Global Biosimilars Market Insights and Trends Report

Market Overview

The COVID-19 pandemic has had a profound impact on both the global economy and public health. Throughout this challenging period, various sectors, including the pharmaceutical industry, have displayed remarkable resilience and collaboration. Notable instances of cross-stakeholder cooperation among academia, industry, and government have emerged, encompassing endeavors such as drug re-purposing initiatives, antibody discovery programs, vaccine research and development, and clinical trial enrolments, particularly for COVID-19 patients.

Key Developments in the Biosimilar Space

One noteworthy milestone in the biosimilar sector occurred in March 2020 when Samsung Bioepis announced the approval of a 420mg multi-dose vial of its Herceptin biosimilar, Ontruzant. This cost-effective product not only reduces waste but also received FDA approval in 2019 in its 150 mg single-dose form.

In the same month, Celltrion and Teva introduced their trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), to the US market. Herzuma, approved in Canada as well, offers treatment options for breast and gastric cancer patients.

Segmentation by Product Class

Biosimilars hold the promise of enhancing patient access to vital treatments while concurrently reducing healthcare costs. However, their development poses significant challenges due to the intricate nature of biologic drugs, which exhibit molecular complexity and sensitivity to manufacturing and handling variations.

One area poised for substantial growth in the biosimilars market is the development of biosimilars for complex monoclonal antibodies (mAbs). Complex mAbs are among the best-selling biologics and are used in the treatment of various conditions, including cancer and autoimmune disorders like rheumatoid arthritis. This growth is driven by the approaching expiration of patents for several top-selling biologics.

As pharmaceutical companies increasingly enter the rapidly expanding mAb biosimilars market, competition for these biosimilars is expected to intensify. This trend reflects the industry's commitment to meeting the rising demand for these critical therapies.

Segmentation by Geography

Biosimilar trends in developed and emerging markets share similarities, except for the United States. Developed markets like Europe, the United States, and Japan lead in biosimilar presence and development. The growth in these markets is driven by incentives from physicians and insurance providers, encouraging the adoption of cost-effective biosimilars.

In contrast, emerging markets have a nascent biosimilar landscape due to limited access for patients and a preference for lower-cost therapies among physicians. Treatment rates for flagship biologics remain low in emerging markets compared to developed ones, hindering biosimilar adoption. However, most emerging markets are poised for significant growth, thanks to streamlined approval processes compared to developing nations.

As healthcare systems evolve and regulations improve, emerging markets are expected to bridge the gap, offering affordable biosimilars to a broader patient base. This trend indicates a promising future for biosimilars, aligning with global efforts to make vital biologic treatments more accessible and cost-effective worldwide.

Competitive Landscape