Biosimilars are biologic drugs that are highly similar to an original Food and Drug Administration (FDA)-approved biological medicine, known as the reference product. Biosimilars play an important role in treating various chronic and complex diseases such as cancer, diabetes, immunological disorders, and others. Biosimilars provide cost-effective treatment options for patients, help in cost savings for the healthcare systems while maintaining high-quality medical care.
Market Opportunity:
The increasing acceptance rates among patients and healthcare providers is expected to offer lucrative growth opportunities for the biosimilars market. Biosimilars provide affordable treatment options to patients, especially those belonging to low-income groups. Additionally, biosimilars help in reducing the economic burden on healthcare systems. As a result, several countries are focusing on educating patients as well as healthcare professionals about the efficacy and safety of biosimilars through awareness programs and campaigns. For instance, EU countries conduct various educational initiatives to inform patients about the crucial role of biosimilars in making biologic medicines more accessible. The increasing awareness about biosimilars is expected to boost their adoption in the coming years.
Porter's Analysis
Threat of new entrants: The biosimilars market has a moderate threat of new entrants given the high costs involved in R&D and clinical trials. However, the opportunity for high profits attracts new companies.
Bargaining power of buyers: Individual consumers have low bargaining power but large pharma companies and national health systems can negotiate lower prices for biosimilars.
Bargaining power of suppliers: Few manufacturers control the supply of biological drug patents and reference medications, giving them strong bargaining power over prices.
Threat of new substitutes: Newer biological therapies and drug delivery methods act as substitutes but biosimilars remain cost effective for many indications.
Competitive rivalry: Strong as leading players compete on pricing, marketing efforts and expanding therapeutic areas.
SWOT Analysis
Strengths: Lower costs than biologics, expanding indications, patent expiries of major biologics create opportunities.
Weaknesses: Uncertainty over interchangeability, long-term safety and efficacy data still emerging for some drugs.
Opportunities: Emerging markets provide growth potential, increasing chronic disease burden drives demand.
Threats: Pricing pressures from reference drug makers, regulatory delays or failure in approvals.
Key Takeaways
The Global Biosimilars Market Growth is expected to witness high over the forecast period of 2023 to 2030 supported by the patent expiry of major biologic drugs and significant cost savings potential. The global biosimilars market is estimated to be valued at US$ 29.4 billion in 2023 and is expected to exhibit a CAGR of 5.9% over the forecast period 2023-2030.
The European region currently dominates the biosimilars market owing to early regulatory approvals and government reimbursement policies supporting biosimilar adoption. Europe accounts for the largest share of biosimilars currently due to supportive regulations and patient cost-saving initiatives in major countries like Germany, UK and France. The U.S. represents a major growth opportunity but uptake has been slowed by regulatory issues. The Asia Pacific region is expanding rapidly led by China, India and South Korea as biologics fill an increasing share of treatment needs.
Key players: Key players operating in the biosimilars market are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), Pfizer, Novartis, Amgen, Samsung Biologics, Celltrion and Dr Reddy’s. Leading firms are focused on expanding their portfolios into new therapeutic classes.
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