Over the years, cell and gene therapies (CGT) and other advanced therapy medicinal products (ATMPs) have managed to capture the interest of both drug developers and healthcare investors. Their popularity can be attributed to various factors, such as minimal side effects, clinical efficacy and their personalized nature. However, there are several complexities associated with the discovery, development and manufacturing of such products. Moreover, owing to several drawbacks, such as high cost, manual processes, and lengthy R&D operations, ATMPs have witnessed high entry barriers in this domain. As a result, outsourcing has emerged as an essential aspect in the development and manufacturing of ATMPs.
Overview of Cell and Gene Therapies
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.
What are the Benefits of Contract Research Organizations?
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.
Cell and Gene Therapy CROs: Current Market Landscape
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. Further, CROs are believed to play a significant role in the successful approval of these drugs in a highly evolving regulatory environment. During our research, we came across 107 industry players that claim to be engaged in the contract research services of cell and gene therapies.
The Increasing Interest in this Field is also Reflected in Recent Partnership Activity
Over the past few years, there has been a steady increase in the partnership activity within this domain, growing at a CAGR of 61%, during the given period. It is worth mentioning that, since 2019, more than 20 agreements have been signed. Recent examples include (in reverse chronological order) those signed between Labcorp and Xcell Biosciences (April 2022), Altasciences and Sinclair Research (January 2022).
Companies are actively investing in upgrading existing infrastructure and expanding their respective CROs capacities in order to enhance their core competencies
Companies are known to expand their existing infrastructure and constructing new facilities or acquiring the facilities of other industry stakeholders in order to accommodate the growth in this respective business. During our research, we identified that, there has been a considerable increase in consolidation activity within the cell and gene therapy CRO domain, growing at a CAGR of 64%, during the given period.
The Cell and Gene Therapy CROs Market is anticipated to grow significantly, during 2022-2035
During our research, we estimated the market under conservative, base and optimistic scenarios. As per the base case forecast scenario, market for cell and gene therapy is estimated to grow at an annualized rate of over 18%, in the given time period. The opportunity is likely to be well distributed in terms of area of expertise, scale of operation, therapeutic area and key geographical regions.
It is worth highlighting that there is a significant rise in the interest of stakeholders in cell and gene therapy CROs segment; this can be validated by the increase in partnership activity within this domain. Further, the growing demand for cell and gene therapies has compelled the players engaged in this domain to expand their existing capabilities / capacities in order to accommodate the future needs of their clients. It is worth highlighting that, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain.
With an experience of over 4 years with Roots Analysis, Jasmeet is adept at generating useful insights from unstructured / structured datasets. As a senior analyst at Roots Analysis, she has assisted several clients across multiple industry verticals within the healthcare domain. These verticals include, contract services, devices / technologies, and drugs / disease indications. Since the findings of the research are aimed at supporting the clients to make thoughtful decisions for their business, she has hands-on experience on competitive landscape assessment, benchmarking, market sizing and forecasting, as well as several quantitative / qualitative / strategic frameworks