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市场调查报告书
商品编码
1371891
到 2030 年的全球生技药品市场预测:按产品、类型、用途和地区进行的全球分析Biologic Therapeutics Market Forecasts to 2030 - Global Analysis By Product (Gene Therapy, Cell Therapy, Vaccines, Antibody Therapeutics and Other Products), Type, Application and By Geography |
根据 Stratistics MRC 的数据,2023 年全球生技药品市场规模为 4,575.6 亿美元,预计将以 11.3% 的年复合成长率成长,到 2030 年达到 9,680.8 亿美元。
专注于生物来源治疗药物的开发、生产和行销的製药工业部门被称为生技药品市场。这些复杂的化学物质是利用活生物体或活生物体的一部分製成的,例如蛋白质、抗体、核酸和细胞。又称生技药品或生物製药。
据世界卫生组织 (WHO) 称,疫苗是减轻全球疾病负担最有力、最具成本效益的方法之一,预计每年可挽救 200-300 万人的生命。
癌症、自体免疫疾病和代谢性疾病等慢性疾病的增加增加了对有效替代疗法的需求。生技药品提供量身定制的、标靶治疗,可以解决许多疾病的根本原因,从而推动市场扩张。此外,生技药品开发还获得了製药和生物技术行业的大量资金。重组蛋白、细胞和基因疗法以及单株抗体等生技药品的发展正在重振市场并刺激创新。
开发和製造生技药品需要复杂的程序和大量的成本,包括研发、临床试验和製造设施。这些高成本可能会限制生技药品的可得性和可负担性,特别是在资源有限的医疗保健系统中。然而,由于其复杂性,生技药品需要专门的生产设施和程序。确保一致的品质、可扩展性和维持强大的供应链可能很困难,并且会影响生技药品治疗的可及性和可负担性。
生物技术、基因工程和重组 DNA 技术的进步正在增加创造创新生物疗法的潜力。这些技术的发展使得能够生产更复杂、更有特异性的生物药品,扩大了可用治疗方法的数量。此外,欧洲药品管理局(EMA)和美国食品药物管理局(FDA)等法规机构也为生技药品的核准制定了精确的规则并加快了核准程序。这些管理体制为生技药品的开发、评估和行销提供了有利的环境。
儘管有有利的法律规范,但生技药品的核准过程复杂且要求严格。公司必须进行广泛的临床前和临床试验来证明安全性、有效性和品质,这需要很长时间并花费大量资金。然而,可能会诱导患者对生物治疗的免疫反应,引发对其安全性和免疫抗原性的担忧。这些免疫反应会不同程度地影响治疗的有效性和安全性。有效监测和管理此类问题对于有效使用生物治疗至关重要。
COVID-19 的爆发使得高效的疫苗生产和分发变得至关重要。因此,利用 mRNA 和病毒载体疫苗等生物平台进行的疫苗研发显着增加。 COVID-19疫苗的有效研发和应用凸显了生物治疗的前景,并强调了生物技术领域在感染疾病控制中的重要性。
预测期内,血液製品领域占据最大份额。血液衍生产品,包括免疫球蛋白、凝血因子和血浆衍生蛋白,用于治疗各种血液疾病和免疫力缺乏,也被认为是生物疗法的一部分。这些物品的使用对于治疗许多血液疾病、免疫力缺乏和其他疾病至关重要。
据估计,细胞治疗领域在预测期内将出现良好的成长。活细胞用于细胞疗法来治疗和治癒疾病。细胞疗法是一个快速发展的领域,旨在替换、修復和修復受损或患病的细胞和组织。此外,细胞疗法在许多治疗领域显示出潜力,包括肿瘤学、心血管疾病、神经退化性疾病疾病和自体免疫疾病。
由于生物治疗行业经历了重大发展和创新,并正在成为一个充满活力和快速变化的中心,预计亚太地区将在预测期内占据最大份额。该地区与许多拥有自己的医疗保健系统的国家相连,使其成为一个复杂但有吸引力的市场。此外,癌症、糖尿病和自体免疫疾病等慢性疾病的流行增加了对生物治疗的需求。
据估计,亚太地区的年复合成长率最高。不断增长的中等收入人口和不断上涨的医疗保健费用正在扩大生物疗法的可用性。再加上政府鼓励医疗基础建设的政策,进一步推动了市场的成长。此外,亚太地区的研发活动蓬勃发展,国内外製药公司大力投资生技药品的开发。蓬勃发展的生物技术生态系统吸引人才并促进创新。该地区各国政府也正在努力简化核准程序,让生物製药公司更容易进入市场。
According to Stratistics MRC, the Global Biologic Therapeutics Market is accounted for $457.56 billion in 2023 and is expected to reach $968.08 billion by 2030 growing at a CAGR of 11.3% during the forecast period. The pharmaceutical industry sector that concentrates on the development, production, and marketing of therapeutic medicines generated from biological sources is referred to as the biologic therapeutics market. These complex chemicals are created using living organisms or their parts, such as proteins, antibodies, nucleic acids, or cells. They are also referred to as biologics or biological pharmaceuticals.
According to World Health Organization, vaccines are one of the most powerful and cost-effective ways to reduce the global burden of disease and are estimated to save 2-3 million lives every year.
The need for efficient treatment alternatives is being driven by the increased prevalence of chronic diseases like cancer, autoimmune conditions, and metabolic diseases. Biologic medicines provide customized, targeted treatments that can address the underlying causes of many disorders, spurring market expansion. Additionally, the development of biologic medicines has received significant funding from the pharmaceutical and biotechnology industries. Biologic medication development, including recombinant proteins, cell and gene therapies, and monoclonal antibodies, is boosting the market and spurring innovation.
Complex procedures and high expenditures, such as those associated with research and development, clinical trials, and manufacturing facilities, are involved in the creation and production of biologic therapies. Particularly in healthcare systems with limited resources, these high costs may restrict the availability and affordability of biologic medications. However, due to their complicated nature, biologic pharmaceuticals need specialized production facilities and procedures. It can be difficult to ensure consistent quality, scaleability, and maintain a strong supply chain, which may have an impact on the accessibility and affordability of biologic treatments.
The potential for creating innovative biological therapies has increased as a result of ongoing developments in biotechnology, genetic engineering, and recombinant DNA technology. These technological developments make it possible to produce biological medications that are more sophisticated and specifically targeted, expanding the number of available treatments. Additionally, regulatory organizations have established precise rules and accelerated paths for the approval of biologic therapies, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). These regulatory regimes offer a favorable environment for the creation, assessment, and marketing of biologic medicines.
Despite the existence of favorable regulatory frameworks, the complex and stringent approval procedures for biologic therapies. Extensive preclinical and clinical trials that must be conducted by companies to prove safety, efficacy, and quality can take a long time and cost a lot of funds. However, patients' immune responses to biological therapies may be induced, raising concerns regarding their safety and immunogenicity. The effectiveness and safety of the treatment may be impacted by these immunological reactions, which can range in severity. For biological treatments to be used effectively, it is crucial to provide effective monitoring and management of these problems.
The COVID-19 epidemic made the creation and distribution of efficient vaccinations essential. As a result, vaccine research and development significantly increased, utilizing biological platforms like mRNA and viral vector-based vaccines. The effective creation and application of COVID-19 vaccines highlighted the promise of biological treatments and emphasized the significance of the biotechnology sector in combating infectious diseases.
Blood products segment commanded the largest share over the forecast period. Blood-derived products, including immunoglobulins, clotting factors, and plasma-derived proteins, which are used to treat a variety of blood illnesses and immunological deficiencies, are also considered to be part of biologic therapies. The use of these items is essential in the management of a number of blood diseases, immunological deficiencies, and other ailments.
Cell therapy segment is estimated to witness lucrative growth over the projection period. Living cells are used in cell therapy to treat or cure diseases. It is a fast-developing area that seeks to replace, restore, or fix damaged or sick cells or tissues. Additionally, cell therapy has demonstrated potential in a number of therapeutic fields, including oncology, cardiovascular illness, neurodegenerative disorders, and autoimmune diseases.
Asia Pacific is expected to hold largest share over the forecast period as the biological therapies industry experiences substantial development and innovation, the Asia-Pacific region is emerging as a vibrant and quickly changing hub. This region is connected to numerous nations with distinctive healthcare systems, making it a complex yet attractive market. Additionally, the region's growing need for biological treatments is being driven by the prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders.
Asia Pacific is estimated to hold highest CAGR. The availability of biological therapies has expanded as a result of an expanding middle-class population and rising healthcare costs. This has further propelled the market's growth, along with government policies to encourage the construction of healthcare infrastructure. Additionally, the Asia-Pacific region is experiencing a boom in research and development activity, with both domestic and foreign pharmaceutical firms making significant investments in the development of biologic drugs. A thriving biotechnology ecosystem has resulted in an outcome that draws in talent and encourages innovation. Governments in the area are also making efforts to simplify approval procedures, improving the simplicity of market access for biopharmaceutical firms.
Some of the key players in Biologic Therapeutics Market include: AbbVie Inc, Amgen Inc., AstraZeneca Plc, Aurobindo Pharma Ltd., Baxter International Inc, Biocon Ltd., Celltrion Healthcare Co. Ltd., GlaxoSmithKline Plc, Merck and Co. Inc, Novartis AG, Pfizer Inc , Precision Biologics Inc and Samsung Electronics Co. Ltd.
In May 2022, Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, announceD the launch of its new CRYOcheck Chromogenic Factor IX assay in Canada, the European Union, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities. The announcement was made at the World Federation of Hemophilia Congress taking place in Montreal