In 2021, the global gene therapy market was estimated to be worth $1.55 billion USD. The market is expected to increase from US$ 1.85 billion in 2022 to US$ 10.1 billion by 2032, at an 18.5% CAGR over the forecast period.
The gene therapy market is at the forefront of medical innovation, offering new hope and possibilities for treating a wide range of genetic disorders and diseases. In this article, we will delve into the insights of the gene therapy market, exploring its growth trajectory, potential opportunities, demand-supply trends, recent notable developments, and the intricate value chain that drives this transformative field of medicine.
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Gene Therapy Market Growth
Companies are strategically investing in research and development (R&D) to shape gene therapy platforms. Focused on building transformative portfolios, these efforts involve in-house capabilities, collaborations, R&D expansion, and potential mergers and acquisitions. An illustration is the Cystic Fibrosis Foundation’s investment in SalioGen Therapeutics, announced in January 2022, supporting preclinical research for a novel gene therapy addressing cystic fibrosis. SalioGen employs a Gene Coding approach, aiming to activate, deactivate, or modify the function of any gene in the genome.
Gene Therapy Market Opportunities
The gene therapy market offers a wealth of opportunities, ranging from addressing rare genetic disorders to targeting more common ailments. One significant opportunity lies in the treatment of rare diseases known as orphan diseases. Gene therapies have shown promise in providing life-changing treatments for patients with conditions that were previously considered incurable. Additionally, cancer gene therapies are being explored vigorously, with the potential to revolutionize oncology treatment by precisely targeting cancer cells. Furthermore, advancements in gene editing technologies like CRISPR-Cas9 have opened doors for the development of customized gene therapies, creating new avenues for personalized medicine.
Key Companies Profiled In This Report
- Novartis AG
- Gilead Sciences Inc.
- Spark Therapeutics Inc.
- Sibiono GeneTech Co. Ltd.
- CELGENE CORPORATION
- Orchard Therapeutics Limited
- BioNTech
Key Challenges Prevalent in the Global Gene Therapy Market
The global gene therapy market faces growth constraints due to the high expenses associated with these medical procedures. Both healthcare providers and patients need to make substantial capital investments, which pose limitations on market expansion.
The need for precise equipment in gene modifications significantly escalates the overall costs of cell and gene therapies, hindering their widespread adoption worldwide. As a result of these high costs and slow adoption rates, viral vector gene therapies are projected to experience comparatively sluggish growth.
Gene Therapy Market Notable Developments
The gene therapy market has witnessed remarkable developments, showcasing the transformative potential of this field. Notable milestones include the approval of Luxturna in 2017, the first gene therapy for an inherited retinal disease, and the approval of Zolgensma in 2019, a gene therapy for spinal muscular atrophy. These breakthroughs have paved the way for more gene therapies in the pipeline. Additionally, advancements in delivery methods, such as viral vectors and nanoparticles, have improved the precision and efficiency of gene therapy administration. The continuous evolution of gene editing technologies and CRISPR-Cas9 applications promises to unlock new therapeutic possibilities.
Gene Therapy Market Value Chain
The gene therapy market’s value chain encompasses various stages, from research and development to patient treatment. It begins with the discovery and development of gene therapy candidates in research laboratories and biotech companies. Once a potential therapy is identified, it undergoes rigorous preclinical testing and clinical trials to demonstrate safety and efficacy. Regulatory approval is a crucial step, followed by the scaling-up of manufacturing processes to produce gene therapies for commercial use. Distribution, patient access, and administration of gene therapies are essential components of the value chain. Patient monitoring and long-term follow-up also play a pivotal role in ensuring the success of gene therapy treatments.
Competitive Landscape
In a significant development in October 2021, a collaborative effort involving the National Institutes of Health, the United States Food and Drug Administration, ten prominent pharmaceutical companies, and five non-profit organizations was announced. This collaboration aims to expedite the development of gene therapies designed to benefit the 30 million Americans afflicted by rare diseases. Such strategic initiatives are anticipated to stimulate the demand for gene therapy solutions.
BioMarin Pharmaceutical Inc. provided notable updates regarding its ongoing gene therapy programs in clinical development in February 2022. During this period, the Food and Drug Administration (FDA) issued additional requests to the company for crucial information aimed at addressing the clinical hold placed on the PHEARLESS Phase 1/2 study of BMN 307, which had been initiated in September 2021.
In December 2021, Novartis made a significant acquisition by adding Gyroscope Therapeutics to its portfolio. This acquisition brought in a groundbreaking one-time gene therapy designed to potentially revolutionize the treatment of geographic atrophy, a leading cause of blindness.
Another notable development occurred in March 2021 when the US Food and Drug Administration granted approval to Abecma (idecabtagene vicleucel). Abecma is a cell-based gene therapy developed to treat adult patients grappling with multiple myeloma, especially those who have not responded to, or have experienced a recurrence after, at least four previous lines of therapy. This marked a milestone as Abecma became 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
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The gene therapy market is a dynamic and rapidly evolving field with immense potential to transform healthcare. Its growth is fueled by scientific advancements, regulatory support, and the rising demand for innovative treatments for genetic disorders and diseases. As gene therapies continue to emerge and mature, they hold the promise of offering new hope to patients and changing the landscape of medicine. The intricate value chain, spanning from research to patient care, is instrumental in bringing these revolutionary therapies to those in need.
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