Biosimilars are biological medical products that are developed to be similar to an already licensed biological product, known as reference medicinal product (RPM). Biosimilars offer an effective alternate to expensive biopharmaceutical drugs with similar quality, safety, and efficacy. They seek to expand patient access to lifesaving medicines by reducing costs. For example, biosimilars have the potential to treat various chronic diseases like cancer, diabetes, and autoimmune conditions at a lower price point.

The global biosimilars market is estimated to be valued at US$ 29.4 Bn in 2023 and is expected to exhibit a CAGR of 5.9% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics:

The biosimilars market is primarily driven by the increasing affordability and accessibility of biologic drugs through biosimilars. Additionally, patent expiration of important biologics is expected to further open opportunities for biosimilar manufacturers to develop copies of reference biologics and market them at lower costs. For instance, the patents for anti-TNF drugs Humira, Remicade and Enbrel are expected to expire between 2023 to 2028 in major markets, attracting biosimilar manufacturers. Furthermore, regulatory support in the form of exclusive data protection periods and fast-track approval pathways are encouraging investments in biosimilars development. Regional healthcare agencies like U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA) are also fostering a conducive environment for biosimilars.

SWOT Analysis

Strength: The biosimilars market offers lower cost alternative to expensive biologic drugs. This lower cost allows more patients to access life-saving medications. Biosimilars require fewer costly clinical trials compared to innovative biologics due to prior FDA approval of the reference product. Biosimilars have exact molecular structure as the reference product and offer similar clinical efficacy.

Weakness: Manufacturers face major challenges in demonstrating biosimilarity to the FDA which requires intensive analytical, animal, and clinical studies. Biosimilars have the perception of being "copies" of original biologics instead of independent products, which impacts physician acceptance and adoption.

Opportunity: The expiry of patents of major biologic drugs provides opportunities for biosimilar market entry and price competition. Emerging markets offer significant growth opportunities due to their large patient populations and increasing healthcare expenditures. The development of a robust regulatory and legal framework further increases biosimilar adoption.

Threats: Aggressive pricing strategies of innovator companies make market penetration challenging for biosimilars. Limited interchangeability approval in some regions hinders automatic substitution. Concerns regarding long term safety and immunogenicity impacts physician confidence despite biosimilarity.

Key Takeaways

The Global Biosimilars Market Demand is expected to witness high growth. The market size for 2023 is forecast to reach US$ 29.4 billion, registering a CAGR of 5.9% during the period of 2023 to 2030.

Regional analysis shows that Europe currently dominates the market due to established regulations, availability of major reference biologics going off-patent, and pushed adoption rates through automatic substitution policies of many countries. However, Asia Pacific region is expected to be the fastest growing market due to rising healthcare expenditure, large patient population, and government initiatives to promote biosimilars.

Key players operating in the biosimilars market are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA). The expiry of major biologic patents such as Rituximab, Trastuzumab, and Insulin Glargine provides significant opportunities for these players. However, pricing pressure and debates around interchangeability continue to impact biosimilar market potential. Overall, the expiry of biologic patents worldwide, emergence of appropriate regulations, and value proposition over reference biologics is expected to drive significant market growth over the forecast period.

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