Hydrophobic Interaction Chromatography Market - Growth Drivers and Challenges
Growth Drivers
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Increasing demand for biopharmaceuticals: The rising global demand for biopharmaceutical products, such as monoclonal antibodies (mAbs), therapeutic proteins, and vaccines, is driving the need for efficient purification techniques. The market offers a gentle yet effective method to separate proteins without denaturing them. Thus, with the continuous expansion and R&D activities in biopharma pipelines, the surge in this sector continues to grow. This can also be testified by the enlarging territory of the GMP biologics industry, where the market value of therapeutic mAbs crossed $300 billion in 2025, as per the NLM.
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Strict regulatory standards for product purity: The tightening of regulations regarding biologic safety and purity is pushing biomanufacturers to invest in the hydrophobic interaction chromatography market. In this regard, the 2023 Journal of Biomaterials unveiled that more than 90% of biologics are delivered through invasive methods, which require >99% purity in order to acquire compliance for production. Moreover, the compliance-friendly offerings and precise separation capabilities are making this technology highly preferred among biopharma producers and institutional researchers.
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Growing deployment of automation: Modernization of systems is increasingly enhancing the efficiency and outcomes gained from the hydrophobic interaction chromatography (HIC) procedures. Particularly, the incorporation of automation with advanced sensors and software improves process control and optimization, hence securing a greater future for this sector. Additionally, the trend of next-generation biomanufacturing is deepening the penetration of automated HIC technologies, allowing real-time monitoring and scalable operations in the hydrophobic interaction chromatography market.
Historic Shifts in the Patient Pool of the Hydrophobic Interaction Chromatography Market
Trends in U.S. Chronic Disease Volume
|
Year / Period |
Chronic Disease Prevalence / Number of Patients |
Key Details |
|
2013 vs 2023 |
Young adults (18-34 years): increased from 52.5% to 59.5% |
Increase in at least 1 chronic condition; multiple chronic conditions (MCC) rose from 21.8% to 27.1% |
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2023 |
76.4% of U.S. adults (~194 million) have at least 1 chronic condition |
By age group: 59.5% young adults, 78.4% midlife adults, 93.0% older adults report ≥1 condition |
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2023 |
51.4% U.S. adults (~130 million) have multiple chronic conditions (MCC) |
MCC prevalence is 27.1% young adults, 52.7% midlife adults, and 78.8% older adults |
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2022 |
Chronic diseases cause 90% of US healthcare costs ($4.5 trillion in 2022) |
Chronic diseases affect ~60% of Americans; many have multiple diseases |
Source: CDC and NIHCM
Current/Recent Activity Overview of the Field of Application in the Hydrophobic Interaction Chromatography Market
Biologics Under Clinical Trials (2022-2025)
|
Year |
Total Biologics Approved by FDA |
Key Therapeutic Areas |
Number of Bispecific Biologics Approved |
Notes |
|
2022 |
15 |
Cancer (6), Autoimmune (4), Rare Diseases |
4 |
Highest number of bispecific biologics approved in recent years; 7 orphan drugs among approvals |
|
2025 |
Approx. 40% of new FDA approvals are biologics |
Expanding indications, including neurodegenerative diseases |
Growing clinical trial volume continues |
The total registered studies is increasing annually |
Source: NLM and Clinicaltrials.gov
Challenges
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Protracted and fragmented process of compliance: The regulatory pathway for a new medical device or consumable is distinct from the drug itself but equally critical. This creates dual pressures on both suppliers and consumers in the hydrophobic interaction chromatography market. The requirement for extensive data on quality, consistency, and leachables further escalates the budget of therapy development and commercialization, which imposes severe economic disparity in this sector, while restricting the cash inflow.
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High R&D and manufacturing costs: Alongside the expensive regulatory process, the development of novel, high-capacity, and more efficient HIC ligands is also capital-intensive. These additional expenditures are ultimately passed down the chain to biopharma companies and then to healthcare systems and patients. Such limitations in comprehensive pricing further restrict access to biologics for both uninsured and underinsured populations, hindering profitability and consumer engagement in the hydrophobic interaction chromatography market.
Hydrophobic Interaction Chromatography Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
7.4% |
|
Base Year Market Size (2025) |
USD 479.9 million |
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Forecast Year Market Size (2035) |
USD 912.4 million |
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Regional Scope |
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