Changing Paradigms in Clinical Trials, 2019-2050

News provided by

Jun 18, 2019, 16:01 ET

NEW YORK, June 18, 2019 /PRNewswire/ -- INTRODUCTION
The process of developing novel and effective healthcare products is both cost and time intensive. Studies suggest that each prescription drug requires around 10 years and over USD 2.5 billion in working capital before it reaches the market. Further, it is estimated that, in the US, 40% of the pharma industry's R&D budget is spent solely on conducting clinical trials. In addition to excessive capital requirement, clinical research is fraught with various other challenges, such as inefficient data handling, risk of failure / termination and a myriad of difficulties associated with patient recruitment and retention. Estimates suggest that nearly 85% of clinical trials fail to retain enough patients for successful study conduct. Patient recruitment and retention-related concerns have been associated with massive delays, with over 90% of clinical trials failing to comply to predetermined completion dates, due to poor participant accrual and excessive subject dropout. Such delays are estimated to result in capital losses of USD 8 million, per day, for a blockbuster drug. Another prominent area of concern is related to the handling of clinical data, which results in delays in data analysis and preparation of outcome reports

Read the full report: https://www.reportlinker.com/p05786221/?utm_source=PRN

Over the years, the pharmaceutical industry has leveraged technological advances to address several of the aforementioned clinical trial-related constraints / challenges. In fact, the clinical research segment has recently witnessed a surge in the availability of vendors, offering a diverse range of services and solutions for conducting and managing various aspects of trials. Apart from novel clinical trial designs, other advances in this domain include the application of decentralized clinical trial models, use of real-world evidence for clinical research, adoption of advanced clinical supply management solutions and introduction of various patient engagement tools. Many of the aforementioned concepts / solutions have demonstrated the potential to disrupt the conventional method of conducting trials, enabling the establishment of a more patient centric approach to drug development research. Such novel initiatives have also received significant funding from both private and public investors. We are led to believe that the ongoing efforts to improve drug / therapy development research are likely to boost the overall growth of the pharmaceutical market in the coming years.

The 'Changing Paradigms in Clinical Trials: Market Landscape and Competitive Insights, 2019-2050' report features an extensive study of the current landscape of industry players that are offering various types of innovative clinical research platforms / solutions to the pharmaceutical and life sciences industries.

Amongst other elements, the report features:
An overview of the current market landscape of companies offering solutions for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, featuring information on year of establishment, geographical location, company size and type of offerings. It also includes a list of virtual clinical trials, clinical studies that have used / are using innovative designs (adaptive trials, basket trials and umbrella trials), and a case study on clinical trials being conducted in real-world settings; the studies are analyzed on the basis of various parameters, such as location of the trial site, target indication, trial phase and study start-date.
Brief profiles of companies offering solutions for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, featuring information on their year of establishment, respective headquarters, company size, key executives, service / technology portfolio, recent developments and an informed future outlook.
A study of prevalent and emerging trends in the domain, as observed on the social media platform, Twitter. The analysis takes into consideration tweets posted on the platform, between 2013 and 2019 (till March), related to virtual trials, innovative trial designs and patient centricity.
A case study on the initiatives of big pharma players related to virtual clinical trials, offering insights on such clinical studies that have been conducted / planned by the aforementioned players, along with details on associated constraints and the future plans of players engaged in this domain.
An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity of the market for virtual clinical trial services, adaptive trial design services, real-world evidence based clinical trial services and clinical operations management services. Based on parameters, such as number of pre- or post-approval studies conducted annually, capital investments made in these studies, and the likely cost and time saving opportunities, we have provided an informed estimate of the likely evolution of the market for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, in the short to mid-term and mid to long term, for the period 2019-2050. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (cardiovascular disorders, infectious disorders, metabolic disorders, neurological disorders, oncological disorders and others), [B] end-users (small-sized players, mid-sized players, large players and academia / others) [C] phase of development (phase I, phase II, phase III and phase IV) and [D] key geographical regions (US, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):
Phillipe Lemmens (Chief Operating Officer, Andaman7)
Himanshu Verma (Founder and Chief Executive Officer, ConsilX) and Rajesh Jain (Co-Founder, ConsilX)
Greg Erman (President and Chief Executive Officer, EmpiraMed)
Jonathan Moshinsky, Head of Market Strategy, uMotif

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.

1.1. RESEARCH METHODOLOGY
The research, analysis and insights presented in this report are backed by a deep understanding of insights gathered from both secondary and primary sources. For all our projects, we conduct interviews with experts in the area (academia, industry 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' views

While the focus has been on forecasting the market till 2050, the report also provides our independent view on various 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.

1.2. CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the market for virtual clinical trials, adaptive trial designs, real-world evidence based clinical trials and clinical operations management, in the mid to long term.

Chapter 3 presents a general overview of the investment, in terms of time and cost, required for developing new healthcare products, along with information on other constraints associated with clinical research, including patient recruitment and retention, evolving regulatory standards and inefficient data handling. Further, it features a detailed outline on the various upcoming trends that are anticipated to play a crucial role in shaping the future of clinical trials, including increasing focus on patient centricity, precision medicine, real-world evidence, big data analytics, virtual clinical trials, innovative trial designs and blockchain-based platforms.

Chapter 4 provides a list of industry players that are actively involved in offering services for virtual clinical trials. The chapter presents analyses of these players based on year of establishment, geographical location, company size and types of services offered (study start-up, patient enrollment, drug logistics, data collection and analysis, and patient retention). It also features an indicative list of virtual clinical trials, which has been analyzed based on various relevant parameters, such as location of the trial site, target indication, trial phase and study start-date.

Chapter 5 provides a detailed list of industry players that are actively engaged in offering services for designing / conducting adaptive clinical trials. The chapter presents analysis of these players on the basis of their year of establishment, geographical location, company size and type of offerings (trial design, trial execution and data analysis). The chapter also provides an indicative list of clinical trials using such designs and their analysis on the basis of various parameters, such as location of the trial site, target indication, trial phase and study start-date.

Chapter 6 provides a list of the industry players that are engaged in providing services for operations management of clinical trials. The chapter presents analysis of these players on the basis of their year of establishment, geographical location, company size and type of offerings (supply management, document handling, trial oversight, data management, unified clinical trials and payment automation).

Chapter 7 provides a detailed list of players that are actively involved in providing real world evidence-based solutions / platforms to facilitate the conduct of clinical trials. The chapter presents analysis of these players on the basis of their year of establishment, geographical location, company size and type of offerings (study start-up, patient enrollment, trial execution, data analytics and regulatory affairs management). The chapter also presents a case study on clinical trials being conducted in real-world settings; the trials are analyzed on the basis of various parameters, such as location of the trial site, target therapeutic area, trial phase, study start-date, type of sponsors and most active players.

Chapter 8 features brief profiles of companies offering solutions for virtual clinical trials, adaptive trial designs, clinical operations management and real-world evidence based clinical trials, featuring information on their year of establishment, respective headquarters, company size, key executives, service / technology portfolio, recent developments and an informed future outlook.

Chapter 9 provides insights on the three popular information segments, namely virtual trials, innovative trial designs and patient centricity as observed on the social media platform, Twitter. The chapter highlights the yearly distribution of tweets posted on the platform in the period between January 2013 and March 2019, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter features the most frequently mentioned keywords, applications, therapeutic areas and players, on the social media platform. It also presents a bubble analysis of the most influential authors on Twitter.

Chapter 10 is a case study on the initiatives of big pharma companies related to virtual clinical trials, offering insights on such clinical studies that have been conducted / planned by the aforementioned players, along with details on associated constraints and the future plans of players engaged in this domain.

Chapter 11 presents details on various investments and grants received by companies that are engaged in this domain, including a detailed analysis of the funding instances that have taken place during the period 2013-2018, highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 12 provides an insightful opportunity analysis, estimating the existing market size and potential growth opportunities across service providers working in different domains, including virtual clinical trials, innovative trial designs, clinical trial operations management and real-world evidence based clinical trials. Based on multiple parameters, such as number of 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 2019-2050. The report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (cardiovascular disorders, infectious disorders, metabolic disorders, neurological disorders, oncological disorders and others), [B] end-users (small-sized players, mid-sized players, large players and academia / others) [C] phase of development (phase I, phase II, phase III and phase IV) and [D] key geographical regions (US, Europe, Asia-Pacific and Rest of the World).

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it summarizes the various evolutionary trends that are likely to influence the future of virtual clinical trials, adaptive trials, real-world evidence based clinical trials and clinical operations management.

Chapter 14 is a collection of interview transcripts of discussions held with key stakeholders in this market. We have presented the details of our discussions with (in alphabetical order of company names) Phillipe Lemmens (Chief Operating Officer, Andaman7), Himanshu Verma (Founder and Chief Executive Officer, ConsilX), Rajesh Jain (Co-Founder, ConsilX), Greg Erman (President and Chief Executive Officer, EmpiraMed) and Jonathan Moshinsky (Head of Market Strategy, uMotif).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains the list of companies and organizations mentioned in the report.

Read the full report: https://www.reportlinker.com/p05786221/?utm_source=PRN

About Reportlinker
ReportLinker 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: [email protected]
US: (339)-368-6001
Intl: +1 339-368-6001