Generics to Impact North American Oral Solid Drug Dosage Excipients Market


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This briefing will investigate the increase in volume of drugs and the relative increase in excipients volume.

Why you should listen On Demand?

1. Understand the different types of excipients used in solid drug dosage forms, their price, current market size and future market scenario.
2. Learn key unmet needs and success factors for oral solid drug dosage excipients.
3. Identify the drivers and restraints of the market.

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Generics to Impact North American Oral Solid Drug Dosage Excipients Market

  1. 1. North American Oral Solid Drug Dosage Excipients Market Blockbuster Drug Patent Expiration Expected to Boost Market Growth Dr. Nandhini Rajagopal, Industry Analyst Chemicals, Materials, and Foods 22nd Jan © 2012 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
  2. 2. Focus Points 1 Outlook for Oral Solid Drug Dosage Excipients Market 2 Key Performance Challenges, Drivers, and Restraints 3 Anticipating Demand for Excipients 4 6 7 8 Opportunity Analysis of Oral Solid Drug Dosage Excipients 5 Focus Points Excipient Functional Groups Go To Market Strategy for Key Success Key Competitive Factors in the Selection of an Excipient Supplier Facing the Change – Strategic Recommendations 2
  3. 3. Outlook for Oral Solid Drug Excipients—A Snapshot Major Growth Factors • Easier drugadministration • Enhanced bioavailability • Longer shelf-life • Improved sensory parameters • Patent Expiration • Multifunctional excipients High Margin Products • Povidone • Acrylics • CrosCarmellose Sodium • Sodium starch glycolate • Hypromellose Oral Solid Drug Dosage Excipients Outlook End-user Needs Assessment Strategic Recommendations 1 Scramble to attain a ‘Comprehensive’ solutions portfolio Unmet Needs • Tailor made excipients • Identifying new applications for existing excipients 2 Foresee the demand and customize according to customer needs Industry Challenges • Low return on investments • Increasing commoditization of products 3 Pioneering in new technologies and innovative products. 3
  4. 4. Excipients—Product Segmentation Total Oral Solid Drug Dosage Market: North America, 2012 Binders and Fillers: Microcrystalline cellulose, sodium carboxy methyl cellulose, methyl cellulose, hypromellose, specialty lactose, partially pre-gelatinized starch, povidone, calcium phosphate, calcium carbonate, gelatin Super-disintegrants: CrossCarmellose Sodium, sodium starch glycolate, Crospovidone Coatings: Intermediate release coating, controlled or modified coating Flavors and Colors Preservative: Antimicrobials and antioxidants Glidants, lubricants, and anti-adherents: Magnesium stearate, Talc, silica Sweeteners: Aspartame, acesulfame, polyols Others: Buffers and adsorbents 4
  5. 5. Drivers and Restraints Oral Solid Drug Dosage Market: Key Market Drivers and Restraints, North America, 2013-2019 Market Restraints Market Drivers 1-2 years 3-4 years 5-7 years Several key block buster drug patent expirations is expected to boost excipient market growth Multifunctional excipients are accelerating market growth Growth in controlled and sustained release coatings drives the market Regulatory issues leading to decrease in domestic market growth New product development barriers slows the pace of development Low-cost competition from emerging markets inhibits market growth Impact: High Medium Low Source: Frost & Sullivan analysis. 5
  6. 6. Number of Patented Drug Expirations Anticipating Demand for Excipients Blockbuster products worth $73,850 million are expected to lose patent protection in the United States between 2009 and 2017. Potential earnings for generic manufacturers is $18.25 billion. Owing to this, the potential revenue gain for excipient manufacturers is $91.4 million. 6
  7. 7. Oral Solid Drug Dosage Excipients—Opportunity Analysis Total Oral Solid Drug Dosage Excipient Market: North America, 2012 Market Overview Market Stage Market Revenue $1193.4 M Growth (2012) Base Year Market Growth Rate Forecast Period Market Growth Rate 5.4 % 4.8% (CAGR, 2012-2019) Decreasing Stable Increasing Market Units/Volume 258,705.1 tons Average Price Per Unit/Kg $4.6 (2012) Customer Price Sensitivity 6 (scale:1 [Low] to 10 [High]) Market Size for Last Year of Study Period $1708.8M (2019) Degree of Technical Change 7 (scale:1 [Low] to 10 [High]) Number of Competitors 45–50 (active market competitors in base year) Note: All figures are rounded. The base year is 2012. Source: Frost & Sullivan analysis. 7
  8. 8. Oral Solid Drug Excipients—Segmentation In terms of overall attractiveness—when measured by relative market size and growth—superdisintegrants and binders and fillers are top market grossers. Percent Revenue Sales Breakdown Total Oral Solid Drug Dosage Excipients Market: North America, 2012 Others* 4.5% Binders and Fillers 47.6% Glidants, Lubricants, and Anti-adherents 2.1% Colors 2.4% Preservatives 2.8% Flavors 3.9% Super-disintegrants 4.3% Sweeteners 5.8% Coatings 26.6% 8
  9. 9. Oral Solid Drug Dosage Excipients—Comparative Analysis A clear balance between success probability and operational margin are factors to be maintained for a successful product launch. Commodity Excipients Specialized Excipients Low High Probability of success Low High Low High Time Low High Low High Cost Low High Low High Pricing Low High Low High Marketing Investment Low High Low High Competitors Low High Low High Point of differentiation Low High Low High Barriers to entry Low High Low High Product operational profit margin Low High • Bargaining power of customers is high due to commodity market scenario and fragmented excipient manufacturer network allows intense competition in the commodity market scenario. • Stringent regulations and safety requirements are the highest entry barriers for new product development • High R&D cost with extensive clinical trials to prove the efficacy of the product also adds up to the cost of production of specialized excipients. Source: Frost & Sullivan 9
  10. 10. Go to Market Strategy for Key Success Setting up local manufacturing facilities in Asia-Pacific will be crucial to compete with the imports from low-cost countries. Long Term Business Expansion Medium Term Immediate term 2018-2020 “Focus on R&D” 2016-2018 “Grow market share” 2014-2015 “Establish partnerships” Improving the drug delivery technologies Product differentiation through specialization Manufacturing units in Asia-Pacific Build track record Focusing on high in the AMR/ AMI margin segments pilot projects Building long standing relationships with customers Identify new applications for existing excipients Increased bioavailability Time Source: Frost & Sullivan Analysis 10 10
  11. 11. Key Competitive Factors Cost Competitiveness Technical Service Patented Products Price Quality Consolidation Key Competitive Factors Value Added Services 11
  12. 12. Facing the Change—Strategic Recommendations • Improve product line • React and respond as needed • Defend and protect company’s presence in the market React Anticipate • Plan ahead for future changes • Instill competitive capabilities • Invest in R&D • Strengthen distribution • Be the agent of the industry change • Force rivals to follow • Influence rules of the game Lead 12
  13. 13. Oral Solid Drug Dosage Excipients—Binders & Fillers Segment Detailed TOC • • • • • • • • • • • • • • • • • • • • • Segment Overview & Breakdown Market Engineering Measurements Volume and Revenue Forecast & discussion Volume Percent Split by Product Type Percent Revenue Forecast by Product Revenue Forecast by Product Volume and Revenue Forecast Trends by Product Types Pricing Trends by Product Type & Discussion Competitive Analysis—Market Share Market Share Analysis Competitive Environment Competitive Factors and Assessment Competitive Analysis – Market Share (Microcrystalline cellulose) Competitive Analysis – Market Share (Sodium carboxy methyl cellulose) Competitive Analysis – Market Share (Methyl cellulose) Competitive Analysis – Market Share (Hypromellose) Competitive Analysis – Market Share (Specialty Lactose) Competitive Analysis – Market Share (Partially pre-gelatinized starch) Competitive Analysis – Market Share (Povidone) Competitive Analysis – Market Share (Calcium Carbonate) Competitive Analysis – Market Share (Calcium Phosphate) Competitive Analysis – Market Share (Gelatin) 13
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  17. 17. For Additional Information Liz Clark Corporate Communications Chemical, Materials, and Food (210) 477-8483 Dr. Nandhini Rajagopal Industry Analyst Foods, Drugs, and Cosmetics (91) 44-66814069 Shomik Majumdar Research Manager Foods, Drugs, and Cosmetics (650) 417-1466 Mark Hicks Sales Manager Chemical, Materials, & Food (210) 247-2490 17