Plasmid DNA Contract Manufacturing Market Size, Share & Trends Report

Plasmid DNA Contract Manufacturing Market Size, Share & Trends Analysis Report By Application (Cell & Gene Therapy, Immunotherapy), By Therapeutic Area (Cancer, Infectious Diseases), By End-user, By Region, And Segment Forecasts, 2023 - 2030

  • Report ID: GVR-4-68040-004-2
  • Number of Report Pages: 275
  • Format: PDF, Horizon Databook
  • Historical Range: 2018 - 2021
  • Forecast Period: 2023 - 2030 
  • Industry: Healthcare

Research Methodology

A three-pronged approach was followed for deducing the plasmid DNA contract manufacturing market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for plasmid DNA contract manufacturing market to gather the most reliable and current information possible.

  • We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
  • We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
  • We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
  • We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
  • We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of plasmid DNA contract manufacturing market data depending on the type of information we’re trying to uncover in our research.

  • Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

  • Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

  • Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

  • Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

  • Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

  • Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

  • This step also entails the finalization of the report scope and data representation pattern.

  • Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Plasmid DNA Contract Manufacturing Market Categorization:

The plasmid DNA contract manufacturing market was categorized into four segments, namely application (Cell & Gene Therapy, Immunotherapy), therapeutic area (Cancer, Infectious Diseases, Autoimmune Diseases, Cardiovascular Diseases), end-user (Pharmaceutical and Biotechnology Companies, Research Institutes), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa).

Segment Market Methodology:

The plasmid DNA contract manufacturing market was segmented into application, therapeutic area, end-user, and region. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

  • Demand estimation of each product across countries/regions summed up to from the total market.

  • Variable analysis for demand forecast.

  • Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

  • Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

  • Used extensively for new product forecasting or analyzing penetration levels.

  • Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

  • Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

  • This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The plasmid DNA contract manufacturing market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into twenty-three countries, namely, the U.S.; Canada; the UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; India; Japan; China; Australia; Thailand; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Plasmid DNA contract manufacturing market companies & financials:

The plasmid DNA contract manufacturing market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

  • Charles River Laboratories offers solutions & services in research, clinical support, drug discovery, safety & efficacy assessment, and process manufacturing to biotechnology, government, pharmaceutical, & academic organizations around the world. Its therapeutic areas include cardiovascular, inflammation, musculoskeletal, respiratory, and CNS metabolic diseases, as well as oncology & ophthalmology. Its product portfolio includes biomarkers, cellular therapeutics, biosimilars, and vaccines. It operates in Australia, Canada, China, Finland, France, Germany, India, Ireland, Italy, Japan, the Netherlands, South Korea, Spain, the UK, and the U.S. Charles River Laboratories, Inc. operates as a subsidiary of Charles River Laboratories International, Inc.

  • Lonza is a global supplier of biopharmaceuticals. The company offers a wide product range in bioresearch, consumer care, pharma & biotech, water treatment, agro ingredients, industrial solutions, and wood protection products. Its operations can be segmented into pharma & biotech and specialty ingredients. In March 2009, the company joined United Nations Global Compact as a strategic initiative to enhance its business. Lonza has worldwide operations in North America, Europe, and Asia, with a strong presence in France, the UK, & other countries.

  • VGXI, Inc. is a leading contract manufacturing organization that produces DNA plasmids under the cGMP regulations. The company offers services from development & clinical production to preclinical plasmids, HD plasmids, & cGMP plasmids. The company along with the core manufacturing services provides additional support & quality-related services. The additional support services include process cost analysis, assay development, CMC support, validation services, cGMP compliance, and audits & consulting. The company has produced over 175 clinical-grade DNA for trials in the Asia, Europe, Australia, Canada and the U.S.

  • Plasmid Factory GmbH & Co. KG is a leading biopharmaceutical contract manufacturing organization. It manufactures minicircle DNA & plasmid and also provides services to therapeutic fields such as gene & cell therapy, cancer research, CAR T-cell development, and genetic vaccination. In September 2022, the company partnered with ARCHIMED, a leading investment firm in the healthcare industry. The company offers stock & storage services, including AAV plasmids, pePito plasmids, molecular size markers, and CGE services.

  • Boehringer Ingelheim is involved in the research and development of human & veterinary medications. It operates in different countries, such as North America, Europe, and Asia. The company operates in various therapeutic areas such as respiratory diseases, diseases of the central nervous system, cardiovascular diseases, metabolic diseases, oncology, and virological diseases. Boehringer BioXcellence is a subsidiary of the parent group and operates as a contract manufacturer for pharmaceutical & biotechnology companies. The company offers a portfolio of technologies, including the production of nonantibody scaffolds, antibodies, Fab fragments, recombinant proteins, as well as pDNA from either microbial fermentation systems or mammalian cell culture.

  • BioCina is a biologics Contract Development and Manufacturing Organization (CDMO) that provides services ranging from preclinical to commercial production. It specializes in process development and cGMP manufacturing of microbial-based therapies & pDNA. The company also offers extended services that include cell banking, quality control, process characterization, process validation, and stability studies. The company has worked with more than 40 global clients and developed more than 50 distinct products.

  • TriLink BioTechnologies, a division of Maravai LifeSciences, is a CDMO that offers scale-up expertise and distinctive mRNA production capabilities, along with its Clean Cap mRNA capping technology, to assist in the synthesis and scale-up of nucleic acids, nucleoside triphosphates, & mRNA capping technology. The company operates a quality system that complies with ISO 9001:2015, Section 19, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, and ICH Q7. The company continues to expand its capacity for general cGMP & mRNA, oligonucleotide, and plasmid manufacturing, to serve its therapeutic, vaccine, & diagnostic clients.

  • Esco Aster Pte. Ltd. is a vertically integrated Contract Research, Development, and Manufacturing Organization (CRDMO). The company provides manufacturing services for the development of vaccines, biologics, cell therapies, and gene therapies, primarily using its patented Adherent Tide Motion Platform and supplemental downstream-bioprocessing, single-use fermentation, & custom bioengineering equipment for client-specific therapeutics. The company also specializes in the developing of single-domain radio imaging antibodies, RT-PCR reagents, and mAb-based antigens.

  • Thermo Fisher Scientific, Inc. is a publicly held biotechnology company established after the collaboration of Thermo Electron and Fisher Scientific. Thermo Fisher offers products in life sciences, industrial & applied science, and clinical diagnostics. The company has operations in over 50 countries. It offers products through the following brands: Thermo Scientific, Invitrogen, Fisher Scientific, Applied Biosystems, and Unity Lab Services. In 2019, Thermo Fisher acquired Brammer Bio.

  • Vivebiotech is a GMP CDMO that specializes in lentiviral vectors. It focuses on producing GMP-grade lentiviral vectors, preclinical toxicology, and research-grade lentiviral vectors. The company offers its services under regulations of both FDA & EMA. The lentiviral vectors developed by the company are utilized to treat a variety of conditions, including uncommon diseases and solid & hematological tumors.

Value chain-based sizing & forecasting

Supply Side Estimates

  • Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

  • Segment revenue determination via variable analysis and penetration modeling.

  • Competitive benchmarking to identify market leaders and their collective revenue shares.

  • Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

  • Identifying parent markets and ancillary markets

  • Segment penetration analysis to obtain pertinent

  • revenue/volume

  • Heuristic forecasting with the help of subject matter experts

  • Forecasting via variable analysis

Plasmid DNA Contract Manufacturing Market Report Objectives:

  • Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

  • Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

  • Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Plasmid DNA Contract Manufacturing Market Report Assumptions:

  • The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

  • The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

  • We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

  • All market estimates and forecasts have been validated through primary interviews with the key industry participants.

  • Inflation has not been accounted for to estimate and forecast the market.

  • Numbers may not add up due to rounding off.

  • Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

  • Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

  • Latin America includes Central American countries and the South American continent

  • Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

  • Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

  • Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.

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