[研究报告] 2023 年肿瘤生物仿制药市场价值为 94.6 亿美元,预计到 2031 年将达到 247.1 亿美元;预计 2023 年至 2031 年的复合年增长率为 12.8%。
市场洞察和分析师观点:
生物仿制药是与现有参考生物药物在安全性、有效性和质量方面非常相似但不完全相同的生物制药产品。生物仿制药(例如单克隆抗体和支持剂,包括非格司亭、培非格司亭、依泊汀 α 和依泊汀 ζ)可用于治疗各种类型的癌症。因素包括癌症发病率激增、生物仿制药的成本效益以及肿瘤生物仿制药的批准增加。此外,预计生物仿制药制造商之间的合作和临床试验将在未来几年带来新的肿瘤生物仿制药市场趋势。然而,生物仿制药产品制造的高成本和复杂性是市场阻碍因素之一。
肿瘤生物仿制药市场规模和份额 – 市场驱动因素:
根据世界卫生组织(WHO)的数据,2022年全球报告的癌症新发病例约为2000万,癌症死亡病例约为970万。此外,世卫组织全球癌症观察站的最新估计显示,2022年,10种不同类型的癌症约占全球癌症新发病例和死亡病例的三分之二。其中,肺癌是全球最常见的癌症,新发病例为250万,占新发病例总数的12.4%。女性乳腺癌位居第二,为230万例,占新发病例总数的11.6%,其次是结直肠癌,占新发病例总数的9.6%。前列腺癌位居第四,为150万例,胃癌位居第五,为97万例。更实惠的肿瘤生物仿制药作为一种医疗武器的出现,可以减轻医疗支出负担,并提高获得有效癌症治疗的机会,因为它们在现实场景中被证明是安全的和有效的,有临床证据和物理化学质量数据。例如,在多学科数字出版研究所 (MDPI) 于 2023 年 7 月发表的一篇文章中,进行了一项比较和描述性研究,以评估用于癌症的生物仿制药单克隆抗体 (mAb) 与相应参考药物的安全性信息,并评估上市后药物警戒数据。研究得出结论,贝伐单抗、曲妥珠单抗和利妥昔单抗生物仿制药及其原研药的安全性没有显著差异。结果验证了生物仿制药的安全性等效性,并支持将其用作生物原研药的竞争性替代品。因此,癌症负担加重以及由此导致的死亡人数增加产生了对可负担得起的治疗方法的需求,从而推动了肿瘤生物仿制药市场的增长。
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细分和范围:
“肿瘤生物仿制药市场分析和预测至 2030 年”是一项专业而深入的研究,重点关注全球市场动态,以帮助确定关键驱动因素、未来市场趋势和有利可图的市场机会,进而有助于确定主要收入来源。该报告旨在提供市场概况,并根据药物类别、癌症类型和分销渠道对市场进行详细细分。该报告还包括对主要市场参与者及其关键战略发展的全面分析。肿瘤生物仿制药市场报告的范围包括对北美、欧洲、亚太地区、南美和中美以及中东和非洲市场表现的评估。
分段评估:
根据药品类别,市场细分为单克隆抗体、粒细胞集落刺激因子和红细胞生成刺激剂 (ESA)。2023 年,单克隆抗体领域占据肿瘤生物仿制药市场的最大份额,预计 2023 年至 2031 年期间的复合年增长率最高。单克隆抗体可以通过多种方式摧毁癌细胞,例如通过阻断配体-受体生长和存活途径。主要作用机制包括抗体依赖性细胞毒性 (ADCC) 和补体介导的细胞毒性。截至 2019 年 12 月,利妥昔单抗、曲妥珠单抗和贝伐单抗是欧洲药品管理局 (EMA) 和美国食品药品管理局 (FDA) 批准用于癌症治疗的几种生物仿制药单克隆抗体。
根据癌症类型,市场分为结直肠癌、宫颈癌、乳腺癌、支持性治疗、淋巴瘤等。支持性治疗部分在 2023 年占据了最大的市场份额。预计结直肠癌将在 2023 年至 2031 年期间实现最高复合年增长率。据世界卫生组织称,癌症是一个严重的健康问题,也是全球死亡的主要原因。随着癌症患病率的不断上升,许多肿瘤生物仿制药制造商都在致力于开发和向市场推出新产品。例如,Celltrion 的 CT-P16、Prestige Biopharma 的 163 HD204、Cipla Biotech 的 CBT124 和北京天工生物的 MIL60 是贝伐单抗的潜在生物仿制药,目前正在进行 3 期研究,并在安全性和有效性参数上进行比较。它们还在接受治疗非小细胞肺癌患者的能力评估。
根据分销渠道,市场分为医院药房、零售药房和在线药房。2022 年,医院药房占据了最大的市场份额。在线药房预计将在 2023 年至 2031 年期间实现最高复合年增长率。医院药房是患者购买生物仿制药等处方药的主要平台。
区域
分析:
从收入方面来看,北美在 2023 年占据了肿瘤生物仿制药市场的主要份额,其次是欧洲。癌症病例不断增加,预计在预测期内,癌症治疗生物仿制药的批准数量不断增加以及先进的医疗保健基础设施将推动北美肿瘤生物仿制药市场的发展。
癌症病例的增加、用于治疗癌症的生物仿制药获批的增加以及先进的医疗保健基础设施是推动北美肿瘤生物仿制药市场发展的因素。生物制剂是美国最昂贵的药物。生物仿制药预计比其参考产品更具成本效益。在 PubMed Central 于 2022 年 10 月发表的一篇文章中,基于截至 2021 年 6 月的美国药品价格,使用生物制剂和生物仿制药每单位的平均批发价 (AWP) 进行了成本比较。分析表明,生物仿制药可以为贝伐单抗节省 15-23%。在贝伐单抗生物仿制药中,与原研产品 Avastin 相比,Zirbes 提供了显着更高的节省。用于支持性癌症治疗的生物仿制药,例如 Filgrastim 生物仿制药,与参考产品相比,可节省 17.3% 至 34% 的费用,而 pegfilgrastim 生物仿制药可节省 33% 至 37% 的费用。此外,Epogen 生物仿制药可节省 33.5% 的费用。根据 2022 年发布的 Cardinal Health 生物仿制药报告,FDA 已在美国批准了 33 种生物仿制药,其中 21 种已上市。其中 17 种用于癌症治疗。根据同一来源,到 2025 年,生物仿制药预计将使美国药品支出减少 1330 亿美元。因此,在美国,生物仿制药具有降低生物药物成本、使患者更容易获得护理以及创造创新和科学突破的巨大潜力,从而推动该地区的肿瘤生物仿制药市场。
肿瘤生物仿制药市场区域洞察
Insight Partners 的分析师已详细解释了预测期内影响肿瘤生物仿制药市场的区域趋势和因素。本节还讨论了北美洲、欧洲、亚太地区、中东和非洲以及南美洲和中美洲的肿瘤生物仿制药市场细分和地理分布。
- 获取肿瘤生物仿制药市场的区域特定数据
肿瘤生物仿制药市场报告范围
报告属性 | 细节 |
---|---|
2023 年的市场规模 | 94.6亿美元 |
2031 年市场规模 | 247.1亿美元 |
全球复合年增长率(2023 - 2031) | 12.8% |
史料 | 2021-2023 |
预测期 | 2023-2031 |
涵盖的领域 | 按药物类别
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
市场参与者密度:了解其对商业动态的影响
肿瘤生物仿制药市场正在快速增长,这得益于终端用户需求的不断增长,而这些需求又源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。
市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。
在肿瘤生物仿制药市场运营的主要公司有:
- CELLTRION 公司
- 梯瓦制药工业有限公司
- 辉瑞公司
- 山德士集团
- 比奥康
免责声明:上面列出的公司没有按照任何特定顺序排列。
- 了解肿瘤生物仿制药市场主要参与者概况
行业发展和未来机遇:
肿瘤生物仿制药市场预测可以帮助该市场的利益相关者规划其增长战略。根据公司新闻稿,以下是肿瘤生物仿制药市场主要参与者采取的一些关键发展和举措:
- 2022 年 11 月,Organon 在加拿大推出了 Avastin 的生物仿制药 AYBINTIO。该疗法适用于加拿大患有某些恶性癌症的患者,包括转移性结直肠癌 (mCRC)、转移性肺癌、铂敏感和耐药性复发性上皮性卵巢癌(包括输卵管癌和原发性腹膜癌)和胶质母细胞瘤。此次上市旨在扩大公司的生物仿制药产品组合。
- 2022 年 5 月,Biocon Biologics 和 Viatris 推出了罗氏 Avastin(贝伐单抗)的生物仿制药 Abemy。Biocon Ltd. 的子公司 Biocon Biologics Ltd. 和 Vietris' Inc. 宣布在加拿大推出这种肿瘤生物仿制药。由 Biocon Biologics 和 Vietri's 共同开发的 bevy 已获得加拿大卫生部批准,用于治疗四种类型的癌症。
- 2020 年 4 月,辉瑞获得欧盟委员会 (EC) 批准,其产品 RUXIENCE 是一种单克隆抗体 (mob),与 Mather (利妥昔单抗) 类似。该批准用于治疗某些癌症,例如非霍奇金淋巴瘤 (NHL)、慢性淋巴细胞白血病 (CLL) 和自身免疫性疾病。
- 2020年1月,Chorus Biosciences与Innocents Biologics Co., Ltd.签订了许可协议,用于在美国和加拿大开发和商业化任何剂型和呈现方式的贝伐单抗(Avastin)生物仿制药。
竞争格局和重点公司:
CELLTRION, Inc.;Teva Pharmaceutical Industries Ltd;辉瑞公司;山德士集团;Biocon;安进公司;三星 Bioepis;Coherus BioSciences;BIOCAD;礼来公司是肿瘤生物仿制药市场报告中介绍的顶级公司。这些公司专注于推出新的高科技产品、现有产品的技术进步和地域扩张,以满足全球日益增长的消费者需求。
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
- PEST and SWOT Analysis
- Market Size Value / Volume - Global, Regional, Country
- Industry and Competitive Landscape
- Excel Dataset
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
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Frequently Asked Questions
Biosimilars are biopharmaceutical products that closely resemble existing reference biologic drugs in terms of safety, efficacy, and quality but are not identical. Biosimilars such as monoclonal antibodies and supportive agents, including filgrastim, pegfilgrastim, epoetin α, and epoetin ζ, are available to treat various types of cancers.
The oncology biosimilars majorly consists of the players, including CELLTRION, Inc.; Teva Pharmaceutical Industries Ltd; Pfizer Inc; Sandoz Group AG; Biocon; Amgen Inc; Samsung Bioepis; Coherus BioSciences; BIOCAD; and Lilly.
Key factors driving the oncology biosimilars growth are the surging in incidences of cancers, the cost-effectiveness of biosimilar drugs, and a rise in the approvals of oncology biosimilars.
The oncology biosimilars market is segmented into monoclonal antibodies, granulocyte colony-stimulating factor, and erythropoiesis-stimulating agents.
The oncology biosimilars is expected to be valued at US$ 24.71 billion in 2031.
The oncology biosimilars was valued at US$ 9.46 billion in 2023.
Trends and growth analysis reports related to Life Sciences : READ MORE..
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.