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市場調査レポート
商品コード
1345459
新規ドラッグデリバリーシステムの世界市場-2023年~2030年Global Novel Drug Delivery System Market - 2023-2030 |
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カスタマイズ可能
適宜更新あり
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新規ドラッグデリバリーシステムの世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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概要
世界の新規ドラッグデリバリーシステム市場は、2022年に126億米ドルに達し、2023-2030年の予測期間中にCAGR 21.2%で成長し、2030年には557億米ドルに達すると予測されています。
新規ドラッグデリバリーシステム(NDDS)は、薬剤や製剤を必要最小限の量だけ、安全かつ効果的に選択した活動領域に送達し、最高の成果を達成するための多様な技術戦略や技術に関するものです。NDDSは、高分子科学、製薬技術、調剤薬局、包装技術、バイオコンジュゲート化学、分子生物学を包含する手順に基づいて確立された、薬物動態学や薬力学、非特異的毒性、免疫原性、生物学的認識、薬の有効性といった様々な要素をカバーしています。
米国化学会(American Chemical Society)が発表した2023年の調査によると、低分子医薬品からタンパク質、ペプチド、モノクローナル抗体、核酸、生細胞などの新世代の治療薬へと治療トポグラフィーの拡大に伴い、ドラッグデリバリー技術はその卓越したデリバリー要件を満たすためにさらに成長しています。ナノテクノロジーの飛躍的な進歩は、高精度で薬物放出を制御する最先端のドラッグ・デリバリー・システムの進化に道を開いています。
慢性伝染性疾患や非伝染性疾患の症例の増加、製品認可の増加、研究活動からの好結果、合併、買収、製品調査、認知度の向上などの市場の発展は、予測期間における世界の新規ドラッグデリバリーシステム市場の成長を後押しすると予想されます。さらに、新規ドラッグデリバリーアプローチ開発のための投資や資金調達も、予測期間における世界市場の成長に貢献すると期待されています。
ダイナミクス
新製品の開発と市場開拓
新製品の開発と市場開拓は、予測期間中の世界市場の成長を後押しすると予想されます。例えば、2022年6月、Gufic Biosciences Ltd.は、新しいドラッグデリバリーシステムであるデュアルチャンバーバッグ(DCB)を発表しました。同グループによると、このデュアルチャンバーバッグは、ポリプロピレン(DEHPフリー)で構成され、剥離可能なアルミ箔付きで、患者への投与前に再構成が必要な不安定な薬剤の保管を可能にする2チャンバーIVバッグです。
さらに、2022年5月、Jabil Inc.の一部門であるJabilヘルスケアは、皮下(SC)薬剤自己投与のための簡単で再利用可能なモジュール式ソリューションであるQfinity自動注射器プラットフォームを発表しました。さらに、2022年3月、シンガポールの南洋理工大学(NTUシンガポール)の科学者たちは、大きな生物学的分子を利用し、最初にタンパク質ベースの微小液滴で包み込むことによって、ヒト細胞に薬剤を送達する新しい技術を設計しました。
慢性疾患の増加
感染症や非感染症を含む慢性疾患の症例が増加しており、正確かつ制御された薬物送達と患者の快適性が求められていることも、予測期間中の世界市場の成長に寄与しています。例えば、米国心臓協会(American Heart Association)の調査結果によると、心血管系疾患(CVD)は米国だけで約80万人の死亡の原因となっています。CVDは世界全体の死亡原因の31%を占めており、2030年までにCVDの治療にかかる費用は1兆440億米ドルに達すると予測されています。アフリカ系米国人社会では、女性のほぼ48%、男性の46%が何らかの心血管系疾患を抱えており、年間の直接的・間接的費用は4,000億米ドルに上ると予想されています。
さらに、WHOによると、年間多国籍死亡者数(推定1,800万人)の約3分の1は心臓疾患に起因しています。特に冠動脈疾患(CAD)は心血管疾患の代表的な疾患であり、2020年には1,100万人近くがこの疾患に関連して死亡しています。パンデミックが始まった2020年以降、心臓疾患に関連する死亡者数は3%以上増加しました。さらに、疾病管理予防センターによると、心血管障害に関連する金銭的負担(年間医療費および生産性の損失)は、2030年には1兆米ドルを超えると予想されています。
製品回収
患者の健康安全への懸念に起因する製品回収は、予測期間中の世界市場の成長を妨げると予想されます。例えば、2022年10月、ロシュ社は、ラニビズマブの独自製剤を使用する湿性加齢黄斑変性症(AMD)治療用インプラントであるサスビモの製造上の問題による強制回収を開始しました。この問題は、ポートデリバリーデバイスのセプタムまたはシールに関連するもので、薬剤が注入された後、薬剤が滴り落ちないように制御するものです。
同様に、2023年8月、バクスターはSIGMA Spectrum Infusion Pumps with Master Drug Library(バージョン8)およびSpectrum IQ Infusion Systems with Dose IQ Safety Software(バージョン9)のリコールを開始しました。真実でない上流詰まりの警告は、治療の中断や遅延を引き起こし、臨床医の疲弊の原因となります。これらの開発品の使用は、重篤な損傷や死亡につながる可能性があります。バクスターは、131件の異議申し立て、3件の重大な損害、およびこの問題に関連した死傷者はなかったと報告しています。
高いデバイス開発費
低機能の新規ドラッグデリバリーデバイスの開発コストが高いことは、予測期間中の世界市場の発展の妨げになると予想されます。例えば、米国保健社会福祉省の経済分析によると、新規治療用複合医療機器の中間開発コストは5,400万米ドルで、95%信頼区間は2,500万米ドルから2億米ドルです。
失敗した調査費用と資本費用を含めると、新規治療用複合医療機器を米国市場に投入するための平均資本支出は5億2,200万米ドルで、95%信頼区間は2億500万米ドルから33億8,200万米ドルでした。この費用に関連する重要な側面は、非臨床試験からフィージビリティー調査へのフェーズ変更の可能性が46.9%、フィージビリティー調査からピボタル調査への可能性が48.0%、ピボタル調査からFDA市販前クリアランス申請への可能性が75.7%、FDA市販前クリアランス申請から認可への可能性が80.5%でした。
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.
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.
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.
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.
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.
The global novel drug delivery system market is segmented based on route of administration, mode, indication, end-user and region.
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.
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 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.
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.
The global novel drug delivery system market report would provide approximately 61 tables, 58 figures and 186 Pages.
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