Within pharma services, Biospring maintains a strong conviction in contract development and manufacturing organizations (CDMOs) and other outsourced services. As part of this theme, we have been tracking the emerging field of radiopharma over the last several years. Due to requirements specific to this space, radiopharma’s supply chain will need to leverage multiple categories of outsourced manufacturing and services to support its growth.  In recent years, there’s been a significant uptick of activity in the field of radiopharma from investors and industry participants. While radiopharma has existed for decades for diagnostic purposes (in addition to several first-generation drugs), growth in the space is being driven by more potent isotopes, expanding diagnostic use cases, and the general advancement of targeted therapeutics, such as ADCs. Many companies have nuclear medicine teams that have been working together over their entire careers and are currently applying that know-how to developing cancer drugs. There are now numerous development-stage biotech companies aiming to create the next generation of radiotherapeutics. Since 2018, there has been ~$3 billion invested into more than 90 companies1. The rise in radiopharma biotech companies, and growing large pharma interest, will require significant investment in the radiopharma supply chain to ensure the success of these novel therapeutics.

What is Radiopharma?

Radiodiagnostics:

Radiopharma is a class of drugs that contain chemical elements called radioisotopes that can be used to diagnose or treat diseases2. Radiodiagnostics is the larger, more established market and is currently sized at ~$7B3. These diagnostics, such as positron-emission tomography (PET) scans can be used to track cancer, cardiovascular disease, and even neurodegenerative disease. In October 2023, CMS lifted a once-per-lifetime limitation and announced it would cover amyloid PET scans to help diagnose Alzheimer’s Disease. This announcement is a significant part of the growth story for radiodiagnostics, as PET scans move from mostly cancer diagnoses (which are also growing rapidly) into neurological conditions. Interestingly, radiodiagnostics will be market-expanding for pharma. More patients will now be diagnosed using radiodiagnostics, treated with the appropriate drug, and then monitored again using radiodiagnostics.

Radiotherapeutics:

Radiotherapeutics, the second market within radiopharma, has attracted substantial investor and industry interest in recent years. While radiodiagnostics diagnose and monitor conditions, radiotherapeutics aim to treat diseases, namely cancer. This class of medicine is a rapidly-evolving modality that pairs a radioisotope (e.g. a radioactive molecule) linked to a targeting molecule with the goal of delivering the drug to the tumor with precision.

Figure 1. Radiotherapeutics bind to cancer cells and emit radiation to kill the tumor

Source: National Cancer Institute, Biospring Partners

These drugs are similar to antibody-drug conjugates (ADCs), in that they consist of a targeting molecule linked to a payload. The key differentiator with radiotherapeutics, however, is the following: if you can target the tumor, the drugs will kill cancer cells because they are emit radiation. In this regard, the mechanism of action of radiotherapeutics is straightforward. They do not need to get inside the cell and release their payload in the way that ADCs operate (although some are endocytosed by the cell), and they are not reliant on a biological cascade to induce cell death. Further, tumors cannot develop resistance to radiotherapeutics.

Figure 2. Two broad markets within radiopharma

Source: Current market size estimates per Solomon Partners

The radiotherapeutics market size is currently ~$3B, but growing rapidly3. There have been several approved radiotherapeutics on the market within the last decade, but the first drug launched in a large patient indication (prostate cancer, although not first-line therapy), Pluvicto, was launched by Novartis in 2022. Pluvicto achieved $980M in sales – near blockbuster status – in its first full year on the market4. On the R&D front, next-gen isotopes called “alpha” emitters are driving excitement in the space. Compared to the existing “beta” emitters currently on the market, these alpha isotopes pack a much stronger punch over a shorter range. Alpha emitters also aim to kill the tumor cells while not harming the surrounding healthy tissue. Some alphas, such as Actinium-225, also have a significantly longer half-life, which enables them to be centrally manufactured and shipped to the point of care vs manufacturing near the patient. Alpha emitters should improve drug profiles across categories: more energy emitted means more cancer cell death, shorter range means better safety, and longer half-life means more scalability.

Why Now?

We are witnessing an uptick in deal activity and investment in the radiopharma space. Novartis, which historically was the main player in radio, is now joined by multiple other big pharma companies. AstraZeneca, BMS, and Eli Lilly all have entered the radiopharma space in recent months via multi-billion dollar acquisitions. These acquisitions were of clinical-stage radiotherapeutic assets that accelerate large pharma’s path to commercialization for those that get approved. In addition to the strategic transactions, the pace of institutional investment in the field is accelerating. According to Pitchbook data, institutional investment in radiopharma reached $947M in 2023, a 57% increase over 2022 figures.

Figure 3. Radiopharma institutional investment since 2018

Source: Pitchbook

The Path Forward

While there has been recent unmatched enthusiasm in radiopharma, supply chain challenges need to be addressed before these drugs can reach their full potential for companies and patients. Access to raw materials is an acute challenge for many radiopharma manufacturing companies, affecting the downstream supply. Producing the radioisotope efficiently with limited waste and purified finished products is another hurdle. Further, certain targeting molecules will work better with specific isotopes, which will influence manufacturing and distribution decisions depending on the half-lives of the drugs. Investment is needed in the companies that manufacture the radioisotopes to meet future demand. Given their unique attributes, more infrastructure will be required to make and deliver these drugs to patients. Radiopharma is poised to become another major modality, and investing in its supply chain will be key to unlocking its full potential for patients worldwide.

1.Pitchbook; Biospring data pull for radiopharma financings since 2018
2.IAEA:What are Radiopharmaceuticals?
3.Market size estimates per Solomon Partners
4.Novartis 2023 Product Sales