‘Clinical Trials’ Metamorphosing into a Connected, Streamlined Landscape
Complexities and data volumes in clinical trials are on a ceaseless rise. There is an urging need for pharma companies to increase R&D efforts, as development costs break records and patent cliffs approach. Integration of cloud and analytics is pervasively evident, and digital transformation in healthcare are making holistic changes in the clinical trial process. The healthcare models are undergoing tectonic shifts and seeing massive inflow of new clinical trial models, which are organized, streamlined, and nurture patient engagement. Pharmaceutical companies are pushing the limits of R&D efforts to improvise their clinical trial models, which will help them cope up with ever-increasing developmental costs.
Clinical Trials Sector Outlook: Key Research Findings
- The global spending on clinical trials is projected ~ US$ 95 Bn in 2019.
- The spending on clinical trials is projected to grow at ~4% CAGR through 2029. The sustained growth in spending on clinical trials can be attributed to a persistent focus on identifying and developing novel therapies that are better than the current standard of care.
- The average cost of carrying out a clinical trial represents only a fraction of the entire cost attributed to drug development, whereas spending on clinical trials for rare diseases are typically much lesser than the average due to smaller patient enrollment.
- Europe and North America collectively held ~80% of overall spending on clinical trials in 2018, owing to well-established clinical infrastructure and preference by trial sponsors and collaborators to carry out clinical trials in countries with a robust regulatory landscape
- The U.S. is one of the most popular destinations for clinical trials across various therapy areas, except for China, where the number of clinical trials for cardiovascular indications exceeded those in the U.S. in 2018
- Industry-sponsored clinical trials held ~50% of all spending on clinical trials since a large proportion of these trials are pivotal and necessitate significant patient recruitment to demonstrate safety and efficacy.
Key Factors Shaping the Clinical Trials Landscape
Spending on Oncology Drugs Remains High, Despite Complexities
Clinical trials for various oncology indications accounted for approximately 30% of all trials registered, also representing the therapeutic indication with the most number of drug launches. Most of the top industry sponsors of clinical trials allocated a significant proportion of their R&D expenditure to the oncology drug portfolio. Among various oncology indications, non-small cell lung cancer (NSCLC) and breast cancer were predominantly targeted for clinical development. However, clinical trials for oncology are steadily becoming more complex in terms of patient recruitment, clinical trial design parameters such as endpoints, narrower eligibility criteria, among others.
Growing Focus on Enhancing Clinical Trial Design Using Predictive Analytics
Predictive analytics tools including artificial intelligence and machine learning are already being used in several companies to develop models and guide decisions. Considering the plethora of health data currently available to clinical trial investigators, predictive analytics tools can be effectively leveraged in clinical trial design to identify patient characteristics that are more likely to respond to a specific treatment pattern, thereby increasing the success rates and reducing risk to large, multi-center clinical trials. It can also aid in the development of precision approaches by assessing the effect of a certain therapeutic approach on a subset of patient population based on certain biomarkers. The potential for predictive analytics to influence clinical trial design is likely to hinge on the understanding of complex disease models by clinical trial investigators, and collaborative efforts are still underway to unlock the maximum impact on clinical development.
Developing Countries Offer Unprecedented Value to Clinical Trial Sponsors
Despite a third of all clinical trials registered are located in the U.S., clinical trial sponsors have been offshoring clinical trials to countries such as China, India, Russia, and Brazil for the past few years. These countries are attractive for several reasons: a large patient pool, well-developed healthcare infrastructure in urban areas, an abundance of skilled clinical staff for monitoring clinical trials, among other factors. Governments in certain countries are also offering incentives for clinical trial sponsors to carry out clinical trials in these countries, which typically tend to be shorter and thus, also cost-effective. There have also been several ethical questions raised pertaining to clinical trials in developing countries, which put a damper on offshoring clinical trials.
Clinical Trials Landscape: Stakeholder Assessment
- A significant proportion of clinical trials were initiated by large pharmaceutical companies, with Bristol-Myers Squibb, AstraZeneca, Merck & Co., Roche, and Johnson & Johnson rounding out the top 5 in terms of the number of trials.
- Emerging pharmaceutical and biotechnology companies are continuing to exert their influence on the clinical trials sector, with a robust pipeline of therapeutic agents paving the way.
- Companies such as Bristol-Myers Squibb, Merck & Co., Amgen, and some others focused their efforts on clinical trials for currently approved drugs to obtain marketing expansion, while companies such as AstraZeneca, GlaxoSmithKline, Johnson & Johnson, among others have a greater focus on drugs with no prior marketing authorization.
- While assessing the therapeutic area focus, most companies heavily depended on oncology, where the number of clinical trials initiated was disproportionately large compared to the rest of their respective portfolios. Only a limited number of companies had a diverse allocation of therapeutic focus.
The New-Age Clinical Trials Are ‘Web’ Based
Biopharmaceutical companies are focused on implementing digital health in the clinical trials and operations. It is highly likely that pilot projects and investments to validate digital measures will continue to rise, abreast the uptake of patient centricity to empower convenient and personalized approaches. The initial years of the ‘digitalization era’ also left some major imprints on the clinical trials landscape. Pzifer has already started focusing on new launches of web-based clinical trial outreach platforms, and other companies followed suit. Such efforts mark a new milestone for the global clinical trials space and fine tune the way clinical trials were conducted.
North America and Europe – The Goldilocks Zone
North America and Europe present a favorable and standardized ecosystem for the clinical trials landscape – collectively estimated to create an opportunity worth ~ US$ 76 Bn in 2019. These regions often gain the first mover advantage in almost every technological disruption in light of their economic vigor; and in case of clinical trials, pharmaceutical giants are adopting artificial intelligence to disrupt all stages of the process – from linking eligible patients to respective studies, to monitoring data collection and adherence.
* This data is only a representation. Actual data may vary and will be available in report.
The Broader Perspective
The clinical trials landscape is witnessing a revolutionary phase, where new sources of data are being generated and put in the hands of patients. Pharma and medical device companies are emphasizing to bridge the gap between current scope of patient access at present and future, to help them maintain a healthy lifestyle. As today’s clinical trials are way more sophisticated than the previous ones, the clinical trials landscape has been spectating persistent reformations to ensure that the essential supplies of patient kits are in right place at right time. High focus is also being placed on adaptive trial designs, which eases mid-study modifications based on accumulated data.
Industry sponsors leading the way, with over 50% shares
Steady increase projected in government sponsors
Oncology continues to garner a majority of research interests
Significant spending expected on neuroscience & CVDs
A majority of spending prevails on Phase III clinical trials
Spending on Phase II clinical trials gaining pace
How Growth will Unfold
Faster clinical trials are crucial for pharma and medical device companies, as these are time- and capital-intensive. Spending on phase III clinical trials remains comparatively higher than phase II and phase I trials, owing to their greater complexity and need for larger patient pool. Sponsors are highly likely to see greater room for success in developing regions, such as South Asia and East Asia. Moreover, the conduction of clinical trials across this fast-growing regions promises a new shade of advantages, including tax incentives and efficient regulatory pathways.
* This data is only a representation. Actual data may vary and will be available in report.Click Here To Know How The Growth Will Unfold
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Clinical Trials Landscape: Embracing the AI
A recent study published by FMI titled “Clinical Trials: Global Industry Landscape Analysis 2014 – 2018 and Outlook, 2019 – 2029” offers a comprehensive assessment of the vital aspects covering clinical trials. After conducting a thorough review of the evolution of clinical trials, as well as recent developments, the future projections and outlook are presented with maximum precision.
Clinical Trials Market Taxonomy
The clinical trials landscape is segmented in detail to cover every aspect of the market and present a complete market intelligence approach to the reader.
- Infectious Disease
- Metabolic Disorders
- Phase 0
- Phase I
- Phase II
- Phase III
- Phase IV
- Government / Public
- Non-governmental Organizations
- Others (Academic Medical Centers, Individuals, etc.)
- North America
- Latin America
- East Asia
- South Asia
- Middle East & Africa
The report commences with an executive summary of the clinical trials landscape, which includes a summary of the key findings and key statistics of the market. It also includes the spending (US$ million) attributable to the leading segments in the clinical trials landscape.
Readers can find the detailed taxonomy and the definition of various segments covered in the clinical trials landscape in this chapter, which will help them understand the basic information about clinical trials. This section also highlights the inclusions and exclusions, which helps the reader understand the scope of the clinical trials landscape report.
The report provides key trends that are expected to impact the scenario of the clinical trials landscape significantly during the forecast period. Detailed industry trends are provided in this section, along with key market developments as well as regulatory outlook.
This section includes various contextual information pertaining to the report. It includes an overview of the existing regulatory landscape navigated by key stakeholders, infrastructure necessary for clinical research, technical and IT support factors, skill sets of clinical investigators, among various other factors.
This section explains the global spending analysis and forecast for clinical trials between the forecast period of 2019-2029. This chapter includes the detailed analysis of the historical spending on clinical trials, along with projected spending in the future. Readers can also find a breakdown of the number of ongoing, completed, and suspended trials by research area in each of the regions covered in the scope of the study.
This chapter explains the key macro-economic factors that are expected to influence the growth in spending on clinical trials over the forecast period. Along with macroeconomic factors, this section also highlights the opportunity analysis for various stakeholders in the clinical trials landscape. This chapter also highlights the key dynamics impacting the clinical trials landscape, which include growth drivers, challenges, and trends. Moreover, it will enable readers to understand the key trends specific to various stakeholders in the clinical trials landscape.
This section covers the digital transformation efforts pertaining to clinical trials, including the impact on approach to clinical trial design, data collection, data analysis, as well as the use of cutting-edge technology such as artificial intelligence and big data, and predictive analysis to aid clinical trial sponsors in effectively executing trials and minimizing costs.
Some of the key statistics pertaining to clinical trials, including number of clinical trials by each phase and research area, are covered in this chapter.
This section details some of the macro factors expected to impact the clinical trials landscape, including health expenditure per capita for key countries, the outlook for the healthcare sector, as well as other overarching factors.
An in-depth breakdown of trial costs by phase is estimated at a per-patient level, including an assessment of factors and their respective impact in determining trial costs. Analysis by research area has also been provided, which incorporates factors such as patient recruitment costs based on different disease indications.
Based on sponsor, the spending analysis on clinical trials is segmented into: industry-sponsored, government / public-sponsored, non-governmental organizations, association-sponsored, as well as other sponsors. In this chapter, readers can find information about prominent sponsors of clinical trials and the impact these key stakeholders are expected to exercise over the forecast period.
This chapter provides details about the clinical trials landscape on the basis of research area, and has been classified into oncology, infectious diseases, metabolic diseases, cardiovascular diseases, neuroscience, respiratory diseases, and others. In this chapter, readers can understand the potential investment opportunity based on research area.
This chapter provides details about the clinical trials landscape on the basis of stage of trial, and has been classified into phase I, phase II, phase III, and phase IV. In this chapter, readers can understand the breakdown of spending based on trial phase, and which stages require a significant investment.
This chapter explains the outlook for clinical trials landscape across various geographic regions, such as North America, Latin America, Europe, South Asia, East Asia, Oceania, and the Middle East & Africa.
This chapter includes a detailed analysis of the North America clinical trials landscape, along with a country-wise assessment that includes the U.S. and Canada. Readers can also find the regional trends, regulations, and spending growth based on phase, area, sponsor, and countries in North America.
Readers can find detailed information about several factors, such as the trial cost structure and the regional trends, which are impacting the Latin America clinical trials landscape. This chapter also includes the investment prospects in clinical trials in leading countries such as Brazil, Mexico, and the rest of Latin America.
Key growth drivers of spending on clinical trials based on stakeholders in several countries, such as Germany, the UK, France, Spain, Italy, Russia, and the rest of Europe, are included in this chapter.
China and Japan are the prominent countries in East Asia region that are the prime subjects of assessment to obtain the growth prospects of the clinical trials landscape in this chapter. Readers can find detailed information about the growth parameters of the clinical trials landscape during the period 2019-2029.
This chapter highlights the clinical trials landscape in South Asia by focusing on Thailand, Indonesia, Malaysia, India, and the rest of South Asia. This section also helps readers understand the key factors that are responsible for the growing number of clinical trials being carried out in this region.
In this chapter, the clinical trials landscape in Australia and New Zealand has been reviewed and analyzed to provide a detailed understanding of key aspects pertaining to these countries.
This chapter provides information about how the clinical trials landscape will evolve in prominent countries in the MEA region, such as GCC Countries, North Africa, South Africa, and the rest of MEA, during the forecast period 2019 - 2029.
In this chapter, readers can find detailed information about the various industry participants carrying out clinical trials in terms of number of trials correlated with R&D spend and other key metrics. An assessment of number of active drugs and active clinical trials has also been covered for top pharmaceutical and medical device companies. Additionally, a dashboard of key clinical research organizations (CROs) in the market has been presented.
This chapter includes a list of acronyms and assumptions that provide a base to the information and statistics included in the clinical trials landscape report.
This chapter helps readers understand the research methodology followed to obtain the various conclusions as well as important qualitative and quantitative information about clinical trials.
How the research was conducted?
- C - Level Executives
- Marketing Directors
- Sales Heads
- Portfolio Managers
- Purchasing Managers
- Medical Officers
- Drug Development Heads
- Strategy Advisors
- R&D Managers
- Drug Manufacturers
- Trial Investigators
- Trial Sponsors
- Insurance Companies
- Physicians / Nursing Managers
- Industry Experts
- Current Market Dynamics and Challenges
- Market Characteristics
- Market Performance and Growth Quadrants
- Competition Structure and Market Structure
- Strategic Growth Initiatives
- Disease Patterns, Treatment and Prescription Patterns
- Regulatory and Reimbursement Landscape
- Products in Pipeline and Clinical Development
- Near-term and Long-term Market Growth Prospects
- Market Segment Splits and Authenticity
- Opinions on Market Projections and Validity of Assumptions
- Industry Magazines
- Association of Clinical Research Professionals
- Society for Clinical Trials
- Association of Clinical Research Organizations
- U.S. FDA Center for Drug Evaluation and Research
- Patient-Centered Outcomes Research Institute
- Company Press Releases
- Annual Reports and Investor Presentations
- Peer-reviewed Journals
- Government Websites and Publications
- Trade Websites
- Clinical Trial Registries
- Country-specific Regulatory Authorities
- World Bank, WHO, IMF, OECD
Primary Interview Splits