Cell and Gene Therapy Manufacturing Services Market Report | 2022–2030

Cell and Gene Therapy Manufacturing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Cell Therapy (Autologous and Allogenic) and Gene Therapy (Viral and Non-Viral Vector)], Indication (Cancer, Orthopaedics, and Others), Application (Clinical Manufacturing and Commercial Manufacturing), End User [Pharmaceutical and Biotechnology Companies and Contract Research Organization (CROs)], and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

Publication Month : Sep 2023

  • Report Code : TIPRE00024304
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 216
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[Research Report] The cell and gene therapy manufacturing services market size is expected to grow from US$ 7,581.97 million in 2022 to US$ 26,724.90 million by 2030; it is estimated to register a CAGR of 17.1% during 2022–2030.

Market Insights and Analyst View:

The cell and gene therapy manufacturing services involve producing therapeutic products using advanced cellular and genetic techniques. These services often encompass everything from process development to large-scale production, ensuring the safe and effective creation of personalized treatment for various medical conditions. Companies offering these services focus on maintaining rigorous quality control and adhering to regulatory guidelines to ensure the highest safety and efficacy standards. The global cell and gene therapy manufacturing services market growth is attributed to factors such as increasing R&D expenditures in the pharmaceutical & biopharmaceutical companies, increasing approvals of cell and gene therapies, and increasing popularity of outsourcing cell and gene therapy manufacturing. However, the high cost of cell and gene therapy manufacturing is restraining the market growth.

Growth Drivers & Challenges:

Incorporating automation in cell and gene therapy manufacturing would lead to a reduced risk of contamination, improved consistency, and decreased cost of production. Lonza Cocoon and the CliniMACS Prodigy system from Miltenyi are a few devices available in the market to enable automation. These products have been designed to automate the most sequential unit operations for a CAR-T process within a single system. The rising demand for cell and gene therapies has shifted the production of cell and gene therapy products from a small-volume process to a large-volume process worldwide. In addition to the increasing research activities, the evolution of cell and gene therapy from an academic and clinical setting to mass production and commercialization has propelled the demand for automation in commercial manufacturing.

In July 2020, Thermo Fisher Scientific Inc. and Lyell Immunopharma partnered to develop and manufacture processes to design effective cell therapies for cancer patients. Under this partnership, the companies aim to improve the capability of T-cells and support the development of an integrated current good manufacturing practice (cGMP) compliant platform (system and software), along with reagents, consumables, and instruments. Further, government agencies are adopting automation in the manufacturing of cell therapies to increase the national production capabilities of the country. As of March 2023, the UK Stem Cell Bank of the Medicines and Healthcare Products Regulatory Agency (MHRA) tested automated robotic technology for developing stem cell technology for manufacturing stem cell-based therapies. Thus, automation is emerging as a new trend in the cell and gene therapy manufacturing services market.

Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories International Inc., Lonza Group AG, WuXi AppTec Co Ltd, Catalent Inc, Takara Bio Inc., Nikon Corp, FUJIFILM Holdings Corp,  National Resilience Inc, and Oxford BioMedica Plc. are among the major players operating in the cell and gene therapy manufacturing services market.

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Cell and Gene Therapy Manufacturing Services Market: Strategic Insights

cell-and-gene-therapy-manufacturing-services-market
Market Size Value inUS$ 7,581.97 million in 2022
Market Size Value byUS$ 26,724.90 million by 2030
Growth rateCAGR of 17.1% from 2022 to 2030
Forecast Period2022-2030
Base Year2022
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Report Segmentation and Scope:

The “Global Cell and Gene Therapy Manufacturing Services Market” is segmented based on type, indication, application, end user, and geography. The cell and gene therapy manufacturing services market, based on geography, is segmented into North America (the US, Canada, and Mexico), Europe (Germany, France, Italy, the UK, Russia, and the Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and the Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

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Segmental Analysis:

The market is segmented based on type, indication, application, and end user. In terms of type, the cell and gene therapy manufacturing services market is segmented into cell therapy and gene therapy. The cell therapy segment is further bifurcated into autologous and allogeneic. Further, the gene therapy segment is divided into viral vectors and non-viral vectors. The cell therapy segment held a larger market share in 2022. The gene therapy segment is anticipated to register a higher CAGR during 2022–2030. The autologous cell therapy manufacturing segment held a larger market share, and the allogeneic cell therapy manufacturing segment is anticipated to register a higher CAGR during 2022–2030. The advantages of allogeneic treatments include a potentially wider availability and diversity of cells and tissues.

The growing awareness about allogeneic cell therapies, an upsurge in funds for new cell lines, and the development of advanced genomics methods for cell analysis benefit the allogeneic cell and gene therapies segment. Physicians are inclined toward the therapeutic use of allogeneic therapies as these cell therapies have allowed enormous leaps in treating various cancer types (leukemia or lymphoma) and other diseases. Thus, these factors are responsible for the cell and gene therapy manufacturing services market growth.

Endoscopy Procedures Market, by Product Type – 2022 and 2030

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Based on indication, the cell and gene therapy manufacturing services market is divided into cancer, orthopedics, and others. The cancer segment held the largest share of the market in 2022 and is expected to register the highest CAGR during 2022–2030. The broadfield of cell and gene therapy promises many innovative treatments that can potentially prevent cancer deaths. According to the April 2022 newsletter by Alliance for Cancer Gene Therapy, Inc., 6 CAR T-cell therapies have been approved by the US Food and Drug Administration (FDA) for treating myeloma, leukemia, and lymphoma. In December 2022, the FDA approved Adstiladrin, a non-replicating adenoviral vector-based gene therapy, for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. In 2022, the FDA approved Kimmtrak, a T-cell receptor therapy for a rare type of melanoma in the eye—uveal melanoma. As there is an increase in the number of FDA approvals of cell and gene therapy for cancer treatment, the production of these therapies has increased in the last several years. Thus, many CDMOs are focusing on manufacturing services for cancer cell and gene therapies.

Regional Analysis:

Based on geography, the cell and gene therapy manufacturing services market is divided into five key regions: North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa. The North American cell and gene therapy manufacturing services market has been analyzed based on three major countries—the US, Canada, and Mexico. The US cell and gene therapy manufacturing services market is estimated to hold the largest cell and gene therapy manufacturing services market share during the forecast period. Cell and gene therapies (CGTs) treat patients suffering from serious and rare diseases with unaddressed therapeutic needs. Manufacturing CGTs is a highly complex process, with insufficient infrastructure and expertise being a major limiting factor. Logistical challenges associated with intermediates and the final product also limit the CGT manufacturing capacity of companies. The CGT manufacturing process involves extracting autologous cells through "apheresis," dispatching them to specialized labs, and sending them back to clinics for administration into patients, all of which must be performed with strict quality control. The US Food and Drug Administration (USFDA) has approved only 7 CGT drugs, with the pipeline of new products reaching ~1,200 experimental therapies. Half of these are in Phase 2 clinical trials, with estimates of annual sales growth accounting for 15% for cell therapies and ~30% for gene therapies, as per the Chemical & Engineering News report 2023 estimates.

Many manufacturers approach contract development manufacturing organizations (CDMOs) such as Labcorp, Lonza, and Catalent to overcome the barriers associated with producing and commercializing their cell and gene therapy products. Lonza has invested ~US$ 9.2 million to strengthen its cell and gene therapy manufacturing capabilities and support. Such initiatives by CDMOs are contributing to the growth of the US cell and gene therapy market.

The UK is among the world's best ecosystems for research, development, manufacturing, clinical adoption, and reimbursement of advanced therapeutics. Currently, over 85 clinical trials are ongoing in the UK, and 70 CGT companies are operating for the development of potentially curative therapies.

Catapult is another top company contributing significantly to the CGT ecosystem in the UK; it stands as one of the top five companies in developing manufacturing processes in the country. The company is developing smarter automated CGT manufacturing processes that can automatically adapt to changing environments and process requirements with minimal intervention. Therefore, efforts made by these companies to enhance productivity and reduce the final costs are the major factors driving the growth of the UK's cell and gene therapy market. Moreover, the UK holds a strong position in Europe's cell and gene therapy market owing to sustained and targeted investment in research

Opportunity:

Various initiatives taken by key players operating in the global cell and gene therapy manufacturing services market are listed below:

  • In March 2022, Oxford Biomedica plc completed its deal with Homology Medicines Inc. to establish Oxford Biomedica Solutions LLC, a new US-based full-scope, Adeno-Associated Virus (AAV) manufacturing and innovation business. The new business is fully operational and offers a proprietary ‘plug and play’ platform. The unique platform and fully integrated end-to-end capabilities, including vector design and process development through to clinical trials, are now available to customers.
  • In March 2023, Thermo Fisher Scientific and Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage cell therapy company engineering advanced CAR-T cell therapies for solid tumors, entered into a strategic collaboration to develop manufacturing processes for new cancer treatments. The research and process development-focused collaboration enabled ArsenalBio to develop a robust manufacturing process.
  • In June 2022, National Resilience, Inc. and The University of Texas MD Anderson Cancer Center launched a joint venture, the Cell Therapy Manufacturing Center (CTMC), to accelerate the development and manufacturing of innovative cell therapies for patients with cancer. The joint venture advances its work within an academic innovation and industrial expertise culture. The joint venture engages with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development.  

Competitive Landscape and Key Companies:

Some of the cell & gene therapy manufacturing companies operating in the market are Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories International Inc., Lonza Group AG, WuXi AppTec Co Ltd, Catalent Inc., Takara Bio Inc, Nikon Corp, FUJIFILM Holdings Corp,  National Resilience Inc, and Oxford BioMedica Plc. These companies focus on various growth strategies such as collaboration, product launches, business expansions, and agreements to retain their position in the global market. Their widespread global presence allows them to serve many customers, increasing their cell and gene therapy manufacturing services market share.

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Type, Indication, Application, End User, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


Which indication segment held the largest revenue (US$ Mn) in the Cell and Gene Therapy Manufacturing Services market?

Based on indication, the cell and gene therapy manufacturing services market is divided into cancer, orthopedics, and others. The cancer segment held the largest share of the market in 2022 and same segment is expected to grow at the highest CAGR during the forecast period.

Who are the key players in the Cell and Gene Therapy Manufacturing Services market?

Companies operating in the market are Thermo Fisher Scientific Inc, Merck KGaA, Charles River Laboratories International Inc, Lonza Group AG, WuXi AppTec Co Ltd, Catalent Inc, Takara Bio Inc, Nikon Corp, FUJIFILM Holdings Corp, National Resilience Inc, and Oxford BioMedica Plc.

What is the regional market scenario of the Cell and Gene Therapy Manufacturing Services market?

Cell and Gene Therapy Manufacturing Services market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance the cell and gene therapy manufacturing services market during 2022–2030.

What is meant by the cell and gene therapy manufacturing services?

Cell & gene therapy (CGT) programs are rapidly advancing from research & development to clinical trials and commercial approval. Establishing a robust, repeatable, and sustainable process help accelerate development, avoiding manufacturing transfer-related delays. Additionally, cell and gene therapy comprises the next generation of life-enhancing and curative therapies. With therapies experiencing new approvals, the demand for skilled professionals in cell and gene therapy manufacturing services will rise.

Which segment led the cell and gene therapy manufacturing services market?

Cell and Gene Therapy Manufacturing Services market, based on type, is segmented into cell therapy and gene therapy. Cell therapy is segmented as autologous and allogenic. Further, gene therapy is bifurcated into viral vector and non-viral vector. The cell therapy segment held a larger market share in 2022. However, gene therapy segment is anticipated to register the highest CAGR during the forecast period (2020-2030).

What are the driving factors for the cell and gene therapy manufacturing services market across the globe?

Major factors driving the market growth includes increase in number of approvals of cell and gene therapies and increasing popularity of outsourcing cell and gene therapy manufacturing. Additionally, automation of cell and gene therapy manufacturing services are likely to emerge as significant future trends in the market during the forecast period.

The List of Companies - Cell and Gene Therapy Manufacturing Services Market

  1. Thermo Fisher Scientific Inc
  2. Merck KGaA
  3. Charles River Laboratories International Inc
  4. Lonza Group AG
  5. WuXi AppTec Co Ltd
  6. Catalent Inc
  7. Takara Bio Inc
  8. Nikon Corp
  9. FUJIFILM Holdings Corp
  10. National Resilience Inc,
  11. Oxford BioMedica Plc       

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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