Cell And Gene Therapy Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, II, III, IV), By Indication (Oncology, CNS), By Region (Asia Pacific, North America), And Segment Forecasts, 2023 - 2030

Research Methodology

A three-pronged approach was followed for deducing the cell and gene therapy clinical trials market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for cell and gene therapy clinical trials market to gather the most reliable and current information possible.

• We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
• We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
• We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
• We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
• We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of cell and gene therapy clinical trials market data depending on the type of information we’re trying to uncover in our research.

• Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

• Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

• Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

• Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

• Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

• Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

• This step also entails the finalization of the report scope and data representation pattern.

• Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Cell And Gene Therapy Clinical Trials Market Categorization:

The cell and gene therapy clinical trials market was categorized into three segments, namely phase (Phase I, Phase II, Phase III, Phase IV), indication (Oncology, Cardiology, CNS, Musculoskeletal, Infectious Diseases, Dermatology, Endocrine, Metabolic, Genetic, Immunology & Inflammation, Ophthalmology, Hematology, Gastroenterology), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa).

Segment Market Methodology:

The cell and gene therapy clinical trials market was segmented into phase, indication, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

• Demand estimation of each product across countries/regions summed up to from the total market.

• Variable analysis for demand forecast.

• Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

• Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

• Used extensively for new product forecasting or analyzing penetration levels.

• Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

• Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

• This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The cell and gene therapy clinical trials market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into twenty-three countries, namely, the U.S.; Canada; Germany; the UK; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; Australia; Thailand; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Cell and gene therapy clinical trials market companies & financials:

The cell and gene therapy clinical trials market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

• ICON plc: ICON is a global CRO that provides clinical, consulting, & commercialization services. It specializes in strategic development management and analysis of programs that support clinical development ranging from the selection of a compound to phase I to phase IV clinical studies. The company also provides functional outsourcing & laboratory services. Its laboratory services include a range of high-value testing services including vaccines, biomarkers, good manufacturing practices, and bioanalytical & central laboratory services. The company offers full-service & functional service partnerships to customers. ICON provides development & commercialization services to medical device, biotechnology, pharmaceutical, and public health & government organizations. The company focuses on various therapeutics in areas such as cardiology, central nervous system, cell & gene therapies, genomics, infectious diseases, ophthalmology, endocrine & metabolic disorders, transplant immunology, internal medicine & immunology, rare & orphan diseases, and women’s health.

• Labcorp: The company has transformed from a local laboratory operating from a hospital basement to a leading global life sciences company that is deeply integrated in guiding patient care. Labcorp has grown organically and through targeted acquisitions that have added to its geographic and technological scope. In February 2015, Laboratory Corporation of America Holdings (LabCorp) acquired Covance, Inc. The company offered preclinical, nonclinical, clinical, and commercialization services to biotechnological & pharmaceutical companies to manage drug development efficiently through its product, Solutions Made Real.

• Syneos Health Inc.: The company provides phase I to phase II clinical development services. The company offers its services to medical devices and biopharmaceutical companies. The company has two functional segments, namely Phase I services and clinical development services. The Phase I service segment includes support for Phase I studies for established compounds, exploratory medicine, and first-in-human studies. The clinical development segment offers global studies, clinical monitoring, patient recruitment, quality assurance reviews, consulting services, investigator recruitment, and study reports to facilitate drug development.

• Charles River Laboratory: The company providesclinical laboratory services and preclinical services for pharmaceutical, and biotechnology industries. Charles operates through three segments: Research Models and Services (RMS), Discovery and Safety Assessment (DSA), and Manufacturing Support. Its DSA segment offerings include bioanalysis, drug metabolism, toxicology, and pharmacokinetics services. It caters its product & services to biotechnology & pharmaceutical companies, medical device companies, hospitals, clinics, and academic institutions. The company has a presence in Canada, Finland, Belgium, France, Hungary, Germany, Italy, China, Italy, Japan, Spain, the Netherlands, and the UK.

• Medpace Holdings Inc.: Medpace is a contract research organization that provides clinical development services for pharmaceutical, biologics, and medical device companies. The company’s clinical development services include management of medical & global regulatory affairs, clinical trial management, medical writing, pharmacovigilance, and core laboratory & quality assurance services. Its regulatory affairs services include regulatory strategies for early-stage development and regulatory writing for clinical studies. Medpace also provides regulatory approval services and post-market support services such as clinical study reports, literature reviews, market approvals, post-market registries, and vigilance writing.

• PPD, Inc.: The company is a global provider of clinical development and laboratory services focused on operational excellence. The company was acquired by Thermo Fisher Scientific in April 2021. Its broad range of analytical and clinical development services allows Thermo Fisher Scientific customers to drive innovation and increase drug development productivity. The company is recognized for accelerating promising medicines from early development stages through regulatory approvals to market. Its customized solutions are used by biotech, medical devices, pharma, and government organizations.

• PAREXEL International Corporation: The company offers services such as medical communications, clinical research, consulting, advanced technology products & services, and commercialization. These services are utilized by biotechnological, pharmaceutical, and medical device companies globally. The company operates in three segments: PAREXEL Consulting Services, PAREXEL Informatics, and Clinical Research Services. The services offered by the CRS segment are clinical trial management, biostatistics, observational studies, clinical logistics, and patient disease registries. The company became a subsidiary of Pamplona Capital Management in 2017.

• The Novotech: The company is a leading biotech specialist in the Asia-Pacific region. The company operates through 2 brands; namely, “Novotech” and “PPC”. The company offers full-service clinical CRO with labs, phase I facilities, and drug development consulting services. The company has site partnerships with key medical institutes and offices across 11 countries in Asia Pacific. The company provides clinical development services across all clinical trial phases and therapeutic areas including ethics committee and regulatory submissions, feasibility assessments, data management, medical monitoring, safety solutions, statistical analysis, central lab services, project and vendor management, and report write-up to ICH requirements.

• Veristat: The company is a scientific-minded global Clinical Research Organization (CRO). The company enables sponsors to solve complex and unique challenges associated with accelerating therapies through clinical development to regulatory approval. The company has more than 26 years of experience in clinical trial planning and execution, which makes it fully equipped to support any development program. Veristat's focus on novel drug development has led to its success in handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare diseases, cell & gene therapies, oncology, and infectious disease trials.

Value chain-based sizing & forecasting

Supply Side Estimates

• Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

• Segment revenue determination via variable analysis and penetration modeling.

• Competitive benchmarking to identify market leaders and their collective revenue shares.

• Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

• Identifying parent markets and ancillary markets

• Segment penetration analysis to obtain pertinent

• revenue/volume

• Heuristic forecasting with the help of subject matter experts

• Forecasting via variable analysis

Cell And Gene Therapy Clinical Trials Market Report Objectives:

• Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

• Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

• Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Cell And Gene Therapy Clinical Trials Market Report Assumptions:

• The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

• The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

• We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

• All market estimates and forecasts have been validated through primary interviews with the key industry participants.

• Inflation has not been accounted for to estimate and forecast the market.

• Numbers may not add up due to rounding off.

• Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

• Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

• Latin America includes Central American countries and the South American continent

• Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

• Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

• Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.