Cell & Gene Therapy Manufacturing Services Market Size, Share, By Type, Workflow, Mode, Indication, Application, and Region - Trends, Analysis, and Forecast till 2035

• By 2035, the cell & gene therapy manufacturing services market size is expected to achieve a valuation of USD 42.3 billion.
• In 2024, the market was worth USD 8.4 billion.
• The focused market is expected to witness a steady CAGR of 19.4%.

Cell & gene therapy manufacturing services encompasses a range of specialized processes and technologies aimed at producing cell-based and gene-based therapies. These services are critical in the biopharmaceutical industry, which focuses on the development and manufacturing of innovative treatments designed to modify genetic material to treat, prevent, and potentially cure diseases. The target market is boosted by a growing reliance on contract development and manufacturing organizations (CDMOs) particularly among smaller biotech firms lacking large-scale production infrastructure.

For instance, in January 2024, Pluri Inc., a biotech company, launched a new business division offering cell therapy manufacturing services as a contract development and manufacturing organization (CDMO), PluriCDMO. PluriCDMO will offer development and manufacturing services from its state-of-the-art, 47,000 sq.-ft. GMP cell therapy production facility to help customers address key challenges in the development and manufacturing of cell-based therapies.

Key Takeaways:

• North America held the largest share of the market in 2024 due to the increasing advanced healthcare infrastructure and significant R&D investments across the region.
• Asia Pacific is expected to be the fastest-growing region in the market during the forecast period owing to increasing government and private investments in the region. 
• By Workflow, the cell processing is expected to account for the largest share of the Cell & Gene Therapy Manufacturing Services market in the upcoming years as this process requires highly specialized technology and stringent quality control to ensure cell viability, potency and purity.

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Key Drivers of Target Market:

Increasing Prevalence of Chronic Diseases is Expected to Propel Market Growth

Advanced cell and gene therapies are being driven by the increasing prevalence of genetic diseases and chronic, life-threatening ailments, such as cancer. One kind of gene therapy i.e. CAR-T cell therapy helps cure immune-related chronic disorders such autoimmune diseases and Contract Manufacturing.

• For Instance, In April 2024, the president of India introduced the country's first domestically produced CAR T-cell therapy. Considered to be the first "Made in India" CAR T-cell therapy, "NexCAR19 CAR T-cell therapy" is anticipated to considerably reduce treatment costs, this treatment is a phenomenal advance in medical sciences.

Advancements in Manufacturing Technologies to Speed Up Market Expansion

Innovations such as automation, AI integration and also closed system manufacturing processes are enhancing production efficiency and scalability which makes it easier to meet the increasing demand for therapies.

• For Instance, in October 2024, Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, is expanding its offerings in Latin America to help bring automated manufacturing to cell and gene therapy companies in Brazil, Colombia, and Mexico. Cell and gene therapies are a rapidly advancing field and hold the potential to treat diseases and transform lives. Affordability and the ability to scale these treatments in the manufacturing process are key factors that make automated technologies promising in helping cell and gene therapies touch more patients' lives. 

Restraints:

Challenges in Scaling Production Can Hamper the Target Market Growth

Many major companies face difficulties in scaling up production to meet increasing demand due to the complex nature of cell and gene therapies. This complexity leads to inefficiencies and increased costs. 

• For Instance, In October 2024, NewBiologix, a technology innovation company pioneering innovative tools enabling efficient, cost-effective, and large-scale production of viral vectors for gene therapy, announced the launch of the Xcell Portfolio. The Xcell suite of advanced technologies offer reliable and scalable solutions that address critical challenges in gene therapy production, such as low yields, batch heterogeneity, scalability, and high cost.
• Counterbalance Statements: Despite infrastructure limitations, partnerships with CDMOs provide access to established facilities and expertise enabling companies to scale their production capabilities without the need for massive capital investments.

Opportunities & Market Trends:

Surge in Clinical Trials Provide Better Future Growth Opportunities

• The ongoing increase in clinical trials particularly for CAR-T cell therapies present a significant opportunity for manufacturing services. With over 360 clinical trials currently underway there is a growing demand for scalable and compliant manufacturing solutions to support these developments underscoring the need for specialized services in the target expanding market growth.
• For instance, in November 2024, UCSF Benioff Children’s Hospital Oakland is enrolling patients in an innovative clinical trial that seeks to cure sickle cell disease. The trial is the first in the U.S. to apply non-viral CRISPR-Cas9 gene-editing technology in humans to directly correct the genetic mutation that causes the disease. This clinical study is part of BCH Oakland's ongoing efforts to treat sickle cell disease and discover a cure.

The cell & gene therapy manufacturing services market is classified into type, workflow, mode, indication, application, and region.

Type:

Cell & gene therapy manufacturing services systems market by type is categorized into cell therapy (allogeneic and autologous) and gene therapy (viral vectors, non-viral vectors, and others). The cell therapy segment is expected to dominate over the forecast period cell & gene therapy manufacturing services market share as cell therapy is a revolutionary approach in the field of regenerative medicine involving the use of living cells to treat diseases.

• For instance, in November 2024, the University of Texas MD Anderson Cancer Center announced the launch of its Institute for Cell Therapy Discovery & Innovation, which will build upon longstanding MD Anderson clinical and research expertise to lead the world in developing and advancing impactful cell therapies for patients in need. The institute will integrate across MD Anderson’s unique research ecosystem to accelerate the discovery and development of new cell therapies from preclinical studies through clinical trials.

Workflow:

By workflow, the cell & gene therapy manufacturing services market is segmented into cell processing, cell banking, process development, fill & finish operations, analytical and quality testing, raw material testing, and others. The cell processing segment dominate the market with 85.4% cell & gene therapy manufacturing services market share due to the increasing Type approval by regulatory authorities.

• For instance, in November 2020, Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing.

Mode:

The target market is divided into in-house manufacturing, and contract manufacturing under the mode segment. Due to the rising demand for cell and gene therapies as well as the growing factor of outsourcing manufacturing activities to optimize production processes and take advantage of specialized skills, the contract manufacturing segment held a greater than 67.13% share of the market for cell & gene therapy manufacturing services.

Indication:

The target market is divided into oncology diseases, cardiovascular diseases, orthopedic diseases, infectious diseases, ophthalmology diseases, and other indications under the indication segment. Target market share is anticipated to be dominated by the oncology segment due to the growing number of clinical studies and the strong demand for treatments that target different types of cancer. Further, it is projected that this focused market segment will continue to dominate the target market as developments in gene and cell therapies expand to address this crucial healthcare issue.

End-User:

The target market is divided into hospital & clinic, biopharmaceutical companies, academic research institutes, and other under the end-user segment. Biopharmaceutical companies segment is accounted for the highest share of approximately 69.4% of the focused market reflecting their significant role in the development and commercialization of cell and gene therapies.

Region:

Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: North America holds the dominant cell & gene therapy manufacturing services market share as this region benefits from a high concentration of biopharmaceutical companies, advanced research and development capabilities, and also strong governmental support for regenerative medicine.

• For instance, in December 2023, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.

Asia Pacific: This is largest and fastest-growing region in target market due to the growing R&D expenditures and partnerships, which enhances cell and gene therapy manufacturing capabilities that are propelling countries, such as China and Japan to become major players.

• For instance, in October 2023, Dr. Reddy’s Laboratories Ltd. announced the launch of Elobixibat, a first-in-class drug to treat chronic constipation, in India. According to the company’s statement, Dr. Reddy’s will market Elobixibat under the brand name BixiBat in India.

Cell & Gene Therapy Manufacturing Services Market Report Scope:

Segmentation:

By Type:

• Cell Therapy
  • Allogeneic
  • Autologous
• Gene Therapy
  • Viral Vectors
  • Non-Viral Vectors

By Workflow:

• Cell Processing
• Cell Banking
• Process Development
• Fill & Finish Operations
• Analytical and Quality Testing
• Raw Material Testing
• Others

By Mode:

• In-House Manufacturing
• Contract Manufacturing

By Indication:

• Oncology Diseases
• Cardiovascular Diseases
• Orthopedic Diseases
• Infectious Diseases
• Ophthalmology Diseases
• Other Indications

By End-User:

• Hospitals & Clinics
• Biopharmaceutical Companies
• Academic Research Institutes
• Other End Users

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating in the cell & gene therapy manufacturing services market include KBI Biopharma, Inc., Cell Therapies Pty Ltd, RoslinCT, CGT Catapult and among others. The target market growth is concentrating majorly as companies strive to increase their service offerings, strengthen their manufacturing capacities, and broaden their global reach.

For instance, in October 2023, Bayer AG has opened a new cell therapy production plant in Berkeley, California, U.S. to bring cell therapies to patients on a global scale. The USD 250 million investment will support the production of material required for clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson’s disease. The new facility will also support the future production of additional cell therapies as Bayer’s cell therapy portfolio advances.

List of Key Players in the Market:

• Lonza Group
• KBI Biopharma, Inc.
• Cell Therapies Pty Ltd.
• RoslinCT
• CGT Catapult
• ABL, Inc.
• Batavia Biosciences B.V.
• Aldevron LLC.
• Oxford Biomedica USA
• Vivebiotech
• Rentschler Biopharma
• AGC Biologics
• ElevateBio
• Pharmaron
• Recipharm AB
• Exothera

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• In October 2024, Governor Kathy Hochul unveiled plans for New York BioGenesis Park, a groundbreaking USD 430 million Cell and Gene Therapy Innovation Hub in Nassau County, Long Island. To be developed by The Albanese Organization, Inc., this state-of-the-art facility would catalyze CGT research, development, clinical manufacturing, and commercialization across New York tate.
• In September 2024, LumaCyte, a leader in advanced cellular analysis and precision bioanalytics, proudly announced the launch of its groundbreaking cell therapy application for predictive CAR T donor analytics. Leveraging its novel Laser Force Cytology technology and Radiance instrument, LumaCyte uncovers deep data insights into highly variable and complex patient and donor cellular starting material, enabling cell therapy developers to predict manufacturing success for specific donors or patients.
• In February 2024, AstraZeneca is investing USD 300 million in a state-of-the-art facility in Rockville, MD to launch its life-saving cell therapy platforms in the U.S. for critical cancer trials and future commercial supply. More than 150 new highly skilled jobs will be created to initially focus on manufacturing T-cell therapies to enable clinical trials to be conducted around the world. Over time, the site may expand its focus to support other disease areas.
• In June 2024, Longeveron Inc., a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the launch of its contract development and manufacturing business at the Company’s 15,000 square feet state-of-the-art Good Manufacturing Practice (GMP) facility.
• In April 2024, Memel Biotech, a Lithuania-based contract development and manufacturing organization, announced that it has launched a fully integrated advanced therapy development and manufacturing service at its facility in Klaipeda, Lithuania, which will serve markets in the European Union (EU).

Analyst View:

Cell & gene therapy manufacturing services market is experiencing robust growth which is driven by the increasing global adoption of advanced therapies for treating cancer, genetic disorders and also rare diseases, which further expected to boost the target market growth in coming years.

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