presents a benchmarking analysis of the leading industry players (in terms of the number of trials conducted).Chapter 8 provides information on certain recent publications that we came across during our research on real world evidence. This chapter features a detailed analysis the key prevalent trends associated with these publications, including information on type of publication, year of publication, study objective, popular keywords, types of real world datasets utilized, key disease indications, type of publisher, leading players (in terms of number of publications), region, and key journals (in terms of number of articles published in this domain and impact factor of the journal) to offer better insights on the emerging trends in this area.Chapter 9 provides insights on the popularity of real world evidence on the social media platform, Twitter. The chapter highlights the yearly distribution of tweets posted on the platform in the last few years and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter showcases the most frequently mentioned keywords, real world data sources, target applications, therapeutic areas and players, on the social media platform. It elucidates the most prolific authors and presents a bubble analysis of the most influential authors related to real world evidence on Twitter.Chapter 10 presents the insights obtained from a detailed analysis of the events organized for stakeholders in this domain. In addition, the chapter provides details on the different agendas of the summits / forums / conferences / workshops that have been conducted over the last few years or are planned to be held in the coming years. The analyses presented in the chapter are based on different parameters related to the shortlisted global events, such as the date of event, location, type of event and focus area, organizer, and most active stakeholders, and designations / affiliated departments of the participants.Chapter 11 presents information on the needs of different stakeholders (manufacturers, regulators, payers, providers and patients) involved in this domain. The chapter qualitatively assesses the real world evidence related needs of each stakeholder group and the relative importance of their expectations within this domain.Chapter 12 provides a detailed acquisition target analysis, taking into consideration the historical trend of the activity of the companies that have acquired other firms, and offering a means for other industry stakeholders to identify potential acquisition targets.Chapter 13 provides details on the key parameters and trends that are likely to influence the future of the real world evidence market, under a comprehensive SWOT framework. The chapter also features a schematic Harvey ball analysis to highlight the relative impact of each SWOT parameter on the overall real world evidence market.Chapter 14 provides a comprehensive list of notable real world evidence use cases of pharmaceutical / medical device companies in the recent past (since 2016). The chapter highlights how these companies leveraged real world evidence to support their regulatory decisions, advance disease understanding and clinical guidelines, and assist outcome-based reimbursement decisions. In addition, the chapter presents an insightful opportunity analysis, estimating the existing market size and potential growth opportunities of real world evidence across different applications (early stage research, clinical development, regulatory approval, pricing / reimbursement, and post-approval studies). Based on multiple parameters, such as number of pre- or post-approval studies conducted annually, investment associated with these studies, and the likely cost and time saving opportunities, we have provided an informed estimate on the likely evolution of the market over the period 2021-2030. In addition, the report provides detailed market segmentation on the basis of type of real world data sources (medical claims, clinical trials, clinical setting, patient-powered and other data sources), therapeutic area (autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, neurological / psychiatric disorders, oncological disorders, respiratory disorders and other disorders), and the geographical distribution of the market (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World).Chapter 15 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the real world evidence domain. The participants, who were primarily Directors / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their offerings and the associated commercial potential.Chapter 16 highlights the impact of COVID-19 outbreak on the real world evidence market. In addition, it features a brief discussion on the key initiatives undertaken by players.Chapter 17 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario.Chapter 18 is a collection of transcripts of interviews conducted with various key stakeholders during the course of this study. We have presented the details of our discussions with Limor BH Epstein (Founder, Data2Life), Anonymous (Vice President, Big Pharmaceutical Company), Wirth Peter (Vice President, RTI Health Solutions), Douglas Drake (Senior Director, Clinerion), Fernando Santa (Chief Operating Officer, Adarna Health Data), Jonathan Moshinsky (Chief Strategy Officer, uMotif), and Anonymous (Savana).Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures included in the report.Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p06064556/?utm_source=GNWAbout ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.__________________________ CONTACT: Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001
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