Cell and Gene Therapy CRO Market by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular

Cell and Gene Therapy CRO Market by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and Other disorders), End-Users (Industry Players and Non-Industry Players) and Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World): Industry Trends and Global Forecasts, Till 2035

CELL AND GENE THERAPY CRO MARKET: OVERVIEW

As per Roots Analysis, the global cell and gene therapy CRO market is estimated to grow from USD 1.7 billion in the current year to USD 3.5 billion by 2035, at a CAGR of 7.1% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Cell Therapy

CAR-NK

CAR-T

TCR-T

Others

Type of Genetic Modification

Ex vivo

In vivo

Stage of Development

Discovery

Preclinical

Clinical

Therapeutic Area

Blood Disorders

Cardiovascular Disorders

Dermatological Disorders

Immunological Disorders

Infectious Diseases

Metabolic Disorders

Musculoskeletal Disorders

Neurological Disorders

Oncological Disorders

Rare Diseases

Other Disorders

End Users

Industry Players

Non- Industry Players

Key Geographical Regions

North America

Europe

Asia-Pacific

Rest of the World

CELL AND GENE THERAPY CRO MARKET: GROWTH AND TRENDS

The ongoing advancements in cell and gene therapies domain, along with several FDA-approved therapies, demonstrate the potential of these innovative therapies in treating a wide range of diseases (including rare and complex diseases) for which no effective treatment is currently available. As a result, this promising therapeutic modality has garnered the interest of both investors and drug developers alike. It is worth highlighting that, at present, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include Elvediys (for the treatment of duchenne muscular dystrophy) developed by Sarepta Therapeutics, Fucaso (for the treatment of multiple myeloma) developed by IASO Bio and Vyjuvek (for the treatment of dystrophic epidermolysis bullosa) developed by Krystal Biotech. In addition, more than 3,500 clinical trials are currently underway to investigate cell and gene therapies across 16 therapeutic areas. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. As the cell and gene therapy field rapidly evolves, CROs offer valuable expertise in optimizing study designs, managing complex regulatory frameworks and seamless transition from preclinical to clinical success. At present, over 105 industry players claim to have the necessary capabilities to offer contract research services across different scales of operations.

CELL AND GENE THERAPY CRO MARKET: KEY INSIGHTS

The report delves into the current state of the cell and gene therapy CRO market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, over 105 players (established as well as start ups) claim to have the necessary capabilities to offer contract research services; majority of these firms are based in North America.

2. Stakeholders offer contract research services for cell and gene therapies across different scales of operations; close to 20% of the players offer all types of clinical services.

3. More than 65 deals have been inked between various stakeholders involved in this domain; acquisitions emerged as the most common type of partnership model.

4. The rising interest of players is reflected by the number of mergers and acquisitions reported in the last few years; 58% of such initiatives were signed to incorporate additional capabilities to their existing portfolio offerings.

5. Since 2019, more than 3,000 clinical trials have been registered for cell therapies; over 70% of the trials recently initiated are currently recruiting patients.

6. Close to 500 clinical trials (with over 48,000 enrolled patients) have been registered to investigate gene therapies, across different geographies.

7. In order to meet the rising demand for cell and gene therapies, stakeholders are striving to upgrade / expand their capabilities to enhance their respective service portfolios.

8. Total cost of ownership model offers an informed estimate of capital and operational expenses associated with the establishment and maintenance of a contract research facility, over a span of 20 years.

9. Driven by the increasing number of chronic indications (requiring novel personalized therapies), and ongoing research on cell and gene therapies, this market is anticipated to grow at a CAGR of 7.1%, till 2035.

10. About 25% of the market is expected to be captured by revenues generated from cell and gene therapies for oncological disorders; it is also worth highlighting that the CRO market in China is likely to grow at a faster pace.

CELL AND GENE THERAPY CRO MARKET: KEY SEGMENTS

Currently, the CAR-T Cell Therapy Market Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market

Based on the type of cell therapy, the market is segmented into CAR-NK, CAR-T, TCR-T, and others. It is worth highlighting that the CAR-T cell therapies segment is likely to dominate the market in the coming decade. This can be attributed to the proven efficacy of CAR-T cell therapies in treating CD19-positive haematological malignancies, acute lymphoblastic leukemia and multiple myeloma.

Ex Vivo Segment Holds the Maximum Share within the Cell and Gene Therapy CRO Market

Based on the type of genetic modification, the market is segmented into ex vivo and in vivo. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the ex vivo segment and this trend is likely to remain the same in the forthcoming years. This can be attributed to the fact that ex vivo techniques utilize viral vectors, which are effective in delivering and integrating modified genetic material into cells.

Currently, the Clinical Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market

Based on the stage of development, the market is segmented into discovery, preclinical and clinical. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the clinical segment and this trend is likely to remain the same in the forthcoming years. This can be primarily attributed to the rigorous clinical testing that these therapies undergo in order to meet the regulatory standards before commercialization.

Oncological Disorders Segment is Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period

Based on therapeutic areas, the market is segmented into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the oncological disorders segment and this trend is likely to remain the same in the forthcoming years.

Industry Players are Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period

Based on end user, the market is segmented into industry and non-industry players. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the industry players and this trend is likely to remain the same in the forthcoming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Majority share is expected to be captured by CROs based in North America. It is worth highlighting that, over the years, the market for Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Cell and Gene Therapy CRO Market

Altasciences

Allucent

CMIC

Labcorp

Linical

Medpace

PPD

Precision for Medicine

QPS

Syneos Health

CMED

ICON

Pharmalex

Novotech

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Business Development Executive, Aixial

Clinical Trial Manager, Gsap

Former Director, Marketing and Sales, CATO SMS

CELL AND GENE THERAPY CRO MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the cell and gene therapy CRO market, focusing on key market segments, including [A] type of cell therapy, [B] type of genetic modification, [C] stage of development, [D] therapeutic area, [E] end users and [F] key geographical regions.

Market Landscape: A comprehensive evaluation of contract research service providers engaged in cell and gene therapy market, considering various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] area of expertise (cell therapy and gene therapy), [E] scale of operation (discovery, preclinical, clinical and commercial), [F] type of preclinical services offered (toxicology studies, in-vivo testing, safety studies, PK / ADME studies, bioanalytical studies, and other preclinical services), [G] type of clinical services offered (clinical trial management / clinical project management, clinical research monitoring, data management, safety and pharmacovigilance, and other clinical services), [H] type of regulatory services offered (legal representation, GAP analysis, Technical Dossier Submission, and IND Preparation) and [I] type of general support services offered (consulting, training, biostatistics, post-market assessment, and re-imbursement).

Company Profiles: In-depth profiles of key cell and gene therapy contract research service providers based in North America, Europe and Asia-Pacific, focusing on [A] company overviews, [B] service portfolio, [C] insightful recent developments and [D] an informed future outlook.

Benchmark Analysis: A detailed benchmark analysis of the various players involved 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.

Total Cost of Ownership: A thorough examination of the total cost of ownership for large and very large contract research organizations (CROs) specializing in cell and gene therapy, highlighting the costs associated in both the establishment and ongoing maintenance of a CRO facility over the short and long term. This chapter includes insights derived from an in-depth analysis of the total cost of ownership for cell and gene therapy CROs during the period from Y0-Y20.

Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2015, based on several parameters, [A] year of partnership, [B] type of partnership, [C] area of expertise, [D] most active players (in terms of number of partnerships inked) and [E] regional distribution of partnership activity.

Merger and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement, [C] key value drivers of the deal, [D] most active players (in terms of number of agreements signed) and [E] geographical location of companies. Furthermore, this chapter provides details on the financial aspects of these deals (where available) to calculate deal multiples based on the annual revenues of the acquired companies at the time of acquisition and their years of experience in the industry.

Key Acquisition Targets: A detailed analysis of acquisitions that have taken place in the cell and gene therapy domain, taking into consideration the 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. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of companies involved in this domain, that are likely to be acquired in the recent future.

Clinical Trial Analysis: Examination of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several parameters, such as [A] trial registration year, [B] trial status, [C] trial phase, [D ]enrolled patient population, [E] type of sponsor, [F] most active industry players (in terms of number of registered trials), [G] study design, [H] therapeutic area and [I] key geographical regions.

Business Model Analysis: A detailed discussion of 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.

SWOT Analysis: A SWOT analysis of cell and gene therapy CRO services focuses on identifying industry-specific trends, key market drivers and challenges faced by companies providing these services.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading CROs in this market?

What kind of partnership models are commonly adopted by industry stakeholders?

What factors are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

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The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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