NEW YORK, Dec. 5, 2018 /PRNewswire/ -- INTRODUCTION
In the recent past, cell and gene therapies have emerged as promising treatment options for a myriad of complex clinical conditions, including cancers and inherited disorders. Currently, more than 25 such advanced therapy medicinal products are available in the market; examples of recently approved therapies include Alofisel® (2018), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017) and INVOSSA™ (2017). In addition, over 500 cell and gene therapy candidates are being investigated in different stages of clinical development, across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials that are currently active were initiated to evaluate the potential of these therapies across multiple therapeutic indications. Due to several development challenges, such as fragile nature of cells being used, safety and efficacy issues, laborious procedures for conducting clinical studies, complex regulatory framework and exorbitant costs, it is difficult for the companies with limited expertise and finances to successfully develop these therapies in-house. The aforementioned challenges have led several players to outsource a significant part of their clinical stage research to capable contract research organizations (CROs), which claim to offer cost-efficient solutions as well as intellectual and operational expertise.
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In fact, various therapy developers have partnered with CROs to seek their support in advancing product candidates towards approval. Moreover, contract service providers have formed alliances to enhance their capabilities and provide an integrated suite of services. It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company's geographical reach. Furthermore, service providers have invested in developing / adopting advanced tools, technologies and platforms in order to provide robust and evidence based clinical data for approval. Given these technological advancements, the cost and time-related advantages of outsourcing research and the expanding pipeline of cell and gene therapy candidates, the demand for CROs is projected to grow in the foreseen future.
SCOPE OF THE REPORT
The 'Cell and Gene Therapy CROs Market, 2018-2030' report features a comprehensive study on the current landscape of contract research service providers in the cell and gene therapy sector. The study presents an in-depth analysis, highlighting the capabilities of stakeholders engaged in this domain, across different regions of the globe. Amongst various elements, the report includes:
• An assessment of the current market landscape, featuring a comprehensive list of more than 70 active CROs and a detailed analysis based on a number of parameters, such as the company size, location of their headquarters, year of establishment, type of therapy (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operations (scale and preclinical) and types of services offered including [A] clinical services (clinical trial management, clinical trial monitoring, data management and project management, clinical safety and quality studies, regulatory services, consultancy services and IT / informatics services) and [B] preclinical services (bioanalytical services, toxicology studies, in vivo studies, preclinical safety and quality studies and support services).
• A comprehensive discussion on the various outsourcing business models adopted in this field, along with a list of key considerations that need to be taken into account by therapy developers while selecting a CRO partner.
• Elaborate profiles of prominent players that offer contract research services for cell and gene therapies; each profile provides an overview of the company, its financial status (if available), information on its service(s) portfolio and a detailed future outlook.
• A comprehensive benchmark analysis, highlighting the key focus areas of small, mid- and large companies, comparing their existing capabilities within and beyond their respective peer groups, and providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
• A comprehensive clinical trial analysis of ongoing studies related to the cell and gene therapy candidates in order to estimate the total number of product candidates under clinical evaluation. It provides detailed information related to clinical trials based on various parameters, such as geography, current status of trials, type of cell therapies (stem cells, T cells, dendritic cells, NK cells and tumor cells), key therapeutic area(s), disease indication(s) and number of patients enrolled.
• A detailed analysis of the recent collaborations (since 2013) focused on the contract services signed for cell and gene therapies based on various parameters, such as the year of establishment, type of agreement, type of services for which the companies partnered, type of cell and gene therapy and geographical location.
• A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell and gene therapy CRO market.
One of the key objectives of this report is to evaluate the current opportunity and the future potential of the cell and gene therapy CROs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on [A] type of therapy (cell therapy and gene therapy) [B] scale of operation (clinical and preclinical), [C] type of therapeutic areas (oncology and non-oncology) and [D] geographical region regions (covering North America, Europe, Asia Pacific and rest of the world). To account for the uncertainties associated with the growth of cell and gene therapy CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.
All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary sources. For all our projects, we conduct interviews 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. 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 2030, 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.
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view of current scenario of cell and gene therapy CRO services 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, and legacy and contemporary trends in outsourcing activity. It also includes details on the various types of services offered by different CROs. Further, the chapter highlights the several advantages and risks associated in partnering with contract service providers, and also describes the role of CROs 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. In addition, the chapter 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 comprehensive view on the global landscape of cell and gene therapy CROs. It includes information related to over 70 CROs that claim to offer services for cell and gene therapies. It features an in-depth analysis of the players based on geographical location, company size, year of establishment, scale of operation, and range of services offered by clinical and preclinical CROs.
Chapter 6 features detailed profiles of key CROs offering cell and gene therapy related services, across different geographies. Each company profile includes a brief overview of the company, financial details / information (if available), information on service portfolios and a comprehensive 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 a comprehensive clinical trial analysis of ongoing clinical studies for the evaluation of various cell and gene therapy product candidates. The analysis provides details related to cell and gene therapy clinical studies investigated across various geographies, based on the number of trials registered, start year of the clinical trial, current trial status, current phase of development, key therapeutic area (including indication-wise distribution), type of cell therapeutic (stem cells, T cells, dendritic cells, NK cells and tumor cells) and number of enrolled patients.
Chapter 9 provides an elaborate discussion and analysis of the various partnerships / collaborations that have been inked among the different players in the market. It includes a brief description on various types of partnerships models (such as outsourcing agreements, licensing agreements, service alliances, mergers and acquisitions) that have been employed by stakeholders in this domain since 2013. In addition, this chapter features details insights on mergers and acquisition in this domain.
Chapter 10 features a comprehensive market forecast analysis, highlighting the likely growth of cell and gene therapy contract research service market till the year 2030. We have provided inputs on the likely distribution of the opportunity by type of therapy (cell therapy and gene therapy), scale of operations (clinical and preclinical), type of therapeutic area (oncology and non-oncology) and across different regions (North America, Europe, Asia Pacific and rest of the world).
Chapter 11 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of cell and gene therapies research services, under a SWOT framework.
Chapter 12 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the industry.
Chapter 13 is a collection of interview transcripts of the discussions that were held key stakeholders in the industry. We have presented details of interviews held with Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) and Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado).
Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. With more than 70 CROs offering services for the development and clinical stage operations of cell and gene therapies, the outsourcing market landscape is fragmented, featuring a mix of small-sized (less than 50 employees, 34%), mid-sized (51-500 employees, 41%), large (501-5,000 employees, 12%) and very large sized (more than 5,000 employees, 13%) companies. Examples of very large companies include (in alphabetical order, no selection criteria) CMIC Group, Covance, ICON, Medpace, PPD and Syneos Health.
2. More than half of the CROs claim to provide clinical stage support only. Examples of companies offering clinical services include (in alphabetical order, no selection criteria) BioniX, CTI Clinical Trial & Consulting, FGK Clinical Research, JSB Solutions, Linical Accelovance, PRC Clinical and Symbion Research International. Around one-third of the total number of CROs provide both clinical and preclinical stage services; examples of such companies include (in alphabetical order, no selection criteria) Boston Biomedical Associates, Creative BioLabs, FARMACORE BIOTECHNOLOGY, GenoSafe®, IQVIA and Quality Assistance.
3. Popular clinical development services offered by contract service providers include clinical trial management (46%), safety and quality studies (36%), clinical trial monitoring (24%) and clinical project management (20%). In terms of preclinical stage services, 51% currently provide safety and quality studies, 41% presently offer ADME studies and in vivo studies, respectively and 30% currently provide toxicology studies.
4. More than 1,000 ongoing clinical studies of cell therapies (including stem cell therapies, T-cell therapies, dendritic cell therapies, NK cell therapies and tumor cell therapies) were registered across different geographies in the last five years. Amongst many others, oncological disorders (57%) emerged as the most researched therapeutic area by therapy developers in this domain.
5. Several collaborations have been inked amongst various stakeholders in this domain during the period 2013-2018. Most of these partnerships were outsourcing agreements (41%), signed between CROs and sponsor companies to advance the development of various therapies. Service alliances (8%) were another important type of partnerships, representing deals signed between different CROs to expand their service portfolio. It is important to highlight that over 15 mergers and acquisitions have taken in the last five years. Examples of companies that were recently acquired are SNBL USA's preclinical business by Altasciences (September 2018), Ascendance Biotechnology by BioIVT (March 2018) and MPI Research by Charles River Laboratories (February 2018).
6. Driven by the rapidly evolving pipeline and increasing adoption of novel tools and technologies, we expect the cell and gene therapy services market to grow at an annualized rate of ~9% between 2018 and 2030. It is important to highlight that North America (primarily US) and Europe currently capture the largest share (in terms of revenues) in cell and gene therapy CRO market. This is followed by Asia Pacific and rest of the world, which currently capture about 25-30% of the overall market share. This trend is unlikely to change significantly in the future.
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NEW YORK, Dec. 5, 2018 /PRNewswire/ -- INTRODUCTION