Cell And Gene Therapy Manufacturing Market Size, Share & Trends Analysis Report By Therapy Type, By Scale (R&D, Commercial), By Mode, By Workflow (Vector Production, Cell Banking), By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global cell and gene therapy manufacturing market size was valued at USD 13.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 20.3% from 2021 to 2028. The emergence of advanced therapies has played a major role in reshaping the biopharmaceutical industry as well as transformed the treatment paradigm of several life-threatening and rare diseases. The exponential growth of the advanced therapy landscape is a key driving factor for the growth of the market.

The ongoing COVID-19 pandemic has positively influenced the market for cell and gene therapy manufacturing. Several entities expanded their production capabilities for vector production as well as signed strategic agreements to produce investigational therapies. This is to address the urgent need for effective therapies as well as a vaccine against the infection. For instance, in March 2021, Tevogen Bio collaborated with BioCentriq to produce Tevogen’s investigational COVID-19 T-Cell Therapy. Currently, this therapy is under review by the U.S. FDA.

Over the past few years, the healthcare industry is witnessing an improved ratio of clinical success to the number of clinical trials of cellular and gene-modified therapy products. This can be attributed to the better scientific and clinical understanding of safety risks related to the application of these products. The number of phase III clinical trials has reached 362 in early 2020 and is expected to increase significantly in the coming years.

The expanding cell and gene therapies arena has triggered several strategic alliances and the entry of several new players in this market. A substantial number of companies are collaborating with contract manufacturers to produce their drug candidates. Furthermore, CMOs/CDMOs continue to expand their manufacturing capabilities to meet the rising demand for services. For instance, in May 2020, Thermo Fisher Scientific invested a significant amount of USD 180 Million for the expansion of its viral vector production capacity twofold.

Therapy Type Insights

The cell therapy manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 58.0% in 2020. The growth is owing to the high number of ongoing clinical trials and the increasing number of products entering the marketplace. More than 250 clinical trials focusing on CAR T cell therapies and other cell therapies are studied to decipher the potential of cell therapies for the treatment of various cancer indications. Furthermore, allogeneic CAR T cell therapies are receiving traction as a more profitable business by biopharma companies, compared to existing manufacturing and business models.

Owing to the low immunogenicity, tissue repair capabilities, and immunosuppressive properties of mesenchymal stem cells, the implantation of allogeneic MSCs serves as a promising tool for the development of cell-based therapy. Furthermore, process automation is considered a suitable option to reduce the costs and time required for large-scale manufacturing of cell therapies. Such technological evolution to advance therapy manufacturing is anticipated to greatly benefit the growth of the market for cell and gene therapy manufacturing.

Since the first U.S. FDA approval for gene therapy in 2017, this space is growing at a tremendous pace. With the increased investments from the operating entities coupled with the clinical success of these products, many gene therapy companies are focusing on the manufacturing and commercialization of their products. The key manufacturers are undertaking various strategic initiatives to bolster their presence in the gene therapy manufacturing market space.

Scale Insights

The pre-commercial/ R&D scale manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 73.0% in 2020. This can be attributed to the strong and constantly growing pipeline of cell and gene therapies across the globe. As of March 2020, more than 1,000 clinical trials are underway for various cell therapies. Furthermore, according to the Journal of Gene Medicine, the number of gene therapy clinical trials has reached 3,025 as of 2019. This high number depicts the growing demand for manufacturing services in pre-clinical stage product candidates.

The recent outbreak of SARS-CoV-2 is expected to positively impact the growth of this segment. According to the U.S. FDA official, the regulatory agency is receiving an increased number of applications for the use of cell therapies to treat COVID-19. For instance, in June 2021, Cartesian Therapeutics has initiated the recruitment for the clinical trial of its RNA cell therapy, Descartes-30 for COVID-19 Related ARDS.

Supportive regulatory bodies are playing a crucial role in driving the market for commercial upstream manufacturing. As of July 2020, the U.S. FDA has approved 18 cellular and gene therapy products for commercial production and use. The regulatory body has expected to receive over 200 gene and cell therapy INDs annually from the beginning of 2020 and planning to approve up to 20 products per year from 2025. Such advances in the segment are anticipated to drive the commercial scale manufacturing segment.

Mode Insights

The in-house manufacturing segment dominated the market for cell and gene therapy manufacturing and accounted for the largest revenue share of 85.0% in 2020. The presence of a substantial number of companies with large capital, as well as academic institutes with personalized patient treatment programs is the largest contributor to this segment. Greater agility in process troubleshooting, ownership of supply channels, and efficient development of a corporate knowledge base to help future in-house scale-up are key factors accelerating segment growth.

The rising popularity of advanced therapies has intensified market competition among players. Cell therapy manufacturing companies and CDMOs are signing contracts and deals to speed up their product development and gain a competitive edge. Also, ongoing clinical research initiatives have fueled the revenue generation for the contract manufacturing segment. Besides, 65% or more of the cell and gene therapy manufacturing process is outsourced, in turn, supporting segment growth.

Small biotech firms developing cell and gene therapies lack resources, infrastructure, and capacity leading to strategic alliances with contract manufacturers. This has propelled the market growth in this segment. In addition, the investments in this space are expanding 30-35% per year further driving the market.

Workflow Insights

The process development segment dominated the market and accounted for the largest revenue share of 17.0% in 2020. With the increasing number of therapies advancing from clinical trials to regulatory approval, the development of well-characterized and robust methods for cell therapy production has become increasingly important. Process development strategies provide efficiency while improving the quality and safety profiles of candidate programs.

On the other hand, owing to the high penetration of manufacturing services in vector production space, this segment is expected to witness the fastest growth throughout the forecast period. The viral vectors have been employed for the treatment of various diseases such as cardiovascular, metabolic, hematologic, muscular, infectious diseases, and ophthalmologic and different types of cancer indications.

CDMOs and bio manufacturers such as Thermo Fisher Scientific, Lonza, Merck KGaA, and others are investing a significant amount to expand their viral vector capabilities and meet the changing market demands. For instance, on 15^th June 2021, French CDMO Yposkesi invested USD 71 Million to expand its viral vector production capacity. The company announced its plans to build a second commercial gene and cell therapy manufacturing plant.

Regional Insights

North America dominated the cell and gene therapy manufacturing market and accounted for the largest revenue share of 43.0% in 2020. A substantial number of ongoing clinical trials coupled with the rising engagement of companies in the R&D of gene and cell therapy is the major driving factor for regional market growth. North America pegged the first rank for exhibiting the highest number of gene therapy clinical trials with the presence of more than 400 companies in the region actively engaged in the development of cell and gene therapy products for various diseases.

In Europe, multiple new collaborative research and innovation projects were launched, under Horizon 2020 initiative. These projects include viral vector-based gene therapy trials for rare conditions. This is expected to drive the growth of cell and gene therapy manufacturing services across the European nations. A strong facility network coupled with a strong workforce in European countries is anticipated to further fuel the market growth.

On the other hand, Asia Pacific countries are emerging as strong contenders in this space. The establishment of accelerated approval pathways, growing private and government investments, and increasing healthcare needs are the key driving factors for the emergence of Asian markets. Moreover, China is recognized as the fast-growing market for cell and gene therapy development and has been ranked second in terms of clinical trials across the globe.

Key Companies & Market Share Insights

The increasing interest of public and private investors in advance therapy development is anticipated to accelerate the market revenue during the forecast period. In addition, the major players are undertaking various strategic initiatives such as mergers and acquisitions, licensing, and partnering to enhance their market presence. In the past few years, the market has witnessed several notable mergers and acquisitions.

For instance, in January 2021, Thermo Fisher Scientific acquired Novasep’s viral vector manufacturing business. This deal helped the company expand its global capacity for vector manufacturing. Similarly, in February 2020, Catalent Inc. announced the acquisition of MaSTherCell Global, Inc., for USD 315 Million to expand its market presence in cell and gene therapy platforms. In addition, CDMOs are also investing a significant amount to expand their capabilities, thereby propelling market growth. Some of the prominent players in the cell and gene therapy manufacturing market include:

• Thermo Fisher Scientific

• Merck KGaA

• Lonza

• Catalent Inc.

• Takara Bio Inc.

• F. Hoffmann-La Roche Ltd

• Wuxi Advanced Therapies

• Samsung Biologics

• Boehringer Ingelheim

• Novartis AG

• Hitachi Chemical Co., Ltd.

• Cellular Therapeutics

• Miltenyi Biotec

• Bluebird Bio Inc.

Cell And Gene Therapy Manufacturing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global cell and gene therapy manufacturing market report on the basis of therapy type, scale, mode, workflow, and region:

• Therapy Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Cell Therapy Manufacturing

    • Stem Cell Therapy

    • Non-Stem Cell Therapy

  • Gene Therapy Manufacturing

• Scale Outlook (Revenue, USD Million, 2017 - 2028)

  • Pre-commercial/ R&D Scale Manufacturing

  • Commercial Scale Manufacturing

• Mode Outlook (Revenue, USD Million, 2017 - 2028)

  • Contract Manufacturing

  • In-house Manufacturing

• Workflow Outlook (Revenue, USD Million, 2017 - 2028)

  • Cell Processing

  • Cell Banking

  • Process Development

  • Fill & Finish Operations

  • Analytical And Quality Testing

  • Raw Material Testing

  • Vector Production

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East Africa (MEA)

    • South Africa

    • Saudi Arabia