Cell and Gene Therapy Biomanufacturing Market - A Global and Regional Analysis: Focus on Product Type, Application, Usage, End User, and Region - Analysis and Forecast, 2025-2035

Robust Clinical Pipeline Creating Demand for Biomanufacturing Infrastructure Presents Lucrative Business Opportunities

The global cell and gene therapy biomanufacturing market is experiencing rapid growth, driven by advancements in manufacturing technologies, increased demand for innovative therapies, and substantial investments in biopharmaceutical research. Key drivers include the integration of automation and AI in manufacturing processes, improvements in viral vector technologies, and the rising prevalence of chronic diseases that demand personalized treatments.

The growing focus on personalized medicine, along with increasing support from government initiatives and venture capital, is fueling further market expansion. Additionally, regulatory bodies such as the FDA and EMA are facilitating faster approval pathways for gene therapies, while the industry works to overcome challenges related to high production costs and scalability.

Several key factors are driving the growth of the cell and gene therapy biomanufacturing market. Ongoing advancements in biomanufacturing technologies, such as improvements in cell culture systems, viral vector production, and gene editing tools such as CRISPR, are creating an increased need for specialized manufacturing capabilities. As gene and cell therapies become more complex and personalized, the manufacturing processes also require greater precision, specialized equipment, and tailored approaches to ensure high-quality production.

Moreover, regulatory bodies such as the FDA and EMA are enforcing stringent requirements for the production of these therapies, necessitating robust quality control (QC) measures to meet safety, efficacy, and compliance standards. The rise of personalized medicine, where therapies are designed based on an individual’s genetic profile, is contributing to the growing demand for more sophisticated manufacturing processes and higher QC standards.

Despite the significant opportunities, several challenges persist in the cell and gene therapy biomanufacturing market. One of the major hurdles is the complexity of the manufacturing processes, which are significantly more intricate than those used for traditional pharmaceutical products. This complexity leads to higher production costs, longer timelines, and greater risk in terms of consistency and quality. Furthermore, the constantly evolving regulatory environment, particularly with regard to personalized therapies, presents a challenge for manufacturers who must continuously adapt to new guidelines and maintain compliance.

Additionally, the high cost of cell and gene therapy manufacturing, paired with the need for advanced infrastructure and skilled personnel, further complicates scalability. These barriers may hinder the ability of smaller biotech companies and emerging manufacturers to compete on a larger scale, limiting the accessibility and affordability of these therapies, especially in early-stage markets. These challenges may also affect the broader adoption of cell and gene therapies, as they often require large investments in specialized equipment, training, and regulatory processes that can be prohibitively expensive.

Market Lifecycle Stage of Cell and Gene Therapy Biomanufacturing:

The global cell and gene therapy biomanufacturing market is currently in a phase of rapid advancement, characterized by significant growth and development. This growth is primarily driven by the increasing demand for personalized medicine, technological innovations, and heightened investment in research and development. As more gene therapies are developed, there is a greater focus on advanced manufacturing technologies such as improved viral vector production, gene editing techniques such as CRISPR, and stem cell applications. The regulatory environment has also evolved to support these therapies, with clearer approval pathways from organizations such as the FDA and EMA, facilitating faster time-to-market for new therapies.

The complexity of these therapies, coupled with the need for specialized manufacturing systems, has resulted in the expansion of quality control (QC) services, process optimization, and manufacturing scalability. The market is witnessing an influx of partnerships between biotech firms, pharmaceutical companies, and contract manufacturing organizations (CMOs), driving further innovation and access to production capabilities.

At this stage, the market is transitioning from early-stage development to expansion, with increasing commercialization and a growing focus on scaling production to meet the demands of global markets. This phase is marked by a competitive race among industry leaders to establish more efficient and cost-effective production systems, ensuring broad access to these therapies in the future.

Impact on Cell and Gene Therapy Biomanufacturing

The cell and gene therapy biomanufacturing market is at the forefront of revolutionizing medical treatments, offering cutting-edge therapies for a range of genetic disorders, cancers, and other complex diseases. The industry is growing rapidly due to technological advancements in gene editing, viral vector production, and stem cell applications. As these therapies move toward clinical and commercial stages, significant improvements in biomanufacturing processes are essential to meet rising demand.

Key technological advancements in the industry include:

• CRISPR and Gene Editing: CRISPR technology has unlocked the potential for precise and targeted genetic modifications, enabling the development of highly personalized therapies for genetic diseases. This technology allows for more efficient gene editing, leading to innovations in manufacturing processes that require fewer resources and time.
• Viral Vector Production: Viral vectors, especially AAV (Adeno-Associated Virus) and lentivirus, play a critical role in gene delivery systems. Advances in viral vector manufacturing, purification, and scale-up technologies are essential to the success of gene therapy production, particularly as therapies become more personalized.
• Stem Cell Technologies: Stem cell-based therapies are increasingly integrated into gene therapies for regenerative medicine. Innovations in stem cell manufacturing processes, including cell culturing and differentiation techniques, are opening up new treatment possibilities, particularly in regenerative and immune therapies.
• Automation and AI: The integration of automation and AI in biomanufacturing is enhancing efficiency, reducing human error, and improving the consistency of production. AI is also being used for predictive analytics, streamlining quality control, and optimizing manufacturing processes.
• Modular and Single-Use Technologies: The use of modular biomanufacturing systems and single-use technologies allows for more flexible, cost-efficient, and scalable production, which is particularly crucial for meeting the needs of personalized medicine.

Impact of Technological Advancements on the Cell and Gene Therapy Biomanufacturing Market:

Improved Manufacturing Efficiency: Technological innovations are drastically reducing production time, costs, and resource consumption. The adoption of automated systems and modular platforms has improved manufacturing scalability and consistency, enabling companies to produce gene therapies more efficiently and at a larger scale.

Lower Costs and Increased Accessibility: Advances in cell culture systems, viral vector production, and automation have the potential to reduce the high costs associated with gene therapy manufacturing. As production costs decrease, these therapies could become more accessible to a broader patient population, especially in emerging markets.

Enhanced Product Quality: The integration of advanced quality control (QC) technologies, such as real-time monitoring and AI-driven analytics, ensures that gene therapies meet the highest standards for safety, efficacy, and consistency. These technologies improve the reliability of the products, which is essential in personalized medicine.

Faster Time-to-Market: The combination of more efficient manufacturing processes and regulatory pathways is enabling companies to bring gene therapies to market faster. Regulatory bodies such as the FDA and EMA have streamlined approval processes for breakthrough therapies, creating opportunities for quicker commercialization.

Personalization of Medicine: The demand for personalized medicine is at an all-time high. Technologies such as CRISPR and advances in viral vector production allow for the development of treatments tailored to individual genetic profiles, which enhances the effectiveness of therapies and opens new markets for targeted treatments.

Challenges and Market Impact on Cell and Gene Therapy Biomanufacturing Market:

Despite these advancements, there are significant challenges impacting the cell and gene therapy biomanufacturing market:

Scalability: Scaling production to meet the global demand for gene therapies remains a challenge. While technological advancements have improved efficiency, achieving large-scale, cost-effective production that maintains high quality is still an ongoing challenge.

High Costs: The high cost of manufacturing, particularly due to the specialized equipment, skilled personnel, and advanced technologies required, is still a major barrier. These costs can limit the accessibility of gene therapies, especially for smaller biotech firms and early-stage companies.

Regulatory Hurdles: While regulatory bodies have streamlined some approval processes, navigating the complex regulatory environment for gene therapies - especially personalized treatments - requires ongoing adaptation and investment. These evolving regulations can slow down the development process and increase costs.

Market Segmentation for Cell and Gene Therapy Biomanufacturing Market:

Segmentation 1: by Product Type

• Consumables
• Equipment
• Software Solutions

Based on product, the consumables segment in the global cell and gene therapy biomanufacturing market dominated in 2024. The equipment has a shelf life of five to seven years and software solutions also require a one-time investment with yearly maintenance costs. However, consumables are required more frequently and in large quantities for the production of cell and gene therapies.

Segmentation 2: by Usage

• Commercial Stage Manufacturing
• Research Stage Manufacturing

Based on usage, the global cell and gene therapy biomanufacturing market was dominated by the research stage manufacturing segment in 2024.

Segmentation 3: by Application

• Upstream Processing
• Harvesting
• Downstream Processing

Based on application, the downstream processing segment accounted for the largest share of the global cell and gene therapy biomanufacturing in 2024.

Segmentation 4: by End User

• Life Science Companies
• Contract Research Organizations (CROs)
• Contract Manufacturing Organizations (CMOs)
• Cell Banks

Based on end user, the global cell and gene therapy biomanufacturing market is dominated by the life sciences companies segment in 2024.

Segmentation 5: by Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

Recent Developments in the Global Cell and Gene Therapy Biomanufacturing Market

• In January 2023, Sartorius AG collaborated with Roosterbio Inc. to advance its downstream purification processes for the development of exosomes.
• In February 2022, Sartorius AG completed the acquisition of Novasep's chromatography division to complement its product portfolio.
• In August 2022, Merck KGaA launched the VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform to speed up the development of cell and gene therapies.
• In June 2022, Lonza Group AG and Adva Biotechnology Ltd. entered into a license agreement that provides the latter access to the former's core intellectual property enabling the expansion of automated bioreactors worldwide.
• In June 2022, Becton, Dickinson and Company launched FACSDiscover S8 Cell Sorter featuring CellView Image Technology.
• In January 2023, Bio-Techne Corporation launched RNAscope plus assay to advance its gene therapy development.
• In April 2023, Danaher (Cytiva) introduced X-platform bioreactors, designed to optimize single-use upstream bioprocessing operations. These bioreactors offer flexibility and efficiency in the production of monoclonal antibodies, protein-based drugs, cell and gene therapies, and viral vectors, supporting the development and manufacturing of a broad range of therapeutic products.

Demand - Drivers and Limitations

Market Demand Drivers for Cell and Gene Therapy Biomanufacturing:

• Increasing number of approved therapies and growing infrastructure requirements creating an upsurge in demand for cell and gene therapy biomanufacturing products
• Expansion in target indications for cell and gene therapies creates a demand for large-scale biomanufacturing
• Entry of new market participants in cell and gene therapies driving the demand for biomanufacturing facilities and equipment
• Increasing investments and funding in cell and gene therapy fuelling the growth of cell and gene therapy biomanufacturing

Market Restraints for Cell and Gene Therapy Biomanufacturing:

• High set-up cost of biomanufacturing facilities

Market Opportunities for Cell and Gene Therapy Biomanufacturing:

• Increasing demand for tailored therapies based on individual genetic profiles creates opportunities for specialized manufacturing processes.
• Increased demand for viral vectors in gene delivery systems offers opportunities for companies specializing in scalable viral vector production, especially in the development of AAV and lentivirus vectors.

How can cell and gene therapy biomanufacturing market reports add value to an organization?

Workflow/Innovation Strategy: The cell and gene therapy biomanufacturing market (by product type) has been segmented into consumables, equipment, and software solutions. Moreover, the study provides the reader with a detailed understanding of the different applications of cell and gene therapy biomanufacturing in raw material preparation, upstream processing, downstream processing, and packaging.

Growth/Marketing Strategy: Cell and gene therapy biomanufacturing is being used for raw material preparation, upstream processing, downstream processing, and packaging. Various companies are providing products and services to aid in the manufacturing of various cell and gene therapies, which is also the key strategy for market players to excel in the current cell and gene therapy biomanufacturing market.

Competitive Strategy: Key players in the global cell and gene therapy biomanufacturing market have been analyzed and profiled in the study, including manufacturers involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the global cell and gene therapy biomanufacturing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

• The base year considered for the calculation of the market size is 2024. The historical year analysis has been done from FY2021 to FY2023, and the market size has been estimated for FY2024 and projected for the period 2025-2035.
• The regional distribution of the market revenue has been estimated to be the same as the company’s net revenue distribution. All the numbers have been adjusted off to two digits after decimal for report presentation reasons. However, the real figures have been utilized for compound annual growth rate (CAGR) estimation. The CAGR has been calculated for the forecast period 2025-2035.
• The market has been mapped based on different types of products available in the market for various applications. All key companies having a significant number of offerings for the global cell and gene therapy biomanufacturing market have been considered and profiled in the report.
• The primary respondent’s verification has been considered to finalize the estimated market for the global cell and gene therapy biomanufacturing market.
• The latest annual reports of each market player have been taken into consideration for market revenue calculation.
• Market strategies and developments of key players have been considered for the calculation of the sub-segment split.
• The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year. The currency conversion rate has been taken from the historical exchange rate of the Oanda website.

Primary Research

The key data points taken from the primary sources include:

• Validation and triangulation of all the numbers and graphs
• Validation of the report’s segmentation and key qualitative findings
• Understanding of the numbers of the various markets for market type
• Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

• Alliance for Regenerative Medicine (ARM), American Society of Gene and Cell Therapy (ASGCT), Centre for Biologics Evaluation and Research (CBER), Centre for Drug Evaluation and Research (CDER), Central Drugs Standard Control Organization (CDSCO), Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), European Medicines Agency (EMA), Institute for Health Metrics and Evaluation (IHME), Medicines and Healthcare Products Regulatory Agency (MHRA), National Organization for Rare Disorders (NORD), Pharmaceuticals and Medical Devices Agency (PMDA), World Health Organization (WHO), and World Intellectual Property Organization (WIPO)
• Annual reports, SEC filings, and investor presentations of the leading market players
• Company websites and detailed study of their portfolio
• Gold standard magazines, journals, whitepapers, press releases, and news articles
• Databases

The key data points taken from the secondary sources include:

• Segmentations, split-ups, and percentage shares
• Data for market value
• Key industry trends of the top players in the market
• Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
• Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis for Cell and Gene Therapy Biomanufacturing:

Cell and gene-based therapies, particularly chimeric antigen receptor T-cell (CAR-T) therapies and gene-editing technologies have garnered significant attention in the biomanufacturing market. Key players in the cell and gene therapy biomanufacturing market are leading the way in developing innovative therapies, manufacturing processes, and scaling production. These companies are heavily investing in advancing biomanufacturing technologies, forming strategic partnerships, and navigating regulatory hurdles to bring cutting-edge therapies to market.

Some of the prominent companies in the cell and gene therapy biomanufacturing market are:

• Lonza.
• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Danaher (Cytiva)
• WuXi AppTec
• Becton, Dickinson, and Company
• Bio-Rad Laboratories, Inc.
• Bio-Techne Corporation
• Endress+Hauser Group Services AG (Analytik Jena GmbH)
• General Electric Company (GE Healthcare)
• Getinge AB
• Infors AG
• Miltenyi Biotec B.V. & Co. KG
• PIERRE GUERIN
• Sartorius AG (Sartorius Stedim Biotech S.A.)

Companies that are not a part of the aforementioned pool have been well represented across different sections of the cell and gene therapy biomanufacturing market report (wherever applicable).

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