CGT CDMO Market Size, Share, Growth, and Industry Analysis, By Type (Immune Cells, Stem Cells, Viral Vectors and Plasmid DNA), By Application (Pharmaceutical and Biotechnology Companies, Research and Academic Institutions and Others) and Regional Insight and Forecast to 2032

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CGT CDMO MARKET OVERVIEW

The global CGT CDMO market size was USD 7.04 billion was 2024 and will touch USD 59.61 billion by 2032, exhibiting a CAGR of 30.6% during the forecast period.

A CDMO in the realm of CGT stands for a Contract Development and Manufacturing Organization specializing in serving as a one-stop-shop for developing and manufacturing cell and gene therapies. These companies support CGT development in biotech and pharmaceutical businesses by offering services to develop the finished product beginning with research.

COVID-19 IMPACT

CGT CDMO Industry Had a Negative Effect Due to Disruptions of Supply Chain during COVID-19 Pandemic

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

COVID-19 affected global supply chains in a way that restricted the use of CGT within several key areas that includes viral vectors, plasmids, and raw materials. This impacted the continuous production schedule that CDMOs needed in order to operate. Production plants observed difficulties in the availability of some materials, limitations in transportation, and delays in the delivery of goods, which may result in long periods of clinical research and therapeutic development.

LATEST TREND

Integration of Advanced Technology to Drive Market Growth

One of the emerging trends in the Cell and Gene Therapy (CGT) CDMO market is seen in making use of sophisticated technology so as to improve and optimize the development and manufacturing of CGT products. New techniques such as CRISPR, TALENs, and Zinc Finger Nucleases (ZFNs) have made gene editing easier while enhancing the precision in the process; which is imperative for gene therapies. Also, the increasing use of artificial intelligence (AI) and machine learning (ML) in the drug discovery process and drug manufacturing is shaping the design of gene therapies, outcomes’ forecasters, and quality management.

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CGT CDMO MARKET SEGMENTATION

By Type

Based on Type, the global market can be categorized into Immune Cells, Stem Cells, Viral Vectors and Plasmid DNA.

• Immune Cells- Among the well-known sub-sector of CGT, the immune cell therapies particularly CAR-T (Chimeric Antigen Receptor T-cell) therapies have come to hold a lot of light. The therapies related to this category are the production of alterations from patients’ cells in a bid to increase their capacity to selectively destroy cancer cells.

• Stem Cells-  Cell-based therapies where pluripotent or adult stem cells are used to replace damaged tissues or treat disease (neurodegenerative disorders, cardiac disease, etc.) is another segment of CGT.

• Viral Vectors- Adenoviral and lentiviral vectors are the usual vectors used to transfer therapeutic genes into patients’ cells. These vectors are central components of gene therapy, providing the means for delivering genetic information to address diseases such as certain illnesses and genetic disorders or some malignancies.

• Plasmid DNA- In gene therapy, plasmid DNA is important since it transports genetic material into cells as a vector. They are commonly employed, and most of the delivery system used in therapeutic genomic treatment such as DNA vaccines and some of the gene-editing systems.

By Application

Based on application, the global market can be categorized into Pharmaceutical and Biotechnology Companies, Research and Academic Institutions and Others.

• Pharmaceutical and Biotechnology Companies- As for CGT CDMOs, these companies increasingly depend on them to offer sophisticated manufacturing solutions for gene therapies production. CDMOs provide basic services that may include cell culture development, vector production, purification, and scale up manufacturing services which remains a very complex and expensive task to manage within the organization.

• Research and Academic Institutions- Few educational and research organizations have the facilities and personnel necessary for the mass production of gene therapies. These institutions source manufacturing with CGT CDMOs for developing more clinical trial research and commercial technology.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.                         

Driving Factors

Increasing Demand for Gene Therapies to Boost the Market

A factor in the CGT CDMO market growth is the Increasing Demand for Gene Therapies. The growth of CT GMs industry particularly due to the higher demand in gene therapies acts as a key driver to the CGT CDMO sector. Since, over the recent years, science has progressed to a degree where biotechnology and genetic engineering can provide a host of new treatments for genetic diseases, where before there was little hope for successful treatments, the market for these new therapies has risen significantly. Please look at the following diseases: Rare genetic disorders, cancers, and inherited disorders are now potentially treatable by gene therapies, which are rather quickly gaining approvals from the regulatory authorities.

Complexity of CGT Manufacturing to Expand the Market

Gene therapy preparation itself is a technical challenge, including manufacturing, technical and scientific skills, technology, and knowledge of the therapeutic products. For those reasons, the large players, including pharmaceutical companies, usually do not possess sufficient internal capabilities to manage such processes adequately. As a result, outsourcing to CGT CDMOs has also been on the rise to take advantage of their capabilities and capacity to handle the complex requirements of CGT manufacturing such as viral vector manufacturing, cell-based manufacturing, and other scales of manufacturing.

Restraining Factor

High Manufacturing Costs to Potentially Impede Market Growth

One of the principal factors influencing the CGT CDMO market is the expensive manufacturing cost of gene therapies. The production of cell and gene therapies, gene editing, vectors and personalized treatments requires large capital investments in facilities and skills, time and money spent on regulatory compliance to the industry standards. When potential targets are rare, these high costs can make gene therapies costly to produce and therefore not easily affordable.

Opportunity

Rising Demand for Personalized Medicine for the Product in the Market

The growth in the personalized medicine market, where treatments are customized based on a patient’s biology, forms one of the primary growth factors of the CGT CDMO market.  With the emerging advancement in gene therapies required to cure rare genetic diseases, Cancer, and other chronic illnesses, there is a need to establish unique solutions for manufacturing the therapies. Thus, CDMOs are in a good place to meet these requirements by offering the most suitable Room & React service models on a ‘plug-and-play’ basis that would suit the individualistic character of these treatments.

Challenge

Regulatory and Compliance Hurdles Could Be a Potential Challenge for Consumers

Of course managing the various and at times piecemeal regulatory regimes that apply to gene therapies can be challenging. Every country or a region has its own rules and regulatory requirements for approval and these aspects cause time delays and increased costs for CGT developers and CDMOs. In addition, there are high quality control demands and pressure from corporate goals performance in compliance with high cGMP (current Good Manufacturing Practice) standards as well.

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CGT CDMO MARKET REGIONAL INSIGHTS

• North America

North America has emerged as the most dominant region in the CGT CDMO share due to a convergence of factors that propel its leadership in this dynamic industry.  Today, North America takes most of the market share of the CGT CDMO (Cell and Gene Therapy Contract Development and Manufacturing Organization). This dominance is mostly attributed to a high emphasis on the biotechnology and pharmaceutical industry, a strong and developed health care system as well as top companies like Novartis International AG, Pfizer Inc, and Gilead sciences Inc involved in gene therapy.

• Europe

Europe has especially grown to be in high demand for cell and gene therapies in curable diseases and disorders. The rising trend of clinical trials and the emphasis on new treatment methods in European countries have created demand for outsourced CDMO services.

•  Asia

The Asia Pacific (APAC) is projected to be the most attractive region within the CGT CDMO market due to growth in investment in biotechnology, healthcare infrastructure developments, and increased need for improved therapies. Some of the leading Asian countries that boast about hi-tech biotech are China, Japan, and South Korea.

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the CGT CDMO Market Through Innovation and Market Expansion

Key enterprise players are shaping the CGT CDMO marketplace through strategic innovation and marketplace growth. Recent market trends show that major market players in the CGT CDMO market like WuXi AppTec, Lonza, and Samsung Biologics work towards the deepening of their market share by partnering with biotechnology and pharmaceutical companies. These collaborations aim at enhancing the routes of development and manufacture of gene and cell therapies .

List of Top CGT CDMO Companies  

• Novartis(Switzerland)
• Pharmaron(China)
• Porton(China)
• Thermo Fisher(U.S.)

KEY INDUSTRY DEVELOPMENTS

Jan 2022: Self-control, a start-up based on technology invented by Harvard University scientists, Cellino Biotech, recently received USD 80m in the largest start-up funding for the massive production of allogeneic and autologous cell therapies.

REPORT COVERAGE

The study encompasses a comprehensive SWOT analysis and provides insights into future developments within the market. It examines various factors that contribute to the growth of the market, exploring a wide range of market categories and potential applications that may impact its trajectory in the coming years. The analysis takes into account both current trends and historical turning points, providing a holistic understanding of the market's components and identifying potential areas for growth.

The research report delves into market segmentation, utilizing both qualitative and quantitative research methods to provide a thorough analysis. It also evaluates the impact of financial and strategic perspectives on the market. Furthermore, the report presents national and regional assessments, considering the dominant forces of supply and demand that influence market growth. The competitive landscape is meticulously detailed, including market shares of significant competitors. The report incorporates novel research methodologies and player strategies tailored for the anticipated time frame. Overall, it offers valuable and comprehensive insights into the market dynamics in a formal and easily understandable manner.