Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Automated Radiosynthesis Module Market size was valued at USD 226.6 million in 2024 and is projected to reach USD 651.4 million by the end of 2037, rising at a CAGR of 10.3% during the forecast period, i.e., 2025-2037. In 2025, the industry size of automated radiosynthesis module is assessed at USD 246.8 million.
The market is unfolding remarkable growth opportunities owing to the advancements in radiopharmaceutical production, AI-based synthesis optimization, and the need for oncology diagnostics. Moreover, the increasing burden of cancer and neurological disorders among the worldwide population is creating a heightened necessity. In this regard, the WHO estimated 20.4 million new cancer cases annually, including prostate, breast, and neuroendocrine cancers, which comprise a significant count, further compelling PET-based therapeutics and diagnostics. NIH notes that above 56.2 million individuals worldwide are affected by dementia, extending the need for GMP-compliant radiosynthesis systems.
Furthermore, the global market is enhancing, relying on the supply chain aspect that constitutes raw materials such as cyclotron-produced isotopes - F-18, Ga-68, Lu-177, chemical precursors, and precision-engineered module components. In this context, the U.S. Department of Energy data in 2024 notes that domestic isotope production remains critical, with over 58.9% being imported from international reactors. On the economic front, the PPI for medical isotope synthesis is enhanced by 4.5%, simultaneously CPI for radiopharmaceuticals witnessed an annual rise of 7.4%, thus ensuring elasticity in the automated radiosynthesis module market.
Automated Radiosynthesis Module Sector: Growth Drivers and Challenges
Growth Drivers
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Efficiency of AI in radiosynthesis: This is one of the primary drivers in the market, as the AI-based radiosynthesis fuels efficiency. In this regard, NIH in 2024 reported that AI algorithms conserve tracer synthesis time by 36.3% at the Mayo Clinic. Besides, Germany-based BMBF allocated €91.5 million towards AI-based modules. Further machine learning reduces Ga-68 waste by 20.4%, lowering production costs further, denoting a positive market development.
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Focus on early-stage theranostic intervention: This is yet another driver that positively impacts the automated radiosynthesis module market across all nations. In this regard AHRQ study in 2023 found that employing PSMA-PET guided treatments remarkably reduced prostate cancer hospitalizations by 34%, i.e., USD 2.2 billion in the U.S. healthcare expenditure in a span of two years. Besides, hospitals that leverage radiosynthesis systems reported a 40.3% fast tracer production, improving patient outcomes.
Historical Patient Growth and Its Impact on the Automated Radiosynthesis Module Market
During the assessed time frame, the leading marketplaces across the world witnessed a huge expansion in the patient base of the automated radiosynthesis module market. Over the last decade, there has been an upsurge in consumer base requiring PET or CT diagnostics and theranostics owing to the rise in aging demographics, improved diagnostic capabilities, and gradual progress in healthcare access in emerging nations. This exponential growth has directly influenced ARM adoption as hospitals and radiopharmaceutical manufacturers scaled up production to meet tracer demand.
Historical Patient Growth (2010–2020) – Radiopharmaceutical Users (Millions)
|
Country |
2010 Patients |
2020 Patients |
CAGR |
Key Driver |
|
U.S. |
1.4 |
3.2 |
9.2% |
PSMA-PET adoption |
|
Germany |
0.8 |
1.6 |
9.1% |
Neuroendocrine tumor diagnostics |
|
France |
0.6 |
1.2 |
9.8% |
Government-funded theranostics |
|
Spain |
0.4 |
0.9 |
13.5% |
Improved PET infrastructure |
|
Australia |
0.3 |
0.6 |
15.2% |
Rising prostate cancer cases |
|
Japan |
1.2 |
2.3 |
10.2% |
Aging population + dementia research |
|
India |
0.07 |
0.5 |
19.8% |
Urban diagnostic expansion |
|
China |
0.5 |
1.7 |
17.6% |
State-backed oncology programs |
Manufacturer Strategies Shaping the Automated Radiosynthesis Module Market
The ultimate aim of the international expansion of the automated radiosynthesis module market can be achieved with the implementation of strategies such as product innovation, penetrating into emerging nations, and emphasizing regulatory reimbursements. For instance, in 2024, the U.S FDA’s approval for an AI-based automated radiosynthesis module resulted in the creation of a USD 221.3 million niche market. Besides, IBA Radiopharma announced a partnership with India’s Tata Memorial Hospital that gained USD 51.2 million in orders, facilitating access in domestic settings.
Revenue Growth Opportunities for ARM Manufacturers (2023–2025)
|
Company |
Strategy |
Revenue Impact |
Market Expansion |
|
Siemens Healthineers |
AI-integrated Synthra Pro |
+$120.2 million (U.S./EU) |
Neurology tracers |
|
GE Healthcare |
FASTlab 2 cost reduction |
+$82.3 million (Asia) |
Compact ARM demand |
|
IBA Radiopharma |
India/LATAM partnerships |
+$51.2 million |
Theranostics focus |
|
Sumitomo Corp. |
Modular ARM systems |
+$40.3 million (Japan/Asia) |
Aging population |
Challenges
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Fiscal restraints: This is one of the primary uncertain factors in the automated radiosynthesis module market, as the government price controls limit profit margins of manufacturers. For instance, in 2023 in Europe, the imposed price caps resulted in reduced profitability by 22.5% in ARM systems. Besides, Siemens Healthineers addressed this with value-based pricing agreements with Spain’s MoH, increasing market access by 10.3%.
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Limited reimbursement: The novel radiotracers emphasized in the automated radiosynthesis module market witness limited reimbursements that pose a negative outcome for market expansion. WHO reports in 2023 state that only 12 out of 27 nations in the EU reimburse Ga-68 PSMA-PET. However, companies such as Bayer overcame this by collaborating with France’s HAS to secure €52.2 million per year reimbursement for LU-177 therapies.
Automated Radiosynthesis Module Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
10.3% |
|
Base Year Market Size (2024) |
USD 226.6 million |
|
Forecast Year Market Size (2037) |
USD 651.4 million |
|
Regional Scope |
|
Automated Radiosynthesis Module Segmentation
Application (Oncology, Neurology, Cardiology)
The oncology segment is expected to garner the highest share of 60.2% in the automated radiosynthesis module market by the end of 2037. This dominance is facilitated by the accelerated adoption of PSMA-PET diagnostics for prostate cancer, with the U.S. alone anticipated to diagnose 2.4 million new cases annually as of the NIH SEER 2024 report. Besides the theranostics evolution that combines diagnostics and therapy, further established ARMs in oncology units, as 42.4% of cancer centers in the U.S. now operate multiple modules to meet rigorous demand.
End user (Pharmaceutical Companies, Academic & Research Institutes, CROs & CDMOs)
The pharmaceutical company’s segment is projected to account for a share of 48.7% in the automated radiosynthesis module market during the forecast period. The exceptional growth in the segment is caused as they are the largest ARM adaptors, driven by USD 13.2 billion in radiopharmaceutical research investment. The spending is particularly concentrated on scaling production of targeted therapies implemented by Novartis, deploying above 50 ARMs across its worldwide facilities to manufacture Pluvicto. Furthermore, the growth in the segment is propelled by pipeline expansion, with above 120 radiopharmaceuticals in Phase III trials requiring GMP-compliant synthesis.
Our in-depth analysis of the global market includes the following segments:
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Product Type |
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|
Application |
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End user |
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Customize this ReportAutomated Radiosynthesis Module Industry - Regional Synopsis
North America Market Analysis
North America’s automated radiosynthesis module market is anticipated to dominate with the largest market share of 40.9% during the assessed timeframe. The market is driven by a 10.2% growth rate owing to factors such as enhanced Medicare spending and the tremendous adoption of PSMA-PET in the region. The leadership of the region is further propelled by the development tendency of countries such as the U.S. and Canada, which remarkably contribute to the industrial expansion, positioning North America as a key leader in the global market.
The U.S. automated radiosynthesis module market is poised for growth with immense exposure towards research and development. In this regard, NIH in 2024 assigned USD 1.4 billion towards AI-based R&D; simultaneously, Medicaid enhanced its Lu-177 coverage to above 86% of eligible patients. CMS in 2024 reports that there has been a USD 1.9 billion annual Medicare spending for radiopharmaceuticals, reflecting an extensive demand. Besides, PSMA-PET adoption for prostate cancer is expected to grow at 21.3% annually, with 2.4 million new cases by 2037, as of NIH SEER 2024 data.
The Canada automated radiosynthesis module market is undergoing exceptional expansion, rising at a CAGR of 9.6% during the forecast timeline. The country benefits from both federal and provincial healthcare investments, with Health Canada in 2024 allocating USD 3.4 billion towards precision medicine. Besides, Ontario extended its support with USD 201.3 million in PET infrastructure as of MOH 2024 data, with a collective aim to boost the ARM adoption by 52% by the end of 2030. Therefore, these factors will readily blister the market growth in Canada.
Europe Market Statistics
The Europe automated radiosynthesis module market is poised to hold a significant share of 30.2% by the end of the assessed timeframe. The growth is being facilitated with a 9.3% CAGR, coupled with isotope funding and theranostic trials. With a consolidated aim to reduce dependency on foreign reactors, the EU’s USD 602.3 million Isotope Strategy positioned Germany and France as the leading producers. Besides, there is a 46% increased demand for PSMA-PET diagnostics fueled by the increased burden of prostate cancer, accounting for 1.3 million cases in 2024.
Germany is the key contributor to expansion in Europe’s automated radiosynthesis module market, holding a 36.7% regional revenue share. The growth in the country is highly attributed to the presence of vigorous radiopharmaceutical strategies and enhanced demand for theranostics. In 2024, BMG allocated €1.3 billion, while Siemens Healthineers led the market with domestic ARM production. Besides, BFS data in 2024 unveiled that particularly theranostics account for 62% demand, with above 200 ARM units installed in 2024.
The market in France is projected to hold approximately 26.4% of the overall regional automated radiosynthesis module market, propelled by favorable reimbursement policies. HAS in 2024 reports that it offers €51.2 million per year reimbursement for Ga-68 and CEA’s AI-based synthesis research. Furthermore, INSERM data in 2024 expects that the mounting demand for neurology tracers will grow at 12.4% CAGR, thereby suitable for the automated radiosynthesis module market growth in the country.
Companies Dominating the Automated Radiosynthesis Module Landscape
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The key organizations involved in the automated radiosynthesis module market are readily implementing strategies such as modular system designs, GMP compliance, and AI-integrated optimization to strengthen their global market positions. The merchandise is collectively dominated by the presence of leading firms such as GE Healthcare, Siemens, and IBA, which captured over 50% market share. Besides, the emerging players are leveraging microfluidics and closed-loop automation to compete in the highly consolidated landscape. Furthermore, the development relies on partnerships with pharma firms and academia, which are critical for market expansion.
Here is the list of some prominent players in the industry:
|
Company Name |
Country |
Market Share |
Industry Focus |
|
GE Healthcare |
U.S. |
23.4% |
Leading ARM systems like FASTlab for PET radiopharmaceuticals. |
|
Siemens Healthineers |
Germany |
21.7% |
Synthera platform for high-yield radiochemistry. |
|
IBA Radiopharma Solutions |
Belgium |
16.3% |
Specializes in cyclotron-based radiopharma production. |
|
Eckert & Ziegler |
Germany |
13.2% |
Modular ARMs for clinical and research applications. |
|
Trasis |
Belgium |
9.5% |
Compact systems like All-in-One for FDG and niche tracers. |
|
Sumitomo Heavy Industries |
Japan |
xx% |
Integrated radiopharmacy solutions. |
|
Raytest (Berthold Technologies) |
Germany |
xx% |
Lab automation and quality control for radiopharmaceuticals. |
|
Comecer |
Italy |
xx% |
GMP-compliant ARM systems for nuclear medicine. |
|
Sofie Biosciences |
U.S. |
xx% |
Focus on microfluidic radiosynthesis. |
|
Scintomics |
Germany |
xx% |
GRP synthesis modules for research labs. |
|
Pharmalogic |
U.S. |
xx% |
Customizable ARM solutions for academia. |
|
Tema Sinergie |
Italy |
xx% |
Compact modules for small-scale production. |
Below are the areas covered for each company under the top 15 global manufacturers:
Recent Developments
- In March 2024, GE Healthcare launched FASTlab 2.0, a next-gen ARM with AI-driven synthesis optimization for PET radiopharmaceuticals. Reduces tracer production time by 25% and improves yield consistency.
- In January 2024, Siemens Healthineers launched Synthera, a modular upgrade supporting theranostic isotopes such as Lu-177, Ga-68. The U.S. FDA is cleared for dual-tracer production, addressing oncology demand.
Author Credits: Radhika Pawar
- Report ID: 7732
- Published Date: Jun 10, 2025
- Report Format: PDF, PPT
