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Cytokine Pathways, Autoimmune Disease, Type 2 Inflammation, Retinal Biologics and the Engineering Behind the Next Wave of Antibody Medicines

Mobility Foresights Healthcare & Life Sciences Research | Hub Analysis | September 2026

Immunology is the second-largest therapeutic area in biopharma after oncology, and it is going through two structural shifts at the same time. The first is a patent cliff. Humira, once the world's best-selling drug, peaked at roughly $21 billion in 2022 before U.S. biosimilars arrived in 2023. Its global sales had fallen by more than half by 2024. Stelara followed, with U.S. biosimilars launching in 2025. The second shift is scientific. The field is moving from broad immunosuppression, built on corticosteroids, methotrexate and TNF blockade, toward precise control of individual immune pathways, and toward therapies that aim to reset the immune system rather than suppress it indefinitely.

The companies that anticipated the cliff show where value is moving. AbbVie's IL-23 antibody Skyrizi and JAK inhibitor Rinvoq together generated close to $18 billion in 2024, more than replacing Humira's lost U.S. revenue. Sanofi and Regeneron's Dupixent built a Type 2 inflammation franchise that now spans atopic dermatitis, asthma, nasal polyps, eosinophilic esophagitis and, since 2024, COPD.

This hub brings together 86 Mobility Foresights market studies in six segments:

• Cytokine-pathway biologics.
• Autoimmune and immune-mediated disease therapies.
• Type 2 inflammation, respiratory and allergy biologics.
• Ophthalmology biologics.
• The antibody and protein engineering platforms that underpin the class.
• The formulation, dosing and biosimilar dynamics that decide commercial value.

Key Takeaways

• Loss of exclusivity is redistributing revenue, not shrinking the market. Humira and Stelara biosimilars are eroding legacy brands, but IL-23, IL-17, Type 2 and JAK/TYK2 successors are capturing the growth.
• Precision is replacing breadth. Biomarker-selected targets such as TL1A, and dual-pathway biologics such as IL-17A/F inhibitors, are designed to lift response rates that have plateaued around the same levels across TNF-era drugs.
• "Immune reset" is the most disruptive idea in the category. CD19 CAR-T and T-cell engagers have produced drug-free remissions in refractory lupus, opening a path from chronic suppression to one-time or short-course treatment.
• Type 2 inflammation is still expanding. COPD, food allergy and chronic urticaria are extending biologics into large populations that were previously managed with inhalers and antihistamines.
• Dosing interval and formulation are now competitive weapons. Twice-yearly antibodies, 16-week retinal dosing, high-concentration subcutaneous forms and interchangeable biosimilars shape share as much as efficacy does.

How We Segment the Immunology and Biologics Landscape

Immunology markets are usually reported by disease: rheumatoid arthritis, psoriasis, inflammatory bowel disease (IBD) and so on. Because the same pathways drive many diseases and the same drug is often approved across five or more indications, we organize this hub by mechanism and platform, then cross-reference diseases within each segment.

1. Cytokine-Pathway Biologics: Beyond TNF

1.1 The core cytokine franchises

Cytokines are the signaling proteins that coordinate inflammation, and blocking them with antibodies built the modern immunology market. Our inflammatory cytokine blocking antibodies market report covers the core antibody classes: anti-TNF, IL-17, IL-23 and IL-6. It quantifies how biosimilar entry is reshaping the TNF segment while newer mechanisms grow. The wider immune cytokine blockade biologics market study adds Fc-fusion proteins and non-antibody formats and extends coverage across the full range of immune-mediated diseases.

Two reports focus on single pathways:

• IL-23. IL-23 has become the preferred target in psoriasis and increasingly in Crohn's disease and ulcerative colitis. Our IL-12/23 axis biologics market report tracks the transition from ustekinumab, now facing biosimilars, to IL-23-selective antibodies (risankizumab, guselkumab, mirikizumab). It also covers the oral IL-23 receptor peptides in late-stage development, which could bring biologic-level efficacy to a pill.
• IL-1 and IL-6. The IL-1 and IL-6 pathway biologics market report covers tocilizumab, sarilumab, anakinra and canakinumab in rheumatic and autoinflammatory disease. IL-6 inhibition is also being tested in cardiovascular inflammation, a potentially very large new population.

How a drug engages its cytokine is itself a source of differentiation:

• The cytokine receptor antagonist biologics market study covers antibodies that block the receptor rather than the ligand. Examples include IL-4R-alpha (dupilumab), IL-6R (tocilizumab) and IL-36R (spesolimab, approved in 2022 for generalized pustular psoriasis).
• The cytokine trap and decoy receptor therapies market report covers soluble receptor fusions that soak up the ligand, a design proven by etanercept and rilonacept.
• The selective cytokine neutralization biologics market analysis looks at molecules that neutralize only the pathogenic form of a cytokine, such as specific isoforms or soluble versus membrane-bound TNF. The aim is to preserve host defense.

1.2 Targeting the signal inside the cell

Not every cytokine drug is an antibody. The cytokine signaling modulation therapies market report covers intracellular signaling blockers, led by JAK inhibitors and the allosteric TYK2 inhibitor deucravacitinib. It also examines how the FDA's 2021 boxed warning on JAK inhibitors reshaped their position in treatment sequences. The broader targeted inflammatory pathway inhibitors market study covers oral small molecules across PDE4, S1P, IRAK4, RIPK1 and NLRP3 targets. Oral convenience is the principal competitive advantage of these drugs against injectables.

A newer chemistry approach targets cytokines from the outside with small molecules. The non-competitive cytokine inhibitor drugs market report covers compounds that bind cytokines at non-competitive sites. One example is oral agents that lock TNF into an inactive trimer shape, which could give an oral alternative to injectable anti-TNF therapy.

1.3 Dual pathways, precision targets and cytokine kinetics

Response rates for single-cytokine drugs have plateaued in many diseases, so developers are hitting two pathways at once. Bimekizumab, which neutralizes both IL-17A and IL-17F, set a new efficacy benchmark in psoriasis after U.S. approval in 2023. Our inflammatory pathway dual-inhibitor biologics market report covers dual-target antibodies and bispecifics, including nanobody-based molecules that combine alarmin and cytokine blockade.

The other route to higher response is patient selection. Our precision inflammation control biologics market study focuses on biomarker-guided targets, most visibly TL1A. TL1A drew two of the largest immunology deals of 2023: Merck's $10.8 billion acquisition of Prometheus Biosciences and Roche's $7.1 billion acquisition of Telavant. Both programs pair the drug with a genetic or diagnostic marker of likely response in IBD.

Another group of reports looks at how cytokine levels are controlled over time and in tissue:

• The long-acting cytokine therapies market report covers engineered cytokines used as drugs, such as Treg-selective IL-2 variants and half-life-extended interferons. These aim to restore immune balance with infrequent dosing.
• The cytokine gradient control biologics market study examines tissue-restricted modulation, such as gut-selective or skin-anchored molecules that act where inflammation occurs, reducing systemic immunosuppression.
• The cytokine clearance acceleration therapeutics market report covers "sweeping" antibodies with pH-dependent binding that release their target inside the cell and recycle. This lets one antibody clear many cytokine molecules.
• The cytokine sink and sequestration therapies market study covers engineered binding proteins and extracorporeal adsorption used in hyperinflammatory states such as cytokine release syndrome and sepsis.

2. Autoimmune and Immune-Mediated Disease: From Suppression to Reset

2.1 The portfolio view

Four reports give the portfolio view of the category:

• Our immunology biologic drugs market report sizes the category across TNF, IL-17, IL-23, IL-4R and integrin-targeted brands, with forecasts that account for biosimilar entry.
• The inflammation and immunology (I&I) biologics market study uses the lens most large pharmaceutical companies use to organize their business units, comparing pipelines and portfolio exposure by company.
• The immune-mediated disease therapies market report covers every modality, both biologic and small molecule, across psoriasis, IBD, rheumatoid arthritis, atopic dermatitis and lupus.
• The companion immune-mediated disease biologics market study isolates the biologic segment to show where injectables are defending share against oral competitors.

Three reports cut autoimmune disease in different ways:

• The autoimmune disease biologics market report is organized by disease: rheumatoid arthritis, lupus, multiple sclerosis, myasthenia gravis and IBD.
• The autoimmune biologic therapies market study is organized by line of therapy, tracking switching behavior between biologic-naive and biologic-experienced patients.
• The autoimmune antibody therapeutics market report focuses on antibody formats and their pipeline, including type I interferon receptor blockade (anifrolumab in lupus), BAFF inhibition and anti-CD38 antibodies.

Two reports address how treatment is targeted and what it replaces:

• Our precision immunology market report tracks the tools that make patient selection possible, including serology, genetic markers and multi-omic endotyping. These are central to lifting response rates above historic ceilings.
• The steroid-sparing immunology biologics market study examines the corticosteroid-reduction endpoints that now support approvals in diseases such as giant cell arteritis and eosinophilic granulomatosis with polyangiitis. Reducing long-term steroid harm is a strong argument with payers.

2.2 Antibody-driven autoimmunity: FcRn and B cells

Many autoimmune diseases are driven by pathogenic IgG antibodies. Blocking the neonatal Fc receptor (FcRn), which normally recycles IgG, lowers those antibodies within days. Efgartigimod launched the class in generalized myasthenia gravis in 2021, followed by rozanolixizumab and nipocalimab, and Johnson & Johnson paid $6.5 billion for Momenta in 2020 to secure nipocalimab. Our FcRn autoimmune therapeutics market report tracks the class as it expands into CIDP, thyroid eye disease and other antibody-mediated conditions.

B-cell depletion with rituximab and ocrelizumab proved that removing the source of autoantibodies works. The next-generation B-cell depletion therapy market study covers deeper-acting approaches: CD19-directed antibodies, T-cell engagers and CAR-T. These reach B cells in tissue that conventional antibodies miss.

2.3 Immune reset and durable remission

The most important clinical development in autoimmunity in years came from academic CAR-T programs. Patients with severe, treatment-refractory lupus achieved drug-free remission after a single infusion of CD19 CAR-T cells, a result published in the New England Journal of Medicine in 2024. Three reports follow this logic:

• Our targeted immune reset biologics market report covers therapies designed to reset rather than suppress, including CAR-T, T-cell engagers and deep depletion regimens.
• The immune memory modulation therapies market study focuses on the long-lived plasma cells and memory lymphocytes that sustain disease and cause relapse, including anti-CD38 and BCMA-directed approaches borrowed from myeloma.
• The immune homeostasis restoration therapies market report covers approaches that rebuild regulatory balance, such as low-dose IL-2 and regulatory T-cell therapies.

The most precise goal is tolerance: switching off the immune response to one antigen while leaving the rest of the immune system intact. The antigen-specific immune modulation therapies market report covers inverse vaccines, tolerogenic nanoparticles and CAR-Treg cells. The anti-CD3 antibody teplizumab provides a regulatory precedent; in 2022 it became the first therapy approved to delay the onset of type 1 diabetes.

Readers tracking CAR-T and T-cell engagers across both fields should also see our oncology and hematology therapeutics landscape, where the same platforms are covered from the cancer side.

2.4 Co-stimulation, trafficking and pathway-selective control

A large group of pipeline assets modulates how immune cells are activated, communicate and move:

• The immune synapse modulation therapies market report covers co-stimulation blockade at the point where T cells meet antigen-presenting cells. Abatacept established the approach; CD40/CD40L antibodies and OX40/OX40L antibodies, now in Phase 3 in atopic dermatitis, are the next wave.
• The immune cell activation modulators market study covers agonists of inhibitory receptors, such as PD-1 and BTLA agonist antibodies. These dampen overactive immune cells, the mirror image of cancer checkpoint inhibition.
• The immune cell trafficking modulation therapies market report covers drugs that stop immune cells reaching inflamed tissue. Examples are vedolizumab (gut-selective alpha4-beta7 integrin), natalizumab and S1P receptor modulators such as ozanimod and etrasimod.

Two further reports address the balance between control and host defense:

• The selective immune pathway dampening therapies market study examines drugs that suppress a single disease-driving arm of immunity, such as the Th17 or type I interferon pathway, while preserving the rest. These tend to have a more favorable infection-risk profile than broad immunosuppressants.
• The immune pathway redundancy blockade therapies market report covers cases where blocking one pathway is not enough because another compensates. Responses include combination biologic trials in IBD, such as guselkumab with golimumab, and multi-target molecules.

2.5 Transplant, fibrosis and neuroimmunology

Three adjacent areas complete the segment:

• Our transplant immunosuppression drugs market report covers calcineurin inhibitors, mTOR inhibitors and co-stimulation blockers such as belatacept, plus desensitization therapies for highly sensitized patients and the new immunosuppression needs raised by xenotransplantation research.
• The fibrosis and inflammatory disease therapies market study covers idiopathic pulmonary fibrosis, systemic sclerosis-associated lung disease and other conditions where inflammation leads to fibrosis. Established antifibrotics (nintedanib, pirfenidone) are being joined by PDE4B inhibition and other late-stage mechanisms.
• The neuroimmune inflammation biologics market report covers the growing interface between the immune and nervous systems. It spans IL-31 blockade for itch (nemolizumab, approved in 2024 for prurigo nodularis) and B-cell and IL-6-receptor therapies in multiple sclerosis and neuromyelitis optica.

3. Type 2 Inflammation, Respiratory and Allergy Biologics

Type 2 inflammation, driven by IL-4, IL-13, IL-5, IgE and the epithelial alarmins TSLP and IL-33, underlies atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and a subset of COPD. It is the fastest-expanding area of immunology. Our Type 2 inflammation targeted therapies market report sizes the category across all of these indications and all mechanisms.

The IL-4/IL-13 axis is its commercial center. Dupixent, which blocks the shared IL-4 receptor alpha, generated roughly €13 billion in 2024 and gained U.S. approval in COPD with type 2 inflammation in September 2024. That was the first biologic approval in a disease affecting hundreds of millions of people worldwide. The IL-4/IL-13 pathway biologics market study tracks dupilumab alongside the IL-13-selective antibodies tralokinumab and lebrikizumab, approved in the U.S. for atopic dermatitis in 2024.

Three reports cover the eosinophilic and severe-asthma segments:

• The eosinophilic inflammation biologic therapies market report covers IL-5 and IL-5-receptor antibodies (mepolizumab, benralizumab) and GSK's depemokimab, which completed Phase 3 on a twice-yearly dosing schedule.
• Our asthma and respiratory biologics market report sizes severe asthma, COPD and nasal polyps, where biologic penetration of eligible patients is still low. It includes tezepelumab, the anti-TSLP antibody approved in 2021 without restriction to an asthma phenotype.
• The steroid-sparing respiratory biologics market study quantifies the oral-corticosteroid burden that biologics are displacing, one of the strongest pharmacoeconomic arguments for earlier biologic use.

Three reports look at patient selection and the barrier biology behind Type 2 disease:

• The precision respiratory and immunology market report covers biomarker-guided prescribing using blood eosinophils, exhaled nitric oxide and endotyping. This is increasingly important in COPD, where only a subset of patients respond.
• The barrier dysfunction biologic therapies market study covers alarmin-targeted antibodies against TSLP, IL-33 and IL-25 that act upstream of the classic Type 2 cascade.
• The epithelial barrier restoration biologics market report tracks a different strategy: repairing the skin, airway or gut barrier, for example through IL-22 pathway agonists, rather than blocking the inflammation that follows its breakdown.

Delivery innovation is opening new options. The inhaled biologic respiratory therapies market report covers inhaled antibody fragments and proteins that act directly in the lung at lower systemic exposure. The approach is early-stage but strategically important for respiratory franchises.

Allergy is being transformed in parallel:

• Omalizumab became the first medicine approved to reduce reactions to multiple foods in February 2024. Our severe allergic disease biologic therapies market report covers food allergy, chronic spontaneous urticaria and anaphylaxis.
• The targeted immune desensitization therapies market study covers oral, sublingual and epicutaneous immunotherapy, including the peanut product Palforzia, and the emerging use of biologics to make desensitization faster and safer.
• At the consumer end, the intranasal allergy spray market report covers corticosteroid, antihistamine and combination sprays for allergic rhinitis. It also covers a new category created by the 2024 approval of an epinephrine nasal spray for anaphylaxis.

4. Ophthalmology Biologics: The Race to Fewer Injections

Intravitreal anti-VEGF antibodies transformed the treatment of wet age-related macular degeneration (AMD), diabetic macular edema and retinal vein occlusion. They also created one of the largest biologic markets outside immunology proper. Our anti-VEGF biologic therapies market report sizes ranibizumab, aflibercept, brolucizumab and faricimab. It tracks the arrival of ranibizumab biosimilars since 2021 and aflibercept biosimilars since 2024.

The competitive axis is now treatment burden, because monthly or bimonthly eye injections are the main reason patients drop out of therapy:

• The long-interval dosing ophthalmology biologics market report tracks products and pipelines that extend dosing to 12, 16 weeks or longer, including faricimab, high-dose aflibercept, refillable port delivery and sustained-release tyrosine kinase inhibitor implants.
• The high-affinity anti-VEGF biologics market study focuses on the molecular route to longer intervals: higher molar doses and tighter binding, exemplified by the 8 mg aflibercept formulation approved in 2023.

Molecular design and new targets are the other axis:

• The high-potency ophthalmic antibody therapies market report covers small-format antibodies that deliver more drug per injection. Brolucizumab's retinal vasculitis signal shows the safety trade-offs such formats must manage.
• The high-affinity retinal antibody drugs market study looks beyond VEGF to Ang-2 (targeted alongside VEGF by the bispecific faricimab), IL-6 in uveitic macular edema and complement pathways, where the first geographic atrophy therapies were approved in 2023.
• The diabetic retinopathy biologic therapies market report addresses one of the largest under-treated populations in ophthalmology. It covers the case for earlier intervention and the role of autonomous AI screening, first cleared by the FDA in 2018, in finding patients.

The ultimate reduction in treatment burden is a one-time therapy. Voretigene (Luxturna) became the first gene therapy for an inherited retinal disease in 2017, and anti-VEGF gene therapies designed to turn the eye into its own drug factory are now in Phase 3. Our ophthalmology gene therapy market report covers both the inherited-disease and the chronic-AMD opportunity.

5. Antibody and Protein Engineering: The Platform Layer

Everything above depends on the ability to design proteins with precise properties. The FDA approved its 100th monoclonal antibody in 2021, and antibodies are now the dominant class of new biologic medicines. Our antibody-based medicines market report sizes the whole category across therapeutic areas. The next-generation antibody engineering market study covers the platform technologies and service providers behind it: humanization, developability optimization, bispecific formats and conditional activation.

5.1 Affinity, Fc and valency

Three properties can be tuned in almost any antibody:

• Affinity. The high-affinity monoclonal antibody therapies market report covers affinity-matured antibodies whose potency allows lower doses, smaller injection volumes and longer intervals.
• The Fc region. The Fc-engineered antibody therapeutics market study covers half-life-extending mutations (used in the RSV antibody nirsevimab, which protects infants for a full season with one dose), silenced Fc for non-depleting antibodies and afucosylation for enhanced cell killing.
• Valency. The antibody valency optimization therapeutics market report examines how the number of binding arms (monovalent, bivalent or multivalent) changes whether an antibody blocks, activates or clusters its target.

Clustering is its own design space. Many immune receptors, particularly in the TNF receptor superfamily, only signal when several are pulled together. The receptor clustering-based biologic therapies market report covers agonist antibodies and hexamer-forming formats engineered to trigger that clustering on purpose.

5.2 Multi-specifics and alternative scaffolds

Bispecifics are no longer an oncology specialty. Emicizumab, which mimics a missing clotting factor in hemophilia A, and faricimab in the eye show how dual binding creates functions that a single antibody cannot. Two reports cover the class:

• Our multi-specific antibody therapeutics market report sizes the approved and pipeline class across therapeutic areas.
• The next-generation multi-specific antibodies market study tracks trispecific, tetraspecific and nanobody-based designs that combine several immunology targets in one molecule.

Smaller formats open routes that full antibodies cannot:

• The next-generation protein scaffold therapeutics market report covers nanobodies (caplacizumab was the first approved, in 2019), DARPins, anticalins and affibodies. Their small size enables tissue penetration, high-concentration formulation and potentially inhaled or oral delivery.
• The next-generation recombinant biologics market study covers engineered enzymes, fusion proteins and cytokine muteins, together with the expression platforms that produce them.

5.3 Receptors, ligands and interactions

Several reports cover how engineered proteins act on receptors and the interactions between proteins:

• The receptor agonist and antagonist biologics market report analyzes the class by pharmacology, comparing blocking antibodies with the smaller but growing group of agonist biologics that switch receptors on.
• The receptor-targeted protein therapeutics market study covers Fc-fusions and engineered ligands directed at specific receptors.
• The high-affinity ligand protein drugs market report covers engineered ligands and ligand traps with picomolar affinity.
• The allosteric protein therapeutics market study covers biologics that bind away from a receptor's active site to bias or fine-tune its signaling rather than block it outright. The allosteric principle has already produced an oral TYK2 inhibitor and is now being applied to antibodies.
• The protein conformation-selective biologics market report covers antibodies that recognize only a disease-associated shape of a protein, such as aggregated rather than normal forms. This approach underpins the anti-amyloid antibodies in Alzheimer's disease.

Protein-protein interactions were long considered undruggable by small molecules. The protein-protein interaction inhibitor drugs market report covers the progress since then, from lifitegrast (LFA-1/ICAM-1, approved for dry eye) to macrocycles and oral peptides. The precision protein interaction modulators market study adds the reverse strategy: molecular glues and stabilizers that strengthen beneficial interactions.

5.4 AI-designed proteins

The 2024 Nobel Prize in Chemistry recognized computational protein design and AI-based structure prediction, marking the point at which AI moved from research tool to drug-discovery engine. Pharmaceutical partnerships followed quickly, including Isomorphic Labs' agreements with Eli Lilly and Novartis in January 2024. Our AI in precision protein design market report covers the platforms, partnership economics and first AI-designed antibodies and binders entering the clinic.

6. Formulation, Dosing and Biosimilars: Where Commercial Value Is Decided

In a crowded market with similar efficacy, convenience decides share. The main lever is moving from intravenous infusion to subcutaneous self-injection:

• Our high-concentration subcutaneous biologics market report covers the IV-to-subcutaneous conversion now under way across IBD, neurology and autoimmune disease, including subcutaneous vedolizumab and hyaluronidase-enabled formulations such as subcutaneous efgartigimod.
• The high-concentration biologics market study addresses the underlying formulation challenge: concentrations of 150 mg/mL and above raise viscosity, stability and manufacturing difficulties that only some developers and CDMOs can solve.
• The high-dose subcutaneous biologic therapies market report covers large-volume on-body injectors that deliver induction or maintenance doses at home, such as the on-body device used for risankizumab in Crohn's disease.

Dosing frequency is the second lever:

• The long-acting injectable biologics market study tracks half-life-extended antibodies heading toward twice-yearly dosing.
• The long-interval dosing biologic medicines market report models how 8-, 12- and 16-week maintenance intervals affect adherence, patient preference and annual treatment cost.
• The sustained-release biologic formulations market study covers depots, hydrogels, microspheres and implants that release protein drugs over weeks or months.
• The high-potency biologic medicines market report covers biologics active at microgram doses, which changes fill volumes, handling and manufacturing economics.
• The high-durability biologic response therapies market study looks at the other end of the spectrum: short-course or tapering regimens that aim for sustained remission after treatment stops.

Some supportive categories have been biologic markets for decades. The recombinant growth factor drugs market report covers G-CSF, erythropoietin, growth hormone and related proteins, a category reshaped by filgrastim and epoetin biosimilars and by weekly long-acting growth hormone.

Biosimilar policy is moving in parallel. An interchangeable biosimilar can be substituted at the pharmacy without the prescriber's involvement, where state law allows. In 2024 the FDA proposed dropping the requirement for dedicated switching studies to earn that designation. U.S. biosimilar uptake has also been accelerated by pharmacy benefit managers placing private-label adalimumab on their formularies. Our biosimilar interchangeable biologics market report tracks interchangeability across adalimumab, ustekinumab, aflibercept and the next wave of immunology biosimilars.

Where Value Is Created: The Immunology Biologics Value Chain

U.S. price policy now affects immunology directly. Stelara and Enbrel were among the first ten medicines selected for Medicare price negotiation, with negotiated prices taking effect in January 2026. Combined with biosimilar entry, this compresses the late-lifecycle value of established biologics. Portfolios are shifting toward newer mechanisms, longer-acting formats and assets with a clear differentiation story.

Regional perspective

• United States. The largest market for immunology biologics and the most volatile, because PBM formulary decisions, rebates and private-label biosimilars can move share quickly.
• Europe. Faster biosimilar adoption through tenders and national switching programs means legacy brands lose share earlier. Health technology assessment moderates launch pricing for new mechanisms.
• China. A growing source of licensed immunology assets, including bispecifics and long-acting antibodies, and a large domestic market expanding through national reimbursement listings.
• Japan. A center of antibody-engineering innovation, including recycling and sweeping antibody technologies, and a priority launch market.
• India and other emerging markets. Major biosimilar manufacturing and export hubs that shape global pricing for off-patent biologics.

What to Watch Through 2032

1. Stelara and aflibercept biosimilar erosion: the pace of share loss will show how quickly value transfers to IL-23-selective and long-interval successors.
2. TL1A Phase 3 readouts in IBD: results will test whether biomarker-selected targets deliver the response-rate step-change their valuations assume.
3. CAR-T and T-cell engagers in autoimmunity: larger trials will show whether drug-free remission is durable and reproducible beyond refractory lupus.
4. Oral biologic-class drugs: oral IL-23 receptor peptides and oral TNF modulators could reset the injectable-versus-oral balance in psoriasis and IBD.
5. COPD and food allergy uptake: growth in these large populations will decide the next phase of Type 2 franchise growth.
6. Retinal gene therapy Phase 3 data: a one-time anti-VEGF therapy would redraw the economics of the intravitreal injection market.
7. AI-designed antibodies in the clinic: the first efficacy data will show whether computational design shortens timelines or only reduces discovery cost.

Frequently Asked Questions

What is driving growth in the immunology biologics market?

Growth comes from newer mechanisms replacing TNF-era drugs (IL-23, IL-17, IL-4/IL-13, JAK and TYK2), expansion into large new indications such as COPD and food allergy, and more convenient formats that improve adherence. Biosimilars reduce spending on older brands but free budget for newer therapies.

What happened to the immunology market after Humira lost exclusivity?

U.S. adalimumab biosimilars launched in 2023 and Humira's global sales fell by more than half from their 2022 peak by 2024. Most of that value moved to successor brands rather than leaving the category; AbbVie's Skyrizi and Rinvoq alone generated close to $18 billion in 2024.

What is Type 2 inflammation?

Type 2 inflammation is an immune pathway driven by IL-4, IL-13, IL-5, IgE and epithelial alarmins such as TSLP. It underlies atopic dermatitis, allergic and eosinophilic asthma, nasal polyps, eosinophilic esophagitis, food allergy and a subset of COPD, which is why a single biologic can be approved across many of these diseases.

What are FcRn inhibitors used for?

FcRn inhibitors lower levels of IgG antibodies by blocking the receptor that normally recycles them. They are used in autoantibody-driven diseases such as generalized myasthenia gravis and CIDP and are being studied in a growing list of other conditions.

Can CAR-T or T-cell engagers cure autoimmune disease?

Early academic studies of CD19 CAR-T in severe lupus reported drug-free remission after a single infusion, and T-cell engagers are being tested with the same goal. Larger and longer trials are needed to establish durability and safety, but the approach could shift autoimmune treatment from lifelong suppression to short-course therapy.

Why has TL1A attracted so much investment?

TL1A is a cytokine linked to both inflammation and fibrosis in inflammatory bowel disease, and early trials suggested strong responses, especially in biomarker-selected patients. That combination drove Merck's $10.8 billion acquisition of Prometheus Biosciences and Roche's $7.1 billion acquisition of Telavant in 2023.

Why are retinal biologics moving to longer dosing intervals?

Frequent eye injections are the main reason patients drop out of therapy for wet AMD and diabetic eye disease. Higher-dose, higher-affinity and bispecific molecules, sustained-release implants and gene therapy all aim to reduce injections from monthly to every 16 weeks or less often.

What makes a biosimilar interchangeable?

In the United States, an interchangeable biosimilar can be substituted for the reference biologic at the pharmacy, subject to state law, without a new prescription. The FDA proposed in 2024 that dedicated switching studies should no longer be required to earn this designation.

How is AI changing antibody and protein design?

AI models can predict protein structures and generate new binders computationally, reducing the number of lab cycles needed to find and optimize a candidate. Several pharma companies have signed platform partnerships, and the first AI-designed antibodies and binders are entering clinical trials.

Which region is the largest market for immunology biologics?

The United States is the largest market by revenue. Europe has faster biosimilar adoption and tighter pricing, while China is a rising source of licensed assets and a large, growing domestic market.

What do Mobility Foresights immunology reports include?

Each linked report provides market size and multi-year forecasts, growth drivers and challenges, segmentation by product, indication and region, competitive landscape and company profiles, pipeline analysis and recent developments. Customization is available on request.

Work With Mobility Foresights

Mobility Foresights provides syndicated and custom market intelligence across immunology, biologics and the wider biopharmaceutical value chain. Each report linked above can be purchased individually or tailored to a specific pathway, indication, region or competitive question. To request a sample or commission a bespoke study, contact our healthcare research team.