Cell and Gene Therapy CROs Market, 3rd Edition, 2022-2035

Cell and Gene Therapy CROs Market, 3rd Edition, 2022-2035

Cell and gene therapy candidates have been demonstrated to have the potential to treat rare and complex diseases, including indications, for which no effective treatment is currently available. In this context, it is important to mention that, in case of cell therapy, human cells are transplanted to repair or replace the damaged cells / tissues, thereby, enabling their treatment through alteration or restoration of certain sets of cells. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells). On the other hand, gene therapy aims to correct the underlying genetic problem to ensure the treatment, as well as prevention of diseases, by replacing, inactivating or introducing genes into cells, either inside or outside of the body. It is worth highlighting that some therapeutic interventions can be considered both cell and gene therapies. The mechanism of action of such therapies usually involves alteration of genes in specific types of cells and then, their insertion into the patient body.

Q1. How is the research and development activity evolving in the cell and gene therapy industry?

At present, cell and gene therapy industry is one of the fastest growing therapeutic segments, already having contributed to some of the most significant disruptions in the biopharmaceutical domain. Till date, 23 cell and gene therapies have been approved by the Food and Drug Administration (FDA) in the US, while more than 1,000 IND applications have been filed for candidates being evaluated in ongoing clinical studies. This further indicates a remarkable scientific progress and therapeutic promise of these breakthrough drug candidates.

Q2. What is the need for contract research organizations (CROs) in the cell and gene therapy CROs domain?

At present, only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the necessary infrastructure and capabilities to carry out research. Other key concerns shared by contemporary innovators include limited availability of expertise, high rate of attrition of pipeline drugs / therapies and prolonged development timelines. The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to the CROs, which claim to be well-aware of the nuances of advanced therapy medicinal products (ATMPs) design and development, as well as cell and gene therapy manufacturing process.

Q3. What are the current market opportunities in the cell and gene therapy CROs market?

Due to the upsurge in the research and development related to genetic engineering, there has been a considerable increase in the development of cell and gene therapies. Consequently, there has been a parallel rise in outsourcing of services as more clinical studies are anticipated to start. Specifically, cell and gene therapy companies have made significant investments to support the development / adoption of advanced tools, technologies and platforms, to generate more robust and evidence based clinical data, which is required for gaining the marketing authorizations across different geographies. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. Further, CROs are believed to play a significant role in the successful approval of these drugs in a highly evolving regulatory environment. Since 2005, over 40 CROs have been established in this domain. It is worth mentioning that cell and gene therapy CROs are bolstering their existing capabilities to offer a wide range of services to their clients.

Q4. What are the recent developments and expected trends in the cell and gene therapy industry?

Presently, more than 3,570 cell and gene therapies are being evaluated across various stages of clinical development for a myriad of disease indications. Given that the demand for cell and gene therapies is indubitably rising, more than 53% mergers and acquisitions have been undertaken by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall cell and gene therapies market, we believe that the cell and gene therapy CROs market is likely to witness consistent grow, till 2035 .

Q5. What are the key challenges faced by cell and gene therapy CROs?

One of the key challenges faced by CROs focused on cell and gene therapies is the lack of understanding of the standard operating procedures (SOPs). In addition, various regulatory guidelines render therapies subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives.

Q6. What are the key value drivers in the cell and gene therapy market?

A significant rise in healthcare expenditure, R&D spending and booming research have emerged as key value drivers in the cell and gene therapy domain.

Q7. How is the revenue generation potential associated with cell and gene therapy CROs likely to evolve in the coming years?

The cell and gene therapy CROs market is likely to witness a substantial growth in the coming years. It is worth mentioning that, presently in terms of area of expertise, the market is likely to be driven by cell therapies, and this trend is unlikely to change in the foreseen future as well. Further, based on scale of operation, majority of the revenue share is likely to be associated with clinical operations. Specifically, in terms of global regions, the cell and gene therapy market in Asia-Pacific is likely to grow at a relatively faster pace (21%), in the long term.

Q8. Who are the key players engaged in the cell and gene therapy CROs market?

The key players engaged in this domain (which have also been capture in this report) include Altasciences, Allucent, Accelera Charles River Laboratories, Creative Biolabs, CMIC, Evotec, ICON, IQVIA, Labcorp, Medpace, PPD, Precision For Medicine, QPS and Syneos Health.

SCOPE OF THE REPORT

The “Cell and Gene Therapy CROs Market (3rd Edition), 2022-2035: Distribution by Area of Expertise (Cell Therapy and Gene Therapy), Scale of Operation (Clinical, Preclinical and Discovery), Therapeutic Area (Oncological Disorders, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Autoimmune Disorders, Blood Disorders, Rare / Genetic Disorders, Ophthalmological Disorders, and Other disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa)” report features an extensive study of the current market landscape and future potential of the cell and gene therapy CROs market, over the next decade.

The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report features:

A detailed overview of the overall market landscape of the cell and gene therapy CROs, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, area of expertise (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operation (discovery, preclinical, clinical and commercial) and types of services offered, including [A] preclinical services (bioanalytical services, in-vivo studies, pharmacokinetic and ADME services, preclinical safety studies, toxicology studies and other preclinical services), [B] clinical services (clinical research monitoring, clinical trial management/ clinical project management, data management, safety and pharmacovigilance, and other clinical services), [C] regulatory services (GAP analysis, IND preparation, legal representation and technical dossier submission) and [D] general support services (biostatistics, consulting, post-market assessment, re-imbursement and training).

A detailed analysis on the business models that are commonly adopted by the biopharmaceutical industry for outsourcing cell and gene therapies. In addition, it includes information on various factors that drive developers towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.

Elaborate profiles of key industry players (very large and large companies) based in North America, Europe and Asia-Pacific that offer contract research services for both cell and gene therapies across both preclinical and clinical scales of operation. Each profile features a brief overview of the company, along with details related to its cell and gene therapies-related service portfolio, recent developments, and an informed future outlook.

A benchmark analysis of the various players engaged in this domain. It highlights the capabilities of the companies (in terms of their expertise across various services related to the development of cell and gene therapies). The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to gain a competitive edge in the industry.

An analysis of the recent collaborations within the cell and gene therapy contract research industry, based on several relevant parameters, such as year of partnership, type of partnership, area of expertise, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2015-2022.

A detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022, based on several parameters, such as year, type of agreement, area of expertise, geographical location of the companies and key value drivers.

A detailed acquisition target analysis, taking into consideration historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets.

A list of over 310 cell therapy developers that are anticipated to partner with cell therapy CROs. These players have been shortlisted based on several relevant parameters, such as developer strength (based on company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), and availability of other cell therapy capabilities.

An in-depth analysis of nearly 235 gene therapy developers that are anticipated to partner with gene therapy CROs and have been shortlisted on the basis of several relevant parameters, such as developer strength (based on company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other gene therapy capabilities.

An in-depth analysis of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), therapeutic area and key geographical regions.

A detailed analysis of the total cost of ownership for large / very large cell and gene therapy contract research organizations. It features an informed estimate of direct and indirect expenses taking into consideration various relevant parameters, over a span of 20 years.

A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.

One of the key objectives of this report was to evaluate the current opportunity and the future growth potential of the cell and gene therapy CROs market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features the likely distribution of the current and forecasted opportunity across important parameters, such as [A] area of expertise (cell therapy and gene therapy), [B] scale of operation (clinical, preclinical and discovery), [C] therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, infectious diseases, metabolic disorders, autoimmune disorders, blood disorders, rare / genetic disorders, ophthalmological disorders, and other disorders), and [D] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa).

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.

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.

MARKET SEGMENTATIONS

Cell and Gene Therapy CROs: Market Segmentations

Market Segments Details

Forecast Period 2022 - 2035

Area of Expertise Cell Therapy

Gene Therapy

Scale of Operation Clinical

Preclinical

Discovery

Therapeutic Areas Oncological Disorders

Neurological Disorders

Cardiovascular Disorders

Infectious Diseases

Metabolic Disorders

Autoimmune Disorders

Blood Disorders

Rare / Genetic Disorders

Ophthalmological Disorders

Other Disorders

Key Geographical Regions North America

Europe

Asia-Pacific

Latin America

MENA

Abbreviation: MENA: Middle East and North Africa

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys 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. Wherever 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 2035, the report also provides our independent view on various 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.

1.1. CHAPTER OUTLINES

Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the current state of cell and gene therapy CROs market and its likely evolution in the mid-long term.

Chapter 3 provides a general introduction to CROs, featuring insights on the historical evolution of such organizations, legacy and contemporary trends in outsourcing activity. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Additionally, the chapter includes details on the various types of services offered by different types of CROs. Further, the chapter highlights the advantages and risks associated in partnering with contract service providers, and their role in the development of ATMPs.

Chapter 4 provides a detailed discussion on the business models that are commonly adopted by the biopharmaceutical industry for outsourcing cell and gene therapies. In addition, it includes information on various factors that drive sponsors towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.



Chapter 5 provides a detailed review of the overall landscape of the cell and gene therapy services market, highlighting the contributions of CROs, along with the information on their year of establishment, company size, location of headquarters, area of expertise (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operation (discovery, preclinical, clinical and commercial) and types of services offered, including [A] preclinical services (bioanalytical services, in-vivo studies, pharmacokinetic and ADME services, preclinical safety studies, toxicology studies and other preclinical services), [B] clinical services (clinical research monitoring, clinical trial management/ clinical project management, data management, safety and pharmacovigilance, and other clinical services), [C] regulatory services (GAP analysis, IND preparation, legal representation and technical dossier submission) and [D] general support services (biostatistics, consulting, post-market assessment, re-imbursement and training).

Chapter 6 features an elaborate profiles of key industry players (very large and large companies) based in North America, Europe and Asia-Pacific that offer contract research services for both cell and gene therapies across both preclinical and clinical scales of operation. Each profile features a brief overview of the company, details related to its cell and gene therapies-related service portfolio, recent developments, and an informed future outlook.

Chapter 7 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of the companies (in terms of their expertise across various services related to the development of cell and gene therapies). The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to become more competitive in the industry.

Chapter 8 features an analysis of the recent collaborations within the cell and gene therapy contract research industry, based on several relevant parameters, such as year of partnership, type of partnership, area of expertise, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

Chapter 9 presents a detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022. It is worth mentioning that the data captured during our research was analyzed based on several parameters, such as year, type of agreement, area of expertise, geographical location of the companies and key value drivers.

Chapter 10 provides a detailed acquisition target analysis, taking into consideration historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets.

Chapter 11 features an in-depth analysis of over 310 cell therapy developers that are anticipated to partner with cell therapy CROs. These players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), and availability of other cell therapy capabilities.

Chapter 12 features an in-depth analysis of nearly 235 gene therapy developers that are anticipated to partner with gene therapy CROs and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other gene therapy capabilities.

Chapter 13 features an in-depth analysis of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), therapeutic area and key geographical regions.

Chapter 14 presents a detailed analysis of the total cost of ownership for large / very large cell and gene therapy contract research organizations. It features an informed estimate of direct and indirect expenses taking into consideration various relevant parameters, over a span of 20 years.

Chapter 15 features a comprehensive market forecast analysis, highlighting the likely growth of cell and gene therapy CROs market, for the time period 2022-2035. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] area of expertise (cell therapy and gene therapy) [B] scale of operation (clinical, preclinical and discovery), [C] therapeutic area (Oncological Disorders, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Autoimmune Disorders, Blood Disorders, Rare / Genetic Disorders, Ophthalmological Disorders, and Other disorders), and [D] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa).

Chapter 16 provides a detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.

Chapter 17 is a summary of the entire report. The chapter provides the key takeaways from the report, and presents our independent opinion of the cell and gene therapy CROs market, based on the research and analysis described in the previously mentioned chapters.

Chapter 18 is a collection of interview transcripts of the discussions that were held key stakeholders in the industry.

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 a list of companies and organizations mentioned in this report.