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市場調査レポート
商品コード
1345439
ニューロモデュレーション装置の世界市場-2023年~2030年Global Neuro Modulation Devices Market - 2023-2030 |
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カスタマイズ可能
適宜更新あり
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ニューロモデュレーション装置の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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概要
ニューロモデュレーション装置の世界市場は、2022年に54億米ドルに達し、2023-2030年の予測期間中にCAGR 3.6%で成長し、2030年までに76億米ドルに達すると予測されています。
製品ポートフォリオを拡大するために、主要市場プレーヤーが買収などの有機的戦略を採用する傾向が強まっていることなどが、世界のニューロモデュレーション装置市場を独占すると予想されます。
ニューロモデュレーション装置は、米国では運動障害、てんかん、疼痛、うつ病の治療薬として承認されており、その他の神経学的適応症には適応外で使用されています。
神経刺激装置は、脳、脊髄、末梢神経に電極を装着します。これらの正確に配置されたリード線は、延長ケーブルを介してパルス発生器と電源に接続され、必要な電気刺激を発生させます。低電圧の電流が発生器から神経に流れ、痛みの信号を抑制したり、それまでなかった神経インパルスを刺激したりします。
さらに、世界のニューロモデュレーション装置はさまざまな要因によって牽引されています。慢性疼痛やうつ病などの生活習慣病の有病率の上昇、神経疾患の研究開発のための民間企業による投資の増加、神経疾患の増加などは、市場を牽引する要因の一部です。
さらに、技術的に高度なデバイスの採用、高齢者人口の急増、非侵襲的で低侵襲的な手術に対する需要の増加が、Medtronic Plc、Abbott Laboratories、Boston Scientific Corp、LivaNova Plcなどの主要プレイヤーを有する業界の成長を促進しました。
ダイナミクス
神経疾患の有病率の上昇
神経疾患の有病率の上昇は、予測期間中に市場が成長するのに役立つ主要な要因の1つです。例えば、WHOが2023年に更新したファクトシートによると、てんかんの有病率の上昇は、てんかんが世界中で約5,000万人を罹患させ、最も一般的な神経疾患の1つとなっています。てんかん患者の80%近くが中低所得国に居住しています。てんかんが正しく認識され、治療されれば、最大70%の人が発作を起こさずに生活できると考えられています。
てんかん患者は全世界で500万人に上り、高所得国では10万人当たり49人であるのに対し、中低所得国では10万人当たり139人と高いです。これは、風土病、交通事故、出産に関連する傷害、医療インフラのばらつきなどのリスクが高まるためです。てんかん患者の80%近くが中低所得国に居住しています。
技術進歩
主要企業は、より斬新で効果的なニューロモデュレーション装置を開発するため、研究開発に頻繁に投資しています。新たな技術的ブレークスルーにより、より正確で侵襲の少ない技術が開発され、患者の治療成績が向上しています。
例えば、ここ数年、ニューロモデュレーション技術にはさまざまな発展が見られます。例えば、ワイヤレス充電が可能な充電式バッテリー、プログラミングの改良、外来での侵襲の少ない単段植込み、低価格の新型機器などです。
過去10年間で、ソフトウェアとハードウェアの技術は著しく進歩し、技術的に大きな成功を収めました。ハードウェアの改良はソフトウェアの実装とアルゴリズムの統合に拍車をかけ、洗練されたソフトウェアは効率的なビッグデータの集約とバイオマーカーの発見を可能にしました。患者が既存の技術に慣れ親しんでいることは、デジタルヘルスとニューロモデュレーション療法の統合を促進すると思われます。効果的なソリューションのためのビルディングブロックは、スマートフォンやスマートウォッチなどの代替アプリケーションでヘルスケアのアドオンとして使用されることが多いです。
主要企業による製品発表の増加
市場の主要プレーヤーによる製品発売の増加は、予測期間中の市場全体の成長に貢献します。例えば、2022年7月、高度に洗練された心臓ニューロモデュレーション療法であるOrchestra BackBeat CNTが、BioMedとMedtronicのコラボレーションによって誕生しました。これは複数の降圧剤と組み合わされ、患者のコンプライアンスに依存することなく自動的に作動するように設計されています。さらに、ペースメーカーや他の心拍制御装置と併用するために、標準的なインプラントやリードの取り付け技術を利用して簡単に変更することができます。
さらに、メドトロニックは2022年1月、糖尿病性末梢神経障害(DPN)の慢性疼痛治療用の充電式神経刺激装置IntellisおよびVantaのFDA承認を取得しました。DPNは、糖尿病患者の30%が罹患する進行性の神経疾患で、しびれ、灼熱感、激しい痛みを引き起こします。薬物療法は部分的な効果しかないことが多く、深刻な副作用を引き起こすこともあります。
ニューロモデュレーション手技の高額な費用
ニューロモデュレーション手技や機器のコストが高いことは、特に償還政策が不十分な新興諸国において、世界のニューロモデュレーション市場の成長を抑制する主な要因です。標準的な植え込み型パルスジェネレーターの平均コストは-USDで、植え込み処置には25,000~35,000USDもの費用がかかります。
脊髄刺激装置は約13,000~40,000米ドルです。高額な費用と貧弱な償還シナリオのために、発展途上国で神経学的治療を受けられる患者は非常に限られています。その結果、ヘルスケア施設は新しいシステムや技術的に進んだシステムへの投資に消極的になり、ニューロモデュレーション市場の成長を制限しています。
Global Neuro Modulation Devices Market reached US$ 5.4 billion in 2022 and is expected to reach US$ 7.6 billion by 2030, growing with a CAGR of 3.6% during the forecast period 2023-2030.
The trend such as the increasing adoption of organic strategies such as acquisition by key market players to expand its product portfolio is expected to dominate the Global Neuromodulation Devices Market.
Neuromodulation devices are approved in the United States for the treatment of movement disorders, epilepsy, pain, and depression, and are used off-label for other neurologic indications
Neurostimulation devices involve the application of electrodes to the brain, the spinal cord or peripheral nerves. These precisely placed leads connect via an extension cable to a pulse generator and power source, which generates the necessary electrical stimulation. A low-voltage electrical current passes from the generator to the nerve and can either inhibit pain signals or stimulate neural impulses where they were previously absent.
Furthermore, the global neuromodulation devices are driven by various factors, the rise in the prevalence of lifestyle diseases such as chronic pain and depression, increased investment by private players for research and development of neurological disorders, and the increasing number of neurological diseases are some of the factors driving the market.
Moreover, the adoption of technologically advanced devices, the surge in the geriatric population, and the rise in demand for non-invasive and minimally invasive surgery fueled the industry growth having key players like Medtronic Plc, Abbott Laboratories, Boston Scientific Corp, LivaNova Plc and others
The rise in the prevalence of neurological disorders is one of the key factors that helps the market to grow during the forecast period. For instance, the rise in the Prevalence of Epilepsy according to the WHO updated factsheet 2023, Epilepsy affects around 50 million individuals worldwide, making it one of the most common neurological illnesses. Almost 80% of epileptics reside in low- and middle-income nations. It is believed that if epilepsy is correctly identified and treated, up to 70% of people can live seizure-free.
Epilepsy affects 5 million people globally, with high-income countries experiencing 49 per 100,000 cases, while low- and middle-income countries have a higher rate of 139 per 100,000. This is due to increased risks of endemic conditions, road traffic injuries, birth-related injuries, and variations in medical infrastructure. Nearly 80% of epilepsy patients live in low- and middle-income countries.
Key players frequently spend in R&D to generate more novel and effective neuromodulation devices. New technical breakthroughs enable the creation of more accurate, less intrusive technologies that provide improved patient results.
For instance, in addition, in the last few years, there have been various developments in neuromodulation technology. Some of examples of these developments are rechargeable batteries with wireless charging, improvements in programming, less invasive single-stage implantation in outpatient settings, and lower-cost new devices.
Over the past decade, software and hardware technologies have advanced significantly, leading to significant technological successes. Hardware improvements have fueled software implementation and algorithmic integration, while sophisticated software enables efficient big data aggregation and biomarker discovery. Patients' familiarity with existing technology will facilitate the integration of digital health with neuromodulation therapies. The building blocks for effective solutions are often used in alternative applications, such as smartphones and smart watches for healthcare add-ons.
A rise in the product launches by key players in the market will help the overall market to grow during the forecast period. For instance, in July 2022 Orchestra BackBeat CNT, a highly sophisticated cardiac neuromodulation therapy, was created by collaboration between BioMed and Medtronic. It is combined with several antihypertensive drugs and is designed in a way that it operates automatically without depending on patient compliance. Furthermore, it can be simply modified to work with pacemakers and other cardiac rhythm control devices utilizing standard implant and lead installation techniques.
Additionally, in January 2022 Medtronic received FDA approval for its Intellis and Vanta rechargeable neurostimulator devices for treating chronic pain in diabetic peripheral neuropathy (DPN). DPN is a progressive neurological disorder affecting 30% of diabetes patients, causing numbness, burning, and severe pain. Medications are often only partially effective and can cause serious side effects.
The high cost of neuromodulation procedures and devices is a major factor restraining the growth of the global neuromodulation market, especially in developing countries with poor reimbursement policies. The average cost of a standard implantable pulse generator is -USD implantation procedures can cost as high as USD 25,000-35,000.
Spinal cord stimulator devices cost around USD 13,000-40,000. Owing to high costs and a poor reimbursement scenario, a very limited pool of patients in developing countries can afford neurological treatment. As a result, healthcare facilities are reluctant to invest in new or technologically advanced systems, thus limiting the growth of the neuromodulation market.
The global neuromodulation devices market is segmented based on type, application, biomaterial, end user and region.
The invasive neuromodulation segment from the type segment accounted for 41.7% and it is expected to be dominated during the forecast period. SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as a treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain syndrome, neuropathic pain, and ischemia-related refractory pain. The main benefits of the therapy are the decreased need for pain medication and overall improvement of the quality of life.
For instance, on April 19 2023 the company announced U.S. Food and Drug Administration (FDA) approval for Prospera, a spinal cord stimulation (SCS) system. The system features RESONANCE, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support.
Furthermore, in August 2022 Abbott announced that the U.S. Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy. The next generation of Abbott's proprietary BurstDR stimulation, FlexBurst360 therapy offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person's therapeutic needs evolve.
Designed to fit within a person's life, the Proclaim Plus SCS system is recharge-free with a battery that can last up to 10 years.^ It can be used with Abbott's NeuroSphere Virtual Clinic connected care technology, which allows a person to both communicate with a physician through secure in-app video chat and remotely receive stimulation settings in real-time regardless of location.
North America is estimated to hold about 38.4 % of the total market share throughout the forecast period, owing to the presence of major market players and huge pharmaceutical and biopharmaceutical industries, launches by key players, coupled with the rising investments in the country for the adoption of advanced technologies, an increasing number of patients suffering from neurological disorders, which is increasing the need for the adoption of neuromodulation devices, increased competition among market players, and significant expenditure on research and development.
On March 24, 2022, Medtronic plc, a global leader in healthcare technology, announced the first patient implants in the TITAN 2 pivotal study that will evaluate the safety and efficacy of Medtronic's investigational implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). The minimally invasive technology stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate the neural activity of the bladder.
For instance, in December 2022, Abbott announced the U.S. Food and Drug Administration (FDA) approval of the company's Eterna spinal cord stimulation (SCS) system - the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain. Eterna SCS utilizes Abbott's proprietary low-dose BurstDR stimulation, the only SCS waveform technology with the highest level of clinical evidence (1A evidence), proven to reduce pain 23% more than traditional waveform technology approaches.
The major global players in the market include Medtronic Plc, Abbott Laboratories, Boston Scientific Corp, LivaNova Plc , Integer Holdings Corporation, ElectroCore, Caputron, NeuroPce Inc, Nevro Corporation, BrainsWay and among others.
In the wake of the COVID-19 pandemic, the neurostimulation devices industry witnessed a major slump, due to the supply chain challenges and a limited workforce. Several non-emergency surgical procedures were also postponed during the initial months of the crisis.
Also, in the case of TMS, there was already enthusiastic interest in accelerated TMS protocols for depression before the emergence of COVID-19. During a pandemic, potential reductions in time to response, treatment time, and overall days of treatment with accelerated intermittent theta-burst stimulation (aiTBS), in comparison to standard TMS protocols, may have exciting implications for mitigating viral transmission risk as well as for increasing treatment accessibility.
The Global Neuro Modulation Devices Market report would provide approximately 61 tables, 58 figures and 186 Pages.
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