Latest news with #B.Braun
Yahoo
05-06-2025
- Business
- Yahoo
Regulatory Affairs Outsourcing Market Analysis Report 2025: Globalization of Biopharmaceutical and Medical Device Companies Bolster Growth - Trends, Opportunities, and Forecasts 2020-2030
Regulatory Affairs Outsourcing Market Dublin, June 05, 2025 (GLOBE NEWSWIRE) -- The "Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F" report has been added to Regulatory Affairs Outsourcing Market was valued at USD 6.84 Billion in 2024, and is expected to reach USD 11.94 Billion by 2030, rising at a CAGR of 9.73% Market expansion is primarily driven by increased R&D efforts and a rising number of clinical trial applications and product registrations. Additionally, regulatory measures aimed at controlling drug costs are generating economic pressures that encourage life sciences companies to outsource regulatory functions. The COVID-19 pandemic further accelerated this trend, as the urgent development of vaccines underscored the importance of streamlined regulatory processes. As globalization continues, companies entering international markets face a complex web of regulatory standards, prompting greater reliance on external expertise to navigate compliance efficiently. This demand is especially strong in emerging markets where operational costs are lower and regulatory environments are increasingly attractive for Market Drivers Globalization of Biopharmaceutical and Medical Device CompaniesThe expansion of biopharmaceutical and medical device companies into international markets is a major driver behind the growth of regulatory affairs outsourcing. Each new market introduces unique compliance requirements, demanding specialized regulatory knowledge. Outsourcing helps companies manage these challenges efficiently and cost-effectively. Emerging regions such as Asia Pacific, Latin America, and the Middle East & Africa are particularly appealing due to lower development costs, skilled labor availability, and favorable regulatory climates. For instance, infrastructure investments like B. Braun's five new facilities in Malaysia and Flex Ltd.'s site in India reflect the trend of companies expanding regionally while leveraging outsourced regulatory expertise to ensure Market Challenges Data Security and Privacy ConcernsSecurity and privacy of sensitive regulatory information are critical challenges in this market. As outsourcing increases, so does the risk of data breaches and cyberattacks. The growing use of digital platforms - such as electronic Common Technical Document (eCTD) submissions and digital IND safety reporting - amplifies vulnerabilities. Additionally, mergers and acquisitions within the healthcare sector can expose organizations to greater cybersecurity threats due to the volume and sensitivity of exchanged data, posing a significant risk to business continuity and regulatory Market Trends Technological Advancements in Regulatory ProcessesTechnological progress is reshaping regulatory affairs outsourcing, introducing tools that enhance transparency, speed, and collaboration. Regulatory Information Management Systems (RIMS) are streamlining submission tracking and compliance monitoring. Cloud-based platforms enable real-time interaction between clients and service providers, improving operational efficiency. Furthermore, artificial intelligence (AI) and machine learning are being used to automate administrative tasks like data entry and document processing, allowing regulatory professionals to focus on strategic functions. These technologies are optimizing regulatory workflows, making it easier for companies to meet global compliance standards swiftly and accurately. Key Attributes: Report Attribute Details No. of Pages 180 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $6.84 Billion Forecasted Market Value (USD) by 2030 $11.94 Billion Compound Annual Growth Rate 9.7% Regions Covered Global Report Scope: Competitive LandscapeCompany Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market. Accell Clinical Research, LLC. Genpact Ltd. CRITERIUM, INC. Promedica International. WuXi AppTec Co Ltd. Medpace Inc. Charles River Laboratories Inc. ICON plc. Covance, Inc. Parexel International Corporation. Regulatory Affairs Outsourcing Market, By Service: Regulatory Consulting Legal Representation Regulatory Writing & Publishing Product registration & clinical trial applications Regulatory Submissions Regulatory Operations Other services Regulatory Affairs Outsourcing Market, By Category: Pharmaceutical Medical Device Regulatory Affairs Outsourcing Market, By Company Size: Small Companies Medium Companies Large Companies Regulatory Affairs Outsourcing Market, By Indication: Oncology Neurology Cardiology Immunology Other Indications Regulatory Affairs Outsourcing Market, By Product Stage: Preclinical Clinical Premarket Approval Regulatory Affairs Outsourcing Market, By End Use: Medical Device Companies Pharmaceutical Companies Biotechnology Companies Regulatory Affairs Outsourcing Market, By Region: North America United States Canada Mexico Europe France Germany United Kingdom Italy Spain Asia Pacific China India Japan South Korea Australia South America Brazil Argentina Colombia Middle East & Africa South Africa Saudi Arabia UAE For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Regulatory Affairs Outsourcing Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Star
28-04-2025
- Health
- The Star
Asia, and Malaysia, aim to take the lead in innovating medical devices
As global healthcare demands accelerate in the face of ageing populations, chronic disease burdens and digital transformation, the medical device industry is poised for an era of growth and innovation. Nowhere is this more evident than in Asia, a region that is both a key manufacturing base and a major consumer market. Malaysia, in particular, is emerging as a promising hub for medical device development, underpinned by strategic policies, infrastructure and talent. Over the next decade, Asia is expected to be at the forefront of this industry's transformation, driven by shifting demographics, technological innovation and supportive governmental frameworks. National and regional hubs The global medical device industry – encompassing everything from simple syringes and rubber gloves to advanced diagnostic imaging systems and wearable health monitors – was valued at US$810bil (about RM3.5 trillion) in 2024. Fuelled by rising health consciousness, increased healthcare spending and rapid technological advancement, the sector is undergoing significant transformation. In the wake of the Covid-19 pandemic, governments, health systems and private investors have ramped up spending on diagnostic tools, telemedicine infrastructure and home-based care equipment. Simultaneously, the integration of artificial intelligence (AI), Internet of Things (IoT) and robotics is reimagining how devices are developed, deployed, and maintained. Asia is no longer just a manufacturing base for Western medical device companies; it is becoming a centre of innovation, regulatory reform and domestic market expansion. China and India, for instance, have both launched national initiatives to boost local production of medical technology, reduce import dependence and foster innovation. China's 'Made in China 2025' policy includes high-end medical devices, while India's Production Linked Incentive (PLI) scheme for medical devices offers financial incentives for domestic manufacturing. Asean nations, particularly Malaysia, are positioning themselves as strategic hubs for production, research and development (R&D), and regulatory harmonisation, leveraging a skilled workforce, favourable geography and improving infrastructure. Malaysia's advantages Malaysia stands out within Asean as a particularly promising player in the medical device industry. The country is already home to over 200 medical device manufacturers, including major global players such as Abbott, B. Braun and Boston Scientific. In 2024, Malaysia's medical device exports reached RM37bil, making it one of the leading exporters in the region. The government has adopted a proactive approach in nurturing the industry. It is one of the key sectors in the New Industrial Master Plan 2030, which aims to transform Malaysia into a high-value, innovation-driven medical device hub. Key goals include enhancing local R&D capabilities, streamlining regulatory pathways and strengthening international partnerships. The Medical Device Authority (MDA) plays a central role in regulating and facilitating the growth of the sector. Its efforts to align local regulations with global standards have boosted investor confidence and export potential. Malaysia also offers an integrated ecosystem that supports the full value chain of the medical device industry – from component manufacturing to final assembly and packaging. The country's experience in high-precision electronics and rubber-based manufacturing (especially gloves and catheters) provides a solid foundation for more complex device production. In Penang, a cluster of electronics and medical technology companies are driving innovation and cross-sector collaboration. The state's infrastructure and talent pool have attracted increasing foreign direct investment, particularly in diagnostic and imaging equipment. As simple as they are, even gloves are considered medical devices, playing a crucial role in hygiene and infection control. — Bloomberg Areas of growth As the global and regional landscape evolves, several areas are likely to define the future of the medical device industry in Asia: > Digital health and AI-driven devices The integration of digital technologies – including AI, machine learning and cloud computing – is transforming diagnostic and monitoring tools. Smart wearables, remote patient monitoring systems and AI-assisted imaging are expected to dominate the next wave of innovation. Malaysia has signalled support for digital health, with strategies to improve telemedicine, mobile health services and digital diagnostics creating pathways for medical device integration. > Home and community-based healthcare devices The shift from hospital-centric to patient-centric care models is creating demand for portable, user-friendly devices for home use, especially in managing chronic diseases like diabetes, hypertension (high blood pressure) and cardiovascular (heart) conditions. This will only increase as our population ages and the need for primary, preventive care becomes all the more essential. > Sustainable and green medical devices Environmental concerns are pushing manufacturers to consider the life cycle of medical devices. Recyclable materials, energy-efficient production methods and biodegradable packaging are becoming key factors, especially in export markets with stringent ESG (environmental, social and governance) expectations. Malaysia's National Investment Aspirations encourages sustainable practices in all manufacturing sectors, including medical technology, as part of the country's ambition to become a regional ESG leader. Current challenges Despite the promise, the region – including Malaysia – faces several hurdles that must be addressed in order to realise its full potential. These include: Regulatory complexity While progress has been made, inconsistent regulations across Asean countries can complicate market entry and delay product approvals. The MDA is working hard with its sister entities to help standardise these. Intellectual property (IP) protection Stronger IP frameworks are needed to attract advanced R&D investment and protect local innovation. Talent retention Despite having a skilled workforce, brain drain and talent shortages in specialised medical technology fields can hinder progress. Financing for startups Access to early-stage capital remains limited, particularly for indigenous medical device startups. However, this is beginning to change with the rise of regional venture capital interest in health technology. Malaysia and its regional peers are at a critical juncture, especially as we navigate the challenges of inconsistent American trade policies. With the right mix of policy support, international collaboration and continued investment in human capital and infrastructure, South-East Asia can transform from a production base to an innovation leader in medical devices. For Malaysia, the decade ahead holds the promise of becoming not just a regional hub, but also a global player in shaping the future of healthcare technologies. Success will depend on our ability to harness existing strengths while addressing systemic challenges – and in doing so, write a new chapter in the story of Asia's ascent in the medical technology world. Dr Helmy Haja Mydin is a consultant respiratory physician and an MDA board member. For further information, email starhealth@ The information provided is for educational and communication purposes only. The Star does not give any warranty on accuracy, completeness, functionality, usefulness or other assurances as to the content appearing in this column. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
Reuters
14-03-2025
- Health
- Reuters
US FDA says shortage of dialysis device component to extend through early fall
March 14 (Reuters) - The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in dialysis devices, are expected to continue through early fall 2025 due to recent supplier issues. Hemodialysis bloodlines are sets of tubes that connect a patient's bloodstream to the dialysis device during treatment. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The health agency's statement follows a January announcement from medical device maker B. Braun, which cited supply and labor constraints disrupting production of some hemodialysis bloodlines, with inventory expected to run out by January 20. The FDA recommended health care providers conserve the use of the bloodlines when possible, adding that it is monitoring the situation and is working with manufacturers and dialysis providers to mitigate impact on patients.
Associated Press
24-02-2025
- Business
- Associated Press
B. Braun Settles Ethylene Oxide Litigation
What Does This Mean for the Future of EO Sterilization? HANOVER, PENNSYLVANIA / ACCESS Newswire / February 24, 2025 / The legal landscape around ethylene oxide (EO) sterilization is changing fast. B. Braun, a large and well-respected medical device manufacturer, has recently settled lawsuits over EO emissions - highlighting a growing wave of litigation risk in the industry.B. Braun Settles Ethylene Oxide Litigation What does this mean for the future of EtO sterilization? It appears that the trend of legal challenges and public scrutiny are continuing, regardless of whether companies follow strict safety protocols. How We Got Here EO is a tremendously high-performance sterilization modality that, almost uniquely, is exceptionally gentle on some of the softer polymers that are used in medical devices. However, the properties that make it so desirable as a sterilization agent also make it hard to control: it is deeply penetrative and inimical to life both inside and outside the chambers in which it is contained. We Thought This Was Over Broadly speaking, many viewed the ~$800M of landmark settlements made in 2022 and early 2023 as moves that would draw the litigation around EO to a close. Instead, the opposite seems to have happened, with the announcing of 250 new lawsuits around a Milwaukee facility as well as the pending bankruptcy of an EO facility in NJ due to escalating litigation costs just last November. Even Industry Leaders Are Vulnerable B. Braun's settlement underscores a critical reality-if a sophisticated, responsible operator with extensive compliance measures can face litigation, other manufacturers relying on EO could be next. Where does this end? Regulatory pressures and legal action are evolving in parallel, making long-term reliance on EO an unpredictable and potentially costly decision. We can't shut off EO today-that would be disastrous to the healthcare system. But industry cannot afford to pretend that this risk is going away: given the highly-regulated nature of medical devices, change will not come quickly. How Manufacturers Can Stay Ahead of the Curve For companies currently using EO sterilization, now is the time to explore alternative technologies that reduce both compliance burdens and legal risks. E-beam sterilization offers a chemical-free, highly effective alternative that eliminates EO-related concerns while improving operational efficiency. At NextBeam, we help manufacturers transition to safer, scalable solutions that meet regulatory requirements without exposing them to growing legal threats. Let's talk about how E-beam can safeguard your business for the future.
