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医療機器:ウェアラブル機器、高齢者介護、神経学に多くの好機

Medical Devices: Burgeoning Industry Has Plenty Of Opportunities in Wearables, Old Age Care and Neurology

発行 MarketLine 商品コード 796139
出版日 ページ情報 英文 56 Pages
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医療機器:ウェアラブル機器、高齢者介護、神経学に多くの好機 Medical Devices: Burgeoning Industry Has Plenty Of Opportunities in Wearables, Old Age Care and Neurology
出版日: 2018年12月01日 ページ情報: 英文 56 Pages
概要

医療機器市場は、医療予算への圧力、規制の変更、競争の激化から変化しており、企業は自社の製品を提示する新しい方法について考えることを余儀なくされています。

当レポートでは、世界の医療機器市場について調査分析し、現状と将来の見通し、発展動向、新興技術、規制問題などについて、体系的な情報を提供しています。

エグゼクティブサマリー

医療機器:規制環境の変化に合わせた新しいビジネスモデルが登場

  • 医療機器は非常に多様で、異なる分野で競合
  • 米国とEUの規制経路は、表面上は似ている
  • 医療機器の欠陥品や危険品が明るみに出て、規制上の問題が発生
  • FDAの機器規制は、長年にわたって不適切
  • 競合企業は今後10年間でMedtronicに干渉する
  • 医療予算の締め付けで、企業は慎重に計画すべき
  • ブロックバスター治療分野は、現在かなり混雑
  • 医療機器産業は変わりつつあり、企業は適応する必要がある
  • 中国の医療機器市場の成長は重要、ただし西欧の企業はあまり歓迎しない

ウェアラブル医療機器:著しい技術革新

  • Apple Watch、Apple Healthアプリ
  • その他の企業は優れたウェアラブル機器をピギーバック
  • 世界の糖尿病レベルが急上昇、医療機器メーカーに大きなチャンス
  • インスリンポンプが糖尿病治療のレベルを向上
  • 遠隔モニタリングが新しい産業のゴール
  • シンプルさが規制当局の承認を早める方法
  • ウェアラブル機器の規制は何年も前から時代遅れ

神経学的インプラント:新しい医療機器の成長

  • 修復を必要とする脳の手助けが、神経インプラントとBCIの主要目的
  • BCIの次なるステップは人間の強化
  • 成功したプログラムでさえ、副作用が深刻である可能性

高齢化人口:医療機器にとって非常に重要

  • 新しいアラート技術
  • IoT
  • 新しい医療機器、オーダーメイド義肢
  • 新世代のスマートペースメーカー
  • 出現しようとしている技術
  • トヨタによるモビリティチャレンジ
  • モビリティは技術革新のビジネスチャンス
  • 遠隔医療
  • 65歳以上向け通信技術
  • 最新機器の多くは高齢者に完璧だが、ほとんど市場に出ていない

主な調査結果

情報源

図表

List of Figures

  • Figure 1: Medical Device Industry Theme Report Topics
  • Figure 2: Current Route to Device Regulatory Approval in the US and EU 2019
  • Figure 3: Percentage of Medical Devices in Each Class in the US
  • Figure 4: Difference in Approval Pathway - US and EU
  • Figure 5: Characteristics of EU Approval Pathways
  • Figure 6: Johnson & Johnson Total Sales 2017, Breakdown by Segment, $bn
  • Figure 7: Top R&D Medical Device Spenders by % of Annual Sales
  • Figure 8: Leading Medical Device Players and their Number of Pipeline Products
  • Figure 9: Timeline of Amazon Moves in the Healthcare Market 2018
  • Figure 10: Chinese Median Age and Average Annual Wage Growth (US$), 2010-2017
  • Figure 11: Health and Lifestyle Monitoring from Apple Watches and Health Apps
  • Figure 12: Apple Watch Emergency SOS and Fall Detection
  • Figure 13: Medtronic Guardian Connect App
  • Figure 14: People with Diabetes Worldwide by Region (Millions), 2017-2045
  • Figure 15: Medtronic Guardian Connect Low Profile Sensor
  • Figure 16: Tactio Healthcare App Services Options
  • Figure 17: Kardia Band ECG Monitor
  • Figure 18: Brain Implant Representation
  • Figure 19: Top Six Fastest Growing Medical Equipment Segments by Expected Growth CAGR (%), 2013-2020
  • Figure 20: Cochlear Implant from Advanced Bionics
  • Figure 21: Deep Brain Stimulation Approved Uses and Potential Future Uses
  • Figure 22: Top Five Funded Global Start-ups in Eye Disease and Blindness Therapy Areas ($m), 2018
  • Figure 23: Second Sight Argus II Retinal Implant Device
  • Figure 24: New Flexible Microfibers may Provide Breakthrough in Spinal Injuries
  • Figure 25: Public Opinion in the US on Biological Tech, Pew Research, 2016
  • Figure 26: Over 65s as a % of the Global Population, 1960-2017
  • Figure 27: CareClip
  • Figure 28: Conformis iTotal Custom Made Knee Replacement
  • Figure 29: HAL-5 Robotic Exoskeleton
  • Figure 30: Evowalk Muscle Leg Stimulation Technology
  • Figure 31: RollerScoot
  • Figure 32: Percentage of UK Residents over 65-74 who own a Smartphone
  • Figure 33: Percentage of UK over 65-year-olds who go online
  • Figure 34: Doro 580 Mobile Phone
  • Figure 35: Apple i-watch SOS Function
目次
Product Code: ML00026-022

Summary

The medical device market is extremely broad in its scope and covers devices as innocuous and simple as bandages and condoms, right through to highly sensitive, technologically advanced and critical devices such as pacemakers and implants. The medical device market has good opportunities ahead of it and excellent growth is being seen in neurology, diabetes and wearables as innovative new devices are providing solutions to problems that were previously considered unsolvable. However, the market has its incoming challenges too.

Many regions are seeing healthcare budgets fall or remain static and regulatory bodies are now highly involved in the efficacy process, taking choice away from doctors in many instances. These factors are putting pressure on medical device products, in many cases driving down the price, which is causing difficulty at the premium end of the market as new innovative products have much less time to earn profit before they are swamped with alternatives. Furthermore, some significant changes need to take place in terms of regulation, both to make products safer and to speed up approvals for innovative tech products, both of which will be very hard to achieve.

Key Highlights

The medical device market is changing as pressure on healthcare budgets, regulation changes and high levels of competition are forcing players to think about new ways to present their products. Increasing numbers of non-clinical actors are involved in the procurement process and this means that in some countries, premium and highly specialized product are getting squeezed, while highly innovative breakthroughs are being copied and reworked quickly.

All of these factors are forcing down prices in the market; while this is good for patients and buyers, medical device players are changing their business models to adapt. Increasingly they are using business to consumer strategies and bringing tech partners on board to help them. But they could go further still; there is a possibility that some medical device firms might create "mega plays" in the supply chain, absorbing distribution channels and even players themselves to create an "all under one roof" type of medical business.

Wearable devices are the new hot topic within the medical device market. Much has been said and written about how smart devices, some intended for other purposes, can be adapted and developed to produce powerful new tools to measure all manner of health issues. The beauty of many of these solutions is that they can be consumer focused and sold retail, direct to the consumer in some cases, allowing manufacturers to completely bypass the traditional medical prescription structure. However, there are issues; many of the claims that some of these devices make are not regulatory body approved and, in some cases, can make consumers overly paranoid and confused by their results. Nevertheless, wearable medical devices provide a significant opportunity for manufacturers to spread their tech to a broad audience and provide useful analytical tools.

Currently, the aims of brain computer interfaces are two-fold. The first is to use our greater knowledge of the brain to create devices that can assist and repair brains that have been damaged in some way. The second is to augment the ability of a brain to do much more than it already can. Scientists have made great breakthroughs in neuroscience using implanted neurons in the brain to help repair vision, hearing and paralysis. The next step is to develop less invasive methods of achieving the same goals with an eye by producing implants that can enhance a human's ability to input and output information from the brain, to achieve things such as brain-to-brain communication and enhancing the brain's ability by connecting it to computers. The proponents of this technology see it as a necessary development in order for humans to keep pace with technologies such as AI. Neurology is actually the fastest-growing specialty area of medical devices, estimated to be expanding at a rate of 13.7% per year.

Scope

  • Examine how the medical device industry is developing and what new business techniques players might use
  • See what the emerging technologies are and how they are spreading
  • Understand the impact of wearables in the medical device segment
  • See how technology is improving neurological treatment
  • See how regulation could be an issue in the industry and what might regulators do in future.
  • Reasons to buy
  • Is regulation in the US and EU unfit for purpose?
  • Who are the biggest medical device players and who is spending the most on R&D?
  • What are the most rapidly developing medical device sectors?
  • How is technology unlocking new treatment possibilities?

Table of Contents

  • Executive Summary
    • Medical devices: Very diverse market and new business models are emerging
    • Wearable Medical Devices: Segment is seeing significant technological innovation
    • Neurological Implants: Segment is seeing significant new growth for medical devices
    • Aging Demographics: A highly important segment for medical devices
  • Medical Devices: new business models are emerging to suit the changing regulatory environment
    • Medical devices are extremely diverse and compete in different segments
    • Class I includes low risk devices such as bandages and stethoscopes
    • Class II includes moderate risk devices such as wheelchairs
    • Class III devices include the highest risk devices, such as pacemakers or implants
    • US and EU regulatory pathways are only similar on the surface
    • Concerning cases of defective and dangerous medical devices have surfaced, leading to questions over regulation
    • FDA device regulations have been inadequate for a number of years
    • Competitors starting to move in on Medtronic over next decade
    • Constricted healthcare budgets mean players have to plan carefully
    • Blockbuster treatment areas are now becoming quite crowded
    • The medical device industry is changing, and players need to adapt
    • New business to consumer models are popular at present
    • Future business models might involve a "mega play" across the value chain
    • Amazon might soon become a significant competitor in healthcare
    • Growth of the Chinese medical device market is significant but western players are less welcome
  • Wearable Medical Devices: Segment is seeing significant technological innovation
    • Apple Watch and Apple Health App are strong market offerings acting as potential substitutes
    • Other companies can piggy-back on good wearable devices
    • Global levels of diabetes are expected to rise, providing a huge opportunity for medical device manufacturers
    • Guardian Connect from Medtronic is part of a new wave of wearable diabetes devices
    • Insulin pumps offer an advanced level of diabetes treatment
    • Remote monitoring becoming the new industry goal
    • Kardia Band from AliveCor is another device using wearables, but with a subscription business model
    • Remote monitoring can lead to patient disengagement
    • Simplicity could be a route to faster regulatory approval
    • Regulation for wearables has been obsolete for a number of years
    • The FDA itself is aware of this problem and is taking steps to improve the process
  • Neurological Implants: Segment is seeing significant new growth for medical devices
    • Assisting brains that need repair is a key aim of neural implants and BCIs
    • Cochlear implants are very common place, non-invasive and can restore senses
    • Deep brain stimulation can alleviate the symptoms of Parkinson's disease
    • Retinal implant technology is allowing the blind to see again through a bionic eye
    • Treatment of spinal injuries to allow patients with paraplegia to move again
    • Microfibers are becoming more advanced and this is opening up new possibilities
    • The next step for BCIs is human enhancement
    • DARPA has been working on this field for a number of years for defense purposes
    • Kernel is looking to find ways to improve human intelligence and cure disease
    • Neuralink is planning to create an AI interface between the brain and computers
    • Even successful programs have shown that side effects can be severe
  • Aging Demographics: A highly important segment for medical devices
    • New alert technology allows elderly people to stay at home, keeping many out of care systems
    • Internet of things is changing how care is delivered to an aging population
    • New medical devices coming to the market include bespoke artificial limbs
    • New generation of smart pacemakers could be susceptible to hacking
    • Nascent technology can radically improve the mobility of an aging population, creating new business
    • Toyota's Mobility Challenge means better solutions to lower limb paralysis are coming
    • Mobility presents growing business opportunities for innovation
    • Remotely taking doctors into homes: technology streamlines treatment of elderly patients
    • Communication technology designed for over 65 year olds is a growth industry
    • Many of the latest devices are perfect for seniors, but not marketed as such
  • Key Findings
  • Sources
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