North America GMP Cell Therapy Consumables Market

The North America GMP cell therapy consumables market is expected to grow from US$ 6,233.00 million in 2022 to US$ 26,093.86 million by 2028; it is estimated to grow at a CAGR of 27.0% from 2022 to 2028.  

Growing Regulatory Approvals for Cell and Gene Therapy (CGT) Product Boosts North America GMP Cell

Therapy Consumables Market

The COVID-19 pandemic accelerated the pace of the ongoing developments in cell and gene therapy (CGT). As per the 2019 U.S. Food and Drug Administration (FDA) report, in the last two years, CGT developers submitted ~500 applications to the FDA to initiate clinical trials. Out of those applications, the FDA predicts that ~10-20 CGT products will be approved annually by 2025. Considering the pace with which the therapies are expected to enter the market, the Alliance for Regenerative Medicine expects this industry's revenues to grow at a CAGR of 40% by 2025.

A few of the FDA-approved CGT developments include:

• In 2021, FDA approved Breyanzi. Breyanzi is a cell-based gene therapy to treat patients suffering from certain types of large B-cell lymphoma cancer. Each dose is a customized treatment that uses the patient’s T-cells to fight relapsed or refractory disease.

FDA checks the quality of medication products by carefully monitoring manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The regulations comprise minimum requirements for the methods, facilities, and controls to be used during the manufacturing, processing, and packing of a product. The regulations confirm that the product is safe for usage and has the ingredients and strength it claims to have. The approval process for new therapy/drug marketing applications includes a review of the manufacturer's compliance with the CGMPs. FDA evaluators and investigators verify whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market. Therefore, the outlook of the CGT field is promising due to the increased rate of FDA approvals and patient enthusiasm. In addition, continued advances in CGT following GMP will transform the way diseases are treated and modify healthcare delivery on both the individual and industry levels. Hence, the growing regulatory approvals for cell and gene therapy (CGT) product boosts the North America GMP cell therapy consumables market. 

Market Overview

North America is one of the most developed regions in the world. North America accounts for the major share of the GMP cell therapy consumables market over the forecast period. The US is expected to hold the major share in the market owing to the surge in drug discovery, increase in R&D activities, and rise in strategic collaborations among market players. Moreover, rising incidences of cancer, infectious diseases, autoimmune disorders, and neurological disorders have augmented the demand for personalized medicine and regenerative medicine, which, in turn, drive the growth of the GMP cell therapy consumables market. The US holds a significant share of the North America GMP cell therapy consumables market. The market growth is due to rising government health expenditure, increasing developments in the pharmaceutical industry, and growing demand for novel drugs owing to the prevalence of various infectious diseases. According to US Centers for Medicare & Medicaid Services, the national healthcare expenditure in the US increased by 9.7% in 2019 to reach US$ 4.1 trillion in 2020. National health spending is expected to grow at an annual rate of 5.4% from 2019 to 2028, and it is expected to reach US$ 6.2 trillion by 2028. The rising health expenditure is estimated to increase various funding in the research related to the development of drugs, fueling the North America GMP cell therapy consumables market.  

North America GMP Cell Therapy Consumables

Market Revenue and Forecast to 2028 (US$ Million)

North America GMP Cell Therapy Consumables Strategic Insights

Strategic insights for the North America GMP Cell Therapy Consumables provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

North America GMP Cell Therapy Consumables Report Scope

North America GMP Cell Therapy Consumables Regional Insights

The geographic scope of the North America GMP Cell Therapy Consumables refers to the specific areas in which a business operates and competes. Understanding local distinctions, such as diverse consumer preferences (e.g., demand for specific plug types or battery backup durations), varying economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved areas or adapting their offerings to meet local demands. A clear market focus allows for more effective resource allocation, targeted marketing campaigns, and better positioning against local competitors, ultimately driving growth in those targeted areas.

North America GMP Cell Therapy Consumables Market Segmentation

The North America GMP cell therapy consumables market is segmented on the basis of product, cell therapy, process, end use, and country.  

Based on product, the North America GMP cell therapy consumables market is segmented into kits, reagents/molecular biology reagents, growth factors/cytokines and interleukins (including protein and nucleic acid purification buffers), and others. The kits segment held the largest share of the North America GMP cell therapy consumables market in 2022.

Based on cell therapy, the North America GMP cell therapy consumables market is segmented into NK cell therapy, stem cell therapy, T-cell therapy, and others. The T-cell therapy segment registered the largest share of the North America GMP cell therapy consumables market in 2022.   

Based on process, the North America GMP cell therapy consumables market is segmented into 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, and others. The cell collection and characterization/sorting and separation segment held the largest share of the North America GMP cell therapy consumables market in 2022.

Based on end use, the North America GMP cell therapy consumables market is segmented into clinical, commercial, and research. The clinical segment held the largest share of the North America GMP cell therapy consumables market in 2022. 

Based on country, the North America GMP cell therapy consumables market is segmented into the US, Canada, and Mexico. The US dominated the North America GMP cell therapy consumables market in 2022.  

Bio-Techne Corp, BPS Bioscience Inc, Corning Inc, FUJIFILM Irvine Scientific Inc, Global Life Sciences Solutions USA LLC, Lonza Group AG, Merck KGaA, Miltenyi Biotec BV & Co KG, Sartorius AG, and Thermo Fisher Scientific Inc are the leading companies operating in the GMP cell therapy consumables market in North America.