Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market by Scale of Operation (Preclinical, Clinical and Commercial), Type of Vector (AAV Vectors, Adenoviral Vectors, Lentiviral Vectors, Retroviral Vectors and Othe

Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market by Scale of Operation (Preclinical, Clinical and Commercial), Type of Vector (AAV Vectors, Adenoviral Vectors, Lentiviral Vectors, Retroviral Vectors and Other Vectors), Application Area (Gene Therapies, Cell Therapies and Vaccines), Therapeutic Area (Oncological Disorders, Rare Diseases, Neurological Disorders, Sensory Disorders, Metabolic Disorders, Musculoskeletal Disorders, Blood Disorders, Immunological Disorders and Other Disorders), Type of Manufacturer (In-house and Contract Manufacturing Organizations) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America, and Rest of the World): Industry Trends and Global Forecasts, Till 2035

Viral Vector Manufacturing, Non-viral Vector Manufacturing And Gene Therapy Manufacturing Market: Overview

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.

VIRAL VECTOR MANUFACTURING, NON-VIRAL VECTOR MANUFACTURING AND GENE THERAPY MANUFACTURING MARKET: KEY INSIGHTS

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.

VIRAL VECTOR MANUFACTURING, NON-VIRAL VECTOR MANUFACTURING AND GENE THERAPY MANUFACTURING MARKET: KEY SEGMENTS

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?

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