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Endometriosis - Global Drug Forecast and Market Analysis to 2030

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    Report

  • 124 Pages
  • December 2021
  • Region: Global
  • GlobalData
  • ID: 5530769
Endometriosis is a disease characterized by the presence of endometrial-like tissue outside of the uterus. This results in chronic pelvic pain and can have significant effects on sufferers’ quality of life. Women afflicted with endometriosis are often treated with oral contraceptives and non-steroidal anti-inflammatory (NSAIDs) drugs as a first-line treatment, although these are used off-label and merely treat the pain felt, rather than the cause of the pain. Second-line therapeutics include gonadotropin-releasing hormone (GnRH) agonists and progestins, and in the US, GnRH antagonists. However, endometriosis is difficult to treat and, in some cases, requires surgery in order to remove lesions found in the uterus - and more rarely, distal regions such as the kidney, liver, and even brain.

The launch of GnRH antagonists relugolix and linzagolix across the 7MM will be the main drivers of growth during the forecast period. Other major drivers of growth include the launch of Quinagolide, the first endometriosis therapeutic that can treat pain without interfering with ovulation, and increased awareness of endometriosis, which leads to increased diagnosis rates. The relugolix and linzagolix launch will provide the 5EU and Japanese markets with access to GnRH antagonists for the first time and should also bolster sales of AbbVie’s GnRH antagonist Orilissa (elagolix), which is available in the US. Given the novelty of the endometriosis pipeline paired with the decrease in use of existing endometriosis-specific therapeutics, the publisher expects the GnRH antagonist class to account for the majority of global sales by 2030.

The publisher projects the therapeutic market for endometriosis within the 7MM will grow from $1.061B in 2020 at a compound annual growth rate (CAGR) of 10.6% to $2.9B by 2030. In particular, the publisher expects the US market will contribute the most to the endometriosis market sales, accounting for roughly 68% of global sales in both 2020 ($730.65M) and 2030 ($577.1M).

The consensus among interviewed physicians regarding the current treatment landscape of endometriosis is that there are several unmet needs that have persisted for decades, and that current marketed therapies are insufficient in treating pain without significant side effects. Key Opinion Leaders (KOLs) interviewed by the publisher highlighted the importance of decreasing diagnosis delays, which can be improved by better diagnostic procedures. KOLs also discussed the need for a therapeutic that can treat endometriosis-associated pain while not affecting the patient’s ability to conceive and treatments that can be used long-term.

Key Highlights


  • The endometriosis market is currently highly genericized and contains many off-label medications, such as oral contraceptives and NSAIDs, which provide affordable options with limited side effects. These factors create a stiff barrier for entry of novel therapeutics, but pipeline therapeutics will find success due to strong efficacy and safety profiles compared with existing endometriosis marketed therapies.
  • The awareness surrounding endometriosis has improved over the past few years, but remains an area of concern, according to KOLs. Clinicians, physicians, and the general public all need to be more aware of the signs and symptoms of endometriosis in order to decrease diagnosis delays.
  • Women suffering from endometriosis wait an average of 7 years between symptom onset and diagnosis, during which time the disease can progress significantly, potentially affecting fertility. This diagnosis delay can be improved not only with increased awareness of endometriosis, but also better diagnostic techniques, such as biomarkers. Endometriosis can only be officially diagnosed via laparoscopy, which is an invasive and costly surgical procedure.
  • Orilissa was the first novel therapy launched in the endometriosis market in over 10 years when it was marketed in 2018. Thus, there is a need for novel therapies in this space, which should be met by the promising pipeline.

Key Questions Answered


  • Treatment for endometriosis should improve over the forecast period, but unmet needs remain.
  • Which unmet needs are the most pressing in the 7MM?
  • Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?
  • Novel GnRH antagonists are being developed, with GnRH antagonists reaching the 5EU and Japan for the first time during the forecast period.
  • What are the most promising late-stage candidates and how much they expected to generate over the forecast period?
  • What do KOLs say about their clinical and commercial positioning?
  • An increasing number of companies are investing in women’s health and endometriosis with some entering into large-scale collaborations, such as Evotec and Bayer, in an effort to produce more endometriosis therapies.
  • Which have been historically the companies leading the way?
  • What new companies are emerging in the space?

Scope


  • Overview of endometriosis including epidemiology, disease etiology and management.
  • Topline endometriosis drugs market revenue (including off-label adjunct therapeutics used for metabolic benefits), annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
  • Key topics covered include assessment of current and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU, and Japan over the 10-year forecast period.
  • Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global endometriosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges.

Reasons to Buy


The report will enable you to:
  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global endometriosis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global endometriosis 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.
  • Track drug sales in the global endometriosis therapeutics market from 2020-2030.
  • 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

1 Endometriosis: Executive Summary
1.1 The Endometriosis Market Will Exhibit Considerable Growth Between 2020 and 2030
1.2 Current Therapies Leave Significant Unmet Needs in the Endometriosis Market
1.3 There Is a High Unmet Need for Earlier Endometriosis Diagnosis
1.4 Pipeline Therapies Present Promise in Closing Treatment Gaps
1.5 What Do Physicians Think?
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Forecast Assumptions and Methods
4.4.3 Diagnosed Prevalent Cases of Endometriosis
4.4.4 Diagnosed Prevalent Cases of Endometriosis by Laparoscopy Confirmation Status
4.4.5 Diagnosed Prevalent Cases of Endometriosis by ASRM Stage
4.4.6 Diagnosed Prevalent Cases of Endometriosis by Phenotype
4.4.7 Germany and the UK
4.4.8 Diagnosed Prevalent Cases of Endometriosis Undergoing Laparoscopy
4.4.9 Diagnosed Prevalent Cases of Endometriosis with Comorbidities
4.5 Epidemiological Forecast for Endometriosis (2020-2030)
4.5.1 Diagnosed Prevalent Cases of Endometriosis
4.5.2 Age-Specific Diagnosed Prevalent Cases of Endometriosis
4.5.3 Diagnosed Prevalent Cases of Endometriosis by Laparoscopy
4.5.4 Diagnosed Prevalent Cases of Endometriosis by Stage
4.5.5 Diagnosed Prevalent Cases of Endometriosis by Phenotype
4.5.6 Diagnosed Prevalent Cases of Endometriosis Undergoing Laparoscopy
4.5.7 Diagnosed Prevalent Cases of Endometriosis with Comorbidities
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impact
4.6.3 Limitations of Analysis
4.6.4 Strengths of Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.2 Key Opinion Leader Insights on Disease Management
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Noninvasive Diagnostics
7.3 Disease Awareness and Education of Medical Professionals
7.4 More Effective Drugs with Long-Term Safety and Tolerability
7.5 Non-Hormonal Therapies
7.6 Better Understanding of the Disease Etiology and Pathophysiology
8 R&D Strategies
8.1 Overview
8.1.1 Reformulations and Label Expansion
8.1.2 The Race for the Development of GnRH Antagonists
8.1.3 Development of Novel Non-Hormonal Therapies
8.2 Clinical Trial Design
8.2.1 Pain Scales
8.2.2 Quality of Life Assessment as an Efficacy Tool
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
11.1.1 AbbVie
11.1.2 Bayer
11.1.3 Evotec
11.1.4 Kissei
11.1.5 Pfizer
11.1.6 Additional Companies
11.2 Deal-Making Trends
12 Market Outlook13 Appendix
List of Tables
Table 1: Endometriosis: Key Metrics in the 7MM
Table 2: Summary of Newly Added Data Types
Table 3: Summary of Updated Data Types
Table 4: Role of the Different Theories in the Pathogenesis of Endometriosis
Table 5: Classifications of Endometriosis
Table 6: Risk Factors and Comorbidities for Endometriosis
Table 7: The Most Commonly Used Guidelines by Country
Table 8: AbbVie Portfolio Assessment, 2021
Table 9: Bayer Portfolio Assessment, 2021
Table 10: Evotec Portfolio Assessment, 2021
Table 11: Kissei Portfolio Assessment, 2021
Table 12: Pfizer Portfolio Assessment, 2021
Table 13: Additional Companies Assessment, 2021
Table 14: Endometriosis Market - Global Drivers and Barriers, 2020-2030
Table 15: Key Events Impacting Sales for Endometriosis in the US, 2020-2030
Table 16: Endometriosis Market - Drivers and Barriers in the US, 2020-2030
Table 17: Key Events Impacting Sales for Endometriosis in the 5EU, 2020-2030
Table 18: Endometriosis Market - Drivers and Barriers in the 5EU, 2020-2030
Table 19: Key Events Impacting Sales for Endometriosis in Japan, 2020-2030
Table 20: Endometriosis Market - Drivers and Barriers in Japan, 2020-2030
Table 21: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for Endometriosis in 2020 and 2030
Figure 2: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Endometriosis During the Forecast Period
Figure 3: Roles of estrogen receptor a and estrogen receptor ß in normal endometrium and endometrial lesions
Figure 4: Endometrial lesions of varying depth
Figure 5: Sources of Estradiol in Endometriosis Tissue and Targets of the Current Medical Therapy
Figure 6: 7MM, Diagnosed Prevalence of Endometriosis, Women, %, Ages 12-54 Years, 2020
Figure 7: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of Endometriosis
Figure 8: 7MM, Sources Used to Forecast the Laparoscopy Confirmation Status for the Diagnosed Prevalent Cases of Endometriosis
Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Endometriosis by ASRM Stage
Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Endometriosis by Phenotype
Figure 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Endometriosis Undergoing Laparoscopy
Figure 12: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Endometriosis with Comorbidities
Figure 13: 7MM, Diagnosed Prevalent Cases of Endometriosis, N, Women, Ages 12-54 Years, 2020
Figure 14: 7MM, Diagnosed Prevalent Cases of Endometriosis by Age, N, Women, 2020
Figure 15: 7MM, Diagnosed Prevalent Cases of Endometriosis by Laparoscopy Confirmation Status, N, Women, Ages 12-54 Years, 2020
Figure 16: 7MM, Diagnosed Prevalent Cases of Endometriosis by Stage, N, Women, Ages 12-54 Years, 2020
Figure 17: 7MM, Diagnosed Prevalent Cases of Endometriosis by Phenotype, N, Women, Ages 12-54 Years, 2020
Figure 18: 7MM, Diagnosed Prevalent Cases of Endometriosis Undergoing Laparoscopy, N, Women, Ages 12-54 Years, 2020
Figure 19: 7MM, Diagnosed Prevalent Cases of Endometriosis with Comorbidity, N, Women, Ages 12-54 Years, 2020
Figure 20: Sample Endometriosis Treatment Algorithm
Figure 21: Unmet Needs and Opportunities in Endometriosis
Figure 22: Overview of the Development Pipeline in Endometriosis
Figure 23: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for Endometriosis in the 7MM During the Forecast Period
Figure 24: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Endometriosis During the Forecast Period
Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standards of Care (SOC), GnRH Agonists, Progestins, and Oral Contraceptives
Figure 26: Analysis of the Company Portfolio Gap in Endometriosis During the Forecast Period
Figure 27: Deal-Making Trends, 2016-2021
Figure 28: Global (7MM) Sales Forecast by Country for Endometriosis in 2020 and 2030
Figure 29: Sales Forecast by Class for Endometriosis in the US in 2020 and 2030
Figure 30: Sales Forecast by Class for Endometriosis in the 5EU in 2020 and 2030
Figure 31: Sales Forecast by Class for Endometriosis in Japan in 2020 and 2030

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AbbVie
  • Ipsen
  • Neurocrine Biosciences
  • DebioPharm Group
  • AstraZeneca
  • ValiRX
  • Merck
  • Mitsubishi Tanabe
  • Pfizer
  • Kissei Pharmaceuticals
  • Bayer
  • Gedeon Richter
  • Evotec
  • Myovant Sciences
  • ObsEva
  • Endoceutics
  • Astellas
  • Takeda
  • Nippon Shinyaku
  • Teva