Last Updated: 25 Aug 2025
Source: Statifacts
The biopharma product testing market size was US$ 8,924 million in 2024 and is forecasted to hit US$ 24,886 million by 2034 with a CAGR of 10.8% during the period between 2025 and 2034. The market is growing significantly due to high demand for biologics, new regulatory oversight requiring frequent testing, and overall growth of the pharmaceutical sector.
The rise in demand for monoclonal antibodies, gene and cell therapies, is due to groundbreaking new research such as CRISPR-Cas9 and molecular mapping. The development of these novel therapies is driving demand for testing, with new regulatory frameworks being developed by organizations such as the U.S. Food and Drug Administration, the European Medicines Agency, and ICH to ensure patient safety. Such demands are pushing companies toward outsourcing to contract research organizations (CROs) and contract development & manufacturing organizations (CDMOs) allows biopharma firms to leverage cheaper infrastructure, labor, and import expertise for cost-effective R&D and production. Industry players are expanding testing capacity via new labs, strategic partnerships, and centers of excellence, with larger investments made through fewer rounds.
Despite this growth, the high cost of testing and infrastructure, especially with the prohibitive costs associated with advanced analytical tools like HRMS, NGS, and labor shortages in GMP/GLP labs, bioinformatics fields, is hampering the expansion of the biopharma product testing market. However, the implementation of AI and Machine Learning is set to revolutionize the market in the next few years due to automation of data analysis and error detection, along with predictive modeling for stability and toxicity studies. The use of digital twins and blockchain integration is also expected to grow the biopharma product testing space.
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemical Analysis | 4,105.04 | 4,489.06 | 4,908.14 | 5,365.39 | 5,864.15 | 6,408.06 | 7,001.06 | 7,647.41 | 8,351.70 | 9,118.92 | 9,954.45 |
| Bioanalysis | 4,283.52 | 4,805.47 | 5,390.19 | 6,045.17 | 6,778.74 | 7,600.26 | 8,520.16 | 9,550.11 | 10,703.15 | 11,993.85 | 13,438.50 |
| Others | 535.44 | 593.27 | 657.34 | 728.33 | 806.99 | 894.15 | 990.72 | 1,097.71 | 1,216.27 | 1,347.62 | 1,493.17 |
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmaceutical Research Institute | 5,532.88 | 6,090.88 | 6,704.87 | 7,380.45 | 8,123.73 | 8,941.48 | 9,841.12 | 10,830.78 | 11,919.42 | 13,116.87 | 14,433.95 |
| Hospital | 2,677.20 | 3,005.89 | 3,374.35 | 3,787.33 | 4,250.17 | 4,768.79 | 5,349.87 | 6,000.84 | 6,730.01 | 7,546.69 | 8,461.28 |
| Others | 713.92 | 791.02 | 876.45 | 971.11 | 1,075.99 | 1,192.20 | 1,320.96 | 1,463.62 | 1,621.69 | 1,796.83 | 1,990.89 |
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| North America | 3,034.16 | 3,332.19 | 3,659.19 | 4,017.97 | 4,411.56 | 4,843.30 | 5,316.84 | 5,836.18 | 6,405.67 | 7,030.11 | 7,714.70 |
| Europe | 2,587.96 | 2,916.90 | 3,286.70 | 3,702.36 | 4,169.47 | 4,694.28 | 5,283.82 | 5,945.95 | 6,689.47 | 7,524.23 | 8,461.28 |
| Asia Pacific | 2,141.76 | 2,353.29 | 2,585.54 | 2,840.50 | 3,120.37 | 3,427.57 | 3,764.72 | 4,134.72 | 4,540.73 | 4,986.21 | 5,474.95 |
| Latin America | 624.68 | 697.09 | 777.85 | 867.93 | 968.39 | 1,080.43 | 1,205.37 | 1,344.70 | 1,500.06 | 1,673.30 | 1,866.46 |
| Middle East and Africa | 535.44 | 588.32 | 646.38 | 710.13 | 780.09 | 856.89 | 941.18 | 1,033.68 | 1,135.18 | 1,246.55 | 1,368.74 |
Last Updated: 25 Aug 2025
Source: Statifacts
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemical Analysis | 4,105.04 | 4,489.06 | 4,908.14 | 5,365.39 | 5,864.15 | 6,408.06 | 7,001.06 | 7,647.41 | 8,351.70 | 9,118.92 | 9,954.45 |
| Bioanalysis | 4,283.52 | 4,805.47 | 5,390.19 | 6,045.17 | 6,778.74 | 7,600.26 | 8,520.16 | 9,550.11 | 10,703.15 | 11,993.85 | 13,438.50 |
| Others | 535.44 | 593.27 | 657.34 | 728.33 | 806.99 | 894.15 | 990.72 | 1,097.71 | 1,216.27 | 1,347.62 | 1,493.17 |
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmaceutical Research Institute | 5,532.88 | 6,090.88 | 6,704.87 | 7,380.45 | 8,123.73 | 8,941.48 | 9,841.12 | 10,830.78 | 11,919.42 | 13,116.87 | 14,433.95 |
| Hospital | 2,677.20 | 3,005.89 | 3,374.35 | 3,787.33 | 4,250.17 | 4,768.79 | 5,349.87 | 6,000.84 | 6,730.01 | 7,546.69 | 8,461.28 |
| Others | 713.92 | 791.02 | 876.45 | 971.11 | 1,075.99 | 1,192.20 | 1,320.96 | 1,463.62 | 1,621.69 | 1,796.83 | 1,990.89 |
| Subsegment | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| North America | 3,034.16 | 3,332.19 | 3,659.19 | 4,017.97 | 4,411.56 | 4,843.30 | 5,316.84 | 5,836.18 | 6,405.67 | 7,030.11 | 7,714.70 |
| Europe | 2,587.96 | 2,916.90 | 3,286.70 | 3,702.36 | 4,169.47 | 4,694.28 | 5,283.82 | 5,945.95 | 6,689.47 | 7,524.23 | 8,461.28 |
| Asia Pacific | 2,141.76 | 2,353.29 | 2,585.54 | 2,840.50 | 3,120.37 | 3,427.57 | 3,764.72 | 4,134.72 | 4,540.73 | 4,986.21 | 5,474.95 |
| Latin America | 624.68 | 697.09 | 777.85 | 867.93 | 968.39 | 1,080.43 | 1,205.37 | 1,344.70 | 1,500.06 | 1,673.30 | 1,866.46 |
| Middle East and Africa | 535.44 | 588.32 | 646.38 | 710.13 | 780.09 | 856.89 | 941.18 | 1,033.68 | 1,135.18 | 1,246.55 | 1,368.74 |
It encompasses analytical and bioanalytical testing, stability studies, method development, microbial and raw material testing, crucial steps for validating the safety, efficacy, and quality of pharmaceutical and biopharmaceutical products. These services underpin R&D, biosimilar development, and regulatory submissions.
Rising biologics, biosimilars, and personalized therapies pipelines are boosting demand. Regulatory bodies are imposing tighter testing standards, prompting outsourcing to specialized contract providers for cost efficiency and compliance.
Bioanalytical testing, covering clinical and non-clinical assays, remains foundational, while stability, method validation, and microbial services are also critical. Leading service players include Eurofins, Charles River, WuXi AppTec, SGS, Thermo Fisher, and Labcorp.
North America, especially the U.S., leads due to advanced infrastructure and heavy R&D investment. Asia-Pacific is emerging fastest, driven by cost-effective clinical research and expanding biopharma manufacturing capabilities.
Digital lab integration, AI-powered analytics, high-throughput screening, and automation are driving faster insights and improved reliability. Meanwhile, regulatory shifts, such as reduced reliance on animal models, are accelerating the adoption of human-based assays and organ-on-chip technologies.
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