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レポート概要
| 本調査資料では、世界のeクリニカルソリューション市場について調査し、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、製品種類別（臨床データ管理システム（CDMS）、臨床試験管理システム（CTMS）、ランダム化・試験供給管理、電子データキャプチャ（EDC）、電子臨床転帰アセスメント（eCOA）・電子患者報告アウトカム（ePRO）、その他）分析、展開別（クラウドベースeクリニカルソリューション、オンプレミスeクリニカルソリューション）分析、エンドユーザー別（製薬・バイオテクノロジー企業、委託研究機関（CRO）、その他）分析、地域別分析、競争状況、市場機会/将来の見通しなどを掲載しています。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・世界のeクリニカルソリューション市場規模：製品種類別（臨床データ管理システム（CDMS）、臨床試験管理システム（CTMS）、ランダム化・試験供給管理、電子データキャプチャ（EDC）、電子臨床転帰アセスメント（eCOA）・電子患者報告アウトカム（ePRO）、その他） ・世界のeクリニカルソリューション市場規模：展開別（クラウドベースeクリニカルソリューション、オンプレミスeクリニカルソリューション） ・世界のeクリニカルソリューション市場規模：エンドユーザー別（製薬・バイオテクノロジー企業、委託研究機関（CRO）、その他） ・世界のeクリニカルソリューション市場規模：地域別 ・競争状況 ・市場機会/将来の見通し |
The eClinical Solutions Market was estimated to be USD 6,550 million in 2020 is expected to witness a CAGR of 12.5% to reach USD 13,250 million by 2026 during the forecast period.
The COVID-19 pandemic has created an inflection point for the eClinical solutions market. Most of the pharmaceutical and biotechnological companies have focused their R&D efforts to aid in the development of a vaccine against COVID-19. Many companies have invested a significant amount of resources to utilize analytics in the fight against COVID-19. In June 2020, eClinical Solutions LLC, a leading provider of cloud-based enterprise software collaborated with Karyopharm Therapeutics on randomized clinical trials for low-dose Selinexor (a drug) in hospitalized patients with severe COVID-19. Due to the large volume of clinical trials being conducted across the world, there is an increase in demand for software that can be used to expedite the process of vaccine development. Also, clinical trials that are being conducted for the COVID-19 vaccine involve studies being simultaneously conducted in different countries. For example, Pfizer’s Covid-19 vaccine involved research in countries like Argentina, South Africa, Brazil, Germany, and Turkey as well as the United States. Collating such a large amount of data from different clinical trials in different nationalities requires advanced analytics software. This is expected to have a positive effect on market growth.
The major market drivers include Enormous Data Mounting from the Healthcare Industry, Rising Number of Clinical Trials, and Government Emphasis on Clinical Research.
The costs and risks associated with developing new therapeutics, which are majorly related to drug trials, are continuing to rise. This trend is expected to gain momentum with the advent of personalized medicine and the proliferation of virtual pharma companies, which are emerging as entities, without the traditional large-scale pharma capabilities.
With the increasing prevalence of Internet of Things (IoT) and digitization of healthcare, the amount of data being produced is huge and contains information that can be easily accessed with electronic data mining, which was earlier impossible with paper records. According to World Economic Forum records from 2019, hospitals produce around 50 petabytes of data per year. The information encompasses a variety of areas like clinical notes, lab tests, medical images, sensor readings, genomics, and operational and financial data. eClinical solutions are expected to have a significant impact in this area.
In low- and middle-income countries, healthcare infrastructure continues to face many challenges to provide high-quality, affordable, and universally-accessible care. In response, policy-makers, donors, and program implementers are searching for innovative approaches to eliminate the geographical and financial barriers to health. eClinical solutions are also expected to fill the gap in providing remote populations with government healthcare. Also, due to the COVID-19 pandemic, healthcare systems are stretched, and eClinical solutions are being utilized to provide logistical support in the distribution of essential services.
Also, the need to maintain transparency and eliminate redundancy and forgery of the medical research-related data are the primary reasons for the widespread adoption of eClinical solutions in the market
Key Market Trends
Clinical Data Management Systems Segment, by Product Type, is Expected to Dominate the Market
Due to the COVID-19 pandemic, many pharmaceutical and biotechnology companies are investing significantly in R&D. Many organizations operating in this field are conducting clinical trials for vaccines and treatments against COVID. Across the world, there have been nine vaccines that have received approval for use against COVID-19. A further 56 other candidates are in various stages of clinical development. As the number of clinical trials is expected to increase in the coming months, the demand for robust eClinical solutions is also expected to observe a surge.
Historically, clinical trial activities, including recruitment, retention, delivery of interventions, and data collection, used to be conducted by conventional methods such as ‘face-to-face’, physical form filings, and so on. Over the years, a dramatic change has been observed in terms of clinical trials being conducted with the adoption of e-technologies.
Researchers are now incorporating electronic tools for various activities of clinical trials such as developing protocols, communicating with study personnel, randomize participants, collect data, and analyze results, and others. For example, Medidata Inc. offers an eClinical Solution called Rave EDC which provides fast implementation and maximum control for clinical studies. According to the company, till the end of 2020, 17,000 studies (with one-third ongoing ) and more than 4 million patient experiences have been recorded by using Rave EDC.
Many software tools are now available for clinical data management such as ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. All of these have more or less similar features. However, now the pharmaceutical and biopharmaceutical companies are shifting towards customized software tools related to eclinical solutions. For instance, OpenClinica LLC provides an open-source software of EDC (electronic data capture) and CDMS (clinical data management system) for optimizing clinical trials. Customized software such as these is expected to see an increase in demand in the coming years.
With the adoption of electronic medical records, a growing amount of data is being generated through automated medical equipment and monitoring devices. The adoption of IoT in medical devices necessitates the need for efficient data management systems.
In response to this, many of the companies are developing a single platform that is expected to observe a greater adoption. One such example is Perceptive MyTrials designed by Parexel, a single platform for accessing data, information, and applications related to clinical trials. These emerging comprehensive platforms are further expected to support clinical trial-related strategies and user workflow.
A major trend driving this segment is the integration of the CDMS with clinical randomization, supply management, trial, and patient recruitment solutions. Companies are also developing their existing eClinical tools for extending the capabilities and further easing the whole clinical trial conduction. For instance, in June 2020, eClinical Solution LLC, a cloud-based enterprise software developer has added connectors to the Formedix, Omnicomm, Box, and elluminate which would allow the users to integrate data from various clinical systems. The volume and variety of clinical data are continuing to grow, with most trials relying on five or more different data sources for their studies, thus the clinical analytics platform will play an important role and will also help to identify missed visits and forecast upcoming future visits, including those for dosing, which have a greater likelihood to be missed based on a variety of data sources.
Additionally, the developing economies are expected to drive the growth of the market, due to the increasing adoption of these systems, government funding to support clinical trials, and the presence of a large patient base.
Asia-Pacific is Expected to be the Fastest Growing Region Over the Forecast Period
Asia Pacific is likely to register a good CAGR over the forecast period due to the high unmet medical needs and rising prevalence of chronic diseases such as cancer, cardiovascular conditions, and infectious diseases which are creating the demand for eClinical solutions in the region. The COVID-19 pandemic is expected to have a significant effect on the development of eClinical Solutions in the region. Due to its high population and better management of the COVID-19 pandemic, countries across the region have been reaping the benefits of investing in eClinical solutions.
An increase in research and development activities by governments is also creating avenues for growth. According to the National Bureau of Statistics of China in 2018, the national total R&D expenditures reached 1,967.79 billion yuan, an increase of 207.18 billion yuan or 11.8 percent over the previous year. Thus, the growth in government funding related to research and drug discovery is triggering the overall market growth.
Owing to its rising urban population, Asia-Pacific is one of the preferred destinations associated with clinical trials. Also, according to the United Nations in 2019, the region contained about 54% of the global urban population and is rising at a rapid pace. The United Nations also stated that over half the region’s population lived in urban areas in 2019. India, one of the largest countries in the region, has been investing in its eClinical infrastructure. Several Indian companies are acquiring, partnering, and launching tools in eclinical solutions to strengthen their position on a global and regional level. In August 2020, Quantzig launched a comprehensive portfolio of clinical data analytics solutions to strengthen its market position in the global arena. The presence of a large urban population and an increase in diagnostic services are expected to sustain for some time in the Asia-Pacific region. This can drive the number of admissions into hospitals, which, in turn, is expected to increase the amount of data being generated. The presence of major companies in the region is expected to positively affect market development.
Competitive Landscape
The eClinical solutions market is highly competitive and is growing, due to greater technology adoption and smaller and mid-sized sponsors. The major players were Oracle Corporation, Veeva Systems, PAREXEL International Corporation, and Saama Technologies, Inc amongst others. The firm concentration ratio is expected to increase in emerging markets, like APAC and South America, offering growth opportunities for smaller enterprises. The players are also found to be involved in various growth strategies such as new product development, mergers and acquisitions, and collaborations, which are helping them consolidate their position in the market.
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1 INTRODUCTION
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Enormous Data Mounting from the Healthcare Industry
4.2.2 Rising Number of Clinical Trials
4.2.3 Government Emphasis on Clinical Research
4.3 Market Restraints
4.3.1 Lack of Awareness and Infrastructure in Developing Countries
4.3.2 High Implementation Costs
4.4 Porter’s Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size By Value)
5.1 By Product Type
5.1.1 Clinical Data Management Systems (CDMS)
5.1.2 Clinical Trial Management Systems (CTMS)
5.1.3 Randomization and Trial Supply Management
5.1.4 Electronic Data Capture (EDC)
5.1.5 Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient-reported Outcomes (ePRO)
5.1.6 Clinical Analytics Platforms
5.1.7 eTMF (Electronic Trial Master File)
5.1.8 Other Product Types
5.2 By Deployment Mode
5.2.1 Cloud-based eClinical Solutions
5.2.2 On-premise eClinical Solutions
5.3 By End-user
5.3.1 Pharmaceutical and Biotechnology Companies
5.3.2 Contract Research Organizations (CROs)
5.3.3 Other End-users
5.4 Geography
5.4.1 North America
5.4.1.1 United States (By Product Type, By Deployment Mode and By End User)
5.4.1.2 Canada (By Product Type, By Deployment Mode and By End User)
5.4.1.3 Mexico (By Product Type, By Deployment Mode and By End User)
5.4.2 Europe
5.4.2.1 Germany (By Product Type, By Deployment Mode and By End User)
5.4.2.2 United kingdom (By Product Type, By Deployment Mode and By End User)
5.4.2.3 France (By Product Type, By Deployment Mode and By End User)
5.4.2.4 Italy (By Product Type, By Deployment Mode and By End User)
5.4.2.5 Spain (By Product Type, By Deployment Mode and By End User)
5.4.2.6 Rest of Europe (By Product Type, By Deployment Mode and By End User)
5.4.3 Asia-Pacific
5.4.3.1 China (By Product Type, By Deployment Mode and By End User)
5.4.3.2 Japan (By Product Type, By Deployment Mode and By End User)
5.4.3.3 India (By Product Type, By Deployment Mode and By End User)
5.4.3.4 Australia (By Product Type, By Deployment Mode and By End User)
5.4.3.5 South Korea (By Product Type, By Deployment Mode and By End User)
5.4.3.6 Rest of Asia-Pacific (By Product Type, By Deployment Mode and By End User)
5.4.4 Middle East and Africa
5.4.4.1 GCC (By Product Type, By Deployment Mode and By End User)
5.4.4.2 South Africa (By Product Type, By Deployment Mode and By End User)
5.4.4.3 Rest of Middle East and Africa (By Product Type, By Deployment Mode and By End User)
5.4.5 South America
5.4.5.1 Brazil (By Product Type, By Deployment Mode and By End User)
5.4.5.2 Argentina (By Product Type, By Deployment Mode and By End User)
5.4.5.3 Rest of South America (By Product Type, By Deployment Mode and By End User)
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Oracle Corporation
6.1.2 BioClinicia Inc.
6.1.3 PAREXEL International Corporation (Calyx)
6.1.4 Veeva Systems
6.1.5 ERT Clinical
6.1.6 Covance (LabCorp)
6.1.7 eClinical Solutions Inc.
6.1.8 Dassault Systemes (Medidata Solutions Inc.)
6.1.9 IBM Watson Health (Merge Healthcare Incorporated)
6.1.10 CRF Health Inc.
6.1.11 Saama Technologies, Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS