유전자 치료 시장 규모, 점유율, 동향 분석 보고서 : 적응증별, 벡터 유형별, 투여 경로별, 지역별, 부문별 예측(2024-2030년)

Gene Therapy Market Growth & Trends:

The global gene therapy market is expected to reach USD 18.20 billion by 2030, registering a CAGR of 18.88% from 2024 to 2030, according to a new report by Grand View Research, Inc. The development of the market is owing to an increase in the number of gene therapy-based discoveries, increasing investment in this sector, and rising approval of gene therapy products. According to the WHO, 10 to 20 new cell and gene therapies are expected to be approved each year by 2025.

Continuous developments in recombinant DNA technology are anticipated to enhance the efficiency of gene therapy in the coming years. Hence, ongoing progresses in recombinant DNA technology are anticipated to expand the number of ongoing clinical trials for gene therapy. Primarily, these advancements are taking place in the context of various gene-editing tools and expression systems to augment the R&D for products. The advent of CRISPR/Cas9 nuclease, ZFN, and TALEN allows easy & precise genome editing. As a result, in recent times, the gene-editing space has witnessed a substantial number of research activities, which, in turn, is expected to influence the growth of the gene therapy market.

The growth of the gene therapy market is expected to be majorly benefitted from the increasing prevalence of cancer. The ongoing increase in cancer patients and related death per year emphasizes the essential for the development of robust treatment solutions. In 2020, there were around 18.1 million new cases of cancer worldwide. 9.3 million of these cases involved men, while 8.8 million involved women. Continuing developments in tumor genetic studies have delivered substantial information about cancer-related molecular signatures, which in turn, is expected to support ongoing clinical trials for cancer therapeutics.

With rising demand for robust disease treatment therapies, companies have focused their efforts to accelerate R&D for effective genetic therapies that target the cause of disease at a genomic level. . Furthermore, the U.S. FDA provides constant support for innovations in this sector via a number of policies with regard to product manufacturing. In January 2020, the agency released six final guidelines on the manufacturing and clinical development of safe and efficient products.

Furthermore, facility expansion for cell and gene therapies is one of the major factors driving the gene therapy market growth. Several in-house facilities and CDMOs for gene therapy manufacturing have begun investing to enhance their production capacity, which, in turn, is anticipated to create lucrative opportunities for market players. For instance, in April 2022, the FDA approved commercial licensure approval to Novartis for its Durham, N.C. site. This approval permits the 170,000 square-foot facility to make, test, and issue commercial Zolgensma, as well as manufacture therapy products for current & upcoming clinical trials.

Gene Therapy Market Report Highlights:

• The AAV segment shows a significant revenue contribution of 22% in 2023. Several biopharma companies are offering their viral vector platform for the development of AAV-based gene therapy product.
• By indication, the spinal muscular atrophy (SMA) segment dominated the market in 2023 with a share of 46.8%. Although SMA is a rare disorder, it is one of the most common fatal inherited diseases of infancy.
• The Beta-Thalassemia Major/SCD segment is anticipated to register the fastest CAGR of 38.3% over the forecast period. Gene therapy for SCD and B-thalassemia is based on transplantation of gene-modified hematopoietic stem cells.
• North America dominated the market in 2023 with the largest revenue share of 65.2% in 2023. This region is expected to become the largest routine manufacturer of gene therapy in terms of the number of approvals and revenue generated during the forecast period.
• Europe is estimated to be the fastest-growing regional segment from 2024 to 2030. This is attributed to its large population with unmet medical needs and increasing demand for novel technologies in the treatment of rare but increasingly prevalent diseases.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
  • 1.2.1. Indication
  • 1.2.2. Route of Administration
  • 1.2.3. Vector Type
• 1.3. Information analysis
• 1.4. Market formulation & data visualization
• 1.5. Data validation & publishing
• 1.6. Information Procurement
• 1.7. Primary Research
• 1.8. Information or Data Analysis
• 1.9. Market Formulation & Validation
• 1.10. Market Model
• 1.11. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Robust Gene Therapy Pipeline
    • 3.2.1.2. Introduction Of Technological Advancements
    • 3.2.1.3. Increasing Investment From Companies And Partnerships
    • 3.2.1.4. Growing Prevalence Of Target Diseases And Increased Demand For Innovative Medicine
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Absence Of Effective Diagnosis Framework
    • 3.2.2.2. High Prices Of Gene Therapy
  • 3.2.3. Market Opportunity Analysis
    • 3.2.3.1. Rising Investment For Adoptive T-Cell Transfer Approaches Of Disease Treatment
    • 3.2.3.2. Facility Expansion For Cell And Gene Therapies
    • 3.2.3.3. Technological Advancements In Manufacturing Vectors
• 3.3. Industry Analysis Tools
  • 3.3.1. Porter's Five Forces Analysis
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Route of Administration Business Analysis

• 4.1. Gene Therapy Market: Route of Administration Movement Analysis
• 4.2. Intravenous
  • 4.2.1. Intravenous Market, 2018 - 2030 (USD Million)
• 4.3. Others
  • 4.3.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. Indication Business Analysis

• 5.1. Gene Therapy Market: Indication Movement Analysis
• 5.2. Acute Lymphoblastic Leukemia
  • 5.2.1. Acute Lymphoblastic Leukemia Market, 2018 - 2030 (USD Million)
• 5.3. Inherited Retinal Disease
  • 5.3.1. Inherited Retinal Disease Market, 2018 - 2030 (USD Million)
• 5.4. Large B-Cell Lymphoma
  • 5.4.1. Large B-Cell Lymphoma Market, 2018 - 2030 (USD Million)
• 5.5. Melanoma (lesions)
  • 5.5.1. Melanoma (lesions) Market, 2018 - 2030 (USD Million)
• 5.6. Beta-Thalassemia Major/Sickle Cell Disease (Scd)
  • 5.6.1. Beta-Thalassemia Major/Sickle Cell Disease (Scd) Market, 2018 - 2030 (USD Million)
• 5.7. Spinal Muscular Atrophy (SMA)
  • 5.7.1. Spinal Muscular Atrophy (SMA) Market, 2018 - 2030 (USD Million)
• 5.8. Others
  • 5.8.1. Others Market, 2018 - 2030 (USD Million)

Chapter 6. Vector Type Business Analysis

• 6.1. Gene Therapy Market: Vector Type Movement Analysis
• 6.2. Lentiviral Vectors
  • 6.2.1. Lentiviral Vectors market, 2018 - 2030 (USD Million)
• 6.3. Adeno-Associated Viral (Aav) Vectors
  • 6.3.1. Adeno-Associated Viral (Aav) Vectors market, 2018 - 2030 (USD Million)
• 6.4. RetroVirus & gamma RetroVirus
  • 6.4.1. RetroVirus & gamma RetroVirus market, 2018 - 2030 (USD Million)
• 6.5. Modified Herpes Simplex Virus
  • 6.5.1. Modified Herpes Simplex Virus market, 2018 - 2030 (USD Million)
• 6.6. Adenovirus Vectors
  • 6.6.1. Adenovirus Vectors market, 2018 - 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others market, 2018 - 2030 (USD Million)

Chapter 7. Regional Business Analysis

• 7.1. Gene Therapy Market Share By Region, 2023 & 2030
• 7.2. North America
  • 7.2.1. North America Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. Key Country Dynamics
    • 7.2.2.2. Target disease prevalence
    • 7.2.2.3. Competitive Scenario
    • 7.2.2.4. Regulatory Framework
    • 7.2.2.5. U.S. Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.2.3. Canada
    • 7.2.3.1. Key Country Dynamics
    • 7.2.3.2. Target disease prevalence
    • 7.2.3.3. Competitive Scenario
    • 7.2.3.4. Regulatory Framework
    • 7.2.3.5. Canada Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.2.4. Mexico
    • 7.2.4.1. Key Country Dynamics
    • 7.2.4.2. Target disease prevalence
    • 7.2.4.3. Competitive Scenario
    • 7.2.4.4. Regulatory Framework
    • 7.2.4.5. Mexico Gene Therapy Market, 2018 - 2030 (USD Million)
• 7.3. Europe
  • 7.3.1. Europe Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. Key Country Dynamics
    • 7.3.2.2. Target disease prevalence
    • 7.3.2.3. Competitive Scenario
    • 7.3.2.4. Regulatory Framework
    • 7.3.2.5. UK Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.3.3. Germany
    • 7.3.3.1. Key Country Dynamics
    • 7.3.3.2. Target disease prevalence
    • 7.3.3.3. Competitive Scenario
    • 7.3.3.4. Regulatory Framework
    • 7.3.3.5. Germany Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.3.4. Switzerland
    • 7.3.4.1. Key Country Dynamics
    • 7.3.4.2. Target disease prevalence
    • 7.3.4.3. Competitive Scenario
    • 7.3.4.4. Regulatory Framework
    • 7.3.4.5. Switzerland Gene Therapy Market, 2018 - 2030 (USD Million)
• 7.4. Asia Pacific
  • 7.4.1. Asia Pacific Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Target disease prevalence
    • 7.4.2.3. Competitive Scenario
    • 7.4.2.4. Regulatory Framework
    • 7.4.2.5. Japan Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.4.3. China
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Target disease prevalence
    • 7.4.3.3. Competitive Scenario
    • 7.4.3.4. Regulatory Framework
    • 7.4.3.5. China Gene Therapy Market, 2018 - 2030 (USD Million)
  • 7.4.4. Australia
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Target disease prevalence
    • 7.4.4.3. Competitive Scenario
    • 7.4.4.4. Regulatory Framework
    • 7.4.4.5. Australia Gene Therapy Market, 2018 - 2030 (USD Million)
• 7.5. Rest of the world
  • 7.5.1. Rest of the world Gene Therapy Market, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
• 8.3. Company Market Position Analysis, 2023
• 8.4. Company Profiles
  • 8.4.1. Amgen Inc.
    • 8.4.1.1. Overview
    • 8.4.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.1.3. Product Benchmarking
    • 8.4.1.4. Strategic Initiatives
  • 8.4.2. Novartis AG
    • 8.4.2.1. Overview
    • 8.4.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.2.3. Product Benchmarking
    • 8.4.2.4. Strategic Initiatives
  • 8.4.3. F. Hoffmann-La Roche
    • 8.4.3.1. Overview
    • 8.4.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.3.3. Product Benchmarking
    • 8.4.3.4. Strategic Initiatives
  • 8.4.4. Gilead Sciences, Inc.
    • 8.4.4.1. Overview
    • 8.4.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.4.3. Product Benchmarking
    • 8.4.4.4. Strategic Initiatives
  • 8.4.5. bluebird bio, Inc.
    • 8.4.5.1. Overview
    • 8.4.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.5.3. Product Benchmarking
    • 8.4.5.4. Strategic Initiatives
  • 8.4.6. Bristol-Myers Squibb Company
    • 8.4.6.1. Overview
    • 8.4.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.6.3. Product Benchmarking
    • 8.4.6.4. Strategic Initiatives
  • 8.4.7. Legend Biotech.
    • 8.4.7.1. Overview
    • 8.4.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.7.3. Product Benchmarking
    • 8.4.7.4. Strategic Initiatives
  • 8.4.8. BioMarin.
    • 8.4.8.1. Overview
    • 8.4.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.8.3. Product Benchmarking
    • 8.4.8.4. Strategic Initiatives
  • 8.4.9. uniQure N.V.
    • 8.4.9.1. Overview
    • 8.4.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.9.3. Product Benchmarking
    • 8.4.9.4. Strategic Initiatives
  • 8.4.10. Merck & Co.
    • 8.4.10.1. Overview
    • 8.4.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.10.3. Product Benchmarking
    • 8.4.10.4. Strategic Initiatives
  • 8.4.11. Sarepta Therapeutics, Inc.
    • 8.4.11.1. Overview
    • 8.4.11.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.11.3. Product Benchmarking
    • 8.4.11.4. Strategic Initiatives
  • 8.4.12. Krystal Biotech, Inc
    • 8.4.12.1. Overview
    • 8.4.12.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.12.3. Product Benchmarking
    • 8.4.12.4. Strategic Initiatives
  • 8.4.13. CRISPR Therapeutics.
    • 8.4.13.1. Overview
    • 8.4.13.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
    • 8.4.13.3. Product Benchmarking
    • 8.4.13.4. Strategic Initiatives