Oncology Biosimilars Market to Reach USD 24 Billion by 2035, Growing at 8.1% CAGR

The Oncology Biosimilars Market is estimated to be worth USD 10.9 billion in 2025, according to Fact.MR's report states that the valuation will expand at an 8.1% CAGR during the forecast period and account for USD 24 billion by 2035. The growth in revenue is fueled mainly by the increasing worldwide cancer burden and the imperative necessity to decrease the high expenditure of biologic cancer treatments, thus making biosimilars a viable option for healthcare systems as well as patients.

Oncology biosimilars are increasingly becoming important in the global health environment because they can provide clinically similar therapeutic outcomes as reference biologics but at much lower prices. Since cancer therapy remains costly, both public and private payers are promoting the use of biosimilars to enhance access to life-saving medicines. Patent losses of blockbuster oncology biologics have presented a huge opportunity for biosimilar companies to bring cost-saving treatment options.

With improving acceptance among oncologists and widening regulatory approvals, the oncology biosimilars market is becoming mature and competitive. Stepped-up investments in pharmacovigilance, comparative clinical trials, and education programs have enhanced stakeholder trust in biosimilar safety and efficacy. The advent of high-tech manufacturing technologies has also been instrumental in improving scalability and consistency in biosimilar manufacture.

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Market Drivers

Patent Expirations

The expiration of patents for several blockbuster biologic drugs has opened the door for biosimilar development. By 2023, patents for nearly 20 oncology biologics are set to expire, creating opportunities for biosimilar manufacturers to introduce cost-effective alternatives.

Cost-Effectiveness

Biosimilars offer similar efficacy and safety profiles to their reference biologics but at a lower cost. This cost advantage is particularly significant in oncology, where treatments can be prohibitively expensive. Healthcare systems and patients alike are increasingly turning to biosimilars to reduce treatment costs without compromising quality.

Government Initiatives

Government-led initiatives aimed at reducing cancer mortality rates are also propelling the oncology biosimilars market. For instance, the U.S. government's Cancer Moonshot initiative seeks to reduce cancer death rates by half within 25 years, creating a favorable environment for biosimilar adoption through financial support and regulatory assistance.

Regional Insights

North America

North America holds a significant share of the oncology biosimilars market, driven by a well-established healthcare infrastructure and favorable reimbursement policies. The region is expected to maintain its dominance, with a projected CAGR of 32.0%.

Europe

Europe accounts for approximately 30% of the global oncology biosimilars market. The European Medicines Agency's robust regulatory framework has facilitated biosimilar approvals, while countries like Germany, the UK, and France have implemented policies favoring biosimilar use, leading to increased adoption.

Asia-Pacific

The Asia-Pacific region is experiencing the fastest growth in the oncology biosimilars market, accounting for around 25% of the global share. Factors such as rapid urbanization, a high prevalence of cancer, and increasing healthcare expenditures in countries like China, India, and South Korea are driving biosimilar adoption.

Market Challenges

Regulatory Hurdles

The stringent regulatory requirements for biosimilar approval, including extensive clinical trials to demonstrate biosimilarity in terms of safety, efficacy, and immunogenicity, can be time-consuming and costly. These challenges can delay market entry and increase development costs.

Market Barriers

Despite regulatory approvals, there is a significant level of skepticism and resistance among healthcare providers and patients regarding the safety and efficacy of biosimilars compared to their reference biologics. This hesitancy, often fueled by a lack of awareness and education, can hinder biosimilar adoption.

Key Market Segments

By Drug Class

Monoclonal antibodies dominate the oncology biosimilars market, given their widespread use in cancer treatment. Other significant segments include granulocyte colony-stimulating factors (G-CSF) and immunomodulators.

By Indication

Biosimilars are being developed for various cancer types, including breast cancer, lung cancer, colorectal cancer, cervical cancer, and blood cancers. The blood cancer segment, in particular, is projected to expand at a CAGR of 33.0%.

By Distribution Channel

Hospital pharmacies are the primary distribution channel for oncology biosimilars, given the complexity of cancer treatments. However, retail and online pharmacies are also emerging as important channels, especially in regions with expanding healthcare infrastructure.

Competitive Landscape

The oncology biosimilars market is highly consolidated, with key players including:

Pfizer Inc.
GlaxoSmithKline plc
Novartis AG
Mylan N.V.
Teva Pharmaceutical Industries Ltd.
Sanofi
These companies are investing heavily in research and development to create novel oncology biosimilars and are engaging in strategic collaborations to expand their market presence

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Future Outlook

The oncology biosimilars market is expected to continue its upward trajectory, driven by factors such as increasing cancer prevalence, cost-effectiveness of biosimilars, and supportive government initiatives. Advancements in biotechnology and manufacturing processes are also expected to lead to the development of next-generation biosimilars with improved efficacy and safety profiles. As awareness and acceptance of biosimilars grow among healthcare providers and patients, the market is poised for sustained growth in the coming years

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