Global Radiopharmaceutical CDMO Market Size Likely to Grow at a CAGR of 9.3% By 2034

Market Size and Growth

As per the Radiopharmaceutical CDMO Market size analysis conducted by the CMI Team, the global Radiopharmaceutical CDMO Market is expected to record a CAGR of 9.3% from 2025 to 2034. In 2025, the market size is projected to reach a valuation of USD 3.1 Billion. By 2034, the valuation is anticipated to reach USD 7.2 Billion.

Overview

Radiopharmaceutical CDMO Market Major players are improving growth by investing in more efficient manufacturing systems, ecological design, and advanced automation. To have accurate, scalable and sustainable operations, companies are introducing environmentally friendly and efficient equipment that is easy to recycle, smart software, and energy saving machines. Product products are being diversified with high throughput, miniaturized and customized products to meet the needs of pharmaceutical, diagnostic, and therapeutic applications.

Companies are also progressing in green production technology that uses a lesser amount of chemicals and waste. Active studies in the automated synthesis, isotope labeling and sustainable production techniques are helping to improve the preparation and supply of radiopharmaceuticals in a safer, faster and more dependable way without violating the high standards of the international standards.

Key Trends & Drivers

• Increasing Regulations: Regulations in the pharmaceuticals and diagnostics are becoming stricter with the international agencies and governments demanding more precision, reproducibility, and adherence. Radiopharmaceutical CDMOs are highly important in that they provide GMP-qualified facilities, qualified processes, and compliance to international standards. This guarantees secure, conforming and scalable drug development. An example of this is that in August 2025, Former FDA Commissioner Stephen Hahn was made CEO of Nucleus RadioPharma, a U.S.-based radiopharma CDMO, which further makes the case of an industry that is seeking greater regulatory prowess at the top.

• ESG Agenda (Sustainability Focus): The global ESG trend is influencing radiopharmaceutical production, which is becoming energy-efficient, has components that can be recycled, and is being produced in ways that are more environmentally friendly. To meet the expectations of clients and international sustainability objectives, CDOMS are making investments in the upgrading of their facilities and environmentally sustainable supply chain solutions. In April 2025, Medi-Radiopharma opened a new FDA- and EMA-approved plant that could make 3.5 million vials per year, with sustainable design and operational efficiency to serve the market around the world by having less environmental impact.

• Automation & Digitalization: Automation, IoT, and AI-driven monitoring systems are becoming common among radiopharmaceutical CDMOs in order to enhance efficiency, accuracy, and traceability. Digitalization makes human error less and accelerates development cycles and regulatory compliance in high volume environments. Client trust is also enhanced by the incorporation of cloud-based reporting and smart manufacturing tools. In March 2025, A new AI-based Digital Formulator plus the Self-Driving Datafactory tableting Datafactory that came to pharma R&D demonstrates how automation and predictive modeling can help to shorten drug development time cycles – a technology trend that may soon affect radiopharma CDMOs.

Report Scope

SWOT Analysis

• Strengths: The Radiopharmaceutical CDMO market enjoys the advantage of specialized capability to manufacture high-purity, regulated radiopharmaceuticals in both the diagnostic and therapeutic markets. Precision, reproducibility, and strict adherence to stringent standards of the FDA, EMA and IAEA are ensured with automation and advanced process controls. Quality assurance using AI and IoT-based monitoring and strong R&D expertise augments efficiency and safety. The global reach of the leading players, as well as their collaboration with pharmaceutical, biotechnology, and nuclear medicine centers only contributes to the credibility of the market and its relevance in the long term.

• Weaknesses: The large capital investment and complicated laboratories or operation requirements make them accessible only to bigger firms or labs, especially in the less developed markets. Due to the necessity of staff trained to work with radioisotopes, run cyclotron or reactor-based production, or control compliance, the bottlenecks occur in the operations. There is also the issue of regular system upgrades and modernization of technologies to comply with regulative and safety regulations that create operational and financial overhead that can limit further acceptability.

• Opportunities: The rise in personalized medicine and targeted therapy is enhancing the demand for therapeutic radiopharmaceuticals whereas the increasing number of chronic diseases promotes diagnostic uses. Growth opportunities include expansion of nuclear medicine facilities, government programs on infrastructure development of healthcare, and investments in green and energy efficient production. Asian-pacific, Latin American, and Middle Eastern emerging markets have untapped potential because of industrialization, increasing spending on healthcare, and increased investment in R&D.

• Threats: The supply chain disruption, shortage of raw radioisotopes and regulatory differences by region are threats to market growth. The fast pace of technology can make the current production platforms useless and a constant inflow of investment in innovation is needed. The risk of substitutes ( Low-cost alternatives) and geopolitical uncertainties as well as economic downturns might also slow down the adoption and the expansion of capital. Furthermore, radiopharmaceutical handling is considered a high-risk activity, which requires strict compliance with safety, which imposes even greater pressure on operations.

List of the prominent players in the Radiopharmaceutical CDMO Market:

• NorthStar Medical Radioisotopes
• Eckert & Ziegler
• ITM Isotope Technologies München SE
• Curium Pharma
• Cardinal Health
• SOFIE
• PharmaLogic
• Monrol (Eczacıbaşı‑Monrol)
• SpectronRx
• Ionetix Corporation
• Minerva Imaging
• Seibersdorf Labor GmbH
• Evergreen Theragnostics Inc.
• Global Medical Solutions
• GBI Biomanufacturing
• Others

The Radiopharmaceutical CDMO Market is segmented as follows:

By Application

• Diagnostic Radiopharmaceuticals
• Therapeutic Radiopharmaceuticals

By Radioisotope Type

• Technetium-99m
• Fluorine-18
• Lutetium-177
• Gallium-68
• Actinium-225
• Others

By Source of Manufacturing

• Nuclear Reactors
• Cyclotrons

By Therapeutic Area

• Oncology
• Neurological Disorders
• Cardiovascular Disorders
• Others

By End-user

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutions
• Hospitals & Nuclear Medicine Centers
• Others

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America