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市场调查报告书
商品编码
1845695
2024 年至 2031 年生物製药市场(按产品类型、服务、原料类型、应用和地区划分)Biopharmaceuticals Market By Product Type, Service, Raw Material Type (Formulation Excipients, Active Pharmaceutical Ingredients ), Application & Region for 2024-2031 |
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癌症、糖尿病和自体免疫疾病等慢性疾病的增多,推动了改善和个人化治疗的需求。生物製药以其精准治疗这些复杂疾病而闻名,正在推动这一需求,其市场规模将在2024年达到4,138.3亿美元,2031年达到6,746.6亿美元。
此外,基因治疗、单株抗体和个人化医疗等科学领域的重大发展彻底改变了新药的开发。政府和私营部门对研发的投入不断增加,以及有利于药品核准的有利法律规范,正在推动该行业的扩张,2024 年至 2031 年的复合年增长率约为 6.30%。
生物製药市场定义/概述
生物製药是由活细胞、蛋白质或核酸製成的治疗剂,用于治疗各种复杂疾病,包括癌症、自体免疫疾病和基因异常。这些治疗方法包括单株抗体、疫苗、基因治疗和重组蛋白。生物製药的应用涵盖整个医疗保健产业,提供比标准药物疗法更有效的针对性个人化治疗方法。生物製药的未来一片光明,生物技术、基因编辑和个人化医疗的进一步发展有望推动创新。随着研究的进展,生物製药有望在治疗目前无法治癒的疾病和改善全球医疗保健成果方面发挥关键作用。
全球老化趋势正成为生物製药市场的主要驱动力。根据世界卫生组织(WHO)的数据,2015年至2050年期间,全球60岁及以上人口的比例将几乎翻一番,从12%增加到22%。这项人口结构变化推动了对治疗老龄化疾病的改良疗法的需求。 2024年3月,知名製药公司罗氏宣布将投资20亿美元用于治疗老年人常见的神经退化性疾病的生物製药。此外,美国人口普查局预测,到2030年,婴儿潮世代的所有人口都将年满65岁或以上,使老年人总数达到7,300万人。为因应此趋势,美国国家老龄化研究所已将2024年老龄化相关研究预算增加到42亿美元,比前一年增加15%,以支持老龄化疾病的药物治疗研究。
2024年1月,日本政府宣布在未来五年内投入5,000亿日圆(约45亿美元),用于加速治疗老龄化相关疾病的生物製药的研发。预计到2050年,中国65岁以上人口将达3.3亿人。佛山医药报告称,其针对老年常见慢性病的生物製药销售额年增30%。这些进展,加上个人化医疗和再生医学的进步,显示全球人口老化仍将是推动生物製药市场成长的主要因素。
生物製药的高成本可能在一定程度上限制生物製药市场的成长。由于生物製药复杂的生物结构、繁琐的研发流程以及严格的监管要求,其开发和生产成本通常高于典型的小分子药物。这些高昂的开发成本会转嫁给病患和医疗保健系统,使得这些疗法难以负担,尤其是在医疗资源有限的贫穷国家。因此,负担能力成为一个主要障碍,这可能会阻碍市场成长,尤其是在价格敏感的地区。政府和医疗保健提供者通常难以承担这些成本,从而减缓了生物製药的广泛应用。
此外,专利到期也可能加剧来自廉价生物相似药的竞争,这些生物相似药将成为原厂生物製剂的替代品。虽然生物相似药提供了一种经济高效的选择,但它们的出现可能会对价格造成下行压力,并改变市场动态。然而,对价格的担忧正在推动生物製药行业的创新,各公司纷纷投资新技术和製造工艺,以降低生产成本并提高供应量。总体而言,虽然高成本构成了障碍,但也推动着该行业努力在创新和可负担性之间取得平衡,这可能会对市场成长产生长期影响。
The rising frequency of chronic diseases such as cancer, diabetes, and autoimmune disorders has created a greater demand for improved, tailored treatments. Biopharmaceuticals, which are well-known for their precision in treating these complicated disorders, are driving this need is fuelling the USD 413.83 Billion in 2024 and reaching USD 674.66 Billion by 2031.
Additionally, significant developments in science, such as gene therapy, monoclonal antibodies, and personalized medicine, have transformed the development of new medicines. Increased government and private sector investment in R&D, along with favorable regulatory frameworks that accelerate drug approvals, is hastening industry expansion is grow at a CAGR of about 6.30% from 2024 to 2031.
Biopharmaceuticals Market: Definition/ Overview
Biopharmaceuticals are therapeutic medicines made from living cells, proteins, or nucleic acids that are utilized to treat a wide range of complex ailments, including cancer, autoimmune disorders, and hereditary abnormalities. These treatments include monoclonal antibodies, vaccinations, gene therapies, and recombinant proteins. Their uses span the healthcare industry, providing focused, tailored treatments that are frequently more successful than standard medications. The future of biopharmaceuticals is huge, with further advances in biotechnology, gene editing, and personalised medicine expected to drive innovation. As research progresses, biopharmaceuticals are positioned to play a critical role in treating currently incurable diseases and improving global healthcare outcomes.
The global trend of aging populations is becoming a major driver in the biopharmaceuticals market. According to the World Health Organization, the proportion of the global population over the age of 60 will nearly double between 2015 and 2050, from 12% to 22%. This demographic shift is driving up demand for improved therapies to treat age-related disorders. In March 2024, Roche, a renowned pharmaceutical company, announced a USD 2 Billion investment in biopharmaceuticals to treat neurodegenerative illnesses common in older persons. Furthermore, the United States Census Bureau predicts that by 2030, all baby boomers will be over the age of 65, bringing the total number of older people to 73 million. In response to this trend, the US National Institute on Aging boosted its budget for age-related research by 15% in 2024, compared to the previous year, USD 4.2 Billion was allocated to assist research on pharmacological therapies for age-related disorders.
In January 2024 to accelerate the development of biopharmaceuticals for age-related disorders, allocating 500 billion yen (about USD 4.5 Billion) over five years. In China, which is expected to have 330 million people over the age of 65 by 2050, Fosun Pharma reported a 30% year-over-year rise in sales of its biopharmaceutical treatments addressing chronic diseases common in older individuals. These improvements, combined with advances in personalized medicine and regenerative medicines, suggest that the aging global population will remain a major driver of growth in the biopharmaceuticals market.
The high cost of biopharmaceutical products can limit the growth of the biopharmaceuticals market to some extent. Biopharmaceuticals are frequently more expensive to develop and manufacture than standard small-molecule medications due to the complexity of their biological makeup, extensive R&D procedures, and severe regulatory requirements. These high development costs are passed on to patients and healthcare systems, making these therapies less affordable, particularly in poor countries with limited healthcare resources. As a result, affordability becomes a substantial hurdle, possibly stifling market growth, especially in price-sensitive areas. Governments and healthcare providers frequently have issues in financing these costs, which can delay the uptake of biopharmaceuticals.
Furthermore, the high cost may exacerbate competition from biosimilars, which are less expensive alternatives to branded biopharmaceuticals when patents expire. While biosimilars are a cost-effective choice, their arrival may put downward pressure on prices, causing a shift in market dynamics. However, pricing concerns are driving innovation in the biopharmaceutical industry, with companies investing in new technologies and manufacturing techniques to lower production costs and increase availability. Overall, while high costs provide hurdles, they are also motivating industry attempts to balance innovation and affordability, which may have a long-term impact on market growth.
The increasing demand for monoclonal antibodies (mAbs) is predicted to significantly boost the biopharmaceuticals market. Monoclonal antibodies are highly successful treatments for a variety of complex diseases, including cancer, autoimmune disorders, and infections. Their capacity to precisely target certain cells or proteins has made them a top priority for healthcare practitioners and pharmaceutical businesses alike. As the prevalence of these illnesses rises, so will the demand for sophisticated treatments such as mAbs. For instance, in September 2024, Roche announced the successful approval of a new monoclonal antibody therapy for treating certain cancers, reflecting the growing investment and focus on this segment by key industry players. These developments are likely to drive the expansion of the biopharmaceutical market, as companies prioritize the development of more targeted, innovative therapies.
In August 2024, the United States Food and Drug Administration (FDA) expedited many monoclonal antibody medicines for cancer and autoimmune illnesses, displaying significant government support for these advanced therapies. This favorable regulatory environment promotes innovation and speeds up the introduction of new mAb therapeutics to the market. Furthermore, government support for biopharmaceutical research, particularly mAbs, is expanding globally, driving market expansion.
Recombinant growth factors are the fastest-growing market, driven by their expanding applications in regenerative medicine, wound healing, and the treatment of illnesses such as anemia and growth deficits. The rise in demand for biologics, advances in recombinant DNA technology, and increased R&D investments are all driving this segment's rapid expansion.
The increasing use of active pharmaceutical ingredients (APIs) is expected to drive the expansion of the biopharmaceuticals industry. APIs, or physiologically active components in medicine formulations, are critical for developing biopharmaceutical products such as monoclonal antibodies, vaccines, and recombinant proteins. As the need for these innovative medicines grows, so will the necessity for high-quality, efficient API production. In August 2024, Lonza Group announced a large increase in API production capacity to fulfill escalating worldwide biologics demand. This move demonstrates how prominent firms are investing in API development and manufacturing to support the expanding biopharmaceutical market. The increased frequency of chronic diseases and complex health issues drives the demand for innovative biopharmaceutical treatments.
In June 2024, the European Medicines Agency (EMA) issued new recommendations to expedite the licensing process for APIs used in biopharmaceuticals, with the goal of accelerating access to important treatments across Europe. Furthermore, governments in North America and Asia are increasing funding for biopharmaceutical research and production, particularly API development, as they recognise the growing importance of self-sufficiency in pharmaceutical manufacture. These favorable regulatory frameworks and government initiatives are likely to boost API production and utilization, hence driving the overall expansion of the biopharmaceuticals market.
The fastest-growing segment is formulation excipients, which are non-active substances used in medication formulations to improve API stability, distribution, and absorption. Excipients are becoming increasingly important as complicated biologics and innovative drug delivery systems become more prevalent, fueling their rapid expansion as they improve the overall effectiveness and shelf life of biopharmaceuticals.
Country/Region-wise
North America is expected to grow significantly in biopharmaceuticals market, owing in large part to the region's high R&D investments. According to Verified Market Research, the biopharmaceuticals market was valued at USD 413.83 Billion in 2023 and is predicted to increase at a 6.30% CAGR between 2024 and 2031. This expansion is most noticeable in the United States, which accounted for the highest proportion of the worldwide biopharmaceuticals market in 2021. For instance, in March 2024, Pfizer, announced a USD 5 Billion commitment to strengthen its R&D capabilities in the United States, with a focus on creating new biologics and gene therapies.
Furthermore, a report published by the Canadian Manufacturers & Exporters Association in 2023 revealed that the biopharmaceuticals sector in Canada saw a 12% rise in R&D spending compared to 2022, showing the industry's ambition to remain at the forefront of medical advancement. These expenditures, combined with the region's strong intellectual property protection and talented workforce, are projected to propel the biopharmaceuticals market in North America.
The Asia Pacific area is swiftly emerging as a hub for biotechnology and customized medicine, resulting in significant growth in the biopharmaceutical market. For instance, in February 2024, the Chinese government announced a strategic plan to invest $15 billion over the following five years to grow the country's biotechnology industry, with a special emphasis on personalized medicine and innovative biologic medicines. Similarly, India's Department of Biotechnology predicted a 20% rise in biopharmaceutical businesses' R&D investment in 2023 compared to the previous year, as firms develop their skills in areas such as gene therapy and precision medicine.
Meanwhile, in Japan, Takeda Pharmaceutical, a renowned biopharmaceutical company, plans to construct a new USD 500 Million R&D facility in 2023 to speed the development of revolutionary therapeutics, including personalized medications. These investments, combined with the region's large and diverse patient population, as well as the growing adoption of advanced genomic technologies, indicate that Asia Pacific's focus on biotechnology and personalized medicine will remain a significant driver of the global biopharmaceuticals market.
The biopharmaceuticals market's competitive landscape is defined by a varied spectrum of competitors, including small and medium-sized businesses, biotechnology firms, and established pharmaceutical giants. This market is characterized by rapid innovation and an emphasis on research & development, resulting in the ongoing launch of innovative medicines and biologics. Companies, academic institutions, and research organizations frequently form partnerships and collaborate, allowing for the sharing of expertise and resources to improve drug development procedures. Furthermore, the rise of personalized medicine and advancements in technologies like as gene editing and biologics production have increased competitiveness, forcing corporations to take strategic tactics, such as mergers and acquisitions, to expand their product portfolios and market share.
Some of the prominent players operating in the biopharmaceuticals market include:
Abbott
Amgen, Inc.
Biogen, Inc.
Eli Lilly and Company
Hoffmann-La Roche AG
Johnson & Johnson Services, Inc.
Merck Sharp & Dohme Corp
Novo Nordisk A/S
Pfizer, Inc.
Sanofi
In September 2024, Moderna announced good results from a clinical trial of a novel mRNA-based cancer vaccine. This research demonstrates the growing applicability of mRNA technology outside infectious disorders, which is driving market growth in oncology.
In August 2024, Lonza Group expanded its API manufacturing facilities in Switzerland to meet rising demand for biologics, including monoclonal antibodies. This increase demonstrates the increasing importance of APIs in biopharmaceutical development.
In May 2024, Roche gained FDA approval for their novel monoclonal antibody treatment for Alzheimer's disease, marking a significant advance in treating neurological illnesses and broadening the spectrum of biopharmaceutical uses.