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Biopharmaceutical and Vaccine Production Markets

  • August 2014
  • -
  • Kalorama Information
  • -
  • 98 pages

Though biotechnology has created many new therapies and vaccines – including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders – there are still huge challenges during the final stages of clinical drug testing for new biopharmaceuticals, as manufacturers decide when and how to risk production capital to upscale while anticipating FDA or EMA approval. During the past five years, estimates for biopharmaceuticals have varied widely as analysts and producers have juggled the promise of new drugs with the technological and financial risks of manufacturing them efficiently.

Biopharmaceutical and Vaccine Production Markets examines the total biopharmaceutical manufacturing market, including in its estimates all costs related to biopharmaceutical and vaccine production. It includes the following useful information for business planning:

- Market Forecasts and Estimates of Biopharmaceutical Manufacturing Costs
- Vaccine Production Estimates
- Trend Discussion
- Production Methods
- The Competitive Environment, including Contract Manufacturing and Outsourcing
- Regulation of the Market
- Company Profiles

The report contains production segmentations for the mammalian cell, microbial cell, monoclonal antibody, other recombinant protein, vaccine, and insulin manufacturing markets, with forecasts to 2018. The current competitive environment is noted, listing selected biopharmaceutical contract manufacturers, selected top-selling biopharmaceuticals, selected Asian biomanufacturing contract manufacturing organizations (CMOs), the top 10 biopharma companies based on 2012 biopharma revenues, and the top manufacturers by global biopharmaceutical manufacturing capacity.

Table Of Contents

Biopharmaceutical and Vaccine Production Markets
ONE: Executive Summary
Major Kinds of Biopharmaceuticals
Monoclonal Antibodies
Recombinant Proteins
Vaccines
Insulins
Other Biopharm Protein Products
Approved Biopharmaceutical Products
Biosimilars
TWO: Commercial Production
Process Overview
Production Systems
Cell Culture
Microbial Cells
Mammalian Cell Lines
Plant Cell Cultures
Insect Cells
Transgenics
Transgenic Plants
Transgenic Animals
Cell-Free Protein Production
THREE: Forecasts
Total Biopharmaceutical Manufacturing Costs
FOUR: Regulation
FDA-CBER
Allergenics
Blood and Blood Products
Cellular and Gene Therapy Products
Tissue and Tissue Products
Vaccines
EMA
FIVE: Competitive Environment
Originator and Contract Manufacturing
Outsourcing
Types of Contractors Involved in Biomanufacturing
Demand for Biopharmaceutical Manufacturing Increasing
Production Capacity for Biopharmaceutical Manufacturing
Alternative Methods Of Producing Biopharmaceuticals
CMOs Expanding Operations to Manufacture Biologics
Biomanufacturing in Asia
Top Manufacturers
Integrated RandD, Manufacturing Firms
Merger and Acquisition Activity
Licensing and Collaborations
SIX: Patents
Select Mammalian, Yeast, Insect, Plant, and Transgenic Patents
E. coli Patents
SEVEN: Geography
EIGHT: Profiles
Major Contract Manufacturers
Lonza AG
Boehringer Ingelheim GmbH
FUJIFILM Diosynth Biotechnologies
Sandoz
Royal DSM
Rentschler Biotechnologie
Celonic
BIOMEVA GmbH
ProBioGen AG
Baxter BioPharma Solutions/Baxter Bioscience
Major Biologics Firms
Amgen
Genentech/Roche
AbbVie Inc. (Abbott)
Biogen Idec
Regeneron Pharmaceuticals
Alexion Pharmaceuticals
Crucell /Johnson and Johnson
GlaxoSmithKline
Merck and Co. Inc
Novartis
Pfizer
Sanofi Pasteur
Other Contract Manufacturers
AAIPharma
A-Bio Pharma Pte Ltd.
ABL, Inc.
Affinity Life Sciences, Inc.
Ajinomoto Aminoscience, LLC
Alliance Medical Products, Inc.
Alpha Biologics
Biotecnol
Boston Mountain Biotech
Glycobia
Sutro Biopharma

LIST OF EXHIBITS

ONE: Executive Summary
Table 1-1: Indications for Biologic Class (Erythropoietin, Interferon a, Interferon ß, Monoclonal Antibody, Colony Stimulating Factors, Glucocerebrosidase), Partial
Table 1-2: FDA-Approved Therapeutic Monoclonal Antibodies
Table 1-3: Vaccine-Preventable Diseases, 2014
Table 1-4: Major Vaccine Manufacturers
Table 1-5: 2014 Biological License Application Approvals
Table 1-6: 2013 Biological License Application Approvals
Table 1-7: 2013 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
TWO: Commercial Production
Table 2-1: Biopharma Manufacturing Process Overview
Table 2-2: Systems for the Production of Biopharmaceuticals
THREE: Forecasts
Table 3-1: Total Biopharmaceutical Manufacturing Market, 2012-2018
Table 3-2: Mammalian Cell Production Market, 2012-2018
Table 3-3: Microbial Cell Production Market, 2012-2018
Table 3-4: Monoclonal Antibody Manufacturing Market, 2012-2018
Table 3-5: Other Recombinant Proteins, Manufacturing Market, 2012-2018
Table 3-6: Vaccine Manufacturing Market, 2012-2018
Table 3-7: Insulin Manufacturing Market, 2012-2018
FIVE: Competitive Environment
Table 5-1: List of Selected Biopharmaceutical Contract Manufacturers
Table 5-2: Selected Top-Selling Biopharmaceuticals, 2013
Table 5-3: Selected Asia Biomanufacturing CMOs
Table 5-4: Top 10 Biopharma Companies Based on 2012 Biopharma Revenues
Table 5-5: Top Manufacturers by Global Biopharmaceutical Manufacturing Capacity
Table 5-6: Top Pharmaceutical Acquisitions in 2013
List of Exhibits
Table 5-7: Top Ten Pharmaceutical Acquisitions in 2012
Table 5-8: Biopharmaceutical Licensing and Collaboartions in 2013
SIX: Patents
Table 6-1: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Mammal
Table 6-2: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Yeast
Table 6-3: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Insect
Table 6-4: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Plant
Table 6-5: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Transgenic
Table 6-6: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - E. coli
SEVEN: Geography
Table 7-1: Estimated Biopharmaceutical Manufacturing Capacity by Region,2014, by Revenues

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