The global cell and gene therapy CDMO Market size was valued at USD 5.90 billion in 2023 and is projected to reach USD 69.11 billion by 2033,
The global cell and gene therapy CDMO Market size was valued at USD 5.90 billion in 2023 and is projected to reach USD 69.11 billion by 2033, growing at a CAGR of 27.9% from 2024 to 2033 according to a new report by Nova One Advisor.
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.
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Growing research and development activities in cell and gene therapies, heightened focus on addressing rare diseases, the expanding pipeline of innovative products, a rising need for outsourced services in this field, and continuous technological advancements in the development processes are few of the factors collectively contribute to rising demand for the market.
Furthermore, increasing investments and funding from private and public sectors to develop novel cell and gene therapeutics is another significant factor supporting the market growth. A few of the notable examples of investments and funding in the cell and gene therapy market are mentioned below:
- In August 2021 SeQure Dx, a company specializing in gene editing diagnostics, announced a series A funding round of USD 17.5 million to develop gene therapeutics. This funding was led by Mass General Brigham Ventures and RiverVest Venture Partners, along with Casdin Capital, Digitalis Ventures, KdT Ventures, Alexandria Venture Investments, and Bold Capital Partners
- In August 2021, Eyevensys, a clinical-stage biotechnology company focusing on nonviral gene therapies for ophthalmic diseases, secured USD 12 million in a series B plus funding round
The initial phase of the COVID-19 pandemic adversely affected the market. The slowdown in overall clinical trial activity was a significant factor, primarily due to concerns about the safety of participants and staff, leading to delays and temporary suspensions. The disruption in supply chain management, particularly in transportation and logistics, posed challenges, and the uncertainty surrounding the pandemic created a general lack of demand forecast and feasibility planning. However, the market recovered through a combination of adapting to new norms, enhancing the resilience of supply chains, and implementing safety measures to navigate the challenges posed by the pandemic. Moreover, mergers and acquisition strategies adopted by the major companies have helped mitigate the negative impact of the pandemic by 2021.
Cell And Gene Therapy CDMO Market Trends:
- Increased Demand: The demand for cell and gene therapies continues to rise, driven by advancements in biotechnology and a growing number of clinical trials. This surge in demand has led to an increased need for specialized CDMOs with expertise in manufacturing these complex therapies.
- Technological Advancements: Rapid advancements in cell and gene therapy technologies are driving innovation in manufacturing processes. CDMOs are investing in cutting-edge technologies such as automation, closed-system manufacturing, and advanced analytics to improve efficiency, scalability, and product quality.
- Global Expansion: The cell and gene therapy market is witnessing a global expansion of manufacturing capabilities. CDMOs are establishing or expanding their presence in key regions such as North America, Europe, and Asia-Pacific to better serve local markets and meet the growing demand for these therapies worldwide.
- Partnerships and Collaborations: Collaboration between biopharmaceutical companies and CDMOs is becoming increasingly common. Strategic partnerships allow CDMOs to leverage their expertise in manufacturing while biopharmaceutical companies focus on drug development, thereby accelerating the commercialization of cell and gene therapies.
- Regulatory Challenges: Regulatory requirements for cell and gene therapies are complex and evolving. CDMOs need to stay abreast of changing regulations and ensure compliance throughout the manufacturing process. Additionally, regulatory agencies are increasingly scrutinizing manufacturing processes to ensure product safety and efficacy.
- Scalability and Flexibility: Scalability remains a significant challenge in cell and gene therapy manufacturing. CDMOs are investing in flexible manufacturing platforms that can adapt to varying production scales and accommodate the unique requirements of different therapies, from autologous to allogeneic approaches.
- Cost Pressures: Despite the transformative potential of cell and gene therapies, their high cost remains a barrier to widespread adoption. CDMOs are under pressure to optimize manufacturing processes and reduce costs while maintaining product quality and compliance with regulatory standards.
- Focus on Quality Assurance: Ensuring product quality and consistency is paramount in cell and gene therapy manufacturing. CDMOs are implementing robust quality assurance systems and investing in analytical capabilities to monitor and control manufacturing processes throughout the product lifecycle.
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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)
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