In this report, Kalorama has analyzed the late stage R&D pipeline of the 50 top companies in pharmaceuticals -- the companies that produce the lion's share of industry revenues. While the report looks at the entire pipeline to 2015, a key focus of the report is the increasing role of biopharmaceutical products. The growing interest in biotechnology development has transitioned the pharmaceutical industry to biopharmaceuticals in less than a decade. Companies such as Pfizer, Merck and Novartis have been unable to ignore the benefits of investing in biotechnology and have focused on a pipeline in this direction through strategic acquisitions and partnerships with biotech companies and/or through their own in-house research efforts.
This Kalorama Information market research report, Pharmaceutical Products of the Future: 50-Company Pipeline Analysis to 2015 captures these trends, extracting sales for all pharmaceutical and biopharmaceutical products (excluding prophylactic vaccines) and providing estimates and forecasts of the world biopharma market.
Among the top companies in biopharmaceuticals are, not surprisingly, the same names that have dominated pharmaceuticals for years - Pfizer, Merck and Novartis. These companies have been unable to ignore the benefits of investing in biotechnology and have focused on a pipeline in this direction through strategic acquisitions and partnerships with biotech companies and/or through their own in-house research efforts. Specialist companies such as Amgen and Genzyme, now competing with a growing number of companies. The result of all interest in biological solutions to major diseases? In creased activity in the research and development departments of major pharmaceutical companies in recent years, activity that we believe will have near-term market impact.
Issues and Trends discussed in this report include:
In this comprehensive look a the pipeline of major companies, Kalorama Information presents an accurate picture of the marketplace today, including
Kalorama Information's market research into this topic is based on review of government filings and company literature, but also interviews with executives and experts, and the perspective of an analyst who has authored scores of reports in this industry.
50 top companies make up over 90% of the world biopharmaceutical market; The top three companies have nearly a quarter of global sales in 2009.
Kalorama looks at each key player's late-stage pipeline in detail. The top 50 companies discussed in this report include:
What is Significant About This Report?
One of the trends we've found is that traditional specialist biotech companies are facing competition from the traditional pharmcos and the line between what is a 'biopharmaceutical company' and a 'pharmaceutical company' is hard to see anymore. Ask a major pharmco what they do and they will say - they are a biopharmaceutical company. It's not just PR - its evident in their pipeline, and this report takes a look at that pipeline.
How is the Report Constructed?
Pipeline analysis of government filings of the Top 50 pharmaceutical companies is the basis of the report. This analysis is conducted by an author of scores of market research reports on the topic.
On top of this, we looked at published company reports and most importantly interviewed executives and experts in the industry to verify the secondary research and analyst conclusions.
ONE OF MANY KEY TRENDS IN THIS REPORT
BIOTECHNOLOGY DRUG DEVELOPMENT
Biopharmaceuticals are defined as any substance produced by natural organisms or recombinant techniques consisting of proteins and other products derived from living organisms for the treatment or management of diseases or injuries. Biopharmaceuticals are created through fermentation, recombinant DNA technology, and other bioprocesses. Virtually all biotherapeutic agents on the market are biopharmaceuticals, which is simply any medically useful drug whose manufacture involves microorganisms or substances that living organisms produce. Most biopharmaceuticals are recombinant—that is, produced by genetic engineering. Insulin was among the earliest recombinant drugs.
Genetic engineering, also known as bioengineering, gene splicing, and recombinant DNA technology, comprises altering genetic molecules outside an organism such as inserting a segment of a very different DNA molecule into another DNA molecule and making the resultant DNA molecules (recombinant DNA) function in living things. Recombinant DNA technology enables genetically gearing microorganisms, animals, and plants—giving them human genes, for example—to yield medically useful substances, particularly scarce human proteins. In general, recombinant drugs approved by the FDA are safer than comparable natural-substance derivatives. For example, recombinant-DNA processes are precision techniques that inherently limit contamination and many biopharmaceutical agents are identical to or differ only slightly from, proteins in the human body. Genetic engineering is central to the development of biopharmaceuticals. The history of pharmaceutical biotechnology includes biotherapy is not a new entity.
Administering living things or biologic matter is an ancient approach to disease. History details that crude biologic products were used in China, India, and Persia. In 1928, Alexander Fleming’s discovery of penicillin in a common mold and the subsequent development of antibiotics prompted by World War II injuries necessitated large-scale manufacturing methods to grow the mold in huge tanks of broth. Hence, antibiotics and insulin were originally classified as biologics based on source and production methods. Both product categories have been transferred to CDER for regulation as drugs.
The split between drugs and biopharmaceuticals dates back to 1902 when Congress passed the Virus-Toxin Law, four years before the Food, Drug, and Cosmetic Act brought drugs under federal regulatory control. One of Congress’ first efforts to regulate therapeutic products, the Virus-Toxin Law specified manufacturing, inspection, licensing and labeling requirements for a growing new class of health care products known as biologics. This law became necessary when a batch of contaminated diphtheria antitoxin killed several school children in St. Louis. The equine blood used to prepare the antitoxin was contaminated with tetanus bacteria. In 1944, the original Virus Toxin Law was revised and incorporated into the Public Health Service Act, administered by the National Institutes of Health (NIH). NIH regulated biologics until 1972, when its Division of Biologics Standards moved them to the FDA. The division was eventually renamed the Center for Biologics Evaluation Research (CBER), which has similar responsibilities to regulate biologic products that the Center for Drug Evaluation and Research (CDER) exercises over drug products.
The current definition of biologic in the Public Health Service Act seems clear stating “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment or cure of a disease or condition of human beings.” This seems straightforward in definition but it is anything but settled in practice. In the world of product approvals, the line between biologics and drugs is anything but clear. For example, gamma globulin is clearly a blood component or derivative but that hasn’t slowed generic makers from entering the market. Over the years, CBER has approved products that are clearly drugs, CDER has approved products that are by definition biologics and both have approved products that are clearly medical devices. This has prompted territorial infighting within the FDA over classification of products as drugs, biologics or devices. Drugs versus biologic is more a legal and political distinction than a scientific issue. This blurring of the class lines has allowed innovative manufacturers to guide their own regulatory and commercial future.
In 1991, an agreement between the CDER and the CBER created a regulatory framework for biopharmaceuticals. Prior to this resolution, all ethical products were reviewed by CDER. Afterwards, drug molecules fell under the CDER domain, while products from living organisms/ tissues were governed by CBER. As part of the agreement, a dividing scheme was laid out, which has been criticized for its complexity and lack of consistency. Statutory guidelines are as follows:
Most of the biologic products on the market were approved under a biological license application and were regulated under the FDA’s Center for Biologics Evaluation and Research. However, in October 2003, the FDA switched many of the functions of CBER to CDER. The consolidation of these review functions and personnel is expected to produce a more efficient and effective review process for drugs and biologics by enhancing consistency and coordination of the process.
The Center for Drug Evaluation and Research is now in charge of monoclonal antibodies for in vivo use; cytokines, growth factors, enzymes, immunomodulators, and thrombolytic; proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions, except clotting factors; and other non-vaccine therapeutic immunotherapies. The Center for
Biological Evaluation and Research continues to oversee gene therapy, products composed of human or animal cells, or from physical parts of those cells, allergen patch tests, allergenics, vaccines, antitoxins, antivenins, venoms, in vitro diagnostics, preventative and therapeutic vaccines, toxoid, toxins intended for immunization, and blood and blood products.
TABLE OF CONTENTS
CHAPTER ONE: EXECUTIVE SUMMARY
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
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