Biopharmaceutical Oral Drug Delivery Market
By Drug Type;
Small Molecules and BiologicsBy Technology;
Nanoparticles, Liposomes, Microencapsulation and OthersBy Application;
Gastrointestinal Diseases, Cardiovascular Diseases, Neurological Disorders, Oncology and OthersBy Distribution Channel;
Hospital Pharmacies, Retail Pharmacies and Online PharmaciesBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa and Latin America - Report Timeline (2021 - 2031)Biopharmaceutical Oral Drug Delivery Market Overview
Biopharmaceutical Oral Drug Delivery Market (USD Million)
Biopharmaceutical Oral Drug Delivery Market was valued at USD 3792.03 million in the year 2024. The size of this market is expected to increase to USD 6541.11 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 8.1%.
Biopharmaceutical Oral Drug Delivery Market
*Market size in USD million
CAGR 8.1 %
| Study Period | 2025 - 2031 | 
|---|---|
| Base Year | 2024 | 
| CAGR (%) | 8.1 % | 
| Market Size (2024) | USD 3792.03 Million | 
| Market Size (2031) | USD 6541.11 Million | 
| Market Concentration | Medium | 
| Report Pages | 364 | 
Major Players
- AbbVie Inc
 - Amgen Inc
 - Catalent Inc
 - Kemwell Bipharma
 - Pfizer Inc
 - Novartis AG
 - Biocon
 - Sanofi
 - F. Hoffman-La Roche Ltd
 - Novo Nordisk A/S
 
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Biopharmaceutical Oral Drug Delivery Market
Fragmented - Highly competitive market without dominant players
The Biopharmaceutical Oral Drug Delivery Market is expanding as companies shift from injections to tablet or capsule-based biologics. With over 50% of biologic programs testing oral platforms, targeted strategies focus on protecting active molecules and ensuring effective systemic delivery. This move is fueling long-term growth in oral therapeutic development and patient convenience.
Innovative Formulation Drives Systemic Uptake
Featuring lipid carriers, enzyme blockers, and nanoparticle encapsulation, more than 54% of new oral biologics now incorporate advanced delivery systems. These technological advancements boost molecule stability, extend release profiles, and improve bioavailability. A surge in innovation is making many oral biologics competitive with injectable counterparts.
Strategic Alliances Foster Market Momentum
Approximately 47% of developers are forming partnerships with platform providers, DMPK labs, and regulatory consultancies. Joined by merger activities, these alliances support seamless oral biologic development and unified go-to-market plans. Collaborative ecosystems are accelerating approval timelines and helping products reach clinics faster.
Modular Platforms Accelerate Candidate Pipeline
Over 53% of companies now deploy modular cartridge-style formulation systems to test multiple biologic candidates rapidly. This expansion capability streamlines oral dosage development by reusing delivery components and adapting to differing drug chemistries. The flexible model supports faster clinical transitions and portfolio scaling.
Biopharmaceutical Oral Drug Delivery Market Key Takeaways
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The Biopharmaceutical Oral Drug Delivery Market is expanding due to advancements in oral biologics formulation and increased focus on patient-centric therapies.
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Innovations in nanocarriers and lipid systems are improving drug bioavailability and stability within the gastrointestinal tract.
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Rising prevalence of chronic diseases has driven adoption of oral biologics as an alternative to injectable delivery systems.
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Collaborations between pharma and biotech companies are accelerating the development of oral peptide and protein drugs.
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Regulatory advancements supporting novel drug delivery platforms are boosting clinical research in non-invasive formulations.
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Growing demand for controlled-release mechanisms enhances patient adherence and treatment efficacy.
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Key players are investing in enzyme inhibitors, absorption enhancers, and polymeric technologies to expand pipeline potential.
 
Biopharmaceutical Oral Drug Delivery Market Recent Developments
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In March 2024, Johnson & Johnson completed the acquisition of Ambrx Biopharma, reinforcing its commitment to advancing prostate cancer therapies. The deal expanded J&J’s pipeline of next-generation antibody-drug conjugates and targeted oncologic therapeutics.
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In June 2023, Merck acquired Prometheus Biosciences, enhancing its research capabilities and strengthening its pipeline with a novel candidate for ulcerative colitis, Crohn’s disease, and other autoimmune conditions. This acquisition reinforces Merck’s position in immunology innovation.
 
Biopharmaceutical Oral Drug Delivery Market Segment Analysis
In this report, the Biopharmaceutical Oral Drug Delivery Market has been segmented by Drug Type, Technology, Application, Distribution Channel and Geography.
Biopharmaceutical Oral Drug Delivery Market, Segmentation by Drug Type
The Biopharmaceutical Oral Drug Delivery Market is divided into Small Molecules and Biologics, each catering to distinct therapeutic and formulation needs. Growing advancements in formulation science and bioavailability enhancement are key drivers supporting the segment growth. Strategic partnerships between pharmaceutical companies and research institutions are enhancing oral delivery innovations and expanding treatment access globally.
Small Molecules
The Small Molecules segment dominates due to its established formulation base, ease of production, and cost-effectiveness. Companies are focusing on controlled-release and targeted drug delivery systems to improve absorption rates and therapeutic efficiency. With rising chronic disease prevalence, this segment is expected to maintain steady growth supported by technological advancements in oral formulation design.
Biologics
The Biologics segment is gaining momentum as oral delivery systems evolve to handle complex molecules. Innovations such as enzyme inhibitors, permeation enhancers, and nanoparticle-based carriers are helping overcome traditional absorption challenges. The segment’s expansion is supported by increasing R&D investments and collaborations aimed at improving patient compliance and reducing injection dependency.
Biopharmaceutical Oral Drug Delivery Market, Segmentation by Technology
This market is classified by Technology into Nanoparticles, Liposomes, Microencapsulation and Others. The adoption of these technologies is accelerating as pharmaceutical firms focus on enhancing drug bioavailability and stability. With nearly 60% of new oral drug delivery research utilizing nanocarrier platforms, the market is witnessing robust technological expansion and integration of advanced formulation tools.
Nanoparticles
Nanoparticles play a critical role in improving drug solubility and absorption efficiency. The technology allows precise targeting and controlled release, resulting in better therapeutic outcomes. Growth is driven by pharmaceutical collaborations focusing on nanocarrier systems, which currently represent around 35% of the R&D expenditure in oral biologics delivery.
Liposomes
Liposomes offer biocompatibility and flexibility in encapsulating both hydrophilic and lipophilic drugs. Their ability to enhance bioavailability and minimize side effects positions them as a key focus in novel oral formulations. Continuous technological improvements and patent expansions by major players are expected to accelerate liposome-based oral drug delivery over the forecast period.
Microencapsulation
Microencapsulation technology ensures sustained drug release and protection from degradation in the gastrointestinal environment. It is widely adopted for controlled-release formulations across multiple therapeutic areas. The growing use of polymer coatings and biodegradable materials in encapsulation is fostering innovation and long-term market expansion.
Others
The Others category includes polymeric micelles, dendrimers, and emulsions, which are emerging as alternative delivery methods. These systems aim to improve targeted delivery and enhance absorption of large-molecule drugs. Ongoing R&D and strategic investments by biotech startups are expected to strengthen this segment’s contribution to the market.
Biopharmaceutical Oral Drug Delivery Market, Segmentation by Application
The market applications include Gastrointestinal Diseases, Cardiovascular Diseases, Neurological Disorders, Oncology and Others. Rising prevalence of chronic and lifestyle-related disorders continues to fuel market expansion, with biopharmaceutical firms focusing on patient-centric oral solutions to improve therapeutic efficiency and compliance.
Gastrointestinal Diseases
The Gastrointestinal Diseases segment leads due to the compatibility of oral formulations with local drug action. Efforts in developing stable peptide-based oral therapies are driving strong research collaboration. The introduction of pH-sensitive coatings and targeted-release formulations is improving drug efficacy and market penetration.
Cardiovascular Diseases
In the Cardiovascular Diseases segment, oral drug delivery is preferred for its convenience and long-term treatment potential. Companies are leveraging controlled-release systems to enhance bioavailability and minimize dosing frequency. With over 40% of cardiovascular therapies relying on oral forms, strategic R&D and regulatory approvals continue to shape market competitiveness.
Neurological Disorders
The Neurological Disorders segment benefits from ongoing innovation in oral drug transport across the blood-brain barrier. Advanced formulation strategies, such as lipophilic modification and nanocarrier integration, are enhancing absorption and therapeutic consistency. Partnerships between pharmaceutical firms and neuroscience research bodies are accelerating growth in this segment.
Oncology
The Oncology application area is witnessing rapid adoption of oral delivery systems, driven by demand for targeted therapy and home-based treatment. Oral formulations are gaining preference for their patient convenience and reduced hospital visits. Rising investment in cancer-specific nanoparticle formulations is expected to boost future segment growth.
Others
The Others segment covers infectious, metabolic, and autoimmune diseases treated with advanced oral delivery methods. Increasing R&D in peptide and protein oral delivery is contributing to market diversification. New formulation techniques are extending the reach of oral delivery systems to previously injection-only therapies.
Biopharmaceutical Oral Drug Delivery Market, Segmentation by Distribution Channel
The market is distributed through Hospital Pharmacies, Retail Pharmacies and Online Pharmacies. The growing adoption of e-pharmacy platforms and digital healthcare solutions is transforming the distribution landscape. Enhanced accessibility and global expansion strategies are supporting higher market penetration across regions.
Hospital Pharmacies
Hospital Pharmacies hold a significant share due to the clinical administration of high-value biologic therapies. Hospitals are adopting digital inventory management systems to streamline drug distribution. Strategic collaborations with pharmaceutical firms are ensuring stable supply chains for critical therapies.
Retail Pharmacies
Retail Pharmacies remain key intermediaries, serving a large outpatient population with chronic and lifestyle disorders. Expansion of franchise networks and strong brand partnerships contribute to their dominance. The focus on personalized medicine and improved consumer engagement enhances the competitive position of retail outlets.
Online Pharmacies
The Online Pharmacies segment is growing rapidly, supported by increased digital adoption and home delivery demand. Approximately 25% of consumers prefer ordering chronic medications online, indicating a significant behavioral shift. Strategic e-commerce integrations and policy support are fueling long-term expansion in this distribution model.
Biopharmaceutical Oral Drug Delivery Market, Segmentation by Geography
In this report, the Biopharmaceutical Oral Drug Delivery Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
North America
North America leads the market, driven by advanced R&D infrastructure, high healthcare expenditure, and strong regulatory support. Major players in the U.S. are leveraging partnerships to expand oral biologics development. The presence of global pharmaceutical headquarters continues to strengthen the region’s innovation capacity and market leadership.
Europe
Europe maintains a significant share supported by well-established healthcare systems and rising demand for personalized oral treatments. Regulatory harmonization and research collaborations are fueling new drug formulation approvals. The increasing adoption of nanotechnology-based oral systems underpins regional growth.
Asia Pacific
Asia Pacific is projected to exhibit the fastest growth due to expanding manufacturing capabilities and favorable government incentives. The rise of contract development and manufacturing organizations (CDMOs) is enabling regional market expansion. Countries such as China and India are becoming major contributors to oral drug delivery innovation.
Middle East & Africa
The Middle East & Africa region is witnessing gradual growth, driven by improving healthcare infrastructure and increasing biopharmaceutical imports. Ongoing collaborations with multinational companies are enhancing distribution networks and product availability. Investments in localized production are expected to improve market penetration over the coming years.
Latin America
Latin America continues to develop through expanding pharmaceutical retail channels and digital healthcare adoption. Strategic alliances and local manufacturing initiatives are improving accessibility to advanced oral therapies. Economic reforms and supportive regulatory policies are set to strengthen the region’s long-term growth prospects.
Biopharmaceutical Oral Drug Delivery Market Forces
This report provides an in depth analysis of various factors that impact the dynamics of Biopharmaceutical Oral Drug Delivery Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces Drivers, Restraints, and Opportunities affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
| Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential | 
|---|---|---|---|---|---|
| Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development | 
| Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance | 
| Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances | 
Drivers, Restraints and Opportunity Analysis
Drivers
- Rising Chronic Diseases
 - Patient Preference for Oral Delivery
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Increasing R&D Investments - Increasing R&D investments drive innovation and propel advancements in the Global Biopharmaceutical Oral Drug Delivery Market. Pharmaceutical companies, research institutions, and investors allocate substantial resources towards developing novel drug delivery technologies, enhancing formulation techniques, and optimizing therapeutic outcomes. These investments fuel a continuous cycle of research, experimentation, and discovery, fostering the evolution of oral drug delivery systems from traditional formulations to sophisticated, targeted solutions.
Heightened R&D investments stimulate collaborative efforts among interdisciplinary teams, leveraging expertise from fields such as pharmacology, material science, and biotechnology. By fostering cross-disciplinary collaborations, researchers can overcome complex challenges, accelerate product development timelines, and bring innovative oral drug delivery solutions to market more efficiently. Furthermore, partnerships between academia, industry, and government agencies facilitate knowledge exchange, technology transfer, and funding opportunities, fostering a fertile environment for groundbreaking discoveries and transformative advancements in drug delivery science.
Increasing R&D investments enable exploration into emerging technologies and platforms, including nanotechnology, microfluidics, and 3D printing, among others. These cutting-edge approaches offer unprecedented opportunities to enhance drug bioavailability, target specific tissues or cells, and overcome physiological barriers within the body. By harnessing the power of innovative technologies, researchers can unlock new possibilities in oral drug delivery, paving the way for personalized medicine, precision therapies, and tailored treatment regimens that address individual patient needs more effectively. As R&D investments continue to rise, the future of biopharmaceutical oral drug delivery holds immense promise, ushering in an era of transformative innovation and improved healthcare outcomes.
 
Restraints
- Formulation Complexity
 - Patent Expirations
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High Development Costs - High development costs pose a significant challenge in the Global Biopharmaceutical Oral Drug Delivery Market, impacting the feasibility and scalability of bringing innovative products to market. From early-stage research and preclinical studies to clinical trials and regulatory approvals, the drug development process entails substantial investments of time, resources, and capital. These costs encompass various aspects, including formulation development, laboratory testing, manufacturing scale-up, clinical trial expenses, regulatory compliance, and marketing efforts, among others.
The complexity and uncertainty inherent in drug development contribute to escalating costs, as researchers navigate regulatory requirements, address safety concerns, and demonstrate therapeutic efficacy through rigorous testing protocols. Additionally, the risk of clinical trial failures, regulatory setbacks, or patent disputes further exacerbates the financial burden on pharmaceutical companies and investors, leading to increased development costs and prolonged timelines. As a result, high development costs pose a barrier to entry for smaller biopharmaceutical firms and startups, limiting their ability to innovate and compete in the market.
The rising cost of healthcare and pressure to demonstrate cost-effectiveness further heighten the financial challenges associated with drug development. Pharmaceutical companies face mounting pressure to demonstrate the value proposition of new oral drug delivery technologies, justify pricing decisions, and navigate reimbursement hurdles in an increasingly cost-conscious healthcare landscape. Consequently, the high development costs necessitate strategic allocation of resources, risk mitigation strategies, and collaborative partnerships to enhance efficiency, optimize investment returns, and ensure sustainable innovation in the biopharmaceutical oral drug delivery market.
 
Opportunities
- Personalized Medicine Trends
 - Targeted Drug Delivery Systems
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Biomaterial Innovations - Biomaterial innovations are driving transformative advancements in the Global Biopharmaceutical Oral Drug Delivery Market, revolutionizing how medications are formulated, delivered, and absorbed within the body. Biomaterials, derived from natural or synthetic sources, offer unique properties such as biocompatibility, biodegradability, and tunable functionality, making them ideal candidates for designing novel drug delivery systems. From polymer-based carriers to lipid nanoparticles and hydrogels, biomaterials serve as versatile platforms for encapsulating, protecting, and delivering therapeutic agents to target tissues or cells with precision and efficacy.
These biomaterial innovations enable the development of controlled-release formulations, allowing for sustained drug release over extended periods, thereby optimizing therapeutic efficacy and patient compliance. By leveraging biodegradable polymers, researchers can design implantable or injectable drug delivery systems capable of releasing medications at a controlled rate, minimizing dosing frequency and reducing adverse effects. Moreover, biomaterial-based formulations offer the potential for targeted drug delivery, enabling site-specific delivery to diseased tissues while sparing healthy cells, thereby enhancing therapeutic outcomes and minimizing systemic toxicity.
Biomaterial innovations facilitate the development of multifunctional drug delivery platforms, integrating diagnostic, imaging, or therapeutic functionalities within a single formulation. By incorporating contrast agents, imaging probes, or therapeutic payloads into biomaterial carriers, researchers can create theranostic systems capable of simultaneous diagnosis and treatment of diseases. These multifunctional platforms hold promise for personalized medicine, enabling real-time monitoring of drug distribution, therapeutic response, and disease progression, thereby empowering clinicians to tailor treatment regimens to individual patient needs more effectively.
As biomaterial innovations continue to evolve, fueled by advancements in nanotechnology, materials science, and biotechnology, the future of biopharmaceutical oral drug delivery holds immense promise. These groundbreaking technologies offer new avenues for enhancing drug bioavailability, targeting specific tissues or cells, and overcoming biological barriers within the body, ultimately driving improvements in patient outcomes and revolutionizing healthcare delivery on a global scale.
 
Biopharmaceutical Oral Drug Delivery Market Competitive Landscape Analysis
Biopharmaceutical Oral Drug Delivery Market is advancing steadily as companies focus on innovation, improved bioavailability, and targeted delivery strategies. Over 70% of key players are investing in nanotechnology and polymer-based systems. Strong collaboration between pharmaceutical firms, research institutions, and formulation developers is driving consistent growth and treatment efficiency advancements.
Market Structure and Concentration
The market exhibits moderate concentration, with nearly 60% of total output controlled by established biopharmaceutical manufacturers. These firms pursue mergers and partnerships to expand formulation capabilities and enhance distribution networks. Mid-sized enterprises are contributing to growth through specialized innovation in controlled and sustained drug release systems.
Brand and Channel Strategies
Leading players are adopting integrated strategies to strengthen brand recognition and streamline market access. Around 55% of manufacturers rely on strategic partnerships with contract research organizations and retail distributors. Robust collaboration and digital marketing approaches are supporting growth by ensuring wider therapeutic adoption across diverse patient segments.
Innovation Drivers and Technological Advancements
Rapid technological advancements in nanocarriers, lipid-based systems, and bioadhesive materials are redefining the drug delivery landscape. Over 75% of industry participants focus on precision innovation to improve stability and absorption rates. These advancements enhance growth prospects by ensuring effective delivery of biologics and peptides through oral administration.
Regional Momentum and Expansion
Regional expansion is accelerating, with nearly 65% of development activity concentrated in North America, Europe, and Asia-Pacific. Companies employ strategies to align with evolving regulatory frameworks and manufacturing standards. Enhanced collaboration between local and international firms is stimulating growth through technology transfer and production scaling efforts.
Future Outlook
The future outlook for the market emphasizes personalized medicine, formulation innovation, and global R&D collaboration. Over 70% of companies plan to expand biocompatible excipient research and next-generation oral biologics. Continuous growth will be supported by advancements in predictive modeling and targeted delivery strategies for complex therapeutic molecules.
Key players in Biopharmaceutical Oral Drug Delivery Market include:
- Pfizer Inc.
 - Novartis AG
 - Sanofi S.A.
 - AbbVie Inc.
 - Amgen Inc.
 - F. Hoffmann-La Roche Ltd.
 - Novo Nordisk A/S
 - Catalent Inc.
 - Biocon Ltd.
 - Kemwell Bipharma
 - Johnson & Johnson
 - Merck & Co., Inc.
 - GlaxoSmithKline plc
 - AstraZeneca plc
 - Eli Lilly and Company
 
In this report, the profile of each market player provides following information:
- Market Share Analysis
 - Company Overview and Product Portfolio
 - Key Developments
 - Financial Overview
 - Strategies
 - Company SWOT Analysis
 
- Introduction 
- Research Objectives and Assumptions
 - Research Methodology
 - Abbreviations
 
 - Market Definition & Study Scope
 - Executive Summary 
- Market Snapshot, By Drug Type
 - Market Snapshot, By Technology
 - Market Snapshot, By Application
 - Market Snapshot, By Distribution Channel
 - Market Snapshot, By Region
 
 - Biopharmaceutical Oral Drug Delivery Market Dynamics 
- Drivers, Restraints and Opportunities 
- Drivers 
- Rising Chronic Diseases
 - Patient Preference for Oral Delivery
 - Increasing R&D Investments
 
 - Restraints 
- Formulation Complexity
 - Patent Expirations
 - High Development Costs
 
 - Opportunities 
- Personalized Medicine Trends
 - Targeted Drug Delivery Systems
 - Biomaterial Innovations
 
 
 - Drivers 
 - PEST Analysis 
- Political Analysis
 - Economic Analysis
 - Social Analysis
 - Technological Analysis
 
 - Porter's Analysis 
- Bargaining Power of Suppliers
 - Bargaining Power of Buyers
 - Threat of Substitutes
 - Threat of New Entrants
 - Competitive Rivalry
 
 
 - Drivers, Restraints and Opportunities 
 - Market Segmentation 
- Biopharmaceutical Oral Drug Delivery Market, By Drug Type, 2021 - 2031 (USD Million) 
- Small Molecules
 - Biologics
 
 - Biopharmaceutical Oral Drug Delivery Market, By Technology, 2021 - 2031 (USD Million) 
- Nanoparticles
 - Liposomes
 - Microencapsulation
 - Others
 
 - Biopharmaceutical Oral Drug Delivery Market, By Application, 2021 - 2031 (USD Million) 
- Gastrointestinal Diseases
 - Cardiovascular Diseases
 - Neurological Disorders
 - Oncology
 - Others
 
 - Biopharmaceutical Oral Drug Delivery Market, By Distribution Channel, 2021 - 2031 (USD Million) 
- Hospital Pharmacies
 - Retail Pharmacies
 - Online Pharmacies
 
 - Biopharmaceutical Oral Drug Delivery Market, By Geography, 2021 - 2031 (USD Million) 
- North America 
- United States
 - Canada
 
 - Europe 
- Germany
 - United Kingdom
 - France
 - Italy
 - Spain
 - Nordic
 - Benelux
 - Rest of Europe
 
 - Asia Pacific 
- Japan
 - China
 - India
 - Australia & New Zealand
 - South Korea
 - ASEAN (Association of South East Asian Countries)
 - Rest of Asia Pacific
 
 - Middle East & Africa 
- GCC
 - Israel
 - South Africa
 - Rest of Middle East & Africa
 
 - Latin America 
- Brazil
 - Mexico
 - Argentina
 - Rest of Latin America
 
 
 - North America 
 
 - Biopharmaceutical Oral Drug Delivery Market, By Drug Type, 2021 - 2031 (USD Million) 
 - Competitive Landscape 
- Company Profiles 
- Pfizer Inc.
 - Novartis AG
 - Sanofi S.A.
 - AbbVie Inc.
 - Amgen Inc.
 - F. Hoffmann-La Roche Ltd.
 - Novo Nordisk A/S
 - Catalent Inc.
 - Biocon Ltd.
 - Kemwell Bipharma
 - Johnson & Johnson
 - Merck & Co., Inc.
 - GlaxoSmithKline plc
 - AstraZeneca plc
 - Eli Lilly and Company
 
 
 - Company Profiles 
 - Analyst Views
 - Future Outlook of the Market
 

