骨粗鬆症：主要7カ国市場の薬剤予測と市場分析

骨粗鬆症は、骨量の低下と骨組織の微細構造の劣化を特徴とする全身性骨格疾患と定義され、骨の脆弱性と骨折しやすい素因となります。一般的な骨折部位は、脊椎、股関節、前腕遠位部、上腕骨近位部などです。このような骨折は、一般人口における罹患率の主な原因であり、患者の回復には時間がかかり、その多くは常時介護を必要とします。

当レポートでは、主要7カ国市場における骨粗鬆症の危険因子、併存疾患、世界および過去の疫学動向について概説し、診断済み発症例と診断済み有病率に関する10年間の疫学予測などをまとめています。

目次

第1章 骨粗鬆症：エグゼクティブサマリー

第2章 イントロダクション

第3章 疾患の概要

• 病因と病態生理学
  • 病因
  • 病態生理学
• 分類
• 予後

第4章 疫学

• 病気の背景
• リスク要因と合併症
• 世界と歴史の動向
• 主要7カ国市場予測調査手法
• 出典
• 予測の前提条件と方法
• 予測の前提条件と方法：骨粗鬆症の総罹患数
• 予測の前提条件と方法：骨粗鬆症の診断済み有病例
• 予測の前提条件と方法：原発性骨粗鬆症と続発性骨粗鬆症の総罹患症例数と診断済み罹患症例数
• 予測の前提条件と方法：1型および2型骨粗鬆症の総有病症例数と診断済み有病症例数
• 予測の前提条件と方法：グルココルチコイド使用に起因する骨粗鬆症の総罹患症例数と診断済み罹患症例数
• 予測の前提条件と方法：骨減少症の総有病数
• 予測の前提条件と方法：骨減少症の診断済み有病例
• 骨粗鬆症の疫学的予測（2023年～2033年）
• 骨粗鬆症の総罹患数
• 議論
• 疫学的予測の洞察
• COVID-19の影響
• 分析の限界
• 分析の強み

第5章 疾病管理

• 診断と治療の概要
• 疾病管理に関するKOLの洞察

第6章 現在の治療オプション

第7章 アンメットニーズと機会の評価

• 概要
• 診断率と治療率の向上
• 骨粗鬆症治療の遵守率の向上
• 長期薬物治療における安全性プロファイルの向上

第8章 研究開発戦略

• 概要
• バイオシミラーの開発に注力
• 将来の骨粗鬆症治療のためのWntシグナル伝達経路の調査
• 臨床試験の設計

第9章 パイプライン評価

• 概要
• 臨床開発中の有望な医薬品

第10章 パイプライン評価分析

• 概要
• 競争力評価

第11章 現在の参入企業と将来の参入企業

• 概要
• 取引の動向

第12章 市場見通し

• 世界市場
• 米国
• EU5ヶ国
• 日本

第13章 付録

This report covers the 7MM (US, France, Germany, Italy, Spain, UK, Japan) and provides an Excel-based forecast model for the Osteoporosis market through 2033.

Osteoporosis is defined as a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue, predisposing a person to bone fragility and susceptibility to fracture. Common sites of fracture include the spine, hip, distal forearm, and proximal humerus. Such fractures are a major cause of morbidity in the general population and a patient's recovery can be slow, with many requiring full-time care.

Major drivers of growth in the osteoporosis market during the forecast period include the following -

• The increased use of Evenity across the 7MM, which will be accelerated by growing physician familiarity and clinical experience following recent launch
• The rising use of anabolic therapies, which are typically more expensive than anti-resorptive agents, in particular low-cost bisphosphonates
• An increase in the number of people with osteoporosis, in line with the growth of the global aging population

Major barriers to growth in the osteoporosis market during the forecast period will include the following -

• High cost of anabolic therapies and dual-action Evenity compared to affordable bisphosphonates, which have established long-term safety and efficacy profiles
• Loss of patent protection and/or market exclusivity for some products during the forecast period, and the subsequent launches of biosimilars and generics; this includes the expected launch of denosumab biosimilars in 2025 and 2027 across the 7MM, which will take substantial market share from marketed Prolia/Pralia
• Low patient compliance with many osteoporosis therapies due to adverse side effects, frequent administration leading to lifestyle disruption, the discomfort of regular subcutaneous or intravenous injections, as well as patients missing treatment appointments, especially due to other medical complications in older patients

Scope

• Overview of osteoporosis, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized osteoporosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2023 to 2033.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the osteoporosis therapeutics market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for osteoporosis treatment. The most promising candidates in late-stage development are profiled.
• Analysis of the current and future market competition in the global osteoporosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the 7MM osteoporosis therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM osteoporosis therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1 Osteoporosis: Executive Summary

• 1.1 The osteoporosis market will show steady growth during the forecast period, reaching sales of $17.9B in 2033
• 1.2 Biosimilars and generics are forecast to take substantial market share from originator drugs during the forecast period
• 1.3 Poor compliance presents a significant unmet need in the osteoporosis landscape
• 1.4 Improved long-term safety profiles are necessary for future pipeline osteoporosis therapies
• 1.5 Entera Bio's oral teriparatide is projected to enter the US market during the forecast period
• 1.6 What do physicians think?

2 Introduction

• 2.1 Catalyst
• 2.2 Related Reports

3 Disease Overview

• 3.1 Etiology and pathophysiology
  • 3.1.1 Etiology
  • 3.1.2 Pathophysiology
• 3.2 Classification
• 3.3 Prognosis

4 Epidemiology

• 4.1 Disease background
• 4.2 Risk factors and comorbidities
• 4.3 Global and historical trends
• 4.4 7MM forecast methodology
• 4.5 Sources
• 4.6 Forecast assumptions and methods.
  • 4.6.1 7MM
• 4.7 Forecast assumptions and methods: total prevalent cases of osteoporosis.
  • 4.7.1 US
  • 4.7.2 France, Germany, Italy, Spain, and UK
  • 4.7.3 Japan
• 4.8 Forecast assumptions and methods: diagnosed prevalent cases of osteoporosis.
  • 4.8.1 US
  • 4.8.2 France
  • 4.8.3 Germany
  • 4.8.4 Italy, Spain, and UK
  • 4.8.5 Japan
• 4.9 Forecast assumptions and methods: total prevalent cases and diagnosed prevalent cases of primary osteoporosis and secondary osteoporosis.
  • 4.9.1 7MM
• 4.10 Forecast assumptions and methods: total prevalent cases and diagnosed prevalent cases of type 1 and type 2 osteoporosis.
  • 4.10.1 7MM
• 4.11 Forecast assumptions and methods: total prevalent cases and diagnosed prevalent cases of osteoporosis secondary to glucocorticoid use
  • 4.11.1 7MM
• 4.12 Forecast assumptions and methods: total prevalent cases of osteopenia.
  • 4.12.1 US
  • 4.12.2 France and Germany
  • 4.12.3 Italy
  • 4.12.4 Spain
  • 4.12.5 UK
  • 4.12.6 Japan
• 4.13 Forecast assumptions and methods: diagnosed prevalent cases of osteopenia.
  • 4.13.1 7MM
• 4.14 Epidemiological forecast for osteoporosis (2023-33)
  • 4.14.1 Total prevalent cases of osteoporosis
• 4.15 Age-specific total prevalent cases of osteoporosis
• 4.16 Sex-specific total prevalent cases of osteoporosis
• 4.17 Total prevalent cases of osteoporosis by primary and secondary osteoporosis
• 4.18 Total prevalent cases of primary osteoporosis by type
• 4.19 Total prevalent cases of osteoporosis secondary to glucocorticoid use
• 4.20 Diagnosed prevalent cases of osteoporosis.
• 4.21 Age-specific diagnosed prevalent cases of osteoporosis
• 4.22 Sex-specific diagnosed prevalent cases of osteoporosis
• 4.23 Diagnosed prevalent cases of osteoporosis by primary and secondary osteoporosis.
• 4.24 Diagnosed prevalent cases of primary osteoporosis by type.
  • 4.24.1 Diagnosed prevalent cases of osteoporosis secondary to glucocorticoid use.
• 4.25 Discussion
• 4.26 Epidemiological forecast insight
• 4.27 COVID-19 impact.
• 4.28 Limitations of the analysis
• 4.29 Strengths of the analysis

5 Disease Management

• 5.1 Diagnosis and treatment overview
  • 5.1.1 Diagnosis of osteoporosis
  • 5.1.2 Treatment guidelines for osteoporosis
  • 5.1.3 Treatment among osteoporosis subtypes
• 5.2 KOL insights on disease management

6 Current Treatment Options

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Improved diagnosis and treatment rates
• 7.3 Higher rates of compliance with osteoporosis treatment
• 7.4 Better safety profiles for long-term drug treatment

8 R&D Strategies

• 8.1 Overview
• 8.2 Focus on the development of biosimilars
• 8.3 Investigating the Wnt signaling pathway for future osteoporosis therapies
• 8.4 Clinical trials design
  • 8.4.1 Improvements in patient representation in osteoporosis clinical trials
  • 8.4.2 Novel biomarkers for osteoporosis assessment in clinical trials

9 Pipeline Assessment

• 9.1 Overview
• 9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

• 10.1 Overview
• 10.2 Competitive assessment

11 Current and Future Players

• 11.1 Overview
• 11.2 Deal-making trends

12 Market Outlook

• 12.1 Global markets
  • 12.1.1 Forecast
  • 12.1.2 Drivers and barriers - global issues
• 12.2 US
  • 12.2.1 Forecast
  • 12.2.2 Key events
  • 12.2.3 Drivers and barriers
• 12.3 5EU
  • 12.3.1 Forecast
  • 12.3.2 Key Events
  • 12.3.3 Drivers and barriers
• 12.4 Japan
  • 12.4.1 Forecast
  • 12.4.2 Key events
  • 12.4.3 Drivers and Barriers

13 Appendix

• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
  • 13.3.1 Forecasting Methodology
• 13.4 Primary Research - KOLs Interviewed for This Report
  • 13.4.1 Elizabeth Shane, MD
• 13.5 Primary Research - Prescriber Survey
• 13.6 About the Authors
  • 13.6.1 Analyst
  • 13.6.2 Therapy Area Director
  • 13.6.3 Vice President of Disease Intelligence and Epidemiology
  • 13.6.4 Global Head and EVP of Healthcare Operations and Strategy
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