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市場調查報告書

革新追蹤概況 2016年:醫藥品開發平台的評估

Innovation and Clinical Trial Tracking Factbook 2017: An Assessment of the Pharmaceutical Pipeline

出版商 CBR Pharma Insights 商品編碼 363445
出版日期 內容資訊 英文 69 Pages
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革新追蹤概況 2016年:醫藥品開發平台的評估 Innovation and Clinical Trial Tracking Factbook 2017: An Assessment of the Pharmaceutical Pipeline
出版日期: 2017年05月01日 內容資訊: 英文 69 Pages
簡介

促進從本報告提供藥物研發階段達到預註冊階段到,現在,醫藥品產業的開發平台上20,756項產品,治療領域及各適應症總括性詳細分析,醫藥品產業開發平台的目前規模結構及變遷,這10年的First-in-Class產品 (劃時代的醫藥品)的批准數量的增加要素,及開發平台的組合中企業策略等相關分析。

第1章 目錄

第2章 簡介

  • 醫藥品開發成本的增加
  • 大部分的醫藥品R&D成本的回復失敗
  • 已通過核准醫藥品的契約生命週期
  • First-in-Class醫藥品革新的案例
  • 結論

第3章 醫藥品產業開發平台的評估

  • 開發平台、臨床實驗形勢:各治療領域
  • 開發平台:各開發階段
  • 開發平台:各分子類型
  • 主要的治療領域:各適應症
    • 腫瘤學
    • 感染疾病
    • 中樞神經系統
    • 免疫學
  • 結論

第4章 醫藥品產業開發平台的革新的評估

  • First-in-Class的革新:各開發階段
  • 主要的治療領域:各適應症
    • 腫瘤學
    • 感染疾病
    • 中樞神經系統
    • 免疫學
  • 結論

第5章 企業分析

  • 結論

第6章 契約分析

  • 授權契約
  • 共同開發契約
  • M&A
  • 資本採購

第7章 附錄

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目錄
Product Code: GBI079CBR

Summary

Innovation is a crucial element of the pharmaceutical industry. The market is highly research-intensive, being deeply reliant on a high level of R&D investment and a strong product pipeline to maintain growth and ensure long-term revenue generation. Without successful innovation, which can be broadly defined as the market launch of novel therapeutic molecules that cost-effectively treat or cure diseases, the industry would face a substantial long-term decline in revenue.

Manufacturing processes of existing active pharmaceutical ingredients are inexpensive compared with the development of novel drugs, with the manufacture of small molecules being particularly low-cost. As such, once a pharmaceutical product loses patent protection and market exclusivity, the revenue any individual company can generate from that chemical is drastically decreased, as the exact same compound can be readily copied and synthesized by generics companies. Barring generics manufacturers, the pharmaceutical industry relies on innovation to bring new products to market and generate a profit (Gupta et al., 2010).

While nutrition, sanitation and other public health measures, such as effective diagnosis and non-pharmaceutical interventions, have been pivotal to the general upwards trend in life expectancy since the 1950s, the development of new medicines has played an essential role in facilitating these improvements in life expectancy (PHRMA, 2013a). Across both developing and high-income countries, the uptake of medicines launched after 1990 is estimated to have contributed to 73% of the 1.74-year increase in life expectancy at birth between 2000 and 2009 (Lichtenberg, 2012).

Mortality rates due to heart disease have also decreased dramatically since the introduction of new drugs such as angiotensin II receptor inhibitors and calcium channel blockers and, more recently, statins such as Lipitor (atorvastatin). The US age-adjusted annual death rate per 100,000 people decreased from 401.6 to 173.7 between 1979 and 2011. Even in cancer, in which there is still much progress to be made, the mortality rate declined by 7.6% between 1990 and 2000 and by 15.5% between 2001 and 2011 (PHRMA, 2013a).

Cost-effective, innovative drugs that advance the standard of healthcare are more likely than cost-ineffective drugs to get payer support and achieve market access, owing to healthcare budgetary constraints worldwide. They are therefore more likely to be listed in formularies or insurance plans, which results in increased patient access to the drug and reduced expenditure for healthcare agencies, governments and insurance companies.

In 2013, following a 15-year high in 2012, the number of new drug approvals declined from 39 to 27. The number of new drug applications from big pharma companies remained constant, while in spite of the creation of a breakthrough designation by the FDA in 2012 (a designation that expedites the review process and guarantees a 60-day turnover for approval requests for drugs treating life-threatening conditions that, based on preliminary evidence, offer a substantial benefit above the existing standard of care), the contribution of new drug applications from smaller companies declined substantially, accounting for this drop. The number of new drug approvals recovered to levels exceeding those of 2012 in the following two years.

The report "Innovation and Clinical Trial Tracking Factbook 2017: An Assessment of the Pharmaceutical Pipeline" is a comprehensive, granular analysis of the 25,522 products currently in the pharmaceutical industry pipeline, from the Discovery stage through to Pre-registration and split into therapy areas and key indications. This pipeline is also benchmarked against its size across each segment compared to 2015 and 2016, and an assessment of the level of first-in-class innovation is provided. In addition, a detailed contextual analysis of the key drivers of this pipeline is provided, in addition to an assessment of companies present in the pipeline and historical deal value and volume.

Scope

  • What is the current size and composition of the pharmaceutical industry pipeline and how has it changed in the last two years? What can we learn from this?
  • The largest therapy area, by a substantial margin, is oncology, and, with growth in the pipeline sizes for all major oncology indications since Q1 2015, this trend appears set to continue. Why is this the case?
  • What is the overall advantage for companies including first-in-class product developments in their pipeline portfolio, rather than opting for better-characterized established molecular targets?
  • What factors have been driving the increasing number of first-in-class product approvals over recent decades?
  • Historically, what has the risk of clinical trial attrition been across each therapy area and molecule type in the pharmaceutical industry?
  • How long have their associated clinical trials been and how many patients, on average, were recruited?

Key Reasons to Purchase

  • Achieve an up-to-date understanding of the landscape of the overall pharmaceutical pipeline, on both a broad and granular level; this also provides a highly accessible reference which is useful in any pharmaceutical strategic decision making process
  • Benchmark key therapy areas and indications in terms of the number of pipeline products and level of innovation, and assess one's own strategic positioning against this backdrop
  • Understand the contemporary role and importance of radical and incremental innovation within the various disease areas and indications
  • Make key decisions about the role of innovation within one's own pipeline portfolio
  • Understand and benchmark the risk of attrition, clinical trial duration and size across the pharmaceutical industry

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Introduction 5

2.1 Increasing Cost of Drug Development 7

2.2 Most Drugs Fail to Recuperate R&D Costs 8

2.3 Contracting Life Cycles for Approved Products 9

2.4 The Case for First-in-Class Pharmaceutical Innovation 10

2.5 Conclusion 13

3 Assessment of the Pharmaceutical Industry Pipeline 14

3.1 Pipeline and Clinical Trials Landscape by Therapy Area 14

3.2 Pipeline by Stage of Development 19

3.3 Pipeline by Molecule Type 22

3.4 Key Therapy Areas by Indication 26

3.4.1 Oncology 26

3.4.2 Infectious Diseases 27

3.4.3 Central Nervous System 29

3.4.4 Immunology 32

3.5 Conclusion 33

4 Assessment of Innovation in the Pharmaceutical Industry Pipeline 34

4.1 First-in-Class Innovation by Stage of Development 36

4.2 Key Therapy Areas by Indication 37

4.2.1 Oncology 37

4.2.2 Infectious Diseases 40

4.2.3 Central Nervous System 43

4.2.4 Immunology 46

4.3 Conclusion 48

5 Assessment of the Pharmaceutical Industry Clinical Trial Landscape 49

5.1 Clinical Trial Attrition Rates 49

5.1.1 Therapy area 50

5.1.2 Molecule Type 54

5.2 Clinical Trial Duration 57

5.2.1 Therapy Area 58

5.2.2 Molecule Type 61

5.3 Clinical Trial Size 62

5.3.1 Therapy Area 63

5.3.2 Molecule Type 65

5.4 Conclusion 67

6 Appendix 68

6.1 References 68

6.2 Abbreviations 69

6.3 Contact Us 69

6.4 Disclaimer 69

1.1 List of Tables

Table 1: Trends in Clinical Trial Protocol Complexity, 2000-2011 8

Table 2: Pipeline Products by Therapy Area, 2015-Q1 2017 17

Table 3: Number of Clinical Trials Initiated by Therapy Area, 2006-2016 19

Table 4: Pipeline Products by Therapy Area and Stage of Development, Q1 2017 22

Table 5: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 25

Table 6: First-in-Class Pipeline Products by Therapy Area, Q1 2015-Q1 2017 36

Table 7: First-in-Class Oncology Pipeline Products by Indication, Q1 2015-Q1 2017 39

Table 8: First-in-Class Infectious Diseases Pipeline Products by Indication, Q1 2015-Q1 2016 42

Table 9: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2015-Q1 2016 45

Table 10: First-in-Class Immunology Pipeline Products by Indication, Q1 2015-Q1 2016 48

Table 11: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates by Therapy Area, 2006-Q1 2017 53

Table 12: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates by Molecule Type, 2006-Q1 2017 56

Table 13: Pharmaceutical Industry, Median Clinical Trial Duration by Therapy Area (Months), 2006-Q1 2017 60

Table 14: Pharmaceutical Industry, Clinical Trial Duration by Molecule Type, 2006-Q1 2017 62

Table 15: Pharmaceutical Industry, Median Clinical Trial Size by Therapy Area (Participants), 2006-Q1 2017 65

Table 16: Pharmaceutical Industry, Clinical Trial Size by Molecule Type, 2006-Q1 2017 67

1.2 List of Figures

Figure 1: US Life Expectancy by Sex, 1950-2015 5

Figure 2: FDA Approvals, 1987-2015 7

Figure 3: Average Cost of Developing a Novel Drug ($m), 1970-2015 8

Figure 4: Average Lifetime Sales after Tax by Decile ($m), 1990-1994 9

Figure 5: Drivers of Shortened Pharmaceutical Product Life Cycles, 1970-2003 10

Figure 6: FDA Approvals by Innovation Status, 1987-2015 11

Figure 7: Average Sales of First-in-Class and Non-First-in-Class Products After Launch ($m), 2006-2014 12

Figure 8: Average Projected Sales of First-in-Class and Non-First-in-Class Products Launched in 2015 ($m), 2016-2022 13

Figure 9: Pipeline Products by Stage and Molecule Type, Q1 2017 14

Figure 10: Pipeline Products by Therapy Area, Q1 2017 15

Figure 11: Overall Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q1 2017 16

Figure 12: Number of Clinical Trials Initiated, 2006-2016 17

Figure 13: Number of Clinical Trials Initiated by Therapy Area, 2006-2016 18

Figure 14: Pipeline Products by Therapy Area and Stage of Development (%), Q1 2017 20

Figure 15: Pipeline Products by Therapy Area and Stage of Development, Q1 2017 21

Figure 16: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 23

Figure 17: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 24

Figure 18: Oncology Pipeline Products by Indication, Q1 2017 26

Figure 19: Oncology Pipeline, Number of Products by Indication, Q1 2015-Q1 2016 27

Figure 20: Infectious Disease Pipeline, Number of Products by Indication, Q1 2017 28

Figure 21: Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 29

Figure 22: Central Nervous System Pipeline, Number of Products by Indication, Q1 2017 30

Figure 23: Central Nervous System Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2017 31

Figure 24: Immunology Pipeline, Number of Products by Indication, Q1 2017 32

Figure 25: Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2017 33

Figure 26: Pipeline Products by Therapy Area and Proportion of Established and First-in-Class Products, Q1 2017 34

Figure 27: First-in-Class Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q1 2017 35

Figure 28: First-in-class Pipeline Products by Therapy Area and Stage of Development, Q1 2017 37

Figure 29: First-in-Class Oncology Pipeline Products by Indication, Q1 2017 37

Figure 30: First-in-Class Oncology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2017 38

Figure 31: First-in-Class Infectious-Diseases Pipeline Products by Indication, Q1 2016 40

Figure 32: First-in-Class Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 41

Figure 33: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2016 43

Figure 34: First-in-Class Central Nervous System Disorder Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 44

Figure 35: First-in-Class Immunology Disorder Pipeline, Number of Products by Indication, Q1 2016 46

Figure 36: First-in-Class Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 47

Figure 37: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates, 2006-Q1 2017 50

Figure 38: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase I by Therapy Area, 2006-Q1 2017 50

Figure 39: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase II by Therapy Area, 2006-Q1 2017 51

Figure 40: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase III by Therapy Area, 2006-Q1 2017 51

Figure 41: Pharmaceutical Industry, Clinical Trial Attrition Rates Therapy Area, 2006-Q1 2017 52

Figure 42: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase I by Molecule Type, 2006-Q1 2017 54

Figure 43: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase II by Molecule Type, 2006-Q1 2017 54

Figure 44: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase III by Molecule Type, 2006-Q1 2017 55

Figure 45: Pharmaceutical Industry, Clinical Trial Attrition Rates by Molecule Type, 2006-Q1 2017 56

Figure 46: Pharmaceutical Industry, Clinical Trial Duration by Stage of Development, 2006-Q1 2017 57

Figure 47: Pharmaceutical Industry, Clinical Trial Duration in Phase I by Therapy Area, 2006-Q1 2017 58

Figure 48: Pharmaceutical Industry, Clinical Trial Duration in Phase II by Therapy Area, 2006-Q1 2017 59

Figure 49: Pharmaceutical Industry, Clinical Trial Duration in Phase III by Therapy Area, 2006-Q1 2017 60

Figure 50: Pharmaceutical Industry, Clinical Trial Duration in Phase I by Molecule Type, 2006-Q1 2017 61

Figure 51: Pharmaceutical Industry, Clinical Trial Duration in Phase II by Molecule Type, 2006-Q1 2017 61

Figure 52: Pharmaceutical Industry, Clinical Trial Duration in Phase III by Molecule Type, 2006-Q1 2017 62

Figure 53: Pharmaceutical Industry, Clinical Trial Size by Stage of Development, 2006-Q1 2017 63

Figure 54: Pharmaceutical Industry, Clinical Trial Size in Phase I by Therapy Area, 2006-Q1 2017 63

Figure 55: Pharmaceutical Industry, Clinical Trial Size in Phase II by Therapy Area, 2006-Q1 2017 64

Figure 56: Pharmaceutical Industry, Clinical Trial Size in Phase III by Therapy Area, 2006-Q1 2017 64

Figure 57: Pharmaceutical Industry, Clinical Trial Size in Phase I by Molecule Type, 2006-Q1 2017 65

Figure 58: Pharmaceutical Industry, Clinical Trial Size in Phase II by Molecule Type, 2006-Q1 2017 66

Figure 59: Pharmaceutical Industry, Clinical Trial Size in Phase III by Molecule Type, 2006-Q1 2017 66

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