The U.S. cell and gene therapy market is currently experiencing a massive wave of capital investment and infrastructure expansion. As the industry shifts from early-stage research to large-scale commercialization, major pharmaceutical and biotechnology companies are solidifying their presence by building state-of-the-art manufacturing facilities, acquiring specialized innovators, and forging strategic partnerships.

The Cell and Gene Therapy Market size is projected to reach US$ 25.78 billion by 2031 from US$ 5.30 billion in 2024. The market is expected to register a CAGR of 25.5% during 2025–2031. This growth reflects a significant increase in the number of therapies moving from late-stage clinical trials to commercial availability.

Download Sample Report - https://www.theinsightpartners.com/sample/TIPRE00020854

Recent Strategic Expansions and Investments

The following developments highlight how leading organizations are deepening their U.S. footprint to maintain competitive dominance:

  • Johnson & Johnson: In February 2026, the company announced a massive US$ 1 billion investment to construct a next-generation cell therapy manufacturing facility in Pennsylvania. This site is designed to support the commercial production of its portfolio for cancer and immune-mediated diseases, creating over 500 skilled jobs.
  • Amgen: Building on its robust biologics infrastructure, Amgen recently made significant investments to expand its U.S. innovation and manufacturing footprint. This includes a US$ 600 million science and innovation center at its California headquarters, along with major facility expansions in North Carolina and Ohio, aimed at scaling advanced biologics and cell therapy production.
  • Novartis: Following a comprehensive 5-year strategy, Novartis has initiated a US$ 23 billion investment plan to expand its U.S. manufacturing and R&D presence. This includes the construction of several brand-new facilities specifically equipped for cutting-edge platforms, including gene and cell therapy, enabling end-to-end production of key medicines within the United States.
  • Emerging CDMO Collaboration: Beyond direct pharma investment, the sector is increasingly reliant on a robust ecosystem of Contract Development and Manufacturing Organizations (CDMOs). Leaders such as Thermo Fisher Scientific, Lonza, and Charles River Laboratories continue to expand their U.S. service footprints to provide the scalable "plug-and-play" infrastructure that smaller biotech firms require to bring their pipelines to market.

Strategic Objectives Driving Expansion

These investments are not merely about increasing physical space; they are strategic maneuvers to address the unique complexities of the CGT market:

  1. Ensuring Supply Chain Resilience: By moving manufacturing from external or global sources to domestic, state-of-the-art facilities, companies are mitigating risks associated with the complex cold chain logistics required for living therapeutics.
  2. Adoption of Automation: New facilities are being built with "closed-system" and automated processes. This standardization is critical to reducing the human error inherent in manual processing, ensuring higher product consistency, and achieving the cost-efficiencies needed for long-term commercial sustainability.
  3. Support for Commercial-Scale Production: As therapies like CAR-T treatments gain broader regulatory approval and indications, the need to transition from "clinical-scale" (small batches) to "commercial-scale" (mass production) is a primary driver for these multi-billion dollar capital outlays.

Outlook for the U.S. Market

With North America accounting for roughly half of the global market share, these investments solidify the U.S. position as the primary hub for regenerative medicine innovation. As these facilities come online between 2026 and 2031, the market expects a significant reduction in production bottlenecks, which will ultimately accelerate patient access to life-saving, curative treatments.

Related Report :

·         Cell and Gene Therapy QC & Analytics Market 2026-2034 | Size & Trends

Contact Information -

Email: sales@theinsightpartners.com

Phone: +1-646-491-9876

Also Available in :

Korean German Japanese French Chinese Italian Spanish