2015為止的美國生物製劑市場

美國的生物製劑需求在過去10年的指數成長後，預估在2015年會超過1,000億美元。生產技術的劇烈進歩與標的疾病擴大等因素支持著成長，但也面臨主要生物製劑專利失效造成生物仿製藥的導入等課題。

本報告書為美國生物製劑市場的需求成績（2000年、2005年、2010年）與產品別、各種應用的預測（2015年、2020年）、市場環境因子、相關企業市場佔有率與簡介等整理，概述如下。

導論

第1章 總綱

第2章 市場環境

• 概要
• 人口統計傾向
• 微經濟的概要
• 醫療動向
  • 國家的醫療費
  • 醫藥品需求與供給
  • 各治療等級的藥品出貨
• 患者活動
• 症狀
  • 急性
  • 慢性
• 動物醫療業界前景
• 生物製劑技術概要
  • 替換DNA生物製劑
  • 生物仿製藥
• 法規體制
  • 人類生物學的療法
  • 生物仿製藥產品
  • 生物製劑研究・臨床實驗產品
  • 動物用生物製劑

第3章 產品

• 概要
• 各類別需求
• 擔克隆抗體
• 疫苗・類毒素
• 激素
• 成長因子
• 免疫調整劑
• 血液・血液製劑
• 酵素
• 凝固因子
• 其他

第4章 應用

• 概要
• 對人醫療
  • 癌
  • 自體免疫疾病
  • 感染病
  • 血液疾病
  • 糖尿病
  • 其他
• 其他生物製劑
  • 動物醫療
  • 研究以及其他應用領域

第5章 業界構造

• 概要
• 市場佔有率
• 競爭戰略
• 合併・收購
• 認證・相關契約
• 研究開發
• 製造
• 行銷・流通

企業簡介

Abstract

US demand to exceed $100 billion by 2015

Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products.

Monoclonal antibodies to benefit from biotech boom

Biologics such as insulin and red blood cell stimulants have been available for many years, but since the introduction of recombinant DNA technology, manufacturers have developed a wide range of new products with very specific applications. Monoclonal antibodies are a prime example of this important shift. Proteins that destroy targeted antigens can now be purified, cloned and introduced into patients to instigate immune responses. These products have quickly established themselves as effective therapies for many forms of cancer, rheumatoid arthritis, macular degeneration and other conditions. New antibodies are under intensive investigation, and will be introduced to market within the forecast period.

Routine immunizations to boost vaccines demand

Biologics are also being targeted for a wider range of diseases and population segments. Biologics are complex materials that must be produced by living cells, and their producers have targeted small, niche populations with rare or difficult to treat conditions. However, as the market has grown and matured, many new applications are being found for these products. Vaccines, for example, were once focused on a small number of infectious diseases of early childhood. The number of recommended immunizations has grown significantly over the past decade, however, and since 2006, the Centers for Disease Control has encouraged adolescent and adult boosters and new immunizations, including one against the human papilloma virus associated with cervical cancer. Influenza shots are now recommended not only for the immunocompromised, but for all adults and young children, and investigation is well underway for vaccines that can protect against several core strains, effectively offering herd immunity against widespread pandemic infection. Several new vaccines are available or in late-stage clinical trials for use both as preventives and as therapies against several forms of cancer.

Biosimilar products offer good opportunities

Impending expiry of patents for a number of biopharmaceuticals and consumer demand to reduce treatment costs are encouraging a global market for biosimilar products. Biosimilars are made by new sponsors innovating biopharmaceuticals that reference the original drug. Manufacturers will have access to the original, commercialized products, but not to the original molecular clones and cell banks, fermentation and purification processes, or active drug substances. Biosimilars are subject to careful regulation. Europe has led the global regulatory process, requiring a strict demonstration that the “similar” product is highly comparable to the original. In the US, the FDA has allowed only a few biosimilars for sale following procedures for small molecule generics, but new regulations are under development and biosimilars are expected to become a dominant force by 2020.

Study coverage

This study can help you:

• Determine your market & sales potential
• Learn more about industry competitors
• Assess new products & technologies
• Identify firms to merge with or acquire
• Complement your research & planning
• Gather data for presentations
• Confirm your own internal data
• Make better business decisions

Freedonia' s methods involve:

• Establishing consistent economic and market forecasts
• Using input/output ratios, flow charts and other economic methods to quantify data
• Employing in-house analysts who meet stringent quality standards
• Interviewing key industry participants, experts and end users
• Researching a proprietary database that includes trade publications, government reports and corporate literature

Table of Contents

INTRODUCTION

I. EXECUTIVE SUMMARY

II. MARKET ENVIRONMENT

• General
• Demographic Patterns
• Macroeconomic Outlook
• Healthcare Trends
  • National Health Expenditures
  • Pharmaceutical Supply & Demand
  • Pharmaceutical Shipments by Therapeutic Class
• Patient Activity
• Medical Conditions
  • Acute Conditions
  • Chronic Conditions
• Animal Health Industry Outlook
• Technological Overview of Biologics
  • Recombinant DNA Biologics
  • Biosimilars
• Regulation
  • Regulation of Human Biologic Therapies
  • Regulation of Biosimilar Products
  • Regulation of Biologics Research & Testing Products
  • Regulation of Animal Biologics

III. PRODUCTS

• General
• Demand by Type
• Monoclonal Antibodies
  • Cancer Treatment
  • Rheumatoid Arthritis
  • Macular Degeneration
  • Psoriasis
  • Infectious Disease
  • Other Applications
• Vaccines & Toxoids
  • Vaccines for Human Health
    • Routine Immunizations
    • Influenza
    • Therapeutic Vaccines
    • Other Vaccines
  • Animal Vaccines
• Hormones
  • Insulin
  • Human Growth Hormone
  • Teriparatide
  • Follicle-Stimulating Hormone
  • Estrogen
  • Calcitonin
  • Thyrotropin
  • Corticotropin
  • Other Hormones
• Growth Factors
  • Erythropoietins
  • Colony-Stimulating Factors
  • Bone Morphogenetic Proteins
  • Other Growth Factors
• Immunomodulators
  • Immunosuppressing Agents
  • Interferons
  • Other Immunomodulators
• Blood & Blood Products
  • Plasma & Plasma Fractions
  • Whole Blood
  • Cellular Components
• Enzymes
  • Enzyme Replacement Therapies
  • Neuromodulators
  • Digestive Enzymes
  • Thrombolytics
  • Diagnostics
• Other Enzymes
• Coagulation Factors
  • Antihemophilics
  • Other Coagulation Factors
• Other Biologics

IV. APPLICATIONS

• General
• Human Healthcare
  • Cancer
  • Autoimmune Diseases
  • Infectious Diseases
  • Blood Disorders
  • Diabetes
  • Other Conditions
• Biologics for Other Uses
  • Animal Health
  • Research & All Other Applications

V. INDUSTRY STRUCTURE

• General
• Market Share
• Competitive Strategies
• Mergers & Acquisitions
• Licensing & Related Agreements
• Research & Development
• Manufacturing
• Marketing & Distribution

COMPANY PROFILES

• Abbott Laboratories
• Alere Incorporated
• Alexion Pharmaceuticals Incorporated
• Allergan Incorporated
• Alnara Pharmaceuticals, see Eli Lilly
• American Red Cross
• Amgen Incorporated
• Aptalis Pharma Incorporated
• AstraZeneca plc
• Axcan Intermediate Holdings, see Aptalis Pharma
• Baxter International Incorporated
• Bayer AG
• BBI Enzymes, see Alere
• Biogen Idec Incorporated
• BioMarin Pharmaceutical Incorporated
• BioVex Group, see Amgen
• Blood Systems Incorporated
• Bristol-Myers Squibb Company
• Crucell, see Johnson & Johnson
• CSL Limited
• EKR Therapeutics Incorporated
• Eli Lilly & Company
• EMD Serono, see Merck KGaA
• Emergent BioSolutions Incorporated
• Enzon Pharmaceuticals, see sigma-tau Group
• Eurand, see Aptalis Pharma
• Facet Biotech, see Abbott Laboratories
• Genentech, see Roche Holding
• Genzyme, see Sanofi-Aventis
• GlaxoSmithKline plc
• GSK Biologicals, see GlaxoSmithKline
• Halozyme Therapeutics Incorporated
• Intercell AG
• Inverness Medical Innovations, see Alere
• Ipsen
• Johnson & Johnson
• Lonza Group Limited
• Lundbeck (H.) A/S
• Massachusetts Biologic Laboratories
• Medarex, see Bristol-Myers Squibb
• MedImmune, see AstraZeneca
• Medtronic Incorporated
• Mentor Worldwide, see Johnson & Johnson
• Merck & Company Incorporated
• Merck KGaA
• Merial, see Sanofi-Aventis
• New York Blood Center
• Novartis AG
• Novo Nordisk A/S
• Organon Teknika, see Merck & Company
• Ortho-McNeil-Janssen Pharmaceuticals, see Johnson Johnson
• Ovation Pharmaceuticals, see H. Lundbeck A/S
• Percivia, see Johnson & Johnson
• Pfizer Incorporated
• Questcor Pharmaceuticals Incorporated
• ratiopharm, see Teva Pharmaceutical Industries
• Roche Holding Limited
• Sandoz International, see Novartis
• Sanofi-Aventis
• Shire plc
• sigma-tau Group
• Solstice Neurosciences, see US WorldMeds
• Solvay SA
• Stryker Corporation
• Teva Pharmaceutical Industries Limited
• Theravance, see GlaxoSmithKline
• TL Biopharmaceutical, see Lonza Group & Teva
• Pharmaceutical Industries
• Trubion Pharmaceuticals, see Emergent BioSolutions
• US WorldMeds LLC
• Ventana Medical Systems, see Roche Holding
• ViaCyte Incorporated
• Vivante GMP Solutions, see Lonza Group
• WiCell Research Institute
• Wisconsin International Stem Cell Bank, see WiCell
• Research Institute
• Wyeth, see Pfizer
• ZyStor Therapeutics, see BioMarin Pharmaceutical
• Other Companies Mentioned in Study

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY

• Summary Table

SECTION II -- MARKET ENVIRONMENT

• Population & Households
• Macroeconomic Indicators
• National Health Expenditures by Type & Source of Payment
• Pharmaceutical Supply & Demand
• Pharmaceutical Shipments by Therapeutic Class
• Patient Activity
• Medical Conditions
• Animal Population & Veterinary Health Expenditures

SECTION III -- PRODUCTS

• Biologics Demand by Type
• Monoclonal Antibodies Demand
• Vaccines Demand
• Hormones Demand
• Growth Factors Demand
• Immunomodulators Demand
• Blood & Blood Products Demand
• Enzymes Demand
• Coagulation Factors Demand
• Other Biologics Demand

SECTION IV -- APPLICATIONS

• Biologics Demand by Application
• Biologics Demand for Human Healthcare by Condition & Use
• Cancer Biologics Demand
• Autoimmune Biologics Demand
• Infectious Diseases Biologics Demand
• Blood Disorders Biologics Demand
• Diabetes Biologics Demand
• Other Human Health Biologics Demand
• by Condition & Product
• Biologics Demand for Other Applications

SECTION V -- INDUSTRY STRUCTURE

• US Biologics Sales by Company, 2010
• Selected Acquisitions & Divestitures
• Selected Cooperative Agreements

LIST OF CHARTS

SECTION III -- PRODUCTS

• Biologics Demand by Product Type, 2010

SECTION IV -- APPLICATIONS

• Human Healthcare Biologics Demand by Condition
• & Use, 2010

SECTION V -- INDUSTRY STRUCTURE

• US Biologicals Market Share, 2010

2015年時美國對生物製劑的需求將達到1,020億美元

Global Information, Inc.已開始銷售The Freedonia Group所發行的報告書「Biologics to 2015 (2015為止的美國生物製劑市場)」

預測美國對生物製劑的需求將以年率6.5％成長，2015年時達到1.020億美元。由於生產技術戲劇性的進步和標的疾病的擴大，牽引著成長。新生物製劑的開發乃為了治療癌和糖尿病、以及其他重大疾病。這些疾病之多，促使美國的發病率增加。與過去10年間兩位數的成長比較，顯然市場的成長速度減低，此乃因生物製劑的價格受抑制的市場滲透與穩健的收益有相當程度相抵。期待引進生技仿製藥入美國市場將有助於此動向。除此動向外，本報告書中亦介紹生物製劑市場的動向。

胰島素、疫苗及各種血液製劑長年被利用。然運用最近的重組DNA技術，能廣泛開發特定用途的新藥。在美國有40種以上品牌的單株抗體，2000年以後其26種藥中的15種於2005年以後獲得FDA承認。這些產品作為癌和黃斑變性症、風濕性關節炎及其他疾病有效的治療藥，已急速確立了其地位。有關對新抗體的研究，目前集中進行，預計會在本報告書的預測期間內上市。