Global Orphan Drug Rare Disease Market Patent Insight 2028

Global Orphan Drugs Market & Clinical Trials Insight Report 2028 Highlights.

Global Orphan Drugs Market & Clinical Trials Insight Report 2028 Highlights:

  • Clinical Insight On More Than 400 Marketed Orphan Drugs
  • Clinical Insight On More Than 1300 Orphan Drugs in Clinical Trials
  • Orphan Designated Drug Clinical Status by Indication & Country
  • Global Market Opportunity More Than USD 350 Billion
  • Market Exclusivity & Patent Protection Criteria for Orphan Drugs
  • Global & Regional Orphan Drug Market Sales Opportunity
  • Orphan Drug Reimbursement Policy
  • Orphan Clinical Pipeline Overview Company, Drug Class, Formulation, Indication, Region, Priority Status, Patient Segment, Phase

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In recent times, the pharmaceutical sector is growing with high pace towards transformation. With the advent of enhanced technologies and innovative devices, the industry is reshaping the paradigm of treatments. One particular domain which is witnessing major development these days is rare disease treatment market. This is mainly attributed to the increasing prevalence of rare genetic disorders with high medical needs. Orphan drugs are medicinal or therapeutic products intended for the detection, prevention, or treatment of life-threatening or critical diseases that are extremely rare.

Till date, FDA has granted more than 1000 orphan drug designations and more than 400 orphan drugs have entered the market which have shown encouraging response in the market. The orphan drugs have shown high adoption rates since their entrance, which is boosting the growth of market. Although the market for orphan medicines is developing at a decent rate, certain variables can impede its development. The elevated price of orphan medicines, inadequate data on rare illnesses and the absence of competent health experts are factors that reduce development in the worldwide market for orphan medicines. Furthermore, increasing competition from generic sectors can seriously threaten market growth.

At present, the global orphan drug market is highly competitive and concentrated with big pharmaceutical companies which actively indulge in research and development sector. However, the prominence of big pharmaceutical giants poses a challenge to new entrants in the market. To overcome these, the new companies are adopting strategic alliances including mergers and collaboration. These strategies allow the access to resources that can help them gain sustainability in the market.

In last few years, the focus of drug makers have shifted from the development of blockbuster drugs to the development of therapies to treat rare diseases, which is mainly attributed to benefits associated with their development. The government has created several economic incentives to stimulate orphan drug development. Grants, research design support, FDA fee waivers, tax incentives, orphan drug market exclusivity, and public diffusion of orphan innovation are main incentives for orphan research and development. The major key players in orphan drug market include Abbvie, Amgen, Biogen, AstraZencea, Novartis, Bayer, Roche, and several others.

Based on the component type, the biologics segment is projected to reap significant gains through 2028. This can be credited to the increasing presence of product offerings classified as biologics. It has been claimed that of the total number of drugs with active orphan status, nearly 39% are biologics. Many new biologics receive Orphan Drug designation for treating rare diseases. By therapeutic indication, cancer remains the dominant segment which is attributed to significant rise in prevalence of cancer and unmet need of targeted drugs. In addition, availability of several biosimilars and generics in cancer treatment also boosts the growth of market.

With knowledge of disease mechanisms continuing to expand, novel drug targets are being discovered regularly which is boosting the growth of market. The demand for orphan drugs has increased significantly owing to surge in prevalence of rare diseases. In addition, rise in awareness among the populace regarding the rare diseases, increase in research and development investment and drug development drive the market growth. As per our analysis, global orphan drug market is expected to surpass US$ 350 Billion by 2028. The report on orphan drugs market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global orphan drugs market over the period of 2020 to 2028.

Contact:

Neeraj Chawla

Research Head

Kuick Research

neeraj@kuickresearch.com

+919810410366