市场调查报告书
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1465958
生物製药市场:按产品类型、服务、原料类型、应用划分 - 全球预测 2024-2030Biopharmaceuticals Market by Product Type, Services, Raw Material Type, Application - Global Forecast 2024-2030 |
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预计2023年生物製药市场规模为5,740.4亿美元,2024年预计将达到6,271.9亿美元,2030年预计将达到11.0051亿美元,预计复合年增长率为9.74%。
生物药品,又称生技药品,指利用生物技术生产的医疗药品。它由蛋白质和核酸组成,用于治疗和诊断目的。与化学合成并具有明确分子结构的传统药物不同,生物製药源自活的有机体。这些生物体包括细菌、酵母菌和哺乳动物细胞,它们经过基因工程改造可产生所需的治疗物质,如荷尔蒙、抗体和疫苗。癌症、心血管疾病、结核病、克隆氏症和关节炎等慢性病和感染疾病的增加推动了对新型生物製药的需求。此外,政府鼓励扩大医疗基础设施、增加获得医疗服务的机会以及发现和开发新药的支持措施正在进一步促进行业成长。然而,维持温度敏感产品的低温运输物流却为生物製药带来了障碍。此外,製造过程的复杂性也会严重阻碍该行业的更广泛成长。然而,主要企业正在投资人工智慧/机器学习和资料分析等新技术,以简化和加速生物製药生产。此外,个人化医疗的采用和基因组研究的进步可能会为产业成长创造新的机会。
主要市场统计 | |
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基准年[2023] | 5740.4亿美元 |
预测年份 [2024] | 6271.9亿美元 |
预测年份 [2030] | 1,100,510 百万美元 |
复合年增长率(%) | 9.74% |
产品类型 持续研发倡议,推动单株抗体领域创新
单株抗体 (mAb) 是模仿免疫系统抵抗有害病原体能力的蛋白质。单株抗体是自订设计的,以针对特定抗原,例如癌细胞表面上发现的抗原。精製的蛋白质包括酵素、荷尔蒙和其他具有治疗特性的蛋白质。这些蛋白质用于治疗酵素紊乱、荷尔蒙缺乏和其他需要补充天然蛋白质的疾病。重组生长因子是刺激细胞生长、增生、癒合和细胞分化的蛋白质。它广泛用于各种医疗治疗,例如嗜中性白血球低下症和创伤治疗。重组激素与人体内自然产生的荷尔蒙相同,但经过基因工程改造,包括胰岛素、人体生长荷尔蒙和促红血球生成素。重组蛋白是利用重组 DNA 技术生产的一系列具有生物活性的蛋白,例如酵素、细胞激素和血液因子。合成免疫调节剂是可以透过增强或抑制免疫反应来改变免疫反应的药物。它用于治疗自体免疫疾病和癌症以及器官移植。当需要调节免疫系统来治疗疾病或预防器官移植排斥时,首选合成免疫调节剂。疫苗是一种旨在产生针对特定感染疾病的主动获得性免疫力的生物製药。疫苗含有弱化或杀死的病原微生物、其毒素或其表面蛋白之一。
需要进行补偿性和多标准实验室测试,以确保符合服务法规
在生物製药产业,产品符合各种药典的严格标准和规定,如美国药典(USP)、欧洲药典(EP)、日本药典(JP)等药典和多药典实验室检测服务至关重要。这些测试对于品管是必要的,可确保生物药品上市前的安全、卫生、功效和品质。自订或客户专有的测试是根据生物製药公司的独特需求量身定制的。与遵循既定准则的补充测试不同,自订测试是专门针对公司独特的产品和流程而开发的。这包括稳定性测试、方法开发、验证和标准补充测试方法未涵盖的杂质测试。更广泛意义上的实验室测试包括为确保生物製药符合所需的品质标准和法规而进行的各种类型的分析。这包括但不限于生物分析服务、微生物评估、环境监测等。
成分类型:致力于开发强大的 API 来诊断、治疗和缓解医疗状况
活性药物成分 (API) 是产生预期效果的药物的主要成分。 API 对于新药配方的开发至关重要,并在生物製药的创造中发挥重要作用。原料药受到严格监管,以确保功效和安全性。高活性原料药通常是需要较低剂量的治疗的首选,而稳定、具有成本效益的供应是慢性病的关键。製剂赋形剂是惰性物质,用于增加含有少量有效活性成分的製剂的体积,或增强治疗功效,例如透过促进药物的吸收和稳定性。赋形剂的选择取决于药物传递方法、所需剂型和稳定性要求。赋形剂必须与原料药相容,且不影响药物的功效或安全性。
应用:生活方式的改变导致需要心血管疾病的治疗策略
用于治疗自体免疫疾病的生物製药通常着重于调节免疫系统,以防止其攻击患者自身的细胞。这些药物对于类风湿性关节炎、红斑性狼疮和第 1 型糖尿病等疾病至关重要。生物製药透过提供有助于控制心臟衰竭、高胆固醇症和高血压等疾病的治疗方法来解决心血管疾病。糖尿病和甲状腺功能障碍等激素疾病可透过旨在替代或调节激素水平的生物药物进行治疗。免疫学生物製药通常旨在透过针对特定免疫细胞或免疫途径来治疗免疫介导的疾病。减少全身性免疫抑制的标靶治疗是降低感染疾病风险的首选。用于治疗发炎和传染病的生物製药包括抗生素和发炎药物,旨在提高传统小分子疗法的有效性。重点是能够克服抗药性同时最大限度地减少潜在副作用和毒性的治疗方法。针对代谢疾病的生物製药治疗方法肥胖、骨质疏鬆症和血脂异常症等疾病。能够降低心血管事件风险同时控制代谢疾病的生物製药受到高度重视。酵素替代疗法和单株抗体等生物製药针对多发性硬化症 (MS) 和阿兹海默症神经系统疾病。需要能够穿过血脑障壁(BBB)并对发炎提供调节作用的治疗剂。生物製药在癌症治疗中的使用使癌症治疗取得了一些进展,药物可以特异性针对癌细胞并调节免疫系统来对抗疾病。
区域洞察
在强大的智慧财产权、科学主导的法规结构和竞争性市场条件的推动下,美洲地区,特别是美国和加拿大,仍然是生物製药研发高度发展的地区。美国食品药物管理局(FDA) 不断适应技术创新的快速发展,以确保患者获得安全有效的治疗方法。几家主要企业的存在以及提供报销和健康保险的强大医疗基础设施支持了生物製药行业的成长。欧盟地区在生命科学和生物技术领域拥有强大的研发基础。严格的生物医药开发法规和标准,为生物医药创新创造了标准化、结构化、安全的环境。欧盟的欧洲药品管理局 (EMA) 在促进新治疗方法的开发和使用方面发挥核心作用。强大的官民合作关係和对医疗保健创新的承诺定义了欧盟消费者的需求和行为,倾向于高品质和永续的医疗保健解决方案。在亚太地区,人口老化以及政府为促进获得负担得起的医疗服务而采取的奖励措施和倡议,导致了对生物製药的需求。日本拥有完善的製药业,其特点是在医疗保健解决方案上的支出很高。印度和中国等亚太地区国家专注于生物製药的成本效益製造,并经常投资生物相似药製造。
FPNV定位矩阵
FPNV定位矩阵对于评估生物製药市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对生物製药市场供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估及资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行综合评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.生物医药市场规模及预测如何?
2.生物製药市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3.生物製药市场的技术趋势和法规结构是什么?
4.生物製药市场主要厂商的市场占有率为何?
5.进入生物医药市场的合适型态和策略手段是什么?
[191 Pages Report] The Biopharmaceuticals Market size was estimated at USD 574.04 billion in 2023 and expected to reach USD 627.19 billion in 2024, at a CAGR 9.74% to reach USD 1,100.51 billion by 2030.
Biopharmaceuticals, also known as biologics, refer to medical drugs produced using biotechnology. They are comprised of proteins and nucleic acids and are used for therapeutic or diagnostic purposes. Unlike traditional pharmaceuticals, which are chemically synthesized and have well-defined molecular structures, biopharmaceuticals are derived from living organisms. These organisms can include bacteria, yeast, or mammalian cells that are genetically engineered to produce the desired therapeutic substances, such as hormones, antibodies, or vaccines. The rising incidences of chronic and infectious diseases such as cancer, cardiovascular disorders, tuberculosis, Crohn's disease, and arthritis have created a need for novel biopharmaceuticals. Additionally, the expansion of healthcare infrastructure, growing access to healthcare services, and supportive government initiatives that promote the discovery and development of new pharmaceuticals have further generated growth for the industry. However, maintaining cold chain logistics for temperature-sensitive products can prove to be a hurdle for biopharmaceuticals. Furthermore, complexities in manufacturing processes can also significantly impede the widespread growth of the industry. However, key players are investing in new technologies such as AI/ML and data analytics to streamline and accelerate the production of biopharmaceuticals. Moreover, the adoption of personalized medicine and advancement in genomic research can create new opportunities for the growth of the industry.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 574.04 billion |
Estimated Year [2024] | USD 627.19 billion |
Forecast Year [2030] | USD 1,100.51 billion |
CAGR (%) | 9.74% |
Product Type: Ongoing R&D initiatives to promote innovations in the field of monoclonal antibodies
Monoclonal antibodies (mAbs) are proteins that mimic the immune system's capacity to fight off harmful pathogens. They are custom-designed to target specific antigens, such as those found on the surface of cancer cells. Purified proteins include enzymes, hormones, and other proteins that have therapeutic action. These proteins are employed in the treatment of enzymatic disorders, hormonal deficiencies, and other conditions where supplementation of natural proteins is needed. Recombinant growth factors are proteins that stimulate cellular growth, proliferation, healing, and cellular differentiation. They are widely used in various medical treatments, including neutropenia and wound healing. Recombinant hormones are genetically engineered hormones identical to those produced naturally in the human body, most commonly insulin, human growth hormone, and erythropoietin. Recombinant proteins cover a broad range of biologically active proteins, including enzymes, cytokines, and blood factors, manufactured using recombinant DNA technology. Synthetic Immunomodulators are agents that can modify the immune response by enhancing or suppressing it. They're used in treating autoimmune diseases and cancers and in organ transplantation. They are preferred when modulation of the immune system is necessary to treat disease or prevent rejection in organ transplant scenarios. Vaccines are biological preparations that aim to provide active acquired immunity to particular infectious diseases. They can contain live attenuated or killed forms of the pathogenic microorganism, its toxins, or one of its surface proteins.
Services: Need for compendial & multi compendial laboratory testing to ensure compliance with regulations
In the biopharmaceutical industry, compendial & multicompendial laboratory testing services are essential for ensuring that products meet the strict standards and regulations of various pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopeia (EP), or Japanese Pharmacopeia (JP). These tests are required for quality control and to ensure the safety, hygiene, efficacy, and quality of biopharmaceuticals before they reach the market. Custom testing or customer proprietary testing is tailored to meet the unique needs of a biopharmaceutical company. Unlike compendial testing, which follows established guidelines, custom testing is developed specifically for a company's proprietary products or processes. This can include stability testing, method development, validation, or testing for impurities that are not covered by standard compendial methods. Laboratory testing, in a broader sense, encompasses various types of analyses performed to ensure that biopharmaceutical products adhere to all necessary quality standards and regulations. This can extend from raw material testing to final product release testing, including but not limited to bioanalytical services, microbiological evaluation, and environmental monitoring.
Raw Material Type: Efforts to develop potent APIs to diagnose, cure, or mitigate disease conditions
The active pharmaceutical ingredient (API) is the primary component of any drug product that produces the intended effects. APIs are crucial for the development of new drug formulations and play a significant role in the creation of biopharmaceutical products. They are highly regulated to ensure efficacy and safety. Highly potent APIs are often preferred in treatments requiring lower dosage, while for chronic conditions, consistent and cost-effective supply is key. Formulation excipients are inactive substances used for the purpose of bulking up formulations that contain potent active ingredients in small amounts or to confer a therapeutic enhancement, such as facilitating drug absorption or stability. The choice of excipients is dependent on the drug's delivery method, the required dosage form, and stability requirements. Excipients must be compatible with the API and should not affect the drug's efficacy or safety profile.
Application: Changes in lifestyles leading to the need for treatment strategies for cardiovascular diseases
The biopharmaceuticals used for autoimmune disorders often focus on the modulation of the immune system to prevent it from attacking the patient's own cells. These medications are crucial for conditions such as rheumatoid arthritis, lupus, and type 1 diabetes. Biopharmaceuticals address cardiovascular diseases by offering treatments that can help manage conditions such as heart failure, hypercholesterolemia, and hypertension. Hormonal disorders such as diabetes and thyroid dysfunctions are managed through biopharmaceuticals that aim to replace or regulate hormone levels. Biopharmaceuticals in immunology are typically designed to treat immune-mediated diseases by targeting specific immune cells or pathways. Targeted therapies that reduce systemic immunosuppression are preferred to decrease the risk of infections. Biopharmaceuticals for inflammatory and infectious diseases include antibiotics and anti-inflammatory drugs that seek to improve upon the efficacy of traditional small-molecule treatments. The focus is on treatments that can overcome drug resistance while minimizing potential side effects and toxicity. Biopharmaceuticals tailored for metabolic disorders offer treatments for diseases such as obesity, osteoporosis, and dyslipidemia. Biopharmaceuticals that can reduce the risk of cardiovascular events alongside managing metabolic disorders are highly valued. Biopharmaceuticals in the form of enzyme replacement therapies and monoclonal antibodies target neurological diseases such as multiple sclerosis (MS) and Alzheimer's disease. Therapeutics that are able to cross the blood-brain barrier (BBB) and offer modulatory effects on neuroinflammation are in need. The use of biopharmaceuticals in oncology has driven several improvements in cancer treatment, with drugs that can specifically target cancer cells and modulate the immune system to combat the disease.
Regional Insights
The Americas region, particularly the U.S. and Canada, remains a highly advanced region in biopharmaceutical research and development, spurred by a combination of robust intellectual property rights, a science-driven regulatory framework, and a competitive market landscape. The U.S. Food and Drug Administration (FDA) continuously adapts to the rapid pace of innovation, ensuring safe and effective treatments reach patients. The presence of several key players in the biotechnological sector and a robust healthcare infrastructure that provides reimbursements and health insurance have led to the growth of the biopharmaceutical industry. The EU region boasts a robust ground for research and development in the sphere of life sciences and biotechnology. Stringent regulations and standards pertaining to the development of biopharmaceuticals have created a standardized, systematic, and safe environment for innovations in biopharmaceuticals. The European Medicines Agency (EMA) in the EU plays a central role in facilitating the development and accessibility of new therapies. Strong public-private partnerships and a commitment to healthcare innovation define the EU's consumer needs and behavior, which lean towards high-quality, sustainable healthcare solutions. In the APAC region, a growing aging population and government incentives and initiatives for promoting access to affordable healthcare services have led to a need for biopharmaceuticals. Japan, with its established pharmaceutical sector, is characterized by significant spending on healthcare solutions. Countries in the APAC region, such as India and China, have focused on the cost-effective manufacturing of biopharmaceuticals and often invest in biosimilar production.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biopharmaceuticals Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biopharmaceuticals Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Biopharmaceuticals Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, AbbVie Inc., Abgenex, Amgen Inc., AstraZeneca PLC, Avidea Technologies, Bayer AG, Bio-Techne Corporation, Biogen Inc., bioMerieux SA, Bristol-Myers Squibb Company, BTL Biotechno Labs Pvt. Ltd., Eli Lilly and Company, F. Hoffmann-La Roche AG, Ferring Pharmaceuticals, GlaxoSmithKline PLC, Ipsen Pharma, Johnson & Johnson Services, Inc., LG Chem Life Sciences Innovation Center, Inc., Merck & Co., Inc., Nordic BioSite, Novartis AG, Novo Nordisk A/S, Pfizer, Inc., Sanofi S.A., Takeda Pharmaceutical Company Limited, and Thermo Fisher Scientific Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Biopharmaceuticals Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopharmaceuticals Market?
3. What are the technology trends and regulatory frameworks in the Biopharmaceuticals Market?
4. What is the market share of the leading vendors in the Biopharmaceuticals Market?
5. Which modes and strategic moves are suitable for entering the Biopharmaceuticals Market?