The gene therapy is the next trend of therapeutic modernization in the life sciences industry. These therapy approaches could help the enormous preponderance of newborns with different diseases. Gene therapy possesses the potential to transform medicine and establish opportunities for patients who are living with complicated, and even incurable, diseases. As scientists continue to make great strides in this therapy, FDA is committed to helping speed up the gene therapy development by timely review of pioneering therapies that have the potential to save lives.
The gene therapy market is experiencing significant growth on account of surging prevalence of cancer and rare diseases. According to WHO, in the United States, over 400 products have been approved as therapy for more than 200 rare disease indications and in the EU, over 70 products for about 45 indications. Furthermore, in the field of molecular and cellular biology, rapid and important developments, led by technological advances in genomics and gene editing techniques, have contributed to a growing number of approved gene therapies and an expanding pipeline. According to the Alliance for Regenerative Medicine (ARM), by the end of the Q22019, there were more than 700 ongoing clinical trials globally.
The American Medical Association reports that around 4,000 diseases have been linked to gene disorders (including cancers, AIDS, cystic fibrosis, and Parkinson's and Alzheimer's diseases). The successful treatment with gene therapy could positively affect millions of lives.
The COVID-19 pandemic has disrupted worldwide management efforts around gene therapies. The manufacture and delivery of treatments, research and clinical development, and commercial operations are the three areas within the gene therapy sector which have been most interrupted amid COVID-19 crisis. The development of gene therapies has been less affected. For instance, Peter Marks, Director of FDA's Center for Biologics Evaluation and Research (CBER) stated that with the influx of applications for cell and gene therapies over the last five years, it should have doubled in size while it is only modestly larger, 15-20% larger in size.
Based on vector, the market is fragmented into viral and non-viral vectors. The viral vector segment generated revenue of US$ 3.1 billion in 2019. The market is expected to grow at a CAGR of 29.18% during the forecast period to reach a market valuation of US$ 17.9 billion by 2027 owing to the substantial advances in vector manufacturing, distribution, and security. Furthermore, the viral vector market is mainly bifurcated into the lentivirus, adeno-associated virus, retrovirus & gammaretrovirus, modified herpes simplex virus, and adenovirus.
Based on gene type, the market is mainly fragmented into antigen, cytokine, tumor suppressor, suicide, deficiency, receptor, and others. The antigen segment dominated the market generating total revenue of US$ 0.7 billion in 2019 and is anticipated to maintain its dominance during the analyzed period. The gene therapy holds potential for treating various indications including oncology, rare diseases, cardiovascular, neurology, infectious and others. The oncology segment dominated the market and generated revenue of US$ 1.7 billion in 2019 owing to the increasing number of cancer cases. Cancer is the second leading cause of death worldwide, accounting for an estimated 9.6 million deaths, or 1 in 6 deaths, in 2018.
Based on delivery method, the market is mainly disintegrated into in-vivo and ex-vivo. The ex-vivo segment is expected to grow at the highest CAGR of 35.5% during the forecast period owing to the benefit of expression of the gene and health of the transfected cells that can be verified before it is introduced to the patient.
For a better understanding of the market penetration of the healthcare analytics market, the market is analyzed based on its worldwide presence in the countries such as North America (the U.S, Canada, and Rest of North America), Europe (Germany, France, Italy, Spain, United Kingdom and Rest of Europe), Asia-Pacific (China, Japan, Australia, South Korea, and Rest of APAC), Rest of World. North America constitutes a major market for the gene therapy industry. Some of the major players operating in the market include Biogen, BioMarin Pharmaceuticals, bluebird bio, Bristol Myers Squibb, Gilead Sciences, Novartis, Orchard Therapeutics, Regenxbio, Spark Theraputics, and uniQure.
The global gene therapy market was valued at US$ 3.5 billion in 2019 and is projected to expand significantly with a CAGR of 29.71% from 2021 to 2027. The global gene therapy market is expected to witness a boost, owing to the rising incidence of cancer and other diseases, growing gene therapy pipeline and increasing funding for the gene therapy research.
Gene therapy inserts genetic material into cells to compensate for abnormal genes or to make a beneficial protein. The increasing number of clinical trials that are underway and tremendous mergers, acquisitions, and venture capital investments in the gene-therapy sector make the future looks bright for such therapies. To date, approximately 2,600 gene therapy clinical studies have been completed, are ongoing, or have been approved globally. More than ever, the field of gene therapy seeks to identify a route to the clinic and the market. Approximately 20 gene therapies have now been licensed and over two thousand clinical trials of human gene therapy have been published globally. Such advancements generate great hope that debilitating rare and inherited disorders as well as incurable diseases can be treated.
According to the Alliance for Regenerative Medicine (ARM) Quarterly Regenerative Medicine Global Data Report for the first quarter of 2019, 372 gene therapy clinical trials were in progress as of the end of Q1. Remarkably, a margin (217 or 58%) were studies in Phase II, followed by Phase I (123 or 33%), and Phase III (32 or 9%). The number of gene therapy clinical trials edged up by 10 from the 362 recorded as of the end of 2018. Substantially, the number of clinical studies leaped 17% year-over-year from the 319 trials in development as of Q1 2018. Many of the clinical trials in gene therapy have been aimed at the treatment of cancer indications including lung, gynecological, skin, urological, neurological, and gastrointestinal tumors, as well as hematological malignancies and pediatric tumors. The International Agency for Research on Cancer estimates that worldwide, 1 in 5 people is intended to develop cancer during their lifetime, and 1 in 8 men and 1 in 11 women die from the disease. These new evaluations indicate that approximately 50 million people are living within 5 years of a past cancer diagnosis. Aging populations worldwide and socio-economic risk factors remain among the primary influences driving this surge.
Biogen, BioMarin Pharmaceuticals, bluebird bio, Bristol Myers Squibb, Gilead Sciences, Novartis, Orchard Therapeutics, Regenxbio, Spark Therapeutics, and uniQure are some of the prominent players operating in the global gene therapy market. Several M&A's along with partnerships have been undertaken by these players to facilitate costumers with hi-tech and innovative products.
Insights Presented in the Report
"Amongst vectors, Viral vectors segment holds the major share"
Based on the vector type, the market is fragmented into viral and non-viral vectors. The viral vectors dominated the market with a share of 88.6% in 2019 and is expected to maintain its dominance during the forecast period owing to the significant improvements in vector engineering, delivery, and safety.
"Amongst viral vectors, adeno-associated virus vectors are anticipated to dominate the market during the analyzed period"
Furthermore, the viral vector market is mainly bifurcated into the lentivirus, adeno-associated virus, retrovirus & gammaretrovirus, modified herpes simplex virus, and adenovirus. In 2019, adeno-associated virus sub-segment accounted for a maximum market revenue share of 34% and is expected to remain dominant during the analyzed period owing to the easy integration into the host genome, no viral genes, able to transduce cells not actively dividing, a wide range of host cells, and being non-inflammatory and non-pathogenic. However, the non-viral vector is anticipated to grow at the highest CAGR over the forecast period.
"Amongst gene type, antigen segment dominated the market during the forecast period"
Based on gene type, the market is mainly fragmented into antigen, cytokine, tumor suppressor, suicide, deficiency, receptor, and others. In 2019, the antigen segment accounted for a maximum market revenue share of 19.2% and is expected to remain dominant during the analyzed period.
"Amongst indication, oncology segment holds the major share"
Based on indication, the market is bifurcated into oncology, rare diseases, cardiovascular, neurology, infectious, and others. In 2019, the oncology segment accounted for the maximum market share with 48.6% and is expected to be the leading segment of the gene therapy market during the forecast period due to the increasing incidence of cancer cases.
"Amongst the delivery method, in-vivo segment dominated the market during the forecast period"
Based on the delivery method, the market is mainly disintegrated into in-vivo and ex-vivo. In 2019, in-vivo segment accounted for a maximum market revenue share of 87.5% and is expected to remain dominant during the analyzed period owing to the direct transfer of genes into patients.
"North America represents one of the largest markets of Gene Therapy market"
For a better understanding of the market dynamics of the gene therapy market, a detailed analysis was conducted for different regions across the globe including North America (the U.S, Canada, and the Rest of North America), Europe (Germany, France, Italy, Spain, United Kingdom and Rest of Europe), Asia-Pacific (China, Japan, Australia, South Korea, and Rest of APAC), Rest of World has been conducted. North America dominated the market and generated revenue of US$ 1.7 billion in 2019 owing to the high prevalence rate of cancer, presence of high disposable income, and increase in funding for R&D activities associated with gene therapy.
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? Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry
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? Deep dive regional level analysis of the industry
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Table of Contents
1 MARKET INTRODUCTION
1.1 Market Definitions
1.2 Objective of the Study
1.3 Limitation
1.4 Stake Holders
1.5 Currency Used in Report
1.6 Scope of the Global Gene Therapy Market Study
2 RESEARCH METHODOLOGY OR ASSUMPTION
2.1 Research Methodology for the Global Gene Therapy Market
2.1.1 Main Objective of the Global Gene Therapy Market
3 INDUSTRY PERFORMANCE
4 EXECUTIVE SUMMARY
5 TOP START-UPS UNDER GENE THERAPY SECTOR
6 COVID-19 IMPACT
7 MARKET INSIGHTS BY VECTOR
7.1 Viral Vector
7.1.1 Lentivirus
7.1.2 Adeno-Associated Virus
7.1.3 Retrovirus & Gammaretrovirus
7.1.4 Modified Herpes Simplex Virus
7.1.5 Adenovirus
7.2 Non-Viral Vector
8 MARKET INSIGHTS BY GENE TYPE
8.1 Antigen
8.2 Cytokine
8.3 Tumor Suppressor
8.4 Suicide
8.5 Deficiency
8.6 Receptor
8.7 Others
9 MARKET INSIGHTS BY INDICATION
9.1 Oncology
9.2 Rare Diseases
9.3 Cardiovascular
9.4 Neurology
9.5 Infectious
9.6 Others
10 MARKET INSIGHTS BY DELIVERY METHOD
10.1 In-vivo
10.2 Ex-vivo
11 MARKET INSIGHTS BY REGION
11.1 North America Gene Therapy Market
11.1.1 US
11.1.2 Canada
11.1.3 Rest of North America
11.2 Europe Gene Therapy Market
11.2.1 United Kingdom
11.2.2 France
11.2.3 Germany
11.2.4 Spain
11.2.5 Italy
11.2.6 Rest of Europe
11.3 Asia Pacific Gene Therapy Market
11.3.1 China
11.3.2 Japan
11.3.3 Australia
11.3.4 South Korea
11.3.5 Rest of Asia Pacific
11.4 Rest of World Gene Therapy Market
12 GENE THERAPY MARKET DYNAMICS
12.1 Marke Drivers
12.2 Market Challenges
12.3 Impact Analysis
13 LEGAL & REGULATORY FRAMEWORK
14 DEMAND AND SUPPLY SIDE ANALYSIS
14.1 Demand Side Analysis
14.2 Supply Side Analysis
14.2.1 Top Product Launches
14.2.2 Top Business Partnerships
14.2.3 Top Merger & Acquisitions
14.2.4 Top Business Expansions and Investments
15 VALUE CHAIN ANALYSIS
16 GENE THERAPY MARKET OPPORTUNITIES
17 GENE THERAPY MARKET TRENDS & INSIGHTS
18 COMPETITIVE SCENARIO
18.1 Porter's Five forces analysis
18.1.1 Bargaining power of Supplier
18.1.2 Bargaining power of Buyer
18.1.3 Industry Rivalry
18.1.4 Availability of Substitute
18.1.5 Threat of new Entrants
18.2 Competitive Landscape
18.2.1 Company Shares, By Revenue
18.3 Competition Matrix
18.3.1 Product/Service Portfolio
18.3.2 Target Markets
18.3.3 Target End Users
18.3.4 Research & Development
18.3.5 Strategic Alliances
19 COMPANY PROFILED
19.1 bluebird bio
19.1.1 Key Facts
19.1.2 Business Description
19.1.3 Key Product/Services Offerings
19.1.4 Growth Strategy
19.1.5 SWOT Analysis
19.1.6 Key Financials
19.1.6.1 Revenue Split
19.1.6.2 Financial Overview of bluebird bio
19.1.7 Recent Developments
19.1.7.1 Product Launches
19.1.7.2 Partnerships
19.1.7.3 Business Expansion and Investments
19.1.7.4 Merger and Acquisition
19.2 Biogen
19.3 BioMarin Pharmaceuticals
19.4 Celgene Corporation
19.5 Gilead Sciences
19.6 Novartis
19.7 Orchard Therapeutics
19.8 Regenxbio
19.9 Spark Therapeutics
19.10 uniQure
20 DISCLAIMER
List of Tables
List of Figures
Biogen
BioMarin Pharmaceuticals
bluebird bio
Bristol Myers Squibb
Gilead Sciences
Novartis
Orchard Therapeutics
Regenxbio
Spark Therapeutics
and uniQure