Summary

The Hemophilia market is expected to witness a CAGR of 5.9% during the forecast period (2021-2026).

The outbreak of COVID-19 worldwide is expected to impact the market, as individuals with chronic medical conditions, such as hemophilia, should take extra precautions to minimize the risk of contracting COVID-19, as this group of the population is more prone to infectious diseases. For instance, over the past few decades, several blood-borne viruses targeted hemophilia patients requiring treatment with clotting factors derived from human plasma. They should take measures to keep their blood pressure in check and follow general guidelines to keep their immune system strong. Moreover, it is impossible to estimate how many patients with hemophilia will become infected, and whether their factor deficiency and its treatment can influence the manifestations of the infection, its natural course, treatment, and consequences. In December 2020, the World Federation of Hemophilia (WFH), European Association for Haemophilia and Allied Disorders (EAHAD), European Haemophilia Consortium (EHC), and U.S. National Hemophilia Foundation (NHF) issued a joint COVID-19 vaccination guidance for people with bleeding disorders. It stated that people with bleeding disorders were not at greater risk of contracting COVID-19 or developing a severe form of the disease. Thus, people with these disorders were more likely to get themselves treated after they get vaccinated.

Certain factors that are driving the market growth include growing prevalence of hemophilia, favorable government initiatives, and rising R&D and new product development. Furthermore, according to the World Health Organization (WHO), owing to the sex-linkage of the disorder, there is a bigger prominence in males than females. In about one-third of new diagnoses, there is no earlier family history. Hemophilia occurs worldwide and across all racial groups. According to the World Federation of Hemophilia 2019 global survey report, in 2019, there were 31,997 people diagnosed with hemophilia B, around 5,749 people with unknown hemophilia types, and around 49,083 people were diagnosed for other bleeding disorders. Moreover, according to a study report by Allison Inserro published in the American Journal of Managed Care 2019, the prevalence of hemophilia B at birth is 5 cases for all severities of hemophilia B (per 100,000 males) and 1.5 cases for severe hemophilia B (per 100,000 males). For those born with hemophilia, the chances of living a life of normal duration and quality is reduced by 64% in the upper-middle-income countries, 77% in middle income, and up to 93% in low-income countries. This indicates reduction in quality of life due to hemophilia B, increasing the need for effective hemophilia treatment, which is expected to drive the market in the coming years.

Key Market Trends

Hemophilia A is Expected to Hold Significant Market Share in the Disease Type Segment

Hemophilia A is the most common severe bleeding disorder. Replacement therapy, providing the missing coagulation factor, has been the mainstay of treatment both prophylactically and to treat bleeding. According to the data published by the World Federation of Hemophilia in 2019, hemophilia is more recorded among males, and approximately 24.6 in 100.000 neonates suffer from hemophilia A. This is a rare genetic bleeding disorder projected that affected around 157,517 people worldwide in 2019. The key medication to treat hemophilia A is concentrated FVIII product, also known as clotting factor. The recombinant factor products that are developed in a laboratory using DNA technology impede the use of human-derived pools of donor-sourced plasma. Due to the advances in recombinant protein engineering and the introduction of gene therapy and novel strategies to target the coagulation cascade. In 2018, Roche announced the approval of “Hemlibra” for expanded use in the routine prophylaxis of bleeding episodes in patients with hemophilia A without factor VIII (FVIII) inhibitors. The Takeda Pharmaceutical Company Limited offers "ADVATE“, which is used to replace clotting factor (factor VIII or antihemophilic factor) is missing among people with hemophilia A (also called “classic” hemophilia). Furthermore, according to the National Clinical Registry (NCT), as of August 11, 2020, worldwide, there were about 139 ongoing clinical trials across different phases of development for hemophilia A (HA). Moreover, the increasing demand for advanced products for the diagnosis and treatment of hemophilia is projected to trigger the growth of this segment in the forecast period.

North America Dominates the Market and Expected to do Same in the Forecast Period

The North America region dominates the global market. The major factors driving the growth of the hemophilia market in the region include the therapeutic advances in hemophilia, which led to a wave of new FDA-approved agents and increasing awareness about technologically advanced products, increasing prevalence hemophilia, and the presence of a huge patient pool. The United States is the largest market in the region. According to the World Federation of Hemophilia 2018 report, in 2018, there were about 17,757 people diagnosed with hemophilia in the United States. Furthermore, in 2019, the number of people with hemophilia in the United States increased to about 20,000 individuals, as per NHF (National Health Federation). In the United States, agencies, like hemophilia Association of America, generally offers continuous treatment for patients by introducing different co-pay initiatives. This is further expected to balance the expenditures for patients and assist them in providing access to new products. In the United States, the BioMarin company is conducting Phase III clinical trial with valoctocogene roxaparvovec (BMN 270) to assess the efficacy of BMN 270 in the treatment of hemophilia A. Therefore, advancements in the gene therapy and novel strategies to target the coagulation factors is expected to drive the market in the near future. In the United States, Genzyme Corporation offers "ALPROLIX" (Coagulation Factor IX (Recombinant), Fc Fusion Protein), an injectable medicine used to help control and prevent bleeding in people with hemophilia B. Thus, the increasing research and development in the development of new effective therapies, along with the rising prevalence of hemophilia in the United States, is expected to drive the market over the forecast period.

Competitive Landscape

The Hemophilia market is highly competitive and consists of a few major players. Companies like Bayer AG, BioMarin Pharmaceutical, Inc., CSL Behring, Kedrion, Novo Nordisk, Pfizer, Inc., Roche (Chugai Pharmaceutical Co.), Sanofi (Genzyme Corporation), Takeda Pharmaceutical (Shire Plc.)., among others, hold substantial market share in the Hemophilia market. Additionally, the key players have been involved in various startegic alliances such as acquisitions, collaborations along with the launch of advanced products and research studies to secure the position in the global market.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Growing Prevalence of Hemophilia
4.2.2 Favorable Government Initiatives
4.2.3 Rising R&D and New Product Development
4.3 Market Restraints
4.3.1 High Cost of Treatment
4.3.2 Lack of Awareness Regarding Advanced Technologies
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 By Disease Type
5.1.1 Hemophilia A
5.1.2 Hemophilia B
5.1.3 Others
5.2 By Therapy
5.2.1 Replacement Therapy
5.2.2 Gene Therapy
5.2.3 Others (Immune Tolerance Induction Therapy etc.)
5.3 By Product Type
5.3.1 Recombinant Coagulation Factor Concentrates
5.3.2 Plasma-derived Coagulation Factor Concentrates
5.3.3 Others (Desmopressin etc.)
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Bayer AG
6.1.2 BioMarin Pharmaceutical, Inc.
6.1.3 CSL Behring
6.1.4 Kedrion S.p.A
6.1.5 Novo Nordisk
6.1.6 Pfizer, Inc.
6.1.7 Roche (Chugai Pharmaceutical Co.)
6.1.8 Sanofi (Genzyme Corporation)
6.1.9 Takeda Pharmaceutical (Shire Plc.)
6.1.10 Genentech
6.1.11 Grifols
6.1.12 Medexus
6.1.13 Octapharma

7 MARKET OPPORTUNITIES AND FUTURE TRENDS