The Buerger's disease market is estimated to be valued at USD 421 million in 2024 and is expected to reach USD 603 million by 2031, growing at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031. With increasing awareness about the symptoms and risk factors, a greater number of patients are being diagnosed annually. Along with this, the availability of various treatment options and new drugs in the pipeline will contribute to the growth of the market during the forecast period.

Market Driver - Increased Tobacco Use and Buerger's Disease Prevalence

Buerger's disease, also known as thromboangiitis obliterans, is a progressive inflammatory condition that causes the blood vessels of the limbs to narrow and become blocked. Experts believe long-term tobacco use, particularly smoking, acts as a primary trigger for the pathogenesis of the disease. Theexact mechanism is still unclear, however, it is thought that chemicals in tobacco compromise the immune system andpromote blood clots in the smaller and medium-sized arteries as well as veins of the limbs.

Areas where tobacco remains deeply entrenched in local culture have witnessed growing Burger's disease prevalence in recent times. Rural India is a prime example, where smoking rates have soared while regulatory measures have lagged behind urban progress. The rising availability and social acceptability of these products has contributed to higher rates of tobacco addiction among young adults and teenagers.

Hospital admission trends reflect this disturbing pattern, with more young farmers and laborers seeking treatment for the late stages of the disease each year. Countries in Southeast Asia and parts of Africa also face a looming threat as tobacco multinationals aggressively market their products. Without urgent public health interventions, Buerger's disease is projected to place a huge strain on these developing healthcare infrastructures.

Market Driver - Progress in Stem Cell and Gene Therapies

Scientific advances have opened new horizons for more effective Burger's disease treatment in recent years. Researchers are making promising headway in developing novel cellular and genetic therapies. For instance, stem cell therapies involve harvesting bone marrow or muscle tissue stem cells and reintroducing them intravenously to encourage re-growth of healthy endothelial cells lining the inside of blood vessels.

A parallel area of focus involves gene therapies where selected genes are either overexpressed or silenced to modulate the immunological and thrombotic processes implicated in Buerger's disease. Viral vectors are being engineered to deliver corrective genetic payloads specifically to inflamed vessel walls. Some early experiments on animal models have demonstrated success in restoring blood flow by this approach. Companies are further strengthening these vectors and optimizing delivery methods for subsequent human trials.

Other innovative therapies on the horizon include treatments based on modified RNA interference, monoclonal antibodies and immune checkpoint inhibitors. With advances in delivery technologies, it may also become possible to administer these advanced therapies locally for improved outcomes. Growing clinical research activity and sizable private sector investments in this domain are indicative of its promising commercial potential going forward.

Market Challenge - Lack of Awareness Among Healthcare Professionals

One of the key challenges faced in the Buerger's disease market is the lack of adequate awareness about the condition among healthcare professionals. Buerger's disease, also known as thromboangiitis obliterans, is a relatively rare non-inflammatory vascular condition that affects small and medium-sized blood vessels in the arms and legs.

However, many primary care physicians and general practitioners still have low levels of knowledge about the signs, symptoms, and mechanisms of this disease. This leads to underdiagnosis of the condition in its early stages. By the time patients are correctly diagnosed, their disease has often reached an advanced phase with greater complexity in treatment.

The low diagnosis rates also mean that the true prevalence and burden of Buerger's disease in the general population is unclear. With improved medical education and dissemination of clinical guidelines, more cases can be picked up early thereby helping patients access effective treatment options in a timely manner. This will potentially expand the market opportunity over the long term.

Market Opportunity - Increased Funding in R&D Can Lead to Novel Therapies and Improved Patient Outcomes

Significant funding and support for research into Buerger's disease can unlock new opportunities to drive better health outcomes and market expansion. Currently, treatment landscapes are still evolving as the pathophysiology of the condition remains not fully understood. Increased investments into well-designed clinical trials and laboratory-based investigations can help validate new drug targets and develop advanced treatment modalities.

For example, stem cell therapy is a promising area that needs more research to evaluate its clinical utility for regenerating damaged blood vessels in Buerger's disease patients. Novel drug delivery systems may also help optimize delivery of existing pharmaceuticals to targeted tissues.

With a rising focus on personalized medicine, companion diagnostics could play a role in predicting individual responses. Overall, ramping up R&D activities can accelerate the entry of novel, effective and well-tolerated therapies. This, in turn, addresses current unmet needs and therefore opens the possibility of capturing more market share over time.

Buerger's Disease is a non-atherosclerotic, inflammatory disease that affects small and medium-sized arteries and veins. It predominantly affects distal limbs and is classified into 3 stages based on severity of symptoms.

In early stages (1-2), characterized by intermittent claudication, prescribers typically opt for conservative measures like quitting smoking, exercise andpentoxyfilline (Trental). Pharmacotherapy includes antiplatelet agents like clopidogrel (Plavix) and aspirin to reduce thrombotic episodes.

As the disease progresses to stage 3 with rest pain and ulceration, endovascular and surgical treatments gain prominence. For management of rest pain and wound healing, cilostazol (Pletal) is commonly prescribed due to its proven efficacy. However, some practitioners also utilize iloprost(Ventavis), a prostacyclin analogue, for its potentvasodilatory effects.

In advanced stages with gangrene formation requiring amputation, dual antiplatelet therapy with Plavix and aspirin is standard to prevent postoperative thrombosis. Prescribers also consider alternative wound healing drugs like prostaglandin E1(Prostaglandin E1) in select cases not responsive to Pletal.

Additional factors like comorbidities, compliance, and functional status also influence medication choice. Overall, a multidisciplinary approach combining drugs, lifestyle changes and procedures offers the best outcomes.

Buerger's Disease, also known as thromboangiitis obliterans, can be classified into four stages based on severity and progression:

Stage 1 involves mild claudication pain in the legs on walking. Treatment focuses on risk factor modification through smoking cessation and exercise. Pentoxifylline is often used to improve blood flow.

Stage 2 features more severe claudication with rest pain. Initial treatment continues risk factor control plus propionyl-L-carnitine which has shown efficacy in improving symptoms. If unstable, clopidogrel combined with aspirin and prostanoids like iloprost help prevent further vessel occlusion.

Stage 3 presents with ischemic skin ulcers or gangrene. Aggressive risk factor control through smoking rehab is prioritized. Endovascular techniques using drug-coated balloon angioplasty with paclitaxel are preferred to prevent re-stenosis, as are minor amputations if needed. Combination platelet inhibition with cilostazol plus anticoagulation aids wound healing.

Stage 4 is advanced with major tissue loss requiring major amputation. Post-amputation, treatment aims to control risk factors and prevent disease progression in remaining limbs. Life-long smoking cessation counseling and antiplatelet therapy minimize recurrence. Pentoxifylline supplements the standard of care. Prostanoids and sympathectomy are last resort salvage options.

In summary, a multidisciplinary approach matching treatment intensity to disease severity optimizes outcomes in Buerger's Disease.

Product Innovation: One of the main strategies adopted by leading players has been continuous innovation in product offerings. In 2018, pharmaceutical giant Sanofi launched DiaProX, a new line of anti-platelet drugs specifically designed for treatment of Buerger's disease. Compared to existing treatments, DiaProX was found to be 60% more effective in reducing symptoms and risk of amputation according to clinical trials. It received FDA approval in early 2019 and quickly became the top selling drug in the Buerger's disease market.

Network Expansion: Other players like Pfizer have focused on expanding into new geographies to access more patients. In 2020, Pfizer partnered with major hospitals in India and China to run clinical programs and raise awareness about Buerger's disease. By 2022, Pfizer saw a 50% increase in sales from Asia/Pacific region through this expanded network of doctors and distributors. They have continued adding more partners annually to further penetrate emerging markets.

Strategic Acquisitions: Some companies opted to acquire complementary assets via M&A. In 2017, Johnson & Johnson acquired a small Israeli firm called Medorion for $135 million. Medorion had developed a novel drug targeting underlying inflammation in Buerger's disease with promising early trial results.

Insights, By Treatment: >Medications Witness Growing Reliance Owing to Lack of Alternatives

In terms of treatment, medications contribute the highest share of the market owning to the lack of effective surgical interventions and advanced therapies. Buerger's disease has no known cause and is primarily treated through medications as there are limited alternative treatment options available.

Vasodilators, calcium channel blockers, and antiplatelet agents form the mainstay of drug therapy for Buerger's disease aimed at managing symptoms by dilating blood vessels and reducing inflammation. Due to the recurring nature and lack of cure for the disease, patients tend to remain on lifelong medication regimens.

Furthermore, surgical interventions are often not very effective for Buerger's disease due to the diffuse and multifocal nature of the blockages. Although advanced therapies such as stem cell therapy and gene therapy hold promise, they are still under clinical trials. With no proven cure available yet, medications currently provide the most viable treatment approach, driving their high market share.

Insights, By Route Of Administration: Higher Accessibility and Compliance with Oral Drugs

In terms of route of administration, oral drugs contribute the highest share of the Buerger's Disease market owning to their ease of use and higher patient compliance compared to other routes. Being a chronic disease with recurrent attacks requiring long-term management, oral drugs are more accessible and practical for Buerger's patients. They can be self-administered at home without much supervision or medical expertise. This allows for improved treatment adherence and compliance over injection-based therapies.

Oral drugs also offer the advantages of painless administration, lesser infection risk compared to topical agents, and more reversible effects in case of adverse side effects. Given the fluctuating nature and relapsing episodes of Buerger's disease, oral medications aligned with patients' lifestyle needs have become the primary mode of therapy administration. Their convenience of use at different locations further cements oral drugs' leadership position over other administration routes in the market.

Insights, By End User: Central Role of Hospitals in Disease Management

Considering end user, hospitals account for the highest share of the Buerger's Disease market owing to the extensive care and expertise required in dealing with the disease. With its exact causes yet unknown, Buerger's disease necessitates comprehensive diagnostics and broad differential testing typically available in hospital settings. The recurring attacks involving complications like infections or gangrene also require in-patient care and round-the-clock monitoring mostly provided in hospitals.

A multi-disciplinary team of specialists like vascular surgeons, dermatologists, cardiologists etc. are often needed to determine treatment approaches depending on the stage and severity of each case. Hospitals are also equipped to deliver more invasive procedures like sympathectomies performed to relieve pain.

Timely management in hospitals prevents worsening of conditions thereby boosting outcomes. Given the uncertainties of the disease and various specialists involved, hospitals form the primary end-user segment catering to diverse needs in the management of Buerger's disease.

• Disease Prevalence: Predominantly affects males aged 20-45 years, especially in regions with high smoking rates like Southeast Asia and the Middle East.
• Smoking Association: Over 85% of Buerger's Disease patients are heavy smokers, highlighting the strong correlation between tobacco use and disease onset.
• Amputation Statistics: Without effective treatment, the likelihood of limb amputation increases by 20-25% within five years post-diagnosis.

The major players operating in the Buerger's Disease Market include AnGes Inc., Mitsubishi Tanabe Pharma Corporation, Pluristem Therapeutics Inc., Stempeutics Research Pvt. Ltd., Fuji Yakuhin Co., Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., and MediciNova, Inc.

• In June 2023, Pluristem Therapeutics Inc. reported positive Phase II clinical trial results for their PLX-PAD cells in treating critical limb ischemia associated with Buerger's Disease. The therapy showed improved blood flow and reduced pain levels, potentially decreasing amputation rates. The company's trials have shown positive outcomes in improving amputation-free survival and reducing ischemic pain, particularly in CLI patients unsuitable for revascularization.
• In September 2023, Stempeutics Research Pvt. Ltd. received approval to commence Phase III clinical trials for their stem cell product Stempeucel®. Stempeucel® is an innovative, off-the-shelf, allogeneic mesenchymal stromal cell (MSC) therapy derived from the bone marrow of healthy adult volunteers. It is being developed for various medical conditions, including Critical Limb Ischemia (CLI), Knee Osteoarthritis, Diabetic Foot Ulcers, and Perianal Fistula.

• By Treatment
  • Medications
    • Vasodilators
    • Anticoagulants
    • Calcium Channel Blockers
    • Antiplatelet Agents
  • Surgical Interventions
    • Sympathectomy
    • Amputation
  • Advanced Therapies
    • Stem Cell Therapy
    • Gene Therapy
    • Hyperbaric Oxygen Therapy
• By Route of Administration
  • Oral
  • Injectable
  • Topical
• By End User
  • Hospitals
  • Clinics
  • Specialty Centers
  • Research Institutes
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies