Cell & Gene Therapy Manufacturing Services Market - Growth, Trends, Covid-19 Impact, And Forecasts (2022 - 2027)

The Cell & Gene Therapy Manufacturing Services Market is segmented by Type ((Cell Therapy (Allogeneic, Autologous and Viral Vector) and Gene Therapy (Non-Viral Vectors and Viral Vectors)), By Application (Clinical Manufacturing and Commercial Manufacturing), By Indication (Oncology Diseases, Cardiovascular Diseases, Orthopedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases and Other Indications), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes and Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Cell & Gene Therapy Manufacturing Services Market
Study Period: 2018-2026
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: >12.5 %

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Market Overview

The cell & gene therapy manufacturing services market is projected to register a CAGR of 12.5% during the forecast period.

During the COVID 19 pandemic, the Cell & Gene Therapy Manufacturing Services Market was adversely affected. There were two primary reasons for that, the limited running capacity protocols introduced by the governments and disruption of supply chain and logistics processes. Everything apart from critical and immediate was pushed for later on. Another reason for adversely affecting the market was its being dependent on complex supply chain management for its products and social distancing norms put by the governments across the globe. For instance, allogeneic products cell donors have been less likely to donate because of social distancing restrictions, and the United States Food and Drug Administration (USFDA) requires a 28-day investigation before the donation by the donors with a confirmed or suspected COVID-19 infection. Another reason for many locations was increased prices and reimbursement for cell and gene therapy products.

Certain factors that are driving the market growth include high prevalence of cancer and other target diseases, and Increasing R&D investments in pharmaceutical companies. International Agency for Research on Cancer (IARC) updated Globocan 2020 with new estimates about the global cancer burden, which indicates that it has risen to 19.3 million cases and 10 million cancer deaths in 2020. This new study suggest that more than 50 million people are living within 5 years with a cancer diagnosis. Some of the common factors for increasing cancer cases globally are ageing populations and socio-economic risk factors. Additionally, as per the same source mentioned above, breast cancer represents 1 in 4 cancers diagnosed among women globally. Due to this for the first time, female breast cancer has become the most commonly diagnosed cancer across the globe, surpassing lung cancer, because of its high prevalence in low- and middle-income countries (LMICs). Since, oncology is one of the most complicated disorder known to man, the cell and gene therapy are one the fields that shows huge potential in the treatment of cancer. The cancer treatment can be done via three different gene therapy treatment approaches: immunotherapy, gene transfer and oncolytic virotherapy. As the cases will increase the reliance on gene therapy would also increase thus boosting the growth of the market.

Similarly, there is a huge increase in research and development of cell and gene therapy products in pharmaceutical and biotechnology companies. According to USFDA (United States Food and Drug Administration), there is a huge surge in cell and gene therapy products entering early development, which is evident by the large upswing in the number of investigational new drug (IND) applications. They anticipated that by 2020 they will receive more than 200 INDs per year, building upon the total of more than 800 active cell-based or directly administered gene therapy INDs currently on file with the FDA. And by 2025, the forecast that the FDA will be approving 10 - 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products. Due to aforementioned factors, the tracked market is estimated to witness healthy growth rate during the forecasted period.

Scope of the Report

As per the scope of this report a cell therapy aims to treat disorders and diseases by restoring or changing certain groups of cells or by providing cells to carry a therapy through the body. With cell therapy, cells are formed or modified outside the body before being introduced into the patient. The cells may derive from the patient (autologous cells) or a donor (allogeneic cells). Gene therapy aims to treat disorders by replacing or introducing genes into cells— either inside the body (in vivo) or outside of the body (ex vivo). The cell & gene therapy manufacturing services market is segmented by Type ((Cell Therapy (Allogeneic, Autologous and Viral Vector) and Gene Therapy (Non-Viral Vectors and Viral Vectors)), By Application (Clinical Manufacturing and Commercial Manufacturing), By Indication (Oncology Diseases, Cardiovascular Diseases, Orthopedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases and Other Indications), By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes and Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

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Key Market Trends

The Allogeneic Segment is Expected to Hold a Major Market Share in the Cell Therapy Segment

The cell & gene therapy manufacturing services market is broadly segmented into cell therapy and gene therapy. The cell therapy market is further segmented into Allogeneic, Autologous and Viral Vector. The Allogeneic segment holds the major market share in the Cell Therapy segment. The primary factor for the growth is an increasing awareness about allogeneic cell therapy, growing funding for new cell lines, increasing partnerships and acquisitions, and the development of advanced genomics methods for cell analysis. However, high manufacturing cost is a hindarnce for the growth of the market. Overall the market is likely to grow during the forecast period.

Cancer Incidence by Type

Geography Trends

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

The United States is the most affected country across the world, as the gene therapies are widely used in any diagnostic, therapeutic, drug discovery or other research for oncology and other clinical disorders thus the demand for same will significantly higher in North America region as patient population is increasing compared to other countries.

North America expected to hold a major market share in the global cell & gene therapy manufacturing services marketdue to rise in geriatric population, increasing prevalence and incidence of infectious diseases in this region. In 2020, the United States would witness the major share in North America Cell & Gene Therapy Manufacturing Services Market and this trend will remain in the forecast period as well. Incidence of chronic diseases, like cancer, is also high in the United States. As per the 2019 report by the American Cancer Society, there were an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in 2019. In addition, as per a 2018 report by the Center for Disease Control and Prevention there are around Six in ten Americans are living with at least one chronic disease and chronic diseases are the leading causes of death and disability in America.

Moreover, increase in research and development activities and presence of favorable healthcare infrastructure is fueling the growth of the overall regional market to a large extent. ​For instance, according to a paper named "Profitibility of Larga Pharmaceutical Companies Compared With Other Large Companies" published in March 2020 stated that during first 3 quarters of 2020, the collectively biotech companies (majorily S&P 500) got USD 15.9 billion compared to USD 13.5 billion in 2018 for the same period. According to the Alliance for Regenerative Medicine, the majority of this funding was public financing to support development of cancer-related treatments.

Cell & Gene Therapy Manufacturing Services Market

Competitive Landscape

The Cell & Gene Therapy Manufacturing Services Market is consolidated competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Thermo Fisher Scientific, Inc, Merck KGaA, Charles River Laboratories, Lonza, Catalent, Inc, Takara Bio Inc., and F. HOFFMANN-LA ROCHE LTD.

Recent Development

  • In 2021, Charles River Laboratories acquired Vigene Biosciences, Inc. (a cell & gene therapy CDMO)—to increase its cell and gene therapy manufacturing capabilities. The contract development and manufacturing organization (CDMO) will provide viral vector-based gene delivery solutions.
  • In December 2020, Lonza and Be The Match BioTherapies partner to expand Vein-to-Vein Cell and Gene Therapy Supply Chain Network focusing mainly in North America and Europe.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 High Prevalence of Cancer and Other Target Diseases

      2. 4.2.2 Increasing Grants and R&D Investments in Pharmaceutical Sector

      3. 4.2.3 Increasing Organic and Inorganic Developments Between Pharmaceutical Companies and CDMOs

    3. 4.3 Market Restraints

      1. 4.3.1 High operational costs associated with cell & gene therapy manufacturing

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Service Type

      1. 5.1.1 Cell Therapy

        1. 5.1.1.1 Allogeneic

        2. 5.1.1.2 Autologous

        3. 5.1.1.3 Viral Vector

      2. 5.1.2 Gene Therapy

        1. 5.1.2.1 Non-Viral Vectors

        2. 5.1.2.2 Viral Vectors

    2. 5.2 By Application

      1. 5.2.1 Clinical Manufacturing

      2. 5.2.2 Commercial Manufacturing

    3. 5.3 By Indication

      1. 5.3.1 Oncology Diseases

      2. 5.3.2 Cardiovascular Diseases

      3. 5.3.3 Orthopedic Diseases

      4. 5.3.4 Infectious Diseases

      5. 5.3.5 Other Indication

    4. 5.4 By End User

      1. 5.4.1 Pharmaceutical and Biotechnology Companies

      2. 5.4.2 Academic and Research Institutes

      3. 5.4.3 Others

    5. 5.5 Geography

      1. 5.5.1 North America

        1. 5.5.1.1 United States

        2. 5.5.1.2 Canada

        3. 5.5.1.3 Mexico

      2. 5.5.2 Europe

        1. 5.5.2.1 Germany

        2. 5.5.2.2 United Kingdom

        3. 5.5.2.3 France

        4. 5.5.2.4 Italy

        5. 5.5.2.5 Spain

        6. 5.5.2.6 Rest of Europe

      3. 5.5.3 Asia-Pacific

        1. 5.5.3.1 China

        2. 5.5.3.2 Japan

        3. 5.5.3.3 India

        4. 5.5.3.4 Australia

        5. 5.5.3.5 South Korea

        6. 5.5.3.6 Rest of Asia-Pacific

      4. 5.5.4 Middle-East and Africa

        1. 5.5.4.1 GCC

        2. 5.5.4.2 South Africa

        3. 5.5.4.3 Rest of Middle-East and Africa

      5. 5.5.5 South America

        1. 5.5.5.1 Brazil

        2. 5.5.5.2 Argentina

        3. 5.5.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Catalent, Inc

      2. 6.1.2 CELL AND GENE THERAPY CATAPULT

      3. 6.1.3 Charles River Laboratories

      4. 6.1.4 F. HOFFMANN-LA ROCHE LTD.

      5. 6.1.5 FUJIFILM Holdings Corporation

      6. 6.1.6 Lonza

      7. 6.1.7 Merck KGaA

      8. 6.1.8 Nikon CeLL innovation Co., Ltd.

      9. 6.1.9 Oxford Biomedica plc

      10. 6.1.10 Takara Bio Inc.

      11. 6.1.11 Thermo Fisher Scientific Inc.

      12. 6.1.12 WuXi AppTec

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Cell & Gene Therapy Manufacturing Services Market market is studied from 2018 - 2026.

The Cell & Gene Therapy Manufacturing Services Market is growing at a CAGR of >12.5% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2020.

Charles River Laboratories, F. HOFFMANN-LA ROCHE LTD., FUJIFILM Holdings Corporation, Merck KGaA, Thermo Fisher Scientific Inc. are the major companies operating in Cell & Gene Therapy Manufacturing Services Market .

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