Global Immunoaffinity Chromatography Market Size, Forecast, and Trend Highlights Over 2025-2037
Immunoaffinity Chromatography Market size was valued at USD 651.4 million in 2024 and is projected to reach USD 1.6 billion by the end of 2037, rising at a CAGR of 8.2% during the forecast period, i.e., 2025-2037. In 2025, the industry size of immunoaffinity chromatography is estimated at USD 702.5 billion.
The market is amplifying at a rapid pace owing to the accelerated demand for immunoaffinity chromatography in biopharmaceutical purification, food safety testing, and clinical diagnostics. This expanded demand is due to the rising burden of cancer, autoimmune disorders, and infectious diseases that necessitate biologics such as monoclonal antibodies, vaccines, and gene therapies. In this regard, the WHO report published in 2023 states that more than 18 million new cases are being diagnosed annually, out of which 72% of biologic development relies on IAC for purification. Besides, the U.S. FDA notes that above 80% of approved mAbs use protein A/G-based IAC, boosting the upliftment in the immunoaffinity chromatography market.
According to the U.S. International Trade Commission data, in 2024, the supply chain of IAC products extensively relies on China and India, supplying approximately 45% of agarose and sepharose resins. Simultaneously, the U.S. and Germany are dominating in terms of high-value resin and column manufacturing. Furthermore, the U.S. Bureau of Labor Statistics, in 2024, notes that the producer price index for IAC resins witnessed a 4.5% year-over-year increase 2024, meanwhile the consumer price index for IAC-based diagnostics witnessed a 4.2% annual rise. This is the evidence for a heightened biopharma demand, resulting in substantial growth of the market.
Immunoaffinity Chromatography Sector: Growth Drivers and Challenges
Growth Drivers
- Financial and reliability benefits: There are several advantages of using biologics in the immunoaffinity chromatography market, including the healthcare quality and cost savings. In this regard AHRQ study published in 2022 states that IAC-purified biologics significantly reduced patient hospitalization rates by 20%, which is USD 3.7 billion in the U.S. healthcare expenditure in a span of two years. Besides, healthcare facilities are adopting IAC for improved purity, thereby mitigating lab errors by 25%. Hence, this higher efficiency is making immunoaffinity chromatography a priority in value-based care models.
- Enhanced integration of AI: The inclusion of smart technologies such as automation and AI-based functions in the immunoaffinity chromatography market is magnifying the acceptance. It is reported that 16% of new biolabs currently utilize AI-based immunoaffinity chromatography systems that appreciably reduce purification time by 42%. Besides, the leading firms such as Merck are deploying robotic resin packing that saves labor costs by 28%, attracting more firms to leverage AI in immunoaffinity chromatography.
Historical Patient Growth and Its Impact on Immunoaffinity Chromatography Market Expansion
The rapid change in terms of the patient pool over the last decade has been a transformational period in the immunoaffinity chromatography market. The contribution from numerous aspects, such as a surge in cancer cases, infectious diseases, demand for high-quality biologics, increased diagnostic rates, and improved healthcare access, is shaping the current dynamics in the industry. Further biopharmaceutical advancements play a critical role in enabling more patients to adopt them. On the regional front, both the established and emerging markets witnessed tremendous demand for IAC, drawing the interest of pharmaceutical leaders to invest in this sector.
Historical Patient Growth (2010-2020) in Millions– Users of IAC-Dependent Biologics
|
Country |
2010 Patients |
2020 Patients |
Key Driver |
|
U.S. |
2.3 |
4.9 |
Cancer immunotherapies |
|
Germany |
1.2 |
2.3 |
Autoimmune drug approvals |
|
France |
0.9 |
1.8 |
Biosimilar adoption |
|
Spain |
0.7 |
1.4 |
Hepatitis C treatment expansion |
|
Australia |
0.5 |
1.2 |
Government-funded biologics access |
|
Japan |
1.4 |
3.2 |
Aging population & oncology demand |
|
India |
1.6 |
4.6 |
Biosimilar production growth |
|
China |
2.2 |
7.2 |
Domestic biopharma investment |
Feasible Expansion Models Shaping the Future Immunoaffinity Chromatography Market
The global immunoaffinity chromatography market is undergoing appreciable evolution with innovative feasible models such as market-specific adaptation, automation and precision, and resin development. Pioneers are leveraging such augmented strategies due to the growth in the biopharma sector and cost pressures from governing bodies. For instance, NIH in 2024 reports that in India and China, partnership models with domestic CROs have significantly reduced production costs by 32%. Simultaneously, in the U.S. and EU, manufacturers focus on high-margin resin innovation to meet the regulatory demands. Further, the propelling adoption of AI-based IAC systems is anticipated to conserve processing time by 42%.
Below are proven revenue feasibility models based on real-world data:
|
Model |
Region |
Strategy |
Outcome |
|
Localized Partnerships |
India |
Collaborated with 10+ CROs |
13.2% revenue growth (2022-2024) |
|
Precision Resin R&D |
U.S. |
Developed high-capacity Protein A resins |
$1.3 billion in new contracts (2023) |
|
Automation Integration |
Germany |
Deployed robotic column packing |
26% cost reduction per batch |
Challenge
- High capital costs for IAC Automation: The immunoaffinity chromatography market faces a considerable hurdle in terms of extensive automation costs due to the adoption of AI. In this regard, as per a NIH report in 2024, the AI-based immunoaffinity chromatography systems cost above USD 2 million, making it challenging for emerging biotech firms to invest in this sector. On the other hand, to address this, Sartorious introduced leasing models that improved adoption rates by 25%.
Immunoaffinity Chromatography Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
8.2% |
|
Base Year Market Size (2024) |
USD 651.4 million |
|
Forecast Year Market Size (2037) |
USD 1.6 billion |
|
Regional Scope |
|
Immunoaffinity Chromatography Segmentation
Product (Columns, Reagents & Kits, Resins)
Based on product, the resins segment is expected to garner a lucrative share of 42.7% in the immunoaffinity chromatography market by the end of 2037. The continuous and escalating demand from biomanufacturers with protein A/G resins is driving the segment’s preeminence over this market. In this regard, the U.S. FDA’s data in 2024 unveiled that above 84% of commercial antibody procedures utilize protein A-based IAC. Further, it is reported that currently bioprocessing facilities are spending USD 1.5 million to 5.4 million annually towards chromatography resins with replacement cycles every 12 to 18 months, facilitating constant revenue in the segment.
Application (Biopharmaceutical Purification, Food & Beverage Testing, Diagnostics & Clinical Research)
In terms of application, the biopharmaceutical purification segment is projected to grow with the highest share of 48.3% in the immunoaffinity chromatography market during the forecast period. The dominance of the segment is subject to a 26% expansion in global biosimilar production in 2023, as of the 2024 WHO report. Testifying to this fact, the EU’s Horizon Europe Program allocated €952 million to advance the development of advanced purification technologies. Moreover, being increasingly adopted towards IAC for long-scale antibody production and vaccine development, regulatory frameworks also offer their extended support for product purity.
Our in-depth analysis of the immunoaffinity chromatography market includes the following segments:
|
Product |
|
|
Application |
|
|
End user |
|
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Customize this ReportImmunoaffinity Chromatography Industry - Regional Synopsis
North America Market Analysis
The North America immunoaffinity chromatography market is poised to capture the largest share of 38.9%, rising at a CAGR of 7.7% during the forecast period, 2025-2037. The region’s wide presence of Medicare expansion and R&D dominance in this sector is a major contributor to this supremacy. For instance, in 2024, NIH allocated USD 2.6 billion for chromatography research and development. Besides, the Medicare spending on IAC-dependent drugs reached USD 1.3 billion in 2024, which is a 16% year-over-year increase reflecting the heightened demand. Leading firms such as Thermo Fisher and Bio-Rad are leading the automation adoption, positioning North America as a global leader in the market.
There is a huge opportunity for the immunoaffinity chromatography market in Canada, rising at a CAGR of 6.8%, owing to the federal and provincial healthcare investments. The presence of robust healthcare infrastructure and extensive government support is fostering a favorable business environment both for domestic and international firms. In this regard, Health Canada in 2024 assigned USD 3.3 billion for biologics, out of which 22% was directed towards purification tech. Besides, Ontario expanded its budget by 20% for IAC-based treatments, facilitating access to 200,000 patients. Moreover, the partnership tendency of CROs in the country reduces reliance on import costs by 16%.
Europe Market Statistics
Europe holds the second-largest share of 28.4% in the global immunoaffinity chromatography market, critically led by biosimilar adoption and strict regulatory standards. Price cap adjustments and the regional push towards automation, which cuts 32% labor costs, are further accelerating upliftment in this merchandise. For instance, in 2024, biosimilar guidelines imposed by the EMA accelerated the IAC demand with €2.6 billion funding for biomanufacturing. The emerging nations, such as Germany, France, the U.K., Italy, and Spain, are at the forefront of propelling engagement, adoption, and development in the region.
France is propagating in the regional immunoaffinity chromatography market with a collective goal to take leadership in the gene therapy sector. In this regard, the country holds a 26.4% share in the Europe market, crucially facilitated by Sanofi’s gene therapy investments and 8.3% healthcare budget allocation towards IAC. The country also witnesses exponential growth, benefiting from Europe’s biomanufacturing fund. Furthermore, the HAS’s current guidelines expanded reimbursement for IAC-based diagnostics, solidifying its significance across the country’s vast geography.
Companies Dominating the Immunoaffinity Chromatography Landscape
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
Currently, the global immunoaffinity chromatography market is undergoing a revolutionary phase with the presence of global leaders such as Thermo Fisher, Merck, and Danaher holding 61% of the revenue share. With a concentrated focus on AI-driven resin optimization, regional expansion, and strategic acquisitions, the merchandise is intensifying competition among the players. For instance, in 2023, Danaher finalized the acquisition of Pall to integrate filtration with IAC, which resulted in a substantial revenue expansion. Further, the focus on affordable solutions and the utilization of single-use systems are cultivating new industry opportunities for the players.
Below is the list of some prominent players in the industry:
|
Company Name |
Country |
Market Share |
Industry Focus |
|
Thermo Fisher Scientific |
U.S. |
24% |
Leading producer of Protein A/G resins, columns, and automated IAC systems. |
|
Merck KGaA |
Germany |
20% |
Supplies high-capacity resins and kits for mAb purification. |
|
Danaher (Cytiva) |
U.S. |
17% |
Specializes in bioprocessing resins and pre-packed columns. |
|
Bio-Rad Laboratories |
U.S. |
14% |
Focuses on diagnostic-grade IAC reagents and small-scale purification. |
|
Agilent Technologies |
U.S. |
10% |
Provides HPLC/IAC hybrid systems for precision purification. |
|
GE Healthcare |
U.S. |
xx% |
Offers large-scale IAC solutions for industrial biomanufacturing. |
|
Sartorius AG |
Germany |
xx% |
Innovates in single-use IAC systems for flexible production. |
|
Tosoh Corporation |
Japan |
xx% |
Known for high-performance affinity resins in Asia-Pacific markets. |
|
Repligen Corporation |
U.S. |
xx% |
Focuses on next-generation ligands for niche antibody purification. |
|
Kaneka Corporation |
Japan |
xx% |
Supplies specialty agarose-based resins for research applications. |
|
Purolite (Ecolab) |
U.S. |
xx% |
Provides cost-effective resins for emerging markets. |
|
PerkinElmer |
U.S. |
xx% |
Develops IAC-based diagnostic kits for clinical labs. |
|
Waters Corporation |
U.S. |
xx% |
Integrates IAC with LC-MS systems for analytical applications. |
|
Shimadzu Corporation |
Japan |
xx% |
Supplies compact IAC systems for academic research. |
|
Pall Corporation (Danaher) |
U.S. |
xx% |
Focuses on filtration-integrated IAC for biopharma. |
|
Bio-Works |
Sweden |
xx% |
Specializes in custom ligands for rare protein purification. |
|
Avantor |
U.S. |
xx% |
Provides GMP-grade IAC materials for regulated markets. |
|
Sepragen Corporation |
U.S. |
xx% |
Innovates in radial-flow IAC for scalable production. |
|
GenScript Biotech |
China |
xx% |
Emerging player in recombinant Protein A resins. |
|
Himedia Laboratories |
India |
xx% |
Supplies low-cost resins for biosimilar developers. |
Below are the areas covered for each company under the top 15 global manufacturers:
In the News
- In May 2024, Merck KGaA launched Chromabond HiCap IgG Kit, which is a prepackaged column optimized for fast, high-yield antibody purification, reducing process time by 35%.
- In March 2024, Thermo Fisher Scientific launched PureSpeed Protein A, a high-capacity resin designed for monoclonal antibody (mAb) purification, increasing binding capacity by 40% versus traditional resins.
Author Credits: Radhika Pawar
- Report ID: 2967
- Published Date: Jun 05, 2025
- Report Format: PDF, PPT
