Three Signals That Radiopharmaceuticals Have Become the Next Battleground in 2026

Recently, Hengrui Medicine’s announcement that it had obtained clinical trial approval for Lutetium [177Lu] Oxodotreotide Injection sparked renewed excitement. The narrative that “radiopharmaceuticals are the next strategic battleground” has once again made headlines in mainstream media.

In fact, industry insiders have long felt the urgency surrounding this “battleground.”

Let us first examine the key players in this field. Novartis has solidified its leading position in the global radiopharmaceutical drug conjugate (RDC) sector with two products, Lutathera and Pluvicto, acquired through mergers and acquisitions. Bayer, meanwhile, firmly regards targeted radionuclide therapy (TRT) as one of the three pillars driving growth in its oncology business. Having already launched products in the nuclear medicine space and reaped the benefits, both Novartis and Bayer continue to increase their investments, serving as the strongest endorsement for this industry.

It is not only multinational corporations (MNCs) that have recognized this strategic opportunity. In Europe, the birthplace of innovative radiopharmaceuticals and a powerhouse in the radiopharmaceutical industry, strategically minded upstream companies such as ITM and IBA are also moving quickly to secure their position. Whether through establishing joint ventures or making strategic investments in R&D enterprises, they are aiming for early entry and deployment, seeking to capture a share of what could become a multi-billion-dollar market in the future.

Numerous players have entered the field, driving exceptional industrial innovation: radioligand therapies using novel radionuclides such as Ac-225 are demonstrating significant potential in cancer treatment, while the “battle” for new targets like FAPI has already begun.

This industrial atmosphere also influences domestic players. Despite the presence of industry giants such as Novartis and Bayer, the field of radiopharmaceuticals remains a vast landscape with significant potential for growth. Prior to Hengrui Medicine, companies like Xiantong and Grand Pharma had already made substantial investments to secure early-mover positions. In the highly regulated radiopharmaceutical sector, Chinese companies possess a deeper understanding of the local regulatory environment and market dynamics; if they can capitalize on their first-mover advantage, the future market prospects are promising.

On February 7, VCBeat New Medicine organized an online panel discussion on the annual review of radiopharmaceuticals. We explored why radiopharmaceuticals are becoming the next critical competitive frontier.

Following the market launches of Bayer’s Xofigo and Novartis’s Lutathera and Pluvicto, both international pharmaceutical giants continue to ramp up their investments in the radiopharmaceutical sector. A series of acquisitions and strategic initiatives underscore the ambitions of these two industry titans, setting the stage for direct competition as the battle for dominance in radiopharmaceuticals heats up.

In 2021, Bayer entered into acquisition agreements with Noria Therapeutics (Noria) and PSMA Therapeutics to secure exclusive rights to a differentiated alpha-particle radionuclide therapy based on actinium-225 and a small-molecule agent targeting prostate-specific membrane antigen (PSMA), specifically indicated for prostate cancer. Meanwhile, collaborations with innovative radiopharmaceutical companies such as Ratio Therapeutics are actively progressing. In media interviews, Bayer executives firmly stated that targeted radionuclide therapy (TRT) would become one of the three key pillars driving growth in its oncology business.

Turning to Novartis, Pluvicto has been on the market for less than a year, yet it is demonstrating robust revenue growth, with the CEO regarding it as the next $2 billion blockbuster drug. Novartis continues to deepen its footprint in the field of radiopharmaceuticals by targeting fibroblast activation protein (FAP). The company has entered into an assignment agreement with iTheranostics, a subsidiary of SOFIE Biosciences, securing exclusive global rights to develop and commercialize therapeutic applications of a library of FAP-targeting agents, including FAPI-46 and FAPI-74. Meanwhile, Novartis has forged additional high-value strategic collaborations: it has established a global partnership with Artios Pharma Limited, a company specializing in DNA Damage Response (DDR), to develop and validate next-generation DDR targets and expand its radioligand therapy (RLT) pipeline; furthermore, it has entered into a strategic collaboration with biotechnology firm Molecular Partners to integrate Molecular Partners’ proprietary DARPin technology platform with Novartis’ unique RLT capabilities, exploring novel targeted therapies for cancer.

The sustained investments by Novartis and Bayer are not merely aimed at generating returns; they are also critical to the nuclear medicine industry. These efforts have not only driven the renaissance of the radiopharmaceutical sector but are also expected to spur the market launch of a series of PSMA-targeted radiopharmaceuticals, potentially expanding the nuclear medicine market to tens of billions of dollars.

VCBeat: Recently, Novartis released its 2022 financial report, in which the radiopharmaceutical product Lutathera achieved sales of $471 million in 2022, while another radiopharmaceutical product, Pluvicto, generated annual revenue of $271 million. What prospects for the radiopharmaceutical market are highlighted by the revenue figures of these two products? Can Pluvicto become a blockbuster drug surpassing $2 billion in sales?

Liu Chuanwen, Managing Director of Xinjun Capital:Lutathera’s cumulative sales have yet to surpass $500 million. When benchmarked against traditional drug sales trajectories, this figure is not particularly impressive. However, its performance is attributable to specific circumstances, primarily for two reasons. First, the drug is indicated for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which affect a relatively small patient population. Second, prior to the entry of multinational pharmaceutical companies such as Novartis and Bayer, the radiopharmaceutical industry faced significant supply chain vulnerabilities, particularly in raw material sourcing. Consequently, the industry was not yet prepared for large-scale, feasible clinical trials. Under these conditions, it is understandable that annual revenues have remained in the $400–500 million range over the years.

Looking at Pluvicto, regulatory controls on the use of radiopharmaceuticals in Europe and the United States are relatively flexible, but strict requirements are imposed on personnel qualifications, hardware, and software. From this perspective, although Pluvicto was approved in the first half of last year and thus had only two quarters of sales, it achieved sales revenue of $271 million, which is a commendable performance.

Novartis stated that Pluvicto is poised to become a blockbuster drug with $2 billion in sales, a prospect I consider entirely plausible. First, the radiopharmaceutical supply chain has been continuously strengthened over the past five years. Second, during the development of Lutathera, Novartis established more comprehensive standards for the entire spectrum of radiopharmaceuticals, including CMC (Chemistry, Manufacturing, and Controls) studies and clinical use. Third, Pluvicto is indicated for metastatic castration-resistant prostate cancer (mCRPC), a patient population and market substantially larger—potentially by an order of magnitude—than that for gastroenteropancreatic neuroendocrine tumors. Consequently, Pluvicto is expected to see significant improvements in raw material supply, CMC processes, standardization of clinical administration, and accessibility.

Hui Qi, General Manager of Fuliang Medicine China:A Phase III clinical trial for Pluvicto has concluded, with data demonstrating excellent efficacy, thereby endorsing its future market prospects from a therapeutic standpoint. Meanwhile, the drug is undergoing indication expansion to include hormone-sensitive prostate cancer (HSPC), with the aim of advancing its use from third-line to second-line therapy. Driven by these two factors—further expansion of the patient population and the shift from third- to second-line treatment—it is believed that Pluvicto’s breakthrough of $2 billion in sales is imminent. This underpins why Novartis’ CEO confidently described Pluvicto as a blockbuster product with sales potential of $2 billion or even higher.

Ge Qiang, Deputy General Manager of Neurita:Novartis is likely to achieve this target, especially since Pluvicto has not yet been launched in China. Its market entry in the future would make achieving this goal considerably easier. Novartis has already obtained approval to conduct clinical trials in China, and these trials are currently underway. Should the trials proceed smoothly and regulatory approval for marketing be granted, the company may still face challenges related to logistics, customs clearance, and other market access issues, which will need to be effectively addressed. Regardless, if Pluvicto is launched in China, its future market potential will be substantial.

In my view, Novartis’s Pluvicto has spurred a wave of radiopharmaceutical R&D among pharmaceutical companies. Many firms have identified certain limitations of this product and are working on improvements. I anticipate the emergence of more innovative products in this space in the future. Novartis’s contribution extends beyond the approval of a single PSMA-targeted radiopharmaceutical; it will catalyze the market launch of a series of PSMA-based radiopharmaceuticals.

VBInsight: Bayer is also actively expanding into the radiopharmaceutical sector. How are its radiopharmaceutical products performing in the market?

Liu Chuanwen, Managing Director at Xinjun Capital:Specific data for Bayer’s Xofigo have not yet been released. From my perspective, Xofigo is indicated for bone metastases in late-stage castration-resistant prostate cancer (CRPC). Its therapeutic objective differs from that of Novartis’s two drugs; rather than primarily inhibiting prostate cancer itself, it mainly targets bone metastases. Xofigo bears some similarity to Lutathera, with both having experienced stagnant sales for many years. This may be partly because there are relatively few radionuclides globally, such as Ra-223, at the GMV scale, and partly because the choice of indications is somewhat limited. These factors have objectively placed pressure on Bayer.

Nevertheless, beyond this drug, Bayer has recently undertaken significant efforts in the FAPI and PSMA domains, which we view with considerable anticipation. We believe that Bayer will introduce products capable of competing with Novartis, or deliver surprises in terms of indications and other aspects.

Hui Qi, General Manager of Fuyuan Pharmaceuticals China: In addition to the already marketed Xofigo, Bayer currently has a HER2 project in Phase I clinical trials, which is its most advanced pipeline asset. There are also two PSMA pipeline assets in preclinical research. No further progress has been disclosed for other pipeline assets.

Bayer has been strategically positioning itself in the field of radiopharmaceuticals for many years, acquiring numerous macromolecular radiopharmaceutical pipelines primarily based on thorium-227. Current data suggest that these macromolecular candidates may not demonstrate efficacy superior to that of small-molecule or peptide-conjugated radiopharmaceuticals, resulting in somewhat slower progress.

In the field of radiopharmaceuticals, Bayer is a force to be reckoned with. I speculate that it may engage in significant acquisitions down the line, as its internal pipeline is progressing relatively slowly; consequently, it may seek to in-license or acquire external assets and companies with more advanced development stages.

Ge Qiang, Deputy General Manager of Newrate:Bayer holds a competitive advantage in China, as its radium-223 has already received marketing approval. The company has successfully established comprehensive pathways for registration, clinical trials, hospital listing, and logistics, which constitutes a significant strength given the current scarcity of imported radiopharmaceuticals available on the market. Another advantage lies in Bayer’s focused commitment to alpha-emitting radionuclide therapies. Alpha-particle therapy offers inherent benefits, including lower dosage requirements and shorter path lengths, thereby strengthening Bayer’s strategic positioning in the field of nuclear medicine.

In September 2022, Belgian particle accelerator developer IBA and the Belgian Nuclear Research Centre SCK CEN jointly established the joint venture Pantera SA/NV to ensure the large-scale production of actinium-225 (Ac-225). IBA is a global leader in particle accelerator development, while SCK CEN is Belgium’s largest nuclear research center. The Ac-225 slated for large-scale production is an alpha-emitting radionuclide with significant potential in cancer therapy.

This news signals upstream companies’ entry into the radiopharmaceutical sector.

The close integration of upstream and downstream enterprises is not an isolated case; Chinese companies have already emerged in such collaborations. In 2022, Grand Pharma subscribed to new shares of Germany’s ITM Isotope Technologies Munich SE for €25 million, securing exclusive rights to develop, manufacture, and commercialize three globally innovative radiopharmaceutical drug conjugates (RDCs) developed by ITM within the Greater China region. ITM is one of the few biotechnology companies worldwide that integrates the research and development, production, and supply of radiopharmaceuticals.

Europe boasts a robust foundation for innovative radiopharmaceuticals and stands at the forefront of industry development. Upstream radionuclide producers, such as IBA and ITM, have leveraged their keen market insight and strategic vision to identify the vast potential of the radiopharmaceutical sector. Their entry into this field is underpinned by inherent resource advantages, as radiopharmaceuticals are heavily dependent on upstream radionuclide suppliers. Insufficient radionuclide production capacity would fail to meet the demands of clinical research, drug supply, and therapeutic applications. Whether through external collaborations or by cultivating in-house biotech teams,These upstream companies are all eager to carve out a share of the radiopharmaceutical market through various means, and their entry underscores that this sector has truly become a fiercely contested battleground with numerous participants.

VCBeat New Medicine: What Does the New Collaboration Model Between IBA and SCK CEN in Establishing the Joint Venture Pantera SA/NV Mean for the Radiopharmaceutical Field?

Ge Qiang, Deputy General Manager of Newrite:IBA has demonstrated keen market sensitivity. Although its core business is particle accelerators, it possesses deep expertise in radionuclide production and is well-versed in the supporting infrastructure and processes required by downstream pharmaceutical companies. Since one of the technical routes for producing Actinium-225 (Ac-225) involves accelerator-based methods, and given that some users may have expressed such demands to IBA, coupled with the growing interest among many companies in developing alpha-emitting radionuclide drugs, IBA has identified a significant opportunity in this space. IBA exhibits strong strategic vision and holds considerable advantages as a leader in accelerator technology, enabling it to help customers address the supporting infrastructure and technological challenges associated with radionuclide production. By establishing joint ventures, IBA can not only resolve Ac-225 production issues for downstream enterprises but also expand its established business model of integrating accelerators with radionuclide solutions.

Liu Chuanwen, Managing Director at Xinjun Capital:This is a highly positive development for the entire industry. The radionuclide sector is distinct in that its specialization is not as finely segmented as that of conventional pharmaceuticals. Consequently, the entities truly capable of executing large-scale commercialization are largely those companies that control nuclear reactors and particle accelerators. However, these players have historically been somewhat removed from the medical field.

The situation has improved significantly, particularly after pharmaceutical giants such as Novartis entered the field. Companies like IBA are also keen to promote their core business, especially the widespread adoption of accelerator sales. On the other hand, I believe they have another intention: to enter the radiopharmaceutical sector and capture a share of the market.

Many upstream manufacturers may consider this development insignificant. However, in the past two years, not only has IBA chosen to expand into the radiopharmaceutical sector, but ITM has also been consistently extending its reach downstream, including through its collaboration with Grand Pharma. Traditionally focused on radionuclide production, ITM would not typically venture directly into the pharmaceutical domain; nevertheless, it is now opting to partner with pharmaceutical companies. This shift reflects the broad optimism surrounding the growth of the radiopharmaceutical industry. As upstream suppliers, downstream distributors, pharmaceutical developers, and traditional radionuclide producers all become integrated into the ecosystem, fresh vitality will be injected into the radiopharmaceutical field.

Hui Qi, General Manager of Fulian Pharma China:The establishment of the joint venture was also driven by IBA’s recognition of the broad market prospects for radiopharmaceuticals. Previously, IBA may have considered the radiopharmaceutical sector immature and limited in scale, with only a few small companies engaged in radiopharmaceutical diagnostics. These smaller players generated minimal annual revenue, falling far short of the threshold required for IBA’s direct participation. Now, however, IBA sees it as a multi-billion-dollar market driven by strong demand, recognizing it as a lucrative business opportunity and thus choosing to enter this field to expand its operations.

Once IBA overcomes the technical challenges associated with radionuclides, it will evolve into an integrated enterprise offering both accelerators and radionuclides, significantly expanding its business scope and promising strong future prospects.

The vibrant nuclear medicine market cannot do without the participation of Chinese nuclear medicine companies.

Chinese traditional pharmaceutical companies are transforming into innovative nuclear medicine enterprises. Xiantong Medicine is one of the earliest pioneers in innovative nuclear medicine in China, raising a record-breaking nearly RMB 1 billion in financing within just over two years. They previously told VCBeat that innovative nuclear medicine was their best choice for transformation. Leading domestic pharmaceutical companies are making significant moves into the nuclear medicine sector; Grand Pharma invested USD 1.4 billion to acquire Sirtex in 2018. Hengrui Medicine has also entered the field of nuclear medicine, with its lutetium [177Lu] oxodotreotide injection approved for clinical trials this year.

Innovative nuclear medicine biotech companies are continually emerging. Professors with backgrounds in research institutes have long been engaged in the translation of scientific achievements, contributing to the development of nuclear medicines from basic research and clinical translation to industrialization. Meanwhile, innovative pharmaceutical enterprises with a global perspective, such as Fuyuan Medicine, have also joined this endeavor.

These radiopharmaceutical companies are driving the sector into the mainstream through diverse collaborations, creating a buzz that gives the impression of intensifying competition. However, as industry insiders note, the high barriers to entry in radiopharmaceutical technology and manufacturing make it difficult for true hyper-competition to take hold. Nevertheless, the competitive landscape within the industry is poised to become increasingly fierce.

VCBeat New Medicine: With everyone targeting the same mechanisms, will the radiopharmaceutical sector become overly competitive? Have you observed shifts in China’s radiopharmaceutical industry? If so, what are your specific observations?

Liu Chuanwen, Managing Director at Xinjun Capital:According to our statistics, there are now over 30 nuclear medicine companies in China, with as many as 16 Chinese enterprises focusing exclusively on PSMA-targeted radiopharmaceuticals., this is merely what we are aware of; there remains much that is unknown. The intense competition within the radiopharmaceutical sector is largely a positive phenomenon. As more players enter the field, differentiation can be achieved from various perspectives, thereby gradually allowing superior contenders to emerge.

Hui Qi, General Manager of Fuliang Pharmaceuticals China:Some domestic companies will first develop one or two generic radiopharmaceuticals to establish their qualifications, CMC, logistics, and other systems before proceeding to develop innovative radiopharmaceuticals.Combining imitation with innovation is an excellent strategy, as radiopharmaceuticals face significant geographic barriers, making it difficult for originator companies to enter the market quickly or easily. If these enterprises can also resolve upstream radionuclide supply issues, their growth potential will be substantially greater.

Furthermore, there are currently limited validated targets for radiopharmaceuticals. To date, only a few targets, such as SSTR2 and PSMA (particularly PSMA), have demonstrated clinical success. Consequently, ongoing efforts are focused on exploring additional targets to identify more promising candidates. Theoretically, any target amenable to antibody-drug conjugates (ADCs) is also suitable for radionuclide drug conjugates (RDCs). In this regard, increased research investment is likely to facilitate the discovery of superior targets and the expansion of indications.

Ge Qiang, Deputy General Manager of Neurita:In the radiopharmaceutical industry, we commonly segment the value chain into upstream, midstream, and downstream sectors, corresponding to medical isotope supply, radiopharmaceuticals, and nuclear medicine, respectively. Each sector constitutes its own distinct ecosystem, and all are highly dynamic and active.For instance, in the upstream sector, since the state issued the Medium- and Long-Term Development Plan for Medical Isotopes, many state-owned enterprises, private enterprises, and foreign-invested enterprises have begun to strategize their production and collaboration in medical isotopes. We have already discussed the midstream sector extensively; we pharmaceutical companies are currently operating within this midstream ecosystem. The downstream sector is also highly active, with stakeholders focusing on diverse areas and conducting substantial exploratory, validation, and foundational scientific research.

It can be said that every circle in the upstream, midstream, and downstream is accelerating, spinning faster than before, but it feels like there is a lack of a coordinated mechanism to connect these three circles. I think,The radiopharmaceutical agents we are studying serve as the link connecting the upstream, midstream, and downstream sectors., because after upstream entities produce radionuclides, if midstream pharmaceutical companies lack demand, there will be little enthusiasm for extending downstream; thus, radionuclide production remains merely a technical capability.

Currently, these three circles are already interacting. Many products in the industry have linked the three circles together, but development is still insufficient, and the variety remains limited.

In addition to the three circles of upstream, midstream, and downstream,There is also a fourth circle, that of regulation and compliance.In addition to mastering the “three circles,” we must also develop in compliance with regulatory requirements. Regulatory authorities are now more willing to solicit feedback from enterprises to address practical challenges. However, due to the limited number of products, targeted regulations remain insufficient. As the product portfolio expands and integrates the entire upstream, midstream, and downstream sectors, communication with regulatory agencies will increase, helping to overcome bottlenecks constraining the development of radiopharmaceuticals.