Biosimilars and Follow-on Biologics market is projected to grow at a CAGR of 14.8% by 2034: Visiongain

Visiongain has published a new report entitled Biosimilars and Follow-On Biologics Market Report 2024-2034: Forecasts by Product Type (Recombinant Non-Glycosylated Proteins (Human Growth Hormone, Granulocyte Colony-Stimulating Factor, Insulin, Interferon), Recombinant Glycosylated Proteins (Erythropoietin, Monoclonal Antibodies, Follitropin, Low Molecular Weight Heparin)), by Application (Hematology (Neutropenia, Anemia), Oncology (Lung Cancer, Brain Cancer, Breast Cancer, Cervical Cancer, Colorectal Cancer, Leukemia, Others), Autoimmune Disease (Arthritis, Inflammatory Bowel Disease, Psoriasis, Others), Growth Hormone Deficiency, Diabetes, Others)), by Technology (Recombinant DNA Technology, Monoclonal Antibodies Technology), by Manufacturer (Contract Research and Manufacturing Services, In-house) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.

The Global Biosimilars and Follow-on Biologics Market is estimated at US$33,313.8 million in 2024 and is expected to register a CAGR of 14.8% from 2024 to 2034.

Upcoming Patent Expiries for Biologics

The expiration of patents for original biologics marks a significant turning point in the pharmaceutical industry, offering a window of opportunity for the expansion and maturation of the biosimilar and follow-on biologic market. As the exclusive rights to produce and market a biologic drug expire, it opens the door for biosimilar developers to enter the arena with more affordable versions of these complex therapeutic agents. This phenomenon is particularly notable in the context of rising healthcare costs and the growing demand for accessible, cost-effective treatments. The biosimilar and follow-on biologic market gains traction as developers capitalize on the expiration of patents to introduce alternatives that maintain comparable quality, efficacy, and safety profiles to the original biologics.

Additionally, the increased availability of biosimilars contributes to improved treatment accessibility, empowering healthcare providers with a diverse range of therapeutic options. As the biosimilar and follow-on biologic market grows in response to patent expirations, it plays a pivotal role in reshaping the pharmaceutical landscape, promoting innovation, and advancing the goal of providing high-quality healthcare solutions to a wider demographic.

Some of the leading drugs that will expire in the next five years includes the blockbuster drug Keytruda (Pembrolizumab ) in 2028, Eliquis (Apixaban) in 2027, Opdivo (nivolumab) in 2028, and Xarelto (Rivaroxaban) in 2026 among several others.

How has COVID-19 had a Significant Impact on the Biosimilars and Follow-on Biologics Market?

The COVID-19 pandemic had significantly impacted the supply chain, where disruptions caused by lockdowns, travel restrictions, and workforce shortages have hindered manufacturing and distribution processes. These disruptions led to delays in bringing new biosimilars to market, exacerbating an already competitive landscape.

Moreover, the pandemic has underscored the critical role of biologics in treating various diseases, including severe cases of COVID-19. This increased demand for biologics, coupled with regulatory delays in approval processes, has further complicated market dynamics. Regulatory agencies, faced with the challenge of maintaining operations amidst the crisis, struggled to keep pace with the approval of new biosimilars, impeding market expansion.

The COVID-19 crisis has underscored the importance of enhancing healthcare resilience and diversifying pharmaceutical supply chains. This emphasis on supply chain resilience presents an opportunity for local and regional biosimilar manufacturers to strengthen their market presence. Furthermore, the pandemic has accelerated the digital transformation of healthcare delivery, including telemedicine and remote monitoring. These technological advancements have the potential to facilitate greater patient access to biosimilar by streamlining prescription and distribution processes. The economic impact of the pandemic has heightened the urgency of cost-saving measures, making biosimilars increasingly attractive to healthcare providers and payers alike.

Download Exclusive Sample of Report

How will this Report Benefit you?

Visiongain’s 391-page report provides 156 tables and 200 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the Biosimilars and Follow-on Biologics Market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Biosimilars and Follow-on Biologics. We provide financial analysis of the overall market and different segments including design, delivery and type of application. We believe that there are strong opportunities in this fast-growing Biosimilars and Follow-on Biologics Market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Growing Incidence of Chronic Diseases

The escalating incidence of chronic diseases globally has emerged as a driving force behind the burgeoning biosimilars market. The Lancet global burden studies show that chronic conditions caused 74% of all deaths worldwide rising from 67% of deaths in a decade ago. The mortality data reflect high prevalence’s of chronic conditions across populations. For example, in Australia, the Australian Institute of Health and Welfare has noted 47% of Australians have at least one chronic disease with 20% having 2 or more. 51% of hospitalizations involve chronic disease, 90% of deaths and disease burden is borne disproportionately by adults and those living in remote areas.

As conditions such as cancer, autoimmune disorders, and diabetes become more prevalent, the demand for advanced and affordable therapeutic options intensifies. Biosimilars, offering comparable efficacy to their reference biologics, present a compelling solution to address the therapeutic needs of patients grappling with chronic illnesses. The increasing burden of chronic diseases on healthcare systems underscores the significance of biosimilars as cost-effective alternatives, providing healthcare providers with a viable means to enhance treatment accessibility for a broader patient population.

Moreover, the rising prevalence of chronic diseases accentuates the economic strain on healthcare budgets, prompting a growing interest in biosimilars as a means to curb escalating healthcare expenditures. Biosimilars have the potential to play a transformative role in ensuring sustainable healthcare by offering more budget-friendly alternatives without compromising therapeutic effectiveness. This aligns with the broader goal of achieving optimal patient outcomes while navigating the financial constraints associated with the management of chronic conditions. As the incidence of chronic diseases continues to rise, the biosimilars market stands poised to play a pivotal role in reshaping the landscape of therapeutic interventions, contributing to improved patient access and long-term healthcare sustainability.

Established Guidelines for Approval of Biosimilars Projected to Drive Industry Growth

Regulatory agencies worldwide have taken a proactive approach in shaping the biosimilars landscape by establishing clear and stringent guidelines for their approval. Regulatory guidelines provide a transparent pathway for biosimilar developers, offering a set of rigorous requirements that must be met to obtain regulatory approval. Such clarity not only instils confidence in the biosimilar development process but also fosters a regulatory environment that prioritizes patient safety and therapeutic efficacy.

The established guidelines address critical aspects such as comparative analytical studies, clinical trial design, and post-marketing surveillance, ensuring that biosimilars undergo comprehensive scrutiny before entering the market. This regulatory clarity has not only streamlined the approval process but has also facilitated a more efficient development timeline for biosimilars, promoting competition and widening the array of treatment options available to healthcare providers and patients. As regulatory agencies continue to refine and update these guidelines, they play a crucial role in shaping the evolution of the biosimilars market, supporting innovation, and maintaining the highest standards of quality and safety in biopharmaceutical development.

Get Detailed ToC

Where are the Market Opportunities?

Development of Biosimilar Versions of Monoclonal Antibodies (mAbs)

As patents for originator mAbs expire, there is a growing emphasis on developing biosimilar counterparts that replicate the therapeutic effects of the reference products. The unique challenge with mAbs lies in their complex structures and precise targeting mechanisms, necessitating thorough analytical and clinical evaluations to ensure biosimilarity.

The development of biosimilar mAbs involves intricate processes, including comprehensive analytical characterization and rigorous clinical trials to establish similarity in terms of safety, efficacy, and immunogenicity. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established specific guidelines for the approval of biosimilar mAbs, reflecting the industry's commitment to maintaining high standards of quality and safety. The introduction of biosimilar mAbs into the market offers a promising prospect for expanding patient access to these innovative therapies while addressing the economic challenges associated with the rising costs of biologic treatments. As research and development efforts continue to focus on biosimilar mAbs, this segment of the biosimilars market is poised to play a crucial role in shaping the future of precision medicine and personalized therapeutic approaches.

Growing Demand for Affordable Biologics in Emerging Markets to Offer Lucrative Growth Prospects

The growing demand for affordable biologics in emerging markets represents a significant driver in shaping the dynamics of the global biosimilars market. As healthcare needs rise in these regions, particularly in Asia, Latin America, and parts of Africa, there is a heightened demand for cost-effective alternatives to expensive biologic drugs. The prevalence of chronic diseases, coupled with an expanding middle-class population, has intensified the need for accessible and affordable biologic therapies. Biosimilars, offering comparable efficacy to their reference biologics at a lower cost, are well-suited to meet this demand and bridge the gap in healthcare access.

Emerging markets present a unique set of challenges, including diverse regulatory landscapes, varying healthcare infrastructures, and economic considerations. However, biosimilar manufacturers are increasingly recognizing the immense growth potential in these regions and are strategically positioning themselves to cater to the specific needs and preferences of local healthcare systems. Collaborations between global and local pharmaceutical companies, as well as initiatives to increase awareness and acceptance of biosimilars among healthcare professionals and patients, are instrumental in unlocking the full potential of the biosimilars market in emerging economies. As the demand for affordable biologics continues to rise, the biosimilars market is poised to play a pivotal role in addressing healthcare inequalities and improving patient outcomes in these dynamic and expanding markets.

Competitive Landscape

Key players like Amgen Inc., Apotex (Apobiologix), Biocad, Biocon Biologics Ltd., Bio-Thera Solutions, Coherus Biosciences, Dr. Reddy’s Laboratories, Fresenius Kabi (Fresenius SE & Co. KGaA), Intas Pharma, Pfizer, Reliance Life Sciences, Samsung Bioepis (Samsung Biologics), Sandoz, Teva Pharmaceuticals Industries Ltd. are actively contributing to the competitive landscape with a diverse range of products and advancements. This competition benefits consumers by offering a variety of treatment options that are potentially more affordable, driving accessibility and affordability of essential medications. Overall, the collaborative efforts of manufacturers, regulatory bodies, and technological advancements are instrumental in fostering the growth of the biosimilars and follow-on biologics market, ensuring a dynamic and innovative landscape that ultimately benefits patients worldwide.

Recent Developments

  • In March 2024, Sandoz Group AG announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the initial and only FDA-approved denosumab biosimilars, to treat all indications of the reference drugs.
  • In February 2024, Teva Pharmaceuticals and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis.

To access the data contained in this document please email Avoid missing out by staying informed – order our report now.

To find more Visiongain research reports on the Pharma sector, click on the following links:

Do you have any custom requirements we can help you with? Any need for a specific country, geo region, market segment or specific company information? Contact us today, we can discuss your needs and see how we can help:

About Visiongain

Visiongain is one of the fastest-growing and most innovative independent market intelligence providers around, the company publishes hundreds of market research reports which it adds to its extensive portfolio each year. These reports offer in-depth analysis across 18 industries worldwide. The reports, which cover 10-year forecasts, are hundreds of pages long, with in-depth market analysis and valuable competitive intelligence data. Visiongain works across a range of vertical markets with a lot of synergies. These markets include automotive, aviation, chemicals, cyber, defence, energy, food & drink, materials, packaging, pharmaceutical and utilities sectors. Our customised and syndicated market research reports offer a bespoke piece of market intelligence customised to your very own business needs.


Visiongain Reports Limited
Telephone: +44 (0) 20 7336 6100