Macro-economic factors; Business model; Pharmaceutical industry; Healthcare
Abstract :
[en] Introduction: Technological innovations, new regulations, increasing costs of drug productions and
new demands are only few key drivers of a projected alternation in the pharmaceutical industry and
its underlying business model. Despite significant articles in the press, there is little medical and
economic evidence on the rationale driving the transformation from the traditional Research &
Development (R&D) model to new alternative business models, such as Mergers & Acquisitions
(M&A). The purpose of this review is to understand the macro-economic factors responsible for the
revolution of the pharmaceutical business model, by understanding the needs, desires, new
behavioral patterns, but also challenges within the industry. Considering these changes will be the
key to possessing a competitive advantage over the market players.
Areas covered: Existing literature on new macro-economic factors changing the pharmaceutical
landscape has been reviewed to present a clear image of the current market environment.
Expert commentary: Literature and media sources show that pharmaceutical companies are facing
an architectural alteration in their business model, with more M&A deals and collaborations
headlining the papers. Although Q1 2016 did show a major slowdown in M&A deals by volume since
2013 (with deal cancellations of Pfizer and Allergan, or the downfall of Valeant) pharmaceutical
analysts remain confident that this shortfall was a consequence of the equity market volatility. It
seems likely that the shift to an M&A model will become apparent during the remainder of 2016,
with deal announcements such as Abbott Laboratories, AbbVie and Sanofi worth USD 45billion [1]
showing the appetite of big pharma companies to shift from the fully vertical integrated business
model to more horizontal business models.
G.Appelboom, et al. Smart wearable body sensors for patient self-assessment and monitoring. Arch Public Health. 2014 Aug.;72:01–09. cited June. 13, 2016. Available. from http://archpublichealth.biomedcentral.com/articles/10.1186/2049-3258-72-28•• of considerable interest.
L.Taylor “Pharma business model must change radically:KPMG.” Daily News (April 08, 2014), sec. A.p.1
M.Ringel, P.Tollman, G.Hersch, et al. “Does size matter in R&D productivity. If not, what does?”. Nat Rev Drug Discov. 2013 Oct.;12:901–902. cited Feb02, 2016. Available from http://www.nature.com/nrd/journal/v12/n12/full/nrd4164.html
R.Robinson. Speciality drugs:an evolving commercial model. Pharma Voice. 2014 Feb.;15:20–23. cited Feb. 13, 2016. Available from http://www.pharmavoice.com/product/2862/
Internal Author. “3D-Drucker produziert Leicht-Gips aus Bienenwaben.” Deutsche Wirtschafts Nachrichten (Oct. 27, 2014), sec. A.p.1[8] Internal Author. Medikamententest in Frankreich:ein hirntoter, vier menschen in lebensgefahr. Spiegel. 2016 Jan 15; sec. A.pp.1-2.
L.Dearden. France clinical trial:one person brain-dead and five in hospital after drug testing “accident.” in Rennes. Independent. 2016 Jan 15:sec.A.p.1.
L.Mettler. “Fitnessdaten an einem ort sammeln:apples health-app läuft nun.” Netzwoche (Oct. 01, 2014), sec.A.p.1
M.Swan. Emerging patient-driven health care models:an examination of health social networks, consumer personalized medicine and quantified self-tracing. Int J Environ Res Public Health. 2009 June 13;6:492–525. Available from http://www.mdpi.com/1660-4601/6/2/492
Healthline. “The best weight loss apps for 2016.” Available from:http://www.healthline.com/health/diet-and-weight-loss/top-iphone-android-apps#3, May 24, 2016 [cited Sep.02, 2016]
Healthline. “The best heart disease iphone and android Apps of the year.” Available from:http://www.healthline.com/health/heart-disease/top-iphone-android-apps#2, Aug. 07, 2015 [cited Sep02, 2016]
LiveScience. “A good night’s rest:the best sleep apps.” Available from:http://www.livescience.com/49552-best-sleep-apps.html, Jan. 23, 2015 [cited Sep.02, 2016]
C.Paton et al.“Self-tracking:social media and personal health records for patient empowerment self-care. Contribution of the IMIA social media working group.” Yerb Med Inform [On- line]. Available from:http://www.ncbi.nlm.nih.gov/pubmed/22890336 [June 13, 2016]
Epocrates. “The #1 medical reference app.” Available from:http://www.epocrates.com, Jan. 31, 2016 [cited Sep.02, 2016]
B.P.Kovatchev et al. “Feasibility of outpatient fully integrated closed-loop control:first studies of wearable artificial pancreas.” Diabetes Care [On- line]. Available from:http://www.ncbi.nlm.nih.gov/pubmed/23801798 [June 13, 2016]
Doximity. Available from:https://www.doximity.com/[Sep. 1, 2016]
R.C.Wagenaar, et al. Continuous monitoring of functional activities using wearable, wireless gyroscope and accelerometer technology Annu Int Conf IEE Med Biol 2011. 2016 June 13. Available from https://www.semanticscholar.org/paper/Continuous-Monitoring-of-Functional-Activities-Wagenaar-Sapir/1ec2d2fe25430abe52cf9a01e488a460dd12817c/pdf
PWC. “Drug pricing” Available from:http://www.pwc.com/us/en/health-industries/top-health-industry-issues/drug-pricing.html, Jan 31, 2016 [cited Sep.01, 2016]• of considerable interest.
S.Ocano (2015, May). “TOP 10:medical apps for doctors and physicians.” Healthcare Global (cited May18, 2015), sec.A.p.1
S.Marwaha, S.Savas. “Navigating a changing health-care environment.” Available from:http://www.google.ch/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&cad=rja&uact=8&ved=0ahUKEwjKnOmSh6LLAhWrCJoKHY1qBWoQFgg2MAM&url=http%3A%2F%2Fwww.mckinsey.com%2F~%2Fmedia%2Fmckinsey%2Fdotcom%2Fclient_service%2FBTO%2FPDF%2FMOBT26_Pfizer_QA.ashx&usg=AFQjCNHYV1m46X2EUg8ytrugF4lY3zP1OQ, Jan. 25, 2012 [cited Feb.29, 2016].
OECD Competition Committee. “Competition and regulation issues in the pharmaceutical industry.” Available from:http://www.oecd.org/competition/sectors/1920540.pdf, Feb. 06, 2001 [cited Mar.09, 2016].
PWC. “New regulations bring new risks to life sciences firms.” Available from:http://www.pwc.com/us/en/health-industries/pharma-life-sciences/regulatory-risk-compliance.html, Dec. 15, 2015 [cited Mar.05, 2016].• of considerable interest.
Booz & Company. “Pharma emerging markets 2.2. how emerging markets are driving the transformation of the pharmaceutical industry.” Available from:http://www.strategyand.pwc.com/media/file/Strategyand_Pharma-Emerging-Markets-2.0.pdf, Dec.31, 2015 [cited Sep.01, 2016].
G.Reh et al. “2015 global life sciences outlook. Adapting in an era of transformation.” Available from:https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-life-sciences-report.pdf, Dec. 12, 2014 [cited Mar01, 2016].
N.William. “European council approves first-ever analysis of drug prices with look at IP rights”. Intellectual Property Watch (June 17, 2016), sec.A.p.1
P.Evans. “G7 ultimatum to drug makers on antibiotics.” The Sunday Time (Feb. 07, 2016), sec. A.p.1
European Medicine Agency. “Good pharmacovigilance practices” Available from:http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp Aug. 15, 2016 [cited Sep.01, 2016].
IBIS World. “Global biotechnology:market research report.” Available from:http://www.ibisworld.com/industry/global/global-biotechnology.html, Jan. 10, 2016 [cited Mar01, 2016].
Baxter. “Improving access to renal therapy in China.” Available from:http://www.baxter.com/corporate-responsibility/sustainability/resources/case-studies/2012-china-renal-therapy.page, Dec 01, 2012 [cited Sep.02, 2016].
European Union. “Innovative partnership ensures cheaper insulin in Africa.” Available from:https://europa.eu/eyd2015/en/novo-nordisk/stories/innovative-partnership-ensures-cheaper-insulin-africa, Oct 29, 2015 [cited Sep.02, 2016].
PWC. “New entrants:charting the health industry’s risk and regulatory landscape. Where risk meets opportunity.” Available from:http://www.pwc.com/us/en/health-industries/our-perspective/assets/pwc-healthcare-new-entrants-whitepaper.pdf, July 31, 2015 [cited Mar.01, 2016].• of considerable interest.
R.Mullin. “Cost to develop new pharmaceutical drug now exceeds $2.5B.” Scientific American (Nov. 24, 2014), sec. A. p.1
Tufts. “Tufts CSDD assessment of cost to develop and win marketing approval for a new drug now published.” Available from:http://csdd.tufts.edu/news/complete_story/tufts_csdd_rd_cost_study_now_published, Mar 10, 2016 [cited Sep.01, 2016].
C.Clorkson. “Studies fuel criticism of high drug development cost.” Financial Times (Feb. 15, 2016), sec. A. pp.1-2
C.Humer. “Exclusive:makers took big price increases on widely used U.S. drugs.“ Thomas Retuern (Apr. 05, 2016), sec.A.pp.1
M.Merrill. “The high cost of inventing new drugs - and of not inventing them.” Forbes (Apr. 11, 2015), sec. A. pp. 1-3
Assembly and the Workig Groups. “International medical products anti-counterfeiting taskforce.” Available from:http://apps.who.int/impact/handbook_impact.pdf?ua=1, 2006-2010 [cited Sep. 01, 2016].
M.Edwards. “R&D in emerging markets:a new approach for a new Era.” Available from:http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/r-and-38d-in-emerging-markets-a-new-approach-for-a-new-era, Feb. 12, 2010 [cited Mar.01, 2016].
G.Somra. “Deadly fake viagra:online pharmacies suspected of selling counterfeit drugs.” CNN (Aug. 31, 2015), sec. A. p.1
Internal Author. “Pfizer, lily and other giants team up to fight counterfeits.” Available from:http://www.in-pharmatechnologist.com/Regulatory-Safety/Pfizer-Lilly-and-other-giants-team-up-to-fight-counterfeits Nov. 23, 2015 [cited Mar.05, 2016].
The World Bank. “Anemic recovery in emerging markets to weigh heavily on global growth in 2016.” Available from:http://www.worldbank.org/en/news/press-release/2016/01/06/anemic-recovery-in-emerging-markets-to-weigh-heavily-on-global-growth-in-2016, Jan. 06, 2016 [cited Mar07, 2016].
World Economic Forum. “Health systems leapfrogging in emerging economies project paper 5.” Available from:http://www3.weforum.org/docs/WEF_HealthSystem_LeapfroggingEmergingEconomies_ProjectPaper_2014.pdf, Nov. 12, 2014 [cited Feb.11, 2016].
H.Lee. “China’s drug price-cuts are hitting big pharma where it hurts.” Bloomberg News (Mar. 08, 2016), sex. A.p.1
J.Miller. “Novartis hit by China, emerging market slowdown - CEO on CNBC.” Reuters (Sep. 18, 2015), sec. A.p.1
R.E.McKeown. The epidemiologic transition:changing patterns of mortality and population dynamics. Am J Lifestyle Med.2009 July 1;3:19S-26S. cited Apr.27, 2016. Available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805833
United Nations, Department of Economic and Social Affairs, Population Division. “World population ageing 2015.” Available from:http://www.un.org/en/development/desa/population/publications/pdf/ageing/WorldPopulationAgeing2015_InfoChart.pdf, Dec. 28, 2015 [cited Feb.11, 2016].
United Nations. “World Population Ageing 1950-2050.” Available from:http://www.un.org/esa/population/publications/worldageing19502050/pdf/80chapterii.pdf, Feb. 12, 2010 [cited Feb.23, 2016].
OECD Insights. “Health systems are still not prepared for an ageing population.” Available from:http://oecdinsights.org/2015/04/29/health-systems-are-still-not-prepared-for-an-ageing-population/, Apr. 29, 2015 [cited Feb.14, 2016].
World Health Organization. “Health transition”. Available from:http://www.who.int/trade/glossary/story050/en/, Feb. 13, 2007 [cited Apr. 26, 2016].
B.Rechel et al. “How can health systems respond to population ageing?” Available from:http://www.euro.who.int/__data/assets/pdf_file/0004/64966/E92560.pdf, June 15, 2009 [cited Feb.14, 2016].
Health Insurance Group. “Speciality drug.” Available from:https://www.healthinsurance.org/glossary/specialty-drug, Dec. 31, 2015 [cited Feb.29, 2016].
The Jackson Laboratory. “What is personalized medicine?” Available from:https://www.jax.org/genetics-and-healthcare/personalized-medicine/what-is-personalized-medicine, Dec. 31, 2015 [cited Feb.29, 2016].
A.Ward et al. “Three pharma deals worth $45bn reignite M&A boom.” Available from:http://www.ft.com/cms/s/0/a0199164-0d38-11e6-b41f-0beb7e589515.html, Apr. 28, 2016 [cited July28, 2016].• of considerable interest.