Biosimilars Market to Reach USD 125.9 Billion by 2035, Driven by mAb Adoption, Manufacturing Scale-Up, and Digital-Enabled Patient Management

The global Biosimilars Market is projected to grow from USD 31.6 billion in 2025 to USD 125.9 billion by 2035, expanding at a CAGR of 13.4% during the forecast period.

This rapid expansion is driven by patent expiries on blockbuster biologics, increased payer and hospital adoption of lower-cost alternatives, and rising biosimilar availability across oncology, immunology, and endocrinology.

MarketGenics positions biosimilars as a strategic lever for sustainable healthcare, enabling broad access to biologic therapies while creating new service and digital-health adjacencies that support adherence, safety monitoring, and value-based care.

Get the Detailed Industry Analysis (including the Table of Contents, List of Figures, and List of Tables) - from the Biosimilars Market Research Report: https://marketgenics.co/press-releases/biosimilars-market-04169

Recent Developments Shaping the Market
Samsung Bioepis launches PYZCHIVA with AI monitoring (Feb 2025)

Samsung Bioepis introduced PYZCHIVA (a biosimilar to ustekinumab/Stelara) in the U.S., paired with an AI-enabled real-time monitoring platform that collects RWD and wearable data to personalize dosing and safety surveillance.

Pfizer expands biosimilar portfolio with IXIFI in Canada (Apr 2025)

Pfizer launched IXIFI (infliximab biosimilar) in Canada and rolled out an AI-based Biosimilar Management Hub for oncology and immunology providers to optimize treatment selection and inventory planning.

Manufacturing scale-ups and contract manufacturing momentum

Global CMOs and biopharma (Amgen, Biocon, Celltrion) have announced capacity expansions and modular bioreactor investments to reduce COGS and accelerate time-to-market for high-value mAb biosimilars.

Biosimilars Market Forecast 2035
The market is set to create an incremental opportunity of USD 94.4 billion between 2025 and 2035.

North America will remain the largest and most lucrative market because of strong payer reforms, physician familiarity, and active substitution policies in some jurisdictions.

Europe will sustain high uptake driven by tendering programs and established biosimilar pathways.

Asia-Pacific will be the fastest-growing region as local manufacturers scale capacity, governments push cost containment, and access expands in China, India, Korea and Southeast Asia.

By 2035, biosimilars will be embedded across standard treatment algorithms-lowering cost of care, increasing patient access to biologics, and enabling health systems to reallocate savings to innovative therapies.

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Key Drivers, Challenges, and Opportunities
Driver - Patent cliffs and cost-containment pressure

Expiries of major biologic patents open large addressable markets. Payers and hospitals favor biosimilars to reduce drug spend, driving rapid formulary inclusion-especially for high-cost oncology and autoimmune biologics.

Restraint - Complex development, regulatory hurdles and interchangeability debates

Unlike small-molecule generics, biosimilars require costly analytical comparability, clinical evidence, and robust manufacturing controls. Interchangeability/substitution policies vary by market and can slow uptake where pharmacy-level substitution is restricted.

Opportunity - Value-added services & digital patient hubs

Providers who combine biosimilars with digital adherence tools, RWD safety monitoring, and AI-driven treatment-selection platforms can capture premium margins and accelerate clinician confidence. Examples: AI monitoring platforms paired with PYZCHIVA and Pfizer's management hub.

Key Trend - Manufacturing Scale-Up & Tendering Economics
Large biosimilar wins increasingly hinge on manufacturing cost efficiency and tender-based pricing. Modular biomanufacturing, single-use systems, and regional CMO networks are compressing COGS and enabling more aggressive pricing-particularly in public tender markets in Europe and Latin America.

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Segmental Insights
mAbs Lead (~36% share in 2025)

Monoclonal antibody biosimilars dominate due to wide therapeutic coverage (oncology, RA, IBD) and high list prices for originators-making savings substantial and uptake rapid where policies support substitution.

Recombinant proteins & insulins

Recombinant hormones, insulin analogs and G-CSF biosimilars form growing mid-value segments, especially as diabetic care and supportive oncology therapy volumes rise.

Regional Highlights
North America: Market leader-high pricing pressure, growing payer programs, and increasing physician acceptance; rapid commercialization of complex biosimilars.

Europe: Early biosimilar adopters with mature tender frameworks and high penetration in hospital formularies.

Asia-Pacific: Fastest expansion-local manufacturing scale, price sensitivity, and public programs driving adoption.

Middle East, Africa & Latin America: Selective uptake tied to tender policies, local licensing, and access programs.

Competitive Landscape
The biosimilars market is moderately consolidated, with the top players controlling significant share but with active regional challengers.

Tier-1 Leaders: Pfizer, Amgen, Novartis (Sandoz), Samsung Bioepis, Biocon Biologics.

Tier-2 Players: Celltrion, Fresenius Kabi, Mylan/Viatris, Celltrion, Teva (regional playbooks).

Innovators & Niche: Xbrane, Kashiv BioSciences, regional biotechs focused on cost-optimized pipelines.

Competition centers on manufacturing scale, COGS reduction, regulatory evidence, tender execution, and bundled digital services.

Get a preview of our Biosimilars Market Playbook - your guide to GTM strategy, competitive intelligence, supplier dynamics, and Consumer Behavior Analysis: https://marketgenics.co/playbook/biosimilars-market-04169

Future Outlook
By 2035 the biosimilars market will be characterized by:

Wider therapeutic coverage (mAbs, fusion proteins, insulin analogs) and deeper penetration across hospitals and outpatient clinics;

Lowered treatment costs that enable broader population access to biologics;

Integrated digital ecosystems (monitoring, adherence, RWE) that de-risk substitution and support payer value arguments;

Regional manufacturing hubs reducing lead times and enabling competitive pricing.

These forces will position biosimilars as a major driver of healthcare affordability-capturing a share of a USD 125.9 billion market by 2035.

Prominent Companies Operating in the Global Biosimilars Market
Amgen, Novartis (Sandoz), Pfizer, Samsung Bioepis, Biocon Biologics, Celltrion, Fresenius Kabi, Viatris (Mylan), Teva, Xbrane, Kashiv BioSciences, and other global/regional manufacturers.

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This release was published on openPR.