Global Specialty Generics Market to grow with a CAGR of 9.70% through 2030F
Increasing healthcare
infrastructure and a supportive regulatory environment are the major drivers
for the Global Specialty Generics Market in the forecast period 2026-2030
According
to TechSci Research report, “Specialty Generics Market - Global Industry Size, Share,
Trends, Competition, Opportunity and Forecast, 2020-2030F”, Global Specialty
Generics Market was valued at USD 55.60 billion in 2024 and is anticipated to
witness an impressive growth in the forecast period with a CAGR of 9.70%
through 2030. This can be due to collaborations and partnerships among
leading companies with a diverse approach to merge the expertise of individual
companies and to strengthen their position in the market. The emergence of
biologics and biosimilars has played a significant role in driving the demand
for the global specialty generics market. Biologics, including monoclonal
antibodies, vaccines, and therapeutic proteins, are highly effective but often
high-cost treatments for various medical conditions. Biosimilars, which are
similar but not identical to reference biologics, offer more affordable
alternatives, contributing to the growth of the specialty generics market. Biologics
are often among the most expensive drugs in healthcare. Biosimilars, as
specialty generics of biologics, typically offer significant cost savings,
making these life-saving treatments more accessible to patients and healthcare
systems. The entry of biosimilars into the market introduces competition,
which can lead to price reductions for both the biosimilar and the reference
biologic. This competition benefits patients by lowering treatment costs.
Biosimilars expand treatment options for patients, giving them access to
effective therapies that may have been previously unaffordable. This is
particularly important in the treatment of chronic and complex diseases. Over
time, healthcare providers and patients have become more accepting of
biosimilars due to the growing body of evidence demonstrating their safety and
efficacy. This increased acceptance drives demand. Pharmaceutical companies are
launching biosimilars in various regions and emerging markets, further
increasing their accessibility to a global patient population.
Once a medicine loses its patent protection, it becomes a specialty generic. These medications are used to treat a variety of chronic or complicated medical illnesses, such as autoimmune disorders, epilepsy, HIV, hepatitis, multiple sclerosis, rheumatoid arthritis, and cancer. Since they don't need high-priced research and marketing expenses, specialty generics are more affordable than their branded counterparts. Due to their sophisticated production needs, greater capital expenditures, and generally lower quantities as a result of a smaller patient population, specialist generics have a more competitive market than regular generics.
Market access and reimbursement are significant challenges in the global specialty generics market segmentation. Specialty generics, including biosimilars and complex small-molecule drugs, face specific hurdles related to pricing, reimbursement policies, and market entry. Specialty generics aim to offer cost-effective alternatives to expensive brand-name specialty drugs. However, pricing them competitively while ensuring a sustainable business model can be challenging. Developers of specialty generics must provide robust evidence of cost savings compared to the reference specialty drugs. Convincing payers and healthcare providers of the economic benefits can be complex. Specialty generics must navigate diverse regulatory pathways in different countries. Each regulatory agency may have specific requirements for approval, making it challenging to achieve global market access. Establishing interchangeability with reference drugs and demonstrating therapeutic equivalence can be demanding. Achieving regulatory approval for substitution policies may also vary by region.
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Global
Specialty Generics Market segmentation is based on route of
administration, indication, distribution channel, and region.
Based
on Route of Administration, the Global Specialty Generics Market largest share was held by injectables segment and is predicted to continue expanding over the coming years. Many specialty medications, particularly those used in critical or acute care settings, are administered through injections. These drugs include treatments for cancer, autoimmune diseases, infectious diseases, and certain rare conditions. Injectable medications are preferred when rapid onset of action or precise dosing is required. Some specialty generics require complex formulations or precise delivery mechanisms that are best achieved through injectables. These formulations may involve biologics, complex proteins, or highly potent drugs. Patents on several blockbuster injectable drugs, including biologics, have expired, or were set to expire. This created opportunities for the development and marketing of injectable specialty generics, such as biosimilars and complex generics. Over time, healthcare providers and patients have become more accepting of biosimilars and other injectable specialty generics due to the demonstrated safety and efficacy of these products. This has contributed to their market growth.
Based
on region, Asia-pacific region to witness fastest growth in the
Global Specialty Generics Market. The Asia-Pacific region is
home to a significant and rapidly aging population. As people age, the
prevalence of chronic and complex diseases increases, driving the demand for
specialty medications, including specialty generics, to manage these conditions
effectively. Many countries in the APAC region have been increasing their healthcare
spending to improve healthcare infrastructure and access to advanced
treatments. This has led to greater investments in specialty drugs and
specialty generics. The APAC region has been a hub for the development and
adoption of biosimilars. Regulatory agencies in countries like India and South
Korea have established clear pathways for biosimilar approvals. Biosimilars are
an integral part of the specialty generics market. Healthcare providers,
governments, and patients in the APAC region have become more accepted of
biosimilars due to their cost-effectiveness and demonstrated safety and
efficacy. This has accelerated market growth.
Some of the major companies operating in the Global
Specialty Generics Market include:
·
Teva Pharmaceuticals Industries Ltd
·
Viatris Inc.
·
Novartis AG
·
Hikma Pharmaceuticals PLC
·
Bausch Health Companies Inc.
·
Dr. Reddy’s Laboratories Ltd.
·
Endo Pharmaceuticals Inc.
·
Apotex Corp.
·
Sun Pharmaceutical Industries Ltd
·
STADA Arzneimittel AG
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“North
America is expected to drive substantial demand for specialty generics. This
growth is fueled by an increasingly competitive market landscape and the strong
presence of well-established pharmaceutical companies dedicated to improving
healthcare accessibility. These companies focus on expanding their specialty
generics portfolio, ensuring affordability and effectiveness for patients.
Their commitment to innovation and addressing unmet medical needs is
anticipated to significantly propel the global specialty generics market during
the forecast period. Also, rising healthcare expenditures, regulatory support
for generics, and growing awareness among healthcare providers and patients
will further contribute to market expansion" said Mr. Karan Chechi,
Research Director of TechSci Research, a research-based Global management
consulting firm.
"Specialty Generics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Route of Administration (Injectable, Oral, others), By Indication (Oncology, Autoimmune Diseases, Infectious Diseases, others), By Distribution Channel (Retail Pharmacies, Specialty Pharmacies, Hospital Pharmacies), By Region & Competition, 2020-2030F", evaluated the future growth potential of Global
Specialty Generics Market and provides statistics & information on market
size, structure, and future market growth. The report intends to provide
innovative market intelligence and help decision makers take sound investment
decisions. Besides, the report also identifies and analyzes the emerging trends
along with essential drivers, challenges, and opportunities in Global Specialty
Generics Market.
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