Hyperphosphatemia and Hyperkalemia PROfilers Go to Japan (Part 2)

The CKD and ESRD Landscape in Japan

Our entry into the Japanese market has identified unprecedented commercialization opportunities for drug manufacturers of therapies for cardiorenal associated diseases such as hyperkalemia and hyperphosphatemia. More than 13 million documented Japanese patients suffer from chronic kidney disease (CKD) and a large number of them are experiencing end-stage renal disease (ESRD). The 4,300 dialysis therapy facilities registered with the Japanese Society of Dialysis Therapy, as well as the smaller facilities and clinics that are not a part of the Society, are stretched to their limits.

There is a substantial unmet need in the Japanese market for truly effective drug therapies, just as there is in the United States, but Japan represents a healthcare system in which nearly all costs associated with treatment and medications are covered, making opportunities for the use of a new phosphate binder or a new hyperkalemia drug there particularly intriguing.

Unmet Needs of CKD and ESRD Patients

Because Japan has a higher prevalence of CKD than any other country in the world, Japanese patients represent a fertile environment for the capture of new insights into the need for innovative pharmacological agents that target pathological mechanisms marginally affected by traditional therapies.

Our early research efforts in Japan have successfully identified an array of unmet needs among Japanese CKD and ESRD patients who consistently report frustration with their drug regimens. Based on this data, we can surmise opportunities to meet other needs that would result in a higher compliance rates and subsequently, greater effectiveness on the part of any new therapies brought to market. These unmet needs include but are not limited to:

  • New medicines that are easier to take overall
    • Reduction of the number and frequency of pills that must be taken (phosphate binders in particular) or amounts to be taken per administration.
    • Simplification of the complex and frequent dosing schedule
    • Medications for hyperphosphatemia and hyperkalemia that are easier to take or taste better
  • Medicines with improved GI tolerability and long-term safety.

Some sources also report that CKD and ESRD patients in Japan are frustrated with an apparent lack of understanding on the part of their HCPs about the complex medication regimen required of the patient and suggest measures that would not only increase HCP knowledge but provide them with better educational tools for their patients. Such measures might include:

  • Information about disease progression and what patients can expect along the way
  • Information that will allay patient fears about adverse effects of the drugs
  • Specific details about the drugs themselves and what patients will experience when taking them
  • Possible cues or reminders for patients of each dose
  • Information about the benefits of the medicine if patients are compliant
  • Cost incentives for compliance

Despite the frustrations and issues voiced by the Japanese, however, the medication regimens of these CKD patients remain the crucial cornerstone of their therapy, so novel substances that offer clear benefits over available drugs represent a market with enormous potential for development.

On the other hand, Japanese physicians managing their patients with phosphate binders (i.e. in Japan: Calcium Carbonate, Fosrenol, Riona, Kiklin, P-Tol) or with potassium lowering agents (such as Kayexalate, Argamante or Kalimate) have their own unmet needs:

  • Phosphorus-/ potassium lowering efficacy
  • Steering efficacy and adverse effects via dose-adjustment options or combining treatments.

In addition, their treatment goals, their standard of care and therapy sequencing determine market opportunities and differ from that in other countries.

Shaping strategy for novel phosphate- or potassium lowering agents on how to enter this market successfully and providing their manufacturers with validated data to estimate related market potential is our goal.

Generating Data

Gathering the related reliable and adequate data to assess economic opportunities and to generate high level market forecasts for drug manufacturers is a complicated exercise requiring uncommon expertise. PPP and its proprietary PROfiler system allow drug makers to tap exactly into these aspects and gain real knowledge about the complexities they will face.

We go the extra mile and capture real-world insights from both CKD/ERSD patients and the HCPs who manage their hyperphosphatemia and hyperkalemia in a variety of caregiving and prescribing settings.

Because of the work we have already completed in this market, we have extensive insight (qualitative and quantitative) into Japanese market conditions, the changing dynamics of the patient base, and the complex relationships between health care facilities, physicians and prescribers, and governmental reimbursement agencies.

In the articles that will follow – and in our formal PROfiler report that will be available during this summer – we will elaborate on the unmet needs we’ve identified along with the new market insights we have generated. This proprietary data will allow us to provide clients with the information they need to establish a competitive edge in this exciting market environment.

The pure detection of insights is not enough; only if the 3 levels are checked can an insight be considered as valuable.

Contact us if you want to know more about our hyperkalemia and hyperphosphatemia PROfilers.