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Report Scope & Overview:

The Cell & Gene Therapy Manufacturing Services Market Size was valued at USD 16.92 billion in 2022 and is expected to reach USD 30.86 billion by 2030, and grow at a CAGR of 7.8% over the forecast period 2023-2030.

Growing agreements and partnerships between CDMOs and pharmaceutical companies are propelling the cell and gene therapy manufacturing services market. The increasing rate of investment in new technologies and pharmaceutical research and development activities are also contributing to the expansion of the cell & gene therapy manufacturing services sector. Furthermore, as cancer and other diseases become more prevalent, the cell and gene therapy manufacturing services market is expanding.

Cell & Gene Therapy Manufacturing Services Market Revenue Analysis

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Excessive operational expenses may limit the expansion of the cell and gene therapy manufacturing services business. It could raise the overall cost of the service and, to some extent, limit the potential in the cell and gene therapy manufacturing services market.

MARKET DYNAMICS:

DRIVERS

  • Cancer and Chronic Diseases are becoming more common.

  • Increase in number of investments.

  • The quantity of clinical preliminaries is expanding.

  • Regulatory Environment That Is Favorable

RESTRAINTS

  • Operational charges are high.

OPPORTUNITIES

  • Approvals for drugs and a healthy pipeline

  • Rise in number cell therapy.

CHALLENGES

  • There is a scarcity of reliable vectors for cell and gene therapy.

  • Scarcity of therapy-specific tests

IMPACT OF COVID-19

The current COVID-19 pandemic has had a favorable impact on the manufacture of cell and gene therapies. Several companies increased their vector production capacities and formed strategic partnerships to develop experimental medicines. This is in response to the urgent need for effective treatments as well as an anti-infection vaccination. Tevogen Bio, for example, teamed up with Biocentric to develop Tevogen’s COVID-19 T-Cell Therapy in March 2021.

The ratio of successful treatment to the number of clinical trials of cellular and gene-modified therapeutic products has improved in recent years in the healthcare industry. This is due to greater science and medical awareness of the safety risks associated with their use. In early 2020, there were 362 phase III clinical studies, with the number likely to rise dramatically in the future years.

By Therapy Type:

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 studies concentrating on CAR T cell treatments and other cell therapies are being examined. Furthermore, biopharma companies are seeing allogeneic CAR T cell therapy as a more attractive business strategy than current manufacturing and economic models.

By Scale Type:

This is due to a robust and rapidly expanding pipeline of cell and gene therapies around the world. More than 900 clinical trials for various cell treatments are currently conducted as of March 2020. According to the Journal of Gene Medicine, the number of gene therapy clinical studies has increased to 3,036 in 2020. This high figure reflects the rising need for manufacturing services in the development of preclinical product candidates.

By Mode Type:

The main contribution to this area is the presence of a large number of large capital businesses, as well as academic institutes with individualized patient treatment programs. Improved process troubleshooting agility, ownership of supply networks, and efficient creation of a corporate knowledge base to aid future in-house scale-up are all major elements driving the segment growth.

By Workflow type: 

The development of very well and robust technologies for cell therapy production has become increasingly critical as more medicines progress from clinical trials to regulatory approval. Process development solutions improve the quality and safety profiles of candidate programs while increasing efficiency.

KEY MARKET SEGMENTS:

By Therapy Type

  • Gene Therapy Manufacturing

  • Cell Therapy Manufacturing

    • Non-Stem Cell Therapy

    • Stem Cell Therapy

By Scale Type

  • Commercial Scale Manufacturing

  • Pre-commercial/ R&D Scale Manufacturing

By Mode type

  • In-house Manufacturing

  • Contract Manufacturing

By Workflow type

  • Cell Processing

  • Fill & Finish Operations

  • Vector Production

  • Analytical And Quality Testing

  • Cell Banking

  • Process Development

  • Raw Material Testing

  • Others

Cell & Gene Therapy Manufacturing Services Market Segmentation Analysis

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REGIONAL ANALYSIS

North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa make up the cell and gene therapy production services market. North America, Europe, and Asia Pacific accounted for the highest proportion of the cell and gene therapy manufacturing services market in 2020. The rising commonness of disease and developing exploration exertion in malignant growth and undifferentiated cells are liable for a significant portion of the North American market.

REGIONAL COVERAGE:

  • North America

    • USA

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • The Netherlands

    • Rest of Europe

  • Asia-Pacific

    • Japan

    • south Korea

    • China

    • India

    • Australia

    • Rest of Asia-Pacific

  • The Middle East & Africa

    • Israel

    • UAE

    • South Africa

    • Rest of Middle East & Africa

  • Latin America

    • Brazil

    • Argentina

    • Rest of Latin America

KEY PLAYERS:

There are some of major key players: Merck KGaA, Thermo Fisher Scientific, Catalent Inc., Lonza, Takara Bio Inc., Wuxi Advanced Therapies, F. Hoffmann-La Roche Ltd, Samsung Biologics, Bluebird Bio Inc., Novartis AG, Boehringer Ingelheim, Hitachi Chemical Co., Ltd., Miltenyi Biotec, Cellular Therapeutics.

Catalent Inc-Company Financial Analysis

Cell & Gene Therapy Manufacturing Services Market Report Scope:
Report Attributes Details
Market Size in 2022  US$ 16.92 Billion
Market Size by 2030  US$ 30.86 Billion
CAGR  CAGR of 7.8% From 2023 to 2030
Base Year  2022
Forecast Period  2023-2030
Historical Data  2020-2021
Report Scope & Coverage Market Size, Segments Analysis, Competitive  Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
Key Segments • By Type (Gene Therapy Manufacturing, Cell Therapy Manufacturing)
• By Scale Type (Commercial Scale Manufacturing, Pre-commercial/ R&D Scale Manufacturing)
• By Mode type (In-house Manufacturing, Contract Manufacturing)
• By Workflow type (Cell Processing, Fill & Finish Operations, Vector Production, Analytical And Quality Testing, Cell Banking, Process Development, Raw Material Testing, Others)
Regional Analysis/Coverage North America (USA, Canada, Mexico), Europe
(Germany, UK, France, Italy, Spain, Netherlands,
Rest of Europe), Asia-Pacific (Japan, South Korea,
China, India, Australia, Rest of Asia-Pacific), The
Middle East & Africa (Israel, UAE, South Africa,
Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)
Company Profiles Merck KGaA, Thermo Fisher Scientific, Catalent Inc., Lonza, Takara Bio Inc., Wuxi Advanced Therapies, F. Hoffmann-La Roche Ltd, Samsung Biologics, Bluebird Bio Inc., Novartis AG, Boehringer Ingelheim, Hitachi Chemical Co., Ltd., Miltenyi Biotec, Cellular Therapeutics.
DRIVERS • Cancer and Chronic Diseases are becoming more common.
• Increase in number of investments.
• The quantity of clinical preliminaries is expanding.
RESTRAINTS • Operational charges are high.

Frequently Asked Questions

Ans: - The Cell & Gene Therapy Manufacturing Services Market is expected to reach US$ 30.86 billion by 2030.

North America, Europe, and the Asia Pacific accounted for the highest proportion of the cell and gene therapy manufacturing services market.

Ans: - The Cell & Gene Therapy Manufacturing Services Market is to grow at a CAGR of 7.8% over the forecast period 2023-2030.

The challenges faced by Cell & Gene Therapy Manufacturing Services Market is there is a scarcity of reliable vectors for cell and gene therapy, and the Scarcity of therapy-specific tests.

key drivers of the Cell & Gene Therapy Manufacturing Services Market are an Increase in a number of investments, and the quantity of clinical preliminaries is expanding.

Table of Contents

 

1. Introduction

1.1 Market Definition

1.2 Scope

1.3 Research Assumptions

 

2. Research Methodology

 

3. Market Dynamics

3.1 Drivers

3.2 Restraints

3.3 Opportunities

3.4 Challenges

 

4. Impact Analysis

4.1 COVID-19 Impact Analysis

4.2 Impact of Ukraine- Russia war

4.3 Impact of ongoing Recession

4.3.1 Introduction

4.3.2 Impact on major economies

4.3.2.1 US

4.3.2.2 Canada

4.3.2.3 Germany

4.3.2.4 France

4.3.2.5 United Kingdom

4.3.2.6 China

4.3.2.7 Japan

4.3.2.8 South Korea

4.3.2.9 Rest of the World

 

5. Value Chain Analysis

 

6. Porter’s 5 forces Model

 

7.  PEST Analysis

 

8. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Type

8.1 Gene Therapy Manufacturing

8.2 Cell Therapy Manufacturing

8.2.1 Non-Stem Cell Therapy

8.2.2 Stem Cell Therapy

 

9. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Scale Type

9.1 Commercial Scale Manufacturing

9.2 Pre-commercial/ R&D Scale Manufacturing

 

10. Cell & Gene Therapy Manufacturing Services Market Segmentation, By Mode type

10.1 In-house Manufacturing

10.2 Contract Manufacturing

 

11. Cell & Gene Therapy Manufacturing Services Market Segmentation, By Workflow type

11.1 Cell Processing

11.2 Fill & Finish Operations

11.3 Vector Production

11.4 Analytical and Quality Testing

11.5 Cell Banking

11.6 Process Development

11.7 Raw Material Testing

11.8 Others

 

12. Regional Analysis

12.1 Introduction

12.2 North America

12.2.1 USA

12.2.2 Canada

12.2.3 Mexico

12.3 Europe

12.3.1 Germany

12.3.2 UK

12.3.3 France

12.3.4 Italy

12.3.5 Spain

12.3.6 The Netherlands

12.3.7 Rest of Europe

12.4 Asia-Pacific

12.4.1 Japan

12.4.2 South Korea

12.4.3 China

12.4.4 India

12.4.5 Australia

12.4.6 Rest of Asia-Pacific

12.5 The Middle East & Africa

12.5.1 Israel

12.5.2 UAE

12.5.3 South Africa

12.5.4 Rest

12.6 Latin America

12.6.1 Brazil

12.6.2 Argentina

12.6.3 Rest of Latin America

 

13. Company Profiles

13.1 Merck KGaA

13.1.1 Financial

13.1.2 Products/ Services Offered

13.1.3 SWOT Analysis

13.1.4 The SNS view

13.2 Thermo Fisher Scientific

13.3 Catalent Inc.

13.4 Lonza

13.5 Takara Bio Inc.

13.6 Wuxi Advanced Therapies

13.7 F. Hoffmann-La Roche Ltd

13.8 Samsung Biologics

13.9 Bluebird Bio Inc.

13.10 Novartis AG

13.11 Boehringer Ingelheim

13.12 Hitachi Chemical Co., Ltd.

13.12 Miltenyi Biotec

13.13 Cellular Therapeutics

 

14. Competitive Landscape

14.1 Competitive Benchmarking

14.2 Market Share Analysis

14.3 Recent Developments

 

15. Conclusion

An accurate research report requires proper strategizing as well as implementation. There are multiple factors involved in the completion of good and accurate research report and selecting the best methodology to compete the research is the toughest part. Since the research reports we provide play a crucial role in any company’s decision-making process, therefore we at SNS Insider always believe that we should choose the best method which gives us results closer to reality. This allows us to reach at a stage wherein we can provide our clients best and accurate investment to output ratio.

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The 5 steps process:

Step 1: Secondary Research:

Secondary Research or Desk Research is as the name suggests is a research process wherein, we collect data through the readily available information. In this process we use various paid and unpaid databases which our team has access to and gather data through the same. This includes examining of listed companies’ annual reports, Journals, SEC filling etc. Apart from this our team has access to various associations across the globe across different industries. Lastly, we have exchange relationships with various university as well as individual libraries.

Secondary Research

Step 2: Primary Research

When we talk about primary research, it is a type of study in which the researchers collect relevant data samples directly, rather than relying on previously collected data.  This type of research is focused on gaining content specific facts that can be sued to solve specific problems. Since the collected data is fresh and first hand therefore it makes the study more accurate and genuine.

We at SNS Insider have divided Primary Research into 2 parts.

Part 1 wherein we interview the KOLs of major players as well as the upcoming ones across various geographic regions. This allows us to have their view over the market scenario and acts as an important tool to come closer to the accurate market numbers. As many as 45 paid and unpaid primary interviews are taken from both the demand and supply side of the industry to make sure we land at an accurate judgement and analysis of the market.

This step involves the triangulation of data wherein our team analyses the interview transcripts, online survey responses and observation of on filed participants. The below mentioned chart should give a better understanding of the part 1 of the primary interview.

Primary Research

Part 2: In this part of primary research the data collected via secondary research and the part 1 of the primary research is validated with the interviews from individual consultants and subject matter experts.

Consultants are those set of people who have at least 12 years of experience and expertise within the industry whereas Subject Matter Experts are those with at least 15 years of experience behind their back within the same space. The data with the help of two main processes i.e., FGDs (Focused Group Discussions) and IDs (Individual Discussions). This gives us a 3rd party nonbiased primary view of the market scenario making it a more dependable one while collation of the data pointers.

Step 3: Data Bank Validation

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Data Bank Validation

Step 4: QA/QC Process

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