The global healthcare landscape is rapidly evolving with the emergence of next-generation treatments, particularly Advanced Therapy Medicinal Products (ATMPs). These therapies—encompassing cell therapies, gene therapies, and tissue-engineered products—are revolutionizing how we treat complex and previously untreatable conditions. In response to rising demand, Contract Development and Manufacturing Organizations (CDMOs) specializing in ATMPs are becoming integral to the biotech and pharmaceutical ecosystem. According to Expert Market Research, this sector is experiencing robust growth and is expected to expand significantly in the coming decade.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Size

In 2024, the global ATMP CDMO market was valued at USD 7.08 billion, driven by the increasing number of ATMP clinical trials worldwide. The market is expected to register a CAGR of 15.30% during the forecast period of 2025–2034, ultimately reaching USD 29.40 billion by 2034.

Several factors underpin this growth, including rising investments in regenerative medicine, a favorable regulatory environment, and a global push toward personalized and precision medicine. Additionally, the complex nature of ATMP production has prompted biotech firms to outsource manufacturing to specialized CDMOs with the technical capabilities and regulatory expertise needed.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Share

Regional Highlights

  • North America holds the largest market share, led by robust biotech R&D, a mature pharmaceutical industry, and a favorable regulatory framework from the FDA for ATMPs.

  • Europe, driven by initiatives from the European Medicines Agency (EMA), is the second-largest market.

  • Asia Pacific is the fastest-growing region, with countries like China, Japan, and South Korea investing heavily in biotechnology infrastructure.

Product-Based Segmentation

  • Gene Therapy is the dominant segment in terms of market share, given the surge in approvals and pipeline products targeting rare and genetic diseases.

  • Cell Therapy follows closely, especially in oncology and neurology, where immunotherapies such as CAR-T cells are gaining traction.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Growth & Trends

Growth Drivers

  • Rising clinical trial volume for ATMPs, especially in oncology, cardiology, and neurology.

  • Advancements in cell and gene therapy technologies enabling scalable and reproducible manufacturing processes.

  • Increased outsourcing by small-to-mid-sized biotech companies that lack internal GMP (Good Manufacturing Practice) capabilities.

  • Favorable regulatory pathways, such as fast-track and orphan drug designations by the FDA and EMA, accelerating time-to-market.

Technological Trends

  • Modular biomanufacturing platforms and single-use technologies are streamlining production workflows.

  • Automation and digital monitoring are reducing error rates and enhancing batch reproducibility.

  • Increasing focus on viral vector production, particularly lentiviral and adeno-associated vectors, is shaping facility designs and investment strategies.

For a deeper understanding of what ATMPs entail, visit Wikipedia’s article on Advanced therapy medicinal product, which provides a regulatory and scientific overview.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Case Studies & News

  • Catalent, Inc. expanded its cell and gene therapy footprint by opening a new commercial-scale facility in Maryland, USA.

  • Lonza signed multiple long-term agreements with biotech firms for the production of CAR-T cell therapies.

  • WuXi Advanced Therapies partnered with multiple U.S. and European biopharma companies to provide end-to-end development solutions.

  • Minaris Regenerative Medicine announced expansion plans in both Europe and Asia to meet growing demand for autologous cell therapies.

These strategic moves demonstrate how CDMOs are investing in infrastructure, expertise, and global footprint to serve the ATMP market’s growing complexity and volume.

Advanced Therapy Medicinal Products (ATMP) CDMO Market Analysis

Competitive Landscape

The ATMP CDMO sector is moderately consolidated, with several large players offering end-to-end solutions from preclinical development through commercial manufacturing. The competitive edge often lies in scalability, regulatory knowledge, and the ability to deliver high-quality GMP-compliant outputs.

Key Players:

  • Celonic Group

  • Bio Elpida

  • Cell Therapy Catapult Ltd.

  • Rentschler Biopharma SE

  • AGC Biologics

  • Catalent, Inc.

  • Lonza

  • WuXi Advanced Therapies

  • Minaris Regenerative Medicine

These firms are heavily investing in facility expansion, global collaborations, and technology adoption to enhance service capabilities and reduce turnaround times.

Global Advanced Therapy Medicinal Products (ATMP) CDMO Market Segmentation

By Product:

  • Cell Therapy

  • Gene Therapy

  • Others

By Phase:

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

By Indication:

  • Neurology

  • Cardiology

  • Oncology

  • Ophthalmology

  • Dermatology

  • Immunology

  • Others

By Region:

  • North America

  • Europe

  • Asia Pacific

  • Latin America

  • Middle East and Africa

As ATMPs continue to transform modern medicine by addressing the root causes of disease at the cellular and genetic levels, the role of specialized CDMOs will become increasingly critical. The market’s rapid growth trajectory is a testament to the convergence of scientific innovation, regulatory acceleration, and strategic outsourcing.

For comprehensive forecasts, competitive strategies, and deeper market intelligence, explore the full Expert Market Research report.

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