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DISRUPTIVE INNOVATIONS AND GLOBAL NETWORKS: THE CASE OF GENOMICS AND PHARMACEUTICAL INDUSTRY
MARÍA A . POZAS CENTER FOR SOCIOLOGICAL STUDIES EL COLEGIO DE MEXICO APRIL 2014
The sequencing of the entire human genome - mapping and location of all human genes - achieved in 2001 is considered a radical innovation with potential to change in the coming years the paradigm of medicine and health systems worldwide.
We hypothesize that genomics, as a disruptive innovation, tends to produce global reorganization of several industries. Its global production networks become the fastest channel for genomics diffusion and dissemination.
To illustrate this hypothesis, the case of global pharmaceutical industry is analyzed as well as the form in which the new paradigm for drugs production modifies the domestic pharmaceutical industry in Mexico
DRUGS PRODUCTION CHANGING PARADIGM
MOLECULAR PATHWAY
NEW METHOD OF
DRUGS DISCOVERY
PATENT EXPIRATION DATES OF MAJOR PRODUCTS FOR R&D-BASED PHARMACEUTICAL TRANSNATIONAL CORPORATIONS
Patent owner Drug name Indicated use Patent expiry
Abbott Kaletra HIV/AIDS 2016
Norvir HIV/AIDS 2014
Astellas Prograf Transplant rejection 2008
Protopic Dermatitis 2014
VEScare Overactive bladder 2015
Astra Zeneca Crestor Cholesterol 2016
Seroquel Schizophrenia 2012
Boehringer Ingelheim Flomax Prostatic hypertrophy 2009
Bristol-Myers Squibb Efavirenz HIV/AIDS 2012
Daiichi Sankyo Cravit Infectious disease 2010
Mevalotin Cholesterol 2006
Olmetec High blood pressure 2016
Eisai Aricept Alzheimer’s 2010
AcipHex Gastroesophageal reflux 2013
Eli Lilly Zyprexa Schizophrenia 2011
Glaxo Smith Kline Epivir HIV/AIDS 2014
Relenza Influenza 2014
Seretide/Advair Asthma 2010
Hycamtin Cancer 2010
Johnson & Johnson Cozaar High blood pressure 2010
Merck Diovan High blood pressure 2010
Singulair Asthma 2012
Novartis Zometa Cancer 2013
Pfizer Lipitor Cholesterol 2011
Viagra Erectile dysfunction 2012
Xalatan Glaucoma 2011
Sanofi-Aventis/Bristol-Myers Squibb Plavix Anticoagulant/heart disease 2012
Sanofi-Aventis Taxotere Breast cancer 2013
Takeda Actos Diabetes 2011
Blopress High blood pressure 2012
Leuprorelin Prostate cancer 2014
Prevacid Ulcer 2009
Source: United Nations Conference on Trade and Development (UNCTAD), Investment in Pharmaceutical Production in the Least Developed Countries (UNCTAD/DIAE/PCB/2011/5), Geneva, United Nations, 2011.
[1] Note: Trademark registrations compiled by UNCTAD from United States Patent and Trademark Office, Trademark Electronic Search System; patent expiry dates compiled by UNCTAD from various sources, including investors reports and Internet searches (2011).
NEW GLOBAL STRATEGY
MERGERS BETWEEN LARGE PHARMACEUTICAL COMPANIES TO BALANCE
LOSSES DIVERSIFING THERAPEUTIC CATEGORIES AND EXPANDING THE
MARKET
MERGERS OR ACQUISITIONS OF GENERIC PHARMA COMPANIES IN EMERGING
COUNTIRES TO KEEP MARKET SHARE IN EXPIRED PATENT DRUGS
NEW RESEARCH MODELS IN ORDER TO ADAPT DRUGS TO SPECIFIC NEEDS IN
DEVELOPING COUNTRIES
SALE AS COMBOS, COMBINATIONS OF DRUGS ALREADY IN THE IN ORDER TO
KEEP THE RATE OF NEW PRODUCTS
PHARMACEUTICAL M&A DEALS
Date Company M&A target
1995 Glaxo B.Wellcome
1999 Astra Zeneca
2000 Pfizer Warner-Lambert
2004 Sanofi Aventis
2006 Bayer Schering-Plough
2006 Merck & Co. Serono
2007 Astra Zeneca MedImmune
2008 Novartis Alcon
2008 Teva (generics) Barr Pharma
2008 Roche Genetech
2009 Pfizer Whyeth
2009 Merck & Co. Schering-Plough
2009 Sanofi-Aventis Zentiva (generics)
2009 GlaxoSmithKline Stiefel Laboratories
2009 Sanofi-Aventis Merial (animal health)
2009 Abbott Laboratories/Solvy (pharmaceutical division) Solvy (pharmaceutical division)
2010 Merck-German Millipore
2010 Teva Ratiopharm
2010 Astellas Pharma OSI Pharmaceutical
2011 Sanofi Genzyme
2011 Bristol-Myers-Squibb Amira Pharma
2011 Johnson y Johnson Synthes
2012 Bristol-Myers-Squibb/Astra Zenca Amylin Pharma
2012 Glaxo Smith Kline Human Genome Sciences
2012 Bristol-Myers-Squibb Inhibitex
2012 Novartis Fouguera Pharma
2012 Astra Zeneca Ardea Biosciences
2013 Astra Zeneca Omthera
Source: Compiled by the author from various sources, including companies’ websites and Internet searches (2012).
In 2003 less than 100 trials per year were performed (AMIIF 2009).
In 2005 the figure had risen to 2,025 research, grouped into 425 protocols and 22 therapeutic areas (AMIIF 2009).
Investing in this type of study grew at a rate close to 15% annually (AMIIF 2009)
In these research projects were involved over two thousand researchers coming from research institutions in the whole country, 80% of which are public institutions (AMIIF 2009)
In 2011 the marketing of the 186 companies in the sector established in the country, of which 47 are subsidiaries of large multinationals, increased by 6.4 percent compared to 2010. (CANIFARMA, 2012).
On average industry sales grew 12% in the last five years (2007-2012). (CANIFARMA, 2012).
Finally, between 1993 and 2002 manufacturing of chemicals and pharmaceutical products in the country increased at a real rate of 4.85 % annually (Ministry of Health, 2005)
Diagram 1: Development process for new drugs and treatments
I
Activities performed in public research centers in Mexico
ABSORPTIVE CAPACITIES
A country’s absorptive capacity is measured by the existence of qualified human resources, scientific experience, accumulated technical abilities, infrastructure, and models of cooperation among universities, research centres and health institutions (hospitals and clinics). When combined with an efficient regulatory system, these capacities shape the structure of a host country’s health sector.
CHART 4 SCIENTIFIC AND TECHNICAL SERVICES RENDERED BY FOUR MEXICAN PUBLIC RESEARCH CENTERS TO THE
PHARMACEUTICAL AND FOOD INDUSTRIES, 1999-2012
Public Sector Research Centers Foreign pharmaceutical and food companies Domestic pharmaceutical companies and health centers GREEN: Services 1999-2004 BLUE: Services 2005-2008 RED: Services 2009-2012
EXAMPLE OF SCIENTFIC KNOWLEDGE OUTSOURCED BY PROJECTS NAME Analysis of endometrial genetic expression
Development of a new method to control cervical-uterine cancer
Proteomic analysis and techniques of assisted reproduction Proteomic analysis of spermatozoon
Development of a serological testing system for the early detection of human papillomavirus (HPV) antibodies Evaluation of automated polymerase chain reaction (PCR) tests for the detection of HPV
Evaluation of penetration effectiveness of pesticides for vector control
Clinical trial for diabetes mellitus control Home perimeter infection as a determinant of dengue transmission
Clinical trial phase II to evaluate vaccine immunogenicity and security Evaluation of inhibitory activity of antiseptics and disinfectants in clinical bacterial insulation in hospitals
Sensitivity to broad-spectrum antibiotics in clinic insulation of entire bacterium responsible for nosocomial infections; sensitivity to broad-spectrum in vitro antibiotics in clinic insulation; effect of supplementation with polyunsaturated fatty acids in neurologic development Identification of individuals with high probability of HCV infections
Randomized clinical study of a complementary diet programme in adult Mexican women Food intake of urban Mexican population
Evaluation of fatty acids intake by the Mexican population
Evaluation of the impact of fortified milk on the nutritional condition of beneficiary children Viability of school programs in the National Strategy against obesity and excess weight
Evaluation of the efficacy of incrementing milk in the in children with severe malnutrition; effects of vitamin D on the health of pre-school children
Efficacy of consuming iron-enhanced beans for humans Intake of a diet high in vitamins and minerals in Mexican women