2012 Biotechnology Research Review

Published by: BCC Research

Published: Dec. 1, 2012 - 143 Pages

Table of Contents

CHAPTER 1 2012 BIOTECHNOLOGY RESEARCH REVIEW

FOREWORD

CHAPTER 2 AGRICULTURAL BIOTECHNOLOGY: EMERGING TECHNOLOGIES AND GLOBAL MARKETS (REPORT BIO100A)

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE

SCOPE AND FORMAT

METHODOLOGY

INFORMATION SOURCES

RELATED BCC REPORTS

ANALYST CREDENTIALS

BCC ONLINE SERVICES

DISCLAIMER

TABLE 1 GLOBAL VALUE OF AGRICULTURAL BIOTECHNOLOGY MARKET, BY MARKET SEGMENT, THROUGH 2017 ($ MILLIONS)

FIGURE 1 GLOBAL VALUE OF AGRICULTURAL BIOTECHNOLOGY MARKET BY MARKET SEGMENT, 2011–2017 ($ MILLIONS)

SCOPE OF REPORT

TABLE 2 SCOPE OF THIS REPORT

AGRICULTURAL BIOTECHNOLOGY MARKET

TABLE 3 GLOBAL VALUE OF AGRICULTURAL BIOTECHNOLOGY MARKET BY MARKET SEGMENT, THROUGH 2017 ($ MILLIONS)

GROWTH DRIVING FORCES

TABLE 4 AGRICULTURAL BIOTECHNOLOGY MARKET DRIVING FORCES

LIFE CYCLE STATUS

TABLE 5 LIFE CYCLE STATUS OF AGRICULTURAL BIOTECHNOLOGIES

TABLE 6 IMPACT OF NEW TECHNOLOGIES ON CROP PRODUCTIVITY, 1860–PRESENT

AGRICULTURAL BIOTECHNOLOGY INDUSTRY

TABLE 7 AGRICULTURAL BIOTECHNOLOGY INDUSTRY KEY STRUCTURAL COMPONENTS

TECHNOLOGIES

DNA SEQUENCING

TABLE 8 DNA SEQUENCING TECHNOLOGY

TABLE 9 DNA SEQUENCING TECHNOLOGY IN AGRICULTURAL BIOTECHNOLOGY

GENETIC ENGINEERING/SYNTHETIC BIOLOGY

TABLE 10 COMPARISON OF GENETIC ENGINEERING AND SYNTHETIC BIOLOGY

TABLE 11 GENETIC ENGINEERING/SYNTHETIC BIOLOGY TECHNOLOGY IN AGRICULTURAL

BIOTECHNOLOGY

BIOCHIPS

TABLE 12 BIOCHIPS TECHNOLOGIES

TABLE 13 BIOCHIPS TECHNOLOGIES IN AGRICULTURAL BIOTECHNOLOGY

RNA INTERFERENCE

TABLE 14 RNA INTERFERENCE TECHNOLOGY

TABLE 15 RNA INTERFERENCE AGRICULTURAL TECHNOLOGIES

CROP TECHNOLOGIES

TABLE 16 PLANT TECHNOLOGIES

Development of a Genetically Modified Seed

TABLE 17 GENETICALLY MODIFIED SEED DEVELOPMENT PROCESS

TABLE 18 SEED PRODUCTION, STORAGE AND ENHANCEMENT TECHNOLOGIES

CHAPTER 3 BIOSIMILARS: GLOBAL MARKETS (REPORT BIO090A)

STUDY GOAL AND OBJECTIVES

INTENDED AUDIENCE OF THE STUDY

MARKET DEFINITION, SCOPE AND FORMAT

INFORMATION SOURCES AND METHODOLOGY

AUTHOR CREDENTIALS

RELATED REPORTS FROM BCC RESEARCH

SUMMARY

TABLE 19 GLOBAL DEMAND FOR BIOSIMILARS BY VALUE, THROUGH 2016 ($ MILLIONS)

FIGURE 2 GLOBAL BIOSIMILAR DEMAND BY VALUE AND PRODUCT TYPE, 2011 (%)

MARKET OVERVIEW

TERMINOLOGY

TABLE 20 SIMILAR BIOLOGICAL PRODUCTS: TERMINOLOGIES AND THEIR DEFINITIONS AS USED BY VARIOUS REGULATORY AGENCIES

SMALL MOLECULE GENERICS VERSUS BIOSIMILARS

DISTINCT INTELLECTUAL PROPERTY ISSUES

TABLE 21 BIOSIMILARS VERSUS SMALL MOLECULE GENERICS

THE BIOSIMILAR OPPORTUNITY

TABLE 22 GLOBAL REVENUES OF LEADING BIOPHARMACEUTICALS

TABLE 23 BIOLOGIC DRUGS LOSING PATENT PROTECTION BETWEEN 2012 AND 2017

TABLE 24 POPULAR REFERENCE PRODUCTS TARGETED BY KEY PLAYERS

VERY EXPENSIVE BIOLOGIC DRUGS DRIVING THE DEMAND FOR BIOSIMILARS

TABLE 25 ANNUAL COSTS FOR THE TREATMENT USING SOME OF THE BIOLOGIC DRUGS

TABLE 26 COST COMPARISON FOR RENAL DISEASE-ASSOCIATED ANEMIA TREATMENT IN EUROPE

WORLDWIDE MARKETS FOR BIOSIMILARS-CURRENT STATUS

TABLE 27 BIOSIMILARS APPROVED BY EMA, 2011

TABLE 28 BIOSIMILARS APPROVED IN OTHER REGULATED MARKETS: AUSTRALIA, CANADA, JAPAN AND THE U.S.

TABLE 29 TOP PLAYERS IN THE GLOBAL BIOSIMILAR MARKET

MARKET SIZE AND GROWTH TRENDS OF GLOBAL BIOSIMILAR MARKET

TABLE 30 THE GLOBAL AND REGIONAL BIOSIMILAR MARKETS BY VALUE, THROUGH 2016 ($ MILLIONS)

TABLE 31 THE GLOBAL MARKETS FOR VARIOUS PRODUCT CLASSES OF BIOSIMILARS BY VALUE, THROUGH 2016 ($ MILLIONS)

THE EVOLVING BIOSIMILAR REGULATORY LANDSCAPE

UNRESOLVED SCIENTIFIC AND REGULATORY CONCERNS

TABLE 32 SCIENTIFIC AND REGULATORY CONCERNS RELATED TO BIOSIMILAR

AUTHORIZATION

CHAPTER 4 KINASE INHIBITORS: GLOBAL MARKETS (REPORT BIO053C)

STUDY OBJECTIVES

REASONS FOR DOING THIS STUDY

INTENDED AUDIENCE

SCOPE OF THE STUDY

METHODOLOGY

INFORMATION SOURCES

AUTHOR CREDENTIALS

SUMMARY

TABLE 33 GLOBAL REVENUE OF KINASE INHIBITORS MARKET, THROUGH 2016 ($ MILLIONS)

FIGURE 3 GLOBAL REVENUE OF KINASE INHIBITORS MARKET, 2009–2016 ($ MILLIONS)

OVERVIEW

DEFINITIONS

ENZYME INHIBITORS

WHY ENZYME INHIBITION?

USE OF ENZYME INHIBITORS

MECHANISM OF ENZYME INHIBITION

TYPES OF ENZYME INHIBITORS

CLASSIFICATION OF ENZYME INHIBITORS

TABLE 34 CLASSIFICATION OF ENZYME INHIBITORS

KINASE INHIBITORS

HISTORY OF PROTEIN KINASES

TABLE 35 HISTORY OF PROTEIN KINASES

TYPES OF KINASE INHIBITORS

TABLE 36 TYPES OF KINASE INHIBITORS

Small Molecule Inhibitors

TABLE 37 ATP COMPETITIVE AND NON-COMPETITIVE INHIBITORS

Antibody (Monoclonal) Inhibitors

CLASSIFICATION BY TYPES OF AMINO ACID PHOSPHORYLATION

SERINE/THREONINE KINASE INHIBITORS

TABLE 38 TYPES OF SERINE/THREONINE KINASE INHIBITORS

TYROSINE KINASE INHIBITORS

Receptor Tyrosine Kinase (RTK) Inhibitors

TABLE 39 TYPES OF RECEPTOR TYROSINE KINASE INHIBITORS

Non-Receptor Tyrosine Kinase (NRTK) Inhibitors

TABLE 40 TYPES OF NON-RECEPTOR TYROSINE KINASE INHIBITORS

CLASSIFICATION BY SITE OF ACTION

TABLE 41 CLASSIFICATION OF KINASE INHIBITORS BY SITE OF ACTION

CHAPTER 5 DRUG DISCOVERY TECHNOLOGIES (REPORT BIO020D)

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THIS STUDY

SCOPE AND FORMAT

METHODOLOGY AND INFORMATION SOURCES

INTENDED AUDIENCE

ANALYST CREDENTIALS

RELATED REPORTS

SUMMARY

TABLE 42 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES AND PRODUCTS, THROUGH 2017 ($ BILLIONS)

FIGURE 4 GLOBAL MARKET FOR DRUG DISCOVERY TECHNOLOGIES AND PRODUCTS, 2011–2017 ($ BILLIONS)

INTRODUCTION

PRECLINICAL TESTING AND SUBMISSION OF AN INVESTIGATIONAL NEW DRUG

CLINICAL TRIALS

SUBMISSION OF NEW DRUG APPLICATION OR BIOLOGICAL LICENSING

APPLICATION

POST-FOOD AND DRUG ADMINISTRATION APPROVAL

IMPACT OF GOVERNMENT REGULATIONS AND REGULATORY APPROVALS ON THE DRUG

DISCOVERY INDUSTRY

NEW DRUG APPROVALS

TABLE 43 NEW MOLECULAR ENTITY (NME) APPLICATIONS VERSUS APPROVAL BY THE FDA, 2006–2010

FIGURE 5 NEW MOLECULAR ENTITY (NME) APPLICATIONS VERSUS APPROVAL BY THE FDA, 2006–2010

TIMELINE AND COSTS

FIGURE 6 TIMELINE FOR DRUG DEVELOPMENT PROCESS

TABLE 44 FACTS ABOUT DRUG DISCOVERY AND DEVELOPMENT FOR 2010

TABLE 45 R&D SPENDING FOR DRUG DISCOVERY IN BIOPHARMACEUTICAL COMPANIES, 2008–2012 ($ MILLIONS)

IMPORTANCE OF TECHNOLOGY IN DRUG DISCOVERY

MARKET LANDSCAPE IN THE DRUG DISCOVERY SECTOR

TABLE 46 FDA-APPROVED DRUGS FOR SALE IN THE U.S., 2001–2011

TABLE 47 GLOBAL PHARMACEUTICAL MARKET VALUE, THROUGH 2017 ($ BILLIONS)

MARKET PARTICIPANTS IN THE DRUG DISCOVERY SECTOR

TABLE 48 TOP GLOBAL PHARMACEUTICAL CORPORATION RANKING, 2009

TABLE 49 NUMBER OF DEALS AND THEIR VALUE IN THE PHARMACEUTICAL INDUSTRY IN DIFFERENT COUNTRIES, 2010

PATENTS AND DRUG DISCOVERY TECHNOLOGY

TABLE 50 PATENT APPLICATIONS IN DRUG DISCOVERY FROM MARCH 2012

CHAPTER 6 ANTIBODY DRUGS: TECHNOLOGIES AND GLOBAL MARKETS (REPORT BIO016H)

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

INTENDED AUDIENCE

SCOPE OF REPORT

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED REPORTS

SUMMARY

TABLE 51 GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, THROUGH 2016 ($ MILLIONS)

FIGURE 7 GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES, 2009–2016 ($ MILLIONS)

OVERVIEW

DEFINITIONS

THE IMPORTANCE OF ANTIBODY DRUGS AND DIAGNOSTICS

INTELLECTUAL PROPERTY ISSUES AND PATENT LICENSING

THE HISTORY OF THE COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS

TABLE 52 TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS

ADVANTAGES OF MONOCLONAL ANTIBODY DRUGS

WHY DO MONOCLONAL ANTIBODY PRODUCTS HAVE SO MANY APPLICATIONS

COMPARED WITH POLYCLONAL ANTIBODY PRODUCTS?

VALUATION OF ANTIBODY PRODUCT SALES

TECHNOLOGY AND TECHNICAL ISSUES

TABLE 53 MONOCLONAL ANTIBODIES VERSUS SMALL MOLECULE DRUGS

TABLE 54 MONOCLONAL ANTIBODIES VERSUS POLYCLONAL ANTIBODIES

THE HAMA PROBLEM AND ITS RESOLUTION

PHAGE DISPLAY AND POLYSOME DISPLAY

DIRECTED EVOLUTION

ANTIBODY CLASSES

TABLE 55 ANTIBODY TYPES AND DESCRIPTIONS

ANTIBODY FORMS IN PRODUCTS

TABLE 56 GLOBAL SALES OF THERAPEUTIC MONOCLONAL ANTIBODIES BY ANTIBODY TECHNOLOGY TYPE, THROUGH 2016 ($ MILLIONS)

TABLE 57 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY ANTIBODY FORM (NUMBER/%)

TABLE 58 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TECHNOLOGY FORM AND STAGE OF DEVELOPMENT

TABLE 59 ANTIBODIES IN CLINICAL STAGE DEVELOPMENT BY TARGET

CHAPTER 7 GLOBAL MARKETS FOR MEDIA, SERA AND REAGENTS IN BIOTECHNOLOGY (REPORT BIO014G)

STUDY OBJECTIVES

REASONS FOR DOING THIS STUDY

INTENDED AUDIENCE

SCOPE OF THE STUDY

METHODOLOGY

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED BCC RESEARCH REPORTS

PHAGE DISPLAY AND POLYSOME DISPLAY

TABLE 60 GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, THROUGH 2016 ($ MILLIONS)

FIGURE 8 GLOBAL REVENUES FROM MEDIA, SERA AND REAGENTS USED IN THE BIOTECHNOLOGY MARKET, 2009–2016 ($ MILLIONS)

OVERVIEW

DEFINITIONS

HISTORY

TABLE 61 HISTORICAL EVENTS IN CELL CULTURE DEVELOPMENT

TYPES OF CELL CULTURES

PRIMARY CULTURES

TABLE 62 ADVANTAGES AND DISADVANTAGES OF PRIMARY CELL CULTURE

SECONDARY CELL CULTURE

CONTINUOUS CELL CULTURE

TABLE 63 ADVANTAGES AND DISADVANTAGES OF CONTINUOUS CELL CULTURE

MORPHOLOGY OF CELLS IN CULTURE

FIBROBLASTIC CELLS

EPITHELIAL-LIKE CELLS

LYMPHOBLAST-LIKE CELLS

BASIC SYSTEMS FOR CELL CULTURE

TABLE 64 ADHERENT CULTURE VS. SUSPENSION CULTURE

CELL LINE, CELL STRAIN AND TRANSFORMED CELL LINES

CHARACTERISTICS OF IMMORTALIZED CELL LINES

FACTORS AFFECTING CELL CULTURE

APPLICATIONS OF CELL CULTURE

MODEL SYSTEM

CANCER RESEARCH

VIROLOGY

TABLE 65 CULTURE MEDIA USED FOR THE PRODUCTION OF VACCINES

GENETICALLY ENGINEERED PROTEINS

TABLE 66 POTENTIAL SOURCES OF CELL CULTURE ADDITIVES

Recombinant Thrombolytic Agents

TABLE 67 RECOMBINANT THROMBOLYTIC AGENTS

Recombinant Coagulation Factor

TABLE 68 RECOMBINANT COAGULATION FACTOR

Cytokines

Hematopoietic Growth Factors

Human Growth Hormones

Monoclonal Antibodies

TISSUE AND ORGAN REPLACEMENT

CHAPTER 8 DNA SEQUENCING: EMERGING TECHNOLOGIES AND APPLICATIONS (REPORT BIO045D)

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

INTENDED AUDIENCE

SCOPE AND FORMAT

METHODOLOGY

INFORMATION SOURCES

RELATED BCC REPORTS

ANALYST CREDENTIALS

EXECUTIVE SUMMARY

TABLE 69 GLOBAL VALUE OF SEQUENCING PRODUCTS AND SERVICES BY TYPE, THROUGH 2016 ($ MILLIONS)

FIGURE 9 GLOBAL VALUE OF SEQUENCING PRODUCTS AND SERVICES BY TYPE, 2010–2016 ($ MILLIONS)

INTRODUCTION

TABLE 70 SCOPE OF THIS REPORT

SEQUENCING INDUSTRY MARKET

TABLE 71 GLOBAL VALUE OF THE SEQUENCING MARKET BY PRODUCT TYPE, THROUGH 2016 ($ MILLIONS)

SEQUENCING INDUSTRY GROWTH DRIVING FORCES

TABLE 72 KEY GROWTH DRIVING FORCES IN THE DNA SEQUENCING MARKET

SEQUENCING PRODUCTS

SEQUENCING INSTRUMENTS AND CONSUMABLES

SAMPLE PREPARATION REAGENTS AND KITS

BIOINFORMATICS

SEQUENCING SERVICES

SEQUENCING PRODUCT LIFE CYCLE STATUS

TABLE 73 LIFE CYCLE OF DNA SEQUENCING TECHNOLOGIES

SEQUENCING INDUSTRY

TABLE 74 SEQUENCING INSTRUMENT COMPETITORS BY TECHNOLOGY

Abstract

A comprehensive analysis of the agricultural biotechnology industry, with an emphasis on products and technologies that are commercially important in the 2012 to 2017 time period.

An in-depth look at the demand for biosimilar drugs that have entered the market worldwide and forecasts the growth prospects for these products.

A detailed analysis of the kinase inhibitors industry structure has been conducted. Revenues are broken down by region. Sales figures are estimated for the five-year period from 2011 through 2016.

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