GMP Cell Therapy Consumables Market Research Report and Outlook by 2028

The market for GMP cell therapy consumables is projected to expand significantly, increasing from US$ 11,031.25 million in 2021 to US$ 59,985.89 million by 2028, reflecting a compound annual growth rate (CAGR) of 27.5% from 2022 to 2028.

This growth is primarily driven by heightened research and development activities, advancements in drug discovery, and a surge in strategic partnerships. Nevertheless, the market faces challenges due to stringent regulatory frameworks that can impede progress.

Good Manufacturing Practices (GMP) are essential for ensuring that products are consistently produced and controlled in accordance with established quality standards. The manufacturing processes involved in cell therapy are intricate and necessitate a robust pharmaceutical quality system along with a quality control (QC) laboratory. Furthermore, all facets of cell therapy production require skilled personnel. Given the complexity of these processes, there is a heightened risk of contamination, making adherence to GMP standards in cell therapy increasingly critical. The growing application of cell therapy for various medical conditions is further driving the demand for GMP-compliant cell therapy consumables.

Companies operating within the GMP cell therapy consumables market are actively pursuing strategic collaborations to foster the development of innovative products and therapies. Notable collaborations in this sector include:

• In October 2022, Pluristyx, panCELLa, and Implant Therapeutics management announced a corporate merger, pending shareholder approval. This merger aims to integrate complementary portfolios to provide comprehensive customer support and enhance access to a diverse array of induced pluripotent stem cell (iPSC)-related products and services. The combined technology and service offerings are expected to significantly expedite the development and delivery of groundbreaking cell therapies to patients.
• In November 2021, Laurus Labs entered into an investment agreement with Immunoadoptive Cell Therapy Private Limited (ImmunoACT), an advanced cell and gene therapy firm, to acquire a 26.62% stake (on a fully diluted basis), contingent upon meeting specific conditions.

The rise in strategic partnerships among industry players focused on cell therapy development has significantly increased the utilization of GMP cell therapy consumables, thereby propelling the market's growth.

Additionally, the last five years have marked a renaissance for innovations in cell and gene therapy (CGT), with the COVID-19 pandemic accelerating these advancements. According to a 2019 report from the US Food and Drug Administration (FDA), approximately 500 applications for clinical trials were submitted by CGT developers over the past two years. The FDA anticipates that around 10 to 20 CGT products will receive approval each year by 2025. For instance, in 2021, the FDA approved Breyanzi, a cell-based gene therapy designed to treat patients with specific types of large B-cell lymphoma. Each dose of this therapy is tailored to utilize the patient's T-cells to combat relapsed or refractory disease.

The FDA plays a crucial role in ensuring the quality of pharmaceutical products by closely monitoring manufacturers' adherence to Current Good Manufacturing Practice (CGMP) regulations. The approval process for new therapy or drug marketing applications includes a thorough review of compliance with CGMPs. Consequently, the outlook for the CGT sector appears optimistic, bolstered by an increasing rate of FDA approvals and growing patient interest. Furthermore, ongoing advancements in CGT that comply with GMP standards are set to revolutionize treatment methodologies and enhance healthcare delivery at both individual and industry levels.

Process Insights

The GMP cell therapy consumables market is categorized based on processes, including cell collection and characterization/sorting and separation, cell culture and expansion/preparation, cryopreservation, cell processing and formulation, cell isolation and activation, cell distribution/handling, process monitoring and control/readministration/quality assurance, among others. The segment focusing on cell collection and characterization/sorting and separation held the largest market share in 2021. However, the cryopreservation segment is anticipated to exhibit the highest CAGR during the forecast period. Cryopreservation has emerged as a critical component of the manufacturing process for numerous cellular therapies, often occurring prior to cell culture to preserve the initial cellular material before large-scale production, and typically following cell expansion therapies. The capability to store cells at various stages of the manufacturing process allows for the establishment of a tailored workflow. Employing GMP-grade cryoprotective agents (CPAs) and controlled-rate freezing equipment with suitable cooling profiles for immune cells are among the best practices adopted to ensure the production of high-quality cells. Sartorius, for example, offers NutriFreez cell freezing solutions designed for the cryopreservation of cells produced in compliance with GMP standards.

The Asia Pacific region is recognized as one of the fastest-growing markets for GMP cell therapy consumables, with India projected to experience the highest CAGR in this regional market during the forecast period. The adoption of GMP cell therapy consumable products by pharmaceutical companies in India is driven by the necessity for aseptic and sterile production environments. Factors such as the increasing development of biosimilars, cell therapies, and combination products, along with a high demand for GMP testing at both clinical and preclinical stages, contribute to market growth. In the United States, the cost of CAR T-cell therapy for leukemia treatment ranges from US$ 800,000 to US$ 900,000. However, Indian startups and pharmaceutical firms are striving to provide this treatment at a more affordable price by reducing treatment duration and enhancing the efficacy of cell therapies. Additionally, the government is investing in cell therapy initiatives for leukemia treatment. For instance, in June 2021, the Department of Biotechnology (DBT) supported the first CAR T-cell therapy conducted at ACTREC, Tata Memorial Center in Mumbai, which has increased the demand for cell therapy consumables in India as Phase I/II trials were conducted in the country.

The report on the GMP cell therapy consumables market references primary and secondary sources, including the World Health Organization (WHO), the US Food and Drug Administration (FDA), the US Centers for Medicare & Medicaid Services, and Johns Hopkins University.