Gene Therapy Market

Gene Therapy Market Growth Outlook (2022-2032)

The global gene therapy market size was valued at US$ 1.55 Billion in 2021. The market is projected to grow from US$ 1.85 Billion in 2022 to US$ 10.1 Billion by 2032, exhibiting a CAGR of 18.5% during the forecast period.

The world has witnessed a significant increase in the number of cases of rare diseases, which has fueled the demand for cell and gene therapy. Ex-vivo gene therapy is becoming more popular for neurological treatments, which is expected to drive gene therapy market growth through 2032.

Report Attributes	Details
Anticipated Base Year Value (2021)	US$ 1.55 Billion
Expected Market Value (2022)	US$ 1.85 Billion
Projected Forecast Value (2032)	US$ 10.1 Billion
Global Growth Rate (2022-2032)	18.5% CAGR
Expected Growth Rate of the Asia-Pacific (2022-2032)	18.3% CAGR
Key Gene Therapy Providers	Novartis AG Gilead Sciences Inc. Spark Therapeutics Inc. Sibiono GeneTech Co. Ltd. CELGENE CORPORATION  Orchard Therapeutics Limited BioNTech

Market Revenue Analysis 2015-2021 vs. Future Outlook 2022-2032

Over the last few years, the world has seen a significant increase in focus on health care, which has resulted in a massive increase in research and development activities.

The rising prevalence of rare diseases has also increased the demand for novel treatments, which has driven gene therapy market potential in the past. A CAGR of 18.7% was recorded for the market from 2015 to 2021.

The increasing use of gene modification in a variety of treatments, as well as the increasing use of genome editing in biotechnology applications, are also expected to guide the gene therapy market in the coming years.

The global gene therapy industry is expected to be hampered by high gene therapy costs and a lack of standardization. From 2022 to 2032, demand for gene therapies is expected to grow at an astronomical CAGR of 18.5%.

The presence of companies offering exclusive lentivector platforms is hastening revenue growth in this segment. Oxford Biomedica Plc, for example, has an exclusive lentivector platform, an advanced and safe gene delivery system capable of carrying payloads of up to 9kb and capable of permanent modification of dividing and nondividing cells while requiring no pre-existing immunity.

Prominent Gene Therapy Industry Growth Drivers

Research and development (R&D) activities are also expected to have a significant market impact

Research and development (R&D) activities are also expected to have a significant impact on the market. Several companies are aiming to build a gene therapy platform with a strategy centered on establishing a transformational portfolio through in-house capabilities and enhancing those capabilities through strategic collaborations, R&D expansion, and potential licensing, merger, and acquisition activities.

For example, the Cystic Fibrosis Foundation announced an investment in SalioGen Therapeutics in January 2022 to support the company's preclinical research into novel gene therapy for cystic fibrosis. SalioGen's Gene Coding approach is intended to activate, deactivate, or modify the function of any gene in the genome.

Key Challenges Prevalent in the Global Gene Therapy Market

Gene Therapy's High Costs will stifle overall Market Growth

Gene therapies are expensive medical procedures that necessitate significant capital investment on the part of both the provider and the patient, which limits the global gene therapy market's growth.

Gene modifications necessitate precision equipment, which significantly raises the cost of cell and gene therapy and limits the global adoption of these therapies. Due to high costs and low adoption, viral vector gene therapies are expected to grow at the slowest rate.

Region-wise Analysis

What is the Growth Outlook for Gene Therapy in North America?

With a revenue share of more than 56% in 2022, the North American regional market will lead the industry and will grow at the fastest CAGR over the forecast years. Several government agencies are investing in the region because of a strong regulatory framework for promoting the development of cellular therapy and the presence of a large number of biopharma companies.

This, in turn, is propelling the regional market forward. The presence of centers and institutes engaged in gene therapy research and development is expected to drive the market in North America.

Also, the rising prevalence of chronic diseases, rising healthcare expenditure, the presence of advanced healthcare infrastructure, and the availability of reimbursements are also major factors driving the market growth. The approval of Zolgensma in 2019 has, on the other hand, greatly favored the US market. Despite the price controversies, the product is expected to have profitable revenue growth in the forecast period.

Growing Involvement of Public and Private Research Organizations fueling the growth of the APAC Market

The Asia-Pacific (APAC) gene therapy market was valued at US$ 351 Million in 2021, with a CAGR of 18.3%. This is accomplished through the optimization of vectors such as retroviruses and lentiviruses, the introduction of new techniques such as induced pluripotent stem cells in conjunction with current gene editing models, and even trials in germ cells.

The focus on healthcare in India has increased, and this trend is expected to drive gene therapy demand over the forecast period. The country is also seeing an increase in cancer cases, which is encouraging the use of gene therapy in oncology treatments. The key players in the APAC gene therapy market include Novartis AG, Sibiono GeneTech Co. Ltd., Shanghai Sunway Biotech Co. Ltd., Kolon Life Science Inc., AnGes Inc., and Amgen Inc.

The Europe Gene Therapy market expected to grow rapidly over the Forecast Period

During the period 2022-2032, the European gene therapy market is expected to grow at a CAGR of more than 19%. The European market is the best for manufacturing cell and gene therapy products. Europe is home to more than 238 regenerative medicine companies. Europe is home to nearly a quarter of the world's regenerative medicine therapeutic developers.

In 2020, the oncology segment accounted for 31% of the European cell and gene therapy market. Currently, over 61 companies in Europe are specializing in cell therapy and introducing cell therapy products. Some key players in the Europe market are Novartis, Spark Therapeutics, Amgen, Gilead Sciences and Organogenesis.

Category-wise Insights

Oncology expected to Account for a Sizable Market Share by Application

The cancer segment is expected to account for a sizable portion of the market. The increasing burden of cancer disorder, the growing emphasis on research to develop an effective cancer treatment, and rising cancer research investments are all factors driving the segment growth.

According to Globocan 2020, an estimated 19,292,789 new cancer cases and 9,958,133 cancer deaths were reported worldwide in 2020. Various gene therapy strategies are currently being used in the treatment of cancer. These include anti-angiogenic gene therapy, pro-drug activating suicide gene therapy, immune modulation based on gene therapy, oncolytic virotherapy, gene defect correction/compensation, antisense, genetic manipulation of apoptotic and tumor invasion pathways, and RNAi strategies.

These therapies have targeted cancer types such as lung, brain, breast, pancreatic, liver, colorectal, prostate, bladder, head and neck, skin, renal and ovarian cancer.

Yescarta-based Gene Therapy Commands a Large Market Share

Yescarta received FDA approval for the treatment of diffuse large B-cell lymphoma (DLBCL) in adults, significantly increasing its market share. This therapy is expected to have a market share of more than 44.5% in the global gene therapy industry landscape. Luxturna-based gene therapies are expected to grow rapidly over the forecast period, with a market share of more than 36% by 2032.

Competitive Landscape

The global gene therapy market is fiercely competitive, with only a few major players. Companies like Amgen Inc., Bluebird Bio, Gilead Sciences, Inc., Novartis AG, Orchard Therapeutics, Sibiono GeneTech Co. Ltd., Spark Therapeutics (Roche AG), and UniQure N.V.,  have a sizable market share in the Gene Therapy market. To secure a position in the global market, various strategic alliances such as collaborations, acquisitions, and the launch of advanced products have been formed.

• In October 2021, the National Institutes of Health, the United States Food and Drug Administration, ten pharmaceutical companies, and five non-profit organizations announced a collaboration to accelerate the development of gene therapies for the 30 million Americans who suffer from a rare disease. Such initiatives are expected to boost demand for gene therapy.
• BioMarin Pharmaceutical Inc. reported updates on its investigational gene therapy programs in clinical development in February 2022. The Food and Drug Administration (FDA) issued additional requests to the Company for information needed to resolve the clinical hold of the PHEARLESS Phase 1/2 study of BMN 307 issued in September 2021.
• Novartis acquired Gyroscope Therapeutics in December 2021, adding a one-time gene therapy that could transform care for geographic atrophy, a leading cause of blindness.
• Abecma (idecabtagene vicleucel), a cell-based gene therapy, was approved by the US Food and Drug Administration in March 2021 to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first FDA-approved cell-based gene therapy for the treatment of multiple myeloma.

Key Segments Covered in Gene Therapy Industry Research

• By Product :

  • Yescarta-based 
  • Kymriah-based 
  • Luxturna-based 
  • Strimvelis-based 
  • Gendicine
  • Others

• By Application :

  • Ophthalmology
  • Oncology
  • Adenosine Deaminase/Deficient Severe Combined Immunodeficiency (ADA-SCID)

• By Region :

  • North America 
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • MEA