Global Biosimilars Follow on Biologics Market Size By Type (Human Growth Hormone, Erythropoietin), By Application (Blood Disorders, Oncology Diseases), By Region, And Segment Forecasts, 2023 to 2032

The Global Biosimilars Follow-on Biologics Market was valued at USD 20.1 billion in 2023 and is projected to reach USD 74.6 billion by 2031, growing at a robust CAGR of 17.5% during the forecast period from 2023 to 2031. The rising demand for cost-effective therapeutic alternatives to branded biologics, patent expirations of blockbuster biologics, and an increasing prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes are significantly driving market growth. The expanding healthcare infrastructure in emerging economies and rising healthcare expenditure further support the widespread adoption of biosimilars.

Drivers

1. Patent Expirations of Biologic Drugs

Several high-revenue biologics have lost or are nearing the end of patent protection, creating lucrative opportunities for biosimilar manufacturers to enter the market with lower-cost versions, fueling significant growth.

2. Growing Prevalence of Chronic Diseases

The rise in chronic conditions such as rheumatoid arthritis, cancer, and diabetes has increased the need for long-term, cost-effective biologic therapies, enhancing the demand for biosimilars.

3. Regulatory Support and Government Initiatives

Favorable regulatory frameworks across regions such as the U.S. FDA's abbreviated pathway for biosimilars and the EMA’s biosimilar approval process have streamlined product development and approval, accelerating market expansion.

Restraints

1. Physician and Patient Reluctance

Despite cost advantages, hesitancy from healthcare providers and patients due to concerns about efficacy, safety, and interchangeability compared to reference biologics continues to hamper market penetration.

2. Complex Manufacturing and Development Processes

Biosimilars are complex molecules requiring sophisticated manufacturing capabilities and significant R&D investments, presenting barriers for new entrants and limiting scalability.

Opportunity

1. Expansion in Emerging Markets

Countries such as India, Brazil, and China are becoming key growth frontiers due to increasing healthcare access, supportive regulatory policies, and growing awareness regarding biosimilar benefits.

2. Rising Acceptance Among Physicians

Ongoing education and real-world clinical evidence demonstrating biosimilar safety and efficacy are gradually improving acceptance among healthcare professionals, paving the way for increased adoption.

Market by System Type Insights

Based on system type, monoclonal antibodies (mAbs) accounted for the largest revenue share in 2023. These biosimilars are widely used in oncology, autoimmune disorders, and infectious diseases. Their extensive application, combined with the expiration of patents for several blockbuster mAbs, makes this segment dominant and highly lucrative.

The recombinant glycoproteins segment is expected to witness the fastest growth during the forecast period due to its increasing use in managing hematological and metabolic disorders.

Market by End-use Insights

In terms of end-use, the hospital and clinic segment dominated the market in 2023, holding more than 50% of the market share. These institutions are primary dispensing points for complex therapies like biosimilars, supported by reimbursement policies and bulk purchasing power.

The retail pharmacy segment is expected to witness notable growth, driven by increasing outpatient prescriptions and patient preference for convenient access to biosimilar therapies.

Market by Regional Insights

Geographically, Europe led the global biosimilars market in 2023, thanks to its early regulatory approval of biosimilars, high adoption rate, and strong government initiatives.

Asia-Pacific is anticipated to register the highest growth rate during the forecast period due to favorable government policies, a large patient population, and rapid expansion of healthcare infrastructure in countries like India, China, and South Korea.

Competitive Scenario

Prominent players in the global biosimilars follow-on biologics market include Amgen Inc., Pfizer Inc., Novartis AG (Sandoz), Biocon Limited, Celltrion Healthcare, Samsung Bioepis, Mylan N.V., Teva Pharmaceutical Industries Ltd., Fresenius Kabi, and Coherus BioSciences Inc. These companies are leveraging partnerships, strategic collaborations, and product launches to expand their market footprint.

Scope of Work – Global Biosimilars Follow-on Biologics Market

Key Market Developments

March 2024: Biocon and Viatris launched a biosimilar version of adalimumab in multiple European markets, strengthening their presence in the autoimmune therapeutic area.

July 2023: Pfizer announced expanded distribution of its oncology biosimilar portfolio across Asia-Pacific, targeting greater accessibility and affordability.

May 2023: Sandoz initiated phase III clinical trials for a biosimilar of eculizumab, a key step towards entering the rare disease biosimilars segment.

FAQs

1) What is the current market size of the Global Biosimilars Follow-on Biologics Market?

The market was valued at USD 20.1 billion in 2023.

2) What is the major growth driver of the Global Biosimilars Follow-on Biologics Market?

Patent expirations of blockbuster biologics and the rising demand for cost-effective therapies are major growth drivers.

3) Which is the largest region during the forecast period in the Global Biosimilars Follow-on Biologics Market?

Europe held the largest market share in 2023, while Asia-Pacific is expected to grow fastest through 2031.

4) Which segment accounted for the largest market share in Global Biosimilars Follow-on Biologics Market?

The monoclonal antibodies (mAbs) segment accounted for the largest share in 2023.

5) Who are the key market players in the Global Biosimilars Follow-on Biologics Market?

Key players include Amgen Inc., Pfizer Inc., Novartis AG (Sandoz), Biocon, Celltrion, Samsung Bioepis, and Mylan N.V.