Cell And Gene Therapy CDMO Market Size, Share & Trends Analysis Report By Phase (Pre-clinical, Clinical), By Product Type (Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy), By Indication (Oncology, Infectious Diseases), By Region, And Segment- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The global Cell And Gene Therapy CDMO market size was estimated at USD 5.90 billion in 2023 and is projected to hit around USD 69.11 billion by 2033, growing at a CAGR of 27.9% during the forecast period from 2024 to 2033.

Key Takeaways:

• North America accounts for the largest share of 40.18% in 2023.
• Asia Pacific, on the other hand, is anticipated to register a lucrative CAGR of 29.1% during the forecast period.
• The oncology segment dominated the cell and gene therapy CDMO market and held the largest revenue share of 49.11% in 2023.
• On the other hand, the rare diseases segment is anticipated to witness a lucrative CAGR of 28.5% during the forecast
• The pre-clinical segment held the largest revenue share of 66.3% in 2023
• The clinical segment is anticipated to witness a considerable CAGR of 27.15% during the analysis period.
• The cell therapy segment dominated the market and held the largest revenue share of 41.9% in 2023.
• The gene-modified cell therapy segment, on the other hand, is anticipated to witness a lucrative CAGR of 28.9% during the analysis period.

Cell And Gene Therapy CDMO Market Growth

The market is experiencing robust growth during the analysis period, fueled by an expanding portfolio of cell and gene therapy products, increased researcher attention on rare diseases, substantial investments from both public and private sectors in research and development, rising demand for outsourced services related to cell and gene therapies, increasing prevalence of chronic ailments such as cancer, a surge in mergers & acquisitions activities, and ongoing technological innovations throughout the cell and gene therapy development process.  

Increased R&D funding and investments in cell and gene therapeutics (CGT) is a crucial trend in the biotechnology and pharmaceutical industries. Cell and gene therapies hold significant potential in treating a wide range of diseases, including cancer, genetic disorders, and certain infectious diseases. Hence, owing to the great potential of these therapeutics, there has been a considerable increase in interest from both private and public sectors in the development and discovery of innovative cell and gene therapies. Most big pharmaceutical companies are now investing in CGT to create a strong position in the market. There has been a considerable increase in venture capital investments, especially in the life sciences sector.

For instance, a pharmaceutical giant, Charles River Laboratories stated that the life sciences industry has witnessed a consistent average growth rate of 18% in investments from 2010 to 2021. The growth rate in gene therapy during this same timeframe has also increased to approximately 59%.

The market experienced disruptions during the initial phases of the COVID-19 pandemic, mainly due to a slowdown in overall clinical trial activities. The pandemic significantly affected supply chain management, emerging as a primary factor hindering market growth. The substantial impact was attributed to a lack of demand forecasting and feasibility planning. Lockdowns and restrictions imposed in the early stages of the pandemic raised concerns about logistics and transportation, leading to delays and temporary suspensions of clinical trials.

However, the outbreak of COVID-19 has accelerated certain new models in the cell and gene therapy CDMO industry to ease the crisis and cope with changing trends. Virtual trials are gradually gaining popularity and are expected to grow considerably in the coming years. The pandemic led to certain restrictions, such as social distancing and travel restrictions, owing to which around 80.00% of sites were temporarily suspended or put on hold at least one clinical trial.  Therefore, to avoid such situations, virtual trials are gradually being adopted, which allow the implementation of innovative approaches to trials and help ensure a better patient experience. Furthermore, the CDMOs eradicated the negative impact of the COVID-19 pandemic by involving in in-organic strategic initiatives such as mergers, partnerships, and acquisitions. This helped them in sales rebound by 2021.

Cell And Gene Therapy CDMO Market Report Scope

Segments Insights:

Indication Insight

The oncology segment dominated the cell and gene therapy CDMO market and held the largest revenue share of 49.11% in 2023. This is attributable to the growing prevalence of cancer cases across the world. The high burden of oncology cases has led to the development of novel CGT products for its treatment, thus boosting demand for its outsourced development services. For instance, in January 2023, the American Cancer Society estimated that for the year 2023, projections indicated 1,958,310 new cancer cases and 609,820 cancer-related deaths in the U.S.        

On the other hand, the rare diseases segment is anticipated to witness a lucrative CAGR of 28.5% during the forecast timeframe. High growth is primarily due to the growing number of rare diseases and the rise in investments for developing CGT products in treating the conditions. Oncology and rare diseases remain the top targeted areas in non-genetically modified cell therapy development. As per the American Society of Cell & Gene Therapy, there are 362 CGT products under clinical development for the treatment of rare diseases. Hence, the above-mentioned factors are anticipated to support the segment’s growth.

Phase Insights

The clinical segment is anticipated to witness a considerable CAGR of 27.15% during the analysis period. An increase in cell and gene therapy-related clinical studies is the major factor supporting the growth of the clinical segment. Moreover, the growing demand for gene therapy creates significant investment opportunities as companies focusing on gene therapies enter the public market through Initial Public Offerings (IPOs). Hence, with increasing investments and funding, several gene therapies are anticipated to be launched in the coming future.

• It is estimated that around 13 new cell and gene therapies could secure approval in the U.S. and Europe by the end of 2023.
• Moreover, in 2019, the U.S. FDA stated that around 10 to 20 new cell and gene therapies will be approved by 2025.

The pre-clinical segment held the largest revenue share of 66.3% in 2023 and this growth can be attributed to several factors. Advances in scientific understanding, the growing recognition of the potential for these therapies to address various medical conditions, and increased investment in research and development contribute to expanding preclinical efforts in this field. In addition, the growing pipeline of CGT therapeutics in the preclinical phase is another significant factor supporting the segment's growth during the analysis period.

• For instance, in March 2022, the American Society of cell & gene therapy reported a 16% growth in the gene therapy pipeline since Q1 2021.
• Currently, there are around 3,579 cell, gene, and RNA therapies in several stages of development, ranging from preclinical to pre-registration stages.

Product Type Insights

The cell therapy segment dominated the market and held the largest revenue share of 41.9% in 2023. High segment shares are majorly due to the increase in CDMOs penetrating the cell and gene therapy CDMO industry. Moreover, a significant surge in start-up financings is another considerable factor in augmenting segmental growth.

• For instance, In January 2022, Cellino Biotech, a spin-out from Harvard University, secured USD 80 million in the most significant start-up financing to bolster its extensive production of allogeneic and autologous cell therapies.
• Furthermore, in March 2022, the American Society of Cell & Gene Therapy reported around 56 non-genetically modified cell therapies approved globally. Hence factors mentioned above are anticipated to support the segment’s growth.

The gene-modified cell therapy segment, on the other hand, is anticipated to witness a lucrative CAGR of 28.9% during the analysis period. The segment has been further narrowed down to include its subtypes, such as CAR T-cell therapies, CAR-NK cell therapy, TCR-T cell therapy, etc. The CAR T-cell therapies category has dominated the gene-modified cell therapy segment during the analysis period. This is due to the growth in approved CAR T-cell therapies globally. CAR T-cell therapies remain the most common type used in the pipeline of genetically modified cell therapies from preclinical to pre-registration phases.

Regional Insight

North America accounts for the largest share of 40.18% in 2023. High shares of the region are majorly due to growth in the approvals of CGT products in the region, especially across the U.S. For instance, as per the Alliance for Regenerative Medicine, in 2022, three novel gene therapies gained U.S. FDA approval for treating rare diseases, while another therapy gained approval for treating bladder cancer. In addition, it is estimated that around 13 new CGT products are on the verge of gaining approval in the U.S. and Europe by the end of 2023. Hence, increasing product approvals simultaneously boosts demand for contract manufacturing services, thereby driving the growth of the CDMO sector.

Asia Pacific, on the other hand, is anticipated to register a lucrative CAGR of 29.1% during the forecast period. The region's high growth is due to the surge in CGT clinical trials across countries such as China. Increased investment in research and development, favorable regulatory environments that facilitate clinical trials, a growing focus on healthcare innovation, and a rising awareness of the potential benefits of gene and cell therapies are a few factors supporting the region’s growth. In addition, collaborations between international and local research institutions and the availability of diverse patient populations contribute to the attractiveness of the Asia-Pacific region for conducting these trials.    

Key Companies & Market Share Insights

The major players operating across the market are focused on adopting in-organic strategic initiatives such as mergers, partnerships, acquisitions, etc. Moreover, companies focus on technological innovations to augment their market position. For instance, in September 2023, Charles River Laboratories unveiled its new technology Lentivation lentiviral vector (LVV) manufacturing platform. This platform is designed to streamline the manufacturing timelines for gene and gene-modified cell therapies, potentially reducing them by up to 60%, resulting in fewer than seven months compared to conventional manufacturing workflows.

Key Cell And Gene Therapy CDMO Companies:

• Lonza
• Catalent, Inc
• Cytiva
• Samsung Biologics
• Thermo Fisher Scientific Inc.
• Novartis AG
• WuXi AppTec
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Charles River Laboratories

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell And Gene Therapy CDMO market.

By Phase 

• Pre-clinical
• Clinical

By Product Type 

• Gene Therapy
  • Ex-vivo
  • In-vivo
• Gene-Modified Cell Therapy
  • CAR T-cell Therapies
  • CAR-NK Cell Therapy
  • TCR-T Cell Therapy
  • Other
• Cell Therapy

By Indication 

• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)