The Market for Osteoporosis Testing

The Market for Osteoporosis Testing

Industry Alert

How will the growing popularity of ultrasound systems and bone marker testing affect the osteoporosis testing market? This report focuses on the key product and market developments currently influencing the osteoporosis industry, helping you to establish the best strategy for your company in this fast-moving sector.

It examines:

Different osteoporosis products and therapies available
Purchasing trends for each major product type
The market potential for osteoporosis testing in different countries
Company distribution and marketing strategies

The Market for Osteoporosis Testing examines the wide range of osteoporosis diagnostic products currently available and investigates how new technologies are driving the market. The report provides osteoporosis screening market data to 2005 for each of the five main country markets in the US, Europe and Asia, enabling you to establish the structure and trends of each segment. It also includes detailed information on the companies leading the market in each product sector - outlining their strategies and providing you with invaluable market share data.

PUBLISHED: JUNE 1999
REF: CBS801E
PAGES: 90
PRICE: £250/$525/¥60,000

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CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
GLOSSARY AND ABBREVIATIONS

CHAPTER 1 INTRODUCTION
1.1 Bone as a tissue
1.2 Osteoporosis
1.2.1 Disease definition
1.2.2 Socio-medical significance
1.2.3 Bone mass and fracture risk
1.3 Diagnostic methods in osteoporosis
1.3.1 Bone densitometry methods
1.3.2 Quantitative ultrasound
1.3.3 Biochemical bone markers
1.4 Osteoporosis drugs
1.4.1 Hormone replacement therapy
1.4.2 Bisphosphonates
1.4.3 Calcitonin
1.4.4 Calcium and vitamin D
1.4.5 Other treatments
1.4.6 Osteoporosis treatment in men

CHAPTER 2 CURRENT AND FUTURE PRODUCTS
2.1 Diagnosis of osteoporosis
2.2 Bone densitometers - a technology-driven market
2.2.1 Quantitative computed tomography
2.2.2 Peripheral QCT
2.2.3 Dual energy X-ray absorptiometry
2.2.3.1 Axial DXA bone densitometers
2.2.3.2 Peripheral DXA bone densitometers
2.2.4 Radiographic absorptiometry
2.2.5 Quantitative ultrasound
2.2.5.1 Introduction
2.2.5.2 QUS at the calcaneus
2.2.5.3 QUS at the finger
2.2.5.4 QUS at the tibia and other sites
2.2.6 Future products
2.3 Biochemical bone markers
2.3.1 Introduction
2.3.2 Markers of bone resorption
2.3.3 Markers of bone formation
2.3.4 Future tests

CHAPTER 3 REIMBURSEMENT AND PURCHASING PRACTICES FOR OSTEOPOROSIS TESTS
3.1 Osteoporosis management
3.1.1 Osteoporosis management in Germany
3.1.1.1 The patient
3.1.1.2 The gynaecologist
3.1.1.3 The orthopaedist
3.1.1.4 The general practitioner and the intern
3.1.1.5 The specialist
3.2 Reimbursement of bone densitometry
3.2.1 Reimbursement in the US
3.2.2 Reimbursement in Europe
3.2.3 Reimbursement in Asia
3.3 Reimbursement of bone markers
3.3.1 Reimbursement in the US
3.3.2 Reimbursement in Europe
3.3.3 Reimbursement in Asia
3.4 Purchasing practice for bone densitometers
3.4.1 Purchasing practice in the US
3.4.2 Purchasing practice in Europe
3.4.3 Purchasing practice in Asia
3.5 Purchasing practice for bone markers

CHAPTER 4 THE MARKET FOR OSTEOPOROSIS DIAGNOSTICS AND TEST EQUIPMENT
4.1 Epidemiology of osteoporosis
4.1.1 Demographics: the ageing population
4.1.2 Prevalence of osteoporosis
4.1.3 Incidence of osteoporotic fractures
4.1.4 Prospects for the future
4.2 The market for bone densitometers
4.2.1 World market overview
4.2.2 The axial bone densitometer market
4.2.2.1 The axial bone densitometer market in the US
4.2.2.2 The axial bone densitometer market in Europe
4.2.2.3 The axial bone densitometer market in Asia and the Pacific Rim
4.2.2.4 The axial bone densitometer market in South America
4.2.3 The peripheral bone densitometer market
4.2.3.1 The peripheral bone densitometer market in the US
4.2.3.2 The peripheral bone densitometer market in Europe
4.2.3.3 The peripheral bone densitometer market in Asia
4.2.4 The QUS market
4.2.4.1 The QUS market in the US
4.2.4.2 The QUS market in Europe
4.2.4.3 The QUS market in Asia
4.3 The market for bone markers
4.3.1 World market overview
4.3.2 The bone marker market in the US
4.3.3 The bone marker market in Europe
4.3.4 The bone marker market in Asia

CHAPTER 5 COMPANY PROFILES
5.1 Major suppliers and manufacturers of bone densitometers
5.1.1 Aloka
5.1.1.1 Background
5.1.1.2 Strategy
5.1.2 CompuMed
5.1.2.1 Background
5.1.2.2 Strategy
5.1.3 Diagnostic Medical Systems
5.1.4 Hologic
5.1.4.1 Background
5.1.4.2 Strategy
5.1.5 IGEA
5.1.5.1 Background
5.1.5.2 Strategy
5.1.6 Image Analysis
5.1.6.1 Background
5.1.6.2 Strategy
5.1.7 Lunar
5.1.7.1 Background
5.1.7.2 Strategy
5.1.8 McCue Ultrasonics
5.1.8.1 Background
5.1.9 Mindways Software
5.1.9.1 Background
5.1.10 Myriad Ultrasound Systems
5.1.10.1 Background
5.1.10.2 Strategy
5.1.11 Norland Medical Systems
5.1.11.1 Background
5.1.11.2 Strategy
5.1.12 Osteometer MediTech
5.1.12.1 Background
5.1.12.2 Strategy
5.1.13 Picker International
5.1.13.1 Background
5.1.13.2 Strategy
5.1.14 Schick Technologies
5.1.14.1 Background
5.1.14.2 Strategy
5.1.15 Siemens
5.1.15.1 Background
5.1.15.2 Strategy
5.1.16 Stratec Medizintechnik
5.1.16.1 Background
5.1.16.2 Strategy
5.1.17 Sunlight Ultrasound Technologies
5.1.17.1 Background
5.1.17.2 Strategy
5.2 Major suppliers and manufacturers of biochemical bone marker tests
5.2.1 Bayer Diagnostics
5.2.1.1 Background
5.2.1.2 Strategy
5.2.2 Beckman Coulter
5.2.2.1 Background
5.2.2.2 Strategy
5.2.3 Bio-Rad Laboratories
5.2.3.1 Background
5.2.3.2 Strategy
5.2.4 Cholestech
5.2.4.1 Background
5.2.4.2 Strategy
5.2.5 Cortecs Diagnostics
5.2.5.1 Background
5.2.5.2 Strategy
5.2.6 Diagnostic Products Corporation
5.2.6.1 Background
5.2.6.2 Strategy
5.2.7 Metra Biosystems
5.2.7.1 Background
5.2.7.2 Strategy
5.2.8 Metrika Laboratories
5.2.8.1 Background
5.2.8.2 Strategy
5.2.9 Osteometer BioTech
5.2.9.1 Background
5.2.9.2 Strategy
5.2.10 Ostex International
5.2.10.1 Background
5.2.10.2 Strategy
5.2.11 Pacific Biometrics
5.2.11.1 Background
5.2.11.2 Strategy
5.2.12 Roche Diagnostics
5.2.12.1 Background
5.2.12.2 Strategy

REFERENCES

LIST OF TABLES
Table 1.1 Fracture risk at the age of 50
Table 1.2 Major methods of bone densitometry: advantages and disadvantages
Table 1.3 The intra-individual (day-to-day) variability of bone markers expressed as a coefficient of variation (%)
Table 2.1 Product portfolio categorised by technology of the three major bone densitometer companies - Lunar, Hologic and Norland Medical Systems (all US based)
Table 2.2 Comparison of fan-beam and pencil-beam whole body measurement
Table 2.3 Some device characteristics of major QUS instruments currently marketed
Table 2.4 Biochemical markers of bone turnover
Table 2.5 Biochemical markers of bone resorption, their bone specificity and commercial test kits
Table 2.6 Bone resorption tests on automated systems
Table 3.1 Different types of increments in the GO�
Table 3.2 Sales of osteoporosis drugs in Germany, 1994-1998 (DM million)
Table 4.1 Prevalence of people with a BMD of -2.5SD or below
Table 4.2 Age-adjusted incidence of distal forearm fractures compared with hip fractures in different populations of persons aged 35 and above (age-adjusted to the population structure of US whites (35 years old per 100,000/year), 1985
Table 4.3 Worldwide installed base of bone densitometers by technology and by region, 1997-1999
Table 4.4 Annual worldwide bone densitometry sales at end-user level by segment ($ million), 1994-2001
Table 4.5 Worldwide sales for bone markers ($ million), 1998-2004
Table 5.1 Aloka's financial performance 1991-1996 (¥ million)
Table 5.2 CompuMed's financial data ($ million), 1996-1998
Table 5.3 Hologic's sales breakdown ($ thousand), 1994-1998
Table 5.4 Lunar's sales breakdown by region ($ million), 1994-1998
Table 5.5 Lunar's sales breakdown by product sector ($ million), 1994-1998
Table 5.6 Norland Medical Systems' financial data ($ million), 1997-1998
Table 5.7 Norland Medical Systems' sales breakdown by region ($ million), 1994-1998
Table 5.8 Picker International's financial data ($ million), 1994-1996
Table 5.9 Schick Technologies' financial data ($ million), 1996-1998
Table 5.10 Siemens' financial data (DM million), 1997-1998
Table 5.11 Siemens' sales by region (DM million), 1998
Table 5.12 Bayer's sales figures (DM million), 1994-1997
Table 5.13 Beckman Coulter's sales by region ($ million), 1998
Table 5.14 Bio-Rad's sales figures ($ million), 1994-1998
Table 5.15 Cholestech's turnover ($ million), 1994-1998
Table 5.16 Cortecs International's financial data (£ million), 1995-1998
Table 5.17 Cortecs International's turnover by business sector (£ million), 1995-1997
Table 5.18 DPC's sales figures ($ million), 1994-1998
Table 5.19 DPC's sales figures by region ($ million), 1998
Table 5.20 Metra Biosystems' financial figures ($ thousand), 1994-1998
Table 5.21 Metra Biosystems' products, their applications and current regulatory status
Table 5.22 Ostex International's financial data ($ million), 1995-1998
Table 5.23 Pacific Biometrics' financial data ($ million), 1996-1998
Table 5.24 Roche Diagnostics' sales (SwFr million), 1994-1997
Table 5.25 Roche Diagnostics' sales by business category (SwFr million), 1998

LIST OF FIGURES
Figure 1.1 Definition of osteoporosis on the basis of change in bone mineral content compared with the normal level of young adults
Figure 1.2 The contribution of aetiologic risk factors and clinical risk indicators (falls, bone mass, and existing fractures) to remaining lifetime fracture probability
Figure 1.3 The spinal column
Figure 1.4 Diagnostic sensitivity of different bone density measurement sites (% change in risk per 1SD change)
Figure 2.1 Collagen structure and its breakdown products used as bone resorption markers
Figure 3.1 Flow-sheet of osteoporosis management in Germany
Figure 3.2 Development of bone mass measurements in public outpatient care in West Germany between 1988-1996 and East Germany between 1994-1996 with dates of changes in reimbursement
Figure 4.1 Change in ageing population in major industrialised countries, 1985-2005
Figure 4.2 Hip fracture incidence around the world as a ratio of the rates observed in US white women of the same age, 1990
Figure 4.3 Incidence of hip fracture at different levels of femur neck BMD in the EPIDOS study, 1995
Figure 4.4 Estimated number of fractures (thousands) for men and women in different regions of the world in 1990, 2025 and 2050
Figure 4.5 Growth of axial bone densitometers in key countries worldwide (units sold per million inhabitants), 1995-1998
Figure 4.6 Market shares of installed axial bone densitometers in the US
Figure 4.7 Market share of installed worldwide base of QUS bone densitometers, 1998
Figure 4.8 Market shares in the bone resorption marker market

EXECUTIVE SUMMARY
Osteoporosis is a systemic skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture. As the most common metabolic bone disease, osteoporosis may be regarded as a major source of mortality, morbidity and healthcare expenditure worldwide. Predicted to increase as the world population expands and ages, osteoporosis is also known as 'the unseen epidemic'.

Between one-third and half of all postmenopausal women, and almost half of the population of both sexes over the age of 75, have osteoporosis. A significant increase in the age-adjusted incidence of osteoporotic fractures, the end-point of osteoporosis, over the past 40-50 years has been reported from many countries. Osteoporotic fractures - at the vertebrae, hip or radius - are common, and their incidence will increase as the world population ages. Increased longevity is further compounding the problem. Estimates suggest that the number of hip fractures and their associated costs could triple by 2040. In the US, where osteoporosis is believed to affect 35 million people, the direct and indirect costs are estimated to be over $14 million.

Osteoporosis is now preventable and treatable but, as low bone mass alone causes no symptoms, there are no warning signs until a fracture occurs. Osteoporosis must be assessed indirectly through non-invasive measurement of bone mineral density (BMD). Thus, the disease is defined in practice by an intermediate outcome (BMD), and not a health outcome (eg fracture). In this way, osteoporosis is similar to hypertension, diabetes and hypercholesterinaemia.

The assessment of bone mass is central to the early diagnosis of osteoporosis. Four major methods of bone densitometry have become established in clinical use: dual energy X-ray absorptiometry (DXA), quantitative computed tomography (QCT), peripheral QCT and quantitative ultrasound (QUS). Among these, DXA has become the 'gold standard' due to its enhanced precision and accuracy. However, few physicians have access to these large, expensive machines and so are unable to assess the risk of bone loss in individual patients. QUS systems, which are portable, low cost, emit no radiation and have minimal regulatory requirements, have emerged as an adjunct to DXA techniques in osteoporosis management.

Recently, biochemical bone markers, especially those for bone resorption, have emerged as a new tool to assess bone dynamics. At present, resorption markers are used in the differential diagnosis of patients with low bone mass and, to a lesser extent, are used for monitoring therapy, especially for expensive treatments such as bisphosphonates.

Bone density testing is both concentrated and fragmented because of the diversity of technologies. The market for bone densitometers, divided into three instrument segments - axial densitometry, peripheral densitometry and QUS - is technology-driven. Worldwide, there are an estimated 29,000 installed bone densitometers. Annual sales reached about $500 million in 1998 but since then the market has shown a trend towards the increased use of ultrasound scanners due to their cheaper price, lack of radiation exposure, portability and minimal regulatory requirements.

Because QUS instruments are markedly cheaper, annual worldwide sales of bone densitometers are expected to decrease to $415 million by 2001. Lunar and Hologic, both US companies, dominate the worldwide market for axial bone densitometers. Between them they have created an oligopoly, controlling about 90% of the world market. Regionally, North America is the largest market, followed by Europe. Apart from North America, sales of axial bone densitometers, which are priced between $30,000-140,000 depending on their features, are rather flat.

About 65% of the worldwide market for peripheral bone densitometers is primarily in Asia, particularly Japan. The worldwide leading companies here are Aloka, Osteometer MediTech and Norland, together with Stratec Medizintechnik. Peripheral bone densitometers are selling worldwide at end-user prices of around $30,000 or lower.

The market for QUS devices - with more than 10 different players and technologies - is currently the only growing segment of the market for bone densitometers in absolute value terms. On a worldwide level, Lunar holds a market share of around 50%. QUS devices sell at average end-user prices of between $15,000-20,000.

The biochemical bone marker market is split between markers for calcium homeostasis, bone formation and bone resorption. Resorption markers are looked upon as those with the greatest potential, with an annual growth rate of 5-8%. In the immunoassay sector of the resorption marker market, dominated by manual test kits, Metra Biosystems, Ostex International and Osteometer BioTech have been the sole players because of patent protection.

With more resorption markers on automated systems reaching the market, there will be a shift from manual kits to tests on automated systems within the next 3 years, making resorption testing widely available. However, it has still to be proven that bone markers are of help in osteoporosis management in the individual patient.

The trend towards ultrasound and bone marker assays is greatly reducing the cost of screening and is opening up the market for many new companies. These new tests are also likely to have a positive impact on the market for osteoporosis drug therapies - in particular, the huge market for the prevention of osteoporosis which is largely untapped.

In addition, large pharmaceutical companies have shown a great interest in these developments, opening up the possibility of joint drug/test marketing exercises (Clinica 1999, 859, p17).