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Gene Therapy Market

Gene Therapy Market

Gene Therapy Market Growth to Spur Owing to Technological Advancement in Gene Therapeutics & Synthetic Biology during 2021-2031

Gene Therapy Market
  • Sep-2021
  • List of Tables : 59
  • List of Figures : 79
  • 170 Pages
  • Healthcare

Market Snapshot

Newly released data from Fact.MR shows that global demand for gene therapy will likely reach US$ 2.3 Bn by the end of 2021. With the advent of synthetic biology, gene therapy is undergoing material shifts in a variety of research areas. Thus, the market for gene therapy is expected to surpass US$ 18.72 Bn by registering a CAGR of 23% across the forecast period 2021-2031. Yescarta-based gene therapy is expected to reign supreme, acquiring a market share worth 45% until 2031.

Key Points Covered in Gene Therapy Industry Analysis

  • Market estimates and forecast 2016-2031
  • Key drivers and restraints impacting market growth
  • Segment-wise, Country-wise, and Region-wise Analysis
  • Competition Mapping and Benchmarking
  • Market Share Analysis
  • Key Product Innovations and Regulatory Climate
  • COVID-19 Impact on Gene Therapy and How to Navigate
  • Recommendation on Key Winning Strategies

Know More Details About the Report

Gene Therapy Revenue Analysis 2016-2020 in Comparison to Future Outlook 2021-2031

As Per Fact.MR’s report, over the last five years, from 2016 to 2020, the sales of gene therapy drugs surpassed US$ 2 Bn by the end of 2020. Companies are focusing on providing different payment options and reimbursement methods that would accelerate the growth of gene therapy. In addition, technological advancement is playing a key role in application and growth of gene therapy market.

Prospects further broadened amid the outbreak of COVID-19, as leading biotechnology and pharmaceutical companies embarked on the journey to develop a powerful antiviral drug and vaccine candidate. Players such as Pfizer, BioNTech and Moderna have been at the forefront of developing mRNA vaccines based on gene therapy approaches. 

Thus, due to the factors mentioned above, gene therapy is expected to surpass US$ 18.72 Bn by registering a stupendous CAGR of 23% through the assessment period 2021-2031.

Empirical Novel Drugs Discovery for Rare Disorders Aiding Market Growth?

Influenced by its potential in developing drugs that pose the potential to address rarely-occurring disorders, gene therapy is increasingly becoming an area of interest for myriads academic institutes and research centres, especially in the field of oncology.

Amidst spurts in gene therapy, the healthcare vertical must re-evaluate its development and reimbursement framework for therapies and treatment methods that steer away from the conventional approach to diseases cure.

Market players are teaming with biopharmaceutical companies, research institutes, and clinical research organizations (CROs) to form and scale-up key healthcare technologies as well as novel services and products. While over 150 empirical novel drugs have been patented for gene therapy in recent past, Fact.MR underlines that the number is likely to increase (10-15 annually) in the near term.

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How is Rise in Gene Therapy Treatment Centres Shaping Future Growth?

Given faster regulatory uptake for drug approvals and potential success rates of gene therapy, market players are focusing on establishing gene therapy treatment centres, particularly in the developed regions.

In addition, governments are increasing their expenditure in upgrading their healthcare system in order to address a larger number patient pool requiring gene therapy. Companies are focusing on investing in research and development that would treat several diseases at a larger scale.

For instance, Gilead Sciences Inc. has decided to increase the number of gene therapy centres to 90. In addition, the firm has established the Kite Connect Program to deliver information and aid such as insurance benefits throughout the Yescarta therapy process.

Country-wise Analysis

How are Strong Regulatory Frameworks Aiding Gene Therapy Growth in North America?

At present, the U.S gene therapy market is reflecting opportunities of growth and profitability, procuring nearly 3/5th of overall market revenue. Attributed to the presence of strong regulatory framework for development of cellular therapy and high presence of biopharmaceutical companies, several government agencies are funding research campaigns across the country.

In response to rising cancer caseloads, governments in the region have been showing immediacy by increasing their spending in oncology research, and development of novel drugs and therapeutics. Further, the FDA has granted approval to certain drugs – Yescarta, and Kymriah – for treating rare diseases. Based on these developments, North America is expected to account for 50% of the global gene therapy revenue.

How is Sanctioning of Novel Drug Formulations Accelerating R&D for Gene Therapy in Europe?

The European Medicine Agency (EMA) has approved the use and commercialization of Strimvelis, which is yet to receive approval in the U.S, for treatment of severe adenosine deaminase-deficient severe combined immunodeficiency (ADA-SCID). This, in turn, has accelerated the process of research and development in the region. Europe is expected to offer potential growth avenues particularly in countries such as Germany and France.

As of 2019, Europe was home to 16 of the top 50 life science universities, with 120,000 publications on gene therapeutics being affiliated to European institutions. Thus, the region is expected to possess 40% of market share for gene therapy across the 2021-2031 forecast period.

Gene therapy market forecast analysis by Fact.MR

An Adaptive Approach to Modern-day Research Needs

Category-wise Insights

What is the Scope for Yescarta-based Gene Therapy?

According to Fact.MR, Yescarta continues to generate greater total returns to shareholders (TRS), compared to other drugs. The gene therapy drug received approval from the food & drug administration (FDA) for treating adults having diffuse large B-cell lymphoma (DLBCL).  

This, in turn, has spurred the sales of yescarta. Thus, Yescarta is expected to hold more than 45% market share in the assessment period. Prominent pharmaceutical companies Novartis and Gilead are at the forefront of yescarta-based gene therapy treatment.

Why the Inclination toward Kymriah & Luxturna Gene Therapies?

Market players are also allocating their capital to Kymriah, which has been approved by the FDA as a one-time treatment for adults having relapsed/refractory β-cell ALL (ALL). A CAGR of 10% is projected for Kymriah gene therapy.

Furthermore, Luxturna is experiencing noteworthy growth rate, and would represent multibillion-dollar opportunity by possessing nearly 35% of market share in the sales indicator period.

Competitive Landscape

Gene therapy companies are focusing on investing in factories and launching newer therapies for different diseases. Some notable developments with regards for gene therapy are as follows:

  • In July, 2021, BioNTech entered into a collaborative agreement with Gilead Company owned Kite to acquire its neoantigen TCR cell therapy R&D platform and manufacturing facility situated in Gaithesburg. This acquisition will enhance production capacity to support clinical trials in the U.S and complement its already existing cell therapy manufacturing facility in Germany.
  • In September 2021, NeuExcel Therapeutics and Spark Therapeutics- a Roche Group company- announced a gene therapy collaboration aimed at developing a safe and effective treatment for patients suffering from Huntington’s disease. In this agreement, the latter will acquire the former’s proprietary neuro-regenerative gene therapy platform and capabilities.

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Report Scope



Market size value in 2021

US$ 2.3 Bn

Market forecast value in 2031

US$ 18.72 Bn

Growth Rate

CAGR of 23% from 2021 to 2031

Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value & ‘000 Units for Volume

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania 
  • Middle East & Africa

Key Countries Covered

  • U.S
  • Canada
  • Brazil
  • Mexico
  • Germany
  • UK
  • Spain
  • France
  • Italy
  • Russia
  • India
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • GCC
  • South Africa

Key Market Segments Covered

  • Product
  • Application
  • Region

Key Companies Profiled

  • Novartis AG
  • Gilead Sciences Inc.
  • Spark Therapeutics Inc.
  • Sibiono GeneTech Co. Ltd.
  • Spark Therapeutics, Inc.
  • Orchard Therapeutics Limited
  • BioNTech


Available upon Request

Key Segments Covered

  • Product

    • Yescarta
    • Kymriah
    • Luxturna
    • Strimvelis
    • Gendicine
  • Application

    • Ophthalmology
    • Oncology
    • Adenosine Deaminase/Deficient Severe Combined Immunodeficiency (ADA-SCID)

Gene Therapy Market- Scope of Report

A recent study by Fact.MR on the gene therapy market offers a 10-year forecast for 2021 to 2031. The study analyzes crucial trends that are currently determining the growth of the market. This report explicates on vital dynamics, such as the drivers, restraints, and opportunities for key market players along with key stakeholders as well as emerging players associated with offering gene therapy.

The study also provides the dynamics responsible for influencing the future status of the gene therapy market over the forecast period. A detailed assessment of value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report. A list of prominent companies operating in the gene therapy market, along with their product portfolios, enhances the reliability of this comprehensive research study.

Report Summary

The study offers comprehensive analysis on diverse features, including production capacities, demand, product developments, revenue generation, and sales of gene therapy across the globe.

A comprehensive estimate on the market has been provided through an optimistic as well as a conservative scenario, taking into account the sales of gene therapy products during the forecast period. Price point comparison by region with global average price is also considered in the study.

Key Questions Answered in Report

  • Which are the most lucrative gene therapy markets?
  • Which factors will impact the growth of gene therapy?
  • How will changing trends impact the strategies of market players?
  • How can market players capture the low-hanging opportunities across regions?
  • Which companies are leading the gene therapy industry?
  • What are the winning strategies of stakeholders in the market?

Analysis on Market Size Evaluation

The market has been analyzed for each segment in terms of volume (‘000 Units) and value (US$ Mn).

Estimates at global and regional levels for gene therapy are available in terms of “US$ Mn” for value and in “‘000 Units” for volume. A Y-o-Y growth contrast on prominent market segments, along with market attractiveness evaluation, has been incorporated in the report. Furthermore, absolute dollar opportunity analysis of all the segments adds prominence to the report.

Absolute dollar opportunity plays a crucial role in assessing the level of opportunity that a manufacturer/distributor can look to achieve, along with identifying potential resources, considering the sales and distribution perspective in the global gene therapy market.

Inspected Assessment on Regional Segments

Key sections have been elaborated in the report, which have helped deliver projections on regional markets. These chapters include regional macros (political, economic, and business environment outlook), which are expected to have a momentous influence on the growth of the gene therapy market during the forecast period.

Country-specific valuation on demand for gene therapy has been offered for each region, along with market scope estimates and forecasts, price index, and impact analysis of the dynamics of prominence in regions and countries. For all regional markets, Y-o-Y growth estimates have also been incorporated in the report.

Detailed breakup in terms of value & volume for emerging countries has also been included in the report.

In-depth Analysis on Competition Analysis

The report sheds light on leading manufacturers of gene therapy products, along with their detailed profiles. Essential and up-to-date data related to market performers who are principally engaged in offering gene therapy has been brought with the help of a detailed dashboard view. Market share analysis and comparison of prominent players provided in the report permits report readers to take preemptive steps in advancing their businesses.

Company profiles have been included in the report, which include essentials such as product portfolios and key strategies, along with all-inclusive SWOT analysis on each player. Company presence is mapped and presented through a matrix for all the prominent players, thus providing readers with actionable insights, which helps in thoughtfully presenting the market status, and predicting the competition level in the gene therapy domain. 

Research Methodology

In Fact.MR’s study, a unique research methodology is utilized to conduct extensive research on the growth of the gene therapy industry, and reach conclusions on the future growth parameters. This research methodology is a combination of primary and secondary research, which helps analysts ensure the accuracy and reliability of the drawn conclusions.

Secondary resources referred to by analysts during the preparation of the market study include statistics from governmental organizations, trade journals, white papers, and internal and external proprietary databases. Analysts have interviewed senior managers, product portfolio managers, CEOs, VPs, marketing/product managers, and market intelligence managers, all of whom have contributed to the development of the research report as a primary resource.

- FAQs -

As of 2021, the market for gene therapy is likely to reach US$ 2.3 Bn

The gene therapy is expected to surpass a CAGR of 23% from 2021-2031.

The gene therapy market is expected to reach nearly US$ 18.72 Bn by 2031

Regulatory frameworks sanctioning research & development of novel drug candidates for rare disorders is driving the market for gene therapy

According to Fact.MR, gene therapy in North America account for 50% of global market demand

Key players with strong market presence in global gene therapy market are Novartis AG, Gilead Sciences Inc., Spark Therapeutics Inc., Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., CELGENE CORPORATION, and Orchard Therapeutics Limited, among othe

The European market for gene therapy is poised to possess 40% of global market share

Yescarta type is expected to hold the highest share for sales possessing 45% market share.

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Is the market research conducted by Fact.MR?

Yes, the report has been compiled by expert analysts of Fact.MR, through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

What research methodology is followed by Fact.MR?

Fact.MR follows a methodology that encompasses the demand-side assessment of the market, and triangulates the same through a supply-side analysis. This methodology is based on the use of standard market structure, methods, and definitions.

What are the sources of secondary research?

Fact.MR conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request.

Who are the respondents for primary research?

Fact.MR speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers, and industry experts. For a full list of primary respondents, please reach out to us.

Is a sample of this report available for evaluation?

Yes, you can request a sample, and it will be sent to you through an email.