Our latest research report titled "Cell and Gene Therapy Manufacturing Services Market Forecast to 2030 ? Country Analysis ? by Type, Indication, Application, and End User" indicates that the market for cell and gene therapy manufacturing services is projected to expand significantly, growing from approximately US$ 7,581.97 million in 2022 to around US$ 26,724.90 million by 2030. This growth represents a compound annual growth rate (CAGR) of 17.1% over the period from 2022 to 2030.
The report outlines the prevailing trends in the market, as well as the factors that are both facilitating and obstructing the growth of cell and gene therapy manufacturing services. The market's expansion is primarily driven by an increase in the number of approved cell and gene therapies and a growing trend towards outsourcing manufacturing processes. Conversely, the high costs associated with cell and gene therapy manufacturing present a significant barrier to market growth.
Strategic Initiatives by Companies
Firms within the cell and gene therapy manufacturing services market are actively pursuing strategic initiatives such as collaborations, expansions, agreements, partnerships, and the launch of new products. These efforts are aimed at enhancing sales, broadening geographic reach, and increasing capacity to serve a larger customer base. Below are some notable developments in the sector:
- In May 2023, Lonza introduced the TheraPEAK T-VIVO Cell Culture Medium, featuring a novel chemically defined formulation designed to optimize CAR T-cell manufacturing. This medium performs exceptionally well without the need for human serum or its components, setting it apart from other serum-free media.
- In October 2022, Pfizer Inc. finalized its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the creator of NURTEC ODT (rimegepant), a groundbreaking therapy for migraines that has been approved for both acute treatment and prevention of episodic migraines in adults.
- In March 2022, Cellevolve Bio formed a partnership with Seattle Children?s Therapeutics to develop and commercialize multiplex CARs aimed at treating pediatric cancers. This collaboration will focus on the BrainChild research program, which encompasses five multiplex CARs targeting pediatric central nervous system (CNS) malignancies, utilizing the Seattle Children?s Cure Factory for early clinical GMP research.
- In March 2022, Twist Bioscience Corporation and Kriya Therapeutics, Inc. entered into an agreement for antibody discovery, utilizing adeno-associated viral (AAV) gene therapy for therapeutic oncology applications. Their collaboration aims to merge Twist?s antibody libraries with Kriya?s proprietary vector engineering platform to identify novel antibodies for specific targets using Kriya?s gene therapy technology.
- In February 2022, Edigene Inc. secured a global license agreement with Boston Children?s Hospital (BCH) for intellectual property rights related to the upregulation of fetal hemoglobin through the disruption of a key gene, which could potentially treat various genetic disorders caused by abnormal hemoglobin structures.
- In January 2022, FUJIFILM Corporation announced its intention to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. This facility is designed to be expandable and flexible, capable of producing both clinical and commercial cell therapies, including allogeneic T-cell and CAR T immunotherapies.
- In January 2021, Thermo Fisher Scientific Inc. acquired Henogen S.A., a Belgium-based viral vector manufacturing business, enhancing its capabilities in the production of cell and gene vaccines and therapies.
These strategic initiatives, including the introduction of products like viral vectors and media for cell therapy manufacturing, as well as the development of innovative solutions targeting various health issues, are crucial for maintaining competitiveness in the market. Collaborations and partnerships are essential for accelerating the development of new platforms in cell and gene therapy manufacturing services, thereby creating substantial growth opportunities.
High Cost of Cell and Gene Therapy Manufacturing
The manufacturing of cell and gene therapies is inherently complex and involves biological components, leading to high pricing. For example, Kymriah costs approximately US$ 475,000, while Yescarta is priced around US$ 373,000. According to the Institute for Clinical and Economic Review (ICER), the average cost of gene therapy can range from US$ 1 to 2 million per dose. The manufacturing process is fraught with risks, including the black-box effect, which refers to the lack of visibility into automated processes, potentially leading to increased failures and reduced flexibility. Additionally, obtaining regulatory approval from bodies like the FDA and EMA is a critical challenge, as is ensuring patient safety from potential side effects.
The high costs of consumables and equipment further exacerbate the premium pricing of cell therapies. For instance, reagent kits from Miltenyi Biotec can range from US$ 500 to US$ 5,000, and the capital investment for necessary equipment can reach nearly US$ 2 million. These financial challenges significantly limit the growth of the cell and gene therapy manufacturing services market.
Cell and Gene Therapy Manufacturing Services Market, By Type Insights
The market is categorized by type into cell therapy and gene therapy. Cell therapy is further divided into autologous and allogenic types, while gene therapy is classified into viral vector and non-viral vector categories. In 2022, the cell therapy segment held a larger market share, but the gene therapy segment is expected to experience the highest CAGR of 16.6% during the forecast period (2022-2030). Gene therapy aims to treat or cure diseases by replacing defective genes or adding healthy copies of genes to a patient?s cells. This can involve modifying cells either inside or outside the body, with vectors being used to deliver genes directly into the patient.
Cell and Gene Therapy Manufacturing Services Market, By Indication-Based Insights
The market is also segmented by indication into cancer, orthopedics, and others. The cancer segment dominated the market in 2022 and is projected to grow at the highest CAGR during the forecast period. Cell and gene therapy holds promise for innovative cancer treatments that could significantly reduce mortality rates. As of April 2022, six CAR T-cell therapies have received FDA approval for treating various blood cancers. In December 2022, the FDA approved Adstiladrin, a gene therapy for high-risk non-muscle-invasive bladder cancer. The increasing number of FDA approvals for cancer therapies has led to a surge in production, prompting many contract development and manufacturing organizations (CDMOs) to focus on cancer cell and gene therapy manufacturing.
In terms of application, the market is divided into clinical and commercial manufacturing. The commercial manufacturing segment held the largest market share in 2022 and is expected to grow at a CAGR of 17.1% during the forecast period. Cell and gene therapies offer significant therapeutic benefits across various areas, but their market penetration remains limited. The clinical pipeline for CGT products in Phase 3 trials suggests a potential increase in approvals soon. WuXi Advanced Therapies Inc., a leading CDMO, announced the opening of a new facility in Shanghai in October 2021 to enhance its global capacity for GMP commercial manufacturing and integrated testing services.
Finally, the cell and gene therapy manufacturing services market is categorized by end user into pharmaceutical and biotechnology companies and contract research organizations (CROs). The pharmaceutical and biotechnology segment held the largest market share in 2022 and is expected to register the highest CAGR of 17.1% during the forecast period. Major US-based companies are dedicated to developing CGTs for acute and rare conditions that do not respond to traditional treatments, creating a new segment within the pharmaceutical contract development and manufacturing landscape.