News Related to Rare Disease

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South Korea Fast-Tracks Rare Disease Drug Coverage Amid Budget Concerns

Mar 31, 2026

South Korea has approved fast-track drug listing for rare disease treatments, reducing the insurance coverage process from 240 days to 100 days. The reform includes post-listing effectiveness evaluations and flexible pricing agreements, aiming to improve patient access to innovative treatments amid ongoing budget concerns.

AI in Drug Discovery Market Projected to Reach USD 10.29 Billion by 2031

Mar 30, 2026

The artificial intelligence in drug discovery market is projected to grow from USD 3.25 billion in 2026 to USD 10.29 billion by 2031, representing a 25.94% CAGR. AI technologies are accelerating drug discovery timelines, reducing costs, and improving success rates through advanced analytics and machine learning. North America leads market adoption while Asia-Pacific emerges as a high-growth region driven by expanding biotechnology sectors.

China's Revised Drug Administration Regulations to Take Effect in May 2026

Mar 25, 2026

China's newly revised Implementation Regulations of the Drug Administration Law will take effect on May 15, 2026, representing the first comprehensive revision in over two decades. The regulations strengthen the marketing authorization holder system, improve drug development processes, and introduce new provisions for clinical trials, data protection, and market exclusivity for pediatric and rare disease drugs.

Orphan Drugs Market Projected to Reach $486.51 Billion by 2032

Mar 23, 2026

The global orphan drugs market is projected to grow from $223.76 billion in 2023 to $486.51 billion by 2032, with North America leading at 38% market share. Over 500 orphan drugs are approved with more than 800 candidates in clinical trials, driven by regulatory incentives and major pharmaceutical company investments in rare disease therapies.

Drugmakers Challenge Trump's International Drug Pricing Models

Mar 04, 2026

Major pharmaceutical and biotech companies are urging the Trump administration to withdraw two Medicare pricing proposals that would align U.S. drug prices with international benchmarks, arguing the mandatory models exceed government authority and threaten innovation.