Cell and Gene Therapy Manufacturing Market to Reach US$ 8.8 Billion by 2031 | Driven by Technological Innovations and Strategic Collaborations - Exclusive Report by Transparency Market Research, Inc.

Cell and gene therapy manufacturing is at the forefront of medical innovation, poised to revolutionize treatment by addressing diseases at their cellular and genetic roots. Unlike traditional pharmaceuticals, these advanced therapies involve manipulating patients' own cells or genetic material to offer personalized and targeted interventions. In 2022, the global cell and gene therapy manufacturing market was valued at US$ 1.1 billion and is projected to reach US$ 8.8 billion by 2031, driven by a robust CAGR of 25.2% over the forecast period. Enhanced manufacturing technologies and strategic collaborations are paving the way for scalable and cost-effective production processes, thereby accelerating market growth.

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Industry experts indicate that scientific advancements and a deepening understanding of cellular and genetic mechanisms are fueling the expansion of the cell and gene therapy manufacturing market. The adoption of innovative manufacturing solutions-such as automated bioreactors, closed-system processing, and novel gene delivery techniques-is significantly improving production scalability and cost-effectiveness. Furthermore, regulatory approvals and strategic collaborations between pharmaceutical, biotechnology, and research institutions are creating lucrative opportunities for market players, enabling them to expedite the commercialization of these transformative therapies.

Market Drivers

Rise in Prevalence of Chronic Diseases

Chronic Disease Burden: With chronic diseases such as cancer, cardiovascular disorders, and autoimmune conditions affecting a growing share of the global population (WHO estimates indicate that 60% of adults have at least one chronic disease, projected to reach 70% by 2025), there is an increasing demand for innovative treatments that target disease at its root cause.

Personalized Therapies: Cell and gene therapies offer a tailored approach by harnessing patients' own cells and genetic material, driving significant investment in manufacturing innovations.

Significant Investment by Pharmaceutical & Biotechnology Companies

Robust Funding: Substantial investments by leading pharmaceutical and biotech firms-as well as support from government agencies and regulatory bodies-are accelerating research and development in cell and gene therapy.

Enhanced Production Capabilities: Investments are directed toward integrating cutting-edge technologies, such as automation and advanced bioreactors, which enhance manufacturing efficiency and ensure regulatory compliance.

Increased Demand for Consumables

Critical Role of Consumables: Consumables like culture media, reagents, and assay kits play an essential role in the manufacturing process, accounting for the largest market segment due to their recurring use and critical importance in maintaining product quality.

High Effectiveness in Cancer Treatment

Oncology Focus: The oncology segment is set to dominate the market, driven by the remarkable efficacy of cell and gene therapies such as CAR-T cell treatments in targeting and eliminating cancer cells. These therapies address the complex and heterogeneous nature of cancer, offering new hope for patients.

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Product Segmentation

By Therapy Type

Cell Therapy:

Allogeneic (e.g., T-cells, mesenchymal stem cells, natural killer cells)

Autologous (e.g., T-cells, hematopoietic stem cells)

Gene Therapy:

Viral Vectors (lentiviral, adeno-associated virus vectors, others)

Non-viral Vectors (electroporation, others)

By Product Type

Consumables

Software & Systems

Equipment (cell processing equipment, single-use equipment, other equipment)

By Technology

Cell Culture & Expansion

Viral Vector Production

Cell Sorting & Purification

Gene Editing

Others

By Indication

Oncology

Cardiovascular

Orthopedic

Infectious Diseases

Other Diseases (e.g., ophthalmology, CNS diseases)

By End-user

Pharmaceutical & Biotechnology Companies

Contract Manufacturing Organizations (CMOs)

Regional Outlook

North America: Dominates the market due to its robust pharmaceutical and biotechnology infrastructure, strong regulatory framework, and extensive investments in research and development.

Asia Pacific: Expected to grow rapidly, driven by expanding healthcare infrastructure, favorable regulatory policies, and increasing research and development investments in countries like China, Japan, and South Korea.

Europe: Benefits from a rich scientific heritage and a well-established network of research institutions, supporting advanced manufacturing processes and market growth.

Competitive Landscape
The global cell and gene therapy manufacturing market is highly fragmented, with numerous players investing in R&D and strategic collaborations to expand their market share. Key players include:

Lonza Group Ltd.

Thermo Fisher Scientific, Inc.

Merck KGaA

Danaher Corporation

Bio-Techne Corporation

Sartorius AG (Sartorius Stedim Biotech S.A.)

Bio-Rad Laboratories, Inc.

Becton, Dickinson and Company

Fresenius Medical Care AG & Co. KGaA

MaxCyte

Getinge AB

GE HealthCare

Recent developments, such as the July 2023 strategic platform license between MaxCyte and Vittoria Biotherapeutics and the March 2023 collaboration between Thermo Fisher Scientific and UCSF, underscore the industry's momentum in advancing manufacturing capabilities and accelerating the commercialization of cell and gene therapies.

Future Outlook
The cell and gene therapy manufacturing market is set for sustained expansion as technological innovations and strategic collaborations drive improvements in scalability, cost-effectiveness, and regulatory compliance. As chronic diseases continue to impact a significant proportion of the global population, the demand for personalized and targeted therapies will fuel further investments in manufacturing technologies. With ongoing advancements in automation and process optimization, the market is poised to revolutionize the production of cell and gene therapies, ultimately improving patient outcomes worldwide.

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FAQs

Q1: What is cell and gene therapy manufacturing?
A: It involves the production processes for advanced therapies that manipulate patients' cells or genes to treat diseases at a fundamental level, requiring sophisticated manufacturing technologies to ensure product safety and efficacy.

Q2: What factors are driving market growth?
A: Key drivers include scientific advancements, increased prevalence of chronic diseases, significant investments by pharmaceutical and biotech companies, and a rising demand for consumables and high-effectiveness treatments in oncology.

Q3: What is the projected market value by 2031?
A: The market is forecast to reach US$ 8.8 billion by 2031, growing at a CAGR of 25.2% from 2023 to 2031.

Q4: Which regions are leading the market?
A: North America dominates the market, with rapid growth anticipated in Asia Pacific and steady expansion in Europe.

Q5: Who are the key players in this market?
A: Major players include Lonza Group Ltd., Thermo Fisher Scientific, Inc., Merck KGaA, Danaher Corporation, Bio-Techne Corporation, Sartorius AG, Bio-Rad Laboratories, Inc., Becton, Dickinson and Company, and others.

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