Theranostics — melding precision diagnostics with targeted radiopharmaceutical therapy — has become a central focus in contemporary oncology. Middle-market investors are uniquely positioned to deploy capital into building the critical infrastructure that supports the theranostics supply chain and acquiring or licensing earlier-stage theranostic programs poised for growth.
This article is the last of a three-part series assessing middle-market investment opportunities across the theranostics landscape. This final installment addresses two critical growth vectors: ancillary logistics and services, which ensure compliant, time‑definite movement and handling of radiopharmaceuticals, and radiotracers, the IP-rich diagnostic assets that guide precision therapy. Together, these segments offer defensible, recurring economics and multiple strategic exit pathways as theranostics moves from specialty niche to mainstream oncology. Readers can reference Part I for the sector overview and deep dives on radiopharmacy networks and CDMO/CMO services and Part II for coverage of the isotope and generator ecosystem and clinic enablement and software.
Ancillary Logistics and Services
The ancillary logistics and services segment represents one of the most underappreciated yet mission-critical components of the theranostics value chain. Radiopharmaceuticals — particularly therapeutic isotopes — have unique physical and regulatory constraints that make their movement, storage and disposal more complex than conventional pharmaceuticals. Most radiopharmacies depend on a continuous cold chain for nonradioactive drug components and radiolabeling kits that are later combined with the radionuclide on site, at which point the products are stored at ambient or refrigerated temperatures. Radiopharmaceutical half-lives leave almost no tolerance for supply-chain inefficiency. As a result, logistics and service providers capable of maintaining precise timing, validated cold-chain integrity, radiation safety compliance, and regulatory documentation are indispensable partners to the industry.
From an investment perspective, this segment combines defensible technical barriers with repeatable, contracted revenue streams. Service providers that specialize in nuclear or radioactive logistics operate under the Nuclear Regulatory Commission (NRC), Department of Transportation (DOT) and state radiation transport regulations that create significant licensing and training hurdles for new entrants. This regulatory friction acts as a natural moat. These services are often embedded into the daily operations of radiopharmacies, imaging centers and oncology practices, producing long-term, route-based relationships with high customer retention. The resulting economics resemble those of specialized healthcare logistics or medical-waste firms — steady recurring revenue, moderate capex and attractive incremental margins as route density improves.
In parallel, the packaging and containment segment — including shielded containers, transport casks and temperature-controlled secondary packaging — offers both IP and recurring consumables revenue. Companies that can design lighter, regulatory-approved and reusable containers will be better positioned to capture premium pricing while supporting sustainability and cost-reduction initiatives across the supply chain.
Just as importantly, a rapidly expanding investment subsegment lies in workforce enablement. For years, the radiopharmaceutical industry faced acute shortages of nuclear medicine technologists, radiopharmacists and radiation safety officers — all essential to the safe handling, dispensing and disposal of isotopes. Training and credentialing platforms — whether independent or integrated into logistics providers — may offer scalable recurring-revenue models that mirror trade school or continuing education businesses, with potential for federal or institutional funding.
Growth catalysts include:
- The geographic decentralization of theranostic treatment from major academic centers to regional and community clinics, dramatically increasing the number of end points that require reliable isotopic delivery and retrieval
- Expansion of isotope portfolios beyond traditional beta emitters (Lu-177) into alpha emitters (Ac-225), which carry even stricter handling and disposal requirements, intensifying demand for specialized logistics and waste management capabilities
- Heightened regulatory scrutiny and traceability mandates from the NRC and DOT, which favor operators with robust compliance systems and digital chain-of-custody technologies
From a private-equity standpoint, this segment aligns with the profile of a specialty infrastructure services platform — asset-light, compliance-heavy and characterized by strong route density economics. A roll-up of regional courier and waste-handling operators can yield substantial cost synergies through shared routing software, centralized compliance management and procurement leverage in packaging and transport equipment. The model supports organic growth (via increased isotope volume per route) and inorganic growth (via tuck-ins and adjacency expansion). Furthermore, the segment’s mission-critical nature and scarcity of qualified providers make it attractive to a wide range of strategic acquirers, from global logistics companies to integrated theranostics platforms seeking to secure their last-mile delivery capability.
Diligence in logistics and workforce-enablement platforms requires scrutiny of transport licensing, environmental liability and occupational safety compliance. Companies handling radioactive materials must maintain DOT and NRC transportation permits, hazmat training certifications and waste-manifest documentation consistent with applicable regulations. Investors should review carrier agreements for indemnities related to exposure, contamination or delivery delays, and confirm adherence to ALARA (as low as reasonably achievable) principles and radiation-monitoring programs for personnel. Waste-disposal contractors must hold valid treatment, storage, and disposal licenses and insurance coverage sufficient for nuclear-waste liability. For workforce-training businesses, diligence should confirm accreditation status, professional-licensure recognition, and compliance with state education and continuing-education laws.
Radiotracers
The radiotracers segment represents the intellectual and clinical front end of the theranostics value chain — the discovery, formulation and commercialization of the molecular imaging agents that identify disease targets, stratify patients and guide radioligand therapy. Radiotracers are diagnostic compounds labeled with short-lived isotopes (such as F-18, Ga-68 or Cu-64) that bind to specific biological targets and reveal molecular activity through PET or SPECT imaging. They are the essential compass that directs precision treatment, enabling diagnosis and companion therapeutic selection.
From an investment standpoint, radiotracers combine biotech-like innovation economics with the reimbursement predictability of medical devices. Historically, weak reimbursement and fragmented distribution hindered radiotracer development. That dynamic has shifted dramatically: New CMS policies (e.g., separate payment for diagnostic radiopharmaceuticals exceeding the outpatient prospective payment system [OPPS] threshold) and increasing demand for personalized oncology transformed radiotracers from academic curiosities into commercial products with clear payer pathways. The result is an inflection point in volume and value — with expanding margins, predictable hospital adoption and rising capital interest from pharma, diagnostics companies and infrastructure investors.
The radiotracer market is evolving from commodity F-18-based agents (e.g., FDG) toward targeted molecular imaging tied to oncology, neurology and cardiology applications. The fastest-growing category — oncologic PET tracers — is driven by prostate cancer (PSMA-targeted Ga-68 and F-18 agents) and neuroendocrine tumors (Ga-68-Dotatate), but next-generation programs are rapidly emerging for breast, lung and glioma indications. Importantly, many new tracers function as diagnostic companions to therapeutic radioligands, forming the diagnostic side of a theranostic pairing (e.g., Ga-68-PSMA for Lu-177-PSMA therapy). This creates tight integration between diagnostic and therapeutic franchises, providing long-term commercial visibility and powerful cross-licensing opportunities.
The radiotracer segment offers investors exposure to:
- High-value IP and regulatory defensibility: Each approved tracer represents an FDA-approved, clinically validated asset with data exclusivity, IP protection and significant first-mover advantage within its molecular target class.
- Reimbursement tailwinds: CMS’s 2025 OPPS reform allows high-cost diagnostic radiopharmaceuticals to be reimbursed separately at mean unit cost, materially improving hospital economics and accelerating adoption.
- Pipeline expansion: More than 150 targeted tracers are in development globally; many will serve as biomarkers or companion diagnostics for new radiotherapeutic agents.
- Platform optionality: Radiotracer portfolios can be structured as royalty-bearing IP assets, licensing platforms or vertically integrated distribution businesses paired with radiopharmacies or isotope producers.
- Fragmented market: The field remains populated by university spinouts, small biotech firms and single-product developers — ideal for roll-up or partnership strategies that aggregate IP and accelerate regulatory advancement.
Financially, radiotracer businesses exhibit attractive blended economics: moderate upfront research and development costs relative to therapeutics, high gross margins once commercialized and durable recurring revenue tied to imaging procedure volume. Because manufacturing can be outsourced to radiopharmacies or CDMOs, capital intensity is relatively low.
Exit pathways include large radiopharmaceutical sponsors, diagnostics companies expanding into molecular imaging and infrastructure investors seeking exposure to regulated, reimbursed clinical products.
Ultimately, radiotracers are the enabling technology of precision radiopharmaceutical therapy — driving patient selection, therapy monitoring and regulatory acceptance. As payers and oncologists increasingly demand molecular precision, the companies controlling validated tracer IP will command disproportionate strategic relevance and valuation premiums.
Radiotracer diligence combines regulatory review with radiopharmaceutical-specific risk assessment. Investors must confirm FDA approval pathways and exclusivity periods, evaluate patent coverage of the molecular ligand and isotope-labeling method, and review any technology-transfer or university license agreements for field-of-use or royalty restrictions. Manufacturing compliance under the FDA’s applicable current good manufacturing practices and radiation-safety licensure for isotope incorporation must be verified, along with documentation of clinical trial authorizations and compliance. Distribution agreements should be reviewed for territory rights, quality-agreement alignment and anti-kickback compliance when bundled with therapeutic agents. Because many radiotracers depend on short half-lives and regional compounding, investors must also assess reliance on third-party radiopharmacies and confirm those counterparties’ licensure and quality histories.