生物製剤およびバイオシミラー市場: トレンド、成長、将来の見通し 2024-2031
This report presents a detailed assessment of the global biologics and biosimilars market, covering market size history from 2019 to 2022 and forecast growth from 2024 to 2031. The market size is estimated at USD 23.96 billion in 2023 and is expected to reach approximately USD 73.03 billion by 2031, registering a robust compound annual growth rate (CAGR) of 17.3% during this period. This expansion highlights the growing need for advanced therapeutic solutions and underscores the role of technological innovation in shaping the industry.
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The global biologics and biosimilars market has witnessed significant growth, driven primarily by the prevalence of chronic diseases and the rising demand for innovative therapeutic solutions. Biologics, which consist of complex molecules derived from living organisms, are essential in managing conditions such as cancer, autoimmune diseases, and rare diseases. These therapies offer targeted and effective treatment options. The introduction of biosimilars, which are nearly identical versions of existing biologics, plays a key role in increasing accessibility by providing a cost-effective alternative, widening patient access, and mitigating healthcare costs. Advances in biotechnology and manufacturing techniques are further enabling the development and production of these therapies. Additionally, regulatory frameworks are spurring innovation, encouraging competition, and facilitating market entry.
The market is also driven by an increasing focus on personalized medicine and the integration of digital technologies. However, the industry faces several challenges, including stringent regulatory requirements, high research and development costs, and complex manufacturing processes that may slow the market expansion. Intellectual property considerations and competition are also major obstacles for biosimilars manufacturers.
From a regional perspective, North America and Europe continue to dominate the market due to their well-established healthcare infrastructure and high adoption rates of biological therapies. Meanwhile, emerging markets in Asia and Latin America are experiencing rapid growth, driven by improving healthcare systems and increasing investments in biotechnology. Collaboration between pharmaceutical companies, research institutes and healthcare providers is driving innovation, accelerating the development of new biologic and biosimilar therapies. As the industry evolves, there continues to be a focus on sustainability, quality assurance and accessibility to ensure that biologics and biosimilars effectively contribute to improving global healthcare.
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Regional AnalysisThe
geographical segment analyzes market trends such as supply, demand, key industry participants, and pricing trends from 2019 to 2031. The report offers insights into the following key regions:
• North America
• Asia Pacific
• Europe
• Middle East & Africa
• South AmericaMarket
SegmentationBy
Product Type:
• Biologics
• Biosimilars
• OthersThe
market is broadly categorized into biologics and biosimilars. Biologics include monoclonal antibodies, vaccines, and recombinant proteins and are widely used to treat various conditions such as cancer and autoimmune diseases. Biosimilars, which are close replicas of approved biologics, offer affordable treatment options, thus expanding patient access and reducing the cost of treatment.By
Source:
• Human-derived
• Animal-derived
• Microbial-derived
• Plant-derived
• OthersBiologics
and biosimilars are categorized based on their origin.Human-derived biologics such as monoclonal antibodies and therapeutic proteins have become mainstream due to their effectiveness in treating chronic diseases. Animal-derived products such as vaccines and insulin remain important but are subject to regulatory and ethical considerations. Microbial-derived biologics produced by recombinant DNA technology have been gaining attention as advances in genetic engineering have enabled large-scale production of therapeutic proteins. This category of biosimilars replicates human-derived biologics and provides more affordable treatment options.
By manufacturing process:
• Recombinant DNA technology
• Monoclonal antibody production
• Cell culture technology
• Others
Advanced techniques such as fermentation, cell culture, and purification processes are used in the production of biologics and biosimilars. Fermentation, primarily used for microbial-based products, enables large-scale production of therapeutic proteins. Cell culture techniques utilizing mammalian or insect cells are essential in the development of complex biologics such as monoclonal antibodies, ensuring essential post-translational modifications. Purification processes ensure that the final product meets safety and efficacy standards. Integration of automation and advanced bioprocessing techniques improves manufacturing efficiency, further facilitating market expansion. These segments reflect the diversity within the biologics and biosimilars market and highlight the continuing advancements in targeted healthcare solutions.
Key Market Players
• Amgen
• Roche
•
AbbVie• Bristol-Myers Squibb
• Sandoz
• Pfizer
• Mylan (now part of Viatris)
• Samsung Bioepis
• Celltrion
• TevaThe pharmaceutical industry
competitive landscape includes both global major players as well as smaller industry participants. The report provides detailed insights into each company’s profile, key business activities, financial performance, and market share.
Report Details:
• Base Year: 2023
• Historical Data: 2019-2022
• Forecast Data: 2024-2031For
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