市场洞察和分析师观点:
生物仿制药是在安全性、有效性方面与现有参考生物药物非常相似的生物制药产品和质量但并不相同。单克隆抗体和支持药物等生物仿制药,包括非格司亭、聚乙二醇非格司亭、促红细胞生成素α和促红细胞生成素δ,可用于治疗各种类型的癌症。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批准量的增加等因素。此外,生物仿制药和临床试验制造商之间的合作预计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参与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) 的数据到 2022 年,全球报告约 2000 万新癌症病例和 970 万人因癌症死亡。此外,世卫组织全球癌症观测站的最新估计表明,2022年,10种不同类型的癌症约占全球新癌症病例和死亡人数的三分之二。其中,肺癌是全球最常见的癌症,新增病例250万例,占新增病例总数的12.4%。女性乳腺癌以230万例位居第二,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%。前列腺癌以 150 万例排名第四,胃癌以 97 万例排名第五。更实惠的肿瘤生物仿制药作为医疗装备的出现可以减轻医疗保健支出的负担,并改善获得有效癌症治疗的机会,因为它们在现实世界场景、临床证据和理化质量数据中证明了安全性和有效性。例如,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)与相应的参考药物和药物的安全性信息。评估上市后药物警戒数据。该研究得出的结论是,贝伐珠单抗、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着差异。结果验证了生物仿制药的安全等效性,并支持它们作为生物原研药的竞争替代品。因此,癌症负担的增加和由此导致的死亡人数的增加产生了对负担得起的治疗的需求,从而促进了肿瘤生物仿制药市场的增长。
细分和范围:
< br>“到 2030 年肿瘤生物仿制药市场分析和预测”是一项专门且深入的研究,重点关注全球市场动态,以帮助确定关键驱动因素、未来市场趋势和利润丰厚的市场机会,从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进行详细的市场细分。该报告还包括对领先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北美、欧洲、亚太地区、南美洲和中美洲以及中东和非洲的市场表现评估。
细分评估:
根据药物类别,市场分为单克隆抗体、粒细胞集落刺激因子和红细胞生成刺激剂 (ESA)。 2023 年,单克隆抗体细分市场占据最大的肿瘤生物仿制药市场份额,预计 2023 年至 2031 年复合年增长率最高。单克隆抗体可以通过多种方法破坏癌细胞,例如通过阻碍配体受体生长和生存途径。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。
按药物类别划分的肿瘤生物仿制药市场- 2023 年和 2031 年
市场根据癌症类型分为结直肠癌、宫颈癌、乳腺癌、支持性护理、淋巴瘤等。支持性护理细分市场在 2023 年占据最大的市场份额。预计 2023 年至 2031 年结直肠癌的复合年增长率最高。根据世界卫生组织的数据,癌症是一个重要的健康问题,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致力于开发和在市场上推出新产品。例如,Celltrion的CT-P16、Prestige Biopharma的163 HD204、Cipla Biotech的CBT124和北京Mabworks Biotech的MIL60都是贝伐珠单抗的潜在生物仿制药,目前正在进行3期研究并比较安全性和有效性参数。他们还正在评估其治疗非小细胞肺癌患者的能力。
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,医院药房领域占据最大的市场份额。在线药房领域预计 2023 年至 2031 年复合年增长率最高。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:
就收入而言到2023年,北美将占据主要的肿瘤生物仿制药市场份额,其次是欧洲。癌症病例不断增加、用于癌症治疗的生物仿制药的批准不断增加以及先进的医疗基础设施是预计在预测期内推动北美肿瘤生物仿制药市场的因素。
癌症病例不断增加,用于癌症治疗的生物仿制药的批准以及先进的医疗基础设施预计将推动北美肿瘤生物仿制药市场的发展。生物制剂是美国最昂贵的药物。生物仿制药预计将比其参考产品更具成本效益。 PubMed Central 于 2022 年 10 月发表的一篇文章中,根据截至 2021 年 6 月的美国药品价格,使用每单位生物制剂和生物仿制药的平均批发价 (AWP) 进行了成本比较。分析指出,生物仿制药可以提供贝伐单抗可节省 15-23%。在贝伐单抗生物仿制药中,与原研产品阿瓦斯汀相比,Zirbes 的成本节省明显更高。与参考产品相比,用于支持性癌症护理药物的生物仿制药(例如非格司亭生物仿制药)可节省 17.3% 至 34% 的费用,而聚乙二醇非格司亭生物仿制药可节省 33% 至 37% 的费用。此外,Epogen 生物仿制药可节省 33.5%。根据2022年发布的康德乐生物仿制药报告,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。据同一消息来源称,到 2025 年,生物仿制药预计将使美国药物支出减少 1330 亿美元。因此,在美国,生物仿制药在降低生物医学成本、使患者更容易获得护理和创造创新方面具有巨大潜力和科学突破,从而推动该地区的肿瘤生物仿制药市场。
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进展和举措:
2022 年 11 月,Organon 在加拿大推出了 Avastin 的生物仿制药 AYBINTIO 。该治疗适用于加拿大患有某些侵袭性癌症的患者,包括转移性结直肠癌 (mCRC);转移性肺癌;对铂敏感和耐药的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。此次推出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 Abemy,这是罗氏 Avastin(贝伐珠单抗)的生物仿制药。 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。 bevy 是由 Biocon Biologics 和 Vietri's 共同开发的,已获得加拿大卫生部批准用于四种类型的癌症。 2020 年 4 月,辉瑞的 RUXIENCE 获得了欧盟委员会 (EC) 的批准,这是一种单克隆抗体(mob )和 Mather(利妥昔单抗)的生物仿制药。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. 贝伐珠单抗 (Avastin) 生物仿制药任何剂型的开发和商业化,并在美国和加拿大上市。竞争格局和主要公司:
CELLTRION, Inc.;梯瓦制药工业有限公司;辉瑞公司;山德士集团公司;比奥康;安进公司;三星Bioepis; Coherus 生物科学公司;生物CAD;和礼来公司是肿瘤生物仿制药市场报告中列出的顶级参与者之一。这些公司专注于展示新的高科技产品、现有产品的技术进步以及地域扩张,以满足全球不断增长的消费者需求。
- Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
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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.
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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.