1h Free Analyst Time
The Cell & Gene Therapy Manufacturing Services Market size was estimated at USD 17.34 billion in 2023, USD 19.98 billion in 2024, and is expected to grow at a CAGR of 15.81% to reach USD 48.45 billion by 2030 . Speak directly to the analyst to clarify any post sales queries you may have.
Cell and gene therapy manufacturing services encompass the specialized production processes required for the development and commercialization of cell and gene therapies. The scope of these services includes a comprehensive array of production activities such as the sourcing of raw materials, cell processing, gene transfection or vector integration, culturing, harvesting, purification, quality control, and final product formulation. As cell and gene therapies are widely considered a critical component in modern therapeutic development, the importance of robust, compliant, and scalable manufacturing capabilities becomes critical. The cell and gene therapy manufacturing services market is rapidly expanding, with the increasing prevalence of genetic disorders and cancers, advances in molecular biology, and significant investments from both the public and private healthcare sectors. Collaboration between academic institutions, biotech firms, and service providers further propels the market growth. Despite the growth, the market faces several challenges, including high costs of production, stringent and evolving regulatory requirements, and the complexity of manufacturing processes. The necessity for specialized facilities and skilled personnel increases operational challenges, and ensuring consistent quality and scalability remains a significant hurdle. However, the market is ripe with opportunities, particularly in the development of automation and closed-system manufacturing to improve efficiency and reduce contamination risks. Breakthroughs in cell and gene therapy are promising for personalized medicine, thus creating lucrative opportunities for specialized cell and gene therapy manufacturing services.
Regional Insights
In the Americas, the market for cell and gene therapy manufacturing services is experiencing robust growth. This upsurge is primarily driven by a well-established biotech ecosystem, substantial investments in research and development, and a favorable regulatory environment. Moreover, the presence of established market players and the high adoption rate of advanced therapies are catalyzing the market in America. The EMEA region is witnessing a significant expansion in the cell and gene therapy manufacturing service market, with Europe being at the forefront. The growth in the European Union is supported by strong governmental support, advanced healthcare infrastructure, and increasing collaborations between academic and industrial sectors. The Middle East and Africa are also showing growth potential, with increasing investment in healthcare infrastructure and a growing interest in advanced therapeutic modalities. The Asia-Pacific region is a rapidly emerging market in cell and gene therapy manufacturing services, driven by growing healthcare expenditures and a rising number of local companies entering the space. Technological advancements and increasing partnerships with Western companies are further propelling the market forward in this region.Type: Applications of autologous mesenchymal stem cells for tissue repair and anti-inflammatory treatments
Allogeneic cell therapy manufacturing encompasses the production of cells that are derived from a donor and can be used for multiple recipients. This category includes the processing of allogeneic hematopoietic stem cells for use in blood-related disorders, the generation of allogeneic Induced pluripotent stem cells (iPSCs), which are reprogrammed to an embryonic-like state and can differentiate into various cell types, the cultivation of allogeneic mesenchymal stem cells (MSCs) known for their potential in regenerative medicine and immunomodulation, as well as the expansion of allogeneic natural killer (NK) cells and allogeneic T-cells for immunotherapeutic applications. Autologous cell therapy manufacturing produces personalized treatments where the patient's own cells are collected, processed, and then reintroduced into their body. This process is used for autologous hematopoietic stem cells, which are frequently utilized in the context of bone marrow transplants, autologous mesenchymal stem cells (MSCs) that are being explored for tissue repair and anti-inflammatory treatments, autologous natural killer (NK) cells, and autologous T-cells which can be engineered, as in CAR-T therapies, to target and destroy cancer cells. Viral vector manufacturing is a critical aspect of gene therapy, providing the means for genetic material delivery into host cells. This includes the production of adeno-associated virus (AAV) vectors preferred for their safety profile and long-term expression in non-dividing cells, and retroviral vectors, including lentiviral vectors, which are capable of integrating therapeutic genes into the host genome, thus offering the possibility of a permanent cure for some genetic diseases.In contrast to traditional viral vectors, non-viral vector gene therapy manufacturing utilizes non-viral delivery systems such as plasmids, minicircles, or naked DNA/RNA. These methods offer certain advantages in terms of safety and reduced immunogenicity. Non-viral vectors are engineered to transport genetic materials into host cells with the aim of achieving a therapeutic effect, such as correcting a gene mutation or promoting the expression of a beneficial gene. Oligonucleotides, small strands of DNA or RNA, are crucial for a variety of gene therapy and diagnostic applications. In gene therapy, they can be used as antisense oligonucleotides to bind to specific mRNA molecules and block protein production or as small interfering RNA (siRNA) to silence target genes. The synthesis and production of oligonucleotides require high precision and stringent quality control to ensure the correct sequence and purity are achieved for therapeutic use.
Indication: Growing potential of oncology therapies for personalized medicine in patients with various malignancies
In the landscape of cell and gene therapy manufacturing services, addressing cardiovascular diseases stands as a significant domain. These therapies aim to engineer or repair cardiac tissues and modulate immune responses, offering potentially curative treatments for ailments such as myocardial infarction, cardiomyopathies, and congenital heart diseases. The field of cell and gene therapy presents promising avenues for correcting or mitigating central nervous system (CNS) disorders, which include a broad range of debilitating conditions such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. Cell and gene therapy manufacturing services are at the forefront of creating innovative solutions for infectious diseases. By utilizing genetically modified cells and viral vectors, these therapies aim to enhance the immune system's capacity to combat pathogens and provide durable protective effects. Oncology remains a primary focus within the cell and gene therapy sector due to the high incidence and mortality rates associated with cancer. Manufacturing services are dedicated to the development of therapies such as CAR-T cells and oncolytic viruses that directly target and eliminate cancer cells while striving to minimize damage to healthy tissue. Ophthalmology diseases, including retinal degenerative disorders and corneal dystrophies, are rapidly becoming a target for cell and gene therapies. Manufacturing services in this realm concentrate on advancing precision medicine approaches that can correct genetic mutations at the source or replace dysfunctional cells within the eye. In the field of orthopedic diseases, cell and gene therapy manufacturing services are increasingly focused on the development of regenerative treatments for bone and cartilage repair. These therapies leverage the power of mesenchymal stem cells, gene editing, and growth factor delivery to promote healing and restore function. The capacity to effectively regenerate orthopedic tissues offers promising new alternatives to traditional surgical interventions, particularly for degenerative conditions like osteoarthritis.Application: Significant benefits of customized cell & gene therapy manufacturing services for early-stage products
Clinical manufacturing pertains to the production of cell and gene therapies that are intended for clinical trials rather than widespread commercial distribution. This segment prioritizes flexibility, scalability, and speed to cater to the variable demands of clinical research. Manufacturers and service providers need to adhere to stringent regulatory requirements while maintaining cost-effectiveness to accommodate the limited volumes and highly personalized nature of these therapies. Commercial manufacturing is the large-scale production of approved cell and gene therapies for distribution in the market. This segment requires significant investment in infrastructure and process optimization to achieve the necessary economies of scale while strictly adhering to regulatory standards for quality, efficacy, and safety.End-User: Higher preferences for cost-effective services from academic and research institutes
Academic and research institutes has a crucial role in the cell and gene therapy space as these entities are frequently at the forefront of developing new therapeutic approaches. These institutes often have specific needs based on their focus on innovation and early-stage research. They prioritize access to cutting-edge technology and platforms that allow for higher customization and flexibility, as their work often involves novel and evolving therapies. They also value services that offer scalability, given the variance in project sizes from small-scale exploratory trials to larger collaborative research ventures. Pharmaceutical and biotechnology companies generally have a more commercial focus, with a strong emphasis on the scalability, reliability, and regulatory compliance of manufacturing services. These companies seek service providers that can support the entire lifecycle of a product, from development through clinical trials to commercial-scale manufacturing. Many pharma and biotech firms opt to partner with contract development and manufacturing organizations (CDMOs) owing to the complexities and high cost of setting up in-house cell and gene therapy manufacturing facilities. These end-users demand a track record of regulatory success, robust quality systems, and an ability to handle larger batch sizes for late-stage trials and commercial production.Market Dynamics
The market dynamics represent an ever-changing landscape of the Cell & Gene Therapy Manufacturing Services Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.Market Disruption Analysis
The market disruption analysis delves into the core elements associated with market-influencing changes, including breakthrough technological advancements that introduce novel features, integration capabilities, regulatory shifts that could drive or restrain market growth, and the emergence of innovative market players challenging traditional paradigms. This analysis facilitates a competitive advantage by preparing players in the Cell & Gene Therapy Manufacturing Services Market to pre-emptively adapt to these market-influencing changes, enhances risk management by early identification of threats, informs calculated investment decisions, and drives innovation toward areas with the highest demand in the Cell & Gene Therapy Manufacturing Services Market.Porter’s Five Forces Analysis
The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Cell & Gene Therapy Manufacturing Services Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.Value Chain & Critical Path Analysis
The value chain of the Cell & Gene Therapy Manufacturing Services Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of the <> market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.Pricing Analysis
The pricing analysis comprehensively evaluates how a product or service is priced within the Cell & Gene Therapy Manufacturing Services Market. This evaluation encompasses various factors that impact the price of a product, including production costs, competition, demand, customer value perception, and changing margins. An essential aspect of this analysis is understanding price elasticity, which measures how sensitive the market for a product is to its price change. It provides insight into competitive pricing strategies, enabling businesses to position their products advantageously in the Cell & Gene Therapy Manufacturing Services Market.Technology Analysis
The technology analysis involves evaluating the current and emerging technologies relevant to a specific industry or market. This analysis includes breakthrough trends across the value chain that directly define the future course of long-term profitability and overall advancement in the Cell & Gene Therapy Manufacturing Services Market.Patent Analysis
The patent analysis involves evaluating patent filing trends, assessing patent ownership, analyzing the legal status and compliance, and collecting competitive intelligence from patents within the Cell & Gene Therapy Manufacturing Services Market and its parent industry. Analyzing the ownership of patents, assessing their legal status, and interpreting the patents to gather insights into competitors' technology strategies assist businesses in strategizing and optimizing product positioning and investment decisions.Trade Analysis
The trade analysis of the Cell & Gene Therapy Manufacturing Services Market explores the complex interplay of import and export activities, emphasizing the critical role played by key trading nations. This analysis identifies geographical discrepancies in trade flows, offering a deep insight into regional disparities to identify geographic areas suitable for market expansion. A detailed analysis of the regulatory landscape focuses on tariffs, taxes, and customs procedures that significantly determine international trade flows. This analysis is crucial for understanding the overarching legal framework that businesses must navigate.Regulatory Framework Analysis
The regulatory framework analysis for the Cell & Gene Therapy Manufacturing Services Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Cell & Gene Therapy Manufacturing Services Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Cell & Gene Therapy Manufacturing Services Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.Recent Developments
Fujifilm to Invest USD 200 Million to Expand
FUJIFILM Corporation announces a strategic investment of USD 200 million to enhance its cell therapy contract development and manufacturing (CDMO) services, responding to the rapidly growing market. This funding is allocated to two principal subsidiaries, FUJIFILM Cellular Dynamics, Inc. and FUJIFILM Diosynth Biotechnologies.eXmoor Pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities
eXmoor Pharma announced the inauguration of its state-of-the-art cell and gene therapy center, located in Bristol, which is purpose-built to facilitate the scaling of next-generation CGTs, advancing them from clinical trials to patient reach. Equipped with four expansive grade C processing modules, the facility boasts a process-agnostic architecture suitable for various CGT productions, complete module segregation, and substantial bioreactor capacity. This encompasses options such as two 200L systems for viral vectors or allogeneic therapies and accommodation for five autologous cell therapy stations.Thermo Fisher Scientific Opens Cell Therapy Facility at UCSF to Accelerate Development of Breakthrough Therapies
Thermo Fisher Scientific Inc., alongside the University of California, San Francisco (UCSF), has embarked on an ambitious endeavor to expedite the development of advanced cell therapies. This collaboration is facilitated by the strategic positioning of their state-of-the-art cGMP facility, which is stationed in close proximity to the UCSF Medical Center at Mission Bay. Offering comprehensive services from process and analytical development to clinical and commercial production, Thermo Fisher and UCSF aim to trailblaze advancements in the treatment of diseases, even extending to autoimmune disorders.Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Cell & Gene Therapy Manufacturing Services Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.Key Company Profiles
The report delves into recent significant developments in the Cell & Gene Therapy Manufacturing Services Market, highlighting leading vendors and their innovative profiles. These include Advanced BioScience Laboratories, Inc., AGC Biologics, Bio-Techne Corporation, Bluebird Bio, Inc., Boehringer Ingelheim International GmbH, c-LEcta GmbH, Catalent, Inc., Cell and Gene Therapy Catapult, Cell Therapies Pty Ltd., Cell-Easy SAS, Charles River Laboratories International, Inc., Exmoor Pharma Concepts Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Diosynth Biotechnologies, General Electric Company, Lonza Group, Merck KGaA, Miltenyi Biotec B.V. & Co. KG, Minaris Regenerative Medicine GmbH, Nikon Corporation, Novartis AG, Oxford Biomedica PLC, Recipharm AB, Resonac Corporation, Samsung Biologics Co., Ltd, Takara Holdings Inc., Thermo Fisher Scientific, Inc., uBriGene Biosciences Inc., and Wuxi Apptec Co., Ltd..Market Segmentation & Coverage
This research report categorizes the Cell & Gene Therapy Manufacturing Services Market to forecast the revenues and analyze trends in each of the following sub-markets:- Type
- Cell Therapy
- Allogeneic
- Allogeneic Hematopoietic Stem Cells
- Allogeneic Induced Pluripotent Stem Cells
- Allogeneic Mesenchymal Stem Cells
- Allogeneic Natural Killer Cells
- Allogeneic T-cells
- Autologous
- Autologous Hematopoietic Stem Cells
- Autologous Mesenchymal Stem Cells
- Autologous Natural Killer Cells
- Autologous T-cells
- Viral Vector
- Adeno-associated Virus Vectors
- Retroviral Vectors
- Allogeneic
- Gene Therapy
- Non-viral Vector
- Oligonucleotides
- Cell Therapy
- Indication
- Cardiovascular Diseases
- Central Nervous System Disorders
- Infectious Diseases
- Oncology Diseases
- Ophthalmology Diseases
- Orthopedic Diseases
- Application
- Clinical Manufacturing
- Commercial Manufacturing
- End-User
- Academic & Research Institutes
- Pharmaceutical & Biotechnology Companies
- Region
- Americas
- Argentina
- Brazil
- Canada
- Mexico
- United States
- California
- Florida
- Illinois
- New York
- Ohio
- Pennsylvania
- Texas
- Asia-Pacific
- Australia
- China
- India
- Indonesia
- Japan
- Malaysia
- Philippines
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam
- Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom
- Americas
This research report offers invaluable insights into various crucial aspects of the Cell & Gene Therapy Manufacturing Services Market:
- Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
- Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
- Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
- Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
- Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.
Additionally, the report addresses key questions to assist stakeholders in making informed decisions:
- What is the current market size and projected growth?
- Which products, segments, applications, and regions offer promising investment opportunities?
- What are the prevailing technology trends and regulatory frameworks?
- What is the market share and positioning of the leading vendors?
- What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?
Please note: For this report, the purchase of an Enterprise license allows up to ten worldwide users of an organization access to the report
Please note: This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.
With the purchase of this report at the Multi-user License or greater level, you will have access to one hour with an expert analyst who will help you link key findings in the report to the business issues you're addressing. This will need to be used within three months of purchase.
This report also includes a complimentary Excel file with data from the report for purchasers at the Site License or greater level.
Table of Contents
1. Preface
2. Research Methodology
5. Market Insights
6. Cell & Gene Therapy Manufacturing Services Market, by Type
7. Cell & Gene Therapy Manufacturing Services Market, by Indication
8. Cell & Gene Therapy Manufacturing Services Market, by Application
9. Cell & Gene Therapy Manufacturing Services Market, by End-User
10. Americas Cell & Gene Therapy Manufacturing Services Market
11. Asia-Pacific Cell & Gene Therapy Manufacturing Services Market
12. Europe, Middle East & Africa Cell & Gene Therapy Manufacturing Services Market
13. Competitive Landscape
14. Competitive Portfolio
List of Figures
List of Tables
Companies Mentioned
- Advanced BioScience Laboratories, Inc.
- AGC Biologics
- Bio-Techne Corporation
- Bluebird Bio, Inc.
- Boehringer Ingelheim International GmbH
- c-LEcta GmbH
- Catalent, Inc.
- Cell and Gene Therapy Catapult
- Cell Therapies Pty Ltd.
- Cell-Easy SAS
- Charles River Laboratories International, Inc.
- Exmoor Pharma Concepts Limited
- F. Hoffmann-La Roche Ltd.
- FUJIFILM Diosynth Biotechnologies
- General Electric Company
- Lonza Group
- Merck KGaA
- Miltenyi Biotec B.V. & Co. KG
- Minaris Regenerative Medicine GmbH
- Nikon Corporation
- Novartis AG
- Oxford Biomedica PLC
- Recipharm AB
- Resonac Corporation
- Samsung Biologics Co., Ltd
- Takara Holdings Inc.
- Thermo Fisher Scientific, Inc.
- uBriGene Biosciences Inc.
- Wuxi Apptec Co., Ltd.
Methodology
LOADING...
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 198 |
| Published | May 2024 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 19.98 Billion |
| Forecasted Market Value ( USD | $ 48.45 Billion |
| Compound Annual Growth Rate | 15.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 29 |
