AXLRx Book a callCommission

01 · Market Intelligence · Analysis type · 43 published

Competitive Intelligence

Who controls which cohort, and on what evidence. Drug-by-drug commercial posture, prescribing share and payer positioning.

Every Competitive Intelligence analysis

CI · Neurology · CI Team · Launch Lead US Alzheimer's Disease Competitive Intelligence Lecanemab versus donanemab in early AD. CMS amyloid-confirmation coverage and ARIA monitoring as the access gate. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Immunology · CI Team · Launch Lead US Atopic Dermatitis Competitive Intelligence Dupilumab's 70% biologic share against JAK step-edits. A two-tier US payer landscape for IL-4Ra biologics and oral JAKs. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Metabolic · CI Team · Launch Lead US MASH Competitive Intelligence Rezdiffra and Wegovy now split the noncirrhotic MASH label. This is a Year 0 to Year 1 access and retention fight, not a pre-launch window. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Oncology · CI Team · Launch Lead US NSCLC Competitive Intelligence Four approved IO agents split 1L NSCLC into three PD-L1 cohorts. Pembrolizumab holds an estimated 52% share ahead of 2028 patent expiry. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Metabolic · CI Team · Launch Lead US Obesity Competitive Intelligence Tirzepatide 20.9% versus semaglutide 15.3% weight loss. The Medicare coverage gap and commercial step-edit reality. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead US PNH Competitive Intelligence Iptacopan oral pivot versus the anti-C5 IV class. Orphan-drug exclusion from IRA negotiation (US), NICE HST (UK) and SFDA lag (GCC). US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Metabolic · CI Team · Launch Lead US Type 2 Diabetes Competitive Intelligence Tirzepatide takes 41% of new GLP-1 starts; SELECT CV indication and IRA negotiation reshape US formulary access. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US IgA Nephropathy Competitive Intelligence From zero disease-specific drugs to five in three years: how endothelin, complement and APRIL inhibitors are redrawing the IgAN market. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Hereditary Angioedema Competitive Intelligence The prophylaxis class is fracturing along route: oral berotralstat and the first oral on-demand agent against a still-injectable antibody field. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US ATTR Amyloidosis Competitive Intelligence Tafamidis's ATTR-CM monopoly meets acoramidis — while the orphan-drug exclusion keeps the stabilizer class out of IRA price negotiation. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Myasthenia Gravis Competitive Intelligence Three novel mechanisms in 24 months — FcRn antagonists vs C5 inhibitors, and the AChR+ vs MuSK+ line that segments the market. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Dravet Syndrome Competitive Intelligence Fenfluramine leads on efficacy, cannabidiol anchors the lower-cost branded option, and stiripentol holds the adjunct niche. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Gaucher Disease Competitive Intelligence Five FDA-approved Gaucher type 1 therapies (three IV enzyme replacement vs two oral substrate reduction) and eliglustat's oral first-line pivot. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Pompe Disease Competitive Intelligence Two next-generation ERTs are moving to displace alglucosidase alfa in US late-onset Pompe disease. Avalglucosidase alfa and cipaglucosidase alfa plus miglustat now define the competitive set. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Sickle Cell Disease Competitive Intelligence Two Dec-2023 gene therapies (Casgevy, Lyfgenia) reset a ~100,000-patient market, while voxelotor's 2024 withdrawal thins the oral field. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Cold Agglutinin Disease Competitive Intelligence Sutimlimab (Enjaymo) is the only FDA-approved CAD therapy — competing against off-label rituximab-based standard of care, not a branded rival. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Fabry Disease Competitive Intelligence Pegunigalsidase now challenges Fabrazyme's two-decade lead in US Fabry disease. Two IV enzyme replacement therapies meet an oral chaperone only ~35–50% of patients can take. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access US Spinal Muscular Atrophy Competitive Intelligence Three mechanisms chase one SMN target: a one-time $2.125M gene therapy, chronic intrathecal ASO, and daily oral. Newborn screening resets the battlefield. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Pulmonology · CI Team · Launch Lead US COPD Competitive Intelligence Two 2024 approvals moved the COPD maintenance fight past the inhaler for the first time in a decade. Ensifentrine and dupilumab split the market into an inhaler base and a biology-defined add-on tier. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Immunology · CI Team · Launch Lead US Plaque Psoriasis Competitive Intelligence Six mechanisms now compete for moderate-to-severe plaque psoriasis in the US, and the efficacy bar has moved from PASI 75 to PASI 90. IL-17A, dual IL-17A/F, IL-23p19, IL-12/23, TNF and oral TYK2 all hold ground. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Oncology · CI Team · Launch Lead US Breast Cancer HR+/HER2- Competitive Intelligence Only ribociclib has posted consistent overall-survival wins in the three-way first-line CDK4/6 contest. MONALEESA-2 showed 63.9 versus 51.4 months (HR 0.76). The real competition has moved downstream, where 2023 approvals of an oral SERD and an AKT inhibitor carve the post-CDK4/6 line by biomarker. US · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead · Market Access UK ATTR Amyloidosis Competitive Intelligence Tafamidis's ATTR-CM franchise meets acoramidis under NICE — which now tells clinicians to pick the least-expensive stabiliser. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC PNH Competitive Intelligence Anti-C5 IV therapy holds the GCC PNH market under NPHC and MOH specialist-centre gating. Iptacopan's 82.3% haemoglobin-response rate has not reached a single GCC formulary. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC IgA Nephropathy Competitive Intelligence Novel IgAN agents are registered across the GCC but not yet formulary-listed. Nephrology specialist centres and the private hospital market are the fastest access channel, while biopsy capacity limits diagnosis. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Hereditary Angioedema Competitive Intelligence GCC HAE management is acute-only, with prophylaxis penetration near zero. More than 85% of patients are undiagnosed, and NPHC coverage for lanadelumab would be the access trigger for the region's largest market. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC ATTR Amyloidosis Competitive Intelligence ATTR-CM in the GCC is a pre-commercial opportunity gated by diagnosis, not by drug access. Tafamidis is SFDA-registered and tender-priced 80-90% below US list, but Tc-PYP scintigraphy runs at fewer than 8 centres. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Dravet Syndrome Competitive Intelligence GCC Dravet prescribing runs opposite the US and EU hierarchy. Cannabidiol is de-facto inaccessible under narcotics law, so stiripentol is the specialist standard of care. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Dravet Syndrome Competitive Intelligence Cannabidiol and fenfluramine anchor the NHS-commissioned NICE algorithm; stiripentol still holds a backbone role. New entrants must beat an entrenched three-drug sequence, not just show efficacy. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Myasthenia Gravis Competitive Intelligence NPHC formulary criteria for the FcRn class don't yet exist, so pyridostigmine and steroids still treat 85%+ of GCC patients. Efgartigimod reached GCC neurology centres via SFDA and MOH UAE registration in 2023. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK IgA Nephropathy Competitive Intelligence IgAN doesn't qualify for the ultra-rare HST track, so both novel agents must clear the standard £20,000-30,000/QALY bar. Both sit in Named Patient access ahead of their NICE decisions. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Myasthenia Gravis Competitive Intelligence No novel biologic is yet NHS-commissioned for generalised MG. Eculizumab's manufacturer withdrew its 2020 NICE appraisal before a verdict, and NICE rejected efgartigimod outright in 2025 — leaving rozanolixizumab as the FcRn class's last untested NICE bid. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Sickle Cell Disease Competitive Intelligence GCC carries one of the highest per-capita SCD burdens globally: ~140,000 patients in Saudi Arabia alone. Both novel disease-modifiers hit regulatory trouble in 2023-2024, leaving a 25-year-old generic as the only agent with a stable market position. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Fabry Disease Competitive Intelligence GCC is a two-ERT Fabry market, with agalsidase alfa via the EMA pathway alongside agalsidase beta. Migalastat's oral advantage, covering 35-50% of patients, is bottlenecked by the single GCC lab that can run the amenable-mutation assay. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Spinal Muscular Atrophy Competitive Intelligence All three SMA mechanisms are formulary-listed across the GCC. Outcomes-based rebate contracts now anchor Zolgensma's ~$1.5-1.8M price to a 24-month motor milestone, after an NBS expansion generating 60-80 new gene-therapy candidates a year. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Market Access GCC Pompe Disease Competitive Intelligence Nexviazyme beat Lumizyme on 6-minute-walk distance in COMET, but NPHC has set no switch criteria. So 80-120 GCC ERT patients mostly stay on the 2006-era standard. GCC · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Fabry Disease Competitive Intelligence Pegunigalsidase's suboptimal-responder recommendation (TA915) reshapes NHS-commissioned Fabry therapy. It sets oral migalastat against IV enzyme replacement across the UK treated population. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team UK Hereditary Angioedema Competitive Intelligence England's NICE has issued three positive technology appraisals funding HAE prophylaxis since 2019 (TA606, TA738, TA1101). The two newest MHRA-licensed agents, donidalorsen and sebetralstat, remain in NICE appraisal with no confirmed final NHS funding decision. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team FR PNH Competitive Intelligence HAS reimburses iptacopan second-line only, after at least six months on a C5 inhibitor, while ravulizumab holds first-line. France split the anti-complement class by line of therapy, not by price. FR · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Spinal Muscular Atrophy Competitive Intelligence All three SMA therapies cleared NICE with confidential PAS. The UK's 2021 newborn screening programme is now the real access lever, shifting competition to physician and family preference. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK PNH Competitive Intelligence All three UK PNH agents cleared NICE via the standard Technology Appraisal route, not the ultra-rare one. Ravulizumab (TA698), iptacopan (TA1000) and crovalimab all took it. Convenience and switch dynamics, not pathway-driven affordability, now determine NHS share. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Sickle Cell Disease Competitive Intelligence Crizanlizumab's EMA/MHRA withdrawal leaves a VOC-prevention gap. Casgevy's NICE recommendation is the watershed NHS gene-therapy access event — Lyfgenia has no UK regulatory status. UK · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team DE PNH Competitive Intelligence Iptacopan's orphan-drug status let it clear AMNOG with an established additional benefit and a substantial quality-of-life finding. Ravulizumab, tested on Germany's only PNH-specific G-BA review to date, found no added benefit at all. DE · In-Market · 24–32 pp · PDF · Excel · PPT CI · Rare Disease · CI Team · Launch Lead UK Pompe Disease Competitive Intelligence Avalglucosidase alfa's NICE recommendation (TA821) puts it against entrenched alglucosidase alfa. NHS switch criteria and the Pombiliti queue position define the next 18 months of UK access. UK · In-Market · 24–32 pp · PDF · Excel · PPT

Competitive Intelligence — frequently asked

What formats are included?

A 24–32 page PDF analyst brief, an editable Excel model, and a PowerPoint readout, with a 45-minute analyst call included.

How are figures verified?

Every figure is cited to a live PMID, ClinicalTrials.gov ID or URL at the point of writing, cross-checked against the source, and re-checked in an independent audit pass.

Can I tailor scope?

Yes. Intake captures your indication, comparators, market and the specific commercial question. A scoping call confirms scope before research begins.