Beyond Inhalers: Where Pharma Bets Next

How biologics, specialist therapies and next-generation platforms are reshaping the respiratory growth agenda.

SG
Senthil Ganesan Practice Lead, Pharma and Biotech
Published Updated 13 min read
In short

Respiratory is not leaving inhalers behind. But the center of strategic value is moving toward patient segments that require biomarker identification, specialist care infrastructure, targeted evidence and sustained treatment support. The most attractive opportunities increasingly depend not only on the molecule, but on whether the surrounding care pathway can find, treat and retain the right patients.

Why is the respiratory market splitting into two models?

The traditional respiratory model remains commercially important: large patient populations, inhaled maintenance therapies, primary-care prescribing and established brands. The emerging model is different. It is defined by patients whose treatment depends on phenotype, biomarker, genotype or risk profile, and by the specialist, access and delivery systems needed to turn that identification into sustained use.

Primary care does not become less important. In asthma and COPD, it may become even more important as the point of identification, referral and long-term management. But launches in the emerging model must connect primary care to specialized treatment pathways more effectively than traditional inhaler launches have required.

The respiratory growth model is shifting from broad prescription volume to targeted populations, specialist pathways and care-model execution.

What are the five signals reshaping respiratory strategy?

Five signals define where the strategic value is moving. Select a signal to see what it means for a respiratory portfolio.

01 Administration burden

In severe asthma, dosing convenience may shape patient, clinic and payer value alongside efficacy and safety. Convenience is becoming part of the product proposition rather than a secondary feature.

02 COPD scale test

Clinical potential will depend on whether systems can identify eligible patients at scale. COPD may become the clearest test of whether respiratory innovation can move beyond inhalers while still reaching a meaningful patient population.

03 Specialist infrastructure

Pulmonary arterial hypertension illustrates how diagnosis, monitoring and treatment-center capability influence adoption. Growth is increasingly being sought in markets where care infrastructure is part of the product proposition.

04 CF franchise and platform risk

Residual unmet need sustains investment in cystic fibrosis, but pulmonary delivery and repeat dosing remain difficult. CFTR modulation demonstrates the value of disease-modifying franchises even as next-generation approaches carry delivery risk.

05 Care-pathway execution

Patient identification, referral, access and persistence will increasingly determine commercial durability. These capabilities sit beyond any individual molecule and apply across the portfolio.

Together the signals point to one requirement: the emerging respiratory portfolio is unlikely to be won by one type of asset. Commercial durability will depend on capabilities that sit beyond the product itself.

Is the product becoming a care model in severe asthma?

In severe asthma, biologics already compete across patient phenotype, exacerbation reduction, oral-corticosteroid sparing and safety. Newer programs suggest that administration burden may become a more visible dimension of differentiation. GSK's depemokimab program is positioned around an ultra-long-acting, twice-yearly dosing model for people with severe asthma with an eosinophilic phenotype.

  1. 01

    An ultra-long-acting dosing model

    Depemokimab is positioned around twice-yearly dosing for people with severe asthma with an eosinophilic phenotype.[1]

  2. 02

    A first approval under a brand name

    In March 2026, GSK announced Chinese approval for Exdensur, its brand name for depemokimab, in this population.[1]

  3. 03

    A different question for payers

    Lower-frequency administration could affect patient burden, clinic appointment patterns and adherence tracking, and may change whether a dosing model contributes to persistence, fewer exacerbations or more efficient care.

Twice-yearlythe dosing model depemokimab is positioned around in severe eosinophilic asthma [1]
March 2026GSK announced Chinese approval for Exdensur in this population [1]
Convenienceis becoming part of the product proposition, not a secondary feature
Today's approval for Exdensur in China represents an important advance for patients with severe asthma with an eosinophilic phenotype.
Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D
GSK, March 2026 [1]

The implication is not simply that GSK has another biologic. In this category, convenience is becoming part of the product proposition rather than a secondary feature, and the payer question shifts toward whether a different dosing model contributes to persistence, fewer exacerbations or more efficient care.

Can a biologic reach scale in an inhaler-led disease like COPD?

COPD is the clearest example of the established respiratory model: a large patient population, major primary-care involvement, inhaler-based treatment and persistent challenges around diagnosis, spirometry, inhaler technique and adherence. The development of biologic strategies in selected inflammatory populations introduces a different commercial model.

A clinically promising biologic can remain a narrow specialist product unless exacerbation history, biomarker testing, referral, reimbursement and follow-up work together in practice.
The scale test facing respiratory biologics
Two respiratory engines, running side by side. The established model is not disappearing; a second one is forming beside it with different requirements.
Established respiratory engineEmerging respiratory engine
Prescriber baseBroad primary-care prescribing.Pulmonologists, allergists, specialist centers and advanced-disease networks.
Treatment triggerDiagnosis-led treatment.Phenotype-, biomarker-, genotype- or risk-led treatment.
ChannelRetail pharmacy and inhaler device choice.Biologic pathways, specialty pharmacies, referral networks and care coordination.
Commercial measurePrescription volume.Identification of eligible patients and persistent use.
DifferentiationFormulary and device differentiation.Evidence, access, site of care, administration burden and outcomes differentiation.

Sanofi and Regeneron continue to develop and commercialise Dupixent across respiratory diseases, including COPD populations defined by elevated blood eosinophils. In 2026, Sanofi stated that Dupixent had regulatory approvals in more than 60 countries for one or more indications, including certain patients with asthma and COPD[2].

The commercial question is therefore not simply whether a biologic works in a selected trial population. It is whether healthcare systems can identify the appropriate patient at scale. COPD may become the clearest test of whether respiratory innovation can move beyond inhalers while still reaching a meaningful patient population.

When does specialist infrastructure become part of the asset?

Pulmonary arterial hypertension is smaller than asthma or COPD, but it illustrates a distinct form of respiratory opportunity: complex disease, specialist-center concentration, multi-drug treatment and greater reliance on risk stratification and long-term outcomes.

Four strategic questions, and what the evidence suggests. Each question is answered by a different part of the current respiratory landscape.
Strategic questionWhat the current evidence suggestsRelevant example
Can convenience create durable differentiation?Potentially, where administration burden affects clinic workflow, persistence or access logic.GSK / depemokimab
Can a biologic reach scale in an inhaler-led disease?Only if the system can identify, refer and support eligible patients.Sanofi / Regeneron / Dupixent in COPD
When does specialist infrastructure become a competitive advantage?When diagnosis, monitoring and combination use are concentrated in expert centers.Pulmonary arterial hypertension
How should platforms be assessed in respiratory?Not only by biological rationale, but by delivery, repeat dosing, tolerability and durability.Vertex / Moderna VX-522

The lesson is not that every respiratory company needs a PAH asset. It is that growth is increasingly being sought in markets where care infrastructure is part of the product proposition. In these settings, value depends on whether patients can be diagnosed early enough, specialist centers can adopt and monitor treatment, therapy fits with established combination regimens, and evidence supports a value proposition beyond a short-term clinical endpoint.

What does cystic fibrosis show about franchise strength and platform risk?

Vertex has built cystic fibrosis into one of the clearest examples of a disease-modifying respiratory franchise. In June 2026, it presented additional data for ALYFTREK, framing the work within its long-standing effort to restore CFTR function for people living with CF[3].

The strategic issue is residual unmet need: people whose mutations do not produce enough CFTR protein to respond adequately to current modulators, and people for whom existing outcomes leave meaningful room for improvement. This is why inhaled RNA, gene therapy and gene-editing approaches continue to attract interest.

But it also shows the challenge of translating a compelling platform concept into a viable respiratory treatment. In May 2026, Vertex discontinued the Phase I/II study of VX-522, an investigational inhaled CFTR mRNA candidate developed with Moderna. Moderna said the termination precluded a full efficacy and safety assessment and ended further development of the candidate[4].

CFTR modulation demonstrates the value of disease-modifying franchises. VX-522 highlights that pulmonary delivery, repeat dosing and tolerability remain central risks for next-generation approaches.

Franchise strength beside platform risk. The same disease area shows both what a disease-modifying franchise can achieve and where next-generation delivery still fails.
Franchise strengthPlatform risk
What it showsCFTR modulation has produced a durable disease-modifying franchise.Pulmonary delivery, repeat dosing and tolerability remain central risks.
Evidence pointJune 2026 ALYFTREK data, framed within a 25-year effort to restore CFTR function [3].May 2026 discontinuation of the VX-522 Phase I/II study [4].
ConsequenceResidual unmet need sustains continued investment.Moderna said the termination precluded a full efficacy and safety assessment and ended further development [4].
The data we're presenting today bring us to the cusp of our 25-year mission to advance medicines that restore CFTR function to people living with CF.
The organising principle of pathway adoption

Why is care-pathway execution now a portfolio capability?

The signals point to one common requirement: the emerging respiratory portfolio is unlikely to be won by one type of asset. Companies are pursuing larger but more segmented biologic opportunities, high-value specialist disease franchises and genetic or RNA delivery technologies.

Five signals, five implications. What each signal means for how a respiratory portfolio is built and run.
SignalWhat it means
Administration burden is becoming a competitive variableIn severe asthma, dosing convenience may shape patient, clinic and payer value alongside efficacy and safety.
COPD will test whether biologics can scaleClinical potential will depend on whether systems can identify eligible patients at scale.
Specialist infrastructure is part of the assetPAH illustrates how diagnosis, monitoring and treatment-center capability influence adoption.
CF combines franchise strength with platform riskResidual unmet need sustains investment, but pulmonary delivery and repeat dosing remain difficult.
Care-pathway execution is becoming a portfolio capabilityPatient identification, referral, access and persistence will increasingly determine commercial durability.

Their commercial durability will depend on capabilities that sit beyond the product itself: patient identification, referral, access, site-of-care design and persistent use.

What should respiratory portfolio leaders decide now?

Mature inhaler businesses can remain cash-generative, but they may not provide sufficient innovation-led growth on their own. The immediate task for respiratory portfolio leaders is to determine which opportunities can become durable franchises, and which will remain clinically compelling but operationally difficult niches.

NEXTYN The decision agenda

Five decisions facing respiratory portfolio leaders

  1. 01Which populations can be identified and activated through an achievable real-world pathway?
  2. 02Where does convenience change treatment economics or operating burden?
  3. 03Which specialist care networks need to be built before launch rather than after approval?
  4. 04Which platform risks are specific to respiratory delivery and repeat administration?
  5. 05Which assets can support durable franchise value beyond an initial clinical proof point?
www.nextyncore.com/whitepapers/respiratory-beyond-inhalers

Respiratory is not leaving inhalers behind. But the center of strategic value is moving toward patient segments that require biomarker identification, specialist care infrastructure, targeted evidence and sustained treatment support.

What is still unresolved in respiratory strategy?

The signals show where investment is moving, but they do not settle how each bet resolves. Four questions decide whether an asset becomes a durable franchise or an operationally difficult niche.

Open questions Unresolved as of August 2026
Convenience
Can convenience create durable differentiation? Potentially, where administration burden affects clinic workflow, persistence or access logic, as the depemokimab dosing model suggests [1].
Scale
Can a biologic reach scale in an inhaler-led disease? Only if the system can identify, refer and support eligible patients, which is the test facing Dupixent in COPD populations defined by elevated blood eosinophils [2].
Infrastructure
When does specialist infrastructure become a competitive advantage? When diagnosis, monitoring and combination use are concentrated in expert centers, as in pulmonary arterial hypertension.
Platforms
How should platforms be assessed in respiratory? Not only by biological rationale, but by delivery, repeat dosing, tolerability and durability, as the VX-522 discontinuation showed [4].

Those questions sit with the people shaping respiratory care: pulmonologists and allergists, specialist-center leaders, respiratory nurses and care coordinators, specialty pharmacy and access decision-makers, payers, and former industry executives.

The most attractive respiratory opportunities increasingly depend not only on the molecule, but on whether the surrounding care pathway can find, treat and retain the right patients.

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Frequently asked questions about respiratory care beyond inhalers

SG
Senthil Ganesan Practice Lead, Pharma and Biotech · Nextyn Consulting & Research

Senthil leads the Pharma and Biotech practice at Nextyn Consulting & Research. Senthil on LinkedIn

Sources behind this whitepaper

  1. 01 GSK, March 2026: Chinese approval for Exdensur (depemokimab) in severe asthma with an eosinophilic phenotype, including the quotation from Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology and Inflammation R&D
    URL to be confirmed before publish
  2. 02 Sanofi, March 2026: statement that Dupixent had regulatory approvals in more than 60 countries for one or more indications, including certain patients with asthma and COPD
    URL to be confirmed before publish
  3. 03 Vertex Pharmaceuticals, June 2026: additional ALYFTREK data presentation, including the quotation attributed to Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer. Speaker identity and title require final confirmation against the original release
    URL to be confirmed before publish
  4. 04 Moderna, May 2026: discontinuation of the VX-522 Phase I/II inhaled CFTR mRNA study developed with Vertex, and the statement that termination precluded a full efficacy and safety assessment
    URL to be confirmed before publish

This whitepaper is an analysis of public company communications. The source document carried its citations as company and date attributions without links, so every regulatory status, product label, trial result, numerical claim, company attribution and quotation must be verified against the relevant primary source before publication. It is not medical advice, not a treatment recommendation, and not investment advice.

Hero photograph: Anna Shvets / Pexels.

Cite this whitepaper Nextyn Research, “Beyond Inhalers: Where Pharma Bets Next”, Senthil Ganesan, 2 September 2026, updated 2 September 2026. https://www.nextyncore.com/whitepapers/respiratory-beyond-inhalers

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