Execute Or Decay: Radiopharma's Outsourcing Reality

By Louis Garguilo, Chief Editor, Outsourced Pharma

The radiopharmaceuticals industry is benefiting from increasing investments and a rush of promising innovation.

At the same time, it faces a rather spotty outsourcing services and supply infrastructure.

The Radiopharmaceutical Blueprint Report calls this the industry’s central paradox, “a multi-billion-dollar wave of investment and commercial validation is colliding with a fragile, underdeveloped infrastructure” of isotope supply, GMP manufacturing, and talent.

In radioligand therapy (RLT), the gap between capital and capability needs to fill in soon. If you’re a radiopharma developer, lost time literally diminshes your chances of success.

But time and competition aren’t the only challenges. The Blueprint Report says“execution is the new IP” in radiopharma, and execution is mastered via partnerships with CDMOs.

On the regulatory front, the FDA is keeping pace by issuing new guidance welcomed by experts in the industry (“Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development”).

The guidance should assist sponsors in identifying optimized dosages (administered activity and scheduled) for radiopharmaceutical therapies (RPTs) "for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage." 

Such clearer terms of engagement will help both sponsors and CDMOs move forward.

And there’s a lot to push forward.

The Blueprint Report projects the global radiopharmaceutical market size to grow  from $7.92 billion in 2025 to an eye-catching $16.87 billion by 2033. That’s a CAGR of 9.9% during that forecast period.

Who Wins The Radiopharma Race?

The list of radiopharma developers includes namebrand sponsors (e.g., AstraZeneca, Bayer, Novartis) as well as a growing contingent of emerging companies (e.g., Plus Therapeutics, ARTBIO Inc., Convergent Therapeutics, Precirix NV).

These and other sponsors will require talented scientists and managers (more directly below), but to succeed, they’ll be the organizations that forge productive partnerships with specialized CDMOs, logistics providers, and clinical service experts.

However, according to the Blueprint Report, radiopharma developers face three linked scarcities: isotopes, GMP manufacturing capacity, and sufficient specialized talent.

From the report:

“Fragile ¹⁷⁷Lu production (aging reactors); extreme ²²⁵Ac scarcity (finite stockpiles vs. new tech); shortage of GMP hot cells; just-in-time decay-timed logistics; and a severe shortage of radiochemists, nuclear pharmacists, and medical physicists ... [f]or most developers," a viable outsourcing ecosystem is the only viable path to de-risk programs and accelerate timelines.

"Success in the RLT industry is structurally defined by a mandatory, not optional, reliance on a complex web of external partners.”

Particularly of concern is a “systemic shortage of specialized human capital has surpassed access to capital as the single greatest constraint on the industry’s growth.”

The report even coins a new knowledge-worker archetype — the “Tri-Brid” professional.

This skilled worker combines oncology expertise, nuclear medicine physics, and pharma development know-how. 

Unfortunately, supply of such talent is estimated to currently lag demand by “five-to-one.” 

Only a handful of new radiochemistry PhDs graduate each year in the U.S., and expertise in handling alpha-emitters can’t be learned overnight. The result is competition for scant resources, high turnover and inflated salaries.

Not Just The Humans

Radiopharma developers also face two non-human scarcities: isotopes and GMP manufacturing capacity.

Isotope supply is the first hurdle. Transforming a raw isotope into a patient-ready drug requires GMP “hot cell” manufacturing, dual FDA/NRC compliance, and decay-timed logistics.

The Blueprint Report mentions an isotope bottleneck has been headline news: Lutetium-177 (¹⁷⁷Lu), Actinium-225 (²²⁵Ac); and there’s a shortage of alpha-emitters like Lead-212 (²¹²Pb) because of proprietary supply chain challenges.

Through all this, specialized CDMOs must continue to step up as the manufacturing arms and strategic partners for radiopharma developers of all sizes.

Some CDMOs can in fact offer a range of the services needed for radiopharma development.

The Bluepring Report mentions Nucleus RadioPharma, SpectronRx, and AtomVie Global Radiopharma for investing heavily in facilities and compliance.

The Report also cites organizations as divergent as Cardinal Health and SOFIE Biosciences, which operate as service providers and drug developers.

These organizations leverage their radiopharmacy networks to offer manufacturing, distribution, and their own proprietary therapies.

Such organizations are important because radiopharmaceutical logistics are unlike those of other conventional drug development programs. There’s no “warehouse buffer” for a drug with a half-life measured in hours or days.

This has made radiopharmacy networks – the last-mile command centers – an essential extension of the manufacturing process.

Some developers, like Telix, are moving aggressively to acquire radiopharmacy networks outright.

From isotope suppliers like ITM and NorthStar, to CDMOs like AtomVie, to logistics providers like Life Couriers, the sector now runs on a dense web of partnerships.

Big Pharma’s recent spree of multi-billion-dollar “ecosystem acquisitions” – think Bristol Myers Squibb buying RayzeBio or AstraZeneca acquiring Fusion Pharmaceuticals – isn’t just about assets.

It’s an instant acquiring of infrastructure, securing distributed supply chains, and most importantly as pointed out above, adding an intact skilled workforce.

The Map To Radiopharma Success

The Blueprint Report would of course by incomplete without a plan of some sort. It dubs that effort a “5-year roadmap” applied individually at organizations and to our entire outsourcing ecosystem.

1. Secure the Engine Room

The report advises well-capitalized sponsors and CDMOs to control their isotope supply and manufacturing processes. This means investing in reactors, accelerators, or proprietary isotope technologies.

For emerging biotechs, there should be an effort when contracting to lock in trusted CDMO relationships, and longer term supply agreements where possible.

2. Build the Factory Floor

Smaller developers depend on shared infrastructure, and scaling requires GMP capacity – which necessitates an expanding specialized, pure-play CDMO infrastructure.

This means adding square footage or hot cells, but also building a resilient, distributed network of manufacturing sites to conquer logistics and regulatory burdens.

3. Grow The Talent Pool

As per above, the human-resource crisis has eclipsed capital as a growth constraint.

Expanding training and incentivizing cross-disciplinary education is critical. Sponsors able to should consider acquiring intact teams through M&A. We should encourage universities to teach these skills the industry needs today and in the future.

For a CDMO, the availability and caliber of sustained talent will be a differentiator from its competitors. Biotechs (of all sizes) will have trouble succeeding without stable human resources at their CDMOs.

In radiopharma, the physics of decay make a supply-chain delay untenable. We need to think as an industry as well as individual innovators and service providers about solving for our growth in this arena.