Software as a Medical Device (SaMD) Global Market Opportunities and Strategies to 2033

This report describes and explains the (SaMD) software as a medical device market and covers 2018-2023, termed the historic period, and 2023-2028, 2033F termed the forecast period. The report evaluates the market across each region and for the major economies within each region.

The global (SaMD) software as a medical device market reached a value of nearly $24.3 billion in 2023, having grown at a compound annual growth rate (CAGR) of 24.7% since 2018. The market is expected to grow from $24.3 billion in 2023 to $70.2 billion in 2028 at a rate of 23.7%. The market is then expected to grow at a CAGR of 17.4% from 2028 and reach $156.6 billion in 2033.

Growth in the historic period resulted from the increased demand for remote monitoring in healthcare, growing adoption of digital transformation in the healthcare sector, rising healthcare expenditure and strong economic growth in emerging markets. Factors that negatively affected growth in the historic period were low healthcare access in developing countries.

Going forward, increase in chronic diseases, rising adoption of IoT in the healthcare sector, growing demand for early diagnosis of health problems and growing aging populations will drive the growth. Factor that could hinder the growth of the (SaMD) software as a medical device market in the future include data security and privacy concerns.

The (SaMD) software as a medical device market is segmented by device type into wearable devices, PCs and laptop and smartphone and tablets. The PCs and laptop market was the largest segment of the (SaMD) software as a medical device market segmented by device type, accounting for 44.3% or $10.7 billion of the total in 2023. Going forward, the smartphone and tablets segment is expected to be the fastest growing segment in the (SaMD) software as a medical device market segmented by device type, at a CAGR of 25.6% during 2023-2028.

The (SaMD) software as a medical device market is segmented by deployment method into cloud-based and on-premise. The cloud-based market was the largest segment of the (SaMD) software as a medical device market segmented by deployment method, accounting for 59.5% or $14.5 billion of the total in 2023. Going forward, it is expected to be the fastest growing segment in the (SaMD) software as a medical device market segmented by deployment method, at a CAGR of 25.2% during 2023-2028.

The (SaMD) software as a medical device market is segmented by application into diagnostic and clinical management. The diagnostic market was the largest segment of the (SaMD) software as a medical device market segmented by application, accounting for 52.8% or $12.8 billion of the total in 2023. Going forward, it is expected to be the fastest growing segment in the (SaMD) software as a medical device market segmented by application, at a CAGR of 24.5% during 2023-2028.

North America was the largest region in the (SaMD) software as a medical device market, accounting for 36.8% or $8.9 billion of the total in 2023. It was followed by Western Europe, Asia Pacific and then the other regions. Going forward, the fastest-growing regions in the (SaMD) software as a medical device market will be North America and Asia Pacific where growth will be at CAGRs of 24.2% and 23.9% respectively. These will be followed by Eastern Europe and Western Europe where the markets are expected to grow at CAGRs of 23.8% and 23.4% respectively.

The global (SaMD) software as a medical device market is fairly fragmented, with a large number of players operating in the market. The top ten competitors in the market made up to 25.2% of the total market in 2022. The market concentration can be attributed to the presence of large number of players in different geographies. Prominent players are acquiring the products and entering into partnerships with the other companies to consolidate their market positions across the globe, while others are distributing products. DexCom, Inc. was the largest competitor with a 7.5% share of the market, followed by Koninklijke Philips N.V. with 4.9%, GE HealthCare Technologies Inc with 3.8%, Siemens Healthineers AG with 2.9%, FUJIFILM Holdings Corporation with 1.7%, Medtronic Plc with 1.4%, Abbott Laboratories with 1.1%, Paige AI with 0.8%, Biofourmis with 0.6% and Nihon Kohden Corp with 0.4%.

The top opportunities in the (SaMD) software as a medical device market segmented by device type will arise in the PCs and laptops segment, which will gain $18 billion of global annual sales by 2028. The top opportunities in the (SaMD) software as a medical device market segmented by deployment method will arise in the cloud-based segment, which will gain $30.1 billion of global annual sales by 2028. The top opportunities in the (SaMD) software as a medical device market segmented by application will arise in the diagnostic segment, which will gain $25.5 billion of global annual sales by 2028. The (SaMD) software as a medical device market size will gain the most in the USA at $16.4 billion.

Market-trend-based strategies for the (SaMD) software as a medical device market include introduction of advanced software with improved analysis capabilities, development of artificial intelligence (AI)-powered software to improve efficiencies, launch of advanced digital PCR automation solutions, innovative product launches in diagnostics testing software, strategic partnerships and collaborations among market players and focus on developing innovative and advanced products using latest technology.

Player-adopted strategies in the (SaMD) software as a medical device market include focusing on new product launches to better serve the industry and to strengthen their position and strengthening its operational capabilities through acquisitions.

To take advantage of the opportunities, the analyst recommends the (SaMD) software as a medical device companies to focus on advanced software with enhanced analysis capabilities, focus on AI-powered software development, focus on digital PCR solutions development, focus on diagnostic testing software innovation, focus on innovative product development, focus on cloud-based solutions, expand in emerging markets, continue to focus on developed markets, focus on strategic partnerships and collaborations, provide competitively priced offerings, participate in trade shows and events, continue to use B2B promotions and focus on diagnostic applications.