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1345459

全球新型给药系统市场 - 2023-2030

Global Novel Drug Delivery System Market - 2023-2030

出版日期: 2023年09月06日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 约2个工作天内

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简介目录

概述

全球新型给药系统市场在2022年达到126亿美元，预计到2030年将达到557亿美元，2023-2030年预测期间复合年增长率为21.2%。

新型药物输送系统 (NDDS) 涉及多种技术策略和技术，用于安全有效地将所需数量的药物或製剂输送到选定的活动领域，以实现最佳效果。 NDDS 涵盖各种因素，例如药代动力学和药效学、非特异性毒性、免疫原性、生物识别和药物有效性，这些因素建立在包含聚合物科学、製药技术、配药学、包装技术、生物共轭化学和分子生物学的程序上。

根据美国化学会2023年公布的一项研究，随着治疗拓扑从小分子药物扩展到蛋白质、多肽、单克隆抗体、核酸和活细胞等新一代治疗药物，药物输送技术已经取得了长足的进步。甚至可以满足他们特殊的交付要求。纳米技术的巨大进步正在为最先进的药物输送系统的发展铺平道路，这些系统具有高精度和药物释放控制能力。

慢性传染病和非传染性疾病病例的增加、产品授权的增加、研究活动的积极成果、市场发展（包括合併、收购、产品推出、意识的提高等因素）预计将推动全球新型药物输送系统市场的增长预测期。此外，开发新型药物输送方法的投资和资金预计也将有助于预测期内的全球市场增长。

动力学

新产品开发和市场介绍

新产品开发和市场推出预计将在预测期内推动全球市场增长。例如，2022 年6 月，Gufic Biosciences Ltd. 推出了一种新型药物输送系统——双室袋(DCB)，据该集团称，这些双室袋是由聚丙烯（不含DEHP）製成的2室IV 袋，可剥离的铝箔可以储存不稳定的药物，这些药物在给患者服用之前需要重新溶解。

此外，2022 年5 月，捷普公司(Jabil Inc.) 旗下子公司捷普医疗(Jabil Healthcare) 推出了Qfinity 自动注射器平台，这是一种用于皮下(SC) 药物自我给药的简单、可重复使用的模块化解决方案，与现有市场替代品相比，价格更低维持製药行业内可持续药物输送的新兴优先事项。此外，2022 年 3 月，新加坡南洋理工大学（NTU Singapore）的科学家设计了一种新技术，利用大型生物分子将药物输送到人体细胞中，首先将它们包裹在基于蛋白质的微滴中。

慢性疾病病例不断增加

包括传染性和非传染性疾病在内的慢性疾病病例不断增加，需要精确和受控的药物输送以及患者的舒适度，这也有助于预测期内全球市场的增长。例如，根据美国心臟协会的调查结果，仅在美国，心血管疾病 (CVD) 就导致约 80 万人死亡。 CVD 造成全球死亡人数的 31%，到 2030 年，处理 CVD 的支出预计将达到 10,440 亿美元。非裔美国社会中近 48% 的女性和 46% 的男性患有某种类型的心血管疾病，每年直接和间接费用预计将达到 4000 亿美元。

此外，据世界卫生组织称，每年跨国死亡人数中约有三分之一（估计为 1800 万人）可归因于心脏病。特别是，冠状动脉疾病 (CAD) 是一种非常典型的心血管疾病，2020 年约有 1100 万人死亡与此相关。2020 年大流行开始后，与心脏病相关的死亡率增加了 3% 以上已註册。此外，根据美国疾病控制与预防中心的数据，到 2030 年，与心血管疾病相关的货币负担（以年度医疗费用和生产力损失计算）预计将超过 1 万亿美元。

产品召回

由于患者健康安全问题而从市场召回的产品预计将阻碍预测期内的全球市场增长。例如，2022 年10 月，罗氏公司对Susvimo 进行了非强制召回，Susvimo 是一种授权用于治疗湿性年龄相关性黄斑变性(AMD) 的植入物，由于该设备的製造问题，该植入物销售雷珠单抗的独特配方。问题与端口输送装置上的隔膜或密封件有关，这些装置控製药物在註射后滴出。

同样，2023 年 8 月，Baxter 开始召回带有 Master Drug Library（第 8 版）的 SIGMA Spectrum 输液泵和带有 Dose IQ 安全软件（第 9 版）的 Spectrum IQ 输液系统，原因是泵软件升级至版本分别为v8.01.01 和v9.02.01。不真实的上游堵塞警报会导致治疗受到干扰或减慢，并导致临床医生精疲力尽，这可能会导致极端不利的健康结果，主要是对于获取维持生命药物的个人而言。使用这些开发成果可能会导致严重损害或死亡。 Baxter 报告了与此问题相关的 131 项反对意见、三项严重损害，并且没有人员伤亡。

设备开发成本高

功能低下的新型药物输送设备的高开发成本预计将阻碍预测期内的全球市场增长。例如，根据美国卫生与公共服务部的经济分析，一种新型治疗性复合医疗器械的中间开发成本为5400 万美元（置信区间为95%），在没有任何可能导致批准后调查的情况下，中间开发成本为2500 万至2 亿美元。被需要。

包括失败的调查费用和资本费用后，将一种新型治疗性复合医疗器械推向美国市场的平均资本支出为 5.22 亿美元，置信区间为 95%，即 2.05 亿美元至 33.82 亿美元。与此费用相关的关键方面是，从非临床到可行性调查的相变机率为46.9%，从可行性到关键调查的相变机率为48.0%，从关键调查到FDA 上市前许可请求的相变机率为75.7%，从FDA 上市前许可请求到FDA 上市前许可请求的相变机率为80.5%。授权。

Overview

Global Novel Drug Delivery System Market reached US$ 12.6 billion in 2022 and is expected to reach US$ 55.7 billion by 2030, growing with a CAGR of 21.2% during the forecast period 2023-2030.

Novel Drug Delivery System (NDDS) concerns diverse technological strategies and techniques for delivering a drug or a formulation in a minimum needed quantity to the chosen area of activity safely and effectively to achieve top outcomes. NDDS covers various factors such as pharmacokinetics and pharmacodynamics, non-specific toxicity, immunogenicity, bio-recognition, and medicine effectiveness established on procedures that enclose polymer science, pharmaceutical technology, dispensing pharmacy, packaging technology, bioconjugate chemistry, and molecular biology.

According to a 2023 study publicized by the American Chemical Society, with the expansion of the therapeutic topography from small-molecule drugs to a new generation of therapeutics such as proteins, peptides, monoclonal antibodies, nucleic acids, and live cells, drug delivery technologies have even grown to satisfy their exceptional delivery requirements. The enormous advancements in nanotechnology are paving the course for the evolution of state-of-the-art drug delivery systems that have high precision and control on drug release.

The growing cases of chronic communicable and non-communicables diseases, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global Novel Drug Delivery System market growth in the forecast period. Further, the investmentys and fundings for developing novel drug delivery approchs are also expected to contribute to the global market growth in the forecast period.

Dynamics

New Product Development and Market Introductions

The new product development and market introductions are expected to boost the global market growth during the forecast period. For instance, in June 2022, Gufic Biosciences Ltd. introduced a novel drug delivery system, Dual Chamber Bags (DCB), and according to the group, these Dual Chamber Bags are 2-Chamber IV Bags made up of polypropylene (DEHP free) with a peelable aluminum foil permitting the storage of unstable drugs which require reconstitution prior to the administration to the patient.

Moreover, in May 2022, Jabil Healthcare, a division of Jabil Inc., introduced the Qfinity autoinjector platform, an easy, reusable, and modular solution for subcutaneous (SC) drug self-administration, at a more inferior price compared to available market alternatives sustaining the emerging prioritization of sustainable drug delivery within the pharmaceutical industry. Further, in March 2022, scientists from Nanyang Technological University, Singapore (NTU Singapore) designed a novel technique for delivering drugs into human cells utilizing large biological molecules, by first enveloping them in a protein-based microdroplet.

Growing Cases of Chronic Disorders

The growing cases of chronic disorders including communicable and non-communicable conditions demanding precise and controlled drug delivery with patient comfort are also contributing to the global market growth during the forecast period. For instance, according to the findings of the American Heart Association, cardiovascular disease (CVD) is accountable for approximately 800,000 deaths in the United States only. CVD is liable for 31 % of all mortalities globally and by 2030, the expenditure of handling CVD is anticipated to be USD 1,044 billion. Almost 48 % of females and 46 % of males in the African-American society have some type of cardiovascular condition with the annual direct and indirect expenses anticipated to be USD 400 billion.

Moreover, according to the WHO, about one-third of the annual multinational deaths (an estimated 18 million) can be attributed to cardiac conditions. Particularly, coronary artery disease (CAD) is a highly typical condition of cardiovascular disease, almost 11 million mortalities were related to this indication in 2020. Post the beginning of the pandemic in 2020, a over 3% boost in the mortalities associated with heart disorders was registered. Additionally, according to the Centers for Disease Control and Prevention, the monetary load (in terms of annual medical costs and loss of productivity) associated with cardiovascular disorders is anticipated to exceed USD 1,000 billion, in 2030.

Product Recalls

The product recalls from the market owing to patient health safety concerns are expected to hamper the global market growth during the forecast period. For instance, in October 2022, Roche launched an unforced recall of Susvimo, an implant authorized for wet age-related macular degeneration (AMD) that distributes a unique formulation of ranibizumab owing to manufacturing issues with the device. The problem links to the septum or the seal on the port delivery device that controls the drug from dripping out once it's been injected.

Similarly, in August 2023, Baxter began recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) owing to rising reports of untrue warnings for upstream blockage after pump software advancements to version v8.01.01 and v9.02.01, respectively. Untrue upstream blockage alarms induce disturbed or slowed treatment and contribute to clinician exhaustion, which may induce extreme adverse health outcomes, primarily for individuals obtaining life-sustaining drugs. Usage of these developments may direct to severe damage or death. Baxter reported 131 objections, three severe damages, and no casualties connected to this issue.

High Device Development Costs

The high development cost for Novel Drug Delivery Devices with low capabilities is expected to hamper the global market growth during the forecast period. For instance, according to the economic analysis by the US Department of Health and Human Services, the intermediate development cost for a novel therapeutic complex medical device was $54 million with 95% CI, $25 million-$200 million without any post-approval investigations that might be needed.

After including the expense of failed investigations and expense of capital, the mean capitalized expenditure of getting a novel therapeutic complex medical device to the US market was $522 million with 95% CI, $205 million-$3382 million. The critical aspects associated with this expense were the phase change odds 46.9% for nonclinical to feasibility investigation, 48.0% for feasibility to the pivotal investigation, 75.7% for the pivotal investigation to FDA premarket clearance request, and 80.5% for FDA premarket clearance request to authorization.

Segment Analysis

The global novel drug delivery system market is segmented based on route of administration, mode, indication, end-user and region.

Injectable Route of Administration Expected to Dominate Market

Owing to the increasing market developments in this segment it is expected to hold the majority of the global market share in the forecast period. For instance, in August 2021, Sanofi acquired Translate Bio to boost the evolution of cutting-edge mRNA technologies that can aid in the production of innovative vaccines and therapeutics. The entire equity deal of the contract was assessed to be about $3.2 billion.

Moreover, the Centre for Process Innovation Limited has strategized to establish a brand-new Intracellular Drug Delivery Centre in collaboration with Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool, and Imperial College London to support the design of novel drug delivery approaches and sustain prospective RNA vaccines and therapeutics. Funded by Innovate UK's Transforming Medicines Manufacturing program, with a budget of £10 million over 3 years, the Centre intends to deliver a single point of entry for drug discovery and development developers to access new capacities in intracellular drug delivery.

Geographical Penetration

Growing Cases of Stroke and Aneurysm

Owing to the increasing market developments in North America, the region is expected to dominate the global market in the forecast period. For instance, in July 2021, pharma excipient provider Roquette infused USD 25 million in a brand-new innovation hub in the U.S., to promote drug delivery systems investigation for oral prescription medications. Moreover, in March 2023, AbbVie acquired a Complete Response Letter (CRL) from the FDA for its new drug application (NDA) for ABBV-951, a potential therapy for motor fluctuations in adults with progressive Parkinson's condition. The device, a pump, provides constant subcutaneous foscarbidopa and foslevodopa over 24 hours.

Furthermore, the increased research activities for novel drug delivery approaches developments are also contributing to the regional market growth in the forecast period. For instance, in April 2023, Northwestern University investigators designed a self-powered drug delivery device that can be implanted within the human body. The device utilizes externally laid light pulses of differing wavelengths to discharge the drug, eliminating the requirement for surgical removal. The device holds three drug pools controlled by a phototransistor and optical filter and three light-emitting diodes (LEDs) with distinct wavelengths around the implant site.

COVID-19 Impact Analysis

COVID-19 is estimated to have a positive impact on the global market as the Novel Drug Delivery Systems (NDDS) were seen as a prospective approach for the repurposing of drugs. The function of different NDDS in repurposing existing drugs for the treatment of different viral infections and their applicability in COVID-19 were examined. With a focus on the presently proceeding investigations in the enactment of NDDS in COVID-19.

Moreover, according to the World Intellectual Property Organization, multiple patent offices have concentrated on technological innovation in the evolution of monoclonal antibodies, different drug delivery systems, and nano-antibodies competent in binding to and neutralizing SARS-CoV-2 and its variants. The Nanobodies were expected to deliver a better logistically practical choice to intravenously delivered antibodies since they can be nebulized and delivered straight into a COVID-19 patient's lungs via an inhaler.

By Route of Administration

Oral Drug Delivery Systems
Injectable Drug Delivery Systems
Pulmonary Drug Delivery Systems
Transdermal Drug Delivery Systems
Others

By Mode

Targeted Drug Delivery Systems
Controlled Drug Delivery Systems
Modulated Drug Delivery Systems

Indication
- Oncology
- Infectious Diseases
- Respiratory Diseases
- Diabetes
- Cardiovascular Diseases
- Autoimmune Diseases
- Neurological Disorders
- Others

By End-User

Hospitals
Specialty Clinics
Ambulatory Surgery Centers
Home Care Settings
Academic Research Institutes
Others

By Region

North America
- U.S.
- Canada
- Mexico

Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe

South America
- Brazil
- Argentina
- Rest of South America

Asia-Pacific
- China
- India
- Japan
- Australia
- Rest of Asia-Pacific

Middle East and Africa

Key Developments

In June 2023, Stevanato Group introduced Vertiva, its patented on-body drug delivery system, developed to switch between basal and bolus injections for various subcutaneous therapies.
In April 2023, Lohmann Therapie-Systeme (LTS) completed the acquisition of Sorrel's wearable injection device enterprise, including a large molecule drug delivery platform to its portfolio. Sorrel designs pre-loaded wearable devices for the subcutaneous delivery of large-molecule drugs, including devices with internal drug reservoirs and pre-filled cartridges and vials.
In August 2021, Bayer completed the acquisition of Vividion Therapeutics at $1.5 Bn to support their portfolio from small molecules to new modalities for novel drug discovery platforms.

Competitive Landscape

The major global players in the market include: Abbott Laboratories, Pfizer Inc., Johnson & Johnson Inc., F. Hoffmann-La Roche AG, Bristol-Myers Squibb, Novartis AG, Baxter, Spectrum Pharmaceuticals, Inc, Boston Scientific Corporation, and AstraZeneca PLC among others.

Why Purchase the Report?

To visualize the global novel drug delivery system market segmentation based on route of administration, mode, indication, end-user and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of novel drug delivery system market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as excel consisting of key product of all the major players.

The global novel drug delivery system market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Route of Administration
3.2. Snippet by Mode
3.3. Snippet by Indication
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. New Product Development and Market Introductions
  - 4.1.1.2. Growing Cases of Chronic Disorders
- 4.1.2. Restraints
  - 4.1.2.1. Product Recalls
  - 4.1.2.2. High Device Development Costs
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Patent Analysis
5.6. Technology Trend
5.7. End-User Trend
5.8. SWOT Analysis
5.9. DMI Opinion

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID
- 6.1.2. Scenario During COVID
- 6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Route of Administration

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 7.1.2. Market Attractiveness Index, By Route of Administration
7.2. Oral Drug Delivery Systems*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Injectable Drug Delivery Systems
7.4. Pulmonary Drug Delivery Systems
7.5. Transdermal Drug Delivery Systems
7.6. Others

8. By Mode

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 8.1.2. Market Attractiveness Index, By Mode
8.2. Targeted Drug Delivery Systems*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Controlled Drug Delivery Systems
8.4. Modulated Drug Delivery Systems

9. By Indication

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 9.1.2. Market Attractiveness Index, By Indication
9.2. Oncology*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Infectious Diseases
9.4. Respiratory Diseases
9.5. Diabetes
9.6. Cardiovascular Diseases
9.7. Autoimmune Diseases
9.8. Neurological Disorders
9.9. Others

10. By End-User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Specialty Clinics
10.4. Ambulatory Surgery Centers
10.5. Home Care Settings
10.6. Academic Research Institutes
10.7. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. UK
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.5.7.1. China
  - 11.5.7.2. India
  - 11.5.7.3. Japan
  - 11.5.7.4. Australia
  - 11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. Abbott Laboratories*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Pfizer Inc.
13.3. Johnson & Johnson Inc.
13.4. F. Hoffmann-La Roche AG
13.5. Bristol-Myers Squibb
13.6. Novartis AG
13.7. Baxter
13.8. Spectrum Pharmaceuticals, Inc
13.9. Boston Scientific Corporation
13.10. AstraZeneca PLC

LIST NOT EXHAUSTIVE