市場調査レポート
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1138413
痛風治療薬の世界市場-2022-2029Global Gout Therapeutics Market - 2022-2029 |
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痛風治療薬の世界市場-2022-2029 |
出版日: 2022年10月18日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 約2営業日
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痛風治療薬の世界市場の成長は、ライフスタイルの変化、アルコール消費の増加、肥満および腎臓疾患の増加、高プリン体ダイエット、いくつかの薬物利尿剤に起因する世界の痛風の有病率の上昇が市場成長の主要因の1つとなっています。
生物製剤の採用拡大や再生医療に関する研究開発の増加は、予測期間中に世界の痛風治療薬市場を牽引すると予想されます。
市場の成長を促進する主な要因は、生物製剤の採用の高まりと再生薬の研究開発の増加、画像診断モダリティの技術的進歩の改善です。この状態は、非ステロイド性抗炎症薬、コルチコステロイド、コルヒチン、尿酸降下剤などの薬剤の使用により、治療または予防することができます。
生物学的製剤は急速に普及し、より優れた効果によりNSAIDsやコルチコステロイドに取って代わりつつあります。したがって、生物製剤セグメントは急速なペースで拡大すると予想され、予測期間中に市場の成長を促進する痛風治療薬を獲得する可能性が高いです。
規制当局による製品承認の増加は、痛風治療薬市場の成長を促進すると予想されます。メーカーは、患者プールの大きな割合のアンメットニーズを開拓するために、買収&コラボレーションと新製品開発戦略を採用しています。
尿酸降下薬として作用する、主にURAT1およびOAT4といった尿酸の腎トランスポーターを標的とすると推定されるアルハロフェネートなどの新薬が開発されています。さらに、尿酸降下薬は痛風関節炎の対症療法として、第一選択薬として、あるいは併用療法として利用されています。
痛風治療薬に伴う副作用が市場成長の妨げとなる可能性
食品医薬品局(FDA)によると、痛風の治療に用いられる処方薬で、時に重篤な副作用により、過去8年間に米国で10人の死亡者を出した疑いがあるとされています。コルヒチンは、痛風の治療に広く使用されている強力な抗炎症剤で、40年近く前から使用されており、痛風患者の最前線の治療に利用可能な選択肢の一つとなっています。FDAによると、合計17種類のコルヒチン製品がライセンスされており、全米で毎年約3800万錠のコルヒチンが販売されているとのことです。しかし、2011年から今年8月までに、FDAは同剤の副作用を示唆する353件の報告を受け、そのほとんどが腎機能障害や肝機能障害のある患者であり、10人が死亡したとみられています。腎機能障害や肝機能障害のある方、慢性疾患のために他の薬剤も服用している方は、コルヒチンによる重篤な副作用を経験する可能性があります。
さらに、痛みや炎症を抑えるために、プレドニゾンなどの副腎皮質ホルモンが処方されることがあります。これらの薬は血糖値や血圧を上昇させ、気分の変化を引き起こす可能性があります。副作用として、吐き気、下痢、嘔吐が起こることがあります。日本や欧米では、ベンズブロマロンを使用して腎不全で死亡した患者さんの報告があります。副作用があるため、医師は腎臓や肝臓に障害がある人に低用量のコルヒチンを処方する傾向にあります。このように、薬剤の副作用などの要因が、市場の成長を抑制する可能性があります。
産業分析
世界の痛風治療薬市場は、ポーターのファイブフォース、規制分析、サプライチェーン分析、価格分析、パイプライン、アンメットニーズ、疫学などの様々な産業要因に基づく市場の詳細な分析を提供します。
COVID-19の大流行は、予測期間において痛風治療薬市場の成長に影響を与えると予想されます。CreakyJointsによると、2020年5月、痛風患者は潜在的なCOVID-19合併症の高リスクグループに属すると見なされる可能性があるとのことです。コロナウイルス(COVID-19)の大流行や世界各国でのロックダウンは、あらゆるセクターの企業の財務状況に影響を与えています。民間ヘルスケア部門も、COVID-19の大流行によって大きな影響を受けている部門の1つです。
COVID-19の大流行が続く中、いくつかの企業はその治療のために薬のテストを行っています。例えば、2020年6月22日、抗ウイルス薬ファビピラビル(ファビフル)が軽度から中等度のCOVID-19患者の治療に承認され、1週間以内に本格的に商業化すると医薬品メーカーのGlenmark Pharmaceuticalsは述べています。インド医薬品監督庁は、COVID-19感染の大部分を占める軽度から中等度の症例に対して、この抗ウイルス剤を「制限付き緊急使用」として承認したのです。
痛風やリウマチ性疾患の治療に用いられる抗炎症薬コルヒチンは、COVID-19の治療薬として有望である可能性が、無作為化非盲検試験で示唆されています。GRECCO-19試験(Greek Study on the Effects of Colchicine in COVID-19 Complications Prevention)では、105名のCOVID-19患者を標準治療または標準治療とcolchicineを3週間投与する群に無作為に割り付け、COVID-19を発症した患者を対象にしました。その結果、コルヒチン投与群では、心臓や炎症性バイオマーカーに群間で有意差は認められなかったもの、臨床的悪化までの時間が改善されることがわかりました。
本レポートでは、世界の痛風治療薬市場について、約45以上の市場データ表、40以上の図表、180ページにわたる情報を提供します。
Gout Therapeutics Market size was valued US$ 1.9 billion in 2021 and is estimated to reach US$ 4.1 billion by 2029, growing at a CAGR of 8.2% during the forecast period (2022-2029).
Gout is a type of inflammatory arthritis caused by the overabundance of uric acid in the body, either producing too much or excreting too little. Gout can be acute and chronic. Acute gout mostly affects the major extremity joint, with the small joints of the hands and feet the most affected. In chronic gout, hard swellings (known as tophi) can form on the joints made of uric acid and grow large, even breaking through the skin. The global gout therapeutics market is impacted by several factors such as the rising prevalence of gout globally due to changes in lifestyle, increasing alcohol consumption, increasing obesity & kidney diseases, high purine diet, and several medications diuretics.
The global gout therapeutics market growth is driven by the rising prevalence of gout globally due to changes in lifestyle, increasing alcohol consumption, increasing obesity & kidney diseases, high purine diet, and several medications diuretics are among the key factors driving the market growth.
Growing adoption of biologics and increasing R&D on regenerative medicines are expected to drive the global gout therapeutics market during the forecast period.
The major factors driving the growth of the market are the rising adoption of biologics and increasing R&D on regenerative medicines, technological advancements in imaging modalities improved. This condition can be treated or prevented with the use of drugs such as nonsteroidal anti-inflammatory drugs, corticosteroids, colchicine, and urate-lowering agents.
Biologics have witnessed rapid adoption and are replacing NSAIDs and corticosteroids owing to better results. Hence, the biologics segment is anticipated to expand at a rapid pace and is likely to gain gout therapeutics which drive the market growth in the forecast period.
Increasing product approvals by regulatory authorities are expected to drive the growth of the gout disease treatment market. Manufacturers are adopting acquisition & collaboration and new product development strategies to tap the unmet needs of a large proportion of the patient pool.
The new medication is being developed, such as arhalofenate, which is estimated to target renal transporters of uric acid, primarily URAT1 and OAT4, acting as uricosuric agents. Moreover, urate-lowering drugs are utilized for the symptomatic treatment of gout arthritis, as a first line of therapy or in combination therapy.
Side effects associated with gout therapeutics are likely to hinder the market growth
A prescription medicine used to treat gout is suspected to have caused 10 deaths in the U.S over the past eight years due to side effects that can sometimes be severe, according to the Food and Drug Administration (FDA). Colchicine, a strong anti-inflammatory that is widely used to treat gout, has been used for nearly 40 years and is one of the available options for the frontline treatment of people with gout. A total of 17 colchicine products have been licensed by the FDA and about 38 million colchicine tablets are sold in the nation each year, the FDA said. However, from 2011 to August this year, the FDA received 353 reports suggesting adverse reactions to the drug, mostly among patients with renal and liver dysfunction, with 10 deaths believed to be linked to the problem. People with renal or hepatic impairment and those who also take other drugs for chronic diseases could experience serious side effects from colchicine.
In addition, corticosteroids, such as prednisone, can be prescribed to reduce pain and inflammation. They can increase blood sugar levels and blood pressure and may induce mood changes. Side effects can include nausea, diarrhea and vomiting. In Japan, Europe and the US, there have been reports of patients dying of renal failure after using benzbromarone, because of the side effects, doctors tend to prescribe low-dose colchicine for people with renal or hepatic impairment. Thus, factors such as the adverse effects of the drugs may restrain the market growth.
Industry Analysis
The global gout therapeutics market provides in-depth analysis of the market based on various industry factors such as porter's five forces, regulatory analysis, supply chain analysis, pricing analysis, pipeline, unmet needs, epidemiology.
The Covid - 19 pandemic is expected to impact the growth of the gout therapeutics market over the forecast period. According to CreakyJoints, in May 2020, people with gout may be considered in a higher-risk group for potential COVID-19 complications. The coronavirus (COVID-19) pandemic and lockdowns in various countries across the globe have impacted the financial status of businesses across all sectors. The private healthcare sector is one of the sectors, which has been majorly impacted by the COVID-19 pandemic.
With the ongoing COVID-19 pandemic, several companies are testing their drugs for their treatment. For instance, on June 22nd, 2020, the anti-viral drug Favipiravir (Fabiflu) was approved for the treatment of mild to moderate COVID-19 patients and will be commercialized full scale in a week, says drugmaker Glenmark Pharmaceuticals. The Drug Controller General of India approved the anti-viral for 'restricted emergency use' for treatment of mild to moderate cases, which accounts for a majority of COVID-19 infections.
Colchicine, an anti-inflammatory drug used to treat gout and rheumatic disease, may be a promising treatment for COVID-19, a randomized, open-label trial suggests. In the Greek Study on the Effects of Colchicine in COVID-19 Complications Prevention (GRECCO-19), investigators randomly assigned 105 patients who had COVID-19 to receive either the standard of care or the standard of care plus colchicine for 3 weeks. They found that for patients in the colchicine group, the time to clinical deterioration improved, although there were no significant differences between the groups in cardiac and inflammatory biomarkers.
The non-steroidal anti-inflammatory drugs (NSAIDs) segment is expected to hold the largest market share in global gout therapeutics market
The non-steroidal anti-inflammatory drugs (NSAIDs) are estimated to dominate the market, owing to the availability of these drugs at a lower cost compared to other drugs, high level of penetration of drugs, and the ability to relieve pain in case of an acute gout attack.
NSAIDs are the first-line drugs used to decrease the inflammation and the associated pain of rheumatic and non-rheumatic diseases. The rising number of gout patients, low cost of drugs, and application in combination therapy is likely to drive the market Indomethacin and naproxen are the major choice for the acute attack of gout.
NSAIDs decrease pain and swelling. Some NSAIDs are available over-the-counter, like ibuprofen and naproxen sodium. Stronger NSAIDs like indomethacin and celecoxib are prescribed by the doctor. Although NSAID effects on pain tend to be patient-specific, naproxen and indomethacin are common choices. Use of concomitant gastric protection with misoprostol or consideration of a cyclooxygenase-2 (COX-2)-specific NSAID might be considered if the patient has gastrointestinal (GI) risk or is older than 51 years.
To control the attack as quickly and safely as possible (recalling that it takes 5 half-lives to reach a steady state), NSAIDs with a short half-life (eg, ketoprofen, ibuprofen, or diclofenac) are preferred.
North America region holds the largest market share in the global gout therapeutics market
North America is dominating the global gout therapeutics market, accounting for the largest market share, owing to the large presence of major players, high demand for gout therapy, and high cost of branded pharmaceuticals U.S. Also, the research and development of new drugs for gout treatment is expected to show dominance over the forecast period. In June 2020, Pharma major Dr. Reddy's Laboratories launched the generic Colchicine caused to prevent and treat acute gout flares in the US market.
The Asia Pacific region is expected to grow at the fastest growth rate over the forecast period owing to the diversified patient pool, and growing investment by major players with local manufacturers, and hospital chains in growing countries such as India, China, South Korea, and other South Asian countries. According to the Australian Institute of Health and Welfare report 2022, in 2017-2018, gout cost the Australian health system an estimated USD 196.5 million, representing 1.4% of disease expenditure on musculoskeletal conditions and 0.2% of total disease expenditure. Besides, changing lifestyles with a rising prevalence of smoking & alcohol consumption is expected to boost gout incidence over the period.
In December 2022, Selecta Biosciences, Inc., a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, completed the patient enrollment in the six-month, head-to-head, Phase 2 COMPARE clinical trial. The trial evaluates the superiority of a once-monthly dose of Selecta's lead product candidate, SEL-212 (ImmTOR + pegadricase), versus a bi-weekly dose of pegloticase, the current FDA-approved uricase therapy for adult patients with chronic refractory gout.
Demand for effective therapeutics for gout treatment is increasing. Numerous pipeline products and recent approvals of drugs to treat gout arthritis are expected to drive the market in the region. According to estimates more than 2 million people in the U.S. take medication to decrease serum uric acid levels. However, factors such as increasing competition in the generic sector, patent expiry of blockbuster products, and the high cost of the newly launched drugs are likely to hinder the growth of the market in the United States.
The Public Health Agency of Canada (PHAC), in collaboration with all Canadian provinces and territories, conducts national surveillance of gout and supports public health action.
The global market for gout therapeutics is fragmented and highly competitive and consists of several major players. Few major players dominate the market share, and few emerging companies are expected to enter the market over the forecast period. Some of the market's major players market is Horizon Therapeutics plc, Lannett Company, GlaxoSmithKline PLC, Takeda Pharmaceutical Company Ltd, and Mylan. The key players are adopting various growth strategies such as product launches, acquisitions, and collaborations, contributing to the global market's growth globally. For instance, On March 2nd, 2020, Avion Pharmaceuticals launched Gloperba (colchicine) oral solution for prophylaxis of gout flares in adults.
Companies are entering into collaborations, acquisitions, mergers, approvals and licensing for increasing their market penetration. In January 2020, US-based Novadoz Pharmaceuticals received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets. The approved product is AB-rated to the brand Uloric, marketed by Takeda Pharmaceuticals America, Inc.
Overview: Novartis AG develops, manufactures, and markets healthcare products. The company mainly operates through three business segments: Innovative Medicines, Alcon, Sandoz, and Corporate. The Sandoz segment provides active ingredients and finished dosage forms of pharmaceuticals in the areas of the cardiovascular, central nervous system, dermatology, gastrointestinal and hormonal therapies, metabolism, oncology, ophthalmic, pain, and respiratory; active pharmaceutical ingredients and intermediates primarily antibiotics.
Canakinumab: Canakinumab is a fully human monoclonal antibody targeting IL 1b that has an expanding list of clinical indications. Novartis' canakinumab, an IL-1B inhibitor, has shown remarkable clinical success in treating gout.
Key Developments: In Jun 2022, Novartis announced the approval of Cosentyx by the European Commission (EC). It is used for treatment of juvenile idiopathic arthritis (JIA) a category of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients ages 6 years or older.
The global gout therapeutics market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.
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