글로벌 신약 전달 시스템 시장 – 2023-2030

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
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o 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