Gene Therapy Market Size, Trends, and Growth Report by 2031

Gene Therapy Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Vectors (Non-Viral Vectors and Viral Vectors), Indication (Neurological Diseases, Cancer, Duchenne Muscular Dystrophy, Hepatological Diseases, and Other Indications), Delivery Mode (In-Vivo and Ex-Vivo), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

  • Report Code : TIPHE100001165
  • Category : Biotechnology
  • Status : Data Released
  • No. of Pages : 150
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The gene therapy market is projected to reach US$ 25.69 billion by 2031 from US$ 5.11 billion in 2023; the market is estimated to record a CAGR of 14.3% during 2023–2031.

Market Insights and Analyst View:

Gene therapy is a process for the treatment of diseases by inactivating a disease-causing gene, replacing a disease-causing gene with a healthy copy of the gene, or introducing a new or modified gene into the body to help treat and prevent the disease. Gene therapy can be classified into in vivo and ex vivo gene therapy. Gene therapy aims to replace or correct faulty genes with normal ones, allowing the body to produce the correct proteins or enzymes needed for normal function, which can potentially cure the underlying cause of the diseases. The growing prevalence of genetic diseases and cancer worldwide and the increasing number of FDA approvals of gene therapies favor the gene therapy market growth. In addition, the gene therapy market trends include advancements in gene therapy technologies that will favor the growth of the market in the future.

Growth Drivers:

The advancements in biotechnology have led to the development of treatments for a wide range of indications. Gene therapies are being used to treat various diseases, such as cancer, neurological disorders, and genetic disorders. Globally, gene therapies are widely being adopted owing to the availability of US Food and Drug Administration (FDA) approved products. Following are a few examples of gene therapy products approved by the FDA in recent years:

  • In December 2023, the FDA approved two cell-based gene therapies for sickle cell disease. Bluebird Bio’s Lyfgenia (lovotibeglogene autotemcel) was cleared for sickle cell disease patients aged 12 and older with a history of vaso-occlusive events. It was approved along with Casgevy (exagamglogene autotemcel), from Vertex Pharmaceuticals and CRISPR Therapeutics.
  • In June 2023, the FDA approved Roctavian, an adeno-associated virus vector-based gene therapy for treating adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5. Hereditary hemophilia A is a serious bleeding disorder that happens due to a gene mutation, which is responsible for the production of factor VIII (FVIII), a protein that enables blood clotting. Roctavian is a one-time gene therapy product that contains a viral vector carrying a gene for clotting Factor VIII.
  • In June 2023, the FDA approved Elevidys, the first gene therapy for treating Duchenne muscular dystrophy in pediatric patients aged 4 to 5 years with a confirmed mutation in the Duchenne muscular dystrophy gene and who do not have a pre-existing medical condition that prevents treatment with this therapy.
  • In November 2022, the FDA approved HEMGENIX, manufactured by CSL Behring LLC, a recombinant Adeno-associated virus type 5 gene therapy to treat adult patients with certain kinds of Hemophilia B.

Therefore, the increasing approval of these gene therapies is fueling the gene therapy market growth.

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Gene Therapy Market: Strategic Insights

Market Size Value inUS$ 5.11 billion in 2023
Market Size Value byUS$ 25.69 billion by 2031
Growth rateCAGR of 14.3% from 2023 to 2031
Forecast Period2023-2031
Base Year2023
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Report Segmentation and Scope:

The gene therapy market analysis has been carried out by considering the following segments: vectors, indication, delivery mode, and geography. Based on vectors, the market is categorized into non-viral vectors and viral vectors. In terms of indication, the market is classified into neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other indications. In terms of delivery mode, the market is bifurcated into in-vivo and ex-vivo. The scope of the gene therapy market report covers North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and the Rest of Asia Pacific), the Middle East & Africa (Saudi Arabia, South Africa, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Segmental Analysis:

The gene therapy market, by vectors, is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant market share in 2023. It is anticipated to record a higher CAGR in the market during 2023–2030.

Gene Therapy Market, by Vector – 2023 and 2031

Gene Therapy Market, by Vector – 2023 and 2031
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.

Based on indication, the market is classified into neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other indications. The cancer segment held a significant gene therapy market share in 2023 and is estimated to register the highest CAGR during 2023–2030.

Based on delivery mode, the market is segmented into in-vivo and ex-vivo. The in-vivo segment held a significant gene therapy market share in 2023 and is expected to register a higher CAGR during 2023–2030. In vivo gene therapy enables systematic treatment, implying that it can reach multiple sites and organs throughout the body. This is especially helpful for diseases that affect multiple areas or have systematic signs, allowing for a comprehensive therapeutic approach. In addition, the development of advanced delivery technologies, such as viral vectors, nanoparticles, and lipid-based carriers, has improved the effectiveness and specificity of in vivo therapy. These advancements boost the targeted delivery of genetic material and improve the therapy's safety and efficacy.

Regional Analysis:

Geographically, the gene therapy market is segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2023, North America captured a significant share of the market. In 2023, the US dominated the gene therapy market in this region. The market growth in North America is attributed to the growing prevalence of genetic disorders, rising number of cancer patients, increasing government funding, rising adoption of advanced gene therapy for disease treatment, and growing product approval.

According to the Centers for Disease Control and Prevention (CDC), ~1,603,844 new cancer cases were diagnosed in 2020, with 602,347 cancer deaths in the US. For every 100,000 individuals, 403 new cancer cases were reported. Additionally, as per the International Agency for Research on Cancer, new cancer cases were projected to reach 30.2 million by 2040. As per the estimates of the US Government Accountability Office published in October 2021, ~25 to 30 million of the population suffers from rare diseases in the country; nearly 50% of patients with rare diseases are children. Rare diseases are often the result of a genetic mutation; it is estimated that 80% of rare diseases are genetic.

According to an October 2021 update by the National Institutes of Health, 10 pharmaceutical companies and 5 non-profit organizations have collaborated to accelerate the development of gene therapies for the 30 million American people suffering from rare illnesses. The US FDA has approved 7 cell and gene therapy drugs, with the pipeline of new products reaching ~1,200 experimental therapies. Half of these are in Phase 2 clinical trials, with estimates of annual sales growth accounting for 15% for cell therapies and ~30% for gene therapies, as per the Chemical & Engineering News report 2023 estimates. All these factors mentioned above contribute to the growing gene therapy market size in the region.

Industry Developments and Future Opportunities:

A few initiatives taken by market players operating in the global gene therapy market are listed below:

  • In January 2022, Ori Biotech Ltd secured over US$ 100 million in an oversubscribed Series B funding round to introduce an innovative cell and gene therapy manufacturing platform in the market.
  • In January 2020, Astellas Pharma Inc. acquired Audentes Therapeutics, Inc. The acquisition enables the combined company to become a global leader in AAV-based genetic medicine.

Competitive Landscape and Key Companies:

The gene therapy market forecast can help stakeholders plan their growth strategies. Novartis AG, Astellas Pharma Inc., Bristol-Myers Squibb Company, Bluebird Bio Inc., CSL Behring, Sanofi, F. Hoffmann-La Roche Ltd, Daiichi Sankyo, Biogen, and Oxford Biomedica are among the prominent players profiled in the gene therapy market report. These companies focus on introducing new high-tech products, advancements in existing products, and geographic expansions to meet the growing consumer demand worldwide.

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Vectors, Indication, Delivery Mode, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions

What are the driving and restraining factors for the gene therapy market?

The factors driving the growth of the gene therapy market include the increasing burden of genetic diseases and the rising number of FDA approvals of gene therapies. However, the high cost of gene therapy products hampers the growth of the gene therapy market.

What is gene therapy?

Gene therapy is a process for the treatment of diseases by inactivating a disease-causing gene, replacing a disease-causing gene with a healthy copy of the gene, or introducing a new or modified gene into the body to help treat and prevent the disease.

What are the growth estimates for the gene therapy market till 2031?

The gene therapy market is expected to be valued at US$ 25.69 billion in 2031.

Which segment is dominating the gene therapy market?

The global gene therapy market is segmented based on vectors, indication, and delivery mode. Based on indication, the gene therapy market is categorized into neurological diseases, cancer, Duchenne muscular dystrophy, hepatological diseases, and other indications. The cancer segment held a significant market share in 2023 and is anticipated to record the highest CAGR in the market during 2023–2031.

What was the gene therapy market size in 2023?

The gene therapy market was valued at US$ 5.11 billion in 2023.

Who are the major players in the gene therapy market?

The gene therapy market majorly consists of the players, including Novartis AG, Astellas Pharma Inc., Bristol-Myers Squibb Company, Bluebird Bio Inc., CSL Behring, Sanofi, F. Hoffmann-La Roche Ltd, Daiichi Sankyo, Biogen, and Oxford Biomedica.

The List of Companies - Gene Therapy Market

  1. Novartis AG
  2. Astellas Pharma Inc.
  3. Bristol-Myers Squibb Company
  4. Bluebird Bio Inc.
  5. Sanofi
  6. F. Hoffmann-La Roche Ltd
  7. Daiichi Sankyo
  8. CSL Behring
  9. Biogen
  10. Oxford Biomedica.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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