Market Report Source

Overview

Introduction

The long-standing unmet need of the osteoporosis market has been for improved adherence to treatment. Two pipeline products, Amgen’s Denosumab and Novartis’ Aclasta (zoledronate), have answered this demand with intermittent dosing schedules and consequently are expected to generate blockbuster revenues. This will rejuvenate the market which is otherwise stalling under multiple patent expiries.

Scope

• Analysis of patient potential, unmet needs and clinical trial design in osteoporosis
• Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the R&D pipeline
• Detailed profiles of key compounds in development for use in osteoporosis, with forecasts of drug revenues to 2016
• Review of the key strategies adopted by current market players

Highlights

Despite the genericization of the market leader Fosamax and patent expiries on other key brands, pipeline products are still viable. Datamonitor expects pipeline products to swell the total market value 4.4% between 2007 and 2016 to $10.9 billion. Products that offer intermittent dosing schedules are highly desirable in the osteoporosis market and can generate blockbuster revenues. Such therapies answer the demand from patients and physicians for more convenient delivery mechanisms that increase compliance and ultimately improve treatment outcome. Although bisphosphonates are the mainstay of osteoporosis treatment, there is potential for new and innovative products to gain market share. Those that suit niche populations, such as Amgen’s ED-71 which finds favor as a vitamin D analogue in Japan, will be able to fight generic competition.

Reasons to Purchase

• Understand clinical and environmental unmet needs in the osteoporosis market based on key opinion leader comments
• Benchmark key late-stage pipeline products against the current market leader and class comparator
• Assess the global (US, Japan, five major EU) sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoporosis market

Key metrics

Datamonitor Pipeline Assessment Summary

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Traditional, well-stocked pipeline

Growing PTH class hints at upcoming innovation

Reformulation as a substitute for innovation

Osteoporosis drug development not limited to big pharma

Key companies involved in the osteoporosis pipeline

Merck & Co.: coping with change

Merck’s line expands, but the patent is wide open

Limited hope in the pipeline

Novartis: an old player with new strategies

Osteoporosis indication a key driver in Zometa growth

New classes and patent expiration represent threats

GlaxoSmithKline: A newcomer with a long-term approach

Boniva as a learning curve

Pipeline hints at future success

Key R&D company strategies

Optimizing administration

Yearly dosing has potential as the next stage in intermittent dosing

Options in delivery mode maintain whole brand sales

The addition of mineral supplements: calcium and vitamin D

Additional dose calcium satisfies physicians’ demands

Combining vitamin D aids Merck’s key brand’s lifecycle

Genericization: if you can not beat them, join them

CHAPTER 3 OSTEOPOROSIS – MARKET POTENTIAL

Definition of osteoporosis

Etiology of osteoporosis

Osteoporosis classification: primary and secondary

Pathology and complications

Development of osteoporosis drugs

Segmentation of osteoporosis

Severity

Gender: osteoporosis in men

Niche populations

Glucocorticoid-induced osteoporosis

Paget’s disease

CNS disorder-related fracture risk

Ethnic diversity

Prostate cancer

Premature menopause

HIV

Anorexia nervosa

Epidemiology of osteoporosis

Methodological difficulties in assessing prevalence

Prevalence of osteoporosis and osteopenia in postmenopausal women

Overview of the prevalence of osteoporosis and osteopenia in postmenopausal women

US

Japan

France

Germany

Italy

Spain

UK

Prevalence of osteoporosis and osteopenia in men

Introduction

Overview of the prevalence of osteoporosis/osteopenia in men

US

Japan

France

Germany

Italy

Spain

UK

Osteoporotic fractures, their implications and minor risk groups

Introduction

Limitations of fracture prevalence data

Overview of fracture prevalence

US

Japan

France

Germany

Italy

Spain

UK

Epidemiological trends

Unmet needs in osteoporosis

Unmet clinical needs

Need for improved compliance

Need for efficacy at least equivalent to Fosamax and Actonel

Need for surrogate endpoint efficacy

Need for efficacy at the hip

Unmet environmental needs

Need for increased patient identification, treatment rates and use of appropriate treatments in each patient

Need for primary prevention in osteoporosis – preventing the first fracture reduces the future fracture burden

Need for greater recognition of secondary causes of osteoporosis

Need for greater recognition of male osteoporosis and causes of secondary osteoporosis in men for screening or case-finding purposes

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Bisphosphonates

Mechanism of action

Class breakdown

The gold standard therapy: Fosamax

Bisphosphonates threatened by genericization

Pipeline bisphosphonates

SERMs

Mechanism of action

Pipeline SERMs

Calcitonins

Mechanism of action

Pipeline calcitonins

Parathyroid hormone (PTH) and analogues

Mechanism of action

Pipeline PTH

Dual action bone agents (strontium ranelate)

Mechanism of action

Pipeline DABAs

Hormone replacement therapy (HRT)

Mechanism of action

Class breakdown

Pipeline hormonal therapies

Vitamin D

Mechanism of action

Pipeline vitamin D

Other mechanisms of action

Monoclonal antibodies

Cathepsin K inhibitors

Clinical trial design in osteoporosis

Clinical trial guidelines

Pre-clinical planning: use of animal models

Prevention and treatment: the implications for endpoint selection

Trial design and study population

Osteoporosis trial design and execution: can anything replace fracture data?

Problems with definitions: a need for greater consistency

Large-scale trials: can surrogate endpoints ever predict fracture risk?

The ethics of placebo-controlled trials: is there a realistic alternative?

Recruiting the right study population

Clinical trial endpoints in osteoporosis

Fracture rate

Significance of fracture rate as an endpoint

Considerations with fracture endpoints

Changes in BMD

Significance of BMD as an endpoint

Limitations of BMD as a clinical trial endpoint

Biochemical markers of bone turnover

How useful are bone markers?

Limitations in the use of bone-specific markers

Surrogate endpoints: predicting fracture risk

Changes in bone microarchitecture

Problems associated with microarchitecture assessment

CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview for bisphosphonates

Definition of current comparator therapy – Fosamax

Clinical trial data

Aclasta/Reclast (zoledronate/zoledronic acid)

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Bisponal/ONO-5920 (minodronic acid hydrate)

Drug profile

Clinical trial data

Patient potential

Market potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

MER-103 (alendronate sodium)

Drug profile

Clinical trial data

Patient potential

Market potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the bisphosphonate class

Nerixia (neridronic acid)

Abiogen’s expertise may offset a halting development

CHAPTER 6 SERMS LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for SERMs

Definition of current comparator therapy – Evista

Bazedoxifene

Drug profile

Clinical trial data for the treatment of osteoporosis

Clinical trial data for the prevention of osteoporosis

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the SERM class

Arzoxifene (LY353381)

Lilly’s Evista follow on?

PSK-3471

CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for calcitonins

Definition of current comparator therapy – Miacalcin

Clinical trial data

BN-002

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview of PTH

Definition of current comparator therapy – Forteo

hPTH (1-34)

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Ostabolin-C

Drug profile

Clinical trials

Patient potential

Marketing potential

Satisfaction of unmet need

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the PTH class

MBRI-93.02 (hPTH)

Unhampered development will allay looming class competition

CHAPTER 9 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview of ‘other drugs’

Definition of current comparator therapy

Denosumab (AMG-162)

Drug profile

Clinical trial data

Patient potential

Marketing potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

ED-71

Drug profile

Clinical trial data

Patient potential

Marketing potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the class

MK-0822

Merck diversifies to cathepsin K inhibitors in the event of falling bisphosphonate sales