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1345459

全球新型給藥系統市場 - 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: 約2個工作天內

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簡介目錄

概述

全球新型給藥系統市場在2022年達到126億美元，預計到2030年將達到557億美元，2023-2030年預測期間年複合成長率為21.2%。

新型藥物輸送系統 (NDDS) 涉及多種技術策略和技術，用於安全有效地將所需數量的藥物或製劑輸送到選定的活動領域，以實現最佳效果。 NDDS 涵蓋各種因素，例如藥代動力學和藥效學、非特異性毒性、免疫原性、生物識別和藥物有效性，這些因素建立在包含聚合物科學、製藥技術、配藥學、包裝技術、生物共軛化學和分子生物學的程序上。

根據美國化學會2023年公佈的一項研究，隨著治療拓撲從小分子藥物擴展到蛋白質、多肽、單克隆抗體、核酸和活細胞等新一代治療藥物，藥物輸送技術已經取得了長足的進步。甚至可以滿足他們特殊的交付要求。奈米技術的巨大進步正在為最先進的藥物輸送系統的發展鋪平道路，這些系統具有高精度和藥物釋放控制能力。

慢性傳染病和非傳染性疾病病例的增加、產品授權的增加、研究活動的積極成果、市場發展（包括合併、收購、產品推出、意識的提高等因素）預計將推動全球新型藥物輸送系統市場的成長預測期。此外，開發新型藥物輸送方法的投資和資金預計也將有助於預測期內的全球市場成長。

動力學

新產品開發和市場介紹

新產品開發和市場推出預計將在預測期內推動全球市場成長。例如，2022 年6 月，Gufic Biosciences Ltd. 推出了一種新型藥物輸送系統——雙室袋(DCB)，據該集團稱，這些雙室袋是由聚丙烯（不含DEHP）製成的2室IV 袋，可剝離的鋁箔可以儲存不穩定的藥物，這些藥物在給患者服用之前需要重新溶解。

此外，2022 年5 月，捷普公司(Jabil Inc.) 旗下子公司捷普醫療(Jabil Healthcare) 推出了Qfinity 自動注射器平台，這是一種用於皮下(SC) 藥物自我給藥的簡單、可重複使用的模組化解決方案，與現有市場替代品相比，價格更低維持製藥行業內永續藥物輸送的新興優先事項。此外，2022 年 3 月，新加坡南洋理工大學（NTU Singapore）的科學家設計了一種新技術，利用大型生物分子將藥物輸送到人體細胞中，首先將它們包裹在基於蛋白質的微滴中。

慢性疾病病例不斷增加

包括傳染性和非傳染性疾病在內的慢性疾病病例不斷增加，需要精確和受控的藥物輸送以及患者的舒適度，這也有助於預測期內全球市場的成長。例如，根據美國心臟協會的調查結果，僅在美國，心血管疾病 (CVD) 就導致約 80 萬人死亡。 CVD 造成全球死亡人數的 31%，到 2030 年，處理 CVD 的支出預計將達到 10,440 億美元。非裔美國社會中近 48% 的女性和 46% 的男性患有某種類型的心血管疾病，每年直接和間接費用預計將達到 4000 億美元。

此外，據世界衛生組織稱，每年跨國死亡人數中約有三分之一（估計為 1800 萬人）可歸因於心臟病。特別是，冠狀動脈疾病 (CAD) 是一種非常典型的心血管疾病，2020 年約有 1100 萬人死亡與此相關。2020 年大流行開始後，與心臟病相關的死亡率增加了 3% 以上已註冊。此外，根據美國疾病控制與預防中心的數據，到 2030 年，與心血管疾病相關的貨幣負擔（以年度醫療費用和生產力損失計算）預計將超過 1 兆美元。

產品召回

由於患者健康安全問題而從市場召回的產品預計將阻礙預測期內的全球市場成長。例如，2022 年10 月，羅氏公司對Susvimo 進行了非強制召回，Susvimo 是一種授權用於治療濕性年齡相關性黃斑部病變(AMD) 的植入物，由於該設備的製造問題，該植入物銷售雷珠單抗的獨特配方。問題與端口輸送裝置上的隔膜或密封件有關，這些裝置控製藥物在注射後滴出。

同樣，2023 年 8 月，Baxter 開始召回帶有 Master Drug Library（第 8 版）的 SIGMA Spectrum 輸液泵和帶有 Dose IQ 安全軟體（第 9 版）的 Spectrum IQ 輸液系統，原因是泵軟體升級至版本分別為v8.01.01 和v9.02.01。不真實的上游堵塞警報會導致治療受到干擾或減慢，並導致臨床醫生精疲力盡，這可能會導致極端不利的健康結果，主要是對於獲取維持生命藥物的個人而言。使用這些開發成果可能會導致嚴重損害或死亡。 Baxter 報告了與此問題相關的 131 項反對意見、三項嚴重損害，並且沒有人員傷亡。

設備開發成本高

功能低下的新型藥物輸送設備的高開發成本預計將阻礙預測期內的全球市場成長。例如，根據美國衛生與公共服務部的經濟分析，一種新型治療性複合醫療器械的中間開發成本為5400 萬美元（置信區間為95%），在沒有任何可能導致批准後調查的情況下，中間開發成本為2500 萬至2 億美元。被需要。

包括失敗的調查費用和資本費用後，將一種新型治療性複合醫療器械推向美國市場的平均資本支出為 5.22 億美元，置信區間為 95%，即 2.05 億美元至 33.82 億美元。與此費用相關的關鍵方面是，從非臨床到可行性調查的相變機率為46.9%，從可行性到關鍵調查的相變機率為48.0%，從關鍵調查到FDA 上市前許可請求的相變機率為75.7%，從FDA 上市前許可請求到FDA 上市前許可請求的相變機率為80.5%。授權。

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