Viral Vector & Plasmid DNA Manufacturing Market Report

Viral Vector & Plasmid DNA Manufacturing Market Analysis Report By Application, By Disease (Cancer, Genetic), By Workflow (Upstream, Downstream), By Vector, By End Use, And Segment Forecasts, 2019 - 2025

  • Published Date: Jan, 2019
  • Base Year for Estimate: 2017
  • Report ID: GVR-2-68038-695-0
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2016
  • Number of Pages: 170

Industry Insights

The global viral vector & plasmid DNA manufacturing market size was valued at USD 270.2 million in 2017.It is anticipated to witness a CAGR of about 16.0% during the forecast period. Viral and non-viral vectors have emerged as an efficient delivery mechanism for development of innovative medicines. Development of optimized large-scale production, harvest, and purification strategies play a vital role in achieving compliance with regulatory requirements in context to product purity and traceability. This also aids in acceleration of therapeutic development from clinical evaluation step to market approval.

Vector manufacturing is considered as the most complex and resource-intensive process in the manufacturing of products such as gene therapies and vaccines. However, significant improvements are witnessed with introduction of new protocols. For instance, in April 2018, GE Healthcare launched ‘ready-to-run factory-in-a-box’ for rapid production of virus-based therapeutics.

Japan viral vector & plasmid DNA manufacturing market

Companies involved in development of vector agent-based products often seek support from contract service providers for the launch of clinical grade product. This is primarily because of complexity and limited availability of technologies and platforms used for vector designing, production, packaging, and release testing.

Contract service providers in the market are engaged in expansion of their production capacity. These companies have expanded their capabilities for early-phase manufacturing of both early and late-stage clinical trials. For example, in 2017, Brammer Bio invested more than USD 50 million for expansion of its production capabilities in Florida and Boston.

At present, gene therapy vector manufacturing methods that are available are not suitable for large-scale production. Adressing production gap is one of the major issues faced by entities involved in this field. However, companies are strategizing to address the aforementioned manufacturing challenges through introduction of novel solutions. For example, CEVEC introduced novel helper-virus-free stable production system for scalable manufacturing of AAV.

Vector Type Insights

Several factors are taken into consideration while manufacturing vectors, including efficient transduction, targeted delivery, and controlled gene expression. Adenoviral vectors are most commonly used and have been a part of maximum clinical trials conducted worldwide over the past years. Easy production at high titers and integration ability with large transgenes and transduction of quiescent & dividing cells are translating into greater demand for adenoviral vectors.

Lentiviral vectors are projected to witness substantial growth in the coming years. Success of lentiviral-based Kymriah gene therapy product is poised to support the growth of the segment. Several companies are seeking support from contract manufacturers for development of lentivirus-based products. For example, in August 2018, Boehringer Ingelheim collaborated with Oxford Biomedica for development of lentiviral-based therapy for cystic fibrosis.

Workflow Insights

Surging demand for vectors, due to usage expansion of clinical therapeutics, has boosted the need for optimization of downstream processing & upstream processing. Small-scale virus preparation methods include procedures that are difficult to scale-up and are considered tedious.

As a result, several scalable commercial processes are being investigated and optimized to ensure quantity of virus along with retainment of critical quality attributes. Downstream processing covers clarification, capture, purification, and polishing. This step accounted for the largest revenue share in 2017. It is likely to dominate the market throughout the forecast period.

Vector purification is considered the most complicated process and thus, accounts for majority of the overall manufacturing cost. With increase in the demand for clinical-grade vectors, manufacturers are engaged in development of novel economic downstream processes to address challenges associated with conventional lab-scale manufacturing process.

Application Insights

Over the past few years, there has been a significant growth in gene therapy research in terms of volume, investments, and outcomes. This growth can be attributed to increasing clinical success of AAV and other viral vector-based gene therapies. Antisense therapies are also being explored to significant extent and thus, the demand for vector manufacturing is driven by increasing R&D in this segment.

Compared to other applications, vectors have higher penetration in gene & cell therapy products. As a result, antisense, RNAi, and molecular therapy represented approximately 60.0% of the overall revenue in 2017. On the other hand, several viral vectors are being explored to assess their potential and accelerate the development of viral vector-based vaccines for clinical use. Therefore, the vaccinology segment is expected to register a higher CAGR during the forecast period.

End-use Insights

Pharmaceutical and biopharmaceutical companies are the leading end users in the viral vector and plasmid DNA manufacturing market in 2017. Growing interest of pharma companies in new areas of medicine, including gene therapies, is contributing to the growth of the segment. Vectors are used by them for development of advanced therapies to treat chronic conditions such as cancer and genetic disorders.

On the other hand, contract based manufacturing is gaining popularity among biopharmaceutical manufacturers. However, there are several gene therapy companies that are planning to keep manufacturing process in-house, thus are expected to adopt in-house vector manufacturing. Such companies include AveXis, Audentes, and Sangamo.

Research institutes are estimated to post a CAGR of over 16.0% during forecast period Increasing demand for vectors to conduct disease-related research programs is one of the factors escalating the growth of the segment. Maine Medical Center Research Institute, Viral Vector Core, Penn Vector Core, and American Society of Gene & Cell Therapy are some of the research institutes operating in this space

Disease Insights

Cancer led the overall market in 2017. High usage of vectors for development of cancer therapies is the primary growth simulant for the segment. In addition, constant research endeavors taken up to target cancer and gain approvals in various classes of biopharmaceutical drugs are supplementing the growth of the segment.

Moreover, pharmaceutical companies with robust pipeline portfolio for cancer gene therapy products are anticipated to fuel progress in this segment during the forecast period. Viruses exhibit high efficiency of gene delivery, which makes it an ideal vector for gene therapy production. This is evident through positive results of various clinical trials that are conducted to evaluate efficacy of vectors against different tumor forms. Although immune responses have been relatively modest in some cases, efficacy can be improved by vector engineering and dose optimization.

Global viral vector & plasmid DNA manufacturing market

The growth rate of genetic disorders and cancer during the forecast period is comparable. The growth of the genetic disorders segment can be attributed to presence of numerous research studies implemented to validate efficiency of virus-based therapy in treatment of these disorders. Some disorders for which gene therapy applications are being investigated includes X-linked chronic granulomatous disease, Duchenne muscular dystrophy (DMD), and Rett syndrome.

Regional Insights

Presence of several biopharmaceutical manufacturers in the U.S. coupled with a strong and effective regulatory structure for development of advanced therapies in the country is stoking the growth of the market in North America. Besides this, recent approval of gene therapies by U.S. FDA is projected to augment the demand for vector manufacturing in the coming years.

In August 2017, Novartis announced approval of Kymriah (tisagenlecleucel) for B-cell precursor Acute Lymphoblastic LeU.K.emia (ALL) by FDA. This is designated as the first gene therapy product to receive approval in the U.S. Furthermore, in May 2018, the product gained approval for treatment of relapsed or refractory large B-cell lymphoma.

Viral Vector & Plasmid DNA Manufacturing Market Share Insights

Presence of a few major companies, mid-tier players, and startup firms is rendering the market highly competitive. These companies are adopting various growth strategies to reinforce their market position. Strategic alliances, collaborations, and agreements with biopharmaceutical/pharmaceutical companies are considered as one of the major growth strategies by companies operating in the space.

Merck, Novasep, Cobra Biologics, Aldevron, Creative Biogene, Waisman Biomanufacturing, Addgene, The Cell and Gene Therapy Catapult, uniQure N.V. are among the key companies operating in this market. The companies are engaged in offering services for manufacturing of DNA plasmids and virus for human clinical trials, pre-clinical research, and toxicology studies.

Report Scope

Attribute

Details

Base year for estimation

2017

Actual estimates/Historical data

2014 - 2016

Forecast period

2018 - 2025

Market representation

Revenue in USD Million and CAGR from 2018 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Country scope

U.S., Canada, Germany, U.K., China, Japan, Brazil, South Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

15% free customization scope (equivalent to 5-analyst working days)

If you need specific information, which is not currently within the scope of the report, we will provide it to you as a part of customization


Segments Covered in the Report

This report forecasts revenue growth at global, regional and country levels and provides an analysis of industry trends in each of the sub segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global viral vector & plasmid DNA manufacturing market report on the basis of vector type, workflow, application, end-use, disease, and region:

  • Vector Type Outlook (Revenue, USD Million, 2014 - 2025)

    • Adenovirus

    • Retrovirus

    • Plasmid DNA

    • AAV

    • Lentivirus

    • Others

  • Workflow Outlook (Revenue, USD Million, 2014 - 2025)

    • Upstream Processing

    • Vector Amplification & Expansion

    • Vector Recovery/Harvesting

    • Downstream Processing

    • Purification

    • Fill-finish

  • Application Outlook (Revenue, USD Million, 2014 - 2025)

    • Antisense, RNAi, & Molecular Therapy

    • Vaccinology

  • End-use Outlook (Revenue, USD Million, 2014 - 2025)

    • Pharmaceutical and Biopharmaceutical Companies

    • Research Institutes

  • Disease Outlook (Revenue, USD Million, 2014 - 2025)

    • Cancer

    • Genetic Disorders

    • Infectious Diseases

    • Others

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

    • Asia Pacific

      • China

      • Japan

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

Key questions answered by the report
Request for Customization

Choose License Type

Single User - $5,950
Multi User (2-5) - $6,950
Enterprise Access - $8,950

Buy Chapters or Sections

Avail customized purchase options to meet your exact research needs:

  • Buy sections of this report
  • Buy country level reports
  • Request for historical data
  • Request discounts available for Start-Ups & Universities

Why Choose Us

  • Research support

    24/5 Research support

    Get your queries resolved from an industry expert.

  • Custom research service

    Custom research service

    Design an exclusive study to serve your research needs.

  • Quality assurance

    Quality assurance

    A testimonial for service in the form of BBB "A" Accreditation.

  • BBB Rating dandb
  • Information security

    Information security

    Your personal and confidential information is safe and secure.

  • grand view research PCI DSS complaint grand view research paypal verified