According to Vision Research Reports, the global gene therapy market size is expected to surpass at US$ 5.2 bn by 2028 growing at a CAGR of 40.5% from 2021 to 2028.
Gene therapy is mainly driven by the potential exhibited by CAR T-cell usage which has gained significant attention from commercial and non-commercial sponsors as a new business model. Gene therapy accounts for a significant share in the pharmaceutical industry’s pipeline, and this is anticipated to continue since products in the R&D phase would become commercially available over the next few years.
Furthermore, rapid and significant progress in the molecular and cellular biology arena, driven by technological advancements in genomics and gene-editing tools, has contributed to an increasing number of approved gene therapies as well as an expanding pipeline. According to the Alliance for Regenerative Medicine (ARM), by the end of the second quarter of 2019, there were more than 700 clinical trials ongoing globally.
With recent product approvals, the cell and gene therapy sector is witnessing increasing competition for gene therapy buyouts, resulting in hefty premiums in the marketplace. For instance, in December 2019, Roche acquired Spark Therapeutics, a company that develops and delivers gene therapies.
Despite the significant health gains offered by gene therapy, these usually comprise high upfront costs, which further pose sustainability and budget challenges to the healthcare systems. Although affordability and budget impacts are not considered as key components of the value of new therapy treatments, they are important elements for access-related decision making.
Owing to the presence of the small size of the target patient populations for several products, coupled with their applicability as one-off treatments, the prices of products need to be set at a level that makes the product economically viable for the developer. The gene therapy market has witnessed the withdrawal of several products due to their non-financial viability in the past years. Thus, value to patients and healthcare systems needs to be balanced with the financial sustainability for both, developers and payers.
New product approvals & commercialization drives market
2016, 2017, and 2018 were key milestones in the history of the gene therapy market in the U.S. and Europe, as around four gene therapy products have been approved and commercialized. These products are currently in the infancy stage of commercialization, and have exhibited highly positive therapeutic outcomes. For instance, in May 2016, GlaxoSmithKline (GSK) gene therapy product, Strimvelis, received marketing approval for the treatment of patients with a very rare disease called ADA-SCID (Severe Combined Immunodeficiency, due to Adenosine Deaminase deficiency). Strimvelis is the first ex-vivo stem cell gene therapy to be approved in Europe for the treatment of ADA-SCID. Furthermore, in August 2017, the USFDA approved Novartis AG’s flagship gene therapy product, Kymriah, for the treatment of children and adults up to the age of 25 years affected with B-cell precursor acute lymphoblastic leukemia (ALL). Thus, recent approvals of gene therapy products in the U.S. and Europe for the treatment of various life threatening disorders is projected to fuel the gene therapy market during the forecast period.
Vector type segment review
On the basis of vector type, the market is categorized into viral vector and nonviral vector. Among these, the viral vector segment was the largest contributor toward the market growth in 2020, owing to easier modifications of many viruses such as Lentivirus, Adeno-Associated Virus (AAV), RetroVirus & Gamma RetroVirus to deliver gene therapy drugs, advancements on DNA, RNA and oncolytic viral vectors gene therapy. However, the nonviral vector segment is anticipated to exhibit fastest growth during the forecast period, due to advancements in physicochemical approaches such as physical methods and chemical methods of non-viral vector for gene therapies during preclinical and clinical trials for the treatment of various diseases.
Application segment review
The applications covered in the study include oncological disorders, rare diseases, cardiovascular diseases, neurological disorders, infectious disease, and others. The oncological disorders segment was the largest contributor toward the market growth in 2020, owing to increase in prevalence of cancer worldwide and increase in regulatory approval of gene therapy for cancer. However, the cardiovascular diseases segment is anticipated grow at a lucrative rate during the forecast period, due to increase in number of clinical trials of gene therapies for the treatment of these diseases.
The demand for gene therapies for the treatment of cancer is estimated to grow at a high rate during the forecast period
Based on indication, the market is segmented into neurological diseases, cancer, hepatological diseases, Duchenne muscular dystrophy, and other indications. The cancer segment is estimated to grow at the highest CAGR during the forecast period owing to the approval of a growing number of gene therapies for the treatment of cancer and the rising incidence of hematologic cancers.
Non-viral vectors segment accounted for the largest share of the gene therapy market, by vector, in 2020
The market, by vector, has been segmented into viral and non-viral vectors. The non-viral vectors segment accounted for the largest share of the market in 2020. This can be attributed to the high market penetration of oligonucleotide-based non-viral vector gene therapies.
Region wise, the gene therapy market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America accounted for the largest market share in the gene therapy market in 2020, and is anticipated to continue this trend during the forecast period, owing to high prevalence rate of cancer, presence of high disposable income, and increase in funding for R&D activities associated with gene therapy. However, Asia-Pacific is expected to register the highest growth during the forecast period, owing to rise in number of people prone to various chronic diseases. In addition, approval and launch of gene therapy products can positively influence market expansion in the developed countries, such as Japan, Australia, and New Zealand are the major factors for the growth of the gene therapy market.
Large number of clinical pipeline studies and significant investments in gene therapy to gain the first mover advantage
The global gene therapy market is highly consolidated, with very few global players accounting for a major share. Currently, only five companies; Gilead life Sciences Inc. Spark Therapeutic Inc., Novartis AG, Sibiono GeneTech Co. Ltd, and Orchard Therapeutics Limited offer gene therapy products in the market. Most biopharmaceutical companies have invested significantly in clinical R&D for the development of gene therapy products for different chronic and genetic disorders. Large number of gene therapy products are under different stages of clinical pipeline studies, and the number of gene therapy candidates is projected to rise consistently during the forecast period. For instance, according to the Journal of Gene Medicine, there were around 2,597 gene therapy candidates under clinical trials, as of 2017. Of the total clinical studies, around 65% of studies were focused on oncology, 11% of studies were focused on monogenetic field, 7% on infectious diseases and cardiovascular disease, each.
Gene Therapy Market Segments:
By Vector Type
By Gene Type
The Gene therapy market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Gene therapy market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Gene therapy market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Gene therapy market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Gene therapy market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Gene therapy capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Gene therapy by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Gene therapy market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Gene therapy market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Gene therapy market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Gene therapy industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
Gene therapy market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Gene therapy market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Gene therapy market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Gene therapy market. These factors have benefited the growth of the global market for Gene therapy. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Gene therapy. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Gene therapy are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are:
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