Biologics Outsourcing Global Market - Forecast to 2025

Published by IQ4I on 16th August 2017 | Ref: 1005261 | This Report Is In Stock

$7200 | Single User
$9000 | Site License
$12000 | Enterprise License
$7200 | Single User
$9000 | Site License
$12000 | Enterprise License

Introduction

The biologics outsourcing global market is expected to grow at double digit CAGR to reach .3 billion by 2025. Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids made from natural sources such as human, animal or micro organisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies and gene therapies. Like small molecule drugs, these drugs are intended for treatment of diseases and medical conditions. However, Biologics bring into picture higher range of specificity in treating a disease condition as the biologic entities like monoclonal antibodies and recombinant proteins target specific areas in the molecular mechanism of disease action.

Although biologics are much costlier than small molecule drugs, these classes of drugs prove to be highly beneficial for the patient and also bring about 40% higher profit to the manufacturers when compared to small molecule drug treatments. Due to the increasing demand for biologics drugs and increased regulatory approvals for these drugs, there is huge demand for biologics manufacture and testing at various levels of clinical studies as well as commercial supply. The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing this piece of work to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). These organizations bridge the gap between demand and supply and ensure the drug discovery process gets much faster and convenient thus bringing life saving drugs to the market to reach the needy patients.

In 2016, eight out of 10 blockbuster drugs were biologics showing a steep growth in acceptance of biologics in comparison with small molecule drugs. Some of the top selling biologics in 2016 include Humira ( billion), Rituxan (.5 billion), Herceptin (.7 billion), Prevnar 13 (.0 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologics development starting preclinical stage to commercial manufacturing. The high complexity of biologics development and manufacture requiring huge technical expertise is prompting major biopharma companies turn to outsourcing as a viable option. Various stages of biological development require different types of services as listed below.

Discovery services- Includes lead identification and validation for identifying possible drug candidates targeting specific diseases. The process further involves steps such as target validation, screening preparation, hit generation and lead selection, lead optimization and characterization and finally lead selection.

Preclinical development services- Involves in vitro and in vivo studies of the biologic drug candidates before testing them on humans to test the safety, efficacy and biological functionality against the disease target. Preclinical services include cell line engineering, process development, product analytical characterization, cGMP cell banking, cell line characterization, animal model assay development and testing services.

Clinical development- Clinical development includes testing potential drug candidates on humans in phase I, II and II trials. Services at this stage include cGMP grade clinical supply of biologics such as Mab, or recombinant protein, stability testing, fill/finish and regulatory support.

Commercialization- Once the drug has passed all the necessary approvals, the manufacture, marketing and sale of commercial quantities is performed. Outsourcing partners here manufacture the commercial supply for product launch and sale.

Table of Contents

1 BIOLOGICS OUTSOURCING GLOBAL MARKET 19

1.1 INTRODUCTION 19

1.2 LANDSCAPE OF BIOLOGICS MARKET 20

1.3 BIOLOGICS GLOBAL MARKET 25

1.4 CHINA BIOLOGICS OUTSOURCING MARKET 27

1.5 CHINA VS INDIA - BIOLOGICS MARKET 28

2 MARKET ANALYSIS 37

2.1 INTRODUCTION 37

2.2 FACTORS INFLUENCING MARKET 39

3 BIOLOGICS OUTSOURCING GLOBAL MARKET, MARKET ANALYSIS 58

3.1 INTRODUCTION 58

3.2 DISCOVERY AND PRE-CLINICAL DEVELOPMENT PROCESS 67

3.3 BIOLOGICS OUTSOURCING GLOBAL MARKET, BY PRODUCT TYPE 77

3.4 MARKET SHARE ANALYSIS 108

3.5 COMPANY DEVELOPMENTS 112

3.6 SERVICE COST ANALYSIS 133

4 BIOLOGICS OUTSOURCING GLOBAL MARKET – ANIMAL MODEL

SERVICES 148

4.1 INTRODUCTION 148

4.2 ETHICS AND REGULATIONS 161

4.3 ALTERNATIVES TO ANIMAL MODELS 163

4.4 OVERVIEW OF APPLICATIONS OF ANIMAL MODELS 165

4.5 MARKET SHARE ANALYSIS 175

4.6 COMPETITIVE LANDSCAPE 176

4.7 COMPANY DEVELOPMENTS 187

5 BIOLOGICS OUTSOURING GLOBAL MARKET - BIOMANUFACTURING 196

5.1 INTRODUCTION 196

5.2 CONTRACT BIOMANUFACTURING, BY PROCESS 203

5.3 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY END USERS 209

5.4 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY REGION 218

5.5 COMPETITIVE LANDSCAPE 220

5.6 COMPANY DEVELOPMENTS 226

6 BIOLOGICS OUTSOURCING GLOBAL MARKET - CELL LINE DEVELOPMENT 237

6.1 INTRODUCTION 237

6.2 CELL LINE DEVELOPMENT 241

6.3 HOST CELL LINES 246

6.4 CELL LINE DEVELOPMENT SERVICES MARKET, BY EXPRESSION SYSTEM 250

6.5 CELL LINE DEVELOPMENT SERVICES, BY CELL TYPE 255

6.6 CELL LINE DEVELOPMENT SERVICES, BY APPLICATIONS 264

6.7 KEY DEVELOPMENTS 283

6.8 MARKET SHARE ANALYSIS 305

7 COMPANY PROFILES 310

7.1 ABZENA PLC 310

7.2 ADIMAB LLC. 319

7.3 ALBANY MOLECULAR RESEARCH INC 325

7.4 BEIJING VITAL STAR BIOTECHNOLOGY CO. LTD. 334

7.5 BOEHRINGER INGELHEIM 337

7.6 CATALENT INC. 344

7.7 CHARLES RIVER LABORATORIES 354

7.8 CROWN BIOSCIENCES 365

7.9 GENOWAY 370

7.10 GENSCRIPT BIOTECH CORPORATION 374

7.11 GL BIOCHEM 383

7.12 HORIZON DISCOVERY GROUP, PLC 386

7.13 JACKSON LABORATORY 397

7.14 INNOVENT BIOLOGICS 401

7.15 JHL BIOTECH INC. 403

7.16 JOINN LABORATORIES CO. LTD 407

7.17 LONZA GROUP 410

7.18 MERCK KGAA 419

7.19 PATHEON N.V. 430

7.20 PHARMALEGACY BIOTECHNOLOGY 437

7.21 PHARMARON 443

7.22 PROSCI INC. 447

7.23 PROTEOGENIX 450

7.24 PSYCHOGENICS INC 453

7.25 SELEXIS SA 458

7.26 SHANGHAI MEDICILON 462

7.27 SHANGPHARMA CORPORATION /SHANGHAI CHEMPARTNER 470

7.28 SINO BIOLOGICAL 478

7.29 SUNDIA MEDITECH CO., LTD. 484

7.30 SYNGENE INTERNATIONAL 486

7.31 TACONIC BIOSCIENCES 506

7.32 VIVA BIOTECH LTD. 510

7.33 WUXI APPTEC 514

Additional Details

Publisher

IQ4I

Publisher Information

Reference

1005261 |

Number of Pages

527

Report Format

PDF

Related Reports

Title
Date Published
Price From
Link

This report is published by IQ4I

Download Free Report Summary PDF

Biologics Outsourcing Global Market - Forecast to 2025 | Download PDF Summary

Download our FREE report summary PDF. It contains all the information on these web pages, plus a Proforma Invoice request form, should you need it to satisfy your company's internal order procedures.

Ordering Information

Orders are processed immediately and you will be notified of the despatch date on confirmation of your order.

Accepted Card Types

Payment

Buy now using our secure payment system.