Cambridge University Press
9781107024977 - The Business of Healthcare Innovation - By Lawton Robert Burns
Frontmatter/Prelims

The Business of Healthcare Innovation

The Business of Healthcare Innovation is a wide-ranging analysis of business trends in the manufacturing segment of the healthcare industry. It provides a thorough overview and introduction to the innovative sectors fueling improvements in healthcare: pharmaceuticals, biotechnology, platform technology, medical devices, and information technology. For each sector, the book examines the basis and trends in scientific innovation, the business and revenue models pursued to commercialize that innovation, the regulatory constraints within which each sector must operate, and the growing issues posed by more activist payers and consumers. Specific topics include market structure and competition, the economics and rationale of product development, pricing, sales and marketing, contract negotiations with buyers, alliances versus mergers, business strategies, and prospects for growth. Written by professors of the Wharton School and industry executives, the book shows why healthcare sectors are such an important source of growth in any nation’s economy.

“Since the first edition of The Business of Healthcare Innovation, the workings of the industry have become even more complex, intertwined, and tricky to navigate. The industry’s evolution is effectively captured in this successor edition which includes important updates relevant to traditional and newer, ‘maverick’ innovators who will find the insights and frameworks described to be invaluable.”

Peter A. Tollman, Ph.D., Senior Partner and Managing Director, The Boston Consulting Group

“Burns has produced an exceptional successor to The Business of Healthcare Innovation with this new edition. The original made an important contribution to those of us who work and invest in the life sciences. The updated and expanded chapters on challenges and possibilities for the pharmaceutical and biotechnology industries, the new insights into the potential of digital health, and the overall theme of convergence of technologies into an innovative model of modern medicine, make it a timely and valuable volume.”

G. Steven Burrill, CEO of Burrill & Company

“For an industry that serves the needs of patients with innovative medicines, there are few scholarly books that analyze the underlying business of the life sciences. The Business of Healthcare Innovation addresses this important need with a thoughtful and engaging analysis of the pharmaceutical and biotechnology sectors. I particularly enjoyed the discussion on biotech, including discussions on the range of business models and on the symbiotic relationship of biotech companies with pharma. If you’re interested in the ‘business of science,’ this is really worth a read!”

John Maraganore, CEO, Alnylam

“This book is the authoritative text on the medical device industry. The authors combine extensive research with intimate insights to distill a complex topic to its essential ingredients.”

Dan Starks, Chairman & CEO, St. Jude Medical

“After decades of anxiety, concerns with healthcare quality, costs and safety have become alarm. Several significant efforts by government and the private sector are underway to transform health care. These efforts center on diverse performance-based reimbursement mechanisms that bind those who provide care with those who purchase care.

As Burns astutely notes these efforts appear to view those organizations that provide products and services to the industry as incidental to the transformation of care. This view is a mistake.

Companies that deliver innovative advances in the lifesciences, medical devices and health information technology can be and are significant contributors to our collective efforts to improve care. Vaccines, medical imaging, pacemakers, and electronic health records are examples of these contributions.

The Business of Healthcare Innovation does an exceptional job of describing the nature, challenges and contributions of the companies that produce these products and services. This understanding is essential – effective care transformation requires the efforts of all stakeholders and that each stakeholder understand the nature of the others and how best to form and manage partnerships. Without this understanding care transformation will deliver less than we deserve.”

John Glaser, Ph.D., CEO, Siemens Health Services

“It has never been more important to study and understand the medical device sector of the healthcare market. As our U.S. and global healthcare systems transform themselves for the 21st century, the vital medtech industry approaches an important crossroads. Strong forces are arrayed to reshape the way it interacts with patients, clinicians, regulators, payers, and hospitals – in fact, to reshape fundamentally the medical device business model.

This book does an excellent job of breaking down this complicated subject into its unique elements and analyzing each in a clear, direct style that illuminates the key issues facing this rapidly changing industry. The discussion of the sources of, and impediments to, device innovation are particularly welcome. I recommend this astute analysis to healthcare executives, policy-makers, investors, innovators, and anyone else who wants to understand the critical importance and future direction of the medical device industry and medical device innovation.”

Michael A. Mussallem, Chairman and CEO, Edwards Lifesciences Corporation

“Innovation is the answer to the cost and quality challenges in health care today. Despite its importance, few scholars have offered a comprehensive assessment of innovation in medicine – what it is, how it arises in specific sectors, and what are the barriers to achieving transformation of health care. This ambitious work makes a substantial contribution to our understanding of this key concept in health care.”

Kevin A. Schulman, MD, MBA, Professor of Medicine and Gregory Mario and Jeremy Mario Professor of Business Administration, Duke University

“Health care looms as the central issue for the swarm of baby boomers seeking the goal of wellness in this decade. This primer by Burns and his colleagues nicely summarizes the challenges of developing new technologies that will be relevant and affordable. How will healthcare reform influence the healthcare industry to innovate and invest in new technologies? What will new regulatory approaches do to early stage investment in new therapies? How will the United States remain a net exporter of medical devices and pharmaceuticals that is the envy of the rest of the world? Can uncommon profitability in the device sector be perpetuated? How are the processes of research and development, collaboration, mergers, and acquisitions different in the pharmaceutical, biotechnology, and medical device industries? The answers can be found in this articulate and well-referenced text.”

Stephen Oesterle, MD, Senior Vice-President, Medtronic

“Burns provides an excellent overview of the competitive dynamics of the medical technology sector which has had increasingly significant effects on health service costs and outcomes. Understanding the dynamics of this sector is important for all future healthcare leaders and this comprehensive and accessible book provides first-rate coverage of the subject.”

Regina Herzlinger, Ph.D., Professor, Harvard Business School

“Every entrepreneur, no matter whether they be inexperienced or experienced, biotech or device, scientist or business person needs to read The Business of Health-care Innovation. It is not enough today to have a great idea; successful startups require knowledge of the past, present, and future of the our industry if they want a real shot at making a difference.”

Mark Levin, Partner and co-founder, Third Rock Ventures

Lawton Robert Burns, Ph.D., MBA is the James Joo-Jin Kim Professor, Professor of Health Care Management and Chair of the Health Care Management Department, and Director of the Center for Health Management and Economics at the Wharton School, University of Pennsylvania.


The Business of Healthcare Innovation

Second edition

Lawton Robert Burns


CAMBRIDGE UNIVERSITY PRESS
Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, São Paulo, Delhi, Mexico City

Cambridge University Press
The Edinburgh Building, Cambridge CB2 8RU, UK

Published in the United States of America by Cambridge University Press, New York

www.cambridge.org
Information on this title: www.cambridge.org/9781107607774

© Cambridge University Press 2012

This publication is in copyright. Subject to statutory exception and to the provisions of relevant collective licensing agreements, no reproduction of any part may take place without the written permission of Cambridge University Press.

First published 2005
Second edition 2012

Printed in the United Kingdom at the University Press, Cambridge

A catalogue record for this publication is available from the British Library

Library of Congress Cataloguing in Publication data

The business of healthcare innovation / [edited by] Lawton Robert Burns. – 2nd ed.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-1-107-02497-7 (hardback) – ISBN 978-1-107-60777-4 (pbk.)
I. Burns, Lawton Robert
[DNLM: 1. Diffusion of Innovation. 2. Health Care Sector. 3. Biotechnology–economics.
4. Equipment and Supplies–economics. 5. Technology, Pharmaceutical–economics. W 74.1]
610.28–dc23
2012013418

ISBN 978-1-107-02497-7 Hardback
ISBN 978-1-107-60777-4 Paperback

Cambridge University Press has no responsibility for the persistence or accuracy of URLs for external or third-party internet websites referred to in this publication, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate.


To Alex and Brendan


Contents

List of figures
x
List of contributors
xvi
List of abbreviations
xix
Preface to the first edition
xxvii
Acknowledgements to the first edition
xxix
1     The business of healthcare innovation in the Wharton School curriculum
Lawton Robert Burns
1
2     The pharmaceutical sector: rebooted and reinvigorated
Jonathan P. Northrup, Marina Tarasova, and Lee Kalowski
32
3     Pharmaceutical strategy and the evolving role of merger and acquisition
Lawton Robert Burns, Sean Nicholson, and Joanna P. Wolkowski
116
4     The biotechnology sector: therapeutics
Cary G. Pfeffer
194
5     Biotechnology business and revenue models: implications for strategic alliances and capitalization
Stephen M. Sammut
346
6     The medical device sector
Kurt H. Kruger and Max A. Kruger
376
7     The healthcare information technology sector
Adam C. Powell and Jeff C. Goldsmith
451
8     Healthcare innovation across sectors: convergences and divergences
Lawton Robert Burns, David M. Lawrence, and Stephen M. Sammut
515
Index
564

Figures

1.1         The US healthcare value chain
2
1.2         Technology and intensity of service as drivers of rising healthcare costs in the US
4
1.3         Composition of hospital expenses
12
1.4         Composition of hospital supply costs
13
1.5         Hospital, physician, and retail pharmaceutical spending in the US (1975–2009) (as percentage of national health spending)
14
1.6         Hospital, physician, and retail pharmaceutical spending in Canada (1975–2009) (as percentage of national health spending)
14
1.7         US healthcare manufacturing firms: revenues and rank in Fortune 500
18
1.8         US healthcare manufacturing firms: rank in Fortune Global 500 (2005 and 2010)
22
2.1         World pharmaceutical sales by region ($US billion)
35
2.2         Top forty pharmaceutical companies ($US billion)
43
2.3         Top research and development (R&D) budgets ($US billion)
44
2.4         Drug development attrition rate
70
2.5         Cash flow model
71
2.6         Loss of sales from patent expirations (2010–2012) ($US billion)
74
2.7         Obesity drugs
75
2.8         New chemical entities (NCEs) at the Food and Drug Administration (FDA) (2006–2010)
76
2.9         Approvals of new chemical entities (NCEs) and biologics (1996–2010)
76
2.10        Length of clinical development (2000–2010)
77
2.11        Announced job cuts by sector (2009–2010)
78
2.12        Top announcements of jobs cuts in the pharmaceutical industry
79
2.13        Clinical sites by world region in 2007
82
2.14        Recent notable clinical failures, delays, and setbacks
84
2.15        Recent notable clinical successes
85
2.16        Refuse-to-file letters issued by the Food and Drug Administration (FDA) (2003–2007)
86
2.17        Pharmaceutical sector stakeholders
89
2.18        Increasing control in pharmacy plans
94
2.19        China market and potential ($US billion)
102
3.1         Research and development (R&D) spend and new molecular entity (NME) approvals (1990–2008)
120
3.2         Transforming pharma and biotech merger and acquisition (M&A) deals (1991–2010) (deal price exceeding $US 500 million)
127
3.3         Pharma and biotech merger and acquisition (M&A) deals (1991–2010) (deals of all sizes)
127
3.4         Leading pharma companies emerging from mergers and acquisitions (M&As) (1979–2010)
128
3.5         Pharma–pharma strategic alliances (1991–2010)
129
3.6         Top rationales for 2004 merger of Sanofi/Aventis
160
3.7         Open-source innovation in pharma business model
167
3.8         Deal structures in open-source innovation
168
4.1         Discoveries driving the biotechnology industry
197
4.2         Impact of the Bayh–Dole Act on the biotechnology sector
200
4.3         The biotechnology industry (year of company founding)
201
4.4         Stock market performance
202
4.5         Biotechnology v. Merck and Pfizer
203
4.6         US biotechnology sales and net gain (2001–2008)
206
4.7         Selected biotechnology-derived drugs
207
4.8         Therapeutic monoclonal antibody-based products approved in US, EU, Japan, or China
214
4.9         Alternative protein-based scaffolds under development
215
4.10        Selected recent collaboration deals for novel protein therapeutic scaffolds
216
4.11        Recent acquisitions of antibody (or related technology) companies
216
4.12        Selected genomics companies
217
4.13        Selected personal genomics companies
218
4.14        Selected proteomics companies
220
4.15        Selected Alnylam deals
223
4.16        Selected systems biology companies
224
4.17        Selected biotechnology fully integrated pharmaceutical companies (FIPCOs)
227
4.18        Selected biotechnology platform companies
228
4.19        Selected Millennium Pharmaceutical alliances
230
4.20        Selected millennium pharmaceutical acquisitions
231
4.21        Venture funding trends for no research, development only (NRDO) companies v. research and development (R&D) companies (2000–2004) ($US billion)
234
4.22        No research, development only (NRDO) v. research and development (R&D) company financings (public and private)
234
4.23        Selected recently founded no research, development only (NRDO) biotechnology companies
234
4.24        Initial public offering (IPO) v. venture capital funding (2003–2009)
237
4.25        Ten years of initial public offerings (IPOs), US v. global (2000–2009)
238
4.26        Financing alternatives
240
4.27        Private investment in public equity (PIPE) financings in the US (2000–2009)
241
4.28        US biotechnology financing trends (2003–2009)
244
4.29        US biotechnology financings (2003 v. 2009)
245
4.30        Initial public offerings (IPOs) in the US: ten-year trend
245
4.31        Pharmaceutical v. biotechnology companies
248
4.32        What makes alliances work
250
4.33        $US 100 million+ alliances (1998–2008)
252
4.34        Selected early partial acquisitions in biotechnology
253
4.35        Global sales at risk from patent expiration (2008–2014)
255
4.36        Proportion of drugs originated, by company type (2000–2008)
256
4.37        Percentage of reported pipeline compounds originated externally (2002 and 2007)
257
4.38        Financial effect on pharmaceutical companies of products coming off patent
259
4.39        Drug development scorecard (2006–2007)
260
4.40        First-in-class/innovative drugs launched in 2007 (total of eight)
261
4.41        Pharmaceutical sales generated from in-house discovery efforts
261
4.42        The “biotechification” of big pharma
264
4.43        Number of announced acquisitions > $US 20 million and aggregate total value by year
265
4.44        Early-stage alliances driving most of the activity
265
4.45        Option-based licensing (2004–2009)
266
4.46        Selected recent merger and acquisition (M&A) deals that include an option to buy a company
266
4.47        Aggressive mid-tier pharmaceutical companies accounting for >$US 10 billion in deal value (2007–2009)
267
4.48        Payments in pharma/biotech alliances: mid-stage deals (2005–2009)
267
4.49        Payments in pharma/biotech alliances: late-stage deals (2005–2009)
268
4.50        Selected merger and acquisition (M&A) transactions involving biotechnology companies
268
4.51        Selected acquisitions of biotechnology companies to access technology
269
4.52        Comparing the domestic biotech industry with the rest of the world ($US million) (2008)
275
4.53        EU v. US biotechnology industry comparison (2008)
276
4.54        Biotechnology products in development across Europe (2009)
277
4.55        European biotech financings (1999–2009)
277
4.56        Aggregate market capitalization of biotechnology companies across Europe (2003)
278
4.57        Selected German biotechnology company partnerships (2007–2008)
282
4.58        Venture capital by EU country
283
4.59        Canadian v. US sources of funding for biotechnology (2009)
284
4.60        Asia-Pacific biotechnology growth (2005–2009)
285
4.61        Asia-Pacific biotech market segmentation
286
4.62        Japan biotech market (2005–2014)
288
4.63        Number of biotechnology ventures in Japan (2003–2006)
289
4.64        Recent major biotechnology-related regulations and changes in legal structure that expand biotechnology business opportunities in Japan
290
4.65        Japanese alliances (2006–2008)
291
4.66        Selected recent Takeda deals
291
4.67        Selected top scientific leaders working in Singapore
292
4.68        China-patented product market forecast (2005–2019)
293
4.69        Chinese government policies for the development of the biotechnology industry
295
4.70        Australian biotech public financings (2002–2009)
299
4.71        Recent selected biotechnology deals
300
4.72        Selected challenges of commercializing drugs in foreign markets
303
4.73        Federal biotechnology regulatory framework
304
4.74        Center for Drug Evaluation and Research (CDER) fiscal year 2007 application review (status as of Sept. 30, 2008)
305
4.75        Food and Drug Administration (FDA) drug approvals (1996–2009)
306
4.76        US states funding stem cell-related research
311
4.77        Biotechnology companies focused on stem cell therapies
313
4.78        Selected top biopharmaceuticals and their biogeneric status
315
4.79        Food and Drug Administration (FDA) orphan drug approvals (1990–2009)
317
4.80        Project BioShield biotechnology grants/purchases
319
4.81        Active regional harmonization initiatives around the globe
322
5.1         Biotechnology industry characteristics (2005–2009)
354
5.2         Capitalization trends in the US life sciences industry (2003–2010) ($US million)
355
5.3         Representation of the dynamics of biotechnology strategies and structures and their revenue models
358
5.4         Proteomics toolbox technologies
364
5.5         The “omics” development chain
370
6.1         Medical products sector: worldwide revenues (1995–2009) ($US billion)
377
6.2         Medical devices and hospital supplies/commodities (1995–2009) ($US billion)
379
6.3         Medical devices markets: major categories (2009 worldwide revenues) ($US billion)
382
6.4         Orthopedics product detail (2009 revenue) ($US billion)
383
6.5         Cardiovascular product detail (2009 revenue) ($US billion)
384
6.6         A selection of large medical device companies (2009)
385
6.7         US medical device companies: overseas revenue mix (2009 revenue) ($US million)
387
6.8         Selected non-US medical device company revenues ($US million)
387
6.9         Sources and consumption of medical products, US and outside US (consumption per capita 2009) ($US billion)
389
6.10        Implant and usage rates (per capita 2009)
390
6.11        Wither growth, whither growth? Executive summary: medical device growth drivers
392
6.12        Wither growth, whither growth? Medical device growth drivers
394
6.13        Revenue boost from unidentified products
404
6.14        Attractiveness features of segments
407
6.15        Operating margins for select medical device companies (2004–2010)
410
6.16        Flow diagram: “before”
412
6.17        Flow diagram: “after”
412
6.18        Percutaneous heart valves v. conventional heart valves: prices and margins
417
6.19        Direct sales personnel for selected product segments and geographies
418
6.20        Selling efficiencies (US) per physician dollars and implant rates
422
6.21        Marketing expenses for selected manufacturers (2009) ($US million)
422
6.22        Operating expenses: averages and selected companies (2009) ($US million)
423
6.23        Price-to-earnings ratios (P/E): comparisons between pharmaceuticals and medical products companies
425
6.24        The number of acquisitions and their value (2003–2009)
435
6.25        Medtech concentration ratios: a consolidating industry (revenues $US billion)
437
6.26        Pharmaceutical concentration ratios: a consolidating sector (revenues $US billion)
438
6.27        Medical products initial public offerings (IPOs) (2004–2009)
441
7.1         Information technology (IT) spending as a percentage of operating expenses (2008)
452
7.2         RAND Corporation estimates of the benefits of electronic medical record (EMR) systems ($US billion)
454
7.3         Number of transistors in modern microprocessors over time
456
7.4         Comparison of the 2008 healthcare information technology (IT) and non-healthcare IT revenues of major players
459
7.5         Evolution of electronic medical record (EMR) systems
471
7.6         The iPhone 4, a mobile sensor array
479
7.7         Public demands for healthcare information technology (IT) (Health Information National Trends Survey 2007)
496



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