United States Cell and Gene Therapy Market is expected to reach US$ 105.83 Billion by 2033 | Major key players - Novartis AG, Amgen, Inc., Gilead Sciences, Inc.

Market Size and Forecast:

The Cell and Gene Therapy Market size reached US$ 13.90 Billion in 2024 and is expected to reach US$ 105.83 Billion by 2033, growing at a CAGR of 21.5% during the forecast period 2025-2033.

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The Cell and Gene Therapy Market encompasses the development, manufacturing, and commercialization of therapies that modify or replace cells and genes to treat diseases. These innovative treatments target genetic disorders, cancers, and rare diseases by repairing or altering cellular functions. The market includes viral and non-viral vectors, stem cell therapies, CAR-T therapies, and associated delivery technologies, fueling personalized medicine advancements.

Industry Recent Developments:

United States:

✅ October 2025: The U.S. cell and gene therapy clinical trial market is expected to see significant growth driven by increased R&D funding, a favorable regulatory environment including FDA accelerated approval pathways, and over 2,000 pipeline candidates at various clinical stages. This growth is particularly strong in oncology, rare genetic disorders, and neurodegenerative diseases. (Oct 2025)

✅ October 2025: The North America cell and gene therapy market grew to approximately USD 11.34 billion in 2025 and is projected to reach USD 79.01 billion by 2034, expanding at a CAGR of 24.01%, fueled by advancements in therapeutic approaches and the potential to treat chronic and orphan diseases. (Oct 2025)

✅ October 2025: Expansion opportunities in the U.S. are highlighted in advanced platform developments and personalized therapies, supported by strategic investments and favorable regulatory frameworks promoting innovation in the cell and gene therapy sector. (Oct 2025)

Japan:

✅ September 2025: Japan's CAR T Cell Therapy Market is projected to grow at a CAGR of 20.5% from 2025 to 2033, driven by expanding applications beyond hematological malignancies, gene editing technological advancements, and the increasing prevalence of cancers. (Sep 2025)

✅ March 2025: Collaboration between The CiRA Foundation and Terumo Blood and Cell Technologies aims to advance the industrial-scale use of iPS cells in developing novel therapies, potentially revolutionizing Japan's cell and gene therapy landscape. (Mar 2025)

✅ 2025 (recent ongoing trend): The Japan cell and gene therapy market is expected to grow at a CAGR of 12% from 2025 to 2033, reaching USD 2,016 million by 2033, driven by government support, biotechnology advancements, personalized medicine focus, and aging population-related demand. (2025)

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Major Key Players:

Novartis AG
Gilead Sciences, Inc.
Bristol Myers Squibb Company
Vertex Pharmaceuticals Incorporated
Sarepta Therapeutics, Inc.
CSL Behring LLC
Amgen, Inc.
Orchard Therapeutics group.
Krystal Biotech, Inc.
bluebird bio, Inc.

Key Growth Drivers:

Growing utilization of advanced delivery vectors or vehicles that enhance the efficacy and safety of gene and cell therapies by improving genetic material delivery into target cells, leading to better treatment outcomes and reduced immunological reactions.

Increasing adoption and clinical success of cell therapies, particularly CAR-T cell therapies and stem cell-based treatments, driven by rising investment in R&D, chronic disease prevalence, and growing awareness of personalized medicine benefits.

Expanding pipeline of cell and gene therapies with strong growth in clinical development stages, increased corporate involvement, and numerous ongoing clinical trials addressing unmet needs in chronic, genetic, and life-threatening diseases.

Segments Covered in the Cell and Gene Therapy Market:

By Therapy Type: Cell Therapy, Gene Therapy.

By Application: Oncology, Musculoskeletal Conditions, Ophthalmology, Blood Disorders, Immunodeficiency Disorders, Graft-versus-host disease (GVHD), Rare Diseases, Others.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Cell and Gene Therapy market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Cell and Gene Therapy Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Cell and Gene Therapy market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Cell and Gene Therapy Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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