Gene Delivery System Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Gene Delivery Systems Market Report is Segmented by Delivery Systems (Viral Gene Delivery Systems, and More), Application (Oncology, Infectious Diseases, and More), Route of Administration (Injectable, Oral, and More), End User (Biopharma & Gene-Therapy Developers, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Gene Delivery Systems Market Size and Share

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Global Gene Delivery Systems Market Analysis by Mordor Intelligence

The gene delivery systems market reached USD 6.19 billion in 2025 and is forecast to expand to USD 10.80 billion by 2030 at an 11.78% CAGR, reflecting sustained therapeutic approvals, manufacturing scale-ups, and diverse clinical applications. Momentum stems from the U.S. Food and Drug Administration’s clearances of transformative therapies such as CASGEVY and LYFGENIA for sickle cell disease, alongside large-scale capacity investments that reduce production bottlenecks. Demand is reinforced by oncology’s rapid adoption of viral vectors, infectious-disease programs leveraging novel lipid nanoparticles, and AI-enabled vector optimization that speeds candidate selection. Meanwhile, growing CDMO partnerships mitigate the 500% shortfall in commercial-scale plasmid and viral vector capacity, allowing developers to meet clinical timelines. Heightened venture funding, government incentives, and collaborative R&D hubs further enlarge the opportunity pool.

Key Report Takeaways

  • By delivery system, viral vectors held 62.13% of 2025 gene delivery systems market share, whereas non-viral platforms registered the highest growth at a 13.25% CAGR to 2030. 
  • By application, oncology commanded 48.28% revenue share in 2025; infectious diseases are projected to advance at a 12.85% CAGR through 2030. 
  • By route of administration, injectable formats accounted for 81.36% of the gene delivery systems market size in 2025, while nasal delivery is set to grow at a 13.16% CAGR over the forecast period. 
  • By end user, biopharma and gene-therapy developers controlled 45.56% revenue share in 2025, with contract manufacturing & CDMOs recording the fastest expansion at 13.88% CAGR. 
  • By geography, North America led with 43.72% market share in 2025; Asia-Pacific is on track for the quickest rise at a 14.12% CAGR through 2030.

Segment Analysis

By Delivery Systems: Viral Dominance, Non-Viral Acceleration

Viral platforms captured 62.13% of 2024 revenue, led by AAV vectors validated in recent approvals. Lentiviral systems grow in ex-vivo oncology and hemoglobinopathies despite production complexity. Non-viral approaches expand at 13.25% CAGR, propelled by lipid nanoparticles delivering CRISPR payloads with 90-100% encapsulation efficiency. Hybrid technologies blending viral precision with synthetic materials promise manufacturability and regulatory flexibility. Collectively, these dynamics sustain the gene delivery systems market’s transition toward diversified modalities.

Manufacturing capacity remains a pinch-point; industry surveys reveal potential lentiviral shortfalls without further scale-up. CDMOs respond with large-volume single-use bioreactors and continuous-flow purification that cut cycle times by 30%, narrowing the cost gap between viral and non-viral options.

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Note: Segment shares of all individual segments available upon report purchase

By Application: Oncology Leads, Infectious Diseases Surging

Oncology held 48.28% of 2024 revenue, driven by CAR-T and solid-tumor gene therapies that demonstrably extend survival. Infectious-disease programs exhibit 12.85% CAGR through breakthroughs against HIV, herpes, and hepatitis B. Cardiovascular candidates advance with cBIN1 showing 30% functional improvement in large-animal models. Diabetes and pulmonary pipelines leverage inhaled and tissue-specific vectors that address longstanding delivery challenges. Orphan-disease portfolios benefit from accelerated review pathways, supporting a diverse set of rare-condition approvals.

By Route of Administration: Injectable Standard, Nasal Upswing

Injectable formats retained 81.36% share in 2024, reflecting regulatory familiarity and controlled dosing. Nasal delivery rises at 13.16% CAGR as AAV.CPP.16 and borneol-modified nanoparticles demonstrate high CNS penetration without systemic exposure [2]“AAV.CPP.16 Nasal Delivery Study,” massgeneralbrigham.org . Oral, transdermal, and intra-ocular routes remain niche but evolve through protective coatings and device innovations that improve bioavailability.

Global Gene Delivery Systems Market: Market Share by Route of Administration
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Note: Segment shares of all individual segments available upon report purchase

By End User: Biopharma Core, CDMOs Scaling Fast

Biopharma developers commanded 45.56% revenue in 2024, retaining strategic control of IP and late-stage pipelines. CDMOs are the fastest-expanding cohort at 13.88% CAGR, buoyed by alliances such as Vertex–Lonza for CASGEVY and Catalent’s exclusive FDA-approved commercial AAV line [3]“Catalent Commercial AAV Readiness,” bioprocessintl.com . Academic institutes spearhead early discovery partnerships, while hospitals refine point-of-care manufacturing for autologous cell-based therapies.

Geography Analysis

North America led with 43.72% market share in 2025, backed by 12 FDA approvals in 2024 alone, deep venture capital pools, and cluster-based talent. Capacity additions like GenScript’s USD 224 million ProBio plant in New Jersey and Fujifilm Diosynth’s USD 1.2 billion North Carolina site underpin domestic manufacturing resilience. Europe follows with strong EMA oversight; Lonza’s Geleen facility supplies global CASGEVY demand, and 88% of approved ATMPs operate under additional monitoring, ensuring post-marketing safety. 

Asia-Pacific posts the highest 14.12% CAGR to 2030 as Samsung Biologics invests USD 1.46 billion for 784,000 L of vector capacity and China’s biopharmaceutical sales could top 1.4 trillion yuan by 2029. Regulatory harmonization and local investment incentives attract multinational trials while fostering indigenous innovation. 

Middle East & Africa and South America remain under-penetrated yet promising as vector costs fall and technology transfers expand. Only 5 of 32 approved therapies are currently accessible in LMICs, underscoring a need for collaborative financing and localized manufacturing to broaden treatment equity.

Global Gene Delivery Systems Market CAGR (%), Growth Rate by Region
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Competitive Landscape

Market concentration is moderate: established pharma leaders compete with specialized biotech innovators and AI-centric start-ups. Roche’s USD 1 billion Poseida acquisition and Novartis’ nervous-system investment reflect vertical expansion into delivery science. 

Dyno Therapeutics and the Broad Institute’s machine-learning engines secure competitive edges by predicting capsid performance with 90% accuracy, enabling tailored vectors that improve efficacy while reducing dose-related toxicity. 

Catalent’s status as the only CDMO with FDA-cleared commercial AAV lines positions it strategically amid soaring outsourcing demand. Meanwhile, Pfizer, Novartis, and Roche leverage patent exclusivities and manufacturing alliances to defend share. White-space opportunities persist in extra-hepatic targeting, cost-down process intensification, and combination therapies pairing gene editing with small-molecule modulation.

Global Gene Delivery Systems Industry Leaders

  1. Pfizer, Inc.

  2. Becton, Dickinson and Company

  3. Takara Bio

  4. Novartis AG

  5. F. Hoffmann-La Roche Ltd

  6. *Disclaimer: Major Players sorted in no particular order
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Recent Industry Developments

  • July 2024: UniQure divested its Massachusetts gene-therapy plant to Genezen, which will manufacture Hemgenix, CSL Behring’s hemophilia B therapy.
  • June 2024: Syncona merged Freeline and SwanBio into Spur Therapeutics and injected an additional USD 50 million to fund gene-therapy R&D.
  • April 2024: Ascend Advanced Therapies acquired Beacon Therapeutics’ Florida CMC site, adding GMP capacity and process-development expertise.
  • May 2023: Kytopen launched the Flowfect DiscoverTM early-access program, enabling high-throughput cell engineering for CRISPR, mRNA, and DNA at CDMOs and academic centers.

Table of Contents for Global Gene Delivery Systems Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Burden Of Chronic & Lifestyle Diseases
    • 4.2.2 Rapid R&D Advances By Biopharma Companies
    • 4.2.3 Rising Approvals Of Vector-Based Gene Therapies
    • 4.2.4 Surge In Venture & Strategic Funding Inflows
    • 4.2.5 Ai-Driven Vector Design & Screening Tools
    • 4.2.6 Regional Cdmo Build-Out Of Plasmid Capacity
  • 4.3 Market Restraints
    • 4.3.1 High Treatment & Reimbursement Costs
    • 4.3.2 Safety / Immune-Response Concerns For Viral Vectors
    • 4.3.3 Complex Multi-Jurisdiction Regulatory Pathways
    • 4.3.4 Scarcity Of GMP-Grade Plasmid Manufacturing Slots
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces Analysis
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Delivery Systems
    • 5.1.1 Viral Gene Delivery Systems
    • 5.1.1.1 Adenoviral Vectors
    • 5.1.1.2 Lentiviral Vectors
    • 5.1.1.3 Retroviral Vectors
    • 5.1.1.4 Other Viral Vectors (AAV, HSV, etc.)
    • 5.1.2 Non-viral Gene Delivery
    • 5.1.3 Combined / Hybrid Delivery Systems
  • 5.2 By Application
    • 5.2.1 Oncology
    • 5.2.2 Infectious Diseases
    • 5.2.3 Cardiovascular Disorders
    • 5.2.4 Diabetes
    • 5.2.5 Pulmonary Disorders
    • 5.2.6 Other Applications
  • 5.3 By Route of Administration
    • 5.3.1 Injectable
    • 5.3.2 Oral
    • 5.3.3 Nasal
    • 5.3.4 Transdermal / Topical
    • 5.3.5 Other Routes
  • 5.4 By End User
    • 5.4.1 Biopharma & Gene-therapy Developers
    • 5.4.2 Contract Manufacturing & CDMOs
    • 5.4.3 Academic & Research Institutes
    • 5.4.4 Hospitals & Specialty Clinics
  • 5.5 By Geography
    • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
    • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
    • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
    • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
    • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.3.1 Pfizer Inc.
    • 6.3.2 Novartis AG
    • 6.3.3 F. Hoffmann-La Roche AG
    • 6.3.4 Bayer AG
    • 6.3.5 Amgen Inc.
    • 6.3.6 Takara Bio Inc.
    • 6.3.7 Becton, Dickinson & Company
    • 6.3.8 Thermo Fisher Scientific Inc.
    • 6.3.9 Lonza Group AG
    • 6.3.10 Catalent Inc.
    • 6.3.11 Sirion-Biotech GmbH
    • 6.3.12 GenScript ProBio
    • 6.3.13 Genezen LLC
    • 6.3.14 Oxford Biomedica plc
    • 6.3.15 uniQure N.V.
    • 6.3.16 4D Molecular Therapeutics
    • 6.3.17 Sarepta Therapeutics
    • 6.3.18 Spark Therapeutics

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Gene Delivery Systems Market Report Scope

As per the scope of the report, gene delivery is the process of introducing foreign genetic material, such as DNA or RNA, into host cells. 

The Gene Delivery Systems Market is segmented by Delivery Systems (Viral Gene Delivery Systems, Non-viral Gene Delivery Systems, and Combined Hybrid Delivery Systems), Applications (Oncology, Infectious Diseases, Cardiovascular Disorders, Diabetes, Pulmonary Disorders, Other Applications), Route of Administration (Oral, Injectable, Nasal, and Other Routes of Administration), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments

By Delivery Systems Viral Gene Delivery Systems Adenoviral Vectors
Lentiviral Vectors
Retroviral Vectors
Other Viral Vectors (AAV, HSV, etc.)
Non-viral Gene Delivery
Combined / Hybrid Delivery Systems
By Application Oncology
Infectious Diseases
Cardiovascular Disorders
Diabetes
Pulmonary Disorders
Other Applications
By Route of Administration Injectable
Oral
Nasal
Transdermal / Topical
Other Routes
By End User Biopharma & Gene-therapy Developers
Contract Manufacturing & CDMOs
Academic & Research Institutes
Hospitals & Specialty Clinics
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Delivery Systems
Viral Gene Delivery Systems Adenoviral Vectors
Lentiviral Vectors
Retroviral Vectors
Other Viral Vectors (AAV, HSV, etc.)
Non-viral Gene Delivery
Combined / Hybrid Delivery Systems
By Application
Oncology
Infectious Diseases
Cardiovascular Disorders
Diabetes
Pulmonary Disorders
Other Applications
By Route of Administration
Injectable
Oral
Nasal
Transdermal / Topical
Other Routes
By End User
Biopharma & Gene-therapy Developers
Contract Manufacturing & CDMOs
Academic & Research Institutes
Hospitals & Specialty Clinics
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current Global Gene Delivery Systems Market size?

The market is valued at USD 6.19 billion in 2025 and is projected to reach USD 10.80 billion by 2030.

Who are the key players in Global Gene Delivery Systems Market?

Pfizer, Inc., Becton, Dickinson and Company, Takara Bio, Novartis AG and F. Hoffmann-La Roche Ltd are the major companies operating in the Global Gene Delivery Systems Market.

Which is the fastest growing region in Global Gene Delivery Systems Market?

Infectious-disease programs are expanding at a 12.85% CAGR through 2030, powered by HIV and hepatitis B pipelines.

Which application segment is growing fastest?

In 2025, the North America accounts for the largest market share in Global Gene Delivery Systems Market.

Why are CDMOs becoming important in this market?

Developers face a 500% shortage in commercial-scale capacity; CDMOs fill the gap with specialized facilities and regulatory expertise.

Page last updated on: July 3, 2025

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