The Pharmaceutical Quality Management Systems Market is projected to reach $3.97 billion by 2030, at a CAGR of 15.6% during the forecast period 2023–2030. A pharmaceutical quality management system is a collection of procedures and practices that contribute to the quality of a product. The system ensures quality procedures in various product life cycle stages, such as manufacturing and product testing, by preventing process deviation and emphasizing quality documentation to record all errors and their solutions. With the emphasis on ICH guidelines, most pharmaceutical manufacturers are keen to adopt pharmaceutical quality management systems to improve their production processes.
COVID-19 Impact Assessment
With the increasing need to maintain quality and compliance, demand for quality management systems remained steady during the pandemic. The COVID-19 pandemic caused unprecedented disruption in the global economy and trade, with both production and consumption falling back globally. As a result, the importance of quality and compliance management in the pharmaceutical industry increased significantly. The pandemic put pressure on organizations to upscale their quality processes despite the constraints of social distancing.
Supply chain and process quality remained the prime factor for pharmaceutical players to adopt quality management systems. Supplier quality has always been critical in delivering better products, particularly in highly regulated industries like pharmaceuticals. The common issues in the supply chain, such as scalability and speed, were highlighted even more during the pandemic. Furthermore, companies recognized a lack of adaptability in handling quality processes, especially when teams worked remotely.
Communication and collaboration have become more intense in the present business environment, which traditional paper-based quality management systems cannot accommodate. Thus, most pharmaceutical manufacturers preferred to coordinate their manufacturing processes with quality management systems during the pandemic.
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Increasing Cost of Drug manufacturing is Driving the Market Growth
Manufacturing costs account for a significant portion of a company's total expenses in the pharmaceutical industry. The cost of bringing a new drug to market has also risen steadily. It is estimated that a USD 2 billion investment is required to move from a laboratory idea to successful commercialization. The costs of brand-name pharmaceuticals can be as high as 27-30% of sales.
On one side, pharmaceutical players are increasing their R&D spending to increase product numbers, whereas the productivity of their R&D investment, compared to the number of drugs introduced to the market each year, is decreasing, thus affecting a sizable portion of their total cost structure. With the increasing pressure to reduce overall process costs, many pharma and biotech manufacturers are focusing on streamlining their processes with the help of quality management systems.
Increasing Demand to Comply with Regulatory Requirements
Drugs, medical devices, and other medications directly impact consumer health and well-being, which is why the pharmaceutical industry is strictly regulated. Manufacturers are bound to follow several quality standards to get their products into the market. With the rapid expansion of the pharma sector, small and mid-sized pharmaceutical players are focusing on complying with regulations to deliver better products and stay competitive in the market. Most companies operating in developing countries such as India and China export their products into the U.S. market, which is regulated by the Food and Drug Administration (FDA). To ensure that pharmaceutical products are safe and effective, the FDA inspects the facilities and procedures of all manufacturing operations in the U.S. and those overseas operations of companies that regularly sell their products in the U.S. As a result, these facilities and procedures must be registered with the FDA and adhere to the FDA's current good manufacturing practices (cGMP). Additionally, manufacturers must follow ICH Guideline Q10, 21 CFR Part 211, and International Organization for Standardization (ISO) guidelines to produce and market their products. With the increasing importance of regulatory requirements and the growing international market, manufacturers are keen to adopt quality management systems.
Key Findings in the Global Pharmaceutical Quality Management Systems Market Study:
Based on solution type, in 2023, the non-conformance/deviation management segment is expected to account for the largest share
Based on solution type, in 2023, the non-conformance or deviation management segment is expected to account for the largest share of the pharmaceutical quality management market. Key factors such as the growing emphasis on process deviation records by regulatory authorities to analyze overall process quality primarily contribute to the growth of this segment. The importance of deviation and non-conformance is increasing with the market expansion in emerging countries. FDA and European Medicines Agency (EMA)-approved plants are strictly under the radar of regulatory authorities to ensure the safety and efficiency of the drug product. Thus, several pharmaceutical players are adopting quality management systems to improve the overall process.
Based on deployment mode, the on-cloud segment is projected to register the highest CAGR during the forecast period
The shift towards cloud-based or web-based systems by major pharmaceutical players is primarily contributing to the fast growth of this segment. Cloud-based or web-based deployment offers several benefits, such as scalability, accessibility, mobility, quick and easy access, and reduced IT costs. In addition, cloud-based systems allow for easy audits and help streamline workflow and recordkeeping, which also supports the growth of this segment.
Based on end user, in 2023, the pharmaceutical, life sciences, and biotechnology companies segment is expected to account for the largest share
The large market share of this segment is attributed to the increasing need for quality management systems in pharma and biotech companies. Some of the factors driving systems adoption in pharmaceutical and biotech companies include stringent regulations, frequent changes in the manufacturing process, mounting pressures to increase production capacity, and an increase in drug manufacturing costs.
Asia-Pacific: Fastest growing regional market
The growth of this market is attributed to the presence of a large number of pharmaceutical companies. The pharmaceutical industries in India and China have the largest manufacturers of generics and biopharmaceuticals, and most of the quality management systems providers are focusing on capturing these big pharmaceutical markets. Because most pharmaceutical manufacturers export their products to North America and Europe, the need for documents such as process management, corrective and preventive actions, deviations, training, quality management, and product release documents is critical, which is why most drug manufacturers adopt quality management systems. Furthermore, an increase in the number of contract research organizations has triggered the demand for quality management systems in the region.
Key Players
The report includes a competitive landscape based on an extensive assessment of the key strategic developments that led market participants to adopt over the past three years. The key players profiled in the global pharmaceutical quality management systems market report are ANTARES VISION SpA (Italy), AssurX Inc.(U.S.), AXSource (U.S.), CLARIVATE PLC (U.K.), ComplianceQuest (U.S.), Dassault Systemes (France), EtQ Management Consultants Inc.(U.S.), Honeywell International Inc.(U.S.), Ideagen PLC (U.K.), IQVIA HOLDINGS INC.(U.S), LogicGate Inc.(U.S.), and MasterControl, Inc.(U.S.)
Scope of the Report:
Pharmaceutical Quality Management Systems Market, by Solution Type
Pharmaceutical Quality Management Systems Market, by Deployment Mode
Pharmaceutical Quality Management Systems Market, by End User
Pharmaceutical Quality Management Systems Market, by Geography
Key questions answered in the report:
This study offers a detailed assessment of the pharmaceutical quality management systems market, including the market size & forecast for various segmentations like solution type, deployment mode, and end user. The pharmaceutical quality management systems market studied in this report also includes the value analysis of various segments and sub-segments of pharmaceutical quality management systems at regional and country levels.
The global pharmaceutical quality management systems market is projected to reach $3.97 billion by 2030, at a CAGR of 15.6% during the forecast period.
Based on solution type, in 2023, the non-conformance/deviation management segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the high importance of deviation records during regulatory audits. The increasing use of QMS to track and reduce non-conformance also supports the segment’s growth.
Based on deployment mode, the cloud/web-based segment is projected to register the highest CAGR during the forecast period.
The growth of this market is mainly attributed to the increasing demand to comply with regulatory requirements. Drugs, medical devices, and other medications have a direct impact on consumer health and well-being, which is why the pharmaceutical industry is strictly regulated. Manufacturers are bound to follow several quality standards to get their products into the market. With the rapid expansion of the pharma sector, small and mid-sized pharmaceutical players are focusing on complying with regulations to deliver better products and stay competitive in the market.
The key players profiled in the global pharmaceutical quality management systems market are ANTARES VISION SpA (Italy), AssurX Inc.(U.S.), AXSource (U.S.), CLARIVATE PLC (U.K.), ComplianceQuest (U.S.), Dassault Systemes (France), EtQ Management Consultants Inc.(U.S.), Honeywell International Inc.(U.S.), Ideagen PLC (U.K.), IQVIA HOLDINGS INC.(U.S), LogicGate Inc.(U.S.), and MasterControl, Inc.(U.S.)
Emerging economies such as India and China in Asia-Pacific are projected to offer significant growth opportunities to the market players due to the growing investments in pharmaceutical sectors.
This report provides pre & post COVID-19 market estimates.
1. Introduction
1.1. Market Definition
1.2. Market Ecosystem
1.3. Currency
1.4. Key Stakeholders
2. Research Methodology
2.1. Research Process
2.2. Data Collection & Validation
2.2.1. Secondary Research
2.2.2. Primary Research
2.3. Market Assessment
2.3.1. Market Size Estimation
2.3.1.1. Bottom-up Approach
2.3.1.2. Top-down Approach
2.3.1.3. Growth Forecast
2.3.2. Market Share Analysis
2.4. Assumptions for the Study
2.5. Limitations for the Study
3. Executive Summary
4. Market Insights
4.1. Introduction
4.2. Market Dynamics
4.2.1. Drivers
4.2.1.1. Increasing Cost of Drug Manufacturing
4.2.1.2. Increasing Demand to Comply with Regulatory Requirements
4.2.2. Restraints
4.2.2.1. High Cost of the Systems
4.2.3. Opportunities
4.2.3.1. Development of Solutions Based on Platform-as-a-Service Business Mode
4.2.3.2. Rapid growth in Bio-pharmaceuticals Industry
4.2.4. Challenges
4.2.4.1. Security Concerns Pertaining to On-Cloud Deployment
4.3. Impact of the COVID-19 Pandemic on the Pharmaceutical Quality Management Systems Market
5. Global Pharmaceutical Quality Management Systems Market, by Solution Type
5.1. Introduction
5.2 Non-conformance/Deviation management
5.3 CAPA Management
5.4 Audit Management
5.5 Risk & Compliance
5.6 Suppliers & Materials Management
5.7 Inspection Management
5.8 Document Management
5.9 Change Management
5.10 Training Management
5.11 Other Solution Types
6. Global Pharmaceutical Quality Management Systems Market, by Deployment Mode
6.1. Introduction
6.2. Cloud/Web-based
6.3. On-Premises
7. Global Pharmaceutical Quality Management Systems Market, by End User
7.1. Introduction
7.2. Pharmaceutical, Life Sciences, and Biotechnology Companies
7.3. Contract Research Organizations
7.4 Research Laboratories
8. Pharmaceutical Quality Management Systems Market, by Geography
8.1. Introduction
8.2. North America
8.2.1. U.S.
8.2.2. Canada
8.3. Europe
8.3.1. Germany
8.3.2. France
8.3.3. U.K.
8.3.4. Italy
8.3.5. Spain
8.3.6. Rest of Europe (RoE)
8.4. Asia-Pacific
8.4.1. Japan
8.4.2. China
8.4.3. India
8.4.4. Rest of Asia-Pacific (RoAPAC)
8.5. Latin America
8.5.1. Brazil
8.5.2. Mexico
8.5.3 Rest of Latin America ( RoLATM)
8.6. Middle East & Africa
9. Competitive Landscape
9.1. Introduction
9.2. Key Growth Strategies
9.3. Competitive Benchmarking
9.4. Market Share Analysis (2021)
10. Company Profiles (Business Overview, Financial Snapshot, Product Portfolio, and Strategic Developments)
10.1. ANTARES VISION SpA
10.2. AssurX Inc.
10.3. AXSource
10.4. CLARIVATE PLC
10.5. ComplianceQuest
10.6. Dassault Systemes
10.7. EtQ Management Consultants Inc.
10.8. Honeywell International Inc.
10.9. Ideagen PLC
10.10. IQVIA HOLDINGS INC.
10.11. LogicGate Inc
10.12. MasterControl
11. Appendix
11.1. Questionnaire
11.2. Available Customization
List of Tables
Table 1 Global Pharmaceutical Quality Management Systems Market Drivers: Impact Analysis (2023–2030)
Table 2 Global Pharmaceutical Quality Management Systems Market Restraints: Impact Analysis (2023–2030)
Table 3 Global Pharmaceutical Quality Management Systems Market, by Solution Type, 2021–2030 (USD Million)
Table 4 Global Pharmaceutical Quality Management Systems Market Size for Non-conformance/Deviation management, by Country/Region, 2021–2030 (USD Million)
Table 5 Global Pharmaceutical Quality Management Systems Market Size for CAPA Management, by Country/Region, 2021–2030 (USD Million)
Table 6 Global Pharmaceutical Quality Management Systems Market Size for Audit Management, by Country/Region, 2021–2030 (USD Million)
Table 7 Global Pharmaceutical Quality Management Systems Market Size for Risk & Compliance, by Country/Region, 2021–2030 (USD Million)
Table 8 Global Pharmaceutical Quality Management Systems Market Size for Suppliers & Materials Management, by Country/Region, 2021–2030 (USD Million)
Table 9 Global Pharmaceutical Quality Management Systems Market Size for Inspection Management, by Country/Region, 2021–2030 (USD Million)
Table 10 Global Pharmaceutical Quality Management Systems Market Size for Document Management, by Country/Region, 2021–2030 (USD Million)
Table 11 Global Pharmaceutical Quality Management Systems Market Size for Change Management, by Country/Region, 2021–2030 (USD Million)
Table 12 Global Pharmaceutical Quality Management Systems Market Size for Training Management, by Country/Region, 2021–2030 (USD Million)
Table 13 Global Pharmaceutical Quality Management Systems Market Size for Other Solution Types, by Country/Region, 2021–2030 (USD Million)
Table 14 Global Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021–2030 (USD Million)
Table 15 Global Pharmaceutical Quality Management Systems Market Size for Cloud/Web-based, by Country/Region, 2021–2030 (USD Million)
Table 16 Global Pharmaceutical Quality Management Systems Market Size for On-Premises, by Country/Region, 2021–2030 (USD Million)
Table 17 Global Pharmaceutical Quality Management Systems Market, by End User, 2021–2030 (USD Million)
Table 18 Global Pharmaceutical Quality Management Systems Market Size for Pharmaceutical, Life Sciences, and Biotechnology Companies, by Country/Region, 2021–2030 (USD Million)
Table 19 Global Pharmaceutical Quality Management Systems Market Size for Contract Research Organizations, by Country/Region, 2021–2030 (USD Million)
Table 20 Global Pharmaceutical Quality Management Systems Market Size for Other End Users, by Country/Region, 2021–2030 (USD Million)
Table 21 Global Pharmaceutical Quality Management Systems Market Size, by Country/Region, 2021–2030 (USD Million)
Table 22 North America: Pharmaceutical Quality Management Systems Market Size, by Country/Region, 2021–2030 (USD Million)
Table 23 North America: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 24 North America: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 25 North America: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 26 U.S.: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 27 U.S.: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 28 U.S.: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 29 Canada: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 30 Canada: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 31 Canada: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 32 Europe: Pharmaceutical Quality Management Systems Market Size, by Country /Region, 2021–2030 (USD Million)
Table 33 Europe: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 34 Europe: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 35 Europe: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 36 U.K.: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 37 U.K.: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 38 U.K.: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 39 Germany: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 40 Germany: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 41 Germany: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 42 France: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 43 France: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 44 France: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 45 Italy: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 46 Italy: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 47 Italy: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 48 Spain: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 49 Spain: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 50 Spain: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 51 Rest of Europe: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 52 Rest of Europe: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 53 Rest of Europe: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 54 Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by Country/Region, 2021–2030 (USD Million)
Table 55 Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 56 Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 57 Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 58 China: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 59 China: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 60 China: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 61 Japan: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 62 Japan: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 63 Japan: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 64 India: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 65 India: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 66 India: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 67 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 68 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 69 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 70 Latin America: Pharmaceutical Quality Management Systems Market Size, by Country/Region, 2021–2030 (USD Million)
Table 71 Latin America: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 72 Latin America: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 73 Latin America: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 74 Brazil: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 75 Brazil: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 76 Brazil: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 77 Mexico: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 78 Mexico: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 79 Mexico: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 80 Rest of Latin America: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 81 Rest of Latin America: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 82 Rest of Latin America: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 83 Middle East & Africa: Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2021–2030 (USD Million)
Table 84 Middle East & Africa: Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2021–2030 (USD Million)
Table 85 Middle East & Africa: Pharmaceutical Quality Management Systems Market Size, by End User, 2021–2030 (USD Million)
Table 86 Recent Developments, (2020–2023)
List of Figures
Figure 1 Research Process
Figure 2 Key Secondary Sources
Figure 3 Primary Research Techniques
Figure 4 Key Executives Interviewed
Figure 5 Breakdown of Primary Interviews (Supply-side & Demand-side)
Figure 6 Market Size Estimation
Figure 7 Global Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2023–2030 (USD Million)
Figure 8 Global Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2023–2030 (USD Million)
Figure 9 Global Pharmaceutical Quality Management Systems Market Size, by End User, 2023–2030 (USD Million)
Figure 10 Pharmaceutical Quality Management Systems Market, by Geography
Figure 11 Market Dynamics
Figure 12 Global Pharmaceutical Quality Management Systems Market Size, by Solution Type, 2023–2030 (USD Million)
Figure 13 Global Pharmaceutical Quality Management Systems Market Size, by Deployment Mode, 2023–2030 (USD Million)
Figure 14 Global Pharmaceutical Quality Management Systems Market Size, by End User, 2023–2030 (USD Million)
Figure 15 Global Pharmaceutical Quality Management Systems Market Size, by Geography, 2023–2030 (USD Million)
Figure 16 North America: Pharmaceutical Quality Management Systems Market Snapshot
Figure 17 Europe: Pharmaceutical Quality Management Systems Market Snapshot
Figure 18 Asia-Pacific: Pharmaceutical Quality Management Systems Market Snapshot
Figure 19 Latin America: Pharmaceutical Quality Management Systems Market Snapshot
Figure 20 Competitive Benchmarking: Pharmaceutical Quality Management Systems Market: Based on Products & Services
Figure 21 Competitive Benchmarking: Pharmaceutical Quality Management Systems Market: Based on Geography
Figure 22 Market Share Analysis: Pharmaceutical Quality Management Systems Market, 2021
Figure 23 ANTARES VISION SpA: Financial Overview, 2021
Figure 24 CLARIVATE PLC: Financial Overview, 2021
Figure 25 Dassault Systemes: Financial Overview, 2021
Figure 26 Honeywell International Inc.: Financial Overview, 2021
Figure 27 IQVIA HOLDINGS INC.: Financial Overview, 2021
This report provides pre & post COVID-19 market estimates.
This report provides pre & post COVID-19 market estimates.
Published Date: Feb-2023
