Growth Opportunities in the Oral Solid Dosage Formulation Industry

HealthcareGrowth Opportunities in the Oral Solid Dosage Formulation Industry

Personalized Medicine and Drug Delivery Technologies Enhance Future Growth Potential

RELEASE DATE
09-Apr-2024
REGION
North America
Deliverable Type
Market Research
Research Code: PFI7-01-00-00-00
SKU: HC_2024_658
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HC_2024_658

Growth Opportunities in the Oral Solid Dosage Formulation Industry
Published on: 09-Apr-2024 | SKU: HC_2024_658

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This analysis provides an overview and advancements in the oral solid dosage formulation industry, including an evaluation of the current industry scenario, competitive landscape, and regulatory landscape. The scope of the analysis is global, focusing on North America (NA), Europe, Asia-Pacific (APAC), the Middle East, and Latin America (LATAM). It identifies the most prevalent and emerging business models supporting industry stakeholders in enhancing their competitiveness and service offerings. Discussions on key industry drivers and restraints, partnerships, investment and consolidation activities, disruptive technologies, recent excipient advancements, and present and future trends shed light on the industry’s growth potential. Industry use cases will provide brief insights into game-changing participants working toward developing disruptive technologies and patient-centric drugs. The analysis will also help uncover growth opportunities based on megatrends and business models, clinical needs, use cases, market access strategies, and technology trends.

The Impact of the Top 3 Strategic Imperatives on the Oral Solid Dosage Formulation Industry

Innovative Business Models

  • Why: The pharmaceutical oral solid dosage (OSD) industry is building manufacturing capability and capacity. Emerging and virtual pharma companies seek one-stop-shop solutions to expedite drug development. The trend requires OSD contract development and manufacturing organizations (CDMOs) to possess expertise, agility, and infrastructure to meet their specialized needs.
  • Frost Perspective: In the short to mid-term, OSD manufacturers will focus on vertical and horizontal integration and enhance capabilities for complex and highly potent formulations. CDMOs will expand agreements with clients on new modalities and geographic expansion.
  • Manufacturing automation by CDMOs will attract more outsourcing contracts to drive sustainability and cost-optimization for clients. In the next 5 years, partnerships-based growth strategies will propel analytical technologies, and formulation strategies for new modalities and compounds.

Disruptive Technologies

  • Why: With more drug formulators facing drug solubility challenges, introducing technologies that improve the drug products' solubility and bioavailability is an urgent need. Rising demand for improving medication adherence, lowering chronically ill patients' pill burden, and drug delivery innovation for administering next-generation therapies (e.g., microbiome-based drugs) is driving technological innovations.
  • Frost Perspective: Drug performance optimization, patient compliance, and brand differentiation will be key themes in the next 5 years. OSD manufacturers will provide delivery platforms for targeted drug administration, using novel coating technologies.
  • Focus on patient-centered formulations will heighten demand for new dosage forms that aid in bioavailability and extended release formulations for extended acting and fixed dose combination products. CDMOs will actively engage in new OSD formulation for API release profiles, creating product differentiation.

Transformative Megatrends

  • Why: The growing disease burden and aging population globally are anticipated to drive the continuous demand for effective oral solid dosage medications.
  • Government policies that target chronic illnesses, oncology, CNS, and rare diseases with innovative treatments resulting from financial and policy incentives and accelerated drug approvals will support the megatrend of personalized drugs in the industry.
  • Frost Perspective: Targeted therapeutics will increase in the next 4 to 5 years. Manufacturers will develop cost-effective oral solids with improved bioavailability, solubility, and ease of administration for aging, pediatric, and dysphagic patients.
  • Utilization of advanced manufacturing technologies will rise. For example, the usage of 3D printing in manufacturing for adaptive clinical trials for rare diseases/oncology.
  • CDMOs and manufacturers will increasingly implement continuous "powder-to-tablet" manufacturing to bolster sustainability, resource optimization, and sustainability.

 

Industry Definition and Segmentation

Industry Definition

  • The OSD formulation industry comprises the pharmaceutical sector (e.g., pharma companies and third-party vendors of pharmaceutical development and manufacturing) that produces Small Molecule Drugs in Solid Forms for Oral Administration (to be swallowed and dissolved in the gastrointestinal [GI] tract).
  • For this analysis, pharmaceutical contract development and manufacturing refer to the secondary development and manufacturing of oral finished dose formulations (FDFs) for small molecules. OSDs are relatively easy and cost-effective to manufacture.

Segmentation by Product Type

Oral Solid Dosage Forms

Tablets/Pills

  • Tablets/pills refer to a solid dose of 1 or more active pharmaceutical ingredients (APIs) and the non-active excipient.
  • Coated or uncoated tablets are classified into immediate and modified release (sustained/extended/controlled release form) based on the timing and duration of API release.

Capsules

  • Capsules come in solid dose form, comprising hard/soft gelatin-made shells and enclosing 1 or more APIs.
  • Capsules can be filled with powder/pellets/granules.
  • Designed for precise dosing, capsules are formulated for immediate and controlled release of their contents.

Others

  • Powders are finely divided API particles and excipients consumed after reconstitution.
  • Granules are small solid particles comprising APIs and excipients that offer better flow properties, compressibility, and API distribution uniformity.
  • Lozenges refer to a mix of sugar and gum/gelatin that release drugs while dissolving in the mouth.
  • Gummies are gelatin-based chewable forms designed to improve swallowability for pediatric/geriatric patients.

 

Growth Drivers

  • Increased incidences of chronic illnesses and age-related conditions propel demand for cost-effective medicines. The high incidence rate promote greater drug innovations by pharma companies for small molecule OSDs, the most patient-friendly format. Owing to its ability to simplify patient compliance, over 80% of best-selling drugs are administered orally.
  • Robust R&D by small and mid-sized pharma companies, pioneering more than 70% of small molecule drugs in the early-stage pipeline, generates demand for drug development and manufacturing outsourcing services for OSDs. This drives the growth of pharma R&D and manufacturing infrastructure via capacity and capability enhancement through strategic partnerships, mergers and acquisitions (M&As), and CapEx by OSD CDMOs.
  • Growth in the adjacent excipient segment, owing to the rising demand for functionally enhanced value-added pharmaceutical excipients that enhance drug formulation and CR excipients to improve the bioavailability of CR OSDs, will drive the OSD industry.
  • Drug delivery innovations, artificial intelligence (AI)-powered solutions, and bioavailability enhancement technologies influence patient-centric manufacturing. Drug manufacturers' shift from batch to continuous manufacturing assures robust supply via better process control strategies. The FDA provides guidance to support flexible approaches to manufacturing quality and innovative OSD products through enhanced process control and optimization techniques in clinical and commercial manufacturing.
  • Higher healthcare expenditure due to rising disposable income levels, improving economic conditions in developing economies (e.g., China, India, South Africa, Brazil, and South Korea), and greater focus on domestic drug manufacturing in APAC and the Middle East will bolster industry growth.

 

Growth Restraints

  • Reducing drug development timelines and improving manufacturing efficiency necessitates investments in Pharma 4.0 technologies and a switch from batch to continuous manufacturing. This will likely require a capital investment of between $20 million and $50 million to build new processes and infrastructure, which is difficult for small to mid-sized participants.
  • High global inflation, tightening monetary policy, and higher energy prices will negatively impact industry players’ return on investment. The increasing price of excipients and APIs is a pressing manufacturing cost concern. Global supply chain disruptions and the need to streamline supply chains are ongoing issues for industry participants to ensure uninterrupted manufacturing continuity and optimize performance across the value chain.
  • Swallowing impairment by pediatric, geriatric patients, and psychiatric patients requires companies to reformulate an OSD into oral liquid and other formulation types, such as inhalation and dermal patches, impacting OSD industry growth.
  • Addressing the solubility and bioavailability issues for OSD is challenging. Enhancement in drug delivery for better drug efficacy is a prime focus for pharma companies. Companies need to invest in cost-intensive novel bioavailability enhancement tools and drug delivery innovations.
  • With the demand for complex oral small molecule drugs rising, the complexity of chemical synthesis has grown, leading to increased use of resources. However, this shift to complex drug development will lead to increased resource and energy utilization, expanding carbon footprint and negatively impacting manufacturers’ sustainability goals, a vital industry best practice.

Why is it Increasingly Difficult to Grow?

The Strategic Imperative 8™

The Impact of the Top 3 Strategic Imperatives on the Oral Solid Dosage Formulation Industry

Scope of Analysis

Industry Definition and Segmentation

Definition—OSD Based on API Release Profile

Growth Drivers

Growth Restraints

R&D Pipeline and Product Innovations

Small Molecule Oral Dosage Formulation Industry Overview

Small Molecule Oral Dosage Formulation Industry Overview (continued)

Small Molecule OSD Formulation by Therapy Area

Small Molecule OSD Formulation Therapy Area by Dosage Form

Innovations in Extended Release Dosage forms

Industry Trends and Emerging Technologies

Industry Trends and Emerging Technologies (continued)

Industry Trends and Emerging Technologies (continued)

Industry Trends and Emerging Technologies (continued)

Industry Trends and Emerging Technologies (continued)

Industry Trends and Emerging Technologies (continued)

Industry Trends and Emerging Technologies (continued)

Regional Policies and Initiatives

Regional Policies and Initiatives (continued)

Regional Policies and Initiatives (continued)

Regional Policies and Initiatives (continued)

OSD Manufacturing—Production Flow

OSD Manufacturing—Production Flow (continued)

Vendor Ecosystem

Small Molecule OSD CDMO Industry Revenue

OSD CDMO Industry Overview

Supply Chain Resilience Strategies—Focus Areas

Investment Trends—Expansion and Capability Building

Investment Trends—Expansion and Capability Building (continued)

Consolidation Trends—Mergers & Acquisitions

Growth Themes and Business Models

Company Benchmarking—Oral Drug Delivery Solutions and Services

Company Benchmarking Analysis

Company Benchmarking Analysis (continued)

Companies to Watch

Companies to Watch (continued)

Growth Opportunity 1: Fixed Dose Combination Products for Chronic Diseases

Growth Opportunity 1: Fixed Dose Combination Products for Chronic Diseases (continued)

Growth Opportunity 2: Medical Cannabidiol

Growth Opportunity 2: Medical Cannabidiol (continued)

Growth Opportunity 3: Phase-appropriate Services for Orphan Drugs

Growth Opportunity 3: Phase-appropriate Services for Orphan Drugs (continued)

Growth Opportunity 4: Additive Manufacturing for Personalized Medicine

Growth Opportunity 4: Additive Manufacturing for Personalized Medicine (continued)

Best Practices Recognition

Frost Radar

Benefits and Impacts of Growth Opportunities

Next Steps

Take the Next Step

List of Exhibits

Legal Disclaimer

List of Figures
  • Oral Solid Dosage Formulation Industry: Growth Drivers, Global, 2024?2028
  • Oral Solid Dosage Formulation Industry: Growth Restraints, Global, 2024?2028
  • Small Molecule Oral Solid Dosage Formulation R&D Pipeline, Global, 2024
  • Small Molecule Oral Products Revenue Share by Form, Global, 2023
  • Small Molecule Revenue Share by OSD Form, Global, 2023
  • Small Molecule Revenue Share by Dosage Form, Global, 2023
  • Small Molecule Oral Solid Dosage Formulation Industry: Revenue Share by Therapeutic Area, Global, 2023
  • Capsule and Tablet Segment: Revenue in Key Therapy Areas, Global, 2023
  • OSD Formulation Industry: CDMO Revenue Forecast, Global, 2021–2028
  • Small Molecule OSD CDMO: Expansion Initiatives, Global, 2023–2028
  • Small Molecule OSD CDMO: Consolidation Steps, Global, 2023–2028
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This analysis provides an overview and advancements in the oral solid dosage formulation industry, including an evaluation of the current industry scenario, competitive landscape, and regulatory landscape. The scope of the analysis is global, focusing on North America (NA), Europe, Asia-Pacific (APAC), the Middle East, and Latin America (LATAM). It identifies the most prevalent and emerging business models supporting industry stakeholders in enhancing their competitiveness and service offerings. Discussions on key industry drivers and restraints, partnerships, investment and consolidation activities, disruptive technologies, recent excipient advancements, and present and future trends shed light on the industry s growth potential. Industry use cases will provide brief insights into game-changing participants working toward developing disruptive technologies and patient-centric drugs. The analysis will also help uncover growth opportunities based on megatrends and business models, clinical needs, use cases, market access strategies, and technology trends.--BEGIN PROMO--

Research Highlights:

  • Impact of strategic imperatives on the industry 
  • Growth drivers and restraints 
  • Oral solid dosage based on API release profile
  • R&D pipeline and product innovations
  • Small molecule oral dosage market overview
  • Small molecule oral solid dosage formulation by therapy area
  • Innovations in extended-release dosage forms
  • Industry trends and emerging technologies
  • Supply chain resilience strategies – focus areas
  • Investment trends – Expansion and capability-building initiatives
  • Consolidation trends – mergers & acquisitions
  • company benchmarking
  • oral drug delivery solutions & services
  • Growth opportunities

Author: Supriya Lala Kundu

More Information
Deliverable Type Market Research
Author Supriya Lala Kundu
Industries Healthcare
No Index No
Is Prebook No
Keyword 1 Pharmaceutical Formulation Market Trends
Keyword 2 Oral Solid Dosage Market
Keyword 3 Solid Dosage Formulation Growth
List of Charts and Figures Oral Solid Dosage Formulation Industry: Growth Drivers, Global, 2024?2028~ Oral Solid Dosage Formulation Industry: Growth Restraints, Global, 2024?2028~ Small Molecule Oral Solid Dosage Formulation R&D Pipeline, Global, 2024~ Small Molecule Oral Products Revenue Share by Form, Global, 2023~ Small Molecule Revenue Share by OSD Form, Global, 2023~ Small Molecule Revenue Share by Dosage Form, Global, 2023~ Small Molecule Oral Solid Dosage Formulation Industry: Revenue Share by Therapeutic Area, Global, 2023~ Capsule and Tablet Segment: Revenue in Key Therapy Areas, Global, 2023~ OSD Formulation Industry: CDMO Revenue Forecast, Global, 2021–2028~ Small Molecule OSD CDMO: Expansion Initiatives, Global, 2023–2028~ Small Molecule OSD CDMO: Consolidation Steps, Global, 2023–2028~
Podcast No
WIP Number PFI7-01-00-00-00