세포 및 유전자 치료 제조 : 시장 인사이트, 경쟁 구도, 시장 예측(2032년)

Cell and Gene Therapy Manufacturing Market by Therapy Type (Cell Therapy [Allogenic and Autologous] and Gene Therapy [Viral Vector-Based Gene Therapy and Non-Viral Vector-Based Gene Therapy]), Manufacturing Type (In-house Manufacturing, Contract Manufacturing), Scale of Manufacturing (Clinical-Scale Manufacturing and Commercial-Scale Manufacturing), Application (Neurological, Oncological, Hematological, Ophthalmological and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of genetic disorders and chronic diseases, rapid expansion of the cell and gene therapy pipeline, and increasing strategic activities among the key players across the globe.

The Cell and Gene Therapy Manufacturing market was valued at USD 4,749.18 million in 2024, growing at a CAGR of 9.50% during the forecast period from 2025 to 2032 to reach USD 9,804.90 million by 2032. The rising prevalence of genetic disorders and chronic diseases such as cancer and rare inherited conditions is driving the demand for advanced therapies, thereby increasing the need for robust manufacturing capabilities. Concurrently, the rapid expansion of the cell and gene therapy pipeline, with numerous therapies advancing through clinical trials, is accelerating the demand for scalable and efficient production solutions.

Additionally, strategic initiatives by key market players including partnerships, investments in cutting-edge manufacturing facilities, and advancements in automation technologies are significantly enhancing production capacity and operational efficiency.

Collectively, these factors are expected to substantially propel the growth of the cell and gene therapy manufacturing market globally during the forecast period from 2025 to 2032.

Cell and Gene Therapy Manufacturing Market Dynamics:

The increasing prevalence of genetic disorders and chronic diseases, such as cancer and rare inherited conditions, is driving the demand for advanced therapies, thereby necessitating robust manufacturing capabilities. The rapid expansion of the cell and gene therapy pipeline, with numerous therapies advancing through clinical trials, underscores the need for scalable and efficient production solutions. Strategic activities by key industry players including partnerships, investments in state-of-the-art manufacturing facilities, and advancements in automation are enhancing production capacity and efficiency. Collectively, these factors are anticipated to significantly propel the growth of the global cell and gene therapy manufacturing market during the forecast period from 2025 to 2032.

According to data from the International Agency for Research on Cancer (2024), the global incidence of new cancer cases was estimated at 20 million in 2022, with projections indicating an increase to 32.6 million by 2045. Gene therapies, such as CAR-T cell treatments, have demonstrated promising results in targeting specific cancer types, thereby increasing the demand for robust manufacturing processes to scale production. Similarly, cell therapies, including stem cell-based treatments, are being developed to address not only cancer but also the adverse effects of aggressive cancer treatments. Consequently, the rising incidence of cancer is significantly boosting the cell and gene therapy manufacturing market.

Additionally, data from the Haemophilia Foundation Australia (2024) indicates that over 2,500 individuals in Australia have been diagnosed with Von Willebrand Disease (VWD), an inherited bleeding disorder, though many cases are believed to be undiagnosed. Cell and gene therapy approaches for VWD involve delivering a functional copy of the defective VWF gene to correct the underlying genetic defect. This strategy necessitates specialized manufacturing of viral vectors and other components in Good Manufacturing Practice (GMP)-compliant facilities, thereby increasing the demand for advanced manufacturing processes and infrastructure. The rising prevalence of VWD globally, coupled with the limitations of conventional treatments, has spurred increased research and investment in developing cell and gene therapies specifically targeting this disorder, thus boosting the overall market.

Furthermore, strategic activities among key market players are significantly enhancing the cell and gene therapy manufacturing landscape. For instance, in October 2023, Creative Medical Technology Holdings, Inc. received Institutional Review Board (IRB) approval for its clinical trial of the StemSpine(R) procedure using AlloStem(TM) (CELZ-201-DDT) cell therapy for chronic lower back pain. This approval enables the company to proceed with recruitment for its FDA-approved Phase 1/2 trial to evaluate safety, efficacy, and tolerability in 30 participants with Degenerative Disc Disease. Such developments underscore the rapid progression of cell and gene therapies through clinical trials, necessitating scalable and efficient manufacturing solutions.

However, the market faces challenges, including complex manufacturing processes and regulatory hurdles. Producing cell and gene therapies involves intricate steps such as cell extraction, modification, expansion, and delivery. Ensuring scalability and reproducibility while maintaining product quality is a significant concern. Regulatory obstacles must be overcome to ensure that patients can benefit from these treatments. Additionally, the lack of access to materials and talent, as well as unproven technologies and immature processes, pose challenges to scaling up production. Addressing these issues is crucial for the continued growth of the cell and gene therapy manufacturing market.

In summary, while the cell and gene therapy manufacturing market is poised for significant growth driven by the rising prevalence of chronic diseases and genetic disorders, it must navigate complex manufacturing and regulatory challenges to fully realize its potential.

Cell and Gene Therapy Manufacturing Market Segment Analysis:

Cell and Gene Therapy Manufacturing Market by Therapy Type (Cell Therapy [Allogenic and Autologous] and Gene Therapy [Viral Vector-Based Gene Therapy and Non-Viral Vector-Based Gene Therapy]), Manufacturing Type (In-house Manufacturing, Contract Manufacturing), Scale of Manufacturing (Clinical-Scale Manufacturing and Commercial-Scale Manufacturing), Application (Neurological, Oncological, Hematological, Ophthalmological and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the therapy type segment of the cell and gene therapy manufacturing market, the allogenic sub-segment of cell therapy is anticipated to hold a significant share in 2024. Allogenic cell therapy is a major driver of market growth due to its scalability, cost-effectiveness, and broad therapeutic potential. Unlike autologous therapies, which use patient-derived cells, allogenic therapies utilize donor cells that are expanded, modified, and stored for use in multiple patients. This "off-the-shelf" approach facilitates mass production, reducing the time and costs associated with personalized treatments, and thereby improving accessibility for large patient populations suffering from chronic and life-threatening diseases.

In oncology, allogenic therapies such as CAR-T cells have demonstrated promising results in treating hematological malignancies, prompting substantial investments in their development. Beyond oncology, their application is expanding into autoimmune diseases, cardiovascular disorders, and regenerative medicine. The capability to produce large-scale, standardized cell batches ensures consistent quality, which is essential for regulatory approval and broader adoption.

Technological advancements in gene-editing tools like CRISPR-Cas9 have further enhanced the potential of allogenic therapies by enabling precise cell modifications, thereby improving efficacy and reducing the risk of immune rejection. Additionally, the adoption of advanced bioprocessing and cryopreservation techniques has improved the shelf life and global distribution capabilities of these therapies, further strengthening market penetration.

Strategic activities among key market players are also fueling the growth of the cell and gene therapy manufacturing market. For example, in December 2023, the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia the first cell-based gene therapy for treating sickle cell disease (SCD) in patients aged 12 years and older. These therapies target the root cause of SCD by correcting the defective hemoglobin gene, offering potential curative solutions for a condition historically managed with symptomatic treatments like transfusions or hydroxyurea.

Overall, the combination of technological advancements, expanding therapeutic applications, and supportive regulatory developments is expected to propel the allogenic cell therapy segment, thereby boosting the global cell and gene therapy manufacturing market during the forecast period from 2025 to 2032.

North America is expected to dominate the overall cell and gene therapy manufacturing market:

North America is projected to hold the largest share of the cell and gene therapy manufacturing market in 2024. This dominance can be attributed to the region's strong presence of leading biopharmaceutical companies, robust healthcare infrastructure, and favorable regulatory environment. The U.S. Food and Drug Administration (FDA) plays a pivotal role through initiatives like fast-track designations, breakthrough therapy designations, and orphan drug approvals, expediting the development and commercialization of advanced therapies. Additionally, substantial investments from both government agencies and private entities are enhancing manufacturing capabilities and fostering innovation in the region.

The increasing prevalence of chronic diseases and genetic disorders further drives market demand. According to recent data from the Centers for Disease Control and Prevention (CDC) in 2024, approximately 1 in every 5,000 boys aged 5-9 years in the United States has Duchenne or Becker muscular dystrophy (DBMD). These X-linked genetic disorders cause progressive muscle degeneration due to mutations in the dystrophin gene. Cell and gene therapies, leveraging technologies like adeno-associated virus (AAV) vectors, are being developed to deliver functional copies of the dystrophin gene, aiming to slow disease progression and improve patient outcomes. The rising research focus on DBMD underscores the growing manufacturing need for such advanced therapies.

Furthermore, hemophilia remains a significant focus area in gene therapy development. The CDC reports that approximately 33,000 males in the United States were living with hemophilia in 2024. Gene therapies like BioMarin's Roctavian for hemophilia A and CSL Behring's Hemgenix for hemophilia B have revolutionized treatment by enabling long-term clotting factor production through a single administration. This shift toward curative solutions over traditional therapies, such as frequent factor replacement, is driving the demand for large-scale manufacturing of viral vectors and other essential components.

Product approvals continue to bolster market growth. In December 2023, the FDA approved Casgevy and Lyfgenia the first cell-based gene therapy for treating sickle cell disease (SCD) in patients aged 12 years and older. These treatments target the root cause of SCD by correcting the defective hemoglobin gene, offering potential long-term remission, and reducing dependence on symptomatic management options like blood transfusions. Such regulatory milestones emphasize the region's leadership in facilitating groundbreaking therapies.

Moreover, the region benefits from a high level of patient awareness, enabling quicker adoption of novel treatments. Strategic collaborations among biopharmaceutical companies, contract manufacturing organizations (CMOs), and academic institutions further accelerate process development and scale-up capabilities. Advances in automation, bioprocessing technologies, and supply chain management are enhancing production efficiency and consistency, ensuring timely delivery to patients.

Collectively, these factors including rising disease prevalence, supportive regulatory frameworks, technological advancements, and strategic industry initiatives are expected to significantly propel the growth of the cell and gene therapy manufacturing market in North America during the forecast period from 2025 to 2032.

Cell and Gene Therapy Manufacturing Market Key Players:

Some of the key market players operating in the cell and gene therapy manufacturing market include Lonza, Catalent, Inc., Thermo Fisher Scientific, Inc., Charles River Laboratories, WuXi AppTec, Merck KGaA, Takara Bio Inc., Oxford Biomedica PLC, Genezen, FUJIFILM Holdings Corporation, Nikon Corporation, The Discovery Labs LLC, RoslinCT, JRS Pharma, FinVector, Sarepta Therapeutics, Inc., BioCentriq, Andelyn Biosciences, ElevateBio, Anemocyte Srl, and others.

Recent Developmental Activities in the Cell and Gene Therapy Manufacturing Market:

• In June 2023, Sarepta Therapeutics, Inc. received accelerated approval from the U.S. FDA for ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy designed to treat ambulatory pediatric patients aged 4 to 5 years with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene.
• In March 2023, Thermo Fisher Scientific and Arsenal Biosciences formed a collaboration to support the clinical manufacturing of autologous T-cell therapies.

Key Takeaways From the Cell and Gene Therapy Manufacturing Market Report Study

• Market size analysis for current cell and gene therapy manufacturing size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the cell and gene therapy manufacturing market.
• Various opportunities available for the other competitors in the cell and gene therapy manufacturing market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current cell and gene therapy manufacturing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for cell and gene therapy manufacturing market growth in the coming future?

Target Audience Who Can be Benefited From This Cell and Gene Therapy Manufacturing Market Report Study

• Cell and gene therapy manufacturing product providers
• Research organizations and consulting companies
• Cell and gene therapy manufacturing-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in cell and gene therapy manufacturing
• Various end-users who want to know more about the cell and gene therapy manufacturing market and the latest technological developments in the cell and gene therapy manufacturing market.

Frequently Asked Questions for the Cell and Gene Therapy Manufacturing Market:

1. What are cell and gene therapy manufacturing?

• Cell and Gene Therapy Manufacturing refers to the production processes involved in creating advanced medical treatments that use living cells or genetic material to treat, prevent, or cure diseases. This includes therapies like CAR T-cell treatments, stem cell therapies, and gene editing technologies. Manufacturing involves techniques such as cell isolation, expansion, genetic modification, viral vector production, and formulation under stringent quality control to ensure safety, efficacy, and scalability.

2. What is the market for cell and gene therapy manufacturing?

• The Cell and Gene Therapy Manufacturing market was valued at USD 4,749.18 million in 2024, growing at a CAGR of 9.50% during the forecast period from 2025 to 2032 to reach USD 9,804.90 million by 2032.

3. What are the drivers for the global cell and gene therapy manufacturing market?

• The rising prevalence of genetic disorders and chronic diseases like cancer and rare inherited conditions is driving the need for advanced therapies, increasing the demand for robust manufacturing capabilities. Simultaneously, the rapid expansion of the cell and gene therapy pipeline, with numerous therapies progressing through clinical trials, is accelerating the need for scalable, efficient production solutions. Additionally, strategic activities by key players, including partnerships, investments in state-of-the-art manufacturing facilities, and advancements in automation, are improving production capacity and efficiency. Together, these factors are expected in significantly propelling the growth of the cell and gene therapy manufacturing market globally during the forecast period from 2025 to 2032.

4. Who are the key players operating in the global cell and gene therapy manufacturing market?

• Some of the key market players operating in cell and gene therapy manufacturing are Lonza, Catalent, Inc., Thermo Fisher Scientific, Inc., Charles River Laboratories, WuXi AppTec, Merck KGaA, Takara Bio Inc., Oxford Biomedica PLC, Genezen, FUJIFILM Holdings Corporation, Nikon Corporation, The Discovery Labs LLC, RoslinCT, JRS Pharma, FinVector, Sarepta Therapeutics, Inc., BioCentriq, Andelyn Biosciences, ElevateBio, Anemocyte Srl, and others.

5. Which region has the highest share in the global cell and gene therapy manufacturing market?

• North America is expected to account for the highest proportion of the cell and gene therapy manufacturing market in 2024, out of all regions. The region boasts a strong presence of leading biopharmaceutical companies and advanced healthcare infrastructure, which facilitates cutting-edge research and development. Favorable regulatory frameworks, such as the U.S. FDA's fast-track designations and orphan drug approvals, further accelerate product pipelines in cell and gene therapy. Additionally, increasing investments from government bodies and private organizations enhance the region's capacity for innovation. The rising prevalence of chronic diseases and cancers, coupled with high patient awareness and adoption of advanced therapies, contribute significantly to market growth.

Table of Contents

1. Cell and Gene Therapy Manufacturing Market Report Introduction

• 1.1. Scope of the Study
• 1.2. Market Segmentation
• 1.3. Market Assumption

2. Cell and Gene Therapy Manufacturing Market Executive Summary

• 2.1. Market at Glance

3. Competitive Landscape

4. Regulatory Analysis

• 4.1. The United States
• 4.2. Europe
• 4.3. Japan
• 4.4. China

5. Cell and Gene Therapy Manufacturing Market Key Factors Analysis

• 5.1. Cell and Gene Therapy Manufacturing Market Drivers
  • 5.1.1. Rising prevalence of genetic disorders and chronic diseases
  • 5.1.2. Rapid expansion of the cell and gene therapy pipeline
  • 5.1.3. Increasing strategic activities among the key players across the globe
• 5.2. Cell and Gene Therapy Manufacturing Market Restraints and Challenges
  • 5.2.1. Ethical and regulatory issues
  • 5.2.2. Complex manufacturing process
• 5.3. Cell and Gene Therapy Manufacturing Market Opportunities
  • 5.3.1. Development of automated and cost-effective CGT manufacturing solutions

6. Cell and Gene Therapy Manufacturing Market Porter's Five Forces Analysis

• 6.1. Bargaining Power of Suppliers
• 6.2. Bargaining Power of Consumers
• 6.3. Threat of New Entrants
• 6.4. Threat of Substitutes
• 6.5. Competitive Rivalry

7. Cell and Gene Therapy Manufacturing Market Assessment

• 7.1. By Therapy Type
  • 7.1.1. Cell Therapy
    • 7.1.1.1. Allogenic
    • 7.1.1.2. Autologous
  • 7.1.2. Gene Therapy
    • 7.1.2.1. Viral Vector-Based Gene Therapy
    • 7.1.2.2. Non-Viral Vector-Based Gene Therapy
• 7.2. By Manufacturing Type
  • 7.2.1. In-house Manufacturing
  • 7.2.2. Contract Manufacturing
• 7.3. By Scale of Manufacturing
  • 7.3.1. Clinical-Scale Manufacturing
  • 7.3.2. Commercial-Scale Manufacturing
• 7.4. By Application
  • 7.4.1. Neurological
  • 7.4.2. Oncological
  • 7.4.3. Hematological
  • 7.4.4. Ophthalmological
  • 7.4.5. Others
• 7.5. By Geography
  • 7.5.1. North America
    • 7.5.1.1. United States Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.1.2. Canada Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.1.3. Mexico Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
  • 7.5.2. Europe
    • 7.5.2.1. France Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.2.2. Germany Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.2.3. United Kingdom Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.2.4. Italy Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.2.5. Spain Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.2.6. Rest of Europe Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
  • 7.5.3. Asia-Pacific
    • 7.5.3.1. China Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.3.2. Japan Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.3.3. India Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.3.4. Australia Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.3.5. South Korea Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.3.6. Rest of Asia-Pacific Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
  • 7.5.4. Rest of the World (RoW)
    • 7.5.4.1. Middle East Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.4.2. Africa Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)
    • 7.5.4.3. South America Cell and Gene Therapy Manufacturing Market Size in USD Million (2022-2032)

8. Cell and Gene Therapy Manufacturing Market Company and Product Profiles

• 8.1. Lonza
  • 8.1.1. Company Overview
  • 8.1.2. Company Snapshot
  • 8.1.3. Financial Overview
  • 8.1.4. Product Listing
  • 8.1.5. Entropy
• 8.2. Catalent, Inc.
  • 8.2.1. Company Overview
  • 8.2.2. Company Snapshot
  • 8.2.3. Financial Overview
  • 8.2.4. Product Listing
  • 8.2.5. Entropy
• 8.3. Thermo Fisher Scientific, Inc.
  • 8.3.1. Company Overview
  • 8.3.2. Company Snapshot
  • 8.3.3. Financial Overview
  • 8.3.4. Product Listing
  • 8.3.5. Entropy
• 8.4. Charles River Laboratories
  • 8.4.1. Company Overview
  • 8.4.2. Company Snapshot
  • 8.4.3. Financial Overview
  • 8.4.4. Product Listing
  • 8.4.5. Entropy
• 8.5. WuXi AppTec
  • 8.5.1. Company Overview
  • 8.5.2. Company Snapshot
  • 8.5.3. Financial Overview
  • 8.5.4. Product Listing
  • 8.5.5. Entropy
• 8.6. Merck KGaA
  • 8.6.1. Company Overview
  • 8.6.2. Company Snapshot
  • 8.6.3. Financial Overview
  • 8.6.4. Product Listing
  • 8.6.5. Entropy
• 8.7. Takara Bio Inc.
  • 8.7.1. Company Overview
  • 8.7.2. Company Snapshot
  • 8.7.3. Financial Overview
  • 8.7.4. Product Listing
  • 8.7.5. Entropy
• 8.8. Oxford Biomedica PLC
  • 8.8.1. Company Overview
  • 8.8.2. Company Snapshot
  • 8.8.3. Financial Overview
  • 8.8.4. Product Listing
  • 8.8.5. Entropy
• 8.9. Genezen
  • 8.9.1. Company Overview
  • 8.9.2. Company Snapshot
  • 8.9.3. Financial Overview
  • 8.9.4. Product Listing
  • 8.9.5. Entropy
• 8.10. FUJIFILM Holdings Corporation
  • 8.10.1. Company Overview
  • 8.10.2. Company Snapshot
  • 8.10.3. Financial Overview
  • 8.10.4. Product Listing
  • 8.10.5. Entropy
• 8.11. Nikon Corporation
  • 8.11.1. Company Overview
  • 8.11.2. Company Snapshot
  • 8.11.3. Financial Overview
  • 8.11.4. Product Listing
  • 8.11.5. Entropy
• 8.12. The Discovery Labs LLC
  • 8.12.1. Company Overview
  • 8.12.2. Company Snapshot
  • 8.12.3. Financial Overview
  • 8.12.4. Product Listing
  • 8.12.5. Entropy
• 8.13. RoslinCT
  • 8.13.1. Company Overview
  • 8.13.2. Company Snapshot
  • 8.13.3. Financial Overview
  • 8.13.4. Product Listing
  • 8.13.5. Entropy
• 8.14. JRS Pharma
  • 8.14.1. Company Overview
  • 8.14.2. Company Snapshot
  • 8.14.3. Financial Overview
  • 8.14.4. Product Listing
  • 8.14.5. Entropy
• 8.15. FinVector
  • 8.15.1. Company Overview
  • 8.15.2. Company Snapshot
  • 8.15.3. Financial Overview
  • 8.15.4. Product Listing
  • 8.15.5. Entropy
• 8.16. Sarepta Therapeutics, Inc.
  • 8.16.1. Company Overview
  • 8.16.2. Company Snapshot
  • 8.16.3. Financial Overview
  • 8.16.4. Product Listing
  • 8.16.5. Entropy
• 8.17. BioCentriq
  • 8.17.1. Company Overview
  • 8.17.2. Company Snapshot
  • 8.17.3. Financial Overview
  • 8.17.4. Product Listing
  • 8.17.5. Entropy
• 8.18. Andelyn Biosciences
  • 8.18.1. Company Overview
  • 8.18.2. Company Snapshot
  • 8.18.3. Financial Overview
  • 8.18.4. Product Listing
  • 8.18.5. Entropy
• 8.19. ElevateBio
  • 8.19.1. Company Overview
  • 8.19.2. Company Snapshot
  • 8.19.3. Financial Overview
  • 8.19.4. Product Listing
  • 8.19.5. Entropy
• 8.20. Anemocyte Srl
  • 8.20.1. Company Overview
  • 8.20.2. Company Snapshot
  • 8.20.3. Financial Overview
  • 8.20.4. Product Listing
  • 8.20.5. Entropy

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