United States Cell and Gene Therapy Market to hit US$ 105.83 Billion by 2033 | Top Companies - Novartis AG, Gilead Sciences, Bristol Myers Squibb Company

"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." As per DataM intelligence research report

Download your exclusive sample report today: (corporate email gets priority access): https://www.datamintelligence.com/download-sample/cell-and-gene-therapy-market?sp

United States: Recent Industry Developments

✅ In October 2025, Pfizer Inc. received FDA approval for its gene therapy Beqsurion targeting hemophilia B, marking a major milestone in one-time curative treatments. The therapy uses an optimized AAV vector for enhanced durability and safety.

✅ In September 2025, Vertex Pharmaceuticals and CRISPR Therapeutics announced the U.S. launch of Casgevy, the first CRISPR-based gene editing therapy for sickle cell disease and beta-thalassemia, following FDA approval in late 2024.

✅ In August 2025, Gilead Sciences (Kite Pharma) expanded its CAR-T manufacturing facility in Maryland to boost production capacity for hematologic cancer therapies, strengthening its cell therapy supply chain.

✅ In July 2025, Bluebird Bio secured $200 million in funding to advance its next-generation gene therapies for cerebral adrenoleukodystrophy and beta-thalassemia, supporting its pipeline toward commercial scalability.

Japan: Recent Industry Developments

✅ In October 2025, Takeda Pharmaceutical Co. initiated a Phase III clinical trial for its ex vivo gene therapy targeting rare metabolic disorders, leveraging Japan's fast-track regulatory pathway for regenerative medicine.

✅ In September 2025, Astellas Pharma Inc. announced the expansion of its iPSC-based cell therapy program in collaboration with Center for iPS Cell Research and Application (CiRA), focusing on retinal and cardiac disease treatments.

✅ In August 2025, Daiichi Sankyo entered a strategic alliance with Riken Institute to co-develop next-generation gene delivery platforms using lipid nanoparticles for oncology and rare disease therapies.

✅ In July 2025, Otsuka Pharmaceutical Co. Ltd. launched a regenerative medicine R&D hub in Tokyo dedicated to advancing cell and gene therapies for neurological and immune-mediated disorders.

Cell and Gene Therapy Market: Drivers

The cell and gene therapy market is experiencing transformative growth driven by breakthroughs in regenerative medicine, precision genetics, and personalized healthcare. These advanced therapies offer curative potential for previously untreatable conditions such as cancer, rare genetic disorders, and autoimmune diseases. The success of CAR-T cell therapies and gene-editing technologies like CRISPR has accelerated clinical adoption and regulatory approvals worldwide. Rising investment from pharmaceutical giants, coupled with growing collaboration between biotech firms and academic research centers, is fueling rapid innovation. Increasing patient awareness and expanding reimbursement frameworks are also contributing to market expansion.

Technological advancements in viral vector manufacturing, cell engineering, and delivery mechanisms are enhancing treatment efficacy and scalability. The growing number of clinical trials, along with supportive regulatory pathways such as FDA's RMAT designation and EMA's PRIME program, is streamlining commercialization. The market is also benefiting from the development of allogeneic "off-the-shelf" therapies that promise cost efficiency and broader accessibility. Furthermore, the integration of AI and data analytics is improving therapy design and patient selection. With strong momentum across oncology, neurology, and rare disease segments, the cell and gene therapy market is set to redefine the future of modern medicine through durable, life-changing treatments.

Get Customization in the report as per your requirements: https://www.datamintelligence.com/customize/cell-and-gene-therapy-market?sp

Cell and Gene Therapy Market: Major 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., and among others.

Segment Covered in the Cell and Gene Therapy Market:

By Therapy Type
The market is segmented into Cell Therapy and Gene Therapy. Cell therapy dominates the market owing to its established applications in regenerative medicine and oncology, driven by advancements in stem cell research and personalized treatment approaches. Meanwhile, gene therapy is rapidly growing due to breakthroughs in genetic engineering and increasing regulatory approvals for inherited and rare disease treatments.

By Application
Based on application, the market is categorized into Oncology, Musculoskeletal Conditions, Ophthalmology, Blood Disorders, Immunodeficiency Disorders, Graft-versus-host Disease (GVHD), Rare Diseases, and Others. Oncology holds the largest market share due to the widespread use of CAR-T cell and gene-modified therapies in cancer treatment. Blood disorders and immunodeficiency disorders are also key growth areas, supported by increasing clinical trials and targeted gene correction techniques. Additionally, rare diseases represent a rapidly expanding segment as gene therapies offer transformative potential for conditions with limited or no existing treatments.

Research Process:

Both primary and secondary data sources have been used in the Cell and Gene Therapy Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

Most Frequently Asked Questions in the Cell and Gene Therapy Market Research Industry:

➠ Who leads the Cell and Gene Therapy industry and what's their competitive positioning regarding capacity, performance, and profitability?
➠ What growth opportunities and market challenges do Cell and Gene Therapy market vendors face?
➠ Which segments show the highest growth potential and market share distribution?
➠ What factors are driving or limiting Cell and Gene Therapy market growth?
➠ What are the dominant sales and distribution strategies in the Cell and Gene Therapy industry?

Purchase this report before year-end and unlock an exclusive 30% discount:
https://www.datamintelligence.com/buy-now-page?report=cell-and-gene-therapy-market
(Purchase 2 or more Repots and get 50% Discount)

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)

Request for 2 Days FREE Trial Access:
https://www.datamintelligence.com/reports-subscription?sp

✅ Competitive Landscape
✅ Technology Roadmap Analysis
✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Consumer Behavior & Demand Analysis
✅ Import-Export Data Monitoring
✅ Live Market & Pricing Trends

Have a look at our Subscription Dashboard:
https://www.youtube.com/watch?v=x5oEiqEqTWg

Contact Us -
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.