Cell And Gene Therapy Manufacturing Market Share, Regional Outlook, Survey Report 2028

Cell And Gene Therapy Manufacturing Industry Overview

The global cell and gene therapy manufacturing market size is expected to reach USD 57.4 billion by 2028, according to a new report by Grand View Research, Inc. The market is estimated to expand at a CAGR of 20.3% from 2021 to 2028. An exponential rise in clinical pipeline coupled with a rising number of regulatory approvals for advanced therapies has majorly driven the market.

China cell and gene therapy manufacturing market size, by mode, 2017 - 2028 (USD Million)

Cell And Gene Therapy Manufacturing Market Segmentation

Grand View Research has segmented the global cell and gene therapy manufacturing market on the basis of therapy type, scale, mode, workflow, and region:

Based on the Type Insights, the market is segmented into Cell Therapy Manufacturing and Gene Therapy Manufacturing.

  • 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 othercell therapies are studied to decipher the potential of cell therapies for the treatment of various cancer indications.
  • 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.

Based on the Scale Insights, the market is segmented into Pre-commercial/ R&D Scale and Commercial Scale.

  • 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.
  • 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.

Based on the Mode Insights, the market is segmented into Contract Manufacturing and In-house Manufacturing.

  • 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.
  • 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.

Based on the Workflow Insights, the market is segmented into Cell Processing, Cell Banking, Process Development, Fill & Finish Operations, Analytical And Quality Testing, Raw Material Testing, Vector Production, Others.

  • 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.

Cell And Gene Therapy Manufacturing Regional Outlook

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Key Companies Profile & 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.   

Some of the prominent players operating in the global cell and gene therapy manufacturing market include,

  • Thermo Fisher Scientific
  • Merck KGaA
  • Lonza
  • Catalent Inc.
  • Takara Bio Inc.
  • Hoffmann-La Roche Ltd.
  • Wuxi Advanced Therapies
  • Samsung Biologics
  • Boehringer Ingelheim
  • Novartis AG
  • Hitachi Chemical Co., Ltd.
  • Cellular Therapeutics
  • Miltenyi Biotec
  • Bluebird Bio Inc. 

Order a free sample PDF of the Cell And Gene Therapy Manufacturing Market Intelligence Study, published by Grand View Research.

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