Global Biosimilars Market Research Report, 2030

Market Dynamic

Market Drivers • Expiring Patents of Blockbuster Biologics Worldwide: Globally, a significant driver of the biosimilars market is the expiration of patents and exclusivity rights on major biologic drugs. Many top-selling biologics used to treat cancer, autoimmune diseases, and other chronic conditions are losing patent protection, opening the door for biosimilar manufacturers. This creates a huge opportunity for biosimilars to capture market share by providing more affordable alternatives that can reduce healthcare spending worldwide. The patent cliffs in multiple regions, including North America, Europe, and parts of Asia, fuel competition and innovation, propelling the global biosimilars market growth. • Growing Demand for Affordable Healthcare Solutions: Healthcare systems globally are under pressure to improve patient access to advanced therapies while managing rising costs. Biosimilars provide an effective way to balance quality care with cost containment. Governments, payers, and healthcare providers in both developed and emerging markets are increasingly advocating for biosimilar use to ensure sustainability of healthcare budgets. The rising prevalence of chronic diseases and aging populations worldwide further drive demand for biologic treatments at lower prices, making biosimilars an essential component of future healthcare strategies. Market Challenges • Complexity of Biosimilar Development and Regulatory Barriers: Developing biosimilars is technically more complex and costly than producing small-molecule generics due to the biological nature of the molecules involved. Regulatory requirements vary significantly across regions, involving extensive analytical characterization, clinical trials, and post-marketing surveillance to demonstrate biosimilarity. This complexity increases time to market and development costs. Moreover, regulatory harmonization is limited globally, meaning manufacturers must tailor applications to different markets, increasing administrative burdens. These challenges can delay biosimilar availability and limit the number of players willing to invest in this space. • Market Access and Stakeholder Resistance: Despite regulatory approvals, market penetration of biosimilars faces hurdles such as limited physician and patient acceptance, particularly in markets with low awareness or trust. Prescriber hesitation often stems from concerns about interchangeability, immunogenicity, and efficacy. Additionally, aggressive pricing and rebate strategies by originator biologic manufacturers can hinder biosimilar uptake. Payer policies and reimbursement mechanisms also vary, sometimes limiting biosimilar substitution or favoring originator drugs. These access challenges affect biosimilar adoption rates and can slow the realization of cost savings. Market Trends • Increasing Global Regulatory Convergence and Guidelines: There is a growing trend toward regulatory convergence, driven by efforts from international bodies such as the World Health Organization (WHO) and collaboration between agencies like the FDA, EMA, and other regional regulators. These efforts aim to harmonize requirements for biosimilar approval, improve transparency, and provide clearer pathways for interchangeability and substitution. Such alignment helps manufacturers streamline global development programs, reduce duplication, and accelerate biosimilar availability worldwide. Greater regulatory predictability fosters increased investment and competition in the biosimilars space. • Expansion into New Therapeutic Areas and Innovation: While early biosimilars focused on relatively simpler molecules such as erythropoietins and growth factors, the market is rapidly expanding into complex biologics like monoclonal antibodies used in oncology, immunology, and rare diseases. Innovations in manufacturing processes, analytical techniques, and formulation improvements are enabling the development of more advanced biosimilars. Additionally, there is growing interest in next-generation biosimilars or “biobetters” that may offer improved efficacy, safety, or patient convenience. This evolution broadens the scope and impact of biosimilars globally, opening new market opportunities.

Key Development

• October 2023: Pfizer’s Abrilada (adalimumab-afzb) received approval from the U.S. FDA as the second interchangeable Humira biosimilar. An interchangeable designation is granted by the FDA to only those biosimilars that meet additional data requirements. This data demonstrates that patients who alternate between the reference product and the biosimilar exhibit the same clinical result as patients who are being treated with the reference product alone. • July 2023: Boehringer Ingelheim launched the first interchangeable branded version of Humira, Cyltezo (adalimumab-adbm), in the U.S. market. Cyltezo reinforces the ultimate goal of providing a more affordable and accessible treatment option across the U.S. • January 2023: The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorization for Ximluci, a ranibizumab biosimilar developed in partnership with STADA Arzneimittel and Xbrane Biopharma. The marketing authorization will broaden patient access to ranibizumab in the U.K.