Gene Therapy Market 2030: Australia’s Emerging Role in Global Health

The global gene therapy market was valued at approximately USD 5.54 billion in 2023 and is projected to experience significant growth at a compound annual growth rate (CAGR) of 18.88% from 2024 to 2030. This growth is driven by several key factors, including the expanding scope of advanced therapies, innovations in gene delivery technologies, and the increasing competition among leading companies focused on commercializing their gene therapies. Biotechnology companies are also making strategic moves such as acquisitions, mergers, collaborations, and partnerships to enhance their in-house expertise and strengthen their product development pipelines.

The market's growth is further supported by a robust pipeline of gene therapy products currently under development. Research efforts are focused on making gene therapies more widely available in clinical settings, with numerous universities and research institutes developing a wide range of products. This extensive pipeline is expected to drive significant revenue generation over the forecast period. Notably, the number of clinical trials for gene therapies saw a substantial increase between 2017 and 2018, following the FDA’s approval of the first gene therapy. As reported by the American Society of Gene & Cell Therapy (ASGCT), there are currently about 1,986 gene therapy products in development, including CAR T-cell therapies and other genetically modified cell therapies.

In addition to these developments, regulatory support is playing a pivotal role in creating opportunities for market growth. Various international regulatory bodies have implemented favorable changes to encourage the development and commercialization of gene therapies. For example, the FDA has shown strong support for CAR-T technology and has introduced more flexibility in clinical trial designs, particularly in Phase II and III studies, to streamline the approval process. The FDA has also projected that 10 to 20 new gene therapies could receive approval each year by 2025, further fueling the growth of the gene therapy market over the coming years.

Gather more insights about the market drivers, restrains and growth of the Gene Therapy Market

Regional Insights

In 2023, North America dominated the global gene therapy market, accounting for the largest revenue share of 18.95%. This region is expected to maintain its leadership throughout the forecast period, not only in terms of revenue generation but also in the number of gene therapy approvals. The growth is anticipated to be further fueled by increasing investments in research and development (R&D) from both large and small biotechnology companies focused on developing advanced therapeutic drugs. These investments will play a critical role in propelling North America's position as the largest producer of gene therapies.

U.S. Gene Therapy Market Trends

The United States stands out as the largest market for clinical trials related to gene therapy, with the country conducting approximately 50% of all clinical trials globally. As of March 2023, more than 2,500 clinical studies focused on gene therapy were underway in the U.S. alone. This significant activity in gene therapy trials underscores the country's central role in advancing gene-based medical treatments. The high number of clinical studies reflects both the vast research infrastructure in place and the substantial investments directed toward developing new and innovative therapies.

Europe Gene Therapy Market Trends

Europe has emerged as a key region for gene therapy, with a growing market driven by a large population with unmet medical needs. This is particularly true for rare diseases that are increasingly being recognized and treated with novel technologies. There is also a rising demand for cutting-edge treatments for genetic disorders, which is expected to boost the gene therapy market in the region. In particular, the UK and Germany are witnessing notable growth.

UK: The gene therapy market in the UK is projected to grow at an accelerated pace, driven by substantial investments from major pharmaceutical companies as well as government initiatives, including those by the National Health Service (NHS) and research laboratories. These investments are intended to foster the development and adoption of gene therapies within the UK, further enhancing its position in the European market.
Germany: Germany is expected to experience significant growth in the gene therapy market over the forecast period. A notable event in the region was the launch of Zynteglo, a gene therapy for transfusion-dependent beta-thalassemia, by the U.S.-based company bluebird bio in January 2020. This therapy, which was developed in collaboration with the German manufacturer apceth Biopharma, represents a significant step forward for gene therapy in Germany and is expected to contribute to the country's increasing market share.

Asia Pacific Gene Therapy Market Trends

The Asia Pacific region is expected to witness a significant growth rate of 18.40% CAGR during the forecast period. This growth can be attributed to several factors, including a high birth rate and a rising prevalence of genetic disorders. In particular, consanguineous marriages (marriages between close relatives) and founder mutations, which are more common in certain Asian populations, contribute to the increased incidence of genetic diseases. These factors are creating a larger patient pool in need of gene therapies.

China: The Chinese gene therapy market is expected to experience robust growth in the coming years. In March 2019, Merck KGaA, a global science and technology company, entered into a partnership with GenScript, a Chinese biotech firm, to produce plasmids and viral vectors for gene therapies. This collaboration highlights the growing infrastructure and capability in China to support the development and manufacturing of genetic therapies. This strategic partnership is expected to play a key role in China's advancement in the gene therapy sector.

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Key Gene Therapy Company Insights

The market players operating in the gene therapy market are adopting product approval to increase the reach of their products in the market and improve the availability of their products in diverse geographical areas, along with expansion as a strategy to enhance production/research activities. In addition, several market players are acquiring smaller players to strengthen their market position. This strategy enables companies to increase their capabilities, expand their product portfolios, and improve their competencies.

Key Gene Therapy Companies:

The following are the leading companies in the gene therapy market. These companies collectively hold the largest market share and dictate industry trends.