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.
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.
What is Endometriosis?
- Endometrial-like tissue outside of the uterus
- Symptoms: Chronic pelvic pain, painful periods, pain with intercourse, excessive bleeding, infertility, etc.
- ~10% prevalence worldwide
- How is Endometriosis treated?
- Oral contraceptives + NSAIDs - 1st line
- GnRH agonists, progestin medications, estrogen antagonists - 2nd line Surgery
Why Endometriosis?
Update from 2020 report- Since: Approval of Myfembree in the US (Aug 2022), Relumina in Japan (Dec 2021) and updates to the key pipeline products Ryeqo, Yselty and Quinagolide.
- Increase in interest + awareness of endometriosis among public
- 300% increase in # companies conducting clinical trials (2010 - 2019)
- Large-scale collaborations:
- Bayer + Evotec
- Myovant + Pfizer
- Myovant + Gedeon Richter
- GnRH antagonist(s) launch across 7MM
- The publisher projects the therapeutic market for endometriosis within the 7MM will grow from $1.05B in 2020 at a compound annual growth rate (CAGR) of 10% to $2.72B by 2030.
Main drivers of growth:
- GnRH antagonists Myfembree and Ryeqo (relugolix, estradiol and norethisterone acetate) in the US and EU, respectively, and Yselty (linzagolix) across the 7MM.
- Launch of Quinagolide by Ferring Pharmaceuticals
- Non-interference with ovulation
- Vaginal ring
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 - Updated Dec 2022, Based on Events up to Nov 17, 20221.1 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 - Updated Dec 2022, Based on Events up to Nov 17, 2022
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 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 - Updated Dec 2022, Based on Events up to Nov 17, 2022
6.1 Overview
7 Unmet Needs and Opportunity Assessment - Updated Dec 2022, Based on Events up to Nov 17, 2022
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 - Updated Dec 2022, Based on Events up to Nov 17, 2022
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 - Updated Dec 2022, Based on Events up to Nov 17, 2022
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Pipeline Valuation Analysis - Updated Dec 2022, Based on Events up to Nov 17, 2022
10.1 Overview
10.2 Competitive Assessment
11 Current and Future Players - Updated Dec 2022, Based on Events up to Nov 17, 2022
11.1 Overview
11.1.1 AbbVie
11.1.1 Bayer
11.1.2 Evotec
11.1.3 Kissei
11.1.2 Myovant Sciences
11.1.4 Pfizer
11.1.5 Additional Companies
11.2 Deal-Making Trends
12 Market Outlook - Updated Dec 2022, Based on Events up to Nov 17, 2022
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 - Key Opinion Leaders Interviewed for This Report
13.4.1 Key Opinion Leaders
13.5 Primary Research - Prescriber Survey
13.6 About the Authors
13.6.1 Analyst
13.6.2 Therapy Area Director
13.6.3 Epidemiologist
13.6.4 Epidemiology Reviewers
13.6.5 Vice President of Disease Analysis and Intelligence
13.6.6 Global Head and EVP of Healthcare Operations and Strategy
- Contact the Publisher
Table 1: Endometriosis: Key Metrics in the 7MM
Table 2: Role of the Different Theories in the Pathogenesis of Endometriosis
Table 3: Classifications of Endometriosis
Table 4: Risk Factors and Comorbidities for Endometriosis
Table 5: The Most Commonly Used Guidelines by Country
Table 6: AbbVie Portfolio Assessment, 2022
Table 7: Bayer Portfolio Assessment, 2022
Table 8: Evotec Portfolio Assessment, 2022
Table 9: Kissei Portfolio Assessment, 2022
Table 10: Myovant's Portfolio Assessment, 2022
Table 11: Pfizer Portfolio Assessment, 2022
Table 12: Additional Companies Assessment, 2022
Table 13: Endometriosis Market - Global Drivers and Barriers, 2020-2030
Table 14: Key Events Impacting Sales for Endometriosis in the US, 2020-2030
Table 15: Endometriosis Market - Drivers and Barriers in the US, 2020-2030
Table 16: Key Events Impacting Sales for Endometriosis in the 5EU, 2020-2030
Table 17: Endometriosis Market - Drivers and Barriers in the 5EU, 2020-2030
Table 18: Key Events Impacting Sales for Endometriosis in Japan, 2020-2030
Table 19: Endometriosis Market - Drivers and Barriers in Japan, 2020-2030
Table 20: 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 Marketed and Pipeline Drugs Benchmarked Against the Standards of Care (SOC): GnRH Agonists, Progestins, and Oral Contraceptives
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 the Publisher Expects be Licensed for Endometriosis in the 7MM During the Forecast Period
Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standards of Care (SOC), GnRH Agonists, Progestins, and Oral Contraceptivesr
Figure 25: Analysis of the Company Portfolio Gap in Endometriosis During the Forecast Period
Figure 26: Deal-Making Trends, 2017-2022
Figure 27: Global (7MM) Sales Forecast by Country for Endometriosis in 2020 and 2030
Figure 28: Sales Forecast by Class for Endometriosis in the US in 2020 and 2030
Figure 29: Sales Forecast by Class for Endometriosis in the 5EU in 2020 and 2030
Figure 30: 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
- Ferring Pharmaceuticals
- AstraZeneca
- Mitsubishi Tanabe
- Pfizer
- Kissei Pharmaceuticals
- Bayer
- Gedeon Richter
- Evotec
- Myovant Sciences
- ObsEva
- Astellas
- Takeda
- Nippon Shinyaku
- Teva