The metabolic acidosis market is estimated to be valued at USD 177.9 Mn in 2024 and is expected to reach USD 265.5 Mn by 2031, growing at a compound annual growth rate (CAGR) of 5.89% from 2024 to 2031. The growing geriatric population who are more prone to developing metabolic acidosis due to age-related medical conditions such as kidney diseases is a major factor driving the demand.

Market Driver - Rising prevalence of Chronic Kidney Disease (CKD), leading to an increase in metabolic acidosis cases

Chronic kidney disease is one of the most common causes of metabolic acidosis occurring in advanced CKD stages. As kidney function deteriorates over time with disease progression, metabolic acidosis cases associated increase sharply.

Studies show that approximately 20% of all CKD patients have metabolic acidosis and prevalence rises to 50-60% as kidney disease reaches end stage requiring dialysis.

Rising CKD prevalence globally has significantly contributed to the growing metabolic acidosis patient pool in recent years. As per latest reports, CKD currently affects over 10% of the world's population and cases have increased by more than 30% since 1990.

Developed nations have witnessed over 70-80% surge with ageing population and lifestyle diseases becoming more widespread. Even developing regions are experiencing sharp rises. This unrelenting increase in CKD cases is expected to parallel drive up the need for management of associated metabolic acidosis over the coming decades.

Unless efforts are made to curb kidney disease risk factors, rising CKD prevalence will continue placing upward pressure on the metabolic acidosis market.

Market Driver - Advances in Alkali Therapies and Emerging Treatments

Considerable research efforts have been directed towards developing more effective alkali therapies and novel treatment approaches for metabolic acidosis in recent times. Traditional alkali treatments including sodium bicarbonate have been optimized to overcome issues like poor palatability and compliance. Advances have yielded improved formulations, delivery methods and extended-release profiles. Novel alkali salts and acid binders have also emerged offering enhanced buffering capacity and less volume burden. These emerging alkali options provide physicians and patients with greater flexibility and convenience.

In addition, new mechanisms to address acid accumulation are under investigation. Emerging areas of focus involve inhibiting endogenous acid production, trapping circulating acids and modulating gut microbial activity. Several candidates targeting these alternative approaches have entered clinical trials with few in late-stage development.

Researchers are optimistic some may provide more durable solutions than current alkali therapies alone. If successfully developed, these new generation metabolic acidosis therapies will capture greater market share going forward. Continued progression of candidates through trials and approvals should sustain strong growth opportunities in the metabolic acidosis market in the medium to long term.

Market Challenge - Lack of FDA-approved Therapies for Metabolic Acidosis

A key challenge in the metabolic acidosis market is the lack of FDA-approved drugs to treat chronic metabolic acidosis conditions effectively. Currently, there are no pharmacological agents that are specifically indicated for treating metabolic acidosis. While sodium bicarbonate is widely used off-label to treat metabolic acidosis, it provides only temporary relief and does not address the underlying condition.

Bicarbonate therapy also presents practical challenges like high pill burden and risk of fluid overload. This significant unmet need has kept the market largely untapped. The absence of viable drug treatment options also limits clinical research and understanding of disease progression.

Further confounding the treatment landscape is diagnostic challenges and variability in defining and assessing metabolic acidosis. More research is needed to better characterize subtypes and establish standardized diagnostic protocols. The lack of approved pharmacological interventions continues to present a major barrier to market growth and prevents many patients from obtaining effective long-term treatment for their condition.

Market Opportunity - Launch of Innovative Therapies like Veverimer

One major opportunity in the metabolic acidosis market is the launch of novel drugs which can address the current unmet need for a safe and effective FDA-approved treatment option. Veverimer (Takhzyro) is an innovative non-absorbed, locally-acting polymer that has recently shown promise in treating metabolic acidosis in chronic kidney disease (CKD) patients.

If approved, Veverimer will be the first drug specifically indicated for chronic metabolic acidosis treatment in CKD. This could potentially capture a sizable portion of the underserved CKD patient population suffering from acidosis. Veverimer's novel mechanism of action and strong evidence of acid-lowering benefit without systemic absorption make it well-positioned as a breakthrough drug for CKD.

Its approval may validate acidosis as an important therapeutic target, propelling the market towards more R&D investments and innovative pipeline programs. Overall, first-in-class therapies like Veverimer have the potential to revolutionize treatment options, drive patient uptake and transform the metabolic acidosis market landscape.

Prescriber preferences for treating metabolic acidosis may depend on the underlying cause and severity of the condition. For mild cases where the cause is known and temporary, prescribers may prefer oral bicarbonate supplements as first-line therapy to correct the acid-base imbalance.

For more severe or life-threatening cases, or when the cause is unknown or chronic, prescribers likely consider IV bicarbonate or other buffering agents to more rapidly normalize pH and electrolyte levels. The selection may factor in the patient's clinical stability, comorbidities, and tolerance for different administered substances or routes.

Additional management of underlying contributing issues would also influence prescribing, such as renal replacement therapies for kidney diseases driving acidosis. Younger patients in better overall health may have more flexible options than older adults with multiple chronic conditions.

Costs, insurance coverage, formulary inclusion, and a drug's overall safety profile comparative to others available for same indication could impact brand or generic preferences. Peer-reviewed evidence, clinical experience, advertising or promotion may shape perceptions.

Metabolic acidosis has several potential treatment options depending on the underlying cause and severity of the condition. Mild cases may be treated by addressing the root cause, such as resolving diarrhea, increasing fluid intake, or using supplemental bicarbonate.

For more severe cases, intravenous sodium bicarbonate therapy is the standard first-line treatment to raise blood pH levels. Several drugs are commonly used including sodium bicarbonate (Bicitra), which increases the buffering capacity of the blood. For acute kidney injury cases, bicarbonate therapy seeks to improve the patient's underlying condition and prevent further deterioration of kidney function.

If bicarbonate therapy alone does not sufficiently correct acidosis, adjunctive treatments may be needed. In refractory lactic acidosis scenarios, buffering agents are usually combined with thiamine to support cellular metabolism. Drugs that induce diuresis like furosemide (Lasix) may also help clear excess acid while maintaining adequate hydration and electrolyte levels.

For chronic kidney disease patients requiring long-term management, oral sodium bicarbonate (Bicitra) is preferred over intravenous routes to prevent complications from frequent hospital visits. Close monitoring of electrolyte and acid-base status is still needed, as untreated metabolic acidosis can accelerate kidney damage over time if left unchecked.

Product Innovation: New product development and innovation has been a major strategy for companies to gain an edge. For example, in 2020 AstraZeneca received FDA approval for Lokelma (sodium zirconium cyclosilicate) for treatment of hyperkalemia (high potassium levels) in adult metabolic acidosis patients.

Strategic Acquisitions: Acquiring complementary technologies and companies has helped enlarge product portfolios. In 2017, Fresenius Medical Care acquired NxStage Medical, a leading provider of dialysis equipment and services, for $2 billion. This expanded Fresenius' range of solutions for chronic kidney disease and renal replacement therapies used to treat metabolic acidosis. It boosted their market share in home hemodialysis by almost 50%.

Expanded Distribution Networks: Wider geographical reach allows access to new patient pools. In 2015, Aetna expanded its network of providers in the Northeast U.S., increasing member access to metabolic specialists and broadened coverage for related tests/treatments.

Precision Marketing: Targeted campaigns educating physicians and patients on latest treatment guidelines and options have paid dividends. DaVita's focus on digital and online marketing on metabolic acidosis symptoms and their integrated care services caused referrals from nephrologists to grow by almost 25% between 2018-2020, improving capacity utilization.

Insights, By Type: Emerging Prevalence of Lifestyle Diseases Drives Growth of Acute Metabolic Acidosis Segment

In terms of type, acute metabolic acidosis segment is expected to hold 55.8% share of the market in 2024, owning to rising instances of acute disorders and health conditions that can potentially lead to metabolic acidosis. The growing prevailing of lifestyle diseases such as diabetes owing to sedentary routines and unhealthy diets has significantly increased risk of diabetic ketoacidosis.

Moreover, excessive consumption of alcohol is a major causative factor for lactic acidosis. Certain cardiovascular conditions and liver or kidney impairments as well often result in acute imbalance of acids and bases in the body. The rising geriatric population also drives greater susceptibility to acute infections and health deteriorations that require immediate medical intervention to address resulting metabolic acidosis.

Insights, By Treatment: Increasing Awareness and Demand for Effective Therapies Boosts Bicarbonate Therapy Segment

In terms of treatment, bicarbonate therapy is projected to hold 47.6% share of the market in 2024, owing to its effectiveness in restoring acid-base balance and rising awareness among healthcare providers as well as patients. Oral as well as intravenous bicarbonate supplements help in neutralizing excess acids and ameliorating acidosis symptoms efficiently. Their utilization is extensively documented in case of severe metabolic acidosis conditions.

Moreover, limited availability of alternative pharmacological remedies makes bicarbonate therapy particularly valuable. Growing health consciousness and demand for prompt remedy further drive larger adoption of bicarbonate supplements and solutions in clinical settings.

Insights, By End User: Expanding Patient Pool and Healthcare Infrastructure Strengthen Hospitals Segment

In terms of end user, hospitals contribute the highest share owing to availability of advanced facilities and team of specialist doctors. The growing geriatric demographic prone to metabolic acidosis along with rising lifestyle disease incidence has considerably expanded the patient pool requiring medical care and monitoring.

Additionally, expanding healthcare infrastructure and growing number of multi-specialty hospitals particularly in developing regions offer improved access and patient comfort. Strong regulatory frameworks also ensure best clinical practices and quality of care. These factors have greatly favored the dominance of hospitals as the major end-user segment in the global metabolic acidosis market.

• In 2023, about 1.7 million cases of metabolic acidosis were diagnosed across the seven major markets (7MM). Around 850,000 cases in the US were linked to chronic kidney disease (CKD) stages 3 to 5.
• Gender-specific prevalence: In 2023, males accounted for 55% of diagnosed metabolic acidosis cases due to higher CKD and diabetes prevalence.
• The US market dominated with a 70% market share due to advanced healthcare infrastructure. In 2023, the market size for metabolic acidosis therapies in the US was USD 117.6 million. Germany was the largest market in the EU, with a value of USD 9.1 million.

The major players operating in the metabolic acidosis market include Tisento Therapeutics, Tricida, Advicenne Pharma, Zagociguat, Fresenius Medical Care, Novartis, Relypsa, Inc., Zydus Cadila, and Amneal Pharmaceuticals.

• In June 2024, Tisento Therapeutics announced that Zagociguat, an oral tablet for treating metabolic acidosis, entered Phase II trials, marking significant progress in therapeutic options for acidosis. The trial start date is projected for September 2024, with an expected completion around 2025. Zagociguat is currently moving into Phase 2b clinical trials, aimed at further evaluating its efficacy and safety. This drug is notable for its mechanism as a soluble guanylate cyclase (sGC) stimulator, which acts on both central nervous system (CNS) and peripheral symptoms like fatigue and cognitive impairment.
• In March 2024, Tricida entered partnership with European pharmaceutical companies to distribute metabolic acidosis therapies across EU4 nations. This is expected to increase accessibility and market penetration.
• In August 2023, Advicenne launched ADV7103 in select markets as a treatment for distal renal tubular acidosis (dRTA). This treatment offers a new therapeutic option for patients, targeting a rare kidney condition that affects the body's acid balance. ADV7103 is a combination of potassium citrate and potassium bicarbonate in a prolonged-release formulation, which helps manage the acidity levels in the body, potentially reducing complications like growth retardation in children and kidney-related issues in adults. This launch provides significant relief for patients suffering from this rare condition, for which treatment options had been limited before​.
• In July 2023, Advicenne Pharma announced the development of a new bicarbonate treatment aimed at early-stage CKD-related metabolic acidosis. This will fill a key gap in early intervention therapies. Advicenne's key focus has been on ADV7103 (Sibnayal), a treatment primarily aimed at distal renal tubular acidosis (dRTA), which has seen positive clinical trials and marketing authorizations across Europe, including the UK.
• Earlier in 2019, Tricida had submitted the NDA for Veverimer under the FDA’s Accelerated Approval Program, and the FDA accepted it for review with a PDUFA date set for 2020. However, the FDA later issued a Complete Response Letter (CRL) in August 2020, which delayed its approval, citing the need for additional data on the treatment's effectiveness and its applicability.

• By Type
  • Acute Metabolic Acidosis
    • Drug-induced Acidosis
    • Lactic Acidosis
  • Chronic Metabolic Acidosis
    • Renal Tubular Acidosis
    • Diabetic Ketoacidosis
• By Treatment
  • Bicarbonate Therapy
    • Oral Bicarbonate
    • Intravenous Bicarbonate
  • Dialysis
    • Hemodialysis
    • Peritoneal Dialysis
  • Pharmacological Agents
    • Sodium Bicarbonate Tablets
    • Potassium Citrate Supplements
• By End User
  • Hospitals
    • Inpatient Services
    • Outpatient Services
  • Clinics
    • Specialty Clinics
    • General Clinics
  • Homecare Settings
    • Home Dialysis
    • Home Medication Management