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GSK's Specialty Medicines Drive Growth Amid Looming HIV Patent Cliff
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Key Takeaways
GSK's Specialty Medicines sales rose 14% at CER in the first half of 2026, led by all therapy areas.
GSK expects more than 20 phase III starts in 2026, more than twice the 10 originally planned.
Dolutegravir patents may expire in 2028-2029, raising generic competition risks for key HIV drugs.
GSK plc’s (GSK - Free Report) Specialty Medicines business has become the company’s most important growth engine. The segment includes HIV, Respiratory, Immunology & Inflammation (RI&I) and Oncology, and its performance has been substantially stronger than GSK’s other businesses like Vaccines and General Medicines. Specialty Medicines, which now accounts for more than 40% of GSK’s sales, is expected to be more than 50% of its total revenues by 2031.
New and Established Drugs Drive Specialty Medicines Growth
GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas: HIV, RI&I as well as Oncology. Sales of the Specialty Medicines unit rose 14% at CER in the first half of 2026, driven by double-digit growth in all therapy areas — HIV, RI&I and Oncology.
In the segment, while products like Nucala, Dovato and Benlysta are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth.
GSK’s long-acting injectable medicines (Cabenuva, Apretude) are seeing strong demand trends. Around 25-30% of GSK’s total HIV sales come from new long-acting injectables for treatment and prevention.
GSK’s recent launches and approvals are also broadening its growth base, with Blenrep, Exdensur, Ojjaara, Apretude and Penmenvy among the key newer products. In 2026, approvals for Jideytro, Utebzi and Lynavoy added further growth opportunities.
In 2026, the company expects sales in the Specialty Medicines segment to rise in the low double-digit percentage at CER.
GSK Accelerates R&D to Build a Stronger Late-Stage Pipeline
GSK is increasing R&D investment in promising new long-acting and specialty medicines in HIV, RI&I and Oncology. The company claims it has more than doubled the number of phase II and phase III assets with blockbuster potential since 2022.
The company is significantly increasing the number of phase III starts in 2026. It now expects more than 20 phase III starts in 2026, more than twice the 10 originally contemplated. Oncology, respiratory and hepatology account for much of the incremental investment.
GSK has 19 assets in late-stage development or under regulatory review. Bepirovirsen for chronic hepatitis B and neladalkib, an ALK inhibitor for non-small cell lung cancer, are under review in the United States, with FDA decisions expected later this year. Key candidates in late-stage development are velzatinib, risvutatug rezetecan and mocertatug rezetecan for various cancer indications and efimosfermin alfa for metabolic dysfunction-associated steatohepatitis or MASH.
GSK is also working on expanding the label of marketed products like Exdensur, Jemperli and Zejula into additional indications or earlier lines of treatment. It is also developing innovative ultra-long-acting HIV regimens for treatment and prevention, which can extend the dosing intervals of the injections. GSK expects to launch twice-yearly long-acting injectables for treatment and PrEP between 2028 and 2030.
GSK Faces HIV Patent Cliff as Dolutegravir Exclusivity Nears
GSK is facing a major patent-related challenge in HIV later this decade. Though HIV is the largest part of Specialty Medicines, GSK faces the upcoming loss of exclusivity for dolutegravir, the backbone of several of GSK’s leading HIV medicines, including Tivicay, Triumeq and Dovato. Patents protecting dolutegravir are expected to begin expiring in major markets around 2028-2029, opening the door for generic competition. GSK’s dolutegravir-based products generated £2.74 billion in sales in the first half of 2026.
GSK is increasingly relying on its long-acting HIV franchise and next-generation pipeline in oncology, immunology and respiratory medicine to offset the eventual decline of older dolutegravir-based products.
Competition for GSK’s Specialty Medicines
In the Specialty Medicines segment, most of GSK’s products are up against significant competition from small as well as large pharmaceutical companies like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) , Sanofi (SNY - Free Report) , Gilead, Pfizer, J&J and Novartis, among others.
Nucala faces increasing competition from biologics such as AstraZeneca’s Fasenra and Sanofi’s Dupixent. In HIV, GSK’s medicines face competition from Gilead and MRK’s drugs. AstraZeneca, Pfizer, Merck and Lilly are GSK’s key competitors in the oncology space.
GSK’s Price Performance, Valuation and Estimates
GSK stock has declined 0.8% so far this year against an appreciation of 10.7% for the industry.
Image Source: Zacks Investment Research
GSK stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company’s shares currently trade at 9.75 on a forward 12-month basis, lower than 18.07 for the industry. The stock also trades above its 5-year mean of 9.91.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for earnings has declined from $4.84 to $4.81 per share for 2026, while that for 2027 has risen from $5.03 to $5.04 per share over the past 60 days.
View the Zacks #1 Rank List
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GSK's Specialty Medicines Drive Growth Amid Looming HIV Patent Cliff
Key Takeaways
GSK plc’s (GSK - Free Report) Specialty Medicines business has become the company’s most important growth engine. The segment includes HIV, Respiratory, Immunology & Inflammation (RI&I) and Oncology, and its performance has been substantially stronger than GSK’s other businesses like Vaccines and General Medicines. Specialty Medicines, which now accounts for more than 40% of GSK’s sales, is expected to be more than 50% of its total revenues by 2031.
New and Established Drugs Drive Specialty Medicines Growth
GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas: HIV, RI&I as well as Oncology. Sales of the Specialty Medicines unit rose 14% at CER in the first half of 2026, driven by double-digit growth in all therapy areas — HIV, RI&I and Oncology.
In the segment, while products like Nucala, Dovato and Benlysta are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth.
GSK’s long-acting injectable medicines (Cabenuva, Apretude) are seeing strong demand trends. Around 25-30% of GSK’s total HIV sales come from new long-acting injectables for treatment and prevention.
GSK’s recent launches and approvals are also broadening its growth base, with Blenrep, Exdensur, Ojjaara, Apretude and Penmenvy among the key newer products. In 2026, approvals for Jideytro, Utebzi and Lynavoy added further growth opportunities.
In 2026, the company expects sales in the Specialty Medicines segment to rise in the low double-digit percentage at CER.
GSK Accelerates R&D to Build a Stronger Late-Stage Pipeline
GSK is increasing R&D investment in promising new long-acting and specialty medicines in HIV, RI&I and Oncology. The company claims it has more than doubled the number of phase II and phase III assets with blockbuster potential since 2022.
The company is significantly increasing the number of phase III starts in 2026. It now expects more than 20 phase III starts in 2026, more than twice the 10 originally contemplated. Oncology, respiratory and hepatology account for much of the incremental investment.
GSK has 19 assets in late-stage development or under regulatory review. Bepirovirsen for chronic hepatitis B and neladalkib, an ALK inhibitor for non-small cell lung cancer, are under review in the United States, with FDA decisions expected later this year. Key candidates in late-stage development are velzatinib, risvutatug rezetecan and mocertatug rezetecan for various cancer indications and efimosfermin alfa for metabolic dysfunction-associated steatohepatitis or MASH.
GSK is also working on expanding the label of marketed products like Exdensur, Jemperli and Zejula into additional indications or earlier lines of treatment. It is also developing innovative ultra-long-acting HIV regimens for treatment and prevention, which can extend the dosing intervals of the injections. GSK expects to launch twice-yearly long-acting injectables for treatment and PrEP between 2028 and 2030.
GSK Faces HIV Patent Cliff as Dolutegravir Exclusivity Nears
GSK is facing a major patent-related challenge in HIV later this decade. Though HIV is the largest part of Specialty Medicines, GSK faces the upcoming loss of exclusivity for dolutegravir, the backbone of several of GSK’s leading HIV medicines, including Tivicay, Triumeq and Dovato. Patents protecting dolutegravir are expected to begin expiring in major markets around 2028-2029, opening the door for generic competition. GSK’s dolutegravir-based products generated £2.74 billion in sales in the first half of 2026.
GSK is increasingly relying on its long-acting HIV franchise and next-generation pipeline in oncology, immunology and respiratory medicine to offset the eventual decline of older dolutegravir-based products.
Competition for GSK’s Specialty Medicines
In the Specialty Medicines segment, most of GSK’s products are up against significant competition from small as well as large pharmaceutical companies like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) , Sanofi (SNY - Free Report) , Gilead, Pfizer, J&J and Novartis, among others.
Nucala faces increasing competition from biologics such as AstraZeneca’s Fasenra and Sanofi’s Dupixent. In HIV, GSK’s medicines face competition from Gilead and MRK’s drugs. AstraZeneca, Pfizer, Merck and Lilly are GSK’s key competitors in the oncology space.
GSK’s Price Performance, Valuation and Estimates
GSK stock has declined 0.8% so far this year against an appreciation of 10.7% for the industry.
GSK stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company’s shares currently trade at 9.75 on a forward 12-month basis, lower than 18.07 for the industry. The stock also trades above its 5-year mean of 9.91.
The Zacks Consensus Estimate for earnings has declined from $4.84 to $4.81 per share for 2026, while that for 2027 has risen from $5.03 to $5.04 per share over the past 60 days.
GSK has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.