Cell and Gene Therapy Manufacturing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Cell Therapy (Autologous and Allogenic) and Gene Therapy (Viral and Non-Vira

Cell and Gene Therapy Manufacturing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Cell Therapy (Autologous and Allogenic) and Gene Therapy (Viral and Non-Viral Vector)], Indication (Cancer, Orthopaedics, and Others), Application (Clinical Manufacturing and Commercial Manufacturing), End User [Pharmaceutical and Biotechnology Companies and Contract Research Organization (CROs)], and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

The cell and gene therapy manufacturing services market size is expected to grow from US$ 7,581.97 million in 2022 to US$ 26,724.90 million by 2030; it is estimated to register a CAGR of 17.1% during 2022–2030.

The report highlights trends prevailing in the market and the factors driving and hindering the cell and gene therapy manufacturing services market growth. The growth of the market is attributed increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing. However, high cost of cell and gene therapy manufacturing hinders the market growth.

Strategic Initiatives by Companies

Companies operating in the cell and gene therapy manufacturing services market focus on strategic developments such as collaborations, expansions, agreements, partnerships, and new product launches, which help them improve their sales, expand their geographic reach, and enhance their capacities to cater to a larger than existing customer base. A few of the noteworthy developments in the cell and gene therapy manufacturing services market are mentioned below.

In May 2023, Lonza launched the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation devised to optimize and streamline CAR T-cell manufacturing. The TheraPEAK T-VIVO Cell Culture Medium can exhibit a high performance without the need to add human serum or its components, unlike other serum-free media.
In October 2022, Pfizer Inc. completed the acquisition of Biohaven Pharmaceutical Holding Company Ltd., the manufacturer of NURTEC ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults.
In March 2022, Cellevolve Bio partnered with Seattle Children’s Therapeutics to develop and commercialize new multiplex CARs for paediatric cancers. Under the collaboration, the partners will focus on the BrainChild research program, a suite of five multiplex CARs, to treat pediatric central nervous system (CNS) malignancies. In partnership, they would leverage the Seattle Children’s Cure Factory facility to conduct early clinical GMP research on new CARs.
In March 2022, Twist Bioscience Corporation and Kriya Therapeutics, Inc. entered an antibody discovery agreement for antibodies delivered using adeno-associated viral (AAV) gene therapy in therapeutic oncology applications. Upon collaboration, the companies had plans of combining Twist’s antibody libraries with Kriya’s proprietary vector engineering platform to discover novel antibodies against specific targets of interest to be delivered with Kriya’s gene therapy technology.
In February 2022, Edigene Inc. entered into a global license agreement with Boston Children’s Hospital (BCH) for intellectual property rights covering the upregulation of foetal haemoglobin by disrupting a key gene. Upregulation of foetal haemoglobin is a potential treatment for many genetic diseases resulting from abnormal haemoglobin structures (hemoglobinopathies), replacing the defective haemoglobin molecule with its foetal version.
In January 2022, FUJIFILM Corporation agreed to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. The facility is readily expandable with the flexibility to produce 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., the Belgium-based viral vector manufacturing business of Groupe Novasep SAS. Henogen provides vaccine and therapeutics manufacturing services to biotechnology companies and large biopharmaceutical customers. With this acquisition, Thermo Fisher Scientific expanded its capabilities in the cell and gene vaccines and therapies category.

Therefore, introducing products such as viral vectors, media for cell therapy manufacturing, and allogeneic T-cells; the development of innovative products targeting various health issues to create new or improved products; and the initiation of new businesses to remain competitive in the market, all, through collaborations and partnerships can help speed up the development of new platforms for cell and gene therapy manufacturing services. Thus, these strategic initiatives create significant growth opportunities in the cell and gene therapy manufacturing services market.

High Cost of Cell and Gene Therapy Manufacturing

As cell and gene therapies involve a complex manufacturing process and use biological components, these therapies are priced exorbitantly. For instance, the cost of Kymriah is ~US$ 475,000, and Yescarta is ~US$ 373,000, respectively. According to the analysis by the Institute for Clinical and Economic Review (ICER), the average cost of a gene therapy ranges US$ 1–2 million per dose. The manufacturing of cell and gene therapies involves various risks, such as the black-box effect, amplified failure, and reduced flexibility. The black-box effect refers to the tasks and processes performed in an automated system; there is no visibility to the process, and the progress status is hidden. Thus, the lack of visibility to the manufacturing processes increases failure and reduces the flexibility to adapt to the manufacturing processes. In addition, the most critical challenge for the manufacturers is to gain product approval from the regulatory bodies—such as FDA and EMA—and ensure patient’s safety from the side effects of the therapy.

Furthermore, the cost of consumables and equipment is much higher, which leads to the premium cost of cell therapies. For instance, the cost of the reagent kit offered by Miltenyi Biotec ranges from US$ 500 to US$ 5,000. Similarly, the capital cost of installing the equipment is nearly US$ 2 million. Thus, the challenges pertaining to therapy prices limit the cell and gene therapy manufacturing services market growth.

Cell and Gene Therapy Manufacturing Services Market, By Type Insights

Based on type, the cell and gene therapy manufacturing services market is segmented into cell therapy and gene therapy. Cell therapy is segmented as autologous and allogenic. Further, gene therapy is bifurcated into viral vector and non-viral vector. The cell therapy segment held a larger market share in 2022. However, gene therapy segment is anticipated to register the highest CAGR of 16.6% during the forecast period (2022-2030). Gene therapy is a technique that uses a gene(s) to prevent, treat or cure a medical disorder or disease. Gene therapies often works by replacing a defective, or by adding new copies of a gene that is broken or missing gene in a patient’s cells with a healthy version of that gene. Gene therapy can be used to modify cells outside as well as inside the body. A vector is injected carrying the gene directly into the patient when a gene therapy is used to modify cells inside the body. Whereas blood, bone marrow, or another tissue are taken out when gene therapy is used to modify cells outside the body and separate the specific cell types in the lab.

Cell and Gene Therapy Manufacturing Services Market, By Indication-Based Insights

Based on indication, the cell and gene therapy manufacturing services market is divided into cancer, orthopedics, and others. The cancer segment held the largest share of the market in 2022 and same segment is expected to grow at the highest CAGR during the forecast period. The broad field of cell and gene therapy promises many innovative treatments that have the potential to prevent deaths from cancer. According to the April 2022 newsletter by Alliance for Cancer Gene Therapy, Inc., 6 CAR T-cell therapies have been approved by the US Food and Drug Administration (FDA) for the treatment of myeloma, leukemia, and lymphoma. In December 2022, the FDA approved Adstiladrin, a non-replicating adenoviral vector-based gene therapy, for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. In 2022, FDA approved Kimmtrak, a T-cell receptor therapy for a rare type of melanoma in the eye—uveal melanoma. As there is an increase in the number of FDA approvals of cell and gene therapy for the treatment of cancer, the production of these therapies has increased in the last several years. Thus, a large number of CDMOs are focusing on providing manufacturing services for cancer cell and gene therapies.

Based on Application, the cell and gene therapy manufacturing services market is categorized into clinical manufacturing and commercial manufacturing. The commercial manufacturing segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR of 17.1% in the market during the forecast period (2020-2030). CGTs provide significant value across multiple therapeutic areas, driven by a combination of clinical benefit, durability, and overall response rate. However, these therapies are yet to gain a significant market reach. The therapeutic gain of CGTs is underestimated due to the difficulty associated with delivering the right therapy to the right patients, and thus, only a few commercial CGTs-based products have reached the market over the past decade. However, the clinical pipeline of CGT-based products in Phase 3 clinical trials indicates the possibility of a dramatic rise in the number of approvals in the near future. WuXi Advanced Therapies Inc., a prominent CDMO and a wholly subsidiary of WuXi AppTec, announced the opening of new process development and commercial manufacturing facility in Shanghai in October 2021. This new manufacturing facility would help it expand its global capacity through GMP commercial manufacturing and integrated testing services that would support the commercialization of CGT products in the coming years.

The cell and gene therapy manufacturing services market, by end user, is categorized into pharmaceutical & biotechnology companies and contract research organizations (CROs). The pharmaceutical and biotechnology segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR of 17.1% in the market during the forecast period (2020-2030). Major US-based pharmaceutical and biotechnology companies committed to offering CGTs intended to treat acute and rare conditions, which are unresponsive to traditional approaches, include ElevateBio and Discovery Labs. These companies are focused on creating a completely new branch of pharmaceutical contract development and manufacturing organizations (CDMOs). They would compete with one another and with a handful of giant services firms by investing in CGTs.