Beyond the Molecule: Devices, Data, and Diagnostics in the Next Wave of Advanced Therapies

Advanced therapies are moving from the margins to the center of biopharma strategy in 2026, and the health technology organizations gaining the most traction are the ones connecting what’s happening at the lab bench to what’s changing at the bedside, in the factory, and in the cloud. As winter planning turns into spring execution, leaders across medical devices, biopharma, digital health, and diagnostics are looking not only at a single hot modality but at how a whole constellation of trends, from advanced therapies to data, AI, and new care models, will interact to reshape their portfolios, partnerships, and talent strategies.

Why this matters now

Cell and gene therapies, mRNA platforms, and radiopharmaceuticals are no longer side bets; they are becoming central growth engines.

Recent market analyses estimate the global cell and gene therapy market in the high single‑digit to low double‑digit billions in 2025 and project it to grow at high‑teens to low‑20s annual rates, reaching well over $100 billion by the mid‑2030s.⁸,¹⁰
American Society of Gene and Cell Therapy (ASGCT)–Citeline’s landscape work points to a robust and growing pipeline of more than 4,000 gene, cell, and RNA therapy candidates from preclinical through preregistration.¹²,¹³
mRNA therapeutics are expanding beyond vaccines into oncology, rare genetic disease, and chronic conditions, supported by advances in delivery systems and RNA formats.¹,³,⁴
Radiopharmaceutical theranostics are gaining momentum as targeted imaging‑therapy pairs, but growth is constrained by manufacturing and workforce capacity.⁶,⁷

For health technology executives, the key point is this: advanced therapies cannot scale without enabling technologies – smart delivery devices, precise diagnostics, robust data infrastructure, and industrial‑grade manufacturing.

Cell and gene therapies: building the platform around the product

Cell and gene therapies are moving into more common diseases and more geographies, but operational complexity and cost remain high.

Deloitte highlights the shift from primarily oncology and rare disease into autoimmune, metabolic, and neurological indications, with corresponding demands on manufacturing, safety monitoring, and data.²
ASGCT–Citeline data show a broad and steadily expanding pipeline across gene, cell, and RNA therapies, with significant activity in solid tumors and chronic diseases.¹²,¹³
Multiple market forecasts suggest the cell and gene therapy market could roughly quadruple or more between the mid‑2020s and mid‑2030s, underscoring the need for scale.⁸,¹⁰

Executives in medtech, diagnostics, and digital health can create outsized value in three areas:

Scalable, automated manufacturing: Closed, automated systems for cell processing, vector production, and QC testing reduce variability, reliance on scarce talent, and per‑patient cost.²,⁸
Better patient selection and monitoring: Integrated genomic, imaging, and lab data can help identify eligible patients, monitor minimal residual disease, and detect safety signals early.¹²,¹⁴
Long‑term outcomes and value evidence: Real‑world evidence from registries, remote monitoring, and analytics underpins regulatory decisions, reimbursement models, and label expansions.²,¹³

A number of device and diagnostic companies are already reframing themselves as “advanced therapy enablement” partners, co‑designing platforms with biopharma rather than selling stand‑alone instruments.²,¹¹

mRNA: programmable medicine needs programmable infrastructure

mRNA is evolving from a pandemic solution into a programmable modality for oncology, rare disease, and chronic conditions.

Global mRNA and RNA therapeutics markets are projected to grow strongly through 2035 as applications expand into cancer vaccines, protein replacement, and cardiovascular and metabolic diseases.¹,³
Self‑amplifying mRNA and novel delivery vehicles are improving durability and dosing efficiency.³,⁴
AI and data science are being applied to sequence design, safety prediction, and delivery optimization, compressing development timelines.³,⁴

Enabling technologies will determine which of these concepts translate into viable products:

Delivery and administration: Inhaled, intratumoral, and localized delivery approaches will require specialized devices and human‑factors‑informed design, while connected autoinjectors and wearables can support at‑home, chronic administration.¹,³
Rapid, adaptive diagnostics: Personalized cancer vaccines depend on fast tumor profiling, neoantigen prediction, and frequent response monitoring, making integrated lab–digital platforms essential.¹²,¹³
Data and AI backbones: Seamless data capture from EHRs, devices, and patient‑reported outcomes is crucial for adaptive trials and real‑world evidence packages that regulators and payers will accept.²,¹⁵

For executives, mRNA is less about a single product and more about building a repeatable, data‑rich engine: design, deliver, learn, and iterate.

Radiopharmaceuticals: theranostics as a team sport

Radiopharmaceuticals, especially theranostics that pair a diagnostic tracer with a therapeutic agent, are reshaping parts of oncology and nuclear medicine.

Thought leaders describe theranostics as “the future of radiopharmaceuticals,” with growing evidence in prostate cancer, neuroendocrine tumors, and other indications.⁷,¹⁶,¹⁷
At the same time, supply constraints for radionuclides, limited radiopharmacy capacity, and workforce shortages are slowing adoption.⁶,⁷

This creates a rich opportunity space for health technology firms:

Imaging and analytics: Upgraded PET/CT and SPECT/CT systems, combined with AI‑assisted quantification, can standardize response assessment and support regulatory‑grade endpoints.⁶,¹⁶
Radiopharmacy and manufacturing: Automation, standardized workflows, and safety‑oriented design are critical to scale radiopharmaceutical preparation while protecting staff.⁶
Training and virtual support: Simulation, digital SOPs, and remote guidance can help new centers build nuclear medicine capabilities safely and efficiently.⁶,⁷

Radiopharmaceuticals force coordination across pharma, imaging, and hospital operations, which favors leaders comfortable orchestrating multi‑stakeholder change.

What 2026-ready leaders are doing differently

Across these modalities, a consistent pattern is emerging among organizations that are pulling ahead.

They pick clear adjacencies: Instead of dabbling everywhere, they choose a small number of high‑leverage roles, such as cell processing automation, mRNA delivery, or theranostic imaging, and invest deeply.²,⁸
They co‑develop with biopharma: Enabling technologies are designed into the therapy from mid‑stage development onward, not bolted on at launch, with shared risk around outcomes and evidence generation.²,¹¹,¹⁵
They build “evidence engines”: Devices, diagnostics, and digital tools are architected to capture structured, regulatory‑relevant data, supported by teams that turn this into submissions, publications, and payer dossiers.²,¹²,¹³
They redesign for talent and collaboration: Cross‑functional groups that span R&D, regulatory, market access, and data science are tasked with owning an advanced therapy enablement agenda, not just individual products.²,¹¹,¹⁵

One executive summed up their 2026 pivot this way: “We stopped thinking of ourselves as a device company and started acting like an essential service layer for advanced therapies.” For many health technology organizations, especially those with strong device, diagnostics, or data assets, that mindset shift may be the most important move of all.²,¹¹,¹⁵

If you look at your own strategy, which enabling role feels most natural to lean into over the next 12–24 months: manufacturing platforms, diagnostics and data, or delivery and devices?

Sources

About the Author

Paula Norbom is the Founder and CEO of Talencio, an executive search and staffing firm serving health technology companies. She has worked in the health technology industry for over 30 years.

Beyond the Molecule: Devices, Data, and Diagnostics in the Next Wave of Advanced Therapies

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