Multiple sclerosis has long competed on efficacy: relapse reduction, MRI outcomes and slowing disease activity. That remains essential. But as high-efficacy therapies become established, preference is increasingly shaped by route of administration, monitoring burden, site of care and how well a therapy fits the way neurologists and treatment networks want to deliver care.
Why is MS competition moving beyond efficacy?
Multiple sclerosis has long been a market defined by efficacy: relapse reduction, MRI outcomes and the ability to slow disease activity. That remains essential. But as high-efficacy therapies become more established, treatment preference is being shaped by a broader question: which therapy best fits how neurologists, MS centers and treatment networks want to deliver care[1]?
For much of the modern MS era, therapies competed through a familiar set of attributes: disease activity, safety, dosing frequency and specialist confidence. Infusion centers, hospital outpatient departments and specialist MS clinics were central to administering and monitoring many high-efficacy therapies. Today, treatment choice is more complex.
Neurologists can consider infusion-based anti-CD20 medicines, self-administered anti-CD20 options, oral disease-modifying therapies, immune-reconstitution approaches and emerging BTK inhibitors. The decision is no longer solely about whether a medicine suppresses disease activity[2]. It is also about how treatment fits a patient's clinical course, a provider's workflow and a health system's ability to deliver ongoing care.
What decides treatment preference in multiple sclerosis?
Six terms, taken together, describe the care model a therapy asks a network to run. Select a term to see why it shapes preference.
01 Clinical profile
Relapse control and prevention of new inflammatory activity remain central. Disability-progression evidence is increasingly important in progressive MS and in treatment decisions beyond relapse control.
02 Route of administration
Infusion, subcutaneous injection and oral delivery create different care models. An infusion-based therapy may be clinically well understood but operationally demanding; a self-administered therapy may improve convenience but require different adherence and support infrastructure.
03 Monitoring burden
Laboratory, MRI, infection-risk and safety monitoring affect provider preference. An oral medicine may reduce administration burden but create a distinct monitoring and safety-management profile.
04 Site of care
Treatment may be delivered through hospital infusion, ambulatory centers, community neurology or home and self-administration. Dosing and treatment schedule influence clinic capacity, patient convenience, adherence and service design.
05 Provider workflow
Infusion duration, scheduling, monitoring requirements and care-team workload can become commercially meaningful in a crowded category. Neurologists also need confidence about what can come before and after a therapy.
06 Persistence support
Patient services, specialty-pharmacy coordination and field or medical engagement can affect initiation and persistence, particularly for self-administered and oral therapies.
The next MS winner may not be the medicine with the most novel mechanism. It may be the therapy that best fits the treatment setting in which neurologists want to deliver high-efficacy care.
How has anti-CD20 therapy changed the MS baseline?
Anti-CD20 therapies have become central to high-efficacy MS treatment. But they are not all competing through the same care model[1]. Three products illustrate three different demands on a treatment network.
- 01
Ocrevus made infusion capacity part of the equation
Roche and Genentech's Ocrevus helped establish the role of B-cell depletion across relapsing forms of MS and primary progressive MS. Its infusion-based model has made infusion capacity, hospital workflows, safety monitoring and specialist-center infrastructure part of the treatment equation.[3]
- 02
Kesimpta offered a route out of the infusion center
Novartis's Kesimpta presents a self-administered subcutaneous anti-CD20 therapy. It gives clinicians and patients an option that can reduce dependence on infusion-center capacity while retaining a high-efficacy treatment framing.[4]
- 03
Briumvi turned throughput into positioning
TG Therapeutics' Briumvi adds another anti-CD20 option, with an infusion profile that can affect site throughput and account-level positioning.[5]
Which high-efficacy care model is most appropriate for this patient, this neurologist and this treatment setting?
In a crowded anti-CD20 market, operational questions such as infusion duration, scheduling, monitoring requirements and care-team workload can become commercially meaningful.
How are Roche and Novartis building different preference propositions?
Roche and Novartis illustrate the shift particularly clearly. Roche's position has historically been tied to Ocrevus and its broad MS franchise. Now fenebrutinib, an investigational oral BTK inhibitor, could give Roche a potential route into a different treatment format and a progression-focused clinical conversation[6].
Fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis.
| Roche / Genentech | Novartis | |
|---|---|---|
| Established anti-CD20 position | Ocrevus, infusion-based, across relapsing forms and primary progressive MS [3]. | Kesimpta, self-administered subcutaneous [4]. |
| Care-model implication | Infusion capacity, hospital workflow and specialist-center infrastructure are part of the treatment equation. | Convenience, treatment independence and reduced infusion-center reliance. |
| Next format | Fenebrutinib, an investigational oral BTK inhibitor with a progression-focused conversation [6]. | Potential oral BTK addition to the MS portfolio. |
| Strategic opportunity | Options across infusion-based B-cell depletion and potential oral progression-focused therapy [3][6]. | Addressing several points from early high-efficacy treatment to patients for whom oral administration or progression evidence becomes more relevant. |
In February 2026, Roche stated that fenebrutinib was the first investigational medicine in more than a decade to reduce disability progression in primary progressive MS. For Roche, the strategic opportunity is not merely to add a new asset. It may be to give neurologists options across infusion-based B-cell depletion and potential oral progression-focused therapy[3][6].
Novartis already has a contrasting anti-CD20 model in Kesimpta. If it adds an oral BTK option to its MS portfolio, it could potentially address several points in the treatment journey, from early high-efficacy treatment to patients for whom oral administration or progression-related evidence becomes more relevant. The strategic lesson is that product portfolios may increasingly compete as choice architectures, rather than as individual brands.
What happens when the battleground moves beyond relapse control?
For years, relapse reduction has been the central clinical and commercial metric in MS. But disease progression, especially progression independent of relapse activity, has remained difficult to address. That is why BTK inhibitors are attracting attention: their potential relevance lies in the possibility of influencing both peripheral and central nervous system immune activity.
Cenrifki is the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses.
| Treatment preference factor | Why it matters |
|---|---|
| Clinical efficacy | Relapse control and prevention of new inflammatory activity remain central. |
| Disability-progression evidence | Increasingly important in progressive MS and in treatment decisions beyond relapse control. |
| Route of administration | Infusion, subcutaneous injection and oral delivery create different care models. |
| Dosing and treatment schedule | Influences clinic capacity, patient convenience, adherence and service design. |
| Monitoring burden | Laboratory, MRI, infection-risk and safety monitoring affect provider preference. |
| Site of care | Treatment may be delivered through hospital infusion, ambulatory centers, community neurology or home and self-administration. |
| Switching strategy | Neurologists need confidence about what can come before and after a therapy. |
| Support model | Patient services, specialty-pharmacy coordination and field or medical engagement can affect initiation and persistence. |
Sanofi's Cenrifki (tolebrutinib) illustrates the importance of this shift. In June 2026, the European Commission approved Cenrifki for non-relapsing secondary progressive MS, positioning it as the first disability-targeting therapy for this population[7]. For Sanofi, the opportunity is not simply to compete in the broad relapsing-MS market. It is to create relevance in a patient segment where the clinical and commercial narrative is about disability progression rather than relapse frequency.
The broader question is whether progression-focused evidence will reset what neurologists expect from new MS therapies. If it does, existing high-efficacy brands may need to demonstrate not only relapse control, but also a credible long-term role in preventing disability accumulation.
Who actually decides which MS therapy is used?
Treatment preference is not decided in a vacuum. It is shaped by the institutions and professionals responsible for delivering care, from academic MS centers through infusion providers to specialty pharmacies and payers.
Academic MS centers lead adoption of complex, high-efficacy and emerging therapies and influence treatment standards, while community neurologists determine how far high-efficacy therapy can scale beyond specialist centers. Infusion centers affect scheduling, throughput, staffing and treatment convenience for infused products, and hospital outpatient departments influence protocol adoption, formulary practice and safety-monitoring processes.
Specialty pharmacies coordinate dispensing, adherence and support for self-administered and oral therapies. Integrated neurology networks shape referral, diagnostic, monitoring and follow-up models. Payers and health systems influence product choice through site-of-care, formulary and utilization-management decisions.
An infusion-based therapy may be clinically well understood but operationally demanding. A self-administered therapy may improve convenience but require different adherence and support infrastructure. An oral medicine may reduce administration burden but create a distinct monitoring and safety-management profile. This means commercial success increasingly depends on understanding where each therapy fits at the account level.
| United States | European Union | |
|---|---|---|
| Key adoption setting | MS centers, community neurology, infusion and specialty-pharmacy networks. | Hospital specialists, national pathways and country-specific neurology practice. |
| Commercial friction | Site of care, payer controls, infusion capacity and channel coordination. | Hospital protocols, specialist capacity, national guidelines and reimbursement rules. |
| Primary company challenge | Win account-level preference and support initiation. | Earn a place in country-specific treatment pathways and hospital practice. |
| Route-of-administration value | May influence site of care, pharmacy and patient-support model. | May influence hospital workload, specialist preference and treatment capacity. |
The science may be shared. The treatment-preference model is local.
What are the leading MS companies signaling?
In the US, companies must address not only specialist confidence but also account workflow, site-of-care economics, pharmacy coordination and treatment initiation[8]. In the EU, hospital-based care, national treatment guidelines, country-specific reimbursement and specialist-center capacity play a more prominent role.
| Company | Therapy or portfolio signal | What it may mean |
|---|---|---|
| Roche / Genentech | Ocrevus plus fenebrutinib development. | A potential portfolio spanning established anti-CD20 therapy and an oral progression-focused option. |
| Novartis | Kesimpta and BTK development. | High-efficacy self-administration plus potential oral lifecycle expansion. |
| Sanofi | Cenrifki for non-relapsing SPMS. | A progression-focused position outside the traditional relapse-control narrative. |
| TG Therapeutics | Briumvi. | Anti-CD20 competition may increasingly include infusion logistics and account throughput. |
| Biogen [10] | Tysabri, Tecfidera and Vumerity. | Established MS relationships must adapt to earlier high-efficacy treatment and greater route-of-administration choice. |
| Bristol Myers Squibb [11] | Zeposia. | Oral S1P relevance must be maintained as anti-CD20 and BTK options develop. |
| Merck KGaA [12] | Mavenclad. | Immune-reconstitution approaches offer a distinct dosing and treatment-burden model. |
Sanofi's EU approval of Cenrifki demonstrates how regulatory progress can create a distinct regional opportunity in progressive disease[7]. Meanwhile, Roche's fenebrutinib data could shape a different conversation around progressive MS if it translates into regulatory and clinical adoption[9].
The message is not that route of administration will replace efficacy. It is that, once therapies meet a high-efficacy threshold, treatment delivery may become the next important source of preference.
What should an emerging MS company do differently?
For an emerging MS company, an effective therapy may not be enough. It needs a credible role in the treatment ecosystem. The practical strategic question is which treatment setting is most likely to choose this therapy, and why.
Six decisions that should shape MS development and commercial planning
- 01Define whether the product is designed for academic MS centers, community neurologists, hospital outpatient departments or home-based treatment.
- 02Show how its administration and monitoring profile compares with established high-efficacy therapies.
- 03Build evidence that addresses the intended clinical role: relapse control, disability progression, treatment switching, convenience or reduced treatment burden.
- 04Understand whether the product complements, follows or competes directly with anti-CD20 therapies.
- 05Develop account-specific support models for infusion, specialty pharmacy, laboratory monitoring and provider education.
- 06Anticipate the differences between US account-level adoption and EU hospital and national-pathway adoption.
For smaller companies, the opportunity may be to solve a practical treatment problem that an established franchise does not: reducing monitoring burden, improving convenience, addressing progression or creating a viable option after anti-CD20 treatment.
What is still unresolved in the MS market?
Public clinical data and regulatory milestones show a market moving beyond a single definition of high-efficacy therapy. But they do not fully explain how neurologists will make treatment choices once several clinically credible options are available.
- Infusion centers
- Will infusion-center models retain their central role, given that infusion capacity, hospital workflows and safety monitoring are part of the treatment equation for products like Ocrevus [3]?
- Self-administration
- Will self-administration become a decisive preference, as options such as Kesimpta reduce dependence on infusion-center capacity while retaining a high-efficacy framing [4]?
- Oral progression therapy
- Will oral progression-focused therapies change when clinicians escalate treatment, following the EU approval of Cenrifki for non-relapsing secondary progressive MS [7] and fenebrutinib's progression data [6]?
- Account capacity
- Will account capacity and workflow matter as much as the mechanism of action, given that infusion duration, scheduling, monitoring and care-team workload are commercially meaningful in a crowded anti-CD20 market [5]?
Those questions sit with the professionals shaping MS care: neurologists, MS-center leaders, infusion providers, specialty pharmacists, hospital formulary stakeholders, former industry leaders and care-network administrators.
The next MS winner may not be the therapy with the most differentiated mechanism. It may be the one that best fits how neurologists and treatment networks want to deliver high-efficacy care.
Frequently asked questions about MS treatment preference
Sources: the verified links behind this whitepaper
- 01
PubMed: high-efficacy therapy and treatment choice in multiple sclerosis
https://pubmed.ncbi.nlm.nih.gov/37851189/ - 02
PubMed: disease-modifying therapy selection in multiple sclerosis
https://pubmed.ncbi.nlm.nih.gov/38615277/ - 03
Roche media release, 25 June 2024: Ocrevus
https://www.roche.com/media/releases/med-cor-2024-06-25 - 04
Novartis: Kesimpta prescribing information
https://www.novartis.com/us-en/sites/novartis_us/files/kesimpta.pdf - 05
FDA: Briumvi label
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761238s022s025lbl.pdf - 06
Roche media release, 7 February 2026: fenebrutinib in primary progressive MS
https://www.roche.com/media/releases/med-cor-2026-02-07 - 07
Sanofi media release, 23 June 2026: Cenrifki EU approval
https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-23-05-00-00-3315699 - 08
Early use of high-efficacy therapies in multiple sclerosis in the United States: benefits, barriers, and strategies for encouraging adoption (PubMed)
URL to be confirmed before publish - 09
Roche media release, 7 February 2026: fenebrutinib data
https://www.roche.com/media/releases/med-cor-2026-02-07 - 10
Biogen: investor material
https://investors.biogen.com/static-files/05644731-d13f-4279-8f89-304fa1e48827 - 11
FDA: Zeposia approval letter
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209899Orig01s013%2Cs014ltr.pdf - 12
FDA: Mavenclad label
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561Orig1s009Corrected_lbl.pdf
This whitepaper is an analysis of public company communications, regulatory documents and published literature. Fenebrutinib is investigational. It is not medical advice, not a treatment recommendation, and not investment advice. Product-development status, regulatory status and product labelling change; consult the linked primary sources and qualified professionals.
Hero photograph: Tima Miroshnichenko / Pexels.