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How can companies determine where to focus as they develop their pipelines and determine new growth opportunities? Kx Advisors’ 2020 Hot Indications List can help. In our 6th annual analysis of global R&D investment, our experts identified the top indications for industry focus.

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Women’s Health: The Opportunity in Gynecology and Beyond

Posted on by Jenna Riffell, PhD

Women’s Health: The Opportunity in Gynecology and Beyond

Women’s healthcare and FemTech are garnering increasing attention, yet unmet need remains high, leaving opportunity for investment in an area with significant white space for growth. In this article, we highlight why investment in women’s health is important, where funding gaps lie, and demonstrate the potential for growth if these markets receive sufficient research and development (R&D).

An Underfunded Area in Healthcare

Women comprise half of the population worldwide, yet the women’s health space, which Kx defines as diseases only or disproportionately affecting women, has been consistently underfunded and often disregarded.

In 2021, excluding oncology, only 2% of treatments in the development pipeline were for women’s health conditions. In the US, a recent study analyzing National Institutes of Health (NIH) funding found that 93% of diseases underfunded by the NIH disproportionately affect women, while 58% of overfunded diseases are male-dominant.1 Lack of scientific knowledge of women’s health conditions can then make companies reluctant to develop treatments, a risky venture even when knowledge of the disease is advanced.2,3

Case Study: Endometriosis

Endometriosis occurs in 10% of women between the ages of 15-45,4 typified by tissue similar to the uterine lining growing outside of the uterus. The resulting pain significantly decreases patients’ quality of life, negatively impacting their performance at work, personal relationships, and mental health. Diagnosis is challenging, due to low awareness of the disease and the need for a laparoscopy to make a definitive diagnosis, leaving many patients without appropriate treatment. On average, a patient with endometriosis incurs $10,000 more direct healthcare costs annually than those without, from inpatient, outpatient, and surgical treatment alongside prescription costs. Over-the-counter (OTC) pain relief medications costs are added to these fees. Furthermore, endometriosis costs the US economy over $2,000 more than the average worker in annual absence and short-term disability costs.5 Current treatment options remain limited to painkillers, laparoscopic removal of lesions, and hormonal therapies. For those contraindicated or unresponsive to these treatments, a hysterectomy remains the only option.

Currently, the most effective pharmacotherapies are Gonadotropin Releasing Hormone (GnRH) analogs, such as elagolix (Orilissa) and relugolix (Myfembree, in combination with estradiol and norethindrone acetate), which work by inducing quasi-menopause. However, side effects including bone mineral density loss, depression, and severe nausea can be detrimental to a woman’s long-term health, and have led the FDA to restrict the duration an individual can stay on the treatment to just two years.

The current pipeline looks similarly bleak. Kissie’s Linzagolix, the only treatment in Phase III, has the same GnHR mechanism of action but with greater levels of bone mineral loss compared to approved medications. Although Phase II therapies show more promise, the market remains wide open and given the high prevalence and unmet need in endometriosis, the successful development of a safe drug would likely garner high reward.

It is not just gynecological women’s health conditions that have failed to garner sufficient R&D investment to develop effective treatments. For example, Irritable Bowel Syndrome (IBS) is a chronic disease with significant patient burden with a high prevalence in women (14%), who comprise two-thirds of all IBS patients.6 Symptoms, which include diarrhea, constipation, and bloating, can substantially impact everyday life. Inadequate treatments only targeting symptoms and low market development have left unmet need high.

There are multiple women’s health conditions ripe for development; collectively, the opportunity is vast. In endometriosis alone, a safe treatment displacing GnRHs could see peak sales of up to $3.9bn in the US.7-13

The Case for Investment

Some women’s health diseases that have already seen major market development offer an insight into the high potential patient value that can be unlocked with R&D and commercial investment.

Chronic migraine is one such example. Affecting 1 in 5 women vs 1 in 16 men, it is the leading cause of disability amongst young women.14 In 2009, the market was small, with US sales totaling $1.1bn.15 Treatment options were predominantly limited to triptans, an abortive class of medication that treats individual migraine episodes as and when they occur.16 Though effective, they are not preventative and are not suitable for those who suffer from more frequent episodes due to the risk of medication-overuse headaches (MOH), also known as analgesic rebound headaches.17

However, the market has since experienced explosive growth propelled by two treatment developments: the approval of AbbVie’s Botox in 2010 and, in 2018, the arrival of three calcitonin gene-related peptide (CGRP) antagonist mAbs; Aimovig (erenumab), Ajovy (freanezumab), and Emgality (galcanezumab). Both novel classes of treatment gave prescribers the tools to move away from treating the symptoms of chronic migraine, and towards preventing future episodes.

These landmark changes in the treatment paradigm resulted in a 200% increase in annual US sales in the last four years, from 2018 to 2022.15 Since 2020, newer oral CGRPs have been approved, further reducing patient burden in migraine. With these and further developments, the market is expected to continue to grow exponentially, with total annual US sales predicted to reach >$9bn by 2028.15

The high ROI within chronic migraine shows how a shift from reactively treating symptoms, as in endometriosis and IBS, to developing well-tolerated treatments targeting the underlying cause of women’s health diseases is both desperately needed and a significant upside opportunity. Multiple relatively untapped markets offer just such opportunity on this scale.

19-30

Polycystic ovary syndrome (PCOS), a largely understudied disease that causes metabolic issues, is one example. There are no approved treatment options despite its high prevalence, significant impact on quality of life due to hirsutism, sub-fertility, and increased risk of comorbidities such as type 2 diabetes. The generics used such as combined oral contraceptives and metformin, although effective at inducing ovulation, have little impact on metabolic issues and have tolerability concerns. The development pipeline is also particularly bleak and offers limited potential to address the high unmet need.

In irritable bowel syndrome (IBS), as discussed earlier, unmet need is high with over half of patients dissatisfied with their treatment due to side effects and inadequate efficacy,18 though there are seven marketed treatments. Pipeline development is sluggish with only two drugs currently in Phase III and nine in Phase II. This slow development can largely be attributed to poor knowledge of disease pathogenesis, linked to chronic underfunding.

Conclusion

It is evident there is extensive opportunity and necessity for development in multiple women’s health conditions. Not only are these diseases often chronic and highly prevalent, but they can significantly impact patients’ long-term health outcomes and quality of life, both key for pricing potential and market access.

Unlocking the opportunity in women’s health will require development beyond R&D. To truly address high unmet need and maximize the market opportunity, pharma companies and investors should adopt a three-pronged approach:

  • Increasing awareness of women’s health diseases is vital. In endometriosis, for example, the average delay from symptom onset to diagnosis is 8 years, while 70% of patients with PCOS remain undiagnosed in primary care. Poor PCP awareness leads to misdiagnosis, slow referrals, and a prolonged impact on quality of life.
  • Improving diagnostic tools is crucial to unlocking the full patient population. Endometriosis can only be confirmed with a laparoscopy, which is both invasive and expensive to healthcare systems, and for PCOS there is no single diagnostic test, making diagnosis challenging given the wide range of presenting symptoms. Developing diagnostic biomarkers in IBS could enable treatments to target the cause rather than symptoms, drastically improving patient outcomes.
  • Targeting investment towards effective, safe therapies that go beyond treating symptoms is key to changing outcomes. Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs) or hormonal contraceptives are heavily relied upon, particularly in gynecological women’s conditions. However, not only are women trying to conceive unable to use hormonal contraceptives, but side effects such as headaches or nausea can be unpleasant or even life-threatening in the rare case of blood clots, leading to poor compliance rates.

How Kx can help harness the opportunity in Women’s Health

The experts at Kx Advisors help evaluate opportunities, develop strategy, prioritize pipelines, and bring new treatments in Women’s Health to market. Our unique approach combines real-world experience with qualitative and quantitative data to provide unique solutions supporting our clients’ strategic growth initiatives. To learn more about how Kx Advisors can support your goals in Women’s Health, contact Jenna Riffell at jenna.riffell@kxadvisors.com.

 

Contact Our Team Today

 

References

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  2. Stengel G. Female Founders Are Energizing Investment in Women’s Healthcare: Expect More In 2023. Forbes. January 2023. https://www.forbes.com/sites/geristengel/2023/01/04/female-founders-are-energizing-investment-in-womens-healthcare-expect-more-in-2023. Accessed February 20, 2023.
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  12. Bontempo AC, Mikesell L. Patient perceptions of misdiagnosis of endometriosis: Results from an online national survey. Diagnosis. 2020;7(2):97-106. doi:10.1515/dx-2019-0020
  13. Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating response and failure of medical treatment of endometriosis: A systematic review. Fertility and Sterility. 2017;108(1):125-136. doi:10.1016/j.fertnstert.2017.05.004 ages 15-64 (% of total population). https://data.worldbank.org/indicator/SP.POP.1564.TO.ZS. Published January 1, 2021. Accessed February 21, 2023
  14. Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world’s causes of disability, and first among young women: Findings from GBD2019. The Journal of Headache and Pain. 2020;21(1). doi:10.1186/s10194-020-01208-0
  15. Evaluate Pharma. Migraine: Indication Overview. Evaluate Pharma. https://app.evaluate.com/ux/WebReport/tabbedsummarypage.aspx?itemId=631&lType=modData&compId=1019&tabId=. Published February 15, 2023. Accessed February 21, 2023.
  16. Cameron C, Kelly S, Hsieh SC, et al. Triptans in the Acute Treatment of Migraine: A Systematic Review and Network Meta-Analysis. Headache. 2015;55 Suppl 4:221-235. doi:10.1111/head.12601
  17. De Felice M, Ossipov MH, Wang R, et al. Triptan-induced latent sensitization: a possible basis for medication overuse headache. Ann Neurol. 2010;67(3):325-337. doi:10.1002/ana.21897
  18. The Lancet Gastroenterology & Hepatology. Unmet needs of patients with irritable bowel syndrome. The Lancet Gastroenterology & Hepatology. 2018;3(9):587. doi:10.1016/s2468-1253(18)30236-x
  19. Alzheimer’s Therapeutics Market Size Report, 2022-2030. https://www.grandviewresearch.com/industry-analysis/alzheimers-therapeutics-market. Published July 2022. Accessed March 3, 2023.
  20. Acumen Research and Consulting. Irritable bowel syndrome treatment market size. https://www.globenewswire.com/en/news-release/2022/10/03/2526998/0/en/Irritable-Bowel-Syndrome-Treatment-Market-Size-is-expected-to-reach-at-USD-4-7-Billion-by-2030-registering-a-CAGR-of-9-5-Owing-to-Increasing-Incidences-of-Gastrointestinal-Disorder.html. Published October 3, 2022. Accessed March 3, 2023.
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  25. Mordor Intelligence. Urinary tract infection therapeutics market analysis – industry report – trends, Size & Share. Urinary Tract Infection Therapeutics Market Analysis – Industry Report – Trends, Size & Share. https://www.mordorintelligence.com/industry-reports/urinary-tract-infection-therapeutics-market#:~:text=The%20urinary%20tract%20infection%20therapeutics%20market%20was%20valued%20at%20USD,the%20forecast%20period%202022%2D2027. Accessed March 3, 2023.
  26. Persistence Market Research. Polycystic ovary syndrome (PCOS) treatment market revenue to close value of US$ 6.31 bn with CAGR of 4.7% by 2032- persistence market research. GlobeNewswire News Room. https://www.globenewswire.com/en/news-release/2022/10/27/2542922/0/en/Polycystic-Ovary-Syndrome-PCOS-Treatment-Market-Revenue-to-close-Value-of-US-6-31-Bn-with-CAGR-of-4-7-by-2032-Persistence-Market-Research.html. Published October 27, 2022. Accessed March 3, 2023.
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  29. Buck Louis GM, Hediger ML, Peterson CM, et al. Incidence of endometriosis by study population and Diagnostic Method: The endo study. Fertility and Sterility. 2011;96(2):360-365. doi:10.1016/j.fertnstert.2011.05.087
  30. Butler CC, Hawking MKD, Quigley A, McNulty CAM. Incidence, severity, help seeking, and management of uncomplicated urinary tract infection: A population-based survey. British Journal of General Practice. 2015;65(639). doi:10.3399/bjgp15x686965

Adapting In COVID-19: A Product Forecasting Framework

Posted on by Sean Vander Linde

Adapting In COVID-19: A Product Forecasting Framework

Kx’s Key Takeaways For Product and Finance Teams    

  • Separate The Trough And Rebound: Modeling both the duration of the trough and the slope of the rebound, from peak COVID-19 infections to recovery, is critical to developing an accurate product forecast    
  • Layer In Regional Segmentation: Accurate forecasting requires more regional segmentation than most models demand due to the local variation in COVID-19 cases and varied government restrictions responding to the virus  
  • Expand Data Sources: Although COVID-19 is unprecedented in many respects, historical data can be used to model its impact. Utilizing a variety of data sources—analog regions that roll back restrictions earlier, patient and provider research, and prior economic downturns —can provide a valuable frame of reference to develop a more informed forecast  
  • Make It A Living, Breathing Model: With new restrictions and the medical community’s fast-paced response, it’s critical for companies to regularly monitor and update forecasting assumptions as the pandemic evolves   

COVID-19 Impacts Product Forecasting For Pharmaceutical and Medical Device Companies  

Dealing with significant evolving obstacles associated with COVID-19, businesses worldwide are adjusting their 2020 strategic plans. Pharmaceutical and medical device companies face particularly complicated hurdles, including procedure delays, office closures, and more that prevent patient access to their products. In this time of uncertainty, it’s critical to develop an informed view of future sales to establish a strategic plan and mitigate future risks to the business.  

Your Adaptable Product Forecasting Framework  

Kx Advisors created this framework to assist organizations in accurately forecasting sales during a time of high uncertainty with COVID-19. We recommend approaching the problem in two stages: the trough and the rebound. While organizations around the globe are currently in midst of the trough, understanding both stages is crucial for full-scale recovery. The questions we’ve identified for this framework can be split into three categories of barriers that COVID-19 presents: policy barriers, behavioral barriers, and economic barriers. Policy barriers are directly related to the pandemic management decisions of governments and medical associations, while behavioral barriers are driven by changes in industry competitor, physician, and patient behavior, and economic barriers are those created by changing economic conditions affecting willingness to pay.

 

COVID-19 Product Forecasting Framework Graphic Depicting Trough and Rebound

 Click to expand

Planning During COVID-19  

While no one can predict the future, this framework should help you gain critical insights to better project and respond to these challenges. Leveraging this tool to strategize is only step one; your product team must continually monitor the quickly evolving factors impacting the framework’s components and adjust your strategy as needed to stay ahead of the economic effect of this pandemic.  

Kx Is Here To Help  

Struggling with product forecasting during this crisis? With extensive forecasting experience, we’re experts at quantifying what is hard to quantify.  Our healthcare experts will rapidly analyze the changing field and build strategies with your team around the opportunities we identify. 

 

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How Is COVID-19 Impacting Procedure Volume?

Posted on by Jenna Riffell, PhD

Understanding The Changing Healthcare Landscape Is Key For Commercial Strategy

Treating Patients During A Crisis

The spread of COVID-19 has disrupted the healthcare industry. With hospitals scrambling to prepare for an influx of patients and government officials enacting large-scale safety measures, the overall volume of medical procedures is decreasing dramatically. The Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other healthcare thought leaders are recommending that providers limit non-essential and elective scheduled surgeries and procedures. However, not all procedures are equally impacted.

Graph depicting degree of impact on procedures based on setting and urgency

While COVID-19 is reducing treatment volume, the degree of impact varies depending on the urgency of the condition and the treatment setting. Procedure-focused companies must understand this evolving environment to forecast accurately and make crucial business decisions, such as resource deployment, commercial spending, and launch planning. Due to the fast pace of this pandemic and the corresponding response of the healthcare community, it can be difficult to predict the risks and disruptions organizations face. Without clear insight into the near-daily changes that medical professionals encounter, many companies’ strategic plans are no longer actionable.

How COVID-19 Impacts Orthopedics

The Kx team analyzed the consequences of COVID-19 for the orthopedic field, exploring trends that could inform expectations for the coming weeks and months. Our survey of orthopedic specialists across the US highlights that in most areas of the country, urgent and emergent procedures are still being performed, but elective procedures are being canceled.

US map depicting degree of impact on procedures by location

 

The only orthopedic procedures that are being performed treat truly urgent conditions: cases of infection and trauma. However, even critical treatments like these are being performed at a lower volume than before COVID-19 emerged in the US.

Graph depicting the volume by type of procedure

Lessons Learned For Other Specialties

Our case study in orthopedics serves as an opportunity for companies focused on other specialties to apply insights to their fields. With ~97% of orthopedic specialists only performing urgent procedures (if at all), healthcare professionals and companies can expect to see similar trends throughout the industry. As ~38% of orthopedic specialists are not rescheduling at this time, organizations throughout the healthcare industry must adjust their expectations and expect the repercussions of COVID-19 for an extended period.

Kx Advisors, Experts In Resilience

Is your organization impacted by the sharp decline in procedures due to COVID-19? Kx Advisors can help. Our experts offer tailored guidance in forecasting, commercial strategy, and launch planning, projecting future trends and empowering your organization to adapt during a global pandemic or another unpredictable event. Our team will continue to monitor trends over time to help predict which procedures are resuming and when, giving your organization current data to inform your key business decisions.

Contact Our Team For More Information Today