生物仿制药市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPHE100001246
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 223
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[研究报告]生物仿制药市场规模预计将从2021年的1843,589万美元增长到2028年的136,069.53百万美元;预计2022年至2028年复合年增长率为34.8%。

分析师观点

推动生物仿制药市场增长的主要因素已添加这就是癌症等慢性病发病率不断上升的原因。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,从而推动了生物仿制药市场的增长。主要市场参与者还预计预测期内通过产品发布、并购等各种战略活动实现市场增长。强直性脊柱炎和类风湿关节炎等自身免疫性疾病患病率的增加推动了生物仿制药市场规模的增长。例如,根据《斯堪的纳维亚风湿病学杂志》发表的一篇文章,2020年,标题为“西班牙强直性脊柱炎的患病率”的文章显示,约7.3%的人群在强直性脊柱炎检测中呈阳性结果。生物仿制药,如英夫利昔单抗-axxq (Avsola)、英夫利昔单抗-qbtx (Ixifi)、英夫利昔单抗-dyyb (Inflectra) 和英夫利昔单抗-abda (Renflexis) 用于治疗关节炎慢性疼痛。

市场概览

生物仿制药是一种与另一种已批准的生物药品(“参考药品”)非常相似的生物药品。生物仿制药按照适用于所有生物药品的相同质量、安全性和药效标准进行批准。生物仿制药是许多疾病的安全有效的治疗选择,包括慢性皮肤和肠道疾病(如牛皮癣、肠易激综合症)。 、克罗恩病和结肠炎)、关节炎、肾脏疾病和癌症。生物仿制药增加了以潜在更低的成本获得救生药物的机会。生物仿制药市场的主要驱动力是慢性病发病率的增加。

战略前景

市场驱动力

审批数量上升生物仿制药推动全球生物仿制药市场的增长

美国食品和药物管理局 (FDA) 批准生物仿制药产品,并提供将安全有效的生物仿制药推向市场所需的科学和监管建议。生物仿制药产品的批准可以通过以潜在更低的成本增加药物选择的数量来改善患者护理。

下表列出了最近批准的一些生物仿制药产品。 。 .

< td> < p>参考产品

< tr>< td >

2022 年 12 月

< td>

Riabni(利妥昔单抗)

< /tr>

生物仿制药名称

批准日期

Alymsys(贝伐珠单抗-maly)

2022年4月

阿瓦斯汀(贝伐珠单抗)

Cimerli(雷珠单抗-eqrn)

2022 年 8 月

Lucentis(雷珠单抗)

Fylnetra(聚乙二醇非格司亭) -pbbk)

2022 年 5 月

Neulasta(pegfilgrastim)

Stimufend (pegfilgrastim-fpgk)

2022 年 9 月

Neulasta  (pegfilgrastim)< /p>

Vegzelma(贝伐单抗-adcd)

2022 年 9 月

阿瓦斯汀(贝伐珠单抗)

Idacio(阿达木单抗-aacf)

修美乐(阿达木单抗)

Byooviz(雷珠单抗-努纳)

2021 年 9 月

Lucentis(雷珠单抗)

Rezvoglar(甘精胰岛素-aglr)

2021 年 12 月

来得时(甘精胰岛素)

< /td>

Semglee(甘精胰岛素-yfgn)

2021 年 7 月

来得时(甘精胰岛素)

Yusimry(阿达木单抗-aqvh)

十二月2021

Humira(阿达木单抗)

Hulio(阿达木单抗-fkjp)

2020 年 7 月

修美乐(阿达木单抗)

2020 年 12 月

Rituxan(利妥昔单抗)

Nyvepria (pegfilgrastim-apgf)

2020 年 6 月

< p>Neulasta ( pegfilgrastim)

因此,生物类似药审批的增加正在推动生物类似药的增长生物仿制药市场。

细分分析

根据疾病适应症,生物仿制药市场细分为癌症、糖尿病、自身免疫性疾病和其他疾病适应症。癌症细分市场在 2021 年占据最大的市场份额,而自身免疫性疾病预计在预测期内(2022-2028 年)复合年增长率最高,达到 36.1%。根据药物类别,生物仿制药市场分为粒细胞集落刺激因子、人类生长激素、胰岛素、TNF 阻滞剂和单克隆抗体等(骨质疏松症等)。粒细胞集落刺激因子药物类别细分市场在 2021 年占据最大的市场份额。此外,其他药物类别细分市场预计在预测期内将以最高复合年增长率增长。根据应用,全球生物仿制药市场分为静脉注射、皮下注射和其他应用。静脉注射细分市场在 2021 年占据最大的市场份额,预计在预测期内将以最高复合年增长率增长。按最终用户划分,生物仿制药市场分为医院、专科诊所、家庭护理和其他最终用户。医院细分市场在 2021 年占据最大的市场份额,预计家庭护理细分市场在预测期内(2022-2028 年)的复合年增长率最高,达到 36.6%。

生物仿制药市场(按疾病划分) 2021年和2028年

区域分析

2021年北美洲生物仿制药市场估值为54.7984亿美元预计到2028年将达到477.468亿美元;预计在预测期内复合年增长率为 37.3%。北美生物仿制药市场分为美国、加拿大和墨西哥。 2019年,美国在北美生物仿制药市场占有最大份额。糖尿病、不孕不育发病率上升,生物仿制药市场的产品开发不断增加。据NIH自身免疫疾病协调委员会称,2019年,超过2400万美国人患有自身免疫疾病。八百万人拥有自身抗体,即表明一个人患自身免疫性疾病风险的血液分子。由于未知的原因,自身免疫性疾病正在影响越来越多的人。根据美国国家环境健康科学研究所 (NIEHS) 临床研究分部的数据,2020 年,美国最常见的自身免疫生物标志物抗核抗体 (ANA) 的患病率将显着增加。该研究首次评估了美国人口代表性样本中 ANA 随时间的变化。包括男性、非西班牙裔白人、50 岁以上的成年人和青少年。在美国,生物仿制药用于治疗癌症、肾病、糖尿病和其他自身免疫性疾病(如类风湿性关节炎和克罗恩病)的患者。据康德乐称,FDA 在美国总共批准了 33 种生物仿制药,其中 21 种已上市。在市场上的 21 种生物仿制药中,17 种用于治疗癌症,3 种用于治疗自身免疫性疾病,1 种用于治疗糖尿病。

生物制剂是美国最昂贵的药物,每年每位患者的费用总计数万美元。生物仿制药的价格预计将比参考产品低 15% 至 30%。仅 2020 年,生物仿制药就节省了 79 亿美元,并且随着更多的生物仿制药进入市场,节省的费用预计在未来几年将大幅增长。据康德乐称,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,生物仿制药在降低药品成本和使患者更容易获得护理方面具有巨大潜力。 ,并创造新的创新和科学进步,从而推动该地区生物仿制药市场的增长

主要参与者分析

分析生物仿制药市场由安进公司、Celltrion公司、赛诺菲公司、Biocon有限公司、辉瑞公司、三星Bioepis有限公司、Coherus BioSciences公司、礼来公司、山德士公司、梯瓦制药工业有限公司和Dr. Reddy's Laboratories等公司组成。在生物仿制药市场的参与者中,辉瑞公司和诺华公司由于提供多元化的产品组合而成为两大参与者。

近期发展 < /p>

生物仿制药市场上的公司广泛采用无机和有机策略,例如合并、收购和产品发布。以下列出了近期的一些关键市场动态:

  • 2022 年 1 月,Biocon Ltd. 的子公司 Biocon Biologics 完成了对 Viatris 的收购。全球生物仿制药业务。此次收购为 Biocon Biologics 提供了在先进市场和几个新兴市场的直接商业能力和支持基础设施,使其更接近患者、客户和付款人。通过此次收购,Biocon Biologics 成为全球领先的生物仿制药企业,拥有八种上市产品。
  • 2022 年 10 月,Biocon Biologics 向 Yoshindo 授权两种生物仿制药资产在日本商业化。根据该协议条款,Yoshindo 获得 Biocon Biologics 开发和生产的 bUstekinumab 和 bDenosumab 在日本的独家商业化权利,代表着 7 亿美元的潜在市场机会。
  • 2022 年 12 月,Celltrion USA 宣布提交申请向 FDA 提交 CT-P13 新型皮下制剂的生物制剂许可申请 (BLA)。皮下制剂有可能通过提供高度一致性的药物暴露和便捷的给药方法来改善使用英夫利昔单抗药物的治疗选择。
  • 2022 年 9 月,Celltrion USA 获得美国 FDA 批准其产品肿瘤学生物仿制药 Vegzelma 用于治疗六种癌症,包括转移性结直肠癌;复发性或转移性非鳞状非小细胞肺癌(nsNSCLC);复发性胶质母细胞瘤;转移性肾细胞癌;持续性、复发性或转移性宫颈癌;以及上皮性卵巢癌、输卵管癌或原发性腹膜癌。 Vegzelma 是 Celltrion 获得美国 FDA 批准的第三个肿瘤生物仿制药。
  • 2022 年 5 月,Biocon Biologics 和 Viatris 推出 Abevmy。 Biocon Ltd. 的子公司 Biocon Biologics Ltd. 和 Viatris Inc. 宣布 Abevmy(bBevacizumab)在加拿大上市。 Abevmy 由 Biocon Biologics 和 Viatris 共同开发,是罗氏 Avastin(贝伐珠单抗)的生物仿制药,已获得加拿大卫生部批准用于四种肿瘤适应症。

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

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Frequently Asked Questions


Who are the major players in the biosimilars market across the globe?

The Biosimilars market majorly consists of the players, such as Biocon Ltd, Sanofi-Aventis, Celltrion Inc., Amgen Inc., Pfizer Inc., Samsung Bioepis, Sanofi SA, Coherus BioSciences Inc, Dr. Reddy’s Laboratories Ltd, Eli Lilly and Co, Sandoz AG, and Teva Pharmaceutical Industries Ltd.

Which segment by type led the biosimilars market?

The insulin segment held the largest share of the market in 2022. Also, the same segment is estimated to register the highest CAGR in the market during the forecast period.

What are the driving factors for the global biosimilars market across the world?

The factors that are driving the growth of the biosimilars market are the increasing aging population, changing social behavior, and the rising adoption of a sedentary lifestyle by people with accelerating urbanization boost the prevalence of obesity and various chronic diseases, such as diabetes. Also,twin studies have long established that genes can cause chronic conditions such as cardiovascular disease (CVDs), diabetes, obesity, Alzheimer's disease (AD), and depression. These are some of the major factors contributing to the growth of the biosimilars industry.

What is the market CAGR value of the biosimilars market during the forecast period?

The CAGR value of the biosimilars market during the forecasted period of 2022-2028 is 34.8%.

Which region is projected to be the fastest-growing region in the global biosimilars market?

The Asia Pacific is expected to be the fastest-growing region in the Biosimilars market over the forecast period due to the increasing prevalence of chronic diseases and the cost-effectiveness of biosimilars drugs.

What is the estimated biosimilars market size in 2021?

The Biosimilars market is estimated to be valued at US$ 22,676.15 million in 2022.

What are the growth estimates for the biosimilars market till 2028?

The Biosimilars market is expected to be valued at US$ 1,36,069.53 million in 2028.

What are biosimilars?

Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

The List of Companies - Biosimilar Market

  1. Biocon Ltd
  2. Sanofi-Aventis
  3. Celltrion Inc.
  4. Amgen Inc.
  5. Pfizer Inc.
  6. Samsung Bioepis
  7. Sanofi SA
  8. Coherus BioSciences Inc
  9. Dr. Reddy’s Laboratories Ltd
  10. Eli Lilly and Co
  11. Sandoz AG
  12. Teva Pharmaceutical Industries Ltd.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. 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.

  1. 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.

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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:

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Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

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.

  1. 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.

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  • 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.

  1. 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.

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