세계의 바이러스 벡터 제조, 비바이러스 벡터 제조, 유전자 치료 제조 시장 : 사업 규모별, 벡터 유형별, 응용 영역별, 치료 영역별, 주요 지역별: 업계 동향과 예측(-2035년)
Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market by Scale of Operation, Type of Vector, Application Area, Therapeutic Area, and Key Geographical Regions : Industry Trends and Global Forecasts, Till 2035
상품코드:1624827
리서치사:Roots Analysis
발행일:2025년 01월
페이지 정보:영문 768 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계 바이러스 벡터 제조, 비바이러스 벡터 제조 및 유전자 치료 제조 시장 규모는 2035년까지 예측 기간 동안 11.44%의 연평균 복합 성장률(CAGR)로 확대되며 현재 7억 달러에서 2035년까지 23억 달러로 성장할 것으로 예측됩니다.
지난 수십년동안 다양한 바이러스 및 비 바이러스 벡터가 유전자 도입 목적으로 최적화되고 표준화되어 왔습니다. 또한, 미국 내에서도 폭넓은 적응증을 대상으로 한 200개 이상의 바이러스 벡터 기반 유전자 치료가 임상시험에서 평가되고 있습니다. 하지만 광범위한 개발 노력을 수행하고 있음을 보여주지만, 개발자는 바이러스 벡터와 비 바이러스 벡터의 제조에 대한 복잡성에 직면하고 있습니다. 현재는 세포 치료, 유전자 치료 및 바이러스 벡터 백신 수요 증가에 대응하기 위해 270 개 이상의 산업 및 비 업계 기업이 바이러스 벡터 및 플라스미드 DNA 생산에 종사하고 있습니다.
의약품 개발 기업이 이러한 혁신적인 치료법에 더 많은 투자를 하고 있기 때문에 바이러스 벡터 제조, 비바이러스 벡터 제조, 유전자 치료 제조 시장은 더욱 확대될 것으로 예상됩니다. 승인이 가속화되고 바이러스 벡터 기반 유전자 요법과 관련된 임상시험이 진행됨에 따라 바이러스 및 비 바이러스 벡터에 대한 수요가 증가하고 있으며 벡터 제조업체에게 유리한 기회를 제공합니다.
본 보고서에서는 세계의 바이러스 벡터 제조, 비바이러스 벡터 제조, 유전자 치료 제조 시장에 대해 조사했으며, 시장 개요와 함께 사업 규모별, 벡터 유형별, 응용 영역별, 치료 영역별, 지역별 동향 및 시장 진출기업 프로파일 등의 정보를 제공합니다.
As per Roots Analysis, the global viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing market is estimated to grow from USD 0.70 billion in the current year to USD 2.3 billion by 2035, at a CAGR of 11.44% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Scale of Operation
Preclinical
Clinical
Commercial
Type of Vector
Adeno Associated Virus Vectors
Adenoviral Vectors
Lentiviral Vectors
Retroviral Vectors
Other Vectors
Application Area
Gene Therapies
Cell Therapies
Vaccines
Therapeutic Area
Oncological Disorders
Rare Diseases
Neurological Disorders
Sensory Disorders
Metabolic Disorders
Musculoskeletal Disorders
Blood Disorders
Immunological Disorders
Other Disorders
Type of Manufacturer
In-house
Contract Manufacturing Organizations
End User
Clinics
Health Insurance Agencies
Hospitals
Other End Users
Key Geographical Regions
North America
Europe
Asia
Latin America and Rest of the World
Middle East and North Africa
VIRAL VECTOR MANUFACTURING, NON-VIRAL VECTOR MANUFACTURING AND GENE THERAPY MANUFACTURING MARKET: GROWTH AND TRENDS
Over the last few decades, various viral and non-viral vectors have been optimized and standardized for the purpose of gene delivery. It is worth mentioning that, till date, over 30 viral vector based gene therapy products have been approved by different regulatory agencies, globally. In addition, more than 200 viral vector based gene therapies targeting a wide range of disease indications are being evaluated in clinical trials in the US alone. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. On the contrary, developers continue to face production related complexities for viral and non-viral vectors. In order to overcome such challenges, developers prefer to outsource key operations. At present, over 270 industry and non-industry players are engaged in the production of viral vectors and plasmid DNA in order to meet the growing demand for cell therapies, gene therapies and viral vector vaccines.
As drug developers invest more in these innovative therapies, the market for viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing is anticipated to expand further. In addition, the accelerated approval of cell and gene therapies and ongoing clinical trials related to viral vector based gene therapy, has led to a rise in the demand for viral and non viral vectors, offering lucrative opportunities to vector manufacturers.
The report delves into the current state of the viral vector, non-viral vector and gene therapy manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:
1. Presently, over 270 industry and non-industry players claim to have the necessary capabilities to manufacture different types of viral and non viral vectors, for in-house requirements and / or contract service engagements.
2. The current viral vector manufacturing market landscape features the presence of more than 85 players that offer contract manufacturing services; among these, ~55% players offer services at all scales of operation.
3. Nearly 55% of the industry players and 75% of the non-industry players are capable of manufacturing adeno-associated viral vectors; this is followed by players manufacturing lentiviral vectors and plasmid DNA.
4. In order to cater to the evolving needs of clients / sponsors, stakeholders have established their presence in multiple regions across the world; currently, the US and EU are considered as the manufacturing hubs.
5. More than 90 innovative technological platforms, developed by nearly 65 players, are available for the discovery, development and delivery of cell therapies, gene therapies and vaccines.
6. In pursuit of gaining a competitive edge, industry stakeholders are actively upgrading their existing capabilities and adding new competencies to enhance their respective vector and gene therapy related portfolios.
7. A growing number of expansion projects undertaken by various players and a notable increase in partnership activity are indicative of the increasing interest in the vector-based cell and gene therapy domain.
8. In order to increase efficiency and optimize the manufacturing processes, several vector and gene therapy innovators are anticipated to forge strategic alliances with vector and gene therapy manufacturers.
9. Nearly 40% of the players claim to offer manufacturing services for emerging vectors; majority of these stakeholders have expertise to carry out manufacturing operations at both preclinical and clinical scale.
10. The pricing of vectors varies considerably and is influenced by parameters such as complex scalability, high cost of manufacturing, complex supply chain and high cost of storage / delivery.
11. Given the numerous benefits of cell and gene therapies, the demand for vector, cell and gene therapy manufacturing is anticipated to increase significantly in future.
12. Over 65% of the global installed gene therapy and vector manufacturing capacity is dedicated to viral vector manufacturing; ~55% of viral vector manufacturing capacity is installed in the facilities located in North America.
13. Driven by the expanding pipeline of cell and gene therapies, and increasing investments in the domain, the vector and gene therapy manufacturing market is poised to witness significant growth in the foreseeable future.
14. In 2035, nearly 40% of the vector and gene therapy manufacturing demand is expected to be generated from the Asia-Pacific region.
15. The overall opportunity associated with the vector manufacturing domain is anticipated to grow at the CAGR of 13%; it is likely to be well distributed across different scales of operation, types of vectors and application areas.
16. In the long term, the vector-based recombinant therapies for oncological disorders, with more than 60% of the market share, are likely to emerge as the key growth driver of the vector and gene therapy manufacturing market.
Currently, Clinical Scale Occupies the Largest Share of the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market
Based on the scale of operation, the market is segmented into preclinical, clinical and commercial. At present, majority share is expected to be captured by clinical scale. It is worth highlighting that, over the years, viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing market at commercial scale is likely to grow at a relatively higher CAGR during the forecast period.
Lentiviral Vectors Segment is Likely to Capture the Largest Share of the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market During the Forecast Period
Based on the type of vector, the market is segmented into AAV vectors, adenoviral vectors, lentiviral vectors, retroviral vectors and other vectors. It is worth highlighting that lentiviral vectors are likely to drive the market in the forthcoming years. However, the viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing market for adenoviral vectors is likely to grow at a relatively higher CAGR during the forecast period.
Cell Therapy Segment is Likely to Dominate the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market During the Forecast Period
Based on the application area, the market is segmented into gene therapies, cell therapies and vaccines. It is worth highlighting that the cell therapy segment is expected to capture the highest share of the market in the coming decade. However, the viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing market for vaccines is likely to grow at a relatively higher CAGR during the forecast period.
Oncological Disorders Segment Accounts for the Largest Share of the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market
Based on the therapeutic area, the market is segmented into oncological disorders, rare diseases, neurological disorders, sensory disorders, metabolic disorders, musculoskeletal disorders, blood disorders, immunological disorders and other disorders. While oncological disorders account for a relatively higher market share, it is worth highlighting that the autoimmune disorders segment is expected to witness substantial market growth in the coming years.
At Present, Contract Manufacturing Organizations Occupies the Largest Share of the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market
Based on the type of manufacturer, the market is segmented into in-house and contract manufacturing organizations. It is worth highlighting that the market is primarily driven by revenues generated by contract manufacturing organizations. This trend is unlikely to change in the near future.
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America and the Rest of the World. Majority share is expected to be captured by manufacturers based in North America and Europe.
Example Players in the Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market
Advanced BioScience Laboratories
AGC Biologics
Aldevron
Altruist Biotechnology
BioNTech Innovative Manufacturing Service (a subsidiary of BioNTech)
BioReliance (a subsidiary of Merck KGaA)
Biovian
Celonic
Catalent Biologics
Cobra Biologics
Centre for Process Innovation
CEVEC Pharmaceuticals
Charles River Laboratories
CoJourney
Esco Aster
Jiangsu Puxin Biopharmaceutical
Lonza
Matica Biotechnology
Nikon CeLL innovation
NorthX Biologics
Novartis
Oxford BioMedica
Resilience
Sanofi
Thermo Fisher Scientific
VectorBuilder
Wuxi AppTech
Primary Research Overview
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:
Chief Executive Officer, Batavia Biosciences
Chief Operating Officer, Touchlight
Business Developer, HALIX
Chief Executive Officer and Chief Scientific Officer, CEVEC Pharmaceuticals
Former Business Development Manager and Xavier Leclerc, Head of Gene Therapy, Clean Cells
Director, Massachusetts General Hospital
Former Managing Director, CJ PARTNERS
Director of Marketing and Technical Support, Polypus Transfection
Former Scientific Director, University of Nantes
Scientific Director, ACGT
Former Executive and Scientific Director, Delphi Genetics
Former Director, Amsterdam BioTherapeutics Unit
Head of Communications, VIVEBiotech
Chief Scientific Officer, GEG Tech
Key Account Management, Richter-Helm BioLogics
Head of Project Management and Tatjana Buchholz, Former Marketing Manager, Plasmid Factory
Director of Business Development, Waisman Biomanufacturing
ATMP Key Account Manager, EFS-West Biotherapy
VIRAL VECTOR MANUFACTURING, NON- VIRAL VECTOR MANUFACTURING AND GENE THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the viral vector manufacturing market, focusing on key market segments, including [A] scale of operation, [B] type of vector, [C] application area, [D] therapeutic area, [E] type of manufacturer and [F] key geographical regions.
Market Landscape (Viral Vector and Gene Therapy Manufacturers): A comprehensive evaluation of companies involved in manufacturing viral vectors and gene therapies, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of product manufactured, [E] location of manufacturing facility, [F] type of manufacturer, [G] scale of operation, [H] type of vector manufactured and [I] application area. In addition, the chapter also highlights information on the installed production capacity with stakeholders related to vector manufacturing.
Market Landscape (Plasmid DNA and Gene Therapy Manufacturers): A comprehensive evaluation of companies involved in manufacturing plasmid DNA and gene therapies, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of product manufactured, [E] location of manufacturing facility, [F] type of manufacturer, [G] scale of operation, [H] type of vector manufactured and [I] application area.
Market Landscape (Non-Industry Players): A comprehensive evaluation of non-industry players involved in manufacturing viral, non viral and other novel types of vectors and gene therapies, considering various parameters, such as [A] year of establishment, [B] location of vector manufacturing facility, [C] type of manufacturer, [D] scale of operation, [E] type of vector manufactured, and [F] application area.
Technology Landscape: An analysis of the technologies offered / developed by the companies engaged in this market, based on the [A] type of technology, [B] purpose of technology, [C] scale of operation, [D] type of vector, [E] application area. Additionally, it also highlights the most prominent players within this market, in terms of number of technologies.
Company Competitiveness Analysis: A comprehensive competitive analysis of peptide contract manufacturers, examining factors such as [A] supplier strength, [B] manufacturing strength, [C] service strength and [D] company size.
Company Profiles: In-depth profiles of key industry players based in North America, Europe and Asia-Pacific, focusing on [A] company overviews, [B] financial information (if available), [C] manufacturing facilities, [D] vector manufacturing technology, [E] an insightful recent development and [F] future outlook.
Porter's Five Forces: A qualitative analysis that examines the five competitive forces in the non-viral and viral vector manufacturing market. This includes the threats posed by new entrants, the bargaining power of drug developers, the bargaining power of vector and gene therapy manufacturers, the threats from substitute technologies and the rivalry among existing competitors.
Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2019, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] scale of operation, [D] type of vector, [E] therapeutic area, [F] application area and [G] most active players (in terms of number of partnerships). This section also highlights the regional distribution of partnership activity in this market.
Recent Expansions Analysis: An examination of the different expansion efforts made by various companies in viral vector and non viral vector manufacturing field to enhance their manufacturing capabilities, since 2019. This analysis considers various factors, including the [A] year of expansion, [B] type of expansion, [C] type of vector, [D] application area and [E] geographical location of the expansion.
Strategic Partner Analysis: An analysis highlighting potential strategic partners segregated based on the likelihood of entering into collaboration with vector and gene therapy product developers. These players have been shortlisted based on several relevant parameters, such as [A] developer strength, [B] product strength, [C] type of vector, [D] therapeutic area and [E] pipeline strength.
Emerging Trend 1: An elaborate discussion on the emerging trends of other viral / non viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification.
Emerging Trend 2: An insightful analysis, highlighting the contemporary market trends in the plasmid DNA and viral vector manufacturing industry, through different representations, based on multiple relevant parameters.
Cost Price Analysis: An analysis of the various factors that are expected to impact vector pricing, highlighting different models and approaches that product developers and manufacturers may use to determine the prices of their proprietary vectors.
Outsourcing: Go / No-Go Framework: An insightful framework that emphasizes the key indicators and factors that need to be considered by developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.
Capacity Analysis: The report provides an estimation of global annual vector manufacturing capacity of industry players. The analysis takes into consideration the distribution of global capacity across [A] company size and [B] location of headquarters.
Demand Analysis: Informed estimates of the annual demand for viral vectors and non viral vectors based on several relevant parameters, such as [A] target patient population, [B] dosing frequency and [C] dose strength.
Survey Analysis: A survey analysis featuring inputs solicited from the survey conducted on over 400 stakeholders involved in the development of different types of gene therapy vectors. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
Market Impact Analysis: The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting market growth.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading companies in this market?
What kind of partnership models are commonly adopted by industry stakeholders?
What is the current annual demand for viral and non-viral vectors?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
ADDITIONAL BENEFITS
Complimentary PPT Insights Packs
Complimentary Excel Data Packs for all Analytical Modules in the Report
10% Free Content Customization
Detailed Report Walkthrough Session with Research Team
Free Updated report if the report is 6-12 months old or older
TABLE OF CONTENTS
1. PREFACE
1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Key Questions Answered
1.5. Chapter Outlines
2. RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. COVID Impact
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
3.1. Chapter Overview
3.2. Market Dynamics
3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current and Future Estimates
3.2.2. Currency Coverage and Foreign Exchange Rate
3.2.2.1. Major Currencies Affecting the Market
3.2.2.2. Factors Affecting Currency Fluctuations and Foreign Exchange Rates
3.2.2.3. Impact of Foreign Exchange Rate Volatility on the Market
3.2.2.4. Strategies for Mitigating Foreign Exchange Risk
3.2.3. Trade Policies
3.2.3.1. Impact of Trade Barriers on the Market
3.2.3.2. Strategies for Mitigating The Risks Associated with Trade Barriers
3.2.4. Recession
3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
3.2.5. Inflation
3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
3.2.5.2. Potential Impact of Inflation on the Market Evolution
4. EXECUTIVE SUMMARY
5. INTRODUCTION
5.1. Chapter Overview
5.2. Viral and Non-Viral Gene Transfer Techniques
5.3. Viral Vectors Used in Genetically Modified Therapies
5.4. Types of Viral Vectors
5.4.1. Adeno-associated Viral Vectors
5.4.1.1. Overview
5.4.1.2. Design and Manufacturing
5.4.1.3. Advantages
5.4.1.4. Limitations
5.4.2. Adenoviral Vectors
5.4.2.1. Overview
5.4.2.2. Design and Manufacturing
5.4.2.3. Advantages
5.4.2.4. Limitations
5.4.3. Lentiviral Vectors
5.4.3.1. Overview
5.4.3.2. Design and Manufacturing
5.4.3.3. Advantages
5.4.3.4. Limitations
5.4.4. Retroviral Vectors
5.4.4.1. Overview
5.4.4.2. Design and Manufacturing
5.4.4.3. Advantages
5.4.4.4. Limitations
5.4.5. Other Viral Vectors
5.4.5.1. Alphavirus
5.4.5.2. Foamy Virus
5.4.5.3. Herpes Simplex Virus
5.4.5.4. Sendai Virus
5.4.5.5. Simian Virus
5.4.5.6. Vaccinia Virus
5.4.5.7. Chimeric Viral Vectors
5.5. Types of Non-Viral Vectors
5.5.1. Plasmid DNA
5.5.2. Liposomes, Lipoplexes and Polyplexes
5.5.3. Oligonucleotides
5.5.4. Other Non-Viral Vectors
5.6. Gene Delivery using Non-Viral Vectors
5.6.1. Biolistic Methods
5.6.2. Electroporation
5.6.3. Receptor Mediated Gene Delivery
5.6.4. Gene Activated Matrix (GAM)
5.7. Applications of Viral and Non-Viral Vectors
5.7.1. Cell and Gene Therapy
5.7.2. Vaccine
5.8. Current / Ongoing Trends in Vector Development / Manufacturing
5.8.1. Vector Engineering
5.8.2. Cargo Engineering
5.9. Vector Manufacturing
5.9.1. Types of Vector Manufacturers
5.9.2. Viral Vector Manufacturing Processes
5.9.2.1. Vector Production
5.9.2.2. Adherent and Suspension Cultures
5.9.2.3. Unit Process Versus Multiple Parallel Processes
5.9.2.4. Cell Culture Systems for Production of Viral Vectors
5.9.2.4.1. Small Scale / Laboratory Scale Cell Culture Systems
5.9.2.4.2. Large Scale Cell Culture Systems
5.9.2.4.2.1. Stirred Tank Reactor Systems
5.9.2.4.2.2. Fixed Bed Reactors / Packed Bed Reactors
5.9.2.4.2.3. Wave Bioreactor Systems
5.9.2.5. Serum-Containing versus Serum-Free Media
5.9.3. Bioprocessing of Viral Vectors
5.9.3.1. AAV Vector Production
5.9.3.2. Adenoviral Vector Production
5.9.3.3. Lentiviral Vector Production
5.9.3.4. Y -Retroviral Vector Production
5.9.4. Key Challenges Associated with Vector Manufacturing
