Published Year: 2023
Global Pharmaceutical Excipients Market: Focus on Application, Formulation, Functionality, Product,
The global pharmaceutical excipients market is witnessing robust growth due to the increasing...
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Global Pharmaceutical Dissolution Market Industry Overview
Introduction of Pharmaceutical Dissolution
Pharmaceutical dissolution is the process in which a drug, typically in the form of a tablet, capsule, or powder, dissolves in a liquid, usually a simulated bodily fluid, to release its active pharmaceutical ingredient (API). This process is vital for understanding how a drug functions within the body, as it influences the drug's bioavailability and how quickly and to what extent the active ingredient is absorbed into the bloodstream. Dissolution testing plays a critical role in pharmaceutical development and quality assurance, ensuring that the drug formulation is safe, effective, and consistent when used by patients. It is essential for evaluating and refining oral dosage forms and providing necessary data for drug approval and regulatory compliance.
Market Introduction
The global pharmaceutical dissolution market is expected to witness significant expansion, projected to reach $1,311.2 million by 2035.
The pharmaceutical dissolution market plays a key role in drug development, formulation, and ensuring quality. As regulatory requirements increase, technological innovations advance, and there is a greater emphasis on enhancing patient outcomes, the market is set for significant growth and evolution in the coming years. Pharmaceutical dissolution refers to the process by which a drug dissolves in a solvent, typically water or gastric fluids, allowing it to be absorbed into the bloodstream. This is a crucial phase in the pharmacokinetics of oral medications as it determines the rate and extent to which the active pharmaceutical ingredient (API) becomes available for absorption. The dissolution rate of a drug affects its bioavailability, therapeutic effectiveness, and overall clinical performance. In pharmaceutical product development, dissolution testing is a standardized method used to assess the release of drugs from dosage forms like tablets, capsules, or suspensions. Regulatory agencies, such as the FDA, require this testing to ensure that drug products consistently perform as intended, maintaining quality and safety standards.
The pharmaceutical dissolution ecosystem is undergoing rapid innovation, driven by technological advancements, regulatory demands, and evolving drug development strategies. As dissolution testing continues to evolve with the integration of automation, AI, and real-time monitoring, it is poised to play an even more critical role in ensuring the success of pharmaceutical products in the global market. Analysts are increasingly recognizing dissolution testing not just as a regulatory requirement, but as a vital component of the drug development pipeline, helping to ensure both the efficacy and safety of new medications while supporting the ongoing shift toward more personalized and complex therapies.
Pharmaceutical dissolution ecosystem is multi-faceted in nature and involves various stakeholders that are involved in contributing towards market growth:
Product Manufacturers: At the heart of the dissolution testing market, pharmaceutical companies generate demand for testing services and equipment. They play a crucial role in carrying out dissolution testing throughout the stages of drug development, manufacturing, and quality assurance. For instance, Agilent Technologies, Inc. is at the forefront of driving the pharmaceutical dissolution market with expanding its dissolution business.
Service Providers: Contract Research Organizations (CROs) offer testing and research services to pharmaceutical companies, including dissolution testing. They are especially valuable for companies that lack the in-house expertise or resources to perform this specialized work.
Regulatory Authorities: Regulatory bodies such as the US FDA, EMA, and other national and international regulatory authority are involved in setting the regulatory standards and guidelines for pharmaceutical dissolution testing, certifying that dissolution testing products are under compliance.
Industrial Impact
The pharmaceutical industry's impact on various sectors is vast and multifaceted, affecting public health, economics, employment, and technological innovation.
Impact: Dissolution testing is crucial for ensuring the quality and consistency of pharmaceutical products. It helps verify that a drug’s active pharmaceutical ingredient (API) is released at the correct rate and in the appropriate quantity, as expected under specific conditions. This is essential for ensuring that the drug performs consistently across different batches. Any variability in dissolution rates could lead to inconsistent drug efficacy, which could impact patient safety. Thus, dissolution testing forms a core part of quality control in pharmaceutical manufacturing, ensuring that products meet strict regulatory standards.
Regulatory bodies such as the FDA, EMA, and WHO have established strict dissolution testing protocols to ensure that drugs meet safety and performance criteria before being marketed. Pharmaceutical companies must demonstrate that their products dissolve appropriately for the API to be absorbed in the body, and this must be proven in dissolution testing. This is particularly important for oral solid dosage forms like tablets and capsules, where the dissolution profile directly affects bioavailability. For example, in the U.S., the FDA’s guidance on dissolution testing for immediate-release and extended-release formulations ensures that pharmaceutical companies adhere to scientifically validated methods to assess how the drug is released in a simulated biological environment.
Market Segmentation:
Segmentation 1: By Type
• Product
o Dissolution System
o Dissolution Accessories
• Services
Product type remains the leading segment by type in the global pharmaceutical dissolution market, holding an 63.43% market share in 2024, with a projected CAGR of 8.57% during the forecast period 2024-2033.
The dominance of products i.e. dissolution systems and their accessories in the pharmaceutical market is primarily driven by their critical role in ensuring drug quality, patient safety, and regulatory compliance. With ongoing advancements in technology, precision, and sustainability, these products continue to meet the evolving needs of pharmaceutical development, manufacturing, and global market dynamics. The continuous focus on quality assurance, therapeutic efficacy, cost-effectiveness, and regulatory standards ensures that dissolution systems will remain a cornerstone of the pharmaceutical industry for the foreseeable future.
Segmentation 2: By End User
• Pharmaceutical and Biotechnology Companies
• CROs
• Academic Institutions
Based on end user, pharmaceutical and biotechnology companies is dominating the pharmaceutical dissolution market, which accounted for 48.57% of the global market. Pharmaceutical and biotechnology companies engaged in dissolution testing focus on developing, producing, and marketing drug products that dissolve at the proper rate, ensuring the controlled and consistent release of active pharmaceutical ingredients (APIs). This testing is essential during the development of new drug formulations and plays a vital role in quality control within pharmaceutical manufacturing. is essential during the development of new drug formulations and plays a vital role in quality control within pharmaceutical manufacturing.
Segmentation 3: By Region
• North America
o U.S.
o Canada
• Europe
o Germany
o U.K.
o France
o Italy
o Spain
o Rest-of-Europe
• Asia-Pacific
o Japan
o India
o China
o Rest-of-Asia-Pacific
• Latin America
• MEA
North America dominates the global pharmaceutical dissolution market, holding the largest market share. This growth has been driven by significant advancements in drug formulations, increased regulatory scrutiny, and the growing adoption of dissolution testing in pharmaceutical research and development (R&D) as well as manufacturing processes. The region is highly competitive, with a mix of international and regional players offering a wide range of products and services. Prominent market players include Agilent Technologies, SOTAX, Distek, Inc., and Catalent Inc., among others.
The U.S. pharmaceutical dissolution market has been experiencing robust growth, fueled by several key factors, including the rising demand for generic drugs, stringent regulatory standards, technological innovations, the increasing complexity of drug formulations, and the growing trend of outsourcing. Together, these elements highlight the essential role that dissolution testing plays in ensuring pharmaceutical products' safety, efficacy, and regulatory compliance as companies address an evolving and increasingly complex regulatory environment
The pharmaceutical dissolution market in the Asia-Pacific region has been witnessing continuous growth owing to the rising demand for pharmaceutical products and stringent regulatory standards. Despite several challenges in the pharmaceutical dissolution market in Asian countries, such as regulatory complexity, infrastructure gaps, and a shortage of workforce, the market is advancing due to technological advancements, the rise of generics, and increased focus on quality control. As pharmaceutical manufacturing continues to expand in the region, the need for accurate and efficient dissolution testing will be critical in ensuring the safety and efficacy of oral medications.
Recent Developments in the Pharmaceutical Dissolution Market
• In May 2024, Logan Instrument launched the “EPVT-1200 system” for USP apparatus 1 and 2 performance validation tests, focused on revolutionizing dissolution testers' validation process. This innovative digital toolset performs and records dissolution validation performance electronically, thereby eliminating the uncertainties associated with manual recording methods.
• In August 2024, Logan Instruments Corp. unveiled its newest innovation, the Microsphere Release Testing System. This groundbreaking product is designed to transform the testing and development processes for microsphere dosage forms, meeting the increasing demand for advanced drug delivery solutions.
Demand –Drivers, Challenges, and Opportunities
Market Demand Drivers:
• Expanding Pharmaceutical Manufacturing Facilities Leading to Increased Demand for Dissolution Testing
Dissolution testing is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. As manufacturing facilities expand and increase production to meet the growing global demand, particularly in emerging markets, the need to evaluate the dissolution properties of oral solid dosage forms such as tablets and capsules becomes pronounced. Additionally, dissolution testing is crucial for ensuring that drugs comply with regulatory standards and perform as intended, leading to heightened demand for testing infrastructure within expanding manufacturing facilities.
Major juggernauts in the pharmaceutical industry are involved in opening new facilities to aid R&D activities and growing their manufacturing footprint. For instance, in April 2024, Thermo Fisher Scientific opened a new sterile drug production facility in Singapore to aid in the research, development, and manufacturing of medicines and vaccines for the Asia-Pacific market. This cGMP-compliant facility is expected to provide vaccine fill-finish services, enhancing companies' existing pharmaceutical development and production capabilities.
Dissolution testing is an essential component of pharmaceutical manufacturing, used to evaluate the rate at which active pharmaceutical ingredients (APIs) are released from tablets, capsules, or other solid dosage forms into a solution. This process is crucial for determining bioavailability and ensuring the therapeutic effectiveness of the medication.
Some of the other factors creating an drivers for market growth include:
• Integration of Personalized Medicine in Pharmaceutical Dissolution Market
Note: All of the above factors will be evaluated in detail in the report.
Market Restraints:
• Entry Barrier for New Entrants in Pharmaceutical Dissolution Market
Capital Requirement: Establishing manufacturing and testing facilities equipped for dissolution testing requires significant capital investment. For instance, for a small to mid-sized laboratory performing pharmaceutical dissolution testing, an approximate initial capital investment ranges from $50,000 to $200,000 for basic setups, and costs can increase to $500,000 or more for automated, high-throughput systems with integrated analysis tools. Such high capital requirements are unaffordable for small or mid-sized companies in the pharmaceutical dissolution market. Furthermore, the expenses involved in sourcing high-quality raw materials and developing a skilled workforce add to the financial burden.
Established Competition from Major Players: The pharmaceutical dissolution market is a competitive market such as Agilent Technologies, Inc., Distek, Inc., Sotax, Catalent, and Charles River Laboratories. The market is largely controlled by established companies with strong brand recognition, a broad customer base, and a comprehensive range of products and services. Challenging these dominant players is difficult, as new entrants must find ways to distinguish themselves through innovation, higher quality, or better cost-efficiency to capture market share.
Note: All of the above factors will be evaluated in detail in the report.
Market Opportunities: Rising Implementation of AI And ML for Pharmaceutical Dissolution
Artificial intelligence (AI) and machine learning (ML) are transforming pharmaceutical development by improving efficiency, accuracy, and predictive capabilities across multiple stages, including dissolution testing. These cutting-edge technologies are progressively being incorporated into pharmaceutical research and development (R&D) to enhance drug formulation, streamline testing procedures, and more accurately forecast in vivo behavior.
AI can assess the interactions between formulate and drug components (such as excipients and active pharmaceutical ingredients) and their impact on dissolution rates. This capability enables the optimization of drug formulations to achieve the desired dissolution properties. Machine learning models can determine the optimal combination of ingredients and processing parameters to enhance drug release rates, thereby improving both the drug's efficacy and stability.
Furthermore, AI and ML are transforming drug manufacturing by enhancing process optimization, predictive maintenance, and quality control. AI-powered algorithms can analyze large datasets and uncover patterns that might be overlooked by humans, leading to improved efficiency and cost reductions.
Some of the other factors creating an opportunity for market growth include:
• Shift towards more sophisticated pharmaceutical dissolution testing
Note: All of the above factors will be evaluated in detail in the report.
Market Trends:
• Technological Advancements in Dissolution Testing Apparatus
Recent innovations in dissolution testing equipment, including automation, high-throughput systems, and real-time monitoring, are significantly improving the efficiency, precision, and reliability of testing processes. These advancements enable faster and more accurate measurement of drug release profiles, which is essential for both product development and regulatory compliance. Automation streamlines the testing process, reducing the risk of human error and increasing throughput, while high-throughput systems lead to simultaneous testing of multiple samples, speeding up the overall evaluation process. Moreover, real-time monitoring provides on-line data, offering deeper insights into the dissolution process and allowing for immediate adjustments if required.
These technological developments are transforming the landscape of dissolution testing by making it more efficient and cost-effective, ultimately profiting both pharmaceutical companies and regulatory agencies. As a result, there is a growing demand for suppliers of cutting-edge dissolution testing equipment and related technologies. Companies that offer advanced dissolution apparatus, software solutions, and integration services stand to capitalize on this trend, catering to the increasing need for faster, more accurate, and automated testing systems in the pharmaceutical industry.
Analyst’s Thoughts
According to Revti Bhaskar, Lead Analyst – BIS Research, the pharmaceutical dissolution market is a critical process in drug development and manufacturing, acting as a pivotal determinant of a drug's bioavailability and therapeutic effectiveness. The dissolution rate of a drug—how quickly and efficiently the active pharmaceutical ingredient (API) dissolves in the body—directly influences how effectively the drug can be absorbed into the bloodstream and achieve its intended therapeutic effect. The importance of dissolution testing has only grown as the pharmaceutical industry focuses on developing more complex formulations, including modified-release, biologics, and personalized medicine. For analysts, the role of dissolution testing is increasingly recognized as a multifaceted tool that not only ensures regulatory compliance but also helps optimize drug formulations to maximize patient outcomes. In recent years, analysts have noted a growing trend toward automation and real-time monitoring within dissolution testing systems. These advancements are pushing the boundaries of traditional manual testing, offering higher precision, speed, and reproducibility. The integration of artificial intelligence (AI) and machine learning (ML) into dissolution testing is another significant development, allowing pharmaceutical companies to analyze vast datasets to predict dissolution behaviors more accurately and efficiently. AI models can now identify patterns that may be missed by human analysts, enabling faster decisions on formulation adjustments and reducing the time it takes to bring a drug to market. These technologies are particularly beneficial in high-throughput screening, which is crucial for testing a large number of formulations in early-stage drug development.
Additionally, the increasing focus on personalized medicine and novel drug delivery systems, such as nanomedicines and biologics, has led to more sophisticated dissolution testing approaches. Traditional dissolution methods may not be sufficient to assess the unique characteristics of these new formulations, prompting the development of new testing methodologies and tools. For example, dissolution systems now need to simulate physiological conditions more accurately, including various pH levels, ionic strengths, and flow rates, to mimic the complex environment of the human gastrointestinal tract. Analysts are keenly aware that as the complexity of drug formulations grows, dissolution testing must evolve accordingly to ensure these new drug types perform as expected in vivo.
Pharmaceutical Dissolution Market - A Global and Regional Analysis
Focus on Type, End User, and Region - Analysis and Forecast, 2024-2033
Some Faq's
Frequently Asked Questions
Pharmaceutical dissolution refers to the process by which a drug's active pharmaceutical ingredient (API) dissolves in a solvent, typically water or simulated gastric fluid, to become available for absorption into the bloodstream. This is a critical aspect of the pharmacokinetic profile of oral medications, particularly for solid dosage forms like tablets and capsules. The dissolution rate of a drug determines how quickly and efficiently the active ingredient is released into the body, which in turn influences its bioavailability, therapeutic effect, and overall clinical efficacy.
To strengthen their position in the pharmaceutical dissolution testing market, existing players are embracing a variety of innovative strategies. One of the key approaches is the integration of advanced technologies, such as automation, artificial intelligence (AI), and data analytics. These technologies enhance the efficiency, accuracy, and throughput of dissolution testing, enabling companies to handle large volumes of samples while minimizing human error. Additionally, customization of testing protocols has become increasingly important, especially as drug formulations become more complex. Providers are now offering tailored dissolution testing services for specialized formulations, such as long-acting injectables, nanoparticles, and biologics, ensuring that the unique characteristics of each formulation are accurately assessed.
The following are the USPs of this report:
• Market regulations and key trends in the pharmaceutical dissolution market
• Dynamic analysis of the opportunities, trends, and challenges in the market
This report is essential for healthcare providers, pharma companies, research institutes, hospitals, CROS.
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