Introduction
Global IND submissions surged in 2025, revealing key shifts in Clinical Trials design and strategy. Sponsors embraced new therapeutic modalities, biomarker-driven patient selection, and agile proof-of-concept trial designs, while regulators introduced accelerated pathways to expedite development. This article analyzes 2025 IND trends from the FDA (US), NMPA (China), and MFDS (Korea) – focusing on emerging modalities in Clinical Trials, biomarker usage, early PoC innovations, and regulatory strategies – to predict how they will shape Clinical Trials in 2026. We also highlight Korea’s growing role as a global Clinical Trials hub, with insights from Intoinworld as a local CRO partner in Clinical Trials.
2025 IND Submissions: FDA vs. NMPA vs. MFDS
To compare IND activity, the table below summarizes key 2025 IND metrics and trends for the FDA, NMPA, and MFDS:
| Agency (Region) | 2025 IND Activity Highlights |
| FDA (US) | ~1,800+ new INDs (2024); focus on biologics & cell/gene therapies; ~40% oncology/rare disease Clinical Trials. Small-molecule INDs declining as sponsors shift to advanced modalities. |
| NMPA (China) | Launched 30-day IND review pilot in 2025, halving approval times for innovative drugs. Surge in INDs for CAR-T, gene therapies as China encourages early global Clinical Trials. Aligning with ICH standards to support multi-center trials. |
| MFDS (Korea) | 636 IND approvals in 2025; ~70% for global sponsors. Oncology dominant. Maintains ~30-day review timeline, enabling rapid start-up of both early-phase and Phase III Clinical Trials. |
Monthly MFDS IND approvals in 2025 (total 636), illustrating South Korea’s consistently high Clinical Trials activity
Read More: South Korea’s 2025 MFDS IND Approvals: Key Clinical Trials Trends and Insights
Emerging Therapeutic Modalities
2025’s IND filings saw a surge in next-generation modalities. At FDA, biologic drug INDs and cell & gene therapies reached new highs in Clinical Trials, while traditional small-molecule programs continued to decline. China and Korea likewise reported many INDs for CAR-T cells, gene therapies, and ADCs (antibody-drug conjugates). Regulators adjusted to these complex products: for example, FDA coordinated reviews between drug and biologics centers, and MFDS issued guidance for cell therapy trial oversight. Expect even more advanced modality Clinical Trials in 2026, requiring specialized sites and careful safety monitoring.
Biomarker-Driven Trial Designs
Many 2025 trials were biomarker-driven, especially in oncology. Sponsors designed protocols to enroll patients with specific genetic mutations or protein expressions (e.g. HER2-low in breast cancer, PD-L1 in lung cancer) to heighten efficacy signals. This approach was global – numerous INDs across the US, China, and Korea included companion diagnostics for patient screening in Clinical Trials. Biomarker-based enrollment can greatly improve trial outcomes but demands robust lab support. Regulators supported precision medicine trials by fast-tracking companion test approvals and granting Breakthrough status to targeted therapies. Going into 2026, Clinical Trials will be even more precision-oriented, making upfront biomarker strategy a crucial part of trial planning.
Early PoC and Adaptive Designs
Sponsors in 2025 increasingly embraced adaptive trial designs to accelerate proof-of-concept. Seamless Phase 1/2 trials and master protocols became more common, allowing quick expansion from safety testing to efficacy cohorts once a signal is seen. Korea’s IND data show about 25% of trials used adaptive or combined phases (e.g. seamless Phase 1/2 Clinical Trials). These innovative designs – including basket trials that test one drug in multiple populations – can shave months off development by answering multiple questions within one Clinical Trial protocol. Regulators have shown openness to such designs (with proper safeguards), so 2026 will likely feature more flexible Clinical Trials that aim for faster go/no-go decisions on new therapies.
Accelerated Regulatory Pathways
Major regulators implemented fast-track pathways in 2025 to speed up Clinical Trials initiation. The FDA granted numerous Fast Track and Breakthrough designations, enabling rolling reviews and extra guidance for IND sponsors. China’s NMPA began approving some INDs in as little as 30 working days under its pilot program, dramatically shortening startup times for qualifying trials. South Korea’s MFDS rolled out an overhaul of its review process (with dedicated review teams and rolling submissions) in 2025, and continued its GIFT fast-track program for novel drugs. The table below highlights these 2025 regulatory accelerators:
| Region | 2025 Regulatory Accelerators |
| USA (FDA) | Expedited programs widely used (Fast Track & Breakthrough for dozens of INDs); new FDA guidance (e.g. on AI data and safety reporting) to modernize trial oversight. |
| China (NMPA) | 30-day IND approval pathway introduced; encouraging parallel ethics reviews and site prep for faster trial launches. Continued priority reviews for rare disease and pediatric trials. |
| Korea (MFDS) | Review process reforms (dedicated teams, rolling review) cut timelines; GIFT designation fast-tracks selected innovative drugs. Emphasis on pre-IND consultation to resolve issues early and start Clinical Trials quickly. |
Korea: A Strategic Clinical Trial Hub
South Korea is emerging as a strategic hub for global Clinical Trials execution. Its MFDS approves INDs in ~30 days, and Korean sites are renowned for rapid patient recruitment and high-quality data. In 2025, ~70% of Korea’s trials were sponsored by international companies, reflecting global confidence in Korea’s Clinical Trials infrastructure. Large hospitals with dedicated clinical trial centers and unified health records enable efficient patient identification, contributing to faster enrollment. Trial quality is high (GCP-compliant, low dropout rates, with lower costs), and regulators provide proactive support. These advantages, combined with MFDS’s proactive regulatory stance, make Korea an ideal location to run complex trials. Intoinworld has helped many sponsors navigate Korea’s Clinical Trials landscape – from IND submission to site management – underscoring how a local partner can maximize the country’s value for 2026 studies.
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FAQs
Q1: What were the major trends in FDA IND submissions in 2025?
A1: FDA IND submissions in 2025 were dominated by biologics and advanced therapies (especially oncology and rare diseases). Small-molecule INDs declined, and many innovative programs received Fast Track or Breakthrough status to accelerate Clinical Trials.
Q2: How did China’s NMPA accelerate IND approvals in 2025?
A2: China’s NMPA introduced a 30-working-day IND review pathway in 2025, roughly cutting approval times in half. By meeting the criteria (innovative drug and parallel ethics review), sponsors could launch Clinical Trials in China much faster under this new system.
Q3: What role did biomarkers play in 2025 trial designs?
A3: Biomarkers were pivotal in 2025. Many trials only enrolled patients with specific genetic markers or protein expressions, which improved efficacy signals but required companion diagnostic testing. Regulators supported these precision Clinical Trials by fast-tracking diagnostic approvals alongside the drug.
Q4: Why is South Korea emerging as a preferred trial site for global sponsors?
A4: Korea offers fast IND approvals (~30 days) and top-tier trial infrastructure. Global sponsors value its rapid recruitment, high-quality data (with strict GCP compliance), and lower costs, making Korea – with CRO support like Intoinworld – a prime location for Clinical Trials.
Q5: How are trial designs evolving to get early proof-of-concept results in Clinical Trials?
A5: Trial designs are becoming more adaptive. Seamless Phase 1/2 trials and basket trials allow faster identification of efficacy signals and can shorten development timelines. Regulators in 2025 showed openness to these innovative designs with proper safety oversight, so 2026 will likely see more flexible Clinical Trials designs.
