Growing incidences of Cancer and rare disorders
The growing incidences of cancer and rare disorders are playing a pivotal role in boosting the growth of the global biosimilar market. As the prevalence of these complex and often life-threatening conditions continues to rise, there is an increasing demand for effective and affordable treatment options. Biosimilars, which are highly similar to reference biologic drugs, provide a cost-efficient alternative to expensive therapies, making critical treatments more accessible to patients. For instance, according to the International Agency for Research on Cancer, there were cancer cases of nearly 9,826,539 in Asia, 4,471,422 in Europe, 2,673 174 in Northern America, 1,551,060 in Latin America and the Caribbean, 1,185,216 in Africa, and 269 088 in Oceania cancer cases of both genders in 2022. Furthermore, India also reported increasing incidences of cancer, which is contributing to the growth of the global biosimilar market. As per the International Agency for Research on Cancer, there were 192,020 breast cancer cases, 143,759 lip, oral cavity, 127,526 cervix uteri, 81,748 lung, 70,637 oesophagus, 70,038 colorectum, and 727,588 cancer cases of others. These increased cases of cancer are increasing the demand for biosimilar by healthcare providers and patients which leads to the frequent launches of biosimilar.
For instance, in May 2023, The FDA has granted approval to Yuflyma, the ninth biosimilar of adalimumab. Celltrion USA recently announced that Yuflyma (adalimumab-aaty), a citrate-free, high-concentration (100mg/mL) version of Humira, has been approved for use. This biosimilar is authorized to treat eight inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Moreover, as per the American Lung Association, there were about 30,000 people with cystic fibrosis in the US and nearly 70,000 people worldwide in 2022. Also, in April 2024, the Centers for Disease Control and Prevention reported that nearly 6,000 babies born with Down syndrome in the United States.
Furthermore, the expiration of patents for several high-cost biologics has further accelerated the development and approval of biosimilars, enabling healthcare systems to reduce costs without compromising on quality. This trend is driving the rapid expansion of the biosimilar market, as it addresses the dual challenges of rising disease burden and the need for sustainable healthcare solutions.
Thus, the increasing incidences of cancer and rare disorders across the globe and rising innovative product launches to treat these diseases are boosting the growth of the market.
Increasing launch of Biosimilars
The increasing launch of biosimilars is significantly bolstering the growth of the global biosimilar market, as pharmaceutical companies and regulatory bodies actively work to expand the availability of these cost-effective alternatives to biologic drugs. With the expiration of patents for several blockbuster biologics, manufacturers are seizing the opportunity to develop and introduce biosimilars across a wide range of therapeutic areas, including oncology, autoimmune diseases, and chronic conditions.
May 2024: Teva Pharmaceuticals and Alvotech launched of SIMLANDI (adalimumab-ryvk) injection in the U.S. as the first interchangeable, high-concentration, citrate-free biosimilar to Humira. This biosimilar is designed to treat a range of conditions, including adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis.
July 2024: Sandoz launched of its high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) in the United States, marking its entry into the US immunology market. This citrate-free HCF biosimilar offers US patients a reduced injection volume. As one of the few adalimumab HCF biosimilars approved in the US, Hyrimoz HCF enhances access for millions of individuals with serious inflammatory conditions.
October 2023: The FDA approved Celltrion USA's Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Approved as a novel drug, Zymfentra is developed based on Remicade, the reference intravenous infliximab. It is specifically approved for the treatment of adults with moderate to severe inflammatory bowel disease (IBD), which includes both ulcerative colitis (UC) and Crohn’s disease (CD), following prior treatment with an intravenously administered infliximab product.
June 2022: The FDA has approved RIABNI (rituximab-arrx), a biosimilar to Rituxan, for the treatment of adults with moderate to severe rheumatoid arthritis (RA) in combination with methotrexate, specifically for those who haven't responded adequately to TNF antagonist therapies. RIABNI is also approved for treating Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA), and Microscopic Polyangiitis (MPA).
December 2019: Daiichi Sankyo has announced the launch of its bevacizumab biosimilar for intravenous drip infusions in Japan. The product, developed in collaboration with Amgen, is available in 100 mg and 400 mg doses. It is a biosimilar to the anti-VEGF humanized monoclonal antibody bevacizumab, approved in Japan on September 20, 2019, for treating unresectable advanced or recurrent colorectal cancer. This launch marks a significant step in providing cost-effective cancer treatment options in Japan.
April 2020: Merck launched of ONTRUZANT (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab). Available in 150 mg single-dose vials and 420 mg multiple-dose vials, ONTRUZANT is priced at approximately USD 1,325 for the 150 mg vial and USD 3,709 for the 420 mg vial, offering a 15% discount compared to Herceptin’s list price.
Regulatory agencies, such as the FDA and EMA, have streamlined approval processes, encouraging more companies to enter the market and accelerating the pace of biosimilar launches. This surge in availability is driving competition, reducing treatment costs, and improving patient access to essential therapies. Additionally, healthcare systems worldwide are increasingly adopting biosimilars to alleviate financial burdens while maintaining high standards of care. As a result, the growing pipeline and commercialization of biosimilars are playing a crucial role in expanding the global biosimilar market, making it a cornerstone of modern healthcare innovation.
Rising healthcare costs
Rising healthcare costs have become a significant concern worldwide, driven by factors such as aging populations, increasing prevalence of chronic diseases, and the high prices of innovative biologic drugs. As governments, insurers, and patients grapple with the financial burden, there is a growing demand for cost-effective alternatives that do not compromise on quality or efficacy. This has spurred the burgeoning growth of the global biosimilar market, as biosimilars offer a more affordable option compared to their reference biologics, often at a fraction of the cost. By providing similar therapeutic benefits, biosimilars are increasingly being adopted across various therapeutic areas, including oncology, autoimmune diseases, and diabetes. Regulatory support, coupled with advancements in biomanufacturing technologies, has further accelerated their development and market penetration. As healthcare systems prioritize cost containment without sacrificing patient outcomes, biosimilars are poised to play a pivotal role in shaping a more sustainable and accessible healthcare landscape.
