United States Disease-Modifying Therapies Market Growth Driven by 6.2% CAGR, Led by Roche, Novartis, AbbVie, and Johnson & Johnson in Biologics and Gene Therapy Innovation

The global disease-modifying therapies market reached US$ 65.32 billion in 2024 and is expected to reach US$ 112.64 billion by 2033, growing at a CAGR of 6.2% from 2025 to 2033, according to DataM Intelligence.

United States: Recent Industry Developments

✅ In October 2025, Biogen received FDA accelerated approval for felzartamab, a CD38-directed monoclonal antibody, as a first-in-class therapy for antibody-mediated rejection in kidney transplant patients, expanding DMT options for autoimmune-mediated graft issues.
✅ In September 2025, Pfizer Inc. announced positive Phase 3 results for its gene therapy candidate in Duchenne muscular dystrophy (DMD), marking a breakthrough in disease-modifying genetic interventions for rare neuromuscular disorders.
✅ In August 2025, Roche expanded U.S. access to OCREVUS ZUNOVO subcutaneous formulation, reducing infusion time to 10 minutes for relapsing and primary progressive multiple sclerosis patients.

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China: Recent Industry Developments

✅ In October 2025, Sanofi's Tzield (teplizumab) received NMPA priority approval as the first disease-modifying therapy for delaying stage 3 type 1 diabetes onset in patients aged eight and older.
✅ In September 2025, Novartis partnered with a Chinese biotech firm to advance CRISPR-based gene editing therapies for rare genetic diseases, targeting local manufacturing for faster market access.
✅ In August 2025, AstraZeneca launched a biosimilar version of adalimumab for rheumatoid arthritis, enhancing affordability and penetration in China's growing autoimmune DMT market.

Asia-Pacific: Recent Industry Developments

✅ In October 2025, Roche initiated Phase 3 trials in Japan for fenebrutinib, a BTK inhibitor showing sustained suppression of disease activity in relapsing multiple sclerosis over two years.
✅ In September 2025, UCB received PMDA approval in Japan for BIMZELX (bimekizumab) in psoriatic arthritis and axial spondyloarthritis, addressing unmet needs in inflammatory DMTs.
✅ In August 2025, Biogen expanded QALSODY (tofersen) availability in South Korea for SOD1-ALS, the first therapy targeting the genetic cause of amyotrophic lateral sclerosis.

Market Trends & Drivers
The Global Disease-Modifying Therapies Market is surging due to escalating prevalence of autoimmune and chronic inflammatory diseases, breakthroughs in biologics like monoclonal antibodies and gene therapies, and a shift toward personalized medicine via biomarkers and CRISPR editing. Key trends include rising adoption of oral formulations for better adherence, expansion of biosimilars to reduce costs, and integration of AI for predictive treatment responses. The surge in early diagnostics (e.g., MRI, genetic testing), regulatory fast-tracks for orphan drugs, and investments in next-gen immunomodulators are significantly propelling growth, alongside increasing focus on long-term efficacy and reduced side effects in conditions like MS and RA.

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Competitive Landscape

The market is dominated by biotech and pharma giants emphasizing biologics innovation, biosimilar pipelines, and strategic acquisitions to address unmet needs in autoimmune and neurological disorders.
✦ Genentech USA, Inc. (Roche Group) leads in multiple sclerosis (MS) and autoimmune research with Ocrevus and fenebrutinib, pioneering next-generation BTK inhibitors and targeted biologics in DMT innovation.
✦ Novartis AG drives precision medicine with Kesimpta and gene therapy collaborations, advancing biosimilars and CRISPR-based DMTs for MS, RA, and rare immune disorders.
✦ Teva Neuroscience, Inc. maintains strong presence in MS care with Copaxone and life-cycle innovations in neuroinflammation, exploring new formulations for patient adherence and accessibility.
✦ GSK advances immunology through B-cell and T-cell modulation, developing biologics like otilimab for rheumatoid arthritis and leveraging AI in autoimmune discovery.
✦ AstraZeneca PLC expands its immunology footprint via Alexion assets and biologics such as ALXN2030, combining renal, metabolic, and autoimmune solutions through strategic partnerships.
✦ Johnson & Johnson (Janssen) strengthens autoimmune leadership with IL-23 and IL-12 inhibitors like Stelara and Tremfya, broadening its DMT portfolio across Crohn's, psoriasis, and lupus.
✦ AbbVie Inc. consolidates its dominance in immunomodulation with Rinvoq and Skyrizi, while leveraging Humira biosimilars and pipeline biologics for high-impact autoimmune control.
✦ Amgen Inc. enhances DMT offerings through Enbrel and Otezla, investing in biosimilar expansion and fusion-protein platforms for chronic inflammatory diseases.
✦ UCB, Inc. drives innovation with BIMZELX and bimekizumab, leading IL-17 inhibition strategies across spondyloarthritis, psoriasis, and neuroinflammatory conditions.
✦ Takeda Pharmaceuticals U.S.A., Inc. advances gut-selective therapies like Entyvio for Crohn's and ulcerative colitis, while developing next-generation gene therapies targeting rare immune and metabolic disorders.

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Segmentation

By Drug Class
The Disease-Modifying Therapies (DMT) market is segmented into biologics and small molecule drugs. Biologics dominate due to their targeted mechanism of action and proven efficacy in treating chronic autoimmune conditions. Small molecule drugs, however, are gaining momentum owing to their oral availability, lower cost, and ease of administration.

By Disease Indication
Key disease indications include multiple sclerosis, rheumatoid arthritis, lupus, Crohn's disease, and others. Multiple sclerosis leads the market, driven by strong adoption of advanced DMTs that slow disease progression. Rheumatoid arthritis and lupus segments are also expanding due to increasing awareness and improved therapeutic options.

By Route of Administration
Based on administration, the market is categorized into parenteral and oral routes. Parenteral therapies dominate due to their high bioavailability and established efficacy in biologic formulations. The oral route is witnessing rapid growth as patients prefer convenient, non-invasive treatment options.

By Distribution Channel
Distribution channels include hospital pharmacies and retail pharmacies. Hospital pharmacies account for the largest share, as most biologic DMTs require professional supervision and cold-chain handling. Retail pharmacies are expanding with the growing availability of oral DMTs and improved patient access to long-term therapies.

Regional Analysis

North America leads the global DMT market, propelled by advanced healthcare infrastructure, high adoption of biologics, and robust clinical trial activity in the U.S. and Canada.

Europe follows closely, driven by government support for chronic disease management, established pharmaceutical players, and widespread use of biosimilars.

Asia-Pacific is projected to grow fastest due to increasing healthcare expenditure, improved diagnostic capabilities, and growing awareness of autoimmune disease treatment options.

South America shows gradual growth as Brazil and Argentina strengthen healthcare investments and expand access to specialty drugs.

The Middle East & Africa represent emerging regions, where improving healthcare systems and rising prevalence of chronic inflammatory diseases are creating new market opportunities.

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✅ Competitive Landscape
✅ Biosimilar Penetration & Patent Cliff Analysis
✅ Gene Therapy Pipeline Tracker
✅ KOL / WHO Insights
✅ Early Diagnosis & Adherence Shifts
✅ Regulatory Approvals & Reimbursement Dynamics
✅ Live Pricing & Clinical Trial Trends

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