HEREDITARY ANGIOEDEMA MARKET ANALYSIS

Hereditary Angioedema Market Size and Trends

Hereditary angioedema market is estimated to be valued at USD 2.86 Bn in 2024 and is expected to reach USD 5.36 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 9.4% from 2024 to 2031.

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The hereditary angioedema market growth is primarily driven by increasing awareness of the condition and the availability of novel treatment options. Enhanced diagnostic technologies have led to more accurate and earlier diagnoses, expanding the patient base and boosting demand for effective therapies. The introduction of oral medications allows for convenient self-administration at home, making them preferable to traditional injectable treatments. However, the market faces significant restraints, particularly the high costs associated with these medications, which can limit accessibility for many patients.

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Insights By Type- Rising Awareness Boosts hereditary angioedema Type I Segment Growth

In terms of type, hereditary angioedema type I segment is estimated to contribute the highest market share of 67.3% in 2024, due to increased awareness about the condition. Rising diagnosis rates and awareness initiatives have encouraged patients with mild symptoms to seek treatment. Advancements in targeted therapy have also improved the management of attacks and adherence to treatment protocols.

Insights By Drug Class- C1 Esterase Inhibitor Maintains Dominance Due to Safety Profile

In terms of drug class, C1 esterase inhibitor segment is estimated to contribute the highest market share of 29.6% in 2024, due to its established efficacy and safety profile. It is the first U.S. FDA-approved treatment for acute HAE attacks, enhancing patient adherence through self-administration options. Rapid reconstitution and action of C1 esterase inhibitor within 30 minutes empower patients to manage initial symptoms effectively, solidifying its leading position in the market.

Insights By Route of Administration- Patient convenience drives the subcutaneous segment growth

In terms of route of administration, subcutaneous segment is estimated to contribute the highest market share of 29.6% in 2024, due to its convenience for patients. Self-administered subcutaneous treatments have become increasingly popular among HAE patients, as these eliminate the need for hospital visits, which is particularly beneficial for managing mild-to-moderate attacks away from medical facilities.

Regional Insights

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Dominating Region- North America

North America is expected to dominate the market, with an estimated market share of 35.8% in 2024. This is due to factors such as the strong presence of leading pharma companies, supportive healthcare reimbursement policies, and higher patient awareness levels.

Fastest-Growing Region- Asia Pacific

Asia Pacific region exhibits the fastest growth, with an estimated market share of 22.4% in 2024, due to rapidly developing healthcare infrastructure, improving access to diagnosis and treatment, and efforts by major players to expand their presence in emerging markets.

Hereditary Angioedema Market Outlook for Key Countries

Launch of innovative therapies in U.S.

The U.S. hereditary angioedema industry growth is driven by launches of innovative therapies. Companies are increasingly investing in clinical trials to develop more targeted treatment protocols, focusing on precision medicine that addresses individual patient needs. This investment is crucial as it leads to the emergence of next-generation therapies, including oral medications and subcutaneous injections, which are designed for greater convenience and improved adherence.

Germany’s favorable national guidelines and funding

Germany hereditary angioedema industry growth is driven by favorable national guidelines and funding aimed at rare disease management. The German government's commitment to improving healthcare for rare diseases is evident in its National Action Plan, which outlines comprehensive strategies to enhance diagnostics, treatment, and patient care. Collaboration between healthcare providers and pharmaceutical companies fosters research and development initiatives that aim to bring new therapies to market.

Japan’s increasing clinical focus

Japan’s increasing clinical focus on HAE drives the market growth. Growing recognition of HAE among healthcare professionals is supported by targeted marketing campaigns aimed at enhancing disease awareness. Pharmaceutical companies are actively engaging in educational initiatives to inform physicians about the symptoms, diagnosis, and treatment options available for HAE. Japan hereditary angioedema market is witnessing significant investments from key players in the development of new therapies tailored for HAE patients.

China’s government's commitment to enhancing medical access and improving healthcare infrastructure

China hereditary angioedema industry growth is driven by the government's commitment to enhancing medical access and improving healthcare infrastructure. The Chinese government has prioritized healthcare reform, aiming to provide universal access to medical services and address the disparities in healthcare availability across urban and rural areas. This focus is part of the broader "Healthy China 2030" initiative, which seeks to improve health outcomes and promote disease prevention.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Hereditary Angioedema Market Players

• Established Players in the hereditary angioedema industry focuses extensively on research and development to introduce innovative treatment options. Companies like CSL Behring, Sanofi, invest over 15% of their annual revenues into R&D. Their goal is to develop more targeted and higher-performing therapies to help manage symptoms and reduce attack frequency in patients.
• Mid-sized players have adopted cost-effective solutions as a key strategy. Companies like BioCryst and Ionis Pharmaceuticals focuses on developing generic and biosimilar drugs priced 20-30% lower than existing brand therapies. Their low-cost drugs expand treatment access in emerging markets. KalVista have entered partnerships with larger pharma firms to boost production capacity and commercialization capabilities.
• Small specialized manufacturers target niche patient segments through unique differentiated products. Attack Pharma focuses only on subcutaneous therapies for preventing swelling attacks. Its formulation offers convenience of self-administration and improved adherence.

Emerging Startups in the Hereditary Angioedema Market

• Several innovative startups are developing cutting-edge technologies to transform HAE management. Immunovant Sciences is utilizing antibody engineering platforms to create highly selective therapies that block only the pathways contributing to disease pathology. Apellis utilizes genetically-engineered cells to continuously deliver therapeutic molecules internally. Such targeted and precision-based solutions could reduce side effects and achieve remission in more patients.
• On the sustainability front, companies like BioBridge Science creates eco-friendly formulations using plant-based carriers and degradable polymers. Its plant-derived drugs aim to reduce plastic waste from traditional autoinjectors and syringes. U.K.-based startup Enzymotic works on an orally administered drug relying on engineered bacteria to breakdown antibodies in the gut, with regular injections. Such disruptive innovations can significantly lower HAE treatment costs and environmental footprint.

Hereditary Angioedema Industry News

• On September 3, 2024, KalVista Pharmaceuticals, Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration had accepted its New Drug Application (NDA) for sebetralstat, an investigational oral plasma kallikrein inhibitor intended for the on-demand treatment of HAE attacks in patients aged 12 years and older
• On June 18, 2024, Ionis Pharmaceuticals, Inc., a pharmaceutical company, announced a licensing agreement with Otsuka Pharmaceutical Co., Ltd., a biopharmaceutical company, for granting Otsuka Pharmaceutical Co., Ltd. the exclusive rights to donidalorsen across the Asia Pacific region. Donidalorsen is an investigational RNA-targeted prophylactic treatment for HAE. This agreement expands their collaboration, allowing Otsuka to pursue regulatory approvals and commercialization in this key market
• On June 18, 2024, KalVista Pharmaceuticals, Inc., a pharmaceutical company, announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sebetralstat. This investigational oral plasma kallikrein inhibitor is designed for the on-demand treatment of HAE) attacks in adult and pediatric patients aged 12 years and older

Key Takeaways from Analyst

The global hereditary angioedema market is expected to witness steady growth over the forecast period due to increasing disease awareness and diagnosis rates. The market currently has few approved treatment options and there remains a large unmet need. The launch of novel therapies with improved efficacy and convenience of administration could transform the treatment landscape.

Lack of disease awareness in developing countries may negatively impact the market growth. High unmet needs represent lucrative opportunities for leading pharmaceutical companies to develop novel treatment options and gain more market share. Development of subcutaneous and oral drugs with improved pharmacokinetics will augment patient adherence to treatment.

North America will likely continue dominating the market given the region's high healthcare spending and early adoption of new drugs. However, other developed markets in Europe and Asia Pacific are also expected to see faster growth.

Market Report Scope

Market Dynamics

Market Driver- Increasing prevalence of hereditary angioedema

Increasing prevalence of HAE can drive the market growth. For instance, according to an article published by the National Center for Biotechnology Information, in May 2022, the estimated prevalence of HAE is 1 in 50,000 worldwide. According to the National Organization for Rare Disorders (NORD), the risk of passing the abnormal gene from affected parent to offspring is 50% for each pregnancy regardless of the sex of the resulting child.

Market Challenge- Missed diagnosis or misdiagnosis

The market growth can be hampered due to factors such as frequent misdiagnosis of the condition. For instance, according to an article published by Everyday Health, Inc., in June 2020, people with HAE are often misdiagnosed as having another medical problem. About 40% of people with HAE are diagnosed within the first three years whereas almost 33% of people still face delays of 10 years or longer.

Market Opportunity - Product pipeline for treatment

Robust product pipeline for HAE treatments presents significant growth opportunities for market players. Companies are developing next-generation prophylactic and on-demand therapies, including oral drugs and subcutaneous injections, which enhance treatment adherence. With compounds like long-acting C1 inhibitors and kallikrein inhibitors, these innovations focus on self-administration and variable dosing, promising to improve the quality of life for HAE patients.

Market Segmentation

• By Type Insights (Revenue, USD Bn, 2019 – 2031)
• • Hereditary Angioedema Type I
  • Hereditary Angioedema Type II
• By Drug Class Insights (Revenue, USD Bn, 2019 – 2031)
• • C1 Esterase Inhibitor
  • Kallikrein Inhibitor
  • Bradykinin Receptor
  • Attenuated Androgens
  • Others
• By Route of Administration Insights (Revenue, USD Bn, 2019 – 2031)
• • Subcutaneous
  • Intravenous
  • Oral
• By Distribution Channel Insights (Revenue, USD Bn, 2019 – 2031)
• • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• By Regional Insights (Revenue, USD Bn, 2019 – 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• • CSL Behring
  • Sanofi
  • Takeda Pharmaceutical Company Limited
  • Orchard Therapeutics plc.
  • Pharming Group N.V.
  • BioCryst Pharmaceuticals, Inc.
  • Ionis Pharmaceuticals, Inc.
  • Attune Pharmaceuticals
  • Arrowhead Pharmaceuticals, Inc.
  • Adverum Biotechnologies, Inc.
  • KalVista Pharmaceuticals
  • CENTOGENE N.V.