Global Cell and Gene Therapy Manufacturing Market Outlook (2023 to 2033)

Newly-released Cell and Gene Therapy Manufacturing Market analysis report by Future Market Insights shows that global sales of the Cell and Gene Therapy Manufacturing Market in 2022 were held at USD 15.6 Billion. With a CAGR of 29% from 2023 to 2033, the market is expected to reach a valuation of USD 240 Billion. Market revenue through Cell Therapy Manufacturing is expected to be the highest revenue-generating segment, accounting for an expected CAGR of 31.8% from 2023 to 2033.

Attribute Details
Global Cell and Gene Therapy Market (2023) USD 19.3 Billion
Global Cell and Gene Therapy Market (2033) USD 240 Billion
Global Cell and Gene Therapy Market CAGR (2023 to 2033) 29%
USA Cell and Gene Therapy Market CAGR (2023 to 2033) 28.5%
Key Companies Profiled 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.

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Revenue of Cell and Gene Therapy Manufacturing Market from 2018 to 2022 Compared to Demand Outlook for 2023 to 2033

As per the Cell and Gene Therapy Manufacturing Market research by Future Market Insights - a market research and competitive intelligence provider, historically, from 2018 to 2022, the market value increased at around 22% CAGR.

The rising frequency of cancer and other target diseases, as well as increasing research and development spending in pharmaceutical companies, are driving market expansion. GLOBOCAN 2020 has been revised by the International Agency for Research on Cancer (IARC), which reveals that the worldwide cancer burden has increased to 19.3 million cases and 10 million cancer deaths in 2020.

According to a new study, more than 50 million people will be diagnosed with cancer within the next five years. Aging populations and socioeconomic risk factors are two of the most common causes of cancer cases worldwide. Breast cancer is also one of every four cancers diagnosed in women worldwide, according to the same source.

Breast cancer has surpassed lung cancer as the most commonly diagnosed cancer worldwide for the first time, owing to its high incidence in low- and middle-income nations. Because cancer is one of the most complex diseases, cell and gene therapy is one of the fields with a significant opportunity for cancer treatment.

Immunotherapy, gene transfer, and oncolytic virotherapy are three separate gene therapy treatment techniques that can be used to treat cancer. As the number of instances increases, so will the reliance on gene therapy, thus driving the market growth.

What are the factors driving the growth of the Cell and Gene Therapy Manufacturing Market?

There are around 1,200 cell and gene therapies in clinical trials globally. In the USA alone, there are over 700 investigational cell and gene therapies in clinical trials. Manufacturing facilities, on the other hand, have not kept up. Hundreds of more facilities are expected to be required to manufacture the therapies currently in clinical development. Viral capacity is one of the areas that has to be accelerated.

A large proportion of viral vectors are made utilizing adherent manufacturing, which is costly to run-a vial of 20 million cells can cost anywhere between USD 20,000 and USD 30,000 to generate. The cost of producing gene therapy can range from USD 500,000 to USD 1 million, excluding research and development, clinical trial costs, and the costs of establishing the commercial infrastructure required to offer access to patients.

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Which Region is projected to Offer Significant Opportunity for the Cell and Gene Therapy Manufacturing Market?

The market in Asia Pacific is expected to offer a significant opportunity to the market owing to the continuous developments taking place in the regional marketplace. Best practices are being discovered in cell and gene therapy manufacturing as well as in scaling out strategies, process development, cost optimization, advancements in CAR-T manufacturing, and preparation for commercialization.

Companies such as BeiGene, Gracell Biotechnologies, Fosun Kite Biotechnology, Tessa Therapeutics, CARSgen, Senlang Bio, Kangstem Biotech, Medigen Biotechnology Corp, and Shangai UniCAR Therapy have been actively engaged in the advancement of concurrent techniques.

Country-wise Analysis

USA Cell and Gene Therapy Manufacturing Market Analysis

The USA accounted for a significant proportion of the cell and gene therapy manufacturing market revenues in 2022. The key driving factors for the market expansion in the country are a large number of active clinical trials, as well as the growing engagement of firms in gene and cell therapy research and development. With more than 400 businesses actively engaged in the development of cell and gene therapy products for various diseases, North America was ranked top for having the most gene therapy clinical trials.

United Kingdom Cell and Gene Therapy Manufacturing Market Analysis

The market in the United Kingdom is expected to reach a valuation of USD 6.5 Billion by 2033. Growing with a CAGR of 23.9% in the forecast period, the market in the country is projected to garner an absolute dollar opportunity of USD 5.7 Billion.

Japan Cardiovascular Ultrasound Market Analysis

In Japan, the market is expected to grow at a CAGR of 32.5% from 2023 to 2033, reaching USD 12.6 Billion by 2033. The market in the country is expected to gross an absolute dollar opportunity of USD 11.9 Billion during the forecast period.

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Category-wise Insights

What are the insights about the Therapy Type Segment of Cell and Gene Therapy Manufacturing?

Cell therapy manufacturing led the cell and gene therapy manufacturing market, accounting for a significant proportion of revenue. The high number of active clinical trials and the increasing number of goods entering the market are both contributing to the rise.

To understand the potential of cell therapies for the treatment of various cancer indications, more than 250 clinical trials concentrating on CAR T cell treatments and other cell therapies are explored. Furthermore, biopharma companies are seeing allogeneic CAR T cell therapy as a more attractive business strategy than traditional manufacturing and business models.

Why Pre-commercial Cell and Gene Therapy Manufacturing are Expected to be a Potential Market?

The robust and continually developing pipeline of cell and gene therapies around the world has fuelled the rise of the pre-commercial/ research and development scale manufacturing industry. More than 1,000 clinical trials for various cell treatments were currently conducted as of March 2020. According to the Journal of Gene Medicine, the number of gene therapy clinical studies increased to 3,025 in 2019. This high figure reflects the rising need for manufacturing services in the development of preclinical product candidates.

What are the insights in the Mode segment in Cell and Gene Therapy Manufacturing Market?

The key contribution to this area is the presence of a significant number of huge capital businesses, as well as academic institutes with tailored patient treatment programs. Greater process troubleshooting agility, ownership of supply channels, and the efficient development of a corporate knowledge base to aid future in-house scale-up are the prominent factors driving the segment growth.

The growing popularity of sophisticated medicines has heightened market competitiveness among participants. Contracts and agreements are being signed between cell therapy manufacturing businesses and CDMOs in order to accelerate product development and acquire a competitive advantage.

The contract-manufacturing segment's revenue has also been boosted by ongoing clinical research projects. Furthermore, more than 65% of the cell and gene therapy manufacturing process is outsourced, which is expected to further reduce costs and add to the market growth.

What are the insights about the Workflow segment?

The development of well-characterized and robust technologies for cell therapy production has become increasingly vital owing to an increasing number of medicines progressing from clinical trials to regulatory approval. Process development solutions improve the quality and safety profiles of candidate programs while increasing efficiency.

This segment, on the other hand, is predicted to increase at the fastest rate throughout the forecast period due to the significant penetration of manufacturing services in the vector production area. The viral vectors have been used to treat a variety of disorders, including cardiovascular, metabolic, hematologic, muscular, infectious, and ophthalmologic conditions, as well as numerous types of cancer.

Competitive Analysis

The growing interest of public and private investors in the development of advanced therapies is expected to boost market revenue during the forecast period. In addition, key firms are enhancing their market presence through strategic activities such as mergers and acquisitions, licensing, and partnerships.

Several noteworthy mergers and acquisitions have occurred in the market in recent years.

Some of the recent developments of key Cell and Gene Therapy Manufacturing providers are as follows:

  • In January 2022, Thermo Fisher Scientific bought Novasep’s viral vector production company. This agreement allowed the corporation to increase its global vector manufacturing capacity.
  • In February 2020, to strengthen its market footprint in cell and gene therapy platforms, Catalent Inc. announced the acquisition of MaSTherCell Global, Inc. for USD 315 Million.
  • In December 2020, Be the Match and Lonza BioTherapies and BioTherapies formed a joint venture to develop the vein-to-vein cell and gene therapy supply chain network, primarily in North America and Europe.

Similarly, recent developments related to companies offering Cell and Gene Therapy Manufacturing have been tracked by the team at Future Market Insights, which are available in the full report.

Table of Content
  • 1. Executive Summary
  • 2. Market Overview
  • 3. Market Risks and Trends Assessment
  • 4. Market Background
  • 5. Key Success Factors
  • 6. Global Demand Analysis 2018 to 2022 and Forecast, 2023 to 2033
  • 7. Global Value Analysis 2018 to 2022 and Forecast, 2023 to 2033
  • 8. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Therapy Type
    • 8.1. Cell Therapy Manufacturing
      • 8.1.1. Stem Cell Therapy
      • 8.1.2. Non-Stem Cell Therapy
    • 8.2. Gene Therapy Manufacturing
  • 9. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Scale
    • 9.1. Pre-commercial/ R&D Scale Manufacturing
    • 9.2. Gene Therapy Manufacturing
  • 10. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Mode
    • 10.1. Contract Manufacturing
    • 10.2. In-house Manufacturing
  • 11. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Workflow
    • 11.1. Cell Processing
    • 11.2. Cell Banking
    • 11.3. Process Development
    • 11.4. Fill & Finish Operations
    • 11.5. Analytical And Quality Testing
    • 11.6. Raw Material Testing
    • 11.7. Vector Production
    • 11.8. Other Workflows
  • 12. Global Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
    • 12.1. North America
    • 12.2. Latin America
    • 12.3. Europe
    • 12.4. Asia Pacific
    • 12.5. Middle East and Africa (MEA)
  • 13. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 14. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 15. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 16. Asia Pacific Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 17. Middle East and Africa Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 18. Key Countries Analysis 2018 to 2022 and Forecast 2023 to 2033
  • 19. Market Structure Analysis
  • 20. Competition Analysis
    • 20.1. Thermo Fisher Scientific
    • 20.2. Merck KGaA
    • 20.3. Lonza
    • 20.4. Catalent Inc.
    • 20.5. Takara Bio Inc.
    • 20.6. F. Hoffmann-La Roche Ltd
    • 20.7. Wuxi Advanced Therapies
    • 20.8. Samsung Biologics
    • 20.9. Boehringer Ingelheim
    • 20.10. Novartis AG
    • 20.11. Hitachi Chemical Co., Ltd.
    • 20.12. Cellular Therapeutics
    • 20.13. Bluebird Bio Inc.
  • 21. Assumptions and Acronyms Used
  • 22. Research Methodology

Market Segments Covered in Cell and Gene Therapy Manufacturing Market Analysis

By Therapy Type:

  • Cell Therapy Manufacturing
    • Stem Cell Therapy
    • Non-Stem Cell Therapy
  • Gene Therapy Manufacturing

By Scale:

  • Pre-commercial/ R&D Manufacturing
  • Commercial Scale Manufacturing

By Mode:

  • Contract Manufacturing
  • In-house Manufacturing

By Workflow:

  • Cell Processing
  • Cell Banking
  • Process Development
  • Fill & Finish Operations
  • Analytical And Quality Testing
  • Raw Material Testing
  • Vector Production
  • Other Workflows

By Region:

  • North America
    • USA
    • Canada
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia Pacific
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Rest of the Middle East and Africa

Frequently Asked Questions

How Big is the Cell and Gene Therapy Manufacturing Market?

The cell and gene therapy manufacturing market is expected to reach USD 19.3 billion in 2023.

What is the Anticipated CAGR of the Market?

The market is anticipated to expand at a CAGR of 29%.

Which Factor is Driving the Market Growth?

Constant developments and advancements in the cell and gene therapy manufacturing techniques are driving the market growth.

What is the Forecast CAGR of the United Kingdom Market?

The United Kingdom market for cell and gene therapy manufacturing is forecast to expand at a CAGR of 23.9%.

Who are the Market Leaders in the Cell and Gene Therapy Manufacturing Market?

The market leaders in the cell and gene therapy manufacturing market are Lonza, Catalent Inc., and Takara Bio Inc.

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