The global gene therapy market size was valued at USD 2.26 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 20.4% from 2021 to 2028. The expanding arena of advanced therapies and gene delivery technologies has created an increasingly competitive dynamic where a substantial number of market players are engaged in the commercialization of their gene therapy products. Therapy developers are investing in collaboration/mergers and acquisition deals as a viable strategy to enhance in-house expertise and strengthen product pipelines. These factors are expected to boost the market growth. Although the high prices of currently available therapies incentivize therapy development, it limits accessibility and can result in market withdrawals due to the lack of economic viability of the products.
Thus, several payment models, such as financial-based agreements and health outcomes-based agreements, have been introduced or suggested to increase the accessibility and market survival of therapies. These models have significantly impacted the adoption of therapies in the market. Currently, the world is trying to mitigate the adverse impact of the SARS-CoV-2 pandemic to restore the revenue flow in markets. The cell and gene therapy sector has been impacted to a considerable extent. Since many universities have shut down and halted all non-essential research & enrollment processes for clinical trials, progress in the ongoing R&D has been slow.
However, several initiatives have been undertaken by biopharma companies to gain a competitive edge in the market. Companies are adopting various market entry strategies, such as biopharma facility expansions, collaborations with other key stakeholders, and development with Contract Manufacturing Organizations (CMOs). For instance, in March 2020, Univercells launched Exothera, a viral vector CDMO that serves cell and gene therapy developers.
The delay in commercialization of Zynteglo due to the pandemic has impeded the market growth to a considerable extent. On the other hand, in July 2020, Novartis received the EMA approval for its two European sites for commercial manufacturing of CAR-T therapies. Furthermore, Kite, a Gilead Company, received the U.S. FDA approval for its Tecartus, a CAR T treatment for patients with relapsed or refractory mantle cell lymphoma. These approvals depict the continued momentum of the new area of medicine in this segment.
Spinal Muscular Atrophy (SMA) led the gene therapy market in 2020 with the highest revenue share of over 41%. However, the large B-cell lymphoma segment is estimated to account for the maximum revenue share by 2028. Although Spinal Muscular Atrophy (SMA) is a rare disease, it is one of the most common fatal inherited diseases of infancy. The development of gene therapy, Zolgensma (AVXS-101), has significantly proven its efficiency in the treatment of SMA, along with changing the disease phenotype. In May 2019, Novartis received approval from the U.S. FDA for Zolgensma, which is designed to address the root cause of SMA. Zolgensma is the first and only approved gene therapy in this segment.
Novartis and Gilead continue to expand their customer base across the globe for Kymriah and Yescarta, which are designed for the treatment of large B-cell lymphoma. Recently, in May 2019, Novartis received approval to sell its products in Japan. Moreover, as per the investigation, in 2017, around 51% of patients who received Yescarta treatment achieved remission. Furthermore, Kite Pharma introduced a team for providing training about logistical and biological intricacies for the drug to hospitals and clinics that will be using Yescarta, thereby driving the segment growth.
The AAV segment led the global market in 2020 and held the largest market share of over 43% as a result of the success of AAV-based Zolgensma. In recent times, usage of AAV is rising significantly across various therapeutic areas, consequently witnessing a considerable demand during the forecast years. Proven records of non-pathogenicity is one of the important key factors boosting their adoption.
Companies, such as Dimension Therapeutics, AGTC, Spark Therapeutics, Sangamo Biosciences, Biogen, and AveXis, are involved in the AAV viral vector-based gene therapy R&D. On the other hand, lentiviruses are anticipated to emerge as the fastest-growing vector type segment from 2021 to 2028. This can be attributed to the rising investments by companies and research institutes in this vector type, post-approval of Zynteglo in 2019 and Kymriah in 2017.
Furthermore, the presence of companies that offer exclusive lentivector platform is accelerating revenue growth in this segment. For instance, Oxford Biomedica Plc has an exclusive lentivector platform, an advanced and safe gene delivery system that can carry payloads of up to 9kb and is capable of permanent modification of dividing and nondividing cells along with no pre-existing immunity.
The North America regional market led the industry in 2020 with a revenue share of more than 55% and will grow further at the fastest CAGR over the forecast years. On account of a strong regulatory framework for promoting the development of cellular therapy and the presence of a substantial number of biopharma companies, several government agencies are investing in the region. This, in turn, is driving the growth of the regional market.
The presence of centers and institutes engaged in R&D on gene therapies is likely to continue driving the market in North America. Several companies from regions, such as Europe, which have received EU approvals, are planning to receive FDA approvals over. For example, post-EU approval of bluebird Bio’s Zynteglo (formerly LentiGlobin) in June 2019, the company is planning to file for an FDA approval.
On the other hand, Zolgensma’s approval in 2019 has greatly favored the U.S. market. Despite the price controversies, the product managed to witness lucrative revenue growth in the year 2020. These factors are anticipated to maintain the dominance of this region in the global market during the forecast period.
An increase in funding and investment for advancements in gene therapies is expected to provide lucrative growth opportunities to market players. Furthermore, companies are engaged in strategic alliances to boost their offerings in the space, which is anticipated to intensify the market competition during the forecast period. For instance, in March 2020, REGENXBIO, Inc. and Ultragenyx Pharmaceutical, Inc. collaborated for the use of the NAV technology platform. Under this collaboration, the latter company received a worldwide license to REGENXBIO’s NAV AAV9 and AAV8 vectors for the development of gene therapies for a rare metabolic disorder. Some of the major players in the global gene therapy market are:
REGENXBIO, Inc.
Oxford BioMedica plc
Dimension Therapeutics, Inc.
Bristol-Myers Squibb Company
SANOFI
Applied Genetic Technologies Corporation
F. Hoffmann-La Roche Ltd.
Bluebird Bio, Inc.
Novartis AG
Taxus Cardium Pharmaceuticals Group, Inc. (Gene Biotherapeutics)
UniQure N.V.
Shire Plc
Cellectis S.A.
Sangamo Therapeutics, Inc.
Orchard Therapeutics
Gilead Lifesciences, Inc.
Benitec Biopharma Ltd.
Sibiono GeneTech Co., Ltd.
Shanghai Sunway Biotech Co., Ltd.
Gensight Biologics S.A.
Transgene
Calimmune, Inc.
Epeius Biotechnologies Corp.
Astellas Pharma, Inc.
American Gene Technologies
BioMarin Pharmaceuticals, Inc.
Report Attribute |
Details |
Market size value in 2021 |
USD 3.42 billion |
Revenue forecast in 2028 |
USD 10.0 billion |
Growth Rate |
CAGR of 20.4% from 2021 to 2028 |
Base year for estimation |
2020 |
Historical data |
2017 - 2019 |
Forecast period |
2021 - 2028 |
Quantitative units |
Revenue in USD million/billion and CAGR from 2021 to 2028 |
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Segments covered |
Indication, vector type, region |
Regional scope |
North America; Europe; Asia Pacific; Rest of the World |
Country scope |
U.S.; Canada; Japan; China; Russia; Australia |
Key companies profiled |
REGENXBIO, Inc.; Oxford BioMedica plc; Dimension Therapeutics, Inc.; Bristol-Myers Squibb Company; SANOFI; Applied Genetic Technologies Corp; F. Hoffmann-La Roche Ltd.; Bluebird Bio, Inc.; Novartis AG; Taxus Cardium Pharmaceuticals Group, Inc. (Gene Biotherapeutics); UniQure N.V.; Shire Plc; Cellectis S.A.; Sangamo Therapeutics, Inc.; Orchard Therapeutics; Gilead Lifesciences, Inc.; Benitec Biopharma Ltd.; Sibiono GeneTech Co., Ltd.; Shanghai Sunway Biotech Co., Ltd.; Gensight Biologics S.A.; Transgene; Calimmune, Inc.; Epeius Biotechnologies Corp.; Astellas Pharma, Inc.; American Gene Technologies; BioMarin Pharmaceuticals, Inc. |
Customization scope |
Free report customization (equivalent to up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global gene therapy market report on the basis of indication, vector type, and region:
Indication Outlook (Revenue, USD Million, 2017 - 2028)
Acute Lymphoblastic Leukemia (ALL)
Inherited Retinal Disease
Large B-cell Lymphoma
ADA-SCID
Melanoma (lesions)
Beta-Thalassemia Major/SCD
Head & Neck Squamous Cell Carcinoma
Peripheral Arterial Disease
Spinal Muscular Atrophy (SMA)
Others
Vector Type Outlook (Revenue, USD Million, 2017 - 2028)
Lentivirus
AAV
Retrovirus & gamma Retrovirus
Modified Herpes Simplex Virus
Adenovirus
Non-viral Plasmid Vector
Regional Outlook (Revenue, USD Million, 2017 - 2028)
North America
U.S.
Canada
Europe
Asia Pacific
Japan
China
Russia
Australia
Rest of the World
b. The global gene therapy market size was estimated at USD 2.3 billion in 2020 and is expected to reach USD 3.4 billion in 2021.
b. The global gene therapy market is expected to grow at a compound annual growth rate of 20.4% from 2021 to 2028 to reach USD 10.0 billion by 2028.
b. North America dominated the gene therapy market with a share of 55.7% in 2020. This is attributable to rising healthcare awareness coupled with the growing demand for robust therapeutics to treat chronic illness.
b. Some key players operating in the gene therapy market include Novartis AG; Spark Therapeutics LLC; Bluebird Bio; Gilead Sciences Inc.; Celgene Corporation; Shire Plc; Voyager Therapeutics; Dimension Therapeutics; Chiesi Farmaceutici S.p.A; and Celgene Corporation.
b. Key factors that are driving the gene therapy market growth include recent approval of products such as Zolgensma and LentiGlobin which has accelerated investment in clinical trials of pipeline programs.
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