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非專利藥生技仿製藥

市場調查報告書

商品編碼

1618409

生物相似藥市場規模：依產品、適應症、地區劃分，2024-2031

Biosimilars Market Size By Product (Monoclonal Antibodies, Insulin, Erythropoietin), By Indication (Oncology, Inflammatory And Autoimmune Diseases, Chronic Diseases), & Region For 2024-2031

出版日期: 2024年07月16日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

生物相似藥市場評估，2024-2031

2023年生物相似藥市場規模為183.6億美元，預計到2031年將成長至1,087.4億美元，預測期內複合年增長率為24.90%。隨著醫療保健價格的上漲以及人們對昂貴生物製劑的廉價替代品的需求，生物相似藥市場正在迅速擴大。隨著許多生物製劑的專利到期，生物相似藥在世界各地已廣泛使用，因為它們以較低的成本提供了相當的治療效果。監管支援和生物技術的突破性進展也推動了生物相似藥的成長。歐洲和亞太地區各國政府正在推動生物相似藥的採用，以改善患者獲得挽救生命的治療的機會，同時降低醫療成本。

生物相似藥市場定義/概述

生物相似藥是一種與現有的、已批准的參考生物製品非常相似的生物製品，在安全性、純度或功效方面沒有明顯變化。生物相似藥的製造比化學合成的仿製藥更複雜。生物相似藥旨在治療多種疾病，包括癌症、自體免疫疾病和糖尿病。生物相似藥比原始生物製劑更便宜，這使得它們成為患者和醫療保健系統更實惠的選擇。

生物相似藥的主要用途是為治療癌症、類風濕性關節炎和自體免疫疾病等慢性和複雜疾病提供具有成本效益的生物製劑替代品。生物相似藥旨在精確模仿生物製劑的功效、安全性和質量，並以更低的成本提供相同的治療效果。這將使患者能夠接受創新治療，同時幫助醫療保健系統管理不斷上漲的藥物成本並提高重症監護的整體負擔能力。

生物相似藥的前景一片光明，因為它們在使生物治療更容易獲得和負擔得起方面發揮著重要作用。隨著各種生物製劑的專利到期，生物相似藥可能更頻繁地用於治療癌症、自體免疫疾病和糖尿病等複雜疾病。生物技術的進步將改善生物相似藥的生產，確保它們與原始生物製品一樣有效和安全。隨著醫療保健系統尋求具有成本效益的替代品，生物相似藥可能會在世界各地得到更廣泛的使用，從而改善患者獲得重要治療的機會。

不斷上漲的醫療保健成本將如何推動生物相似藥市場對生物相似藥的需求？

不斷上漲的醫療保健成本是生物相似藥業務需求的主要驅動力。不斷上漲的醫療成本正促使患者、付款人和提供者尋求更便宜的生物製劑。生物相似藥以較低的成本提供相當的安全性和療效，使患者能夠接受所需的治療，而無需承受過高的費用。這些成本問題在慢性病管理中尤其嚴重，因為長期的生物治療可能會對醫療保健財務造成壓力。

此外，醫療保健系統面臨著控製成本上升的壓力，政府正在推廣使用生物相似藥作為降低整體醫療保健成本的一種方式。許多政府和保險公司已製定政策鼓勵採用生物相似藥，包括降低報銷率和加速審批流程。這種監管支持不僅增加了對生物相似藥的信心，而且隨著利益相關者尋求醫療保健成本增加的需求的長期解決方案，也促進了其使用並促進了生物仿製藥的發展。

教育和宣傳工作如何減輕患者和醫療保健提供者對生物相似藥市場中生物相似藥的看法所帶來的限制？

教育和宣傳工作可以幫助患者和醫療保健提供者克服對生物相似藥的誤解。這些努力透過提供有關生物仿製藥的安全性、有效性和審批流程的準確、基於證據的信息，有助於消除誤解並減輕對生物仿製藥的擔憂。可以為特定受眾客製化研討會、網路研討會和資訊資料，以幫助醫療保健專業人員和患者瞭解生物相似藥和參考生物體，包括臨床結果和實際療效的數據，幫助您瞭解其與製劑的比較。

此外，與知名意見領袖和醫療保健從業者合作可以擴大教育措施的影響範圍和合法性。當值得信賴的專家支持使用生物相似藥並分享他們的正面經驗時，他們可以對醫學界的看法產生重大影響。此外，患者倡導團體傳播知識並鼓勵做出明智的決策，從而使生物相似藥在治療方案中得到廣泛接受，並使患者對具有成本效益的替代方案充滿信心。

Biosimilars Market Valuation - 2024-2031 The Biosimilars Market size was valued at USD 18.36 Billion in 2023 and is projected to grow USD 108.74 Billion by 2031 , exhibiting a CAGR of 24.90% during the forecast period. The market for biosimilars is fast expanding as healthcare prices rise and there is a need for affordable alternatives to costly biologic medications. With many original biologics patents expiring, biosimilars provide equivalent therapeutic results at a reduced cost resulting in their widespread use worldwide. Regulatory backing and breakthroughs in biotechnology are also driving biosimilar growth. Governments in Europe and the Asia Pacific are pushing biosimilar adoption to decrease healthcare costs while increasing patient access to life-saving therapies.

Biosimilars Market: Definition/ Overview

Biosimilars are biologic medical products that are extremely like an existing approved reference biologic medication with no discernible changes in safety, purity, or effectiveness. Biosimilars are more complex to create and produce than generic pharmaceuticals which are chemically synthesized. They are intended to treat a variety of ailments including cancer, autoimmune disorders, and diabetes. Biosimilars are less expensive than original biologics making them a more affordable alternative for patients and healthcare systems.

The primary use of biosimilars is to provide cost-effective alternatives to biological medications for the treatment of chronic and complex diseases such as cancer, rheumatoid arthritis, and autoimmune disorders. Biosimilars are intended to accurately mimic the efficacy, safety, and quality of the original biologic medications, providing comparable therapeutic benefits at a lower cost. This increases patient access to innovative treatments while also assisting healthcare systems in managing rising drug costs and improving overall affordability in critical care.

The future of biosimilars seems bright as they will play an important role in making biological treatments more accessible and inexpensive. As patents on various biologic medications expire, biosimilars will be utilized more frequently to treat complicated disorders such as cancer, autoimmune diseases, and diabetes. Biotechnology advancements will improve their manufacture guaranteeing that they are as effective and safe as original biologics. As healthcare systems seek cost-effective alternatives, biosimilars will become more widely used around the world, enhancing patient access to vital treatments.

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How Does the Rising Cost of Healthcare Expenditures Drive the Demand for Biosimilars in the Biosimilars Market?

Rising healthcare costs are a primary driver of demand in the biosimilar business. As healthcare costs rise, patients, insurers, and providers are increasingly looking for less expensive biologic medicines. Biosimilars provide equivalent safety and efficacy at reduced prices allowing patients to obtain necessary therapies without suffering exorbitant costs. This concern for cost is especially evident in chronic disease management where long-term biologic treatment can put a strain on healthcare finances.

Furthermore, healthcare systems are under pressure to contain rising costs encouraging governments to promote the use of biosimilars as a means of lowering overall healthcare costs. Many governments and insurance companies are establishing policies that encourage the adoption of biosimilars such as lower reimbursement rates and faster approval processes. This regulatory support not only enhances confidence in biosimilar goods but also encourages their use increasing demand in the biosimilar sector as stakeholders seek long-term solutions to healthcare cost concerns.

How can Education and Outreach Efforts Mitigate the Restraint Posed by Perceptions of Biosimilars among Patients and Healthcare Providers in the Biosimilars Market?

Education and outreach activities can help patients and healthcare providers overcome misconceptions about biosimilars. These initiatives can assist to demystify and relieve worries about biosimilars by providing accurate, evidence-based information about their safety, efficacy, and approval processes. Workshops, webinars, and instructional materials can be customized for specific audiences ensuring that both healthcare professionals and patients understand how biosimilars compare to reference biologics including data on clinical outcomes and real-world efficacy.

Furthermore, collaborating with prominent thought leaders and healthcare practitioners helps broaden the reach and legitimacy of educational initiatives. When trusted specialists advocate for the use of biosimilars and share positive experiences, they can have a substantial impact on perceptions in the medical community. Furthermore, patient advocacy groups can help disseminate knowledge and encourage informed decision-making, resulting in broader acceptance of biosimilars in treatment protocols and allowing patients to confidently choose these cost-effective alternatives.

Category-Wise Acumens

How has the Expiration of Patents for Blockbuster Monoclonal Antibodies Influenced the Growth of the Biosimilars Market?

Monoclonal antibodies are more dominant in the Biosimilars Market due to their broad application in the treatment of cancer, autoimmune disorders, and infectious diseases. As one of the most successful types of biologics, mAbs have considerably improved patient outcomes resulting in strong demand for these treatments. The expiration of patents for several blockbuster monoclonal antibodies has paved the way for biosimilars allowing manufacturers to create cost-effective replacements while maintaining therapeutic efficacy and safety.

Furthermore, regulatory frameworks developed by health authorities such as the FDA and EMA have shortened the approval process for mAbs biosimilars, allowing businesses to reach the market more easily. The vast clinical data available on original mAbs lays the groundwork for the development and approval of biosimilars fostering trust in healthcare professionals and patients. This combination of significant market demand established regulatory procedures, and mAbs' demonstrated performance places them at the forefront of the Biosimilars Market.

How Might Future Trends in Healthcare Impact the Demand for Biosimilars in the Treatment of GHD?

Growth Hormone Deficiency (GHD) is more dominant in the Biosimilars Market due to the rising awareness and diagnosis of this condition coupled with the increasing demand for affordable treatment options. As healthcare providers and patients become more informed about the benefits of growth hormone therapy, the incidence of diagnosed GHD has risen. This trend drives the need for effective and cost-efficient alternatives to expensive biological growth hormone treatments, positioning biosimilars as an attractive option for patients seeking access to necessary therapies.

Additionally, the expiration of patents for original growth hormone biologics has opened the door for biosimilars to enter the market. This regulatory shift allows manufacturers to develop and offer biosimilar products that mimic the efficacy and safety of established growth hormone therapies at lower prices. As healthcare systems worldwide emphasize cost containment and improved patient access, the demand for biosimilars for GHD treatment is likely to grow, solidifying their position in the Biosimilars Market.

Country/Region-wise Acumens

How can the Introduction of Biosimilars Improve Patient Access to Critical Therapies in the North American Region?

North America is more dominant in the biosimilar industry owing to its strong healthcare infrastructure and large investments in R&D. The region has a strong regulatory structure, led by the United States Food and Drug Administration (FDA) which has provided clear procedures for biosimilar approvals. This legal certainty promotes innovation and encourages pharmaceutical companies to invest in biosimilar development resulting in a varied range of new drugs on the market.

Furthermore, the increased prevalence of chronic diseases and the rising prices of biologic medicines in North America are pushing demand for less expensive treatment choices. Patients and healthcare professionals are looking for alternatives that give comparable therapeutic benefits at a lesser cost. As patents for several high-cost biologics expire, the introduction of biosimilars presents a chance to improve patient access to critical therapies reinforcing North America's position as a biosimilars industry leader.

How are Rising Healthcare Costs and the Prevalence of Chronic Diseases Influencing the Demand for Biosimilars in the Asia-Pacific Region?

Asia Pacific is the fastest-growing region in the Biosimilars Market owing to rising healthcare costs and a higher prevalence of chronic diseases. Governments in nations like as India and China are making significant investments in healthcare infrastructure and adopting policies that enable biosimilar development and licensing. The expanding middle-class population is also driving demand for low-cost treatment choices making biosimilars a viable alternative to expensive biologics.

Furthermore, the region benefits from a strong biotechnology sector and a huge pool of skilled professionals allowing for efficient biosimilar manufacture. The presence of several pharmaceutical businesses and contract manufacturing organizations in Asia Pacific drives innovation and lowers production costs. Furthermore, raising knowledge among healthcare professionals and patients regarding biosimilars' efficacy and safety helps to increase their acceptance. As regulatory organizations in the region continue to streamline approval processes, the Biosimilars Market is likely to grow significantly, meeting the population's expanding healthcare needs.

Competitive Landscape

The Biosimilars Market is a dynamic and competitive space characterized by diverse players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations focus on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the Biosimilars Market include:

Pfizer Inc., Sandoz, Amgen, Biocon, Celltrion, Samsung Biologics, Novartis AG.

Latest Developments

In September 2021, BYOOVIZ (ranibizumab-Nuna), a biosimilar of LUCENTIS (ranibizumab), was approved by the Food and Drug Administration (FDA) for the treatment of myopic choroidal neovascularization, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration. The first ophthalmology biosimilar to be authorized in the US was BYOOVIZ.

1 INTRODUCTION OF GLOBAL BIOSIMILARS MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL BIOSIMILARS MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5 GLOBAL BIOSIMILARS MARKET, BY INDICATION

5.1 Overview
5.2 Oncology
5.3 Inflammatory And Autoimmune Diseases
5.4 Chronic Diseases
5.5 Blood Disorders
5.6 Growth Hormone Deficiency
5.7 Infectious Diseases
5.8 Other Indications

6 GLOBAL BIOSIMILARS MARKET, BY PRODUCT

6.1 Overview
6.2 Monoclonal Antibodies
6.3 Insulin
6.4 Granulocyte Colony-Stimulating Factor
6.5 Erythropoietin
6.6 Recombinant Human Growth Hormone
6.7 Etanercept
6.8 Follitropin
6.9 Teriparatide
6.10 Interferons
6.11 Enoxaparin Sodium
6.12 Glucagon
6.13 Calcitonin

7 GLOBAL BIOSIMILARS MARKET, BY GEOGRAPHY

7.1 Overview
7.2 North America
- 7.2.1 U.S.
- 7.2.2 Canada
- 7.2.3 Mexico
7.3 Europe
- 7.3.1 Germany
- 7.3.2 U.K.
- 7.3.3 France
- 7.3.4 Rest of Europe
7.4 Asia Pacific
- 7.4.1 China
- 7.4.2 Japan
- 7.4.3 India
- 7.4.4 Rest of Asia Pacific
7.5 Rest of the World
- 7.5.1 Latin America
- 7.5.2 Middle East and Africa

8 GLOBAL BIOSIMILARS MARKET COMPETITIVE LANDSCAPE

8.1 Overview
8.2 Company Market Ranking
8.3 Key Development Strategies

9 COMPANY PROFILES

9.1 Novartis AG
- 9.1.1 Overview
- 9.1.2 Financial Performance
- 9.1.3 Product Outlook
- 9.1.4 Key Developments
9.2 Pfizer Inc.
- 9.2.1 Overview
- 9.2.2 Financial Performance
- 9.2.3 Product Outlook
- 9.2.4 Key Developments
9.3 Sandoz
- 9.3.1 Overview
- 9.3.2 Financial Performance
- 9.3.3 Product Outlook
- 9.3.4 Key Developments
9.4 Amgen
- 9.4.1 Overview
- 9.4.2 Financial Performance
- 9.4.3 Product Outlook
- 9.4.4 Key Developments
9.5 Biocon
- 9.5.1 Overview
- 9.5.2 Financial Performance
- 9.5.3 Product Outlook
- 9.5.4 Key Developments
9.6 Celltrion
- 9.6.1 Overview
- 9.6.2 Financial Performance
- 9.6.3 Product Outlook
- 9.6.4 Key Developments
9.7 Samsung Biologics
- 9.7.1 Overview
- 9.7.2 Financial Performance
- 9.7.3 Product Outlook
- 9.7.4 Key Developments