GLOBAL RADIOPHARMACEUTICALS CDMO & CONTRACT MANUFACTURING MARKET (2026 - 2030)

The Radiopharmaceutical CDMO & Contract Manufacturing Market was valued at USD 2.10 billion in 2025 and is projected to reach a market size of USD 3.70 billion by the end of 2030. Over the forecast period of 2026-2030, the market is projected to grow at a CAGR of 12%.

The Radiopharmaceutical CDMO & Contract Manufacturing Market refers to the industry that provides specialty outsourcing services for the development, manufacture, and regulatory management of radiopharmaceuticals that are used for diagnostic imaging and targeted therapy. The sector has become a crucial support for nuclear medicine, facilitating the large-scale production of complex radioisotope-based products by pharmaceutical innovators without the need for heavy capital investment. The rise in clinical applications of PET and SPECT diagnostics, increasing theranostic treatments, and a growing number of targeted radioligand therapies in the pipeline are shaping the demand. CDMOs in this niche provide a wide array of capabilities, such as isotope handling, formulation, aseptic filling, quality control, and adherence to stringent radiation safety regulations. Furthermore, the market is affected by technological improvements in cyclotron and reactor-based isotope production that enhance supply reliability and manufacturing efficiency. The regulatory challenge of handling short half-life products still benefits contract partners with proven infrastructure, global distribution networks, and experience. Besides, pharmaceutical and biotechnology firms are now more dependent on contract manufacturers as a means of speeding up clinical timelines and reducing operational risks. With the growing trend towards precision medicine, radiopharmaceutical CDMOs are set to become strategic partners who not only facilitate innovation and commercialization but also ensure the nuclear medicine applications in oncology, cardiology, and neurology continue to grow sustainably.

Key Market Insights:
 

Rapid diagnostic demand is driving tracer volumes. Total PET procedure volumes rose 10% year-over-year in 2023, and the average scans per fixed PET site rose from 1,401 to 1,495 scans. This rising throughput increases demand for external radiotracer supply and CDMO fill/finish capacity.

The radiopharmaceutical mix remains concentrated but shifting, 74% of PET scans still use F-18 FDG in 2023, while newer tracers (e.g., Ga-68-based agents) represented a small single-digit share but show accelerating adoption, creating niche CDMO needs (generator vs cyclotron workflows).

Rapid adoption of targeted PET (PSMA) shows steep uptake. 350,000 PSMA PET exams were performed in the U.S. in 2024, a rise of 30% year-over-year, signalling fast clinical adoption that will push demand for CDMOs capable of supplying PSMA radiotracers at scale.

Manufacturing capacity investment & reshoring dynamics are accelerating CDMO demand. Construction spending in manufacturing jumped (reported 37% year-over-year in early 2024), and employment is at or above pre-pandemic levels, indicating capital flows and labour availability that CDMOs can leverage for expansion of sterile/aseptic radiopharma lines. Deloitte+1

Isotope supply vulnerabilities are forcing tech diversification, recent pauses, and economics around traditional reactor-sourced Mo-99 have highlighted fragility; as a result, alternative production approaches (cyclotron/electron-accelerator paths and Mo-100 routes) and decentralised Ga-68 production are being pursued, creating opportunity for CDMOs with flexible production platforms.


 

Market Drivers:

Rising Adoption of Precision Oncology and Radioligand Therapies Is Accelerating Demand for Radiopharmaceutical CDMO Services.

With a view to precision oncology and nuclear medicine therapies targeting specific mechanisms, globally, healthcare is shifting, and this trend is currently considered to be the biggest driver of the contract manufacturing market and radiopharmaceutical CDMO market. As the focus of healthcare shifts to treatments that can deliver the highest therapeutic efficacy with the least possible systemic toxicity, the use of more specialized radiopharmaceuticals, particularly beta- and alpha-emitting therapeutics, has led to a spectacular rise in demand, resulting in more pressure on manufacturing. It is difficult for the in-house production to overcome such problems that are brought about by the product's short half-lives, the highly regulated radiation safety environment, the requirement for cold-chain logistics, and the continuous updating of GMP standards. In this way, CDMOs are the solutions to these problems as they provide a licensed facility, the ability to increase production, and expertise in radioisotopes. Hence, they are small and medium-sized biotech firms' indispensable partners. With cancer incidences rising globally and with the increasing use of theranostics (the molecular diagnostic imaging of a disease which guides a targeted molecular therapy), demand for shorter lead-time, precision manufacturing is further driven. Besides facilitating the process by which drugs are approved, health authorities from North America, Europe, and the Asia-Pacific have also increased regulatory compliance standards, thus the trend has been further strengthened through multiple regulatory supports. In short, increased clinical needs, the complexity of the manufacturing requirements, and the regulatory environment have together created continuous growth and the strategic significance of radiopharmaceutical CDMOs worldwide.

Growing Manufacturing Complexity and High Capital Requirements Are Driving Outsourcing to Specialized Radiopharmaceutical Contract Manufacturers.

Still another key reason driving the radiopharmaceutical CDMO and contract manufacturing market is the dramatically increasing capital requirement and technological sophistication of the production process. Whereas conventional drugs can be manufactured relatively easily, radiopharmaceuticals need to be produced using cyclotrons or nuclear reactors, hot cells, automated synthesis modules, and radiation-shielded cleanrooms, all of which entail huge initial investments and continuous costs; thus, deciding to manufacture in-house is an economic non-starter for many developers, especially those who have only early-stage pipelines. Further, technological developments, for instance, PET tracers with short half-life and therapeutic isotopes with high energy, have made the production procedures even more complicated so that now ultra-precise synthesis, quick quality control, and time-critical distribution are required. CDMOs thus to these problems by means of automation, digital batch monitoring, advanced analytics, and multi-site operations, thereby lessening the risk of human exposure, increasing batch consistency, and ensuring the supply continuity even in cases of global disruptions, such as a reactor shutdown or logistical delays. The trend towards personalized medicine (often requiring small-batch, patient-specific production) thereby increases the attractiveness of the model of flexible, just-in-time manufacturing, which in turn leads to higher regulatory compliance costs (radiation safety, environmental disposal, and cross-border transport), which thus becomes another reason for outsourcing to specialized CDMOs. All these factors, i.e., the mixture of technological difficulty, significant capital needs, fragility of the supply chain, demand for personalized therapies, and the regulatory pressures, make radiopharmaceutical contract manufacturers indispensable as main drivers of the industrial growth in the future.
 

Market Restraints and Challenges:

Contract manufacturers are subject to a double source of regulations that combine pharmaceutical GMP requirements with nuclear safety regulations, thus resulting in elongated approval cycles, high compliance costs, and constrained flexibility during scale-up or technology transfer. Regulatory divergence across regions makes it even more difficult for global manufacturing partnerships, thus leading to slower market expansion. At the same time, the industry is limited by production models that are heavily dependent on infrastructure and thus require great capital investment in shielded facilities, radiochemistry systems, and specialized waste management. The reliance on short half-life radioisotopes further increases logistical challenges, as any disruption in isotope supply, transportation, or reactor availability can lead to production schedule stops. All these factors put together limit rapid capacity expansion, raise operational risk, and make it difficult for radiopharmaceutical CDMO services to be scalable in the long run. ​‍​‌‍​‍‌

Market Opportunities:

The​‍​‌‍​‍‌ market of Radiopharmaceutical CDMO & Contract Manufacturing keeps promising areas for development in ultra-precise theranostics and expansion of micro-facilities at the regional level. CDMOs collaborating with biotech companies can thus combine flexible, small-volume manufacturing capacity and regulatory compliance assistance for patient-specific radiopharmaceuticals to offer a range of high-margin, repeatable services linked to the success of the clinical pipeline. At the same time, the creation of a network of geographically dispersed micro-manufacturing units with seamless cold-chain logistics can result in decreased isotope decay losses, increased hospital access, and efficient production on demand. All these strategies put CDMOs in a position to be comprehensive solution providers, thus enabling them to tap into the increasing demand for personalized medicine and faster, more reliable delivery of radiopharmaceuticals.
 

GLOBAL RADIOPHARMACEUTICALS CDMO & CONTRACT MANUFACTURING MARKET (2026 - 2030)

Market Segmentation:

Segmentation By Type:

• Contract Manufacturing
• Contract Development
• Analytical Services / Quality Control
• Packaging, Labeling & Logistics
• Others
   

Contract​‍​‌‍​‍‌ Manufacturing is the major segment in the market of Radiopharmaceutical CDMO, as it helps pharmaceutical companies to simply transfer the large-scale production of radiopharmaceuticals to a third party, who will do so in compliance with all regulations, precise and cost-efficient manner. The segment leadership is largely attributed to the increasing demand for specialized production facilities, the imposition of high-quality standards, and the necessity to shorten the time for novel radiopharmaceutical therapies reaching the market. Contract manufacturing companies, which utilize the most advanced production technologies, provide the underlying foundation of the industry's operation by enabling a scalable and dependable supply of both diagnostic and therapeutic ​‍​‌‍​‍‌radiopharmaceuticals.

Contract​‍​‌‍​‍‌ Development is the fastest-growing subsegment of the market, as it shows that people are getting more and more dependent on external experts for designing and optimizing radiopharmaceuticals. Pharma companies want their specialized development partners to do complex formulation processes, make them ready for clinical trials faster, and ensure they are following all the regulations. There are more and more innovative radiopharmaceutical therapies in the pipeline, which is a good reason for this segment to grow, but basically, it is the need for solutions that are quick, cheap, and do not heavily rely on internal R&D teams that also help in accelerating product development timelines, which is most probably the main reason for the growth of this ​‍​‌‍​‍‌segment.
 

Segmentation By Application

• Diagnostic Radiopharmaceuticals
• Therapeutic Radiopharmaceuticals
• Oncology
• Neurology
• Cardiology
• Others

Oncology​‍​‌‍​‍‌ currently holds the largest share in the market for radiopharmaceutical applications. The rapid increase in demand for targeted diagnostics and therapies for cancer is the main driver of this growth. Radiopharmaceuticals in cancer care are used for the visualization of tumors, planning of personalized therapies, and delivery of effective radiotherapy; thus, they have become necessary tools in the fight against cancer. CDMOs are now putting more emphasis on oncology molecules as they offer high clinical value, have quite challenging manufacturing processes, and are capable of providing patient-specific solutions. A spike in the worldwide cancer cases and the pressing need for highly accurate, less invasive diagnostic and therapeutic methods are further strengthening the growth of this ​‍​‌‍​‍‌segment.

Therapeutic​‍​‌‍​‍‌ radiopharmaceuticals are becoming the fastest-growing subsegment by a significant margin, mainly due to breakthroughs in alpha- and beta-emitting therapy methods, as well as customized treatment mechanisms. The race to develop new radiotherapeutics for oncology, neurology, and other chronic diseases is gaining tremendous momentum; hence, a lot of contract manufacturing investments are being attracted. The rise in the clinical use of therapeutic radiopharmaceuticals, in combination with the fast small-batch production technology improvements by CDMOs, is the main reason why this subsegment will continue to grow at an accelerated ​‍​‌‍​‍‌rate.


 

Market Segmentation: Regional Analysis:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

North​‍​‌‍​‍‌ America dominates the Radiopharmaceutical CDMO & Contract Manufacturing industry mainly due to a highly developed nuclear medicine infrastructure, an increasing uptake of personalized therapies, and supportive regulations for clinical trials. Some established CDMOs and biotechnology firms allow for the effective manufacture of patient-specific radiopharmaceuticals. It also enjoys substantial funding for cyclotron facilities and the development of theranostics, thus making it the biggest regional market ​‍​‌‍​‍‌worldwide.

Asia​‍​‌‍​‍‌ Pacific remains the fastest-growing regional segment. Its growth is driven mainly by healthcare infrastructure expansion, increased awareness of nuclear imaging, as well as government initiatives in countries such as China, India, and Japan. To serve the demand for local manufacturing of affordable radiopharmaceuticals, global CDMOs are attracted to setting up regional facilities. The growth momentum is a manifestation of the region's emphasis on developing sustainable, patient-friendly radiopharmaceutical production ​‍​‌‍​‍‌capacity.
 

COVID-19 Impact Analysis:

The​‍​‌‍​‍‌ COVID-19 crisis deeply affected the Radiopharmaceutical CDMO & Contract Manufacturing Market, leading to profound changes in how the sector operates and its strategic focus. At the beginning of the pandemic, the disruption of supply chains and global lockdowns resulted in shortages of raw materials, isotopes, and essential reagents, causing production to slow down and clinical trials to be postponed. Furthermore, travel bans and limited workforce hours resulted in reduced manufacturing output; thus, most CDMOs were forced to introduce remote supervision systems and machinery automation to sustain operations. On the other hand, the demand for diagnostic agents such as PET and SPECT tracers for COVID research drastically increased, which led to the paradox of having production lines clogged up due to operational issues while the need for products was extremely urgent. Moreover, the pandemic has led to partnerships and collaborations between pharmaceutical developers and CDMOs as the former increasingly outsource to the latter to quickly develop radiopharmaceuticals without straining their internal teams. In addition, regulators have shown a willingness to be more accommodating in terms of approvals and inspections, thereby facilitating the entry of vital radiopharmaceuticals into the market without compromising on the safety aspects. The pandemic situation has, therefore, permanently changed the market and its focus on factors like supply chain resilience, digitalization, and agile manufacturing models. Thus, CDMOs are well-positioned to quickly cater to future healthcare crisis needs. In general, COVID-19 acted as a test of strength for the industry as well as a driver of change, revealing weaknesses and prompting innovation and strategic changes in the radiopharmaceutical contract development and manufacturing ​‍​‌‍​‍‌industry.
 

Latest Market News:
 

• In June 2025, PharmaLogic Holdings Corp. completed its acquisition of a majority stake in Agilera Pharma AS from the Institute for Energy Technology (IFE). This strategic move expands PharmaLogic’s operational footprint across development, manufacturing, and global distribution of commercial and clinical radiopharmaceutical therapeutics, effectively enhancing its CDMO capabilities worldwide.
   
• In June 2025, TAG1 Inc. announced a strategic partnership with PharmaLogic aimed at accelerating the development of TAG1’s proprietary Pb‑212 generator platform. This collaboration is positioned to advance access to alpha‑emitting isotopes and supports Pharmalogic’s mission to scale radiopharmaceutical production infrastructure.
   
• In May 2025, Ratio Therapeutics entered into a deal to build a new radiopharmaceutical R&D and manufacturing facility in Salt Lake City, Utah. This agreement underscores the company’s commitment to strengthening internal manufacturing capacity and broadening its contract manufacturing involvement in the radiopharma sector.
   

Latest Trends and Developments:

The​‍​‌‍​‍‌ Radiopharmaceutical CDMO & Contract Manufacturing Market is changing quickly. This change is influenced by the increasing demand for outsourcing, the digital transformation, and the specialization in advanced radioisotopes. To lower the capital expenditure, speed up the time-to-market, and get through complex regulations, pharmaceutical developers are more and more depending on CDMOs, which is making contract manufacturing the main service segment. Technologies, e.g., AI, IoT, automation, and digital twins, are contributing to higher process stability and quality assurance, whereas the importance of ESG principles and sustainable operations is increasing. The market has been going through a lot of M&As and collaborations to acquire niche technologies and enhance their scaling capabilities. The regional dynamic is changing, with North America currently leading the way in infrastructure and Asia-Pacific becoming a very cost-effective outsourcing hub. Furthermore, the support services like packaging, labeling, and regulated logistics are the fastest-growing sectors, thus ensuring the safety of handling the short half-life isotopes. All these trends taken together represent a market that is highly precise, technologically advanced, and strategically partnering to shape the future of radiopharmaceutical development and ​‍​‌‍​‍‌delivery.

Key Players in the Market:

• Cardinal Health
• Curium Pharma
• Siemens Healthineers
• GE Healthcare
• Eckert & Ziegler
• Lantheus Holdings
• ITM Isotope Technologies Munich
• NorthStar Medical Radioisotopes
• SHINE Technologies

Telix Pharmaceuticals